Dataset Mix for Pre-Training SLMs
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DRAXIMAGE® M A A
Kit for the Preparation of
Technetium Tc 99m
Albumin Aggregated Injection
DIAGNOSTIC - For Intravenous Use
DESCRIPTION
The kit consists of reaction vials which contain the sterile, nonpyrogenic, non-radioactive
ingredients necessary to produce Technetium Tc 99m Albumin Aggregated Injection for
diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5.0 mg of Albumin
Human, 0.06 mg (minimum) stannous chloride (maximum stannous and stannic chloride
0.11 mg) and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an
atmosphere of nitrogen. Sodium hydroxide or hydrochloric acid has been used for pH
adjustment. No bacteriostatic preservative is present.
The Albumin Human was non-reactive when tested for Hepatitis-B Surface Antigen
(HBsAg), antibodies to Human immunodeficiency Virus (HIV-1/HIV-2), antibody to
Hepatitis C virus (anti-HCV) and Antigen to Human Immunodeficiency Virus (HIV-1).
The aggregated particles are formed by denaturation of Albumin Human in a heating and
aggregation process. Each vial contains 4 to 8 million particles. By light microscopy,
more than 90% of the particles are between 10 and 70 micrometers, while the typical
average size is 20 to 40 micrometers; none is greater than 150 micrometers.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is in its final
dosage form when sterile isotonic sodium pertechnetate solution is added to each vial. No
less than 90% of the pertechnetate Tc 99m added to a reaction vial is bound to aggregate
at preparation time and remains bound throughout the 6 hour lifetime of the preparation.
PHYSICAL CHARACTERISTICS
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1
The principal photon that is useful for detection and imaging studies is listed in Table 1.
Table 1. Principal Radiation Emission Data
Radiation
Mean %/Disintegration
Mean Energy (keV)
Gamma-2
89.07
140.5
1 Kocher, David C.; “Radioactive Decay Data Tables’’, DOE/TIC-11026, 108, (1981)
® Registered Trademark of DRAXIS Specialty Pharmaceuticals Inc.
EXTERNAL RADIATION
The specific gamma ray constant for Tc 99m is 0.78 R/mCi-hr at 1 cm.
The first half value layer is 0.017 cm of lead. A range of values for the relative
attenuation of the radiation resulting from the interposition of various thicknesses of lead
is shown in Table 2. For example, the use of 0.25 cm thickness of lead will attenuate the
radiation emitted by a factor of about 1000.
Table 2. Radiation Attenuation by Lead (Pb) Shielding
Shield Thickness
Coefficient of
(Pb) cm
Attenuation
0.017
0.5
0.08
10-1
0.16
10-2
0.25
10-3
0.33
10-4
To correct for physical decay of this radionuclide, the fractions hat remain at selected
intervals after the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart: Tc 99m half-life 6.02 hours
Hours
Fraction
Hours
Fraction
0*
Remaining
1.000
5
Remaining
0.562
1
0.891
6
0.501
2
0.794
8
0.398
3
0.708
10
0.316
4
0.631
12
0.251
*Calibration Time
CLINICAL PHARMACOLOGY
Immediately following intravenous injection, more than 80% of the albumin aggregated
is trapped in the pulmonary alveolar capillary bed. The imaging procedure can thus be
started as soon as the injection is complete. Assuming that a sufficient number of
radioactive particles has been used, the distribution of radioactive aggregated particles in
the normally perfused lung is uniform throughout the vascular bed, and will produce a
uniform image. Areas of reduced perfusion will be revealed by a corresponding
decreased accumulation of the radioactive particles, and are imaged as areas of reduced
photon density.
Organ selectivity is a direct result of particle size. Below 1-10 micrometers, the material
is taken up by the reticuloendothelial system. Above 10 micrometers, the aggregates
become lodged in the lung by a purely mechanical process. Distribution of particles in
the lungs is a function of regional pulmonary blood flow.
The albumin aggregated is sufficiently fragile for the capillary micro-occlusion to be
temporary. Erosion and fragmentation reduce the particle size, allowing passage of the
aggregates through the pulmonary alveolar capillary bed. The fragments are then
accumulated by the reticuloendothelial system.
Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection.
Elimination of the technetium Tc 99m aggregated albumin from the lungs occurs with a
half-life of about 2 to 3 hours. Cumulative urinary excretion studies show an average of
20% elimination of the injected technetium Tc 99m dose 24 hours post-administration.
Following administration of technetium Tc 99m albumin aggregated by intraperitoneal
injection, the radiopharmaceutical mixes with the peritoneal fluid. Clearance from the
peritoneal cavity varies from insignificant, which may occur with complete shunt
blockage, to very rapid clearance with subsequent transfer into the systemic circulation
when the shunt is patent.
Serial images should be obtained of both the shunt and lung (target organ). However, an
adequate evaluation of the difference between total blockage of the shunt and partial
blockage may not be feasible in all cases.
INDICATIONS AND USAGE
Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may
be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric
patients.
Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging
agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.
CONTRAINDICATIONS
Technetium Tc 99m Albumin Aggregated Injection should not be administered to
patients with severe pulmonary hypertension.
The use of Technetium Tc 99m Albumin Aggregated Injection is contraindicated in
persons with a history of hypersensitivity reactions to products containing human serum
albumin.
WARNINGS
Although adverse reactions specifically attributable to Technetium Tc 99m Albumin
Aggregated Injection have not been noted, the literature contains reports of deaths
occurring after the administration of albumin aggregated to patients with pre-existing
severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to
preparations of technetium Tc 99m albumin aggregated have been reported.
PRECAUTIONS
General
The contents of the kit before preparation are not radioactive. However, after the sodium
pertechnetate Tc 99m is added, adequate shielding of the final preparation must be
maintained.
In patients with right to left heart shunts, additional risk may exist due to the rapid entry
of albumin aggregated into the systemic circulation. The safety of this agent in such
patients has not been established. Hypersensitivity reactions are possible whenever
protein-containing materials such as pertechnetate labeled albumin aggregated are used in
man. Epinephrine, antihistamines, and cortico-steroids should be available for immediate
use.
The intravenous administration of any particulate materials such as albumin aggregated
imposes a temporary small mechanical impediment to blood flow. While this effect is
probably physiologically insignificant in most patients, the administration of albumin
aggregated is possibly hazardous in acute cor pulmonale and other states of severely
impaired pulmonary blood flow.
The components of the kit are sterile and non-pyrogenic. It is essential to follow
directions carefully and to adhere to strict aseptic procedures during preparation.
Contents of the vials are intended only for use in the preparation of Technetium Tc 99m
Albumin Aggregated Injection and are NOT to be administered directly to the patient.
The technetium Tc 99m labeling reactions involved depend on maintaining the stannous
ion in the reduced state. Hence, sodium pertechnetate Tc 99m containing oxidants should
not be employed.
The preparation contains no bacteriostatic preservative. Technetium Tc 99m Albumin
Aggregated Injection should be stored at 2-8ºC (36-46ºF) and discarded 6 hours after
reconstitution.
Technetium Tc 99m Albumin Aggregated Injection is physically unstable and
consequently the particles settle with time. Failure to agitate the vial adequately before
use may result in nonuniform distribution of radioactive particles.
If blood is drawn into the syringe, unnecessary delay prior to injection may result in clot
formation in situ.
Do not use if clumping of the contents is observed.
Technetium Tc 99m Albumin Aggregated Injection, as well as other radioactive drugs,
must be handled with care. Once sodium pertechnetate Tc 99m is added to the vial,
appropriate safety measures must be used to minimize radiation exposure to clinical
personnel. Care must also be taken to minimize the radiation exposure to patients in a
manner consistent with proper patient management.
Radiopharmaceuticals should be used only by physicians who are qualified by training
and experience in the safe use and handling of radionuclides and whose experience and
training have been approved by the appropriate government agency authorized to license
the use of radionuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term animal studies have been performed to evaluate carcinogenic potential or
whether Technetium Tc 99m Albumin Aggregated Injection affects fertility in males or
females.
Pregnancy Category C
Animal reproduction and teratogenicity studies have not been conducted with
Technetium Tc 99m Albumin Aggregated Injection. It is also not known whether
Technetium Tc 99m Albumin Aggregated Injection can cause fetal harm when
administered to a pregnant woman or can affect reproductive capacity. There have been
no studies in pregnant women. Technetium Tc 99m Albumin Aggregated Injection
should be given to a pregnant woman only if clearly needed.
Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a
woman of childbearing capability, should be performed during the first few
(approximately 10) days following the onset of menses.
Nursing Mothers
Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula
feedings should be substituted for breast feedings.
Pediatric Use
The lowest possible number of particles should be used in right-to-left shunting, in
neonates, and in severe pulmonary disease.
ADVERSE REACTIONS
The literature contains reports of deaths occurring after the administration of albumin
aggregated to patients with pre-existing severe pulmonary hypertension. Instances of
hemodynamic or idiosyncratic reactions to preparations of technetium Tc 99m albumin
aggregated have been reported (see Warnings).
DOSAGE AND ADMINISTRATION
The recommended intravenous dose range for the average (70 kg) ADULT patient for
lung imaging is 37 to 148 megabecquerels (1-4 millicuries) of Technetium Tc 99m
Albumin Aggregated Injection after reconstitution with oxidant-free Sodium
Pertechnetate Tc 99m Injection.
The suggested intraperitoneal dosage range used in the average patient (70 kg) for
peritoneovenous (LeVeen) shunt patency evaluation is 37 to 111 megabecquerels (1 to 3
millicuries). Adequate measures should be taken to assure uniform mixing with
peritoneal fluid. Serial images of both the shunt and target organ should be obtained and
correlated with other clinical findings. Alternatively, the drug may be administered by
percutaneous transtubal injection. The suggested percutaneous transtubal (efferent limb)
dosage range for the average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0
millicurie) in a volume not to exceed 0.5 mL.
The recommended number of particles per single injection is 200,000-700,000 with the
suggested number being approximately 350,000. Depending on the activity added and
volume of the final reconstituted product, the volume of the dose may vary from 0.2 to
1.4 mL.
The number of particles available per dose of Technetium Tc 99m Albumin Aggregated
Injection will vary depending on the physical decay of the technetium Tc 99m that has
occurred. The number of particles in any dose and volume to be administered may be
calculated as follows:
Assume the average number of particles per vial = 6.0 x 106.
If:
VTc = volume of solution added to reaction vial
D = desired dose to be administered in MBq (mCi)
C = concentration at calibration time of sodium pertechnetate solution to be added to
the reaction vial in MBq/mL (mCi/mL)
Va = volume to be administered in mL
P
= number of particles in dose to be administered
Fr = fraction of technetium Tc 99m remaining after the time of calibration (see Table
3)
Then:
Va =
D
and
P = Va x 6.0 x 106
C x Fr
VTc
In PEDIATRIC patients, the suggested intravenous dose to be employed for perfusion
lung imaging is in the range of 0.925 to 1.85 MBq per kilogram (25 to 50 μCi/kg) of
body weight; a usual dose is 1.11 MBq per kilogram (30 μCi/kg), except in newborns, in
whom the administered dose should be 7.4 to 18.5 MBq (200 to 500 μCi). Not less than
the minimum dose of 7.4 MBq (200 μCi) should be employed for this procedure. The
number of particles will vary with age and weight of the pediatric patient as indicated in
Table 5.
Parenteral drug products should be visually inspected for particulate matter and
discoloration prior to administration whenever solution and container permit.
The patient dose should be measured by a suitable radioactivity calibration system
immediately prior to administration. Mix the contents of the vial by gentle inversion just
prior to with drawing a patient dose.
Mix the contents of the syringe just before injection. If blood is drawn into the syringe,
any unnecessary delay prior to injection may lead to clot formation. For optimum results
and because of rapid lung clearance of the radiopharmaceutical, it is suggested that the
patient be positioned under the imaging apparatus before administration. Slow injection
is recommended. Lung imaging may begin immediately after intravenous injection of the
radiopharmaceutical. Due to high kidney uptake, imaging later than one-half hour after
administration will yield poor results.
RADIATION DOSIMETRY
The estimated absorbed radiation doses2 to an average ADULT patient (70 kg) from an
intravenous injection of 148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated
Injection are shown in Table 4.
2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and
Organs, MIRD Pamphlet No. 11 (1975).
Table 4. Absorbed Radiation Doses
Organs
mGy/148 MBq
rads/4 mCi
Total body
0.60
0.060
Lungs
8.8
0.88
Liver
0.72
0.072
Spleen
0.68
0.068
Kidneys
0.44
0.044
Bladder Wall
2.0 hr. void
1.2
0.12
4.8 hr. void
2.2
0.22
Testes
2.0 hr. void
0.24
0.024
4.8 hr. void
0.26
0.026
Ovaries
2.0 hr. void
0.30
0.030
4.8 hr. void
0.34
0.034
In PEDIATRIC patients, the radiation absorbed doses using the maximum recommended
dose for lung imaging are based on 1.85 MBq (50 μCi) per kilogram of body weight
[except in the newborn where the maximum recommended dose of 18.5 MBq (500 μCi)
is used] and are shown in Table 5, which lists the maximum dose for pediatric patients
from newborn to adults. Note the recommendations regarding number of particles to be
administered.
Table 6 represents the absorbed radiation dose resulting from the intraperitoneal
administration of 111 megabecquerels (3 millicuries) of technetium Tc 99m albumin
aggregated.
Table 5. Pediatric Radiation Dose from Tc 99m MAA for Lung Imaging*
Age
Newborn
1 year
5 years
10 years
15 years
Weight (kg)
3.5
12.1
20.3
33.5
55.0
Max.
