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County Trails
Suffolk is a peaceful rural county on the east coast of England, accessible from London in just over an hour from road and rail.
Miles of beautiful and sometimes wild coast line are lined with sandy beaches and offer far reaching views. The sights and sounds of the sea stretch from the Essex border up to beyond Lowestoft where Suffolk meets its neighbour, Norfolk.
Suffolk Overview
Welcome to Suffolk
The rural nature of Suffolk is a backdrop for rolling countryside, pretty medieval villages with attractive churches and timber framed houses large and small and colourful coastal locations such as Orford, Aldeburgh and Southwold. Suffolk is an ideal location for those seeking some quiet time to explore the English countryside, beaches or forests such Rendlesham, Tunstall and Thetford, at their own pace, with plenty of RSPB sites and areas for birdwatching and fishing.
You can see Anglo Saxon remains at Sutton Hoo, medieval Abbey ruins in Bury St Edmunds and the development of modern radar at Orford. If more lively family entertainment is on the agenda then head to the resort of Felixstowe for traditional seaside fun. There are plenty of theatres throughout Suffolk, and the county town of Ipswich hosts swimming pools, trampolining, go-karting and a ski slope.
Suffolk is well known for locally sourced food and drink with restaurants serving specialities such as Gressingham Duck, Dingley Dell Pork, Aspall Cyder and the breweries of Greene King and Adnams. You can always find a great spot to eat with restaurants and pubs (some of which are dog friendly) scattered across the county from the historic villages of Lavenham, Hadleigh to the larger towns of Woodbridge, Bury St. Edmunds and Newmarket.
The county of Suffolk in East Anglia sits on the east coast of England bordering Essex, Norfolk and Cambridgeshire and has a population of 750,000 people. Ipswich is the county town of Suffolk, with other significant towns at Lowestoft, Bury St. Edmunds, Newmarket, Saxmundham, Stowmarket, and Woodbridge.
The county has over 40 miles of heritage coast line in an Area of Outstanding Natural beauty and combines pretty villages, rolling countryside and coastal views from the beautiful beaches, many of which are dog friendly.
Suffolk has a long rich history with a wide range of historical places to visit. As a coastal county, Suffolk has been both an important trading location and the site of numerous invasions, which can be seen from the presence of Martello Towers.
The National Trust site at Sutton Hoo is one of the UK's most important historic sites in the UK containing 6th and 7th century cemeteries, many artefacts and treasures, along with a 1400 year old Anglo-Saxon burial ship.
Starting in the 14th century with the migration of Flemish weavers seeking a more tolerant society the county had a prominent place in the wool trade and the towns and villages of Lavenham, Clare, Hadleigh and Long Melford provide a great trail to explore.
Along with having a history in wool and silk manufacturing, the town of Sudbury also boasts an incredible 242 listed buildings as well as being the birthplace of the artist Thomas Gainsborough.
Lavenham, one of the most historical villages in the country with about 340 listed buildings is home to De Vere house, the fictional birthplace of Harry Potter. You can learn more about specific areas in Suffolk by visiting one of the many museums or tourist information centres.
Places to visit in Suffolk
Today the Edwardian town of Felixstowe is a mixture of tradition with seafront promenade and listed gardens supported by the backdrop of the largest container port in the country.
Ipswich has undergone a transformation in recent years with a thriving waterfront hosting many events, festivals and places to eat and drink. The town itself retains a sense of history with buildings dating back to the 11th century and Christchurch Mansion. A bronze statue dedicated to Giles the cartoonist sits in the town centre, just off the Cornhill theatre building.