MBq
mCi
MBq
mCi
MBq
mCi
MBq
mCi
MBq
mCi
Recommended
Dose in
Megabecquerels
and Millicuries
18.5
0.5
22.2
0.6
37
1.0
62.9
1.7
103.6
2.8
Range of Particles
Administered
10-50,000
50-150,000
200-300,000
200-300,000
200-700,000
Absorbed
Radiation Dose in
milliGreys and
Rads for the
Maximum Dose
mGy
Rads
mGy
Rads
mGy
Rads
mGy
Rads
mGy
Rads
ORGANS
Total Body
0.60
0.06
0.30
0.03
0.31
0.031
0.48
0.048
0.41
0.041
Lungs
19.00
1.9
6.60
0.66
5.80
0.58
8.70
0.87
7.70
0.77
Liver
1.40
0.14
0.60
0.06
0.62
0.062
1.80
0.18
1.20
0.12
Bladder Wall
2.10
0.21(1)
1.50
0.15(1)
3.10
0.31(2)
3.90
0.39(2)
4.10
0.41
Ovaries
0.38
0.038
0.20
0.020
0.19
0.019
0.44
0.044
0.41
0.041
Testes
0.31
0.031
0.13
0.013
0.19
0.019
0.20
0.020
0.36
0.036
*Assumptions:
(1) 2.0 hour voiding interval
(2) 4.8 hour voiding interval
1. Used biologic data from Kaul et al., Berlin, 1973.
2. For the newborn, 1-year old, and 5-year old, the “S” values calculated from the preliminary phantoms of
ORNL were used. The 10-year old, 15-year old and adult “S” values were taken from Henrichs et al.,
Berlin, 1980.
Table 6. Absorbed Radiation Doses
Shunt
Shunt
Patency
Patency
Organs
(Open)
(Closed)
mGy
Rads
mGy
Rads
Lung
6.9
0.69
1.68
0.168
Ovaries
0.18
0.018
1.68
0.168
& Testes
to 0.30
to 0.030
Organs in the
Peritoneal Cavity
-
-
1.68
0.168
Total Body
0.36
0.036
0.57
0.057
Assumptions:
Calculations for the absorbed radiation dose are based upon an effective half-time of 3 hours for the open
shunt and 6.02 hours for the closed shunt and an even distribution of the radiopharmaceutical in the
peritoneal cavity with no biological clearance.
HOW SUPPLIED
DRAXIMAGE® MAA
Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection
Each kit contains 30 reaction vials, each vial containing in lyophilized form, sterile and
non-pyrogenic:
Albumin Aggregated
2.5 mg
Albumin Human
5.0 mg
Stannous Chloride (minimum)
0.06 mg
(Maximum stannous and stannic chloride 0.11 mg)
Sodium Chloride
1.2 mg
HCl or NaOH has been used for pH adjustment. The vials are sealed under an atmosphere
of nitrogen.
Thirty labels with radiation warning symbols and a package insert are supplied in each
carton.
STORAGE
Store the unreconstituted reaction vials at (2 to 25ºC (36-77ºF). After labeling with
Technetium Tc 99m, store the solution at 2 to 8ºC (36-46ºF) in a suitable lead shield and
discard after 6 hours.
DIRECTIONS FOR PREPARATION
Note: Use aseptic procedures throughout and take precautions to minimize exposure by
use of suitable shielding. Waterproof gloves should be worn during the preparation
procedure.
Before reconstituting a vial, it should be inspected for cracks and/or a melted plug or any
other indication that the integrity of the vacuum seal has been lost.
To prepare Technetium Tc 99m Albumin Aggregated Injection:
1. Remove the protective disc from a reaction vial and swab the rubber septum with
either an alcohol swab or a suitable bacteriostatic agent to disinfect the surface.
2. Place the vial in a suitable lead vial shield which has a fitted cap. Obtain 2-8 mL of
a sterile pyrogen-free Sodium Pertechnetate Tc 99m Injection using a shielded
syringe. The recommended maximum amount of Tc 99m to be added to a reaction
vial is 3.7 GBq (100 mCi). Sodium pertechnetate Tc 99m solutions containing an
oxidizing agent are not suitable for use.
3. Using a shielded syringe, add the Sodium Pertechnetate Tc 99m Injection to the
reaction vial aseptically.
4. Place the lead cap on the vial shield and mix the contents of the shielded vial by
repeated gentle inversion until all the material is suspended. Avoid formation of
foam. Using proper shielding, the vial should be visually inspected to ensure that
the suspension is free of foreign matter before proceeding. Do not administer if
foreign particulates are found in the preparation. To ensure maximum tagging,
allow the preparation to stand for 15 minutes after mixing.
5. Assay the product in a suitable calibrator, record the radioassay information on the
label with radiation warning symbol, and attach it to the vial shield.
6. Withdrawals for administration must be made aseptically using a sterile needle
(18-21 gauge) and syringe. Since the vials contain nitrogen to prevent oxidation of
the complex, the vials should not be vented. If repeated withdrawals are made from
the vial, replacement of the contents with air should be minimized.
7. The finished preparation should be refrigerated at 2 to 8ºC (36-46ºF) when not in
use and discarded after 6 hours.
(The preparation contains no bacteriostatic
preservative.) The vial should also be retained during its life in the reaction vial
shield with cap in place.
Disposal
The residual materials may be discarded in the ordinary trash, provided the radioactivity
in the vials and syringes measures no more than background with an appropriate low-
range survey meter. All identifying labels should be destroyed before discarding.
This reagent kit is approved by the U.S. Nuclear Regulatory Commission for distribution
to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to
persons who have a similar authorization issued by an Agreement State, and, outside the
United States, to persons authorized by the appropriate authority.
DRAXIMAGE, a division of DRAXIS Specialty Pharmaceuticals Inc.
Kirkland, Québec, H9H 4J4 Canada
| custom-source | 2025-02-12T13:43:19.270381 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf', 'application_number': 17881, 'submission_type': 'SUPPL ', 'submission_number': 10} |
1,070 |
1
A2.0 NL 4550 AMP
1
INFORMATION FOR THE PATIENT
2
HUMULIN® R
3
REGULAR
4
INSULIN HUMAN INJECTION, USP
5
(rDNA ORIGIN)
6
100 Units per mL (U-100)
7
8
WARNINGS
9
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM
10
ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL
11
TO THE INSULIN PRODUCED BY YOUR BODY’S PANCREAS AND
12
BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.
13
ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY
14
UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH,
15
MANUFACTURER, TYPE (E.G., REGULAR, NPH, LENTE), SPECIES (BEEF,
16
PORK, BEEF-PORK, HUMAN), OR METHOD OF MANUFACTURE
17
(rDNA VERSUS ANIMAL-SOURCE INSULIN) MAY RESULT IN THE NEED
18
FOR A CHANGE IN DOSAGE.
19
SOME PATIENTS TAKING HUMULIN (HUMAN INSULIN, rDNA ORIGIN)
20
MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH
21
ANIMAL-SOURCE INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY
22
OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS
23
OR MONTHS.
24
DIABETES
25
Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This
26
hormone is necessary for the body’s correct use of food, especially sugar. Diabetes occurs when
27
the pancreas does not make enough insulin to meet your body’s needs.
28
To control your diabetes, your doctor has prescribed injections of insulin products to keep your
29
blood glucose at a near-normal level. You have been instructed to test your blood and/or your
30
urine regularly for glucose. Studies have shown that some chronic complications of diabetes
31
such as eye disease, kidney disease, and nerve disease can be significantly reduced if the blood
32
sugar is maintained as close to normal as possible. The American Diabetes Association
33
recommends that if your pre-meal glucose levels are consistently above 140 mg/dL or your
34
hemoglobin A1c (HbA1c) is more than 8%, consult your doctor. A change in your diabetes
35
therapy may be needed. If your blood tests consistently show below-normal glucose levels you
36
should also let your doctor know. Proper control of your diabetes requires close and constant
37
cooperation with your doctor. Despite diabetes, you can lead an active and healthy life if you eat
38
a balanced diet, exercise regularly, and take your insulin injections as prescribed.
39
Always keep an extra supply of insulin as well as a spare syringe and needle on hand. Always
40
wear diabetic identification so that appropriate treatment can be given if complications occur
41
away from home.
42
REGULAR HUMAN INSULIN
43
Description
44
Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia
45
coli bacteria that has been genetically altered by the addition of the gene for human insulin
46
production. Humulin R consists of zinc-insulin crystals dissolved in a clear fluid. Humulin R has
47
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
2
had nothing added to change the speed or length of its action. It takes effect rapidly and has a
48
relatively short duration of activity (4 to 12 hours) as compared with other insulins. The time
49
course of action of any insulin may vary considerably in different individuals or at different
50
times in the same individual. As with all insulin preparations, the duration of action of
51
Humulin R is dependent on dose, site of injection, blood supply, temperature, and physical
52
activity. Humulin R is a sterile solution and is for subcutaneous injection. It should not be used
53
intramuscularly. The concentration of Humulin R is 100 units/mL (U-100).
54
Identification
55
Human insulin by Eli Lilly and Company has the trademark Humulin and is available in
56
6 formulations — Regular (R), NPH (N), Lente (L), Ultralente (U), 50% Human Insulin
57
Isophane Suspension [NPH]/50% Human Insulin Injection [regular] (50/50), and 70% Human
58
Insulin Isophane Suspension [NPH]/30% Human Insulin Injection [regular] (70/30). Your doctor
59
has prescribed the type of insulin that he/she believes is best for you. DO NOT USE ANY
60
OTHER INSULIN EXCEPT ON HIS/HER ADVICE AND DIRECTION.
61
Always check the carton and the bottle label for the name and letter designation of the insulin
62
you receive from your pharmacy to make sure it is the same as that your doctor has prescribed.
63
Always examine the appearance of your bottle of insulin before withdrawing each dose.
64
Humulin R is a clear and colorless liquid with a water-like appearance and consistency. Do not
65
use if it appears cloudy, thickened, or slightly colored or if solid particles are visible. Always
66
check the appearance of your bottle of insulin before using, and if you note anything unusual in
67
the appearance of your insulin or notice your insulin requirements changing markedly, consult
68
your doctor.
69
Storage
70
Humulin R should be stored in a refrigerator (2º to 8º C [36º to 46º F]), but not in the freezer. If
71
refrigeration is not possible, the bottle of Humulin R that you are currently using can be kept
72
unrefrigerated as long as it is kept as cool as possible (below 30ºC [86º F]), and away from heat
73
and light. Do not use Humulin R if it has been frozen. Do not use a bottle of Humulin R after the
74
expiration date stamped on the label.
75
INJECTION PROCEDURES
76
Correct Syringe
77
Doses of insulin are measured in units. U-100 insulin contains 100 units/mL (1 mL=1 cc).
78
With Humulin R, it is important to use a syringe that is marked for U-100 insulin preparations.
79
Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for
80
you, such as a blood glucose level that is too low or too high.
81
Syringe Use
82
To help avoid contamination and possible infection, follow these instructions exactly.
83
Disposable syringes and needles should be used only once and then discarded. NEEDLES
84
AND SYRINGES MUST NOT BE SHARED.
85
Reusable syringes and needles must be sterilized before each injection. Follow the package
86
directions supplied with your syringe. Described below are 2 methods of sterilizing.
87
Boiling
88
1. Put syringe, plunger, and needle in strainer, place in saucepan, and cover with water. Boil
89
for 5 minutes.
90
2. Remove articles from water. When they have cooled, insert plunger into barrel, and fasten
91
needle to syringe with a slight twist.
92
3. Push plunger in and out several times until water is completely removed.
93
Isopropyl Alcohol
94
If the syringe, plunger, and needle cannot be boiled, as when you are traveling, they may be
95
sterilized by immersion for at least 5 minutes in Isopropyl Alcohol, 91%. Do not use bathing,
96
rubbing, or medicated alcohol for this sterilization. If the syringe is sterilized with alcohol, it
97
must be absolutely dry before use.
98
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For current labeling information, please visit https://www.fda.gov/drugsatfda
3
Preparing the Dose
99
1. Wash your hands.
100
2. Inspect the insulin. Humulin R should look clear and colorless. Do not use Humulin R if it
101
appears cloudy, thickened, or slightly colored or if solid particles are visible.
102
3. If using a new bottle, flip off the plastic protective cap, but do not remove the stopper.
103
When using a new bottle, wipe the top of the bottle with an alcohol swab.
104
4. If you are mixing insulins, refer to the instructions for mixing that follow.
105
5. Draw air into the syringe equal to your insulin dose. Put the needle through rubber top of
106
the insulin bottle and inject the air into the bottle.
107
6. Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in one hand.
108
7. Making sure the tip of the needle is in the insulin, withdraw the correct dose of insulin
109
into the syringe.
110
8. Before removing the needle from the bottle, check your syringe for air bubbles which
111
reduce the amount of insulin in it. If bubbles are present, hold the syringe straight up and
112
tap its side until the bubbles float to the top. Push them out with the plunger and withdraw
113
the correct dose.
114
9. Remove the needle from the bottle and lay the syringe down so that the needle does not
115
touch anything.
116
Mixing Humulin R with Longer-acting Human Insulins
117
1. Regular human insulin should be mixed with longer-acting human insulins only on the
118
advice of your doctor.
119
2. Draw air into your syringe equal to the amount of longer-acting insulin you are taking.
120
Insert the needle into the longer-acting insulin bottle and inject the air. Withdraw the
121
needle.
122
3. Now inject air into your regular human insulin bottle in the same manner, but do not
123
withdraw the needle.
124
4. Turn the bottle and syringe upside down.
125
5. Making sure the tip of the needle is in the insulin, withdraw the correct dose of regular
126
insulin into the syringe.
127
6. Before removing the needle from the bottle, check your syringe for air bubbles which
128
reduce the amount of insulin in it. If bubbles are present, hold the syringe straight up and
129
tap its side until the bubbles float to the top. Push them out with the plunger and withdraw
130
the correct dose.
131
7. Remove the needle from the bottle of regular insulin and insert it into the bottle of the
132
longer-acting insulin. Turn the bottle and syringe upside down. Hold the bottle and
133
syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the
134
insulin, withdraw your dose of longer-acting insulin.
135
8. Remove the needle and lay the syringe down so that the needle does not touch anything.
136
Follow your doctor’s instructions on whether to mix your insulins ahead of time or just before
137
giving your injection. It is important to be consistent in your method.
138
Syringes from different manufacturers may vary in the amount of space between the bottom
139
line and the needle. Because of this, do not change:
140
• the sequence of mixing, or
141
• the model and brand of syringe or needle that the doctor has prescribed.
142
Injection
143
Cleanse the skin with alcohol where the injection is to be made. Stabilize the skin by spreading
144
it or pinching up a large area. Insert the needle as instructed by your doctor. Push the plunger in
145
as far as it will go. Pull the needle out and apply gentle pressure over the injection site for
146
several seconds. Do not rub the area. To avoid tissue damage, give the next injection at a site at
147
least 1/2” from the previous site. Place the used needle in a puncture-resistant disposable
148
container and properly dispose of it as directed by your Health Care Professional.
149
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For current labeling information, please visit https://www.fda.gov/drugsatfda
4
DOSAGE
150
Your doctor has told you which insulin to use, how much, and when and how often to inject it.
151
Because each patient’s case of diabetes is different, this schedule has been individualized for
152
you.
153
Your usual insulin dose may be affected by changes in your food, activity, or work schedule.
154
Carefully follow your doctor’s instructions to allow for these changes. Other things that may
155
affect your insulin dose are:
156
Illness
157
Illness, especially with nausea and vomiting, may cause your insulin requirements to change.
158
Even if you are not eating, you will still require insulin. You and your doctor should establish a
159
sick day plan for you to use in case of illness. When you are sick, test your blood/urine
160
frequently and call your doctor as instructed.
161
Pregnancy
162
Good control of diabetes is especially important for you and your unborn baby. Pregnancy may
163
make managing your diabetes more difficult. If you are planning to have a baby, are pregnant, or
164
are nursing a baby, consult your doctor.
165
Medication
166
Insulin requirements may be increased if you are taking other drugs with hyperglycemic
167
activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin
168
requirements may be reduced in the presence of drugs with hypoglycemic activity, such as oral
169
hypoglycemics, salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants.
170
Always discuss any medications you are taking with your doctor.
171
Exercise
172
Exercise may lower your body’s need for insulin during and for some time after the activity.
173
Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the
174
area of injection site (for example, the leg should not be used for injection just prior to running).
175
Discuss with your doctor how you should adjust your regimen to accommodate exercise.
176
Travel
177
Persons traveling across more than 2 time zones should consult their doctor concerning
178
adjustments in their insulin schedule.
179
COMMON PROBLEMS OF DIABETES
180
Hypoglycemia (Insulin Reaction)
181
Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events
182
experienced by insulin users. It can be brought about by:
183
1. Taking too much insulin
184
2. Missing or delaying meals
185
3. Exercising or working more than usual
186
4. An infection or illness (especially with diarrhea or vomiting)
187
5. A change in the body’s need for insulin
188
6. Diseases of the adrenal, pituitary, or thyroid gland, or progression of kidney or liver
189
disease
190
7. Interactions with other drugs that lower blood glucose, such as oral hypoglycemics,
191
salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants
192
8. Consumption of alcoholic beverages
193
Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:
194
• sweating
• drowsiness
195
• dizziness
• sleep disturbances
196
• palpitation
• anxiety
197
• tremor
• blurred vision
198
• hunger
• slurred speech
199
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
5
• restlessness
• depressed mood
200
• tingling in the hands, feet, lips, or tongue
• irritability
201
• lightheadedness
• abnormal behavior
202
• inability to concentrate
• unsteady movement
203
• headache
• personality changes
204
Signs of severe hypoglycemia can include:
205
• disorientation
• seizures
206
• unconsciousness
• death
207
Therefore, it is important that assistance be obtained immediately.
208
Early warning symptoms of hypoglycemia may be different or less pronounced under certain
209
conditions, such as long duration of diabetes, diabetic nerve disease, medications such as
210
beta-blockers, change in insulin preparations, or intensified control (3 or more insulin injections
211
per day) of diabetes.
212
A few patients who have experienced hypoglycemic reactions after transfer from
213
animal-source insulin to human insulin have reported that the early warning symptoms of
214
hypoglycemia were less pronounced or different from those experienced with their
215
previous insulin.
216
Without recognition of early warning symptoms, you may not be able to take steps to avoid
217
more serious hypoglycemia. Be alert for all of the various types of symptoms that may indicate
218
hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should
219
monitor their blood glucose frequently, especially prior to activities such as driving. If the blood
220
glucose is below your normal fasting glucose, you should consider eating or drinking
221
sugar-containing foods to treat your hypoglycemia.
222
Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar.
223
Patients should always carry a quick source of sugar, such as candy mints or glucose tablets.
224
More severe hypoglycemia may require the assistance of another person. Patients who are unable
225
to take sugar orally or who are unconscious require an injection of glucagon or should be treated
226
with intravenous administration of glucose at a medical facility.
227
You should learn to recognize your own symptoms of hypoglycemia. If you are uncertain
228
about these symptoms, you should monitor your blood glucose frequently to help you learn to
229
recognize the symptoms that you experience with hypoglycemia.
230
If you have frequent episodes of hypoglycemia or experience difficulty in recognizing the
231
symptoms, you should consult your doctor to discuss possible changes in therapy, meal plans,
232
and/or exercise programs to help you avoid hypoglycemia.
233
Hyperglycemia and Diabetic Acidosis
234
Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin.
235
Hyperglycemia can be brought about by:
236
1. Omitting your insulin or taking less than the doctor has prescribed
237
2. Eating significantly more than your meal plan suggests
238
3. Developing a fever, infection, or other significant stressful situation
239
In patients with insulin-dependent diabetes, prolonged hyperglycemia can result in diabetic
240
acidosis. The first symptoms of diabetic acidosis usually come on gradually, over a period of
241
hours or days, and include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity odor
242
on the breath. With acidosis, urine tests show large amounts of glucose and acetone. Heavy
243
breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia
244
or diabetic acidosis can lead to nausea, vomiting, dehydration, loss of consciousness or death.
245
Therefore, it is important that you obtain medical assistance immediately.
246
Lipodystrophy
247
Rarely, administration of insulin subcutaneously can result in lipoatrophy (depression in the
248
skin) or lipohypertrophy (enlargement or thickening of tissue). If you notice either of these
249
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For current labeling information, please visit https://www.fda.gov/drugsatfda
6
conditions, consult your doctor. A change in your injection technique may help alleviate the
250
problem.
251
Allergy to Insulin
252
Local Allergy — Patients occasionally experience redness, swelling, and itching at the site of
253
injection of insulin. This condition, called local allergy, usually clears up in a few days to a few
254
weeks. In some instances, this condition may be related to factors other than insulin, such as
255
irritants in the skin cleansing agent or poor injection technique. If you have local reactions,
256
contact your doctor.
257
Systemic Allergy — Less common, but potentially more serious, is generalized allergy to
258
insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in
259
blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life
260
threatening. If you think you are having a generalized allergic reaction to insulin, notify a doctor
261
immediately.
262
ADDITIONAL INFORMATION
263
Additional information about diabetes may be obtained from your diabetes educator.
264
DIABETES FORECAST is a national magazine designed especially for patients with
265
diabetes and their families and is available by subscription from the American Diabetes
266
Association, National Service Center, 1660 Duke Street, Alexandria, Virginia 22314,
267
1-800-DIABETES (1-800-342-2383).
268
Another publication, DIABETES COUNTDOWN, is available from the Juvenile Diabetes
269
Foundation International (JDF), 120 Wall Street, 19th Floor, New York, New York 10005,
270
1-800-JDF-CURE (1-800-533-2873).
271
Additional information about Humulin can be obtained by calling 1-888-88-LILLY
272
(1-888-885-4559).
273
274
Literature issued XXX, 2003
275
Manufactured by Abbott Laboratories
276
North Chicago, IL 60064, USA
277
for Eli Lilly and Company
278
Indianapolis, IN 46285, USA
279
A2.0 NL 4550 AMP
PRINTED IN USA
280
Copyright 1997, 2003, Eli Lilly and Company. All rights reserved.
281
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
C-671
C-671
CARTON HAS
BEEN OPENED
IMPORTANT—SEE WARNINGS
ON ACCOMPANYING CIRCULAR
Warning:
Any change of Insulin
should be made cautiously
and only under medical
supervision. See enclosed
circular.
As with any drug, if you
are pregnant or nursing a
baby, seek professional
advice when using this
product.
Contains Metacresol 0.25%
added during manufacture
as a preservative.
Neutral
For information call
1-888-885-4559
Exp. Date/Control No.
NDC 0002-8215-01
10 mL HI-210
Keep in a cold place.
Avoid freezing.
U-100
U-100
®
®
NDC 0002-8215-01
10 mL HI-210
100 units per mL
U-100
100 units per mL
®
3
2
0002-8215-01
NL 3820 AMS
NL 3820 AMS
NL 3820 AMS
Manufactured by Abbott Laboratories
North Chicago, IL 60064, USA
for Eli Lilly and Company
Indianapolis, IN 46285, USA
AZ20
1 "
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Humulin R
10 mL HI-210
100 units per mL
®
U-100
Exp. Date/Control No.
NL 4050 AMX
NDC 0002-8215-01
Important: See enclosed insert.
Keep in a cold place. Avoid freezing.
Neutral
Manufactured by Abbott Laboratories
North Chicago, IL 60064, USA
for Eli Lilly and Company
Indianapolis, IN 46285, USA
1 "
This label may not be the latest approved by FDA.
beling information, please visit https://www.fda.go
| custom-source | 2025-02-12T13:43:19.319839 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 80} |
738 |
DRAXIMAGE® M A A
Kit for the Preparation of
Technetium Tc 99m
Albumin Aggregated Injection
DIAGNOSTIC - For Intravenous Use
DESCRIPTION
The kit consists of reaction vials which contain the sterile, non-pyrogenic, non
radioactive ingredients necessary to produce Technetium Tc 99m Albumin Aggregated
Injection for diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5.0 mg of albumin
human, 0.06 mg (minimum) stannous chloride (maximum stannous and stannic chloride
0.11 mg) and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an
atmosphere of nitrogen. Sodium hydroxide or hydrochloric acid has been used for pH
adjustment. No bacteriostatic preservative is present.
The albumin human was non-reactive when tested for Hepatitis B Surface Antigen
(HBsAg), antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2), antibody to
Hepatitis C Virus (anti-HCV) and Antigen to Human Immunodeficiency Virus (HIV-1).
The aggregated particles are formed by denaturation of albumin human in a heating and
aggregation process. Each vial contains 4 to 8 million particles. By light microscopy,
more than 90% of the particles are between 10 and 70 micrometers, while the typical
average size is 20 to 40 micrometers; none is greater than 150 micrometers.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is in its final
dosage form when sterile isotonic sodium pertechnetate solution is added to each vial. No
less than 90% of the pertechnetate Tc-99m added to a reaction vial is bound to aggregate
at preparation time and remains bound throughout the 6 hour lifetime of the preparation.
PHYSICAL CHARACTERISTICS
Technetium Tc-99m decays by isomeric transition with a physical half-life of 6.02
hours.1 The principal photon that is useful for detection and imaging studies is listed in
Table 1.
Table 1
Principal Radiation Emission Data
Radiation
Mean % per Disintegration
Mean Energy (keV)
Gamma-2
89.07
140.5
1 Kocher, David C.; “Radioactive Decay Data Tables’’, DOE/TIC-11026, 108, (1981)
® Registered Trademark of Jubilant DraxImage Inc.
Reference ID: 3019371
Reference ID: 3019533
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For current labeling information, please visit https://www.fda.gov/drugsatfda
EXTERNAL RADIATION
The specific gamma ray constant for technetium Tc-99m is 5.44 µC•kg-1•MBq-1•hr-1
(0.78 R/mCi-hr) at 1 cm.
The first half value layer is 0.017 cm of lead. A range of values for the relative
attenuation of the radiation resulting from the interposition of various thicknesses of lead
is shown in Table 2. For example, the use of 0.25 cm thickness of lead will attenuate the
radiation emitted by a factor of about 1000.
Table 2
Radiation Attenuation by Lead (Pb) Shielding
Shield Thickness
Coefficient of
(Pb) cm
Attenuation
0.017
0.08
0.16
0.25
0.33
0.5
10-1
10-2
10-3
10-4
To correct for physical decay of this radionuclide, the fractions that remain at selected
intervals after the time of calibration are shown in Table 3.
Table 3
Physical Decay Chart of Technetium Tc-99m
half-life: 6.02 hours
Hours
0*
1
2
3
4
Fraction
Remaining
1.000
0.891
0.794
0.708
0.631
Hours
5
6
8
10
12
Fraction
Remaining
0.562
0.501
0.398
0.316
0.251
*Calibration Time
CLINICAL PHARMACOLOGY
Immediately following intravenous injection, more than 80% of the albumin aggregated
is trapped in the pulmonary alveolar capillary bed. The imaging procedure can thus be
started as soon as the injection is complete. Assuming that a sufficient number of
radioactive particles has been used, the distribution of radioactive aggregated particles in
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
the normally perfused lung is uniform throughout the vascular bed, and will produce a
uniform image. Areas of reduced perfusion will be revealed by a corresponding
decreased accumulation of the radioactive particles, and are imaged as areas of reduced
photon density.