The spectacular heritage coast is lined with pretty and historic towns and villages. Visitors can explore a host of attractions including historical steam trains and railways, the 12th Century castle keep at Orford, the Concert Hall and craft shops of Snape, the boating mere at Thorpeness or the charming seaside resorts of Aldeburgh and Southwold. The market town of Framlingham now enjoys huge recognition following Ed Sheeran's hit Castle on the Hill. Woodbridge is a delightful place to spend the day with many restaurants and sights to enjoy including the historic Tide Mill dating back over 800 years and is now the largest commercially working tide mill in the country.
In the west of the county Bury St. Edmunds is an historic market town, with a great choice of days out, including the St. Edmundsbury cathedral and Abbey Gardens.
Suffolk's famous names include the painters Gainsborough and Constable with Dedham Vale the scene of the iconic Hay Wain painting. Art fans wishing to see more can visit one of the many art exhibitions. The composer Benjamin Britten was born in Lowestoft and helped found the both the annual Aldeburgh Festival and the Concert Hall at Snape Maltings. There are many venues such as this throughout Suffolk where visitors can enjoy musical events and concerts.
Suffolk has had its fair share of sporting success. Newmarket is home to the Sport of Kings as the centre of British horse racing and is a great day out for all the family either watching a race or visiting the National Horse Racing Museum, followed by a meal at one of the family friendly restaurants. Ipswich Town Football Club has seen two managers – Sir Alf Ramsey and Sir Bobby Robson enjoy success and go on to manage the England national team.
With 9,800 rights of way, 12,000 acres of open access land, miles of cycling routes, including 2 National Cycle Network routes Suffolk is a great destination to explore, whether on foot, or by horse riding or cycling. The picturesque rivers of the Deben, Orwell and Stour host a wide variety of natural walks, water sports and places to relax and enjoy the scenery whilst having a bite to eat, or something to drink at a pub, or even stopping somewhere nice for a picnic. The areas of Debenham, Eye, Shotley Peninsula, Bawdsey Quay, Pakefield, and Yoxford also provide plenty of serene areas for a relaxed walk.
Suffolk has an array of annual festivals and events, from regular local markets and farmers markets to the well-established 2 day Suffolk Show and the popular Latitude Festival. A new addition in 2017 is Suffolk Day on the 21st June which sees a number of celebratory activities and events across the county.
Click here to find more things to do in Suffolk or read our what's on in Suffolk guide for the latest events in the area.
Despite being on the coast, Suffolk is well connected to the rest of the country. The mainline railway from London Liverpool Street reaches the county town of Ipswich in 1hr 15 mins, Ipswich providing a hub to explore the county by rail. For more information visit Trainline.
The road network provides access to the county via the A12, A14, M11 and A11. Suffolk is also well served by air with airports at Stansted and Southend in neighbouring Essex.
Once in the area, there is plenty of accommodation to choose from, including bed and breakfasts, caravan parks, camp sites, and even dog friendly places to stay.
Click here to go back to The Tourist Trail homepage.
Exploring Suffolk
Browse our Suffolk Guides
What's on in Suffolk
Attractions in Suffolk
Fetes, Fairs & Shows in Suffolk
Car Boot Sales in Suffolk
Suffolk School Holiday Dates
Children's Rainy Day Activities in Suffolk
What's on in Ipswich
Things to do in Ipswich
A Guide to Mildenhall
A Guide to Beccles
Things to do in Woodbridge
A Guide to Kessingland
A Guide to Halesworth
Days Out in Suffolk
Rainy Day Activities in Suffolk
A Guide to Dunwich
A Guide to Walberswick
Popular Trails in Suffolk
The Talbot Trail
Suffolk Vineyards
Heart of Ipswich
Constable Country
View all trails in Suffolk
Businesses in Suffolk
Check out these great places to visit in Suffolk
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Upcoming Events in Suffolk
Wedding Open Day – Hintlesham Golf Club | January
Hintlesham Golf Club | Suffolk
Hintlesham, Ipswich , Suffolk, IP8 3JG


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Merjeuli (; ; ) es un pueblo que pertenece a la parcialmente reconocida República de Abjasia, parte del distrito de Gulripshi, aunque de iure pertenece al municipio de Gulripshi de la República Autónoma de Abjasia de Georgia.

Geografía
Merjeuli se encuentra a orillas del río Machara y está a 11 km al norte de Gulripshi. Al norte, Merjeuli limita con las localidades de Tsebelda y Bagmarani; al este con Vladimirovka y al sur con Machara y Pshapi.

Historia
En el pueblo se han encontrado fragmentos de cerámica griega, que datan del siglo VI a. C. Durante siglos, el pueblo conservó la importancia de una especie de caravasar.

La población abjasia de Merjeuli y aldeas aledañas sufrió constantes deportaciones o masacres (normalmente conocidos como Muhayir o genocidio circasiano) de sus habitantes en el marco de la guerra ruso-circasiana. La mayoría de la población nativa de Abjasia central fue víctima de la limpieza étnica. De hecho, el censo de 1886 reflejaba la escasa población de origen abjasio (solo 20 habitantes) en el pueblo de Merjeuli.

Tras las deportaciones y matanzas de la mayoría de los habitantes originarios durante la segunda mitad del , se estableció una nueva población en Merjeuli compuesta en su mayoría por mingrelianos y rusos, que coexistieron con los pocos abjasios que quedaron. La mayoría de estos pobladores eran campesinos.

Tras el genocidio armenio perpetrado por el Imperio otomano, muchos armenios y hamshenis se establecieron en Merjeuli, principalmente armenios procedentes de la actual Trebisonda (Turquía). Durante el período soviético, la población rusa disminuyó constantemente, mientras que los mingrelianos y armenios aumentaron constantemente. En el pueblo se construyeron una escuela secundaria armenio-georgiana y una escuela primaria armenia. Además, aquí se ubicaron una biblioteca, una casa de la cultura, un centro de salud y una empresa de servicios públicos.

Tras el final de la guerra en Abjasia en 1993, casi toda la población mingreliana y georgiana fue forzada a huir de sus hogares (o incluso masacrada) tras la retirada de las Fuerzas Armadas de Georgia.

Demografía
La evolución demográfica de Merjeuli entre 1886 y 2011 fue la siguiente:La población ha perdido casi un 80% de su población tras la guerra de abjasia. En el pasado la mayoría de la población era georgiana y armenios, pero en la actualidad la gran mayoría son armenios (con una minoría de abjasios y georgianos).

Personajes ilustres
 Lavrenti Beria (1899-1953): dirigente político comunista de la Unión Soviética y jefe de la policía y el servicio secreto (NKVD) desde 1938 hasta 1953.
 Mijáil Lakerbaj (1901-1965): escritor, dramaturgo, crítico de teatro y soldado.