Organ selectivity is a direct result of particle size. Below 1 to 10 micrometers, the
material is taken up by the reticuloendothelial system. Above 10 micrometers, the
aggregates become lodged in the lung by a purely mechanical process. Distribution of
particles in the lungs is a function of regional pulmonary blood flow.
The albumin aggregated is sufficiently fragile for the capillary micro-occlusion to be
temporary. Erosion and fragmentation reduce the particle size, allowing passage of the
aggregates through the pulmonary alveolar capillary bed. The fragments are then
accumulated by the reticuloendothelial system.
Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection.
Elimination of the Technetium Tc 99m Aggregated Albumin from the lungs occurs with
a half-life of about 2 to 3 hours. Cumulative urinary excretion studies show an average
of 20% elimination of the injected technetium Tc 99m dose 24 hours post-administration.
Following administration of Technetium Tc 99m Albumin Aggregated by intraperitoneal
injection, the radiopharmaceutical mixes with the peritoneal fluid. Clearance from the
peritoneal cavity varies from insignificant, which may occur with complete shunt
blockage, to very rapid clearance with subsequent transfer into the systemic circulation
when the shunt is patent.
Serial images should be obtained of both the shunt and lung (target organ). However, an
adequate evaluation of the difference between total blockage of the shunt and partial
blockage may not be feasible in all cases.
INDICATIONS AND USAGE
Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may
be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric
patients.
Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging
agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.
CONTRAINDICATIONS
Technetium Tc 99m Albumin Aggregated Injection should not be administered to
patients with severe pulmonary hypertension.
Reference ID: 3019371
Reference ID: 3019533
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For current labeling information, please visit https://www.fda.gov/drugsatfda
The use of Technetium Tc 99m Albumin Aggregated Injection is contraindicated in
persons with a history of hypersensitivity reactions to products containing human serum
albumin.
WARNINGS
Although adverse reactions specifically attributable to Technetium Tc 99m Albumin
Aggregated Injection have not been noted, the literature contains reports of deaths
occurring after the administration of albumin aggregated to patients with pre-existing
severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to
preparations of Technetium Tc 99m Albumin Aggregated have been reported.
PRECAUTIONS
General
The contents of the kit before preparation are not radioactive. However, after the sodium
pertechnetate Tc-99m is added, adequate shielding of the final preparation must be
maintained.
In patients with right-to-left heart shunts, additional risk may exist due to the rapid entry
of albumin aggregated into the systemic circulation. The safety of this agent in such
patients has not been established. Hypersensitivity reactions are possible whenever
protein-containing materials such as pertechnetate labeled albumin aggregated are used in
man. Epinephrine, antihistamines, and corticosteroids should be available for immediate
use.
The intravenous administration of any particulate materials such as albumin aggregated
imposes a temporary small mechanical impediment to blood flow. While this effect is
probably physiologically insignificant in most patients, the administration of albumin
aggregated is possibly hazardous in acute cor pulmonale and other states of severely
impaired pulmonary blood flow.
The components of the kit are sterile and non-pyrogenic. It is essential to follow
directions carefully and to adhere to strict aseptic procedures during preparation.
Contents of the vials are intended only for use in the preparation of Technetium Tc 99m
Albumin Aggregated Injection and are NOT to be administered directly to the patient.
The technetium Tc-99m labeling reactions involved depend on maintaining the stannous
ion in the reduced state. Hence, sodium pertechnetate Tc-99m containing oxidants
should not be employed.
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
The preparation contains no bacteriostatic preservative. Technetium Tc 99m Albumin
Aggregated Injection should be stored at 2 to 8 ºC (36 to 46 ºF) and discarded 6 hours
after reconstitution.
Technetium Tc 99m Albumin Aggregated Injection is physically unstable and
consequently the particles settle with time. Failure to agitate the vial adequately before
use may result in nonuniform distribution of radioactive particles.
If blood is drawn into the syringe, unnecessary delay prior to injection may result in clot
formation in situ.
Do not use if clumping of the contents is observed.
Technetium Tc 99m Albumin Aggregated Injection, as well as other radioactive drugs,
must be handled with care. Once sodium pertechnetate Tc-99m is added to the vial,
appropriate safety measures must be used to minimize radiation exposure to clinical
personnel. Care must also be taken to minimize the radiation exposure to patients in a
manner consistent with proper patient management.
Radiopharmaceuticals should be used only by physicians who are qualified by training
and experience in the safe use and handling of radionuclides and whose experience and
training have been approved by the appropriate government agency authorized to license
the use of radionuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term animal studies have been performed to evaluate carcinogenic potential or
whether Technetium Tc 99m Albumin Aggregated Injection affects fertility in males or
females.
Pregnancy Category C
Animal reproduction and teratogenicity studies have not been conducted with
Technetium Tc 99m Albumin Aggregated Injection. It is also not known whether
Technetium Tc 99m Albumin Aggregated Injection can cause fetal harm when
administered to a pregnant woman or can affect reproductive capacity. There have been
no studies in pregnant women. Technetium Tc 99m Albumin Aggregated Injection
should be given to a pregnant woman only if clearly needed.
Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a
woman of childbearing capability, should be performed during the first few
(approximately 10) days following the onset of menses.
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Nursing Mothers
Technetium Tc-99m is excreted in human milk during lactation. Therefore, formula
feedings should be substituted for breast feedings.
Pediatric Use
The lowest possible number of particles should be used in right-to-left shunting, in
neonates, and in severe pulmonary disease.
ADVERSE REACTIONS
The literature contains reports of deaths occurring after the administration of albumin
aggregated to patients with pre-existing severe pulmonary hypertension. Instances of
hemodynamic or idiosyncratic reactions to preparations of Technetium Tc 99m Albumin
Aggregated have been reported (see WARNINGS).
DOSAGE AND ADMINISTRATION
The recommended intravenous dose range for the average (70 kg) ADULT patient for
lung imaging is 37 to 148 megabecquerels (1 to 4 millicuries) of Technetium Tc 99m
Albumin Aggregated Injection after reconstitution with oxidant-free Sodium
Pertechnetate Tc 99m Injection.
The suggested intraperitoneal dosage range used in the average patient (70 kg) for
peritoneovenous (LeVeen) shunt patency evaluation is 37 to 111 megabecquerels (1 to 3
millicuries). Adequate measures should be taken to assure uniform mixing with
peritoneal fluid. Serial images of both the shunt and target organ should be obtained and
correlated with other clinical findings. Alternatively, the drug may be administered by
percutaneous transtubal injection. The suggested percutaneous transtubal (efferent limb)
dosage range for the average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0
millicurie) in a volume not to exceed 0.5 mL.
The recommended number of particles per single injection is 200,000 to 700,000 with the
suggested number being approximately 350,000. Depending on the activity added and
volume of the final reconstituted product, the volume of the dose may vary from 0.2 to
1.4 mL.
The number of particles available per dose of Technetium Tc 99m Albumin Aggregated
Injection will vary depending on the physical decay of the technetium Tc-99m that has
occurred. The number of particles in any dose and volume to be administered may be
calculated as follows:
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Assume the average number of particles per vial = 6.0 x 106.
If:
VTc = volume of solution added to reaction vial
D = desired dose to be administered in MBq (mCi)
C = concentration at calibration time of sodium pertechnetate solution to be added to
the reaction vial in MBq/mL (mCi/mL)
Va = volume to be administered in mL
P
= number of particles in dose to be administered
Fr = fraction of technetium Tc-99m remaining after the time of calibration (see Table
3)
Then:
Va =
D
and
P = Va x 6.0 x 106
C x Fr
VTc
In PEDIATRIC patients, the suggested intravenous dose to be employed for perfusion
lung imaging is in the range of 0.925 to 1.85 MBq per kilogram (25 to 50 μCi/kg) of
body weight; a usual dose is 1.11 MBq per kilogram (30 μCi/kg), except in newborns, in
whom the administered dose should be 7.4 to 18.5 MBq (200 to 500 μCi). Not less than
the minimum dose of 7.4 MBq (200 μCi) should be employed for this procedure. The
number of particles will vary with age and weight of the pediatric patient as indicated in
Table 5.
Parenteral drug products should be visually inspected for particulate matter and
discoloration prior to administration whenever solution and container permit.
The patient dose should be measured by a suitable radioactivity calibration system
immediately prior to administration. Mix the contents of the vial by gentle inversion just
prior to withdrawing a patient dose.
Mix the contents of the syringe just before injection. If blood is drawn into the syringe,
any unnecessary delay prior to injection may lead to clot formation. For optimum results
and because of rapid lung clearance of the radiopharmaceutical, it is suggested that the
patient be positioned under the imaging apparatus before administration. Slow injection
is recommended. Lung imaging may begin immediately after intravenous injection of the
radiopharmaceutical. Due to high kidney uptake, imaging later than one-half hour after
administration will yield poor results.
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
RADIATION DOSIMETRY
The estimated absorbed radiation doses2 to an average ADULT patient (70 kg) from an
intravenous injection of 148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated
Injection are shown in Table 4.
2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and
Organs, MIRD Pamphlet No. 11 (1975).
Table 4
Absorbed Radiation Doses
Organs
mGy/148 MBq
rad/4 mCi
Total body
0.60
0.060
Lungs
8.8
0.88
Liver
0.72
0.072
Spleen
0.68
0.068
Kidneys
Bladder Wall
0.44
0.044
2.0 hr. void
1.2
0.12
4.8 hr. void
Testes
2.2
0.22
2.0 hr. void
0.24
0.024
4.8 hr. void
Ovaries
0.26
0.026
2.0 hr. void
0.30
0.030
4.8 hr. void
0.34
0.034
In PEDIATRIC patients, the radiation absorbed doses using the maximum recommended
dose for lung imaging are based on 1.85 MBq (50 μCi) per kilogram of body weight
[except in the newborn where the maximum recommended dose of 18.5 MBq (500 μCi)
is used] and are shown in Table 5, which lists the maximum dose for pediatric patients
from newborn to adults. Note the recommendations regarding number of particles to be
administered.
Table 6 represents the absorbed radiation dose resulting from the intraperitoneal
administration of 111 megabecquerels (3 millicuries) of Technetium Tc 99m Albumin
Aggregated.
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Age
Newborn
1 year
5 years
10 years
15 years
Weight (kg)
3.5
12.1
20.3
33.5
55.0
Max.
MBq
mCi
MBq
mCi
MBq
mCi
MBq
mCi
MBq
mCi
recommended dose
in megabecquerels
and millicuries
18.5
0.5
22.2
0.6
37
1.0
62.9
1.7
103.6
2.8
Range of particles
administered
10,000 to
50,000
50, 000 to
150,000
200,000 to
300,000
200,000 to
300,000
200,000 to
700,000
Absorbed radiation
dose in milligray
and rad for the
maximum dose
mGy
rad
mGy
rad
mGy
rad
mGy
rad
mGy
rad
ORGANS
Total body
0.60
0.06
0.30
0.03
0.31
0.031
0.48
0.048
0.41
0.041
Lungs
19.00
1.9
6.60
0.66
5.80
0.58
8.70
0.87
7.70
0.77
Liver
1.40
0.14
0.60
0.06
0.62
0.062
1.80
0.18
1.20
0.12
Bladder wall
2.10
0.21(1)
1.50
0.15(1)
3.10
0.31(2)
3.90
0.39(2)
4.10
0.41
Ovaries
0.38
0.038
0.20
0.020
0.19
0.019
0.44
0.044
0.41
0.041
Testes
0.31
0.031
0.13
0.013
0.19
0.019
0.20
0.020
0.36
0.036
*Assumptions:
1. Used biologic data from Kaul et al., Berlin, 1973.
2. For the newborn, 1-year old, and 5-year old, the “S” values calculated from the preliminary phantoms of
ORNL were used. The 10-year old, 15-year old and adult “S” values were taken from Henrichs et al.,
Berlin, 1980.
Table 5
Pediatric Radiation Dose from Tc 99m MAA for Lung Imaging*
(1) 2.0 hour voiding interval
(2) 4.8 hour voiding interval
Table 6
Absorbed Radiation Doses
Organs
Shunt
Patency
(Open)
Shunt
Patency
(Closed)
mGy
rad
mGy
rad
Lung
Ovaries
& testes
Organs in the peritoneal
cavity
Total body
6.9
0.18
to 0.30
-
0.36
0.69
0.018
to 0.030
-
0.036
1.68
1.68
1.68
0.57
0.168
0.168
0.168
0.057
Assumptions:
Calculations for the absorbed radiation dose are based upon an effective half-time of 3 hours for the open
shunt and 6.02 hours for the closed shunt and an even distribution of the radiopharmaceutical in the
peritoneal cavity with no biological clearance.
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
HOW SUPPLIED
DRAXIMAGE® MAA
Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection
Each kit contains 30 reaction vials, each vial containing in lyophilized form, sterile and
non-pyrogenic:
Albumin aggregated
2.5 mg
Albumin human
5.0 mg
Stannous Chloride (minimum)
0.06 mg
(Maximum stannous and stannic chloride
0.11 mg)
Sodium chloride
1.2 mg
HCl and/or NaOH has been used for pH adjustment. The vials are sealed under an
atmosphere of nitrogen.
Thirty labels with radiation warning symbol and a package insert are supplied in each
carton.