Referencias

Abjasia
Localidades de Abjasia
Localidades del distrito de Gulripshi
Georgia

redpajama_set_name: RedPajamaWikipedia


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How to Patent Your Invention in the Philippines
by Atty. Joseph Plazo | Apr 29, 2015 | Commercial Law
Discovered the next water car? Make sure you protect it. But before proceeding to the patent office, take note of the law.
1. PATENTABLE MATTERS
Patentable Inventions. — Any technical solution of a problem in any field of human activity which is new, involves an inventive step and is industrially applicable shall be Patentable. It may be, or may relate to, a product, or process, or an improvement of any of the foregoing. (Section 21)
Non-Patentable Inventions. — The following shall be excluded from patent protection:
22.1. Discoveries, scientific theories and mathematical methods;
22.2. Schemes, rules and methods of performing mental acts, playing games or doing business, and programs for computers;
22.3. Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. This provision shall not apply to products and composition for use in any of these methods;
22.4. Plant varieties or animal breeds or essentially biological process for the production of plants or animals. This provision shall not apply to micro-organisms and non-biological and microbiological processes.
Provisions under this subsection shall not preclude Congress to consider the enactment of a law providing sui generis protection of plant varieties and animal breeds and a system of community intellectual rights protection:
22.5. Aesthetic creations; and
22.6. Anything which is contrary to public order or morality. (Section 22)
2. NOVELTY REQUIREMENT
Novelty. — An invention shall not be considered new if it forms part of a prior art. (Section 23)
Prior Art. — Prior art shall consist of:
24.1. Everything which has been made available to the public anywhere in the world, before the filing date or the priority date of the application claiming the invention; and
24.2. The whole contents of an application for a patent, utility model, or industrial design registration, published in accordance with this Act, filed or effective in the Philippines, with a filing or priority date that is earlier than the filing or priority date of the application: Provided, That the application which has validly claimed the filing date of an earlier application under Section 31 of this Act, shall be prior art with effect as of the filing date of such earlier application: Provided further, That the applicant or the inventor identified in both applications are not one and the same. (Section 24)
3. NON-PREJUDICIAL DISCLOSURE
The disclosure of information contained in the application during the twelve (12) months preceding the filing date or the priority date of the application shall not prejudice the applicant on the ground of lack of novelty if such disclosure was made by:
The inventor;
A patent office and the information was contained (a) in another application filed by the inventor and should not have been disclosed by the office, or (b) in an application filed without the knowledge or consent of the inventor by a third party which obtained the information directly or indirectly from the inventor; or
A third party which obtained the information directly or indirectly from the inventor. (Section 25.1)
25.2. For the purposes of Subsection 25.1, "inventor" also means any person who, at the filing date of application, had the right to the patent. (n)
4. INVENTIVE STEP
Inventive Step. — An invention involves an inventive step if, having regard to prior art, it is not obvious to a person skilled in the art at the time of the filing date or priority date of the application claiming the invention. (Section 26)
5. INDUSTRIAL APPLICABILITY REQUIREMENT
Industrial Applicability. — An invention that can be produced and used in any industry shall be industrially applicable. (n)
6. RIGHT TO A PATENT
Right to a Patent. — The right to a patent belongs to the inventor, his heirs, or assigns. When two (2) or more persons have jointly made an invention, the right to a patent shall belong to them jointly. (Section 28)
7. FIRST-TO-FILE RULE
If two (2) or more persons have made the invention separately and independently of each other, the right to the patent shall belong to the person who filed an application for such invention, or where two or more applications are filed for the same invention, to the applicant who has the earliest filing date or, the earliest priority date. (Section 29)
8. OWNERSHIP OF COMMISSIONED WORK
30.1. The person who commissions the work shall own the patent, unless otherwise provided in the contract.
30.2. In case the employee made the invention in the course of his employment contract, the patent shall belong to:
The employee, if the inventive activity is not a part of his regular duties even if the employee uses the time, facilities and materials of the employer.
The employer, if the invention is the result of the performance of his regularly-assigned duties, unless there is an agreement, express or implied, to the contrary. (Section 30)
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9. RIGHT OF PRIORITY
An application for patent filed by any person who has previously applied for the same invention in another country which by treaty, convention, or law affords similar privileges to Filipino citizens, shall be considered as filed as of the date of filing the foreign application: Provided, That:
the local application expressly claims priority;
it is filed within twelve (12) months from the date the earliest foreign application was filed; and
a certified copy of the foreign application together with an English translation is filed within six (6) months from the date of filing in the Philippines. (Section 31)
10. UNITY OF INVENTION
38.1. The application shall relate to one invention only or to a group of inventions forming a single general inventive concept.
38.2. If several independent inventions which do not form a single general inventive concept are claimed in one application, the Director may require that the application be restricted to a single invention. A later application filed for an invention divided out shall be considered as having been filed on the same day as the first application: Provided, That the later application is filed within four (4) months after the requirement to divide becomes final or within such additional time, not exceeding four (4) months, as may be granted: Provided further, That each divisional application shall not go beyond the disclosure in the initial application.
38.3. The fact that a patent has been granted on an application that did not comply with the requirement of unity of invention shall not be a ground to cancel the patent. (Section 38)
11. PUBLICATION OF PATENT APPLICATIONS
44.1. The patent application shall be published in the IPO Gazette together with a search document established by or on behalf of the Office citing any documents that reflect prior art, after the expiration of eighteen ( 18) months from the filing date or priority date.
44.2. After publication of a patent application, any interested party may inspect the application documents filed with the Office.
44.3. The Director General subject to the approval of the Secretary of Trade and Industry, may prohibit or restrict the publication of an application, if in his opinion, to do so would be prejudicial to the national security and interests of the Republic of the Philippines. (Section 44)
12. STATUS BEFORE PUBLICATION
A patent application, which has not yet been published, and all related documents, shall not be made available for inspection without the consent of the applicant. (Section 45)
13. RIGHTS CONFERRED BY PUBLICATION
(Section 46) The applicant shall have all the rights of a patentee under Section 76 against any person who, without his authorization, exercised any of the rights conferred under Section 71 of this Act in relation to the invention claimed in the published patent application, as if a patent had been granted for that invention: Provided, That the said person had:
46.1. Actual knowledge that the invention that he was using was the subject matter of a published application; or
46.2. Received written notice that the invention that he was using was the subject matter of a published application being identified in the said notice by its serial number: Provided, That the action may not be filed until after the grant of a patent on the published application and within four (4) years from the commission of the acts complained of. (n)
14. THIRD PARTY OBSERVATION
Following the publication of the patent application, any person may present observations in writing concerning the patentability of the invention. Such observations shall be communicated to the applicant who may comment on them. The Office shall acknowledge and put such observations and comment in the file of the application to which it relates. (Section 47)
15. SUBSTANTIVE EXAMINATION
SECTION 48. Request for Substantive Examination.
48.1. The application shall be deemed withdrawn unless within six (6) months from the date of publication under Section 41, a written request to determine whether a patent application meets the requirements of Sections 21 to 27 and Sections 32 to 39 and the fees have been paid on time.
48.2. Withdrawal of the request for examination shall be irrevocable and shall not authorize the refund of any fee. (n)
16. AMENDMENT OF APPLICATION
An applicant may amend the patent application during examination: Provided, That such amendment shall not include new matter outside the scope of the disclosure contained in the application as filed. (Section 49)
17. EFFECTIVE DATE OF PATENT
50.1. If the application meets the requirements of this Act, the Office shall grant the patent: Provided, That all the fees are paid on time.
50.2. If the required fees for grant and printing are not paid in due time, the application shall be deemed to be withdrawn.
50.3. A patent shall take effect on the date of the publication of the grant of the patent in the IPO Gazette. (Section 50)
18. TERM OF PATENT
Term of Patent. — The term of a patent shall be twenty (20) years from the filing date of the application. (Section 54)
19. CANCELLATION OF PATENT
61.1. Any interested person may, upon payment of the required fee, petition to cancel the patent or any claim thereof, or parts of the claim, on any of the following grounds:
That what is claimed as the invention is not new or Patentable;
That the patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by any person skilled in the art; or
That the patent is contrary to public order or morality.
61.2. Where the grounds for cancellation relate to some of the claims or parts of the claim, cancellation may be effected to such extent only. (Section 61)
20. REMEDY OF INVENTOR
If a person, who was deprived of the patent without his consent or through fraud is declared by final court order or decision to be the true and actual inventor, the court shall order for his substitution as patentee, or at the option of the true inventor, cancel the patent, and award actual and other damages in his favor if warranted by the circumstances. (Section 68)
RIGHTS OF PATENTEES AND INFRINGEMENT OF PATENTS
21. PATENT RIGHTS
Rights Conferred by Patent (Section 71)
71.1. A patent shall confer on its owner the following exclusive rights:
(a) Where the subject matter of a patent is a product, to restrain, prohibit and prevent any unauthorized person or entity from making, using, offering for sale, selling or importing that product;
(b) Where the subject matter of a patent is a process, to restrain, prevent or prohibit any unauthorized person or entity from using the process, and from manufacturing, dealing in, using, selling or offering for sale, or importing any product obtained directly or indirectly from such process.
71.2. Patent owners shall also have the right to assign, or transfer by succession the patent, and to conclude licensing contracts for the same. (Sec. 37, R.A. No. 165a)
22. LIMITATION OF PATENT RIGHTS
(Section 72) Limitations of Patent Rights. — The owner of a patent has no right to prevent third parties from performing, without his authorization, the acts referred to in Section 71 hereof in the following circumstances:
72.1. (DOCTRINE OF NATIONAL EXHAUSTION) Using a patented product which has been put on the market in the Philippines by the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market;
72.2. Where the act is done privately and on a non-commercial scale or for a non-commercial purpose: Provided, That it does not significantly prejudice the economic interests of the owner of the patent;
72.3. Where the act consists of making or using exclusively for the purpose of experiments that relate to the subject matter of the patented invention;