STORAGE
Store the unreconstituted reaction vials at 2 to 25 ºC (36 to 77 ºF). After labeling with
Technetium Tc-99m, store the solution at 2 to 8 ºC (36 to 46 ºF) in a suitable lead shield
and discard after 6 hours.
DIRECTIONS FOR PREPARATION
NOTE: Use aseptic procedures throughout and take precautions to minimize radiation
exposure by use of suitable shielding. Waterproof gloves should be worn during the
preparation procedure.
Before reconstituting a vial, it should be inspected for cracks and/or a melted plug or any
other indication that the integrity of the vacuum seal has been lost.
To prepare Technetium Tc 99m Albumin Aggregated Injection:
1. Remove the protective disc from a reaction vial and swab the rubber septum with
either an alcohol swab or a suitable bacteriostatic agent to disinfect the surface.
2. Place the vial in a suitable lead vial shield which has a fitted cap. Obtain 2 to 8 mL
of a sterile pyrogen-free Sodium Pertechnetate Tc 99m Injection using a shielded
syringe. The recommended maximum amount of Tc-99m to be added to a reaction
Reference ID: 3019371
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
vial is 3.7 GBq (100 mCi). Sodium pertechnetate Tc 99m solutions containing an
oxidizing agent are not suitable for use.
3. Using a shielded syringe, add the Sodium Pertechnetate Tc 99m Injection to the
reaction vial aseptically.
4. Place the lead cap on the vial shield and mix the contents of the shielded vial by
repeated gentle inversion until all the material is suspended. Avoid formation of
foam. Using proper shielding, the vial should be visually inspected to ensure that
the suspension is free of foreign matter before proceeding. Do not administer if
foreign particulates are found in the preparation. To ensure maximum tagging,
allow the preparation to stand for 15 minutes after mixing.
5. Assay the product in a suitable calibrator, record the radioassay information on the
label with radiation warning symbol, and attach it to the vial shield.
6. Withdrawals for administration must be made aseptically using a sterile needle (18
to 21 gauge) and syringe. Since the vials contain nitrogen to prevent oxidation of
the complex, the vials should not be vented. If repeated withdrawals are made from
the vial, replacement of the contents with air should be minimized.
7. The finished preparation should be refrigerated at 2 to 8 ºC (36 to 46 ºF) when not
in use and discarded after 6 hours. (The preparation contains no bacteriostatic
preservative.) The vial should also be retained during its life in the reaction vial
shield with cap in place.
DISPOSAL
The residual materials may be discarded in the ordinary trash, provided the radioactivity
in the vials and syringes measures no more than background with an appropriate low-
range survey meter. All identifying labels should be destroyed before discarding.
This reagent kit is approved by the U.S. Nuclear Regulatory Commission for distribution
to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to
persons who have a similar authorization issued by an Agreement State, and, outside the
United States, to persons authorized by the appropriate authority.
Jubilant DraxImage Inc.
Kirkland, Québec, H9H 4J4 Canada
Reference ID: 3019533
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:43:19.317159 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf', 'application_number': 17881, 'submission_type': 'SUPPL ', 'submission_number': 16} |
1,071 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:43:19.393704 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 86} |
1,078 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HUMULIN R U-500 safely and effectively. See full prescribing
information for HUMULIN R U-500.
HUMULIN R U-500 (insulin human injection), for subcutaneous use
Initial U.S. Approval: 1994
--------------------------- RECENT MAJOR CHANGES -------------------------
Dosage and Administration (2)
07/2016
Warnings and Precautions (5)
07/2016
----------------------------INDICATIONS AND USAGE --------------------------
HUMULIN® R U-500 is a concentrated human insulin indicated to improve
glycemic control in adults and children with diabetes mellitus requiring more
than 200 units of insulin per day. (1)
Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in
combination with other insulins has not been determined. The safety and
efficacy of HUMULIN R U-500 delivered by continuous subcutaneous
infusion has not been determined. (1.1)
----------------------- DOSAGE AND ADMINISTRATION ---------------------
•
Adhere to administration instructions to reduce the risk of dosing errors.
(2.1, 2.3, 2.4, 5.1)
•
HUMULIN R U-500 is available as a KwikPen or multiple dose vial.
Patients using the vial must be prescribed the U-500 insulin syringe to
avoid medication errors. (2.1)
•
Individualize dose of HUMULIN R U-500 based on metabolic needs,
blood glucose monitoring results and glycemic control goal. (2.2)
•
Administer HUMULIN R U-500 subcutaneously two or three times
daily 30 minutes before a meal. Rotate injection sites to reduce the risk
of lipodystrophy. (2.1, 2.2)
•
Do NOT mix HUMULIN R U-500 with other insulins. (2.1)
•
Do NOT administer HUMULIN R U-500 intravenously or
intramuscularly. (2.1)
•
Do NOT perform dose conversion when using the HUMULIN R U-500
KwikPen. The dose window of the HUMULIN R U-500 KwikPen
shows the number of units of HUMULIN R U-500 to be injected. (2.3)
•
Do NOT transfer HUMULIN R U-500 from the HUMULIN R U-500
KwikPen into any syringe. (2.3)
•
Do NOT perform dose conversion when using a U-500 insulin syringe.
Use only a U-500 insulin syringe with the HUMULIN R U-500 vial.
(2.4)
----------------------DOSAGE FORMS AND STRENGTHS --------------------
HUMULIN R U-500 (500 units per mL) is available in a colorless solution as:
(3)
•
3 mL HUMULIN® R U-500 KwikPen® (prefilled pen containing
1,500 units of insulin)
•
20 mL multiple dose vial (containing 10,000 units of insulin)
-------------------------------CONTRAINDICATIONS-----------------------------
•
Do not use during episodes of hypoglycemia. (4)
•
Do not use in patients with hypersensitivity to HUMULIN R U-500 or
any of its excipients. (4)
------------------------ WARNINGS AND PRECAUTIONS ----------------------
•
Hyperglycemia, Hypoglycemia or Death due to Dosing Errors with Vial
Presentation: Can be life-threatening. Overdose has occurred as a result
of dispensing, prescribing or administration errors. Attention to details at
all levels is required to prevent these errors. (2.1, 2.3, 2.4, 5.1)
•
Never share a HUMULIN R U-500 KwikPen or U-500 insulin syringe
between patients, even if the needle is changed. (5.2)
•
Hyper- or Hypoglycemia with Changes in Insulin Regimen: Carry out
under close medical supervision and increase frequency of blood glucose
monitoring. (5.3)
•
Hypoglycemia: May be life-threatening. Increase monitoring with
changes to: insulin dosage, co-administered glucose lowering
medications, meal pattern, physical activity; and in patients with renal
impairment or hepatic impairment or hypoglycemia unawareness. (5.4)
•
Hypersensitivity Reactions: Severe, life-threatening, generalized allergy,
including anaphylaxis, can occur. Discontinue HUMULIN R U-500,
monitor, and treat if indicated. (5.5)
•
Hypokalemia: May be life-threatening. Monitor potassium levels in
patients at risk for hypokalemia and treat if indicated. (5.6)
•
Fluid Retention and Heart Failure with Concomitant Use of
Thiazolidinediones (TZDs): Observe for signs and symptoms of heart
failure; consider dosage reduction or discontinuation if heart failure
occurs. (5.7)
-------------------------------ADVERSE REACTIONS -----------------------------
Adverse reactions associated with HUMULIN R U-500 include
hypoglycemia, allergic reactions, injection site reactions, lipodystrophy,
pruritus, and rash. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and
Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
------------------------------- DRUG INTERACTIONS -----------------------------
•
Certain drugs may affect glucose metabolism and may necessitate
insulin dose adjustment. (7.1, 7.2, 7.3)
•
The signs of hypoglycemia may be reduced or absent in patients taking
anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and
reserpine). (7.3, 7.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-
approved patient labeling
Revised: 07/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1
INDICATIONS AND USAGE
1.1
Limitation of Use
2
DOSAGE AND ADMINISTRATION
2.1
Important Administration Instructions
2.2
Dosing Instructions
2.3
Delivery of HUMULIN R U-500 using the HUMULIN R U-500
Disposable Prefilled KwikPen Device
2.4
Delivery of HUMULIN R U-500 using the vial presentation and
the U-500 Insulin Syringe
3
DOSAGE FORMS AND STRENGTHS
4
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
5.1
Hyperglycemia, Hypoglycemia or Death due to Dosing Errors
with the Vial Presentation
5.2
Never Share a HUMULIN R U-500 KwikPen or U-500 Insulin
Syringe Between Patients
5.3
Hyperglycemia or Hypoglycemia with Changes in Insulin
Regimen
5.4
Hypoglycemia
5.5
Hypersensitivity and Allergic Reactions
5.6
Hypokalemia
5.7
Fluid Retention and Heart Failure with Concomitant Use of
PPAR-gamma Agonists
6
ADVERSE REACTIONS
7
DRUG INTERACTIONS
7.1
Drugs That May Increase the Risk of Hypoglycemia
7.2
Drugs That May Decrease the Blood Glucose Lowering Effect
of HUMULIN R U-500
7.3
Drugs That May Increase or Decrease the Blood Glucose
Lowering Effect of HUMULIN R U-500
7.4
Drugs That May Affect Signs and Symptoms of Hypoglycemia
Reference ID: 3956468
2
8
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
8.3
Nursing Mothers
8.4
Pediatric Use
8.5
Geriatric Use
8.6
Renal Impairment
8.7
Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1
Mechanism of Action
12.2
Pharmacodynamics
12.3
Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1
Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1
How Supplied
16.2
Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not
listed
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients
with diabetes mellitus requiring more than 200 units of insulin per day.
1.1
Limitation of Use
The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined.
The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.
2
DOSAGE AND ADMINISTRATION
2.1
Important Administration Instructions
•
Prescribe HUMULIN R U-500 ONLY to patients who require more than 200 units of insulin per day.
•
HUMULIN R U-500 is available as a KwikPen or multiple dose vial. Patients using the vial must be prescribed the U-500
insulin syringe to avoid medication errors.
•
Instruct patients using the vial presentation to use only a U-500 insulin syringe and on how to correctly draw the
prescribed dose of HUMULIN R U-500 into the U-500 insulin syringe. Confirm that the patient has understood these
instructions and can correctly draw the prescribed dose of HUMULIN R U-500 with their syringe [see Dosage and
Administration (2.4) and Warnings and Precautions (5.1)].
•
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Train
patients on proper use and injection technique before initiating HUMULIN R U-500. Training reduces the risk of
administration errors such as needle sticks and dosing errors.
•
Instruct patients to always check the insulin label before administration to confirm the correct insulin product is being
used [see Warnings and Precautions (5.1)].
•
Inspect HUMULIN R U-500 visually for particulate matter and discoloration. Only use HUMULIN R U-500 if the
solution appears clear and colorless.
•
Instruct patients to inject HUMULIN R U-500 subcutaneously into the thigh, upper arm, abdomen, or buttocks.
•
Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see
Adverse Reactions (6)].
•
DO NOT administer HUMULIN R U-500 intravenously or intramuscularly.
•
DO NOT dilute or mix HUMULIN R U-500 with any other insulin products or solutions.
2.2
Dosing Instructions
•
Instruct patients to inject HUMULIN R U-500 subcutaneously usually two or three times daily approximately 30 minutes
before meals.
•
Individualize and titrate the dosage of HUMULIN R U-500 based on the patient’s metabolic needs, blood glucose
monitoring results, and glycemic control goal.
•
Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient
content or timing of food intake), changes in renal or hepatic function, changes in medications or during acute illness to
minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.3)].
Reference ID: 3956468
3
2.3
Delivery of HUMULIN R U-500 using the HUMULIN R U-500 Disposable Prefilled KwikPen Device
•
DO NOT perform dose conversion when using the HUMULIN R U-500 KwikPen. The dose window of the
HUMULIN R U-500 KwikPen shows the number of units of HUMULIN R U-500 to be injected and NO dose conversion
is required.
•
DO NOT transfer HUMULIN R U-500 from the HUMULIN R U-500 KwikPen into any syringe for administration as
overdose and severe hypoglycemia can occur [see Warnings and Precautions (5.4)].
•
The HUMULIN R U-500 KwikPen is for single patient use only [see Warnings and Precautions (5.2)].
2.4
Delivery of HUMULIN R U-500 using the vial presentation and the U-500 Insulin Syringe
•
DO NOT perform dose conversion when using a U-500 insulin syringe. The markings on the U-500 insulin syringe show
the number of units of HUMULIN R U-500 to be injected. Each marking on the syringe represents 5 units of insulin.
•
Prescribe patients a U-500 insulin syringe to administer HUMULIN R U-500 from the vial to avoid administration errors.
DO NOT use any other type of syringe [see Warnings and Precautions (5.1)].
3
DOSAGE FORMS AND STRENGTHS
HUMULIN R U-500 (500 units per mL) is available in a colorless solution as:
•
3 mL HUMULIN R U-500 KwikPen (prefilled, 1,500 units of insulin)
•
20 mL multiple dose vial (containing 10,000 units of insulin)
4
CONTRAINDICATIONS
HUMULIN R U-500 is contraindicated:
•
During episodes of hypoglycemia
•
In patients who are hypersensitive to HUMULIN R U-500 or any of its excipients.
5
WARNINGS AND PRECAUTIONS
5.1
Hyperglycemia, Hypoglycemia or Death due to Dosing Errors with the Vial Presentation
Medication errors associated with the HUMULIN R U-500 vial presentation resulting in patients experiencing hyperglycemia,
hypoglycemia or death have been reported. The majority of errors occurred due to errors in dispensing, prescribing or administration.
Attention to details at all levels may prevent these errors.
Dispensing Errors
Instruct patients to always inspect insulin vials to confirm that the correct insulin is dispensed including the correct insulin
brand and concentration.
The HUMULIN R U-500 vial, which contains 20 mL, has a band of aqua coloring, a 500 units/mL concentration statement
consisting of white lettering on a green rectangular background, and a green “U-500” statement prominently displayed next to the
trade name. Additionally, the vial has a green flip top and a red warning on the front panel describing the highly concentrated dose and
a statement advising use with only U-500 insulin syringes.
Prescribing Errors
Dosing errors have occurred when the HUMULIN R U-500 dose was administered with syringes other than a U-500 insulin
syringe. Patients should be prescribed U-500 syringes for use with the HUMULIN R U-500 vials. The prescribed dose of
HUMULIN R U-500 should always be expressed in units of insulin [see Dosage and Administration (2.4)].
Administration Errors
Instruct patients to always check the insulin label before each injection.
Use only a U-500 insulin syringe with HUMULIN R U-500 to avoid administration errors. Do not use any other type of
syringe to administer Humulin R U-500. Adhere to administration instructions [see Dosage and Administration (2.1, 2.4)].
Instruct the patient to inform hospital or emergency department staff of the dose of HUMULIN R U-500 prescribed, in the
event of a future hospitalization or visit to the Emergency Department.
Reference ID: 3956468
4
5.2
Never Share a HUMULIN R U-500 KwikPen or U-500 Insulin Syringe Between Patients
HUMULIN R U-500 KwikPens should never be shared between patients, even if the needle is changed. Patients using
HUMULIN R U-500 vials should never share needles or U-500 insulin syringes with another person. Sharing poses a risk for
transmission of blood-borne pathogens.
5.3
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Changes in insulin, manufacturer, type, or method of administration may affect glycemic control and predispose to
hypoglycemia or hyperglycemia. These changes should be made cautiously and only under medical supervision and the frequency of
blood glucose monitoring should be increased. For patients with type 2 diabetes, adjustments in concomitant oral anti-diabetic
treatment may be needed.
5.4
Hypoglycemia
Hypoglycemia is the most common adverse reaction associated with insulin, including HUMULIN R U-500. Severe
hypoglycemia can cause seizures, may be life-threatening or cause death. Severe hypoglycemia may develop as long as 18 to 24 hours
after an injection of HUMULIN R U-500. Hypoglycemia can impair concentration ability and reaction time; this may place an
individual and others at risk in situations where these abilities are important (e.g., driving, or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual.
Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic
nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions
(7.3, 7.4)], or in patients who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. As with all insulin
preparations, the glucose lowering effect time course of HUMULIN R U-500 may vary in different individuals or at different times in
the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and
temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content
or timing of meals), changes in level of physical activity, or changes to co-administered medication [see Drug Interactions (7.1, 7.2,
7.3, 7.4)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6,
8.7)].
Risk Mitigation Strategies for Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an
essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have
reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. To minimize
the risk of hypoglycemia do not administer HUMULIN R U-500 intravenously, intramuscularly or in an insulin pump or dilute or mix
HUMULIN R U-500 with any other insulin products or solutions [see Dosage and Administration (2.1)].
5.5
Hypersensitivity and Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including HUMULIN R
U-500 [see Adverse Reactions (6)]. If hypersensitivity reactions occur, discontinue HUMULIN R U-500; treat per standard of care
and monitor until symptoms and signs resolve [see Adverse Reactions (6)].
5.6
Hypokalemia
All insulin products, including HUMULIN R U-500, cause a shift in potassium from the extracellular to intracellular space,
possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use
caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking
medications sensitive to serum potassium concentrations).
5.7
Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-
related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure.
Patients treated with insulin, including HUMULIN R U-500, and a PPAR-gamma agonist should be observed for signs and symptoms
of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose
reduction of the PPAR-gamma agonist must be considered.
6
ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere:
Reference ID: 3956468
5
•
Hypoglycemia [see Warnings and Precautions (5.4)].
•
Hypokalemia [see Warnings and Precautions (5.6)].
The following additional adverse reactions have been identified during post-approval use of HUMULIN R U-500. Because
these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their
frequency or to establish a causal relationship to drug exposure.
Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMULIN R U-500 [see
Warnings and Precautions (5.4)].
Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, rash, angioedema,
bronchospasm, hypotension, and shock may occur with any insulin, including HUMULIN R U-500 and may be life threatening [see
Warnings and Precautions (5.5)].
Lipodystrophy
Long-term use of insulin, including HUMULIN R U-500, can cause lipodystrophy at the site of repeated insulin injections.
Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect
insulin absorption. Rotate insulin injections sites within the same region to reduce the risk of lipodystrophy [see Dosage and
Administration (2.1)].
Injection Site Reactions
Patients taking HUMULIN R U-500 may experience injection site reactions, including injection site hematoma, pain,
hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass.
Weight Gain
Weight gain can occur with insulin therapy, including HUMULIN R U-500, and has been attributed to the anabolic effects of
insulin.
Peripheral Edema
Insulin, including HUMULIN R U-500, may cause sodium retention and edema, particularly if previously poor metabolic
control is improved by intensified insulin therapy.
Immunogenicity
As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. The presence of antibodies
that affect clinical efficacy may necessitate dose adjustments to correct for tendencies toward hyper- or hypoglycemia.
The incidence of antibody formation with HUMULIN R U-500 is unknown.
7
DRUG INTERACTIONS
7.1
Drugs That May Increase the Risk of Hypoglycemia
The risk of hypoglycemia associated with HUMULIN R U-500 use may be increased with antidiabetic agents, ACE inhibitors,
angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide,
propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Dose adjustment and increased
frequency of glucose monitoring may be required when HUMULIN R U-500 is co-administered with these drugs.
7.2
Drugs That May Decrease the Blood Glucose Lowering Effect of HUMULIN R U-500
The glucose lowering effect of HUMULIN R U-500 may be decreased when co-administered with atypical antipsychotics
(e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives,
phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol,
epinephrine, terbutaline) and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required
when HUMULIN R U-500 is co-administered with these drugs.
7.3
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of HUMULIN R U-500
The glucose lowering effect of HUMULIN R U-500 may be increased or decreased when co-administered with alcohol, beta-
blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN R U-500 is co-administered with
these drugs.
Reference ID: 3956468
6
7.4
Drugs That May Affect Signs and Symptoms of Hypoglycemia
The signs and symptoms of hypoglycemia [see Warnings and Precautions (5.4)] may be blunted when beta-blockers,
clonidine, guanethidine, and reserpine are co-administered with HUMULIN R U-500.
8
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
Pregnancy Category B
Risk Summary
All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This
background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is
essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and
throughout pregnancy. In patients with diabetes or gestational diabetes, insulin requirements may decrease during the first trimester,
generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is
essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they
become pregnant while taking HUMULIN R U-500.
Human Data
While there are no adequate and well-controlled studies in pregnant women, evidence from published literature suggests that
good glycemic control in patients with diabetes during pregnancy provides significant maternal and fetal benefits.
Animal Data
Reproduction and fertility studies were not performed in animals.
8.3
Nursing Mothers
Endogenous insulin is present in human milk. Insulin orally ingested is degraded in the gastrointestinal tract. No adverse
reactions associated with infant exposure to insulin through the consumption of human milk have been reported. In a study of eight
preterm infants between 26 to 30 weeks gestation, enteral administration of biosynthetic human insulin did not result in hypoglycemia.
Good glucose control supports lactation in patients with diabetes. Women with diabetes who are lactating may require adjustments in
their insulin dose.
8.4
Pediatric Use
There are no well-controlled studies of use of HUMULIN R U-500 in children. Standard precautions as applied to use of
HUMULIN R U-500 in adults are appropriate for use in children. As in adults, the dosage of HUMULIN R U-500 in pediatric patients
must be individualized based on metabolic needs and results of frequent monitoring of blood glucose.
8.5
Geriatric Use
The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN R U-500 has not been studied. Caution
should be exercised when HUMULIN R U-500 is administered to geriatric patients. In elderly patients with diabetes, the initial
dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia.
8.6
Renal Impairment
Frequent glucose monitoring and insulin dose reduction may be required in patients with renal impairment.
8.7
Hepatic Impairment
Frequent glucose monitoring and insulin dose reduction may be required in patients with hepatic impairment.
10
OVERDOSAGE
Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be
treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma,
seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery.
Hypokalemia must be corrected appropriately.
Reference ID: 3956468
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11
DESCRIPTION
HUMULIN R U-500 (insulin human injection, USP) is a human insulin solution used to lower blood glucose. Human insulin
is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. HUMULIN R has the
empirical formula C257H383N65O77S6 with a molecular weight of 5808.
HUMULIN R U-500 is a sterile, aqueous, and colorless solution. HUMULIN R U-500 contains 500 units of insulin in each
milliliter. Each milliliter of HUMULIN R U-500 also contains glycerin 16 mg, metacresol 2.5 mg, zinc oxide to supplement the
endogenous zinc to obtain a total zinc content of 0.017 mg/100 units, and Water for Injection. Sodium hydroxide and hydrochloric
acid may be added during manufacture to adjust the pH.
12
CLINICAL PHARMACOLOGY
12.1
Mechanism of Action
Regulation of glucose metabolism is the primary activity of insulins, including HUMULIN R U-500. Insulins lower blood
glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins
inhibit lipolysis and proteolysis, and enhance protein synthesis.
12.2
Pharmacodynamics
In a euglycemic clamp study of 24 healthy obese subjects (BMI=30-39 kg/m2), single doses of HUMULIN R U-500 at
50 units (0.4-0.6 unit/kg) and 100 units (0.8-1.3 unit/kg) resulted in a mean time of onset of action of less than 15 minutes at both
doses and a mean duration of action of 21 hours (range 13-24 hours). The time action characteristics reflect both prandial and basal
activity, consistent with clinical experience. This effect has been attributed to the high concentration of the preparation.
Figure 1 should be considered a representative example since the time course of action of insulin may vary in different
individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity is known to be affected
by the site of injection, exercise, and other variables [see Warnings and Precautions (5.3)]. graph
Figure 1: Mean Insulin Activity Versus Time Profiles After Subcutaneous Injection of a 100 U Dose of HUMULIN R U-500 in
Healthy Obese Subjects
12.3
Pharmacokinetics
Absorption — In a euglycemic clamp study of 24 healthy obese subjects, the median peak insulin level occurred between 4
hours (50 unit dose) and 8 hours (100 unit dose) with a range of 0.5-8 hours.
Metabolism — The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the
liver being the major organ involved in the clearance of insulin.
Elimination — Mean apparent half-life after subcutaneous administration of single doses of 50 units and 100 units to healthy
obese subjects (N≥21) was approximately 4.5 hours (range=1.9-10 hours) for HUMULIN R U-500.
Reference ID: 3956468
8 graph
Figure 2: Mean Serum Insulin Concentrations Versus Time After Subcutaneous Injection of a 100 U Dose of HUMULIN R
U-500 Healthy Obese Subjects
13
NONCLINICAL TOXICOLOGY
13.1
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity and fertility studies were not performed with HUMULIN R U-500 in animals. Biosynthetic human insulin
was not genotoxic in the in vivo sister chromatid exchange assay and the in vitro gradient plate and unscheduled DNA synthesis
assays.
16
HOW SUPPLIED/STORAGE AND HANDLING
16.1
How Supplied
HUMULIN R U-500 (500 units per mL) is available as:
2 x 3 mL HUMULIN R U-500 KwikPen (prefilled)
20 mL multiple dose vials
NDC 0002-8824-27
NDC 0002-8501-01
16.2
Storage and Handling
Protect from heat and light. Do not freeze. Do not use HUMULIN R U-500 after the expiration date printed on the label or if it
has been frozen. Do not shake the vial.
Not In Use (Unopened) HUMULIN R U-500 KwikPen
Refrigerated
Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen.
Room Temperature
If stored at room temperature, below 86°F (30°C) the pen must be discarded after 28 days.
In-Use (Opened) HUMULIN R U-500 KwikPen
Refrigerated
Do NOT store in a refrigerator.
Room Temperature
Store at room temperature, below 86°F (30°C) and the pen must be discarded after 28 days, even if the pen still contains
HUMULIN R U-500. See storage table below:
Reference ID: 3956468
B5.0LINR500-0004-USPI-YYYYMMDD
9
17
Not In Use (Unopened) HUMULIN R U-500 Vials
Refrigerated
Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen.
Room Temperature
If stored at room temperature, below 86°F (30°C) the vial must be discarded after 40 days.
In-Use (Opened) HUMULIN R U-500 Vials
Refrigerated
Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Vials must be used
within 40 days or be discarded, even if they still contain HUMULIN R U-500.
Room Temperature
If stored at room temperature, below 86°F (30°C) the vial must be discarded after 40 days, even if the vial still contains
HUMULIN R U-500. See storage table below:
Not In-Use (Unopened) Refrigerated
In-Use (Opened)
3 mL HUMULIN R U-500 KwikPen
(prefilled)
Until expiration date
28 days, room temperature.
Do not refrigerate.
20 mL multiple dose vial
Until expiration date
40 days, refrigerated or room temperature
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling.
Patients should be counseled that HUMULIN R U-500 is a 5-times concentrated insulin product. Extreme caution must be
observed in the measurement of dosage because inadvertent overdose may result in serious adverse reaction or life-threatening
hypoglycemia. Accidental mix-ups between HUMULIN R U-500 and other insulins have been reported. To avoid medication errors
between HUMULIN R U-500 and other insulins, patients should be instructed to always check the insulin label before each injection
[see Warnings and Precautions (5.1)].
If using the HUMULIN R U-500 KwikPen, patients should be counseled to dial and dose the prescribed number of units of
insulin (no dose conversion is required) [see Dosage and Administration (2.3)].