72.4. Where the act consists of the preparation for individual cases, in a pharmacy or by a medical professional, of a medicine in accordance with a medical prescription or acts concerning the medicine so prepared;
72.5. Where the invention is used in any ship, vessel, aircraft, or land vehicle of any other country entering the territory of the Philippines temporarily or accidentally: Provided, That such invention is used exclusively for the needs of the ship, vessel, aircraft, or land vehicle and not used for the manufacturing of anything to be sold within the Philippines. (Secs. 38 and 39, R.A. No. 165a)
23. PRIOR USER
73.1. Notwithstanding Section 72 hereof, any prior user, who, in good faith was using the invention or has undertaken serious preparations to use the invention in his enterprise or business, before the filing date or priority date of the application on which a patent is granted, shall have the right to continue the use thereof as envisaged in such preparations within the territory where the patent produces its effect.
73.2. The right of the prior user may only be transferred or assigned together with his enterprise or business, or with that part of his enterprise or business in which the use or preparations for use have been made. (Section 73)
24. USE OF INVENTION BY GOVERNMENT
SECTION 74. Use of Invention by Government.
74.1. A Government agency or third person authorized by the Government may exploit the invention even without agreement of the patent owner where:
(a) The public interest, in particular, national security, nutrition, health or the development of other sectors, as determined by the appropriate agency of the government, so requires; or
(b) A judicial or administrative body has determined that the manner of exploitation, by the owner of the patent or his licensee is anti-competitive.
74.2. The use by the Government, or third person authorized by the Government shall be subject, mutatis mutandis, to the conditions set forth in Sections 95 to 97 and 100 to 102. (Sec. 41, R.A. No. 165a)
25. DOCTRINE OF EQUIVALENTS
For the purpose of determining the extent of protection conferred by the patent, due account shall be taken of elements which are equivalent to the elements expressed in the claims, so that a claim shall be considered to cover not only all the elements as expressed therein, but also equivalents. (Section 75.2)
26. CIVIL ACTION FOR INFRINGEMENT
SECTION 76. CIVIL ACTION FOR INFRINGEMENT.
76.1. The making, using, offering for sale, selling, or importing a patented product or a product obtained directly or indirectly from a patented process, or the use of a patented process without the authorization of the patentee constitutes patent infringement.
76.2. Any patentee, or anyone possessing any right, title or interest in and to the patented invention, whose rights have been infringed, may bring a civil action before a court of competent jurisdiction, to recover from the infringer such damages sustained thereby, plus attorney's fees and other expenses of litigation, and to secure an injunction for the protection of his rights.
76.3. If the damages are inadequate or cannot be readily ascertained with reasonable certainty, the court may award by way of damages a sum equivalent to reasonable royalty.
76.4. The court may, according to the circumstances of the case, award damages in a sum above the amount found as actual damages sustained: Provided, That the award does not exceed three (3) times the amount of such actual damages.
76.5. The court may, in its discretion, order that the infringing goods, materials and implements predominantly used in the infringement be disposed of outside the channels of commerce or destroyed, without compensation.
76.6. Anyone who actively induces the infringement of a patent or provides the infringer with a component of a patented product or of a product produced because of a patented process knowing it to be especially adopted for infringing the patented invention and not suitable for substantial non-infringing use shall be liable as a contributory infringer and shall be jointly and severally liable with the infringer. (Sec. 42, R.A. No. 165a)
27. CRIMINAL ACTION FOR INFRINGEMENT
Criminal Action for Repetition of Infringement. — If infringement is repeated by the infringer or by anyone in connivance with him after finality of the judgment of the court against the infringer, the offenders shall, without prejudice to the institution of a civil action for damages, be criminally liable therefor and, upon conviction, shall suffer imprisonment for the period of not less than six (6) months but not more than three (3) years and/or a fine of not less than One hundred thousand pesos (P100,000) but not more than Three hundred thousand pesos (P300,000), at the discretion of the court. The criminal action herein provided shall prescribe in three (3) years from date of the commission of the crime. (Section 84)
28. NOTICE TO INFRINGER
Damages cannot be recovered for acts of infringement committed before the infringer had known, or had reasonable grounds to know of the patent. It is presumed that the infringer had known of the patent if on the patented product, or on the container or package in which the article is supplied to the public, or on the advertising material relating to the patented product or process, are placed the words "Philippine Patent" with the number of the patent. (Section 80)
Proceed With the Patent
Now, if your product satisfies the elements of an invention and is not prohibited above, then you must prepare the necessary documents which will be submitted with the IPO. They are:
1. Request for the Grant of Patent (this is a form provided by the IPO)
2. Description of the Invention (Specifications and Claims)
3. Formal Drawings
4. Filing Fee (Filing Fee=P1,800; Each sheet in excess of 30= P15 per sheet; Each claim in excess of 5= P150 per claim; Request for Substantive Examination= P1,750)
The description of the invention must contain the Abstract, Background of the Invention, Summary of the Invention, description of the drawings, detailed description of the invention and the claims. It must be emphasized that the claims are important because they enumerate the scope of the invention and the protection thereto.
For a quick view of the process, click here
4 Search Engines