When using HUMULIN R U-500 from a vial, patients should be counseled to use only a U-500 insulin syringe and be
informed that no dose conversion is required [see Dosage and Administration (2.4)].
Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and
management of hypoglycemia and hyperglycemia, especially at initiation of HUMULIN R U-500 therapy. Patients must be instructed
on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped
insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Refer patients to the
HUMULIN R U-500 Patient Information Leaflet for additional information [see Warnings and Precautions (5)].
Women with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Never use HUMULIN R U-500 if it has become viscous (thickened) or cloudy; use it only if
it is clear and colorless.
HUMULIN R U-500 should not be used after the printed expiration date.
Do not dilute or mix HUMULIN R U-500 with any other insulin products or solutions [see Dosage and Administration (2.1)].
Literature Revised: July 2016
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1997, 2016, Eli Lilly and Company. All rights reserved.
Reference ID: 3956468
1
Patient Information
Humulin® (HU-mu-lin) R U-500
insulin human injection
(500 units per mL)
Do not share your Humulin R U-500 KwikPen or U-500 insulin syringes with other people, even if the needle
has been changed. You may give other people a serious infection or get a serious infection from them.
What is Humulin R U-500?
•
Humulin R U-500 is a man-made insulin that is used to control high blood sugar in adults and children with diabetes
mellitus who need more than 200 units of insulin in a day.
•
Humulin R U-500 contains 5 times as much insulin (500 units/mL) in 1 mL as standard insulin (100 units/mL).
•
It is not known if Humulin R U-500 is safe and effective when used in combination with other insulins.
•
It is not known if Humulin R U-500 is safe and effective when given by continuous subcutaneous infusion.
•
It is not known if Humulin R U-500 is safe and effective in children.
Who should not take Humulin R U-500?
Do not take Humulin R U-500 if you:
•
are having an episode of low blood sugar (hypoglycemia).
•
have an allergy to human insulin or any of the ingredients in Humulin R U-500. See the end of this Patient
Information leaflet for a complete list of ingredients in Humulin R U-500.
What should I tell my healthcare provider before using Humulin R U-500?
Before using Humulin R U-500, tell your healthcare provider about all your medical conditions including, if you:
•
have liver or kidney problems.
•
take other medicines, especially ones called TZDs (thiazolidinediones).
•
have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with
Humulin R U-500.
•
are pregnant, planning to become pregnant, or breast-feeding. It is not known if Humulin R U-500 will harm your
unborn or breastfeeding baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, or herbal supplements.
Before you start using Humulin R U-500, talk to your healthcare provider about low blood sugar and how to
manage it.
How should I use Humulin R U-500?
•
Read the detailed Instructions for Use that come with your Humulin R U-500.
•
Use Humulin R U-500 exactly as your healthcare provider tells you to. Your healthcare provider should tell you how
much Humulin R U-500 to use and when to use it.
•
Know the dose of Humulin R U-500 you use. Do not change the dose of Humulin R U-500 you use unless your
healthcare provider tells you to.
•
Check your insulin label each time you give your injection to make sure you are using the correct insulin.
•
When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is specially made to dial and deliver
doses of Humulin R U-500 insulin. Do not use any syringe to remove Humulin R U-500 from your Humulin R U-500
KwikPen. The markings on certain syringes will not measure your dose correctly. A severe overdose can happen,
causing low blood sugar, which may put your life in danger.
•
When using the Humulin R U-500 vial: There is a special U-500 insulin syringe to measure Humulin R U-500.
Use only a U-500 insulin syringe to draw up and inject your Humulin R U-500. If you do not use the right
syringe type, you may take the wrong dose of Humulin R U-500. This can cause you to have too low blood sugar
(hypoglycemia) or too high blood sugar (hyperglycemia). Your healthcare provider should show you how to draw up
Humulin R U-500.
•
Use Humulin R U-500 30 minutes before eating a meal.
•
Inject Humulin R U-500 under your skin (subcutaneously). Do not use Humulin R U-500 in an insulin pump or inject
Humulin R U-500 into your vein (intravenously) or your muscle (intramuscularly).
•
Do not mix Humulin R U-500 in the KwikPen or vial with any other type of insulin or liquid medicine.
•
Change (rotate) your injection site with each dose.
•
Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you
should check your blood sugar levels.
Keep Humulin R U-500 and all medicines out of reach of children.
Reference ID: 3956468
B3.0LINR500-0003-PPI-YYYYMMDD
2
Your dose of Humulin R U-500 may need to change because of:
•
change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or
because of other medicines you take.
What should I avoid while using Humulin R U-500?
While using Humulin R U-500 do not:
•
drive or operate heavy machinery, until you know how Humulin R U-500 affects you.
•
drink alcohol or use over-the-counter medicines that contain alcohol.
What are the possible side effects of Humulin R U-500?
Humulin R U-500 may cause serious side effects that can lead to death, including:
•
low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include:
-
dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast
heartbeat, anxiety, irritability or mood changes, hunger.
-
your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your
blood sugar becomes too low (hypoglycemic) and you are unable to take sugar by mouth.
•
severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or
symptoms of a severe allergic reaction:
-
a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
•
low potassium in your blood (hypokalemia).
•
heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Humulin R U-500 may cause
heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If
you already have heart failure, it may get worse while you take TZDs with Humulin R U-500. Your healthcare
provider should monitor you closely while you are taking TZDs with Humulin R U-500. Tell your healthcare provider
if you have any new or worse symptoms of heart failure including:
-
shortness of breath, swelling of your ankles or feet, sudden weight gain
Treatment with TZDs and Humulin R U-500 may need to be adjusted or stopped by your healthcare provider if you
have new or worse heart failure.
Get emergency medical help if you have:
•
severe hypoglycemia needing hospitalization or emergency room care, and be sure to tell the hospital staff the units
of Humulin R U-500 that your healthcare provider has prescribed for you.
•
trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme
drowsiness, dizziness, confusion.
The most common side effects of Humulin R U-500 include:
•
low blood sugar (hypoglycemia), allergic reactions including reactions at your injection site, skin thickening or pits at
the injection site (lipodystrophy), itching, and rash.
These are not all of the possible side effects of Humulin R U-500. Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.
General Information about the safe and effective use of Humulin R U-500
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use
Humulin R U-500 for a condition for which it was not prescribed. Do not give Humulin R U-500 to other people, even if
they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Humulin R U-500. If you would like
more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information
about Humulin R U-500 that is written for healthcare professionals. For more information go to www.humulin.com or call
1-800-545-5979.
What are the ingredients in Humulin R U-500?
Active ingredient: human insulin
Inactive ingredients: glycerin, metacresol, zinc oxide, water for injection, sodium hydroxide and hydrochloric acid
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
For more information about Humulin R U-500 go to www.humulin.com.
Copyright © 2015, 2016 Eli Lilly and Company. All rights reserved.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: July 2016
Reference ID: 3956468
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Instructions for Use
HUMULIN® R U-500 KwikPen®
insulin human injection U-500 (500 units/mL, 3 mL pen) usage illustration
Important:
•
Know your dose of HUMULIN R U-500 insulin. The Pen delivers your dose in insulin units. Insulin
units may not be the same as syringe markings. Ask your health care provider what your dose
should be for your Pen.
•
Your HUMULIN® R U-500 KwikPen® (Pen) works differently from other pens. It dials 5 insulin units
with each click. Do not count clicks of the dose knob to select your dose. You may not get
enough insulin or you may get too much insulin.
•
HUMULIN R U-500 is a concentrated insulin. Do not transfer HUMULIN R U-500 insulin from
your Pen into a syringe. A severe overdose can happen, causing very low blood sugar, which
may put your life in danger. usage illustration
DO NOT TRANSFER TO A SYRINGE
SEVERE OVERDOSE CAN RESULT
Read the Instructions for Use before you start taking HUMULIN R U-500 and each time you get another Pen.
There may be new information. This information does not take the place of talking to your healthcare provider
about your medical condition or your treatment.
Do not share your HUMULIN R U-500 Pen with other people, even if the needle has been changed. You
may give other people a serious infection or get a serious infection from them.
HUMULIN R U-500 KwikPen (“Pen”) is a disposable prefilled pen containing 1500 units of HUMULIN R. You can
give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 5 units of insulin. You can
give from 5 to 300 units in a single injection. The plunger only moves a little with each injection, and you may not
notice that it moves. The plunger will only reach the end of the cartridge when you have used all 1500 units in the
Pen.
This Pen is not recommended for use by the blind or visually impaired without the help of someone
trained to use the Pen.
Reference ID: 3956468
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2
KwikPen Parts
Pen Cap
Cartridge Holder
Label
Dose Indicator usage illustration
Cap Clip
Rubber Seal
Plunger
Pen Body
Dose
Window
Dose
Knob
Pen Needle Parts
(Needles Not Included)
Needle
Dose Knob
Raised ridges
on end usage illustration
Outer Needle
Inner Needle
Paper Tab
Shield
Shield
How to recognize your HUMULIN R U 500 KwikPen
• Pen color:
Aqua
• Dose Knob:
Aqua with raised ridges on the end
• Label:
HUMULIN R U-500 and 500 units/mL in a green box
Supplies needed to give your injection
•
HUMULIN R U-500 KwikPen
•
KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
•
Alcohol swab
Preparing your Pen
•
Wash your hands with soap and water.
•
Check the Pen to make sure you are taking the right type of insulin. This is especially important if you use
more than 1 type of insulin.
•
Do not use your Pen past the expiration date printed on the Label or for more than 28 days after you first start
using the Pen.
•
Always use a new Needle for each injection to help prevent infections and blocked Needles. Do not
reuse or share your needles with other people. You may give other people a serious infection or get a
serious infection from them.
Reference ID: 3956468
3
Step 1:
•
Pull the Pen Cap straight off.
– Do not remove the KwikPen Label.
•
Wipe the Rubber Seal with an alcohol swab.
HUMULIN R U-500 should look clear and
colorless. Do not use if it is cloudy, colored, or has
particles or clumps in it. usage illustration
Step 2:
•
Select a new Needle.
•
Pull off the Paper Tab from the Outer Needle
Shield. usage illustration
Step 3:
•
Push the capped Needle straight onto the Pen
and twist the Needle on until it is tight. usage illustration
Step 4:
•
Pull off the Outer Needle Shield. Do not throw
it away.
•
Pull off the Inner Needle Shield and throw it
away. usage illustration
Priming your Pen
Prime before each injection.
•
Priming your Pen means removing the air from the Needle and Cartridge that may collect during normal use
and ensures that the Pen is working correctly.
•
If you do not prime before each injection, you may get too much or too little insulin.
Step 5:
•
To prime your pen, turn the Dose Knob to
select 5 units. usage illustration
Step 6:
•
Hold your Pen with the Needle pointing up.
Tap the Cartridge Holder gently to collect air
bubbles at the top. usage illustration
Reference ID: 3956468
4
Step 7:
•
Continue holding your Pen with Needle
pointing up. Push the Dose Knob in until it
stops, and “0” is seen in the Dose Window.
Hold the Dose Knob in and count to 5 slowly.
You should see insulin at the tip of the Needle.
– If you do not see insulin, repeat priming
steps 5 to 7, no more than 8 times.
– If you still do not see insulin, change the
Needle and repeat priming steps 5 to 7.
Small air bubbles are normal and will not affect
your dose. usage illustration
Selecting your dose
This Pen has been made to deliver the dose in insulin units that is shown in the Dose W indow. Ask your
healthcare provider what your dose should be for this Pen.
•
You can give from 5 to 300 units in a single injection.
•
If your dose is more than 300 units, you will need to give more than 1 injection.
– If you need help with dividing up your dose the right way, ask your healthcare provider.
– You must use a new Needle for each injection and repeat the priming step.
Reference ID: 3956468
5
Step 8:
•
Turn the Dose Knob to select the number of
units you need to inject. The Dose Indicator
should line up with your dose.
– The Dose Knob clicks as you turn it. Each
click of the Dose Knob dials 5 insulin
units at a time.
– Do not dial your dose by counting the
clicks. You may dial the wrong dose.
This may lead to you getting too much
insulin or not enough insulin.
– The dose can be corrected by turning the
Dose Knob in either direction until the
correct dose lines up with the Dose
Indicator.
– The even numbers (for example, 80) are
printed on the dial.
– The odd numbers (for example, 125) are
shown as lines between the even
numbers.
•
Always check the number in the Dose
Window to make sure you have dialed the
correct dose. usage illustration
Example: 80 units
shown in Dose W indow
Example: 125 units
shown in Dose W indow usage illustration
•
The Pen will not let you dial more than the number of units left in the Pen.
•
If your dose is more than the number of units left in the Pen, you may either:
– inject the amount left in your Pen and then use a new Pen to give the rest of your dose,
or
– get a new Pen and inject your full dose.
•
It is normal to see a small amount of insulin left in the Pen that you cannot inject. Do not transfer this to a
syringe. Severe overdose can happen.
Reference ID: 3956468
6
Giving your injection
•
Inject your insulin as your healthcare provider has shown you.
•
Change (rotate) your injection site for each injection.
•
Do not try to change your dose while injecting.
Step 9:
•
Choose your injection site.
HUMULIN is injected under the skin
(subcutaneously) of your stomach area,
buttocks, upper legs or upper arms.
•
Wipe your skin with an alcohol swab, and let
your skin dry before you inject your dose. usage illustration
Step 10:
•
Insert the Needle into your skin.
•
Push the Dose Knob all the way in.
•
Continue to hold the Dose
Knob in and slowly count to 5
before removing the Needle. usage illustration
5sec
Do not try to inject your insulin by turning the Dose
Knob. You will not receive your insulin by turning
the Dose Knob. usage illustration
Reference ID: 3956468
7
Step 11:
•
Pull the Needle out of your skin.
– A drop of insulin at the Needle tip is
normal. It will not affect your dose.
•
Check the number in the Dose W indow.
– If you see “0” in the Dose Window, you
have received the full amount you dialed.
– If you do not see “0” in the Dose W indow,
do not redial. Insert the Needle into your
skin and finish your injection.
– If you still do not think you received the full
amount you dialed for your injection, do
not start over or repeat your injection.
Monitor your blood glucose as instructed
by your healthcare provider.
The Plunger only moves a little with each injection,
and you may not notice that it moves.
If you see blood after you take the Needle out of
your skin, press the injection site lightly with a
piece of gauze or an alcohol swab. Do not rub the
area. usage illustration
After your injection
Step 12:
•
Carefully replace the Outer Needle Shield. usage illustration
Step 13:
•
Unscrew the capped Needle and throw it away
(see Disposing of Pens and Needles
section).
•
Do not store the Pen with the Needle attached
to prevent leaking, blocking the Needle, and air
from entering the Pen. usage illustration
Step 14:
•
Replace the Pen Cap by lining up the Cap Clip
with the Dose Indicator and pushing straight
on. usage illustration
Disposing of Pens and Needles
•
Put your used Needles in a FDA-cleared sharps disposal container right away after use. Do not throw away
(dispose of) loose Needles in your household trash.
Reference ID: 3956468
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8
•
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
– made of a heavy-duty plastic,
– can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
– upright and stable during use,
– leak-resistant, and
– properly labeled to warn of hazardous waste inside the container.
•
When your sharps disposal container is almost full, you will need to follow your community guidelines for the
right way to dispose of your sharps disposal container. There may be state or local laws about how you
should throw away used needles and syringes. For more information about safe sharps disposal, and for
specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
http://www.fda.gov/safesharpsdisposal
•
Do not dispose of your used sharps disposal container in your household trash unless your community
guidelines permit this. Do not recycle your used sharps disposal container.
•
The used Pen may be discarded in your household trash after you have removed the needle.
Storing your Pen
Unused Pens
•
Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
•
Do not freeze HUMULIN R U-500. Do not use if it has been frozen.
•
Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the
refrigerator.
In-use Pen
•
Store the Pen you are currently using at room temperature up to 86°F (30°C). Keep away from heat and light.
•
Throw away the Pen you are using after 28 days, even if it still has insulin left in it.
What you should know if you are switching to HUMULIN R U 500 KwikPen
Ask your healthcare provider what your dose should be for your Pen in insulin units. Always follow your
healthcare provider’s instructions for dosing.
If you are:
It is important to know:
Switching from
HUMULIN R U-500 vial
(and syringe)
Your Pen may measure your dose differently. The markings in the Dose
Window may not be the same as the markings on the syringe you used in
the past.
Ask your healthcare provider what dose in insulin units you should
dial on your Pen.
Switching from another
type of insulin device or
pen.
The HUMULIN R U-500 KwikPen is different from other pens. It dials 5
insulin units with each click of the Dose Knob.
Do not select your dose by counting clicks. You may not get enough
insulin or you may get too much insulin.
General information about the safe and effective use of your Pen
•
Keep your Pen and Needles out of the sight and reach of children.
•
Do not use your Pen if any part looks broken or damaged.
•
Always carry an extra Pen in case yours is lost or damaged.
Reference ID: 3956468
A4.0-LINRU500-0000-IFU-20151229
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Troubleshooting
•
If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap straight off.
•
If it is hard to push the Dose Knob:
–
Pushing the Dose Knob more slowly will make it easier to inject.
–
Your Needle may be blocked. Put on a new Needle and prime the Pen.
–
You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.
If you have any questions or problems with your HUMULIN R U-500 KwikPen, contact Lilly at 1-800-LillyRx
(1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN R U-500 KwikPen
and insulin, go to www.humulin.com.
Scan this code to launch
www.humulin.com
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
HUMULIN® and HUMULIN® KwikPen® are trademarks of Eli Lilly and Company.
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
Copyright © 2015, Eli Lilly and Company. All rights reserved.
HUMULIN R U-500 KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1:2014.
Document revision date: December 29, 2015
Lilly (red script)
Reference ID: 3956468
1
Instructions for Use
Humulin® R U-500
insulin human injection (500 units/mL, 20 mL vial)
Please read these instructions before use.
Warnings
• For your safety, always inject Humulin® R U-500 insulin with a U-500 syringe.
• If you use another kind of syringe, you may get a dangerous overdose.
Needle Shield
(green)
Needle
Plunger
Syringe
Body
U-500 Symbol
(green)
85 units shown
at Plunger Tip
Plunger Rod
U-500 syringe – for single injection only
The U-500 syringe has a green U-500 symbol and a green Needle Shield on the syringe.
Important Information
• Humulin R U-500 is a concentrated insulin.
• Know your dose. Your health care provider will tell you the number of insulin units that you
should take.
• Always inject Humulin R U-500 insulin with a U-500 syringe. Other syringes will not
measure your dose correctly.
• If you use the wrong syringe, you can give yourself a severe overdose. This can cause
very low blood sugar, which may put your life in danger. For example, using a U-100
syringe can give you a 5 times overdose.
• If you do not have a U-500 syringe, you should contact your health care provider or pharmacist.
Additional Safety Information
• Each line on the U-500 syringe measures 5 units of U-500 insulin.
• You can give from 5 to 250 units in one injection.
• If your dose is more than 250 units, you will need to give more than 1 injection.
• Make sure you know how to draw up your dose with a U-500 syringe. If you need help, call your
health care provider.
• Do not reuse your U-500 syringe.
Reference ID: 3956468
2
• Do not share your U-500 syringes with other people. You may give other people a serious
infection or get a serious infection from them.
• Do not mix Humulin R U-500 with other insulins in the same syringe.
• You can get more instructions by calling Lilly at 1-800-LillyRx (1-800-545-5979).
Supplies
Protective Cap
• Humulin R U-500 vial
Rubber Stopper
• U-500 Syringe
(under Cap)
(BD [Becton, Dickinson
and Company] syringes
recommended)
• 2 alcohol swabs
Green 500 units/mL
• 1 sharps container
symbol
Before You Start
• Check your vial. Make sure it says Humulin R U-500.
• Check the expiration date on the vial. Do not use it if it is expired. Throw away the opened vial
after 40 days, even if there is still insulin left in the vial.
• See if the insulin in the vial is clear. Do not use if it is thick, cloudy, or colored or has solid
particles.
• Make sure you have a new U-500 Syringe. Check for the green U-500 symbol and green Needle
Shield.
• Check your supply. Make sure you have enough Humulin R U-500 insulin and U-500 syringes for
several injections. Always reorder before you run out.
• Check with your health care provider if you have any questions.
Use only a U-500 syringe to inject Humulin R U-500 insulin
Reference ID: 3956468
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3
Prepare
• Wash your hands with soap and water.
• Always use a new syringe for each injection to help prevent infections and blocked needles.
Step 1:
Find the line on the U-500 syringe that
matches your prescribed dose. This is your
Dose Line.
Each line is 5 units.
Step 2:
If you are using a new vial, pull off the plastic
Protective Cap.
Do not remove the Rubber Stopper.
Step 3:
Wipe the Rubber Stopper with an alcohol
swab.
Step 4:
Hold the syringe with the Needle pointing up.
Pull down on the Plunger Rod until the Plunger
Tip reaches your Dose Line.
Step 5:
Push the Needle through the Rubber Stopper
of the vial.
Reference ID: 3956468
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Step 6:
Push the Plunger all the way in. This puts air
into the vial.
Step 7:
Turn the vial and syringe upside down and
slowly pull the Plunger down until the Plunger
Tip is past your Dose Line.
If there are air bubbles, tap the syringe gently
a few times. This lets the air bubbles rise to the
top.
Step 8:
Slowly push the Plunger up until the Plunger
Tip reaches your Dose Line.
Check the syringe to make sure that you have
the right dose.
Step 9:
Pull the syringe out of the vial’s Rubber
Stopper.
Inject
• Inject your insulin exactly as your healthcare provider has shown you.
• Change (rotate) your injection site for each injection.
Reference ID: 3956468
u
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5
Step 10:
Choose your injection site.
Humulin R U-500 is injected under the skin
(subcutaneously). You may inject into your
stomach area, buttocks, upper legs, or upper
arms.
Wipe the skin with an alcohol swab. Let the
injection site dry before you inject your dose.
Step 11:
Insert the Needle into your skin.
Step 12:
Push down on the Plunger to inject your dose.
Then keep the Needle in your skin for at least
5 seconds, to make sure you have injected all
of your dose.
Step 13:
Pull the Needle out of your skin.
• You may see blood after you take the
Needle out of your skin. This is normal.
Press the injection site lightly with a piece of
gauze or an alcohol swab. Do not rub the
area.
• Do not put the Needle Shield back on the
Needle, because you may get a needle stick
injury.
Disposal of used syringes
• Put your used syringes in a FDA-cleared sharps disposal container right away after use. Do
not throw away (dispose of) syringes in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household
container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come
out,
- upright and stable during use,
- leak-resistant, and
Reference ID: 3956468
6
- properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to
follow your community guidelines for the right way to dispose of your
sharps disposal container. There may be state or local laws about
how you should throw away used needles and syringes. For more
information about safe sharps disposal, and for specific information
about sharps disposal in the state that you live in, go to the FDA’s
website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your
household trash unless your community guidelines permit this. Do not recycle your used
sharps disposal container. usage illustration
Storage and Handling
• Keep away from heat and out of direct light.
• Do not shake the vial.
Unopened vials:
• Store unopened vials in the refrigerator.
• Do not freeze Humulin R U-500. If it has been frozen, do not use it.
• If unopened vials have been stored in the refrigerator, you may use them until the expiration
date.
After the vial has been opened:
• Store opened vials in the refrigerator or at room temperature (less than 86°F [30°C]) for up to 40
days.
• Throw away the opened vial after 40 days, even if there is still insulin left in the vial.
General Information usage illustration
• Always use a U-500 syringe to inject Humulin R U-500 insulin.
• Never use other syringes. The lines and numbers on other syringes will not measure your
dose correctly.
• You can give yourself the wrong dose if you use any other syringe, such as a U-100,
tuberculin or allergy syringe.
For example, a U-100 syringe is made to measure U-100 insulin. If you use a U-100 Syringe
for your U-500 dose, you can give yourself a 5 times overdose.
• Do not make any changes to your dose or the type of insulin you use unless you are told to do
so by your health care provider.
• Keep your vials and syringes out of the sight and reach of children.
Reference ID: 3956468
A4.0-LINR500VL-0002-IFU-YYYYMMDD
7
Frequently Asked Questions
• Why do I need to use a U-500 syringe?
Humulin R U-500 insulin and a U-500 syringe work together to help you inject the correct dose.
Using any other syringe may result in dosing mistakes. This may put your life in danger.
• Do I have to convert my Humulin R U-500 insulin dose when I use the U-500 syringe?
No, you do not have to convert your dose. Your health care provider should tell you how much
Humulin R U-500 insulin to take in units and when to take it. Your health care provider should
show you how to draw up your dose using the U-500 syringe.
• What should I do if I run out of U-500 syringes?
If you run out of U-500 syringes, do not use any other syringe to inject Humulin R U-500 insulin.
Call your health care provider or pharmacist for help. You may also call Lilly at 1-800-Lilly-Rx
(1-800-545-5979).
Where to get more information and help
• If you have any questions about Humulin R U-500 insulin or U-500 syringes, contact Lilly at
1-800-Lilly-Rx (1-800-545-5979).
• You can also call your health care provider or pharmacist.
• For more information on Humulin R U-500 insulin, go to www.humulin.com
Scan this code to launch the humulin.com website
These Instructions for Use have been approved by the U.S. Food and Drug
Administration.
Humulin® is a trademark of Eli Lilly and Company.
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1996, 2016, Eli Lilly and Company. All rights reserved.
Literature issued: July 2016
Lilly (red script)
Reference ID: 3956468
| custom-source | 2025-02-12T13:43:19.755469 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 153} |
1,074 | " \n \n \nA3.03 NL 5990 AMP \n \n \n \nINFORMATION FOR THE PHYSICIAN \nHUMULIN® R \nREGULAR \nINS(...TRUNCATED) | custom-source | 2025-02-12T13:43:19.837218 | "{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf', 'application_(...TRUNCATED) |
1,082 | " \n1 \n \nA3.0 NL 3680 AMP \n1 \nINFORMATION FOR THE PATIENT \n2 \n3 ML DISPOSABLE INSULIN DELIVERY(...TRUNCATED) | custom-source | 2025-02-12T13:43:19.969401 | "{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781scm074_humulin_lbl.pdf', 'ap(...TRUNCATED) |
1,077 | " \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \(...TRUNCATED) | custom-source | 2025-02-12T13:43:20.081784 | "{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf', 'applicat(...TRUNCATED) |
1,083 | " \n \n5.01 PA 9135 FSAMP \n1 \nINFORMATION FOR THE PATIENT \n2 \n3 ML DISPOSABLE INSULIN DELIVERY D(...TRUNCATED) | custom-source | 2025-02-12T13:43:20.185797 | "{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781slr076_humulin_lbl.pdf', 'ap(...TRUNCATED) |
1,085 | "This label may not be the latest approved by FDA. \nFor current labeling information, please visit(...TRUNCATED) | custom-source | 2025-02-12T13:43:20.188077 | "{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf', 'app(...TRUNCATED) |
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