redpajama_set_name: RedPajamaCommonCrawl


At OneTenth consulting, we want to hear from YOU - the end user, the administrator, the fundraiser, the major gift officer, the chief development officer, the CIO and all other stakeholders who work with or rely on your data every day.
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It is no surprise that CRM implementations have a high failure rate. And non-profits face another disadvantage where IT support and expertise is limited when on-boarding a new CRM system. As a result, the selected product often falls short of the strategic need of the organization, or it is implemented with "shortcuts" to meet tight timelines and budget. Often times, clients simply end up with a "product", without any best practices or knowledge transfer on how it can most effectively meet your organization's strategic needs. This is why OneTenth offers a holistic approach in addressing all facets of your technology needs - strategy, product, project management, and user adoption.
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Despite our deep experience and rich skill set, OneTenth understands that every nonprofit is different and faces unique challenges. OneTenth approaches each engagement with empathy and understanding. We do not consider ourselves just consultants, but instead, an extension of your team. Our aim is to partner with you on solutions that tie in to your mission, brand, and culture.


Original member, Singer and lead guitarist, Tony Hicks says: "People get what they come for. The trademark Hollies harmonies, our musical diversity and lots of original songs from our extensive musical back catalogue."
Hollies drummer since 1963, Bobby Elliott ... "We still tour the world performing to sell-out audiences. Our loyal fans keep coming back for more and we're happy to oblige. A Hollies live performance usually lasts for over two hours. There's no finer feeling than taking that final bow and seeing the sea of beaming friendly faces standing before us"
Motueka Library: Are You a Fiction Fiend?


text:
Franz svobodný pán von John (20. listopadu 1815 Bruck an der Leitha – 25. května 1876 Vídeň) byl rakousko-uherský generál a politik, v letech 1866–1868 ministr války Rakouského císařství (od roku 1867 oficiálně ministr války Rakouska-Uherska).

Biografie
V letech 1827–1835 vystudoval Tereziánskou vojenskou akademii. Vyřazen byl v hodnosti poručíka a přidělen k pěchotnímu pluku 52. Roku 1845 byl povýšen na nadporučíka, roku 1848 hejtmana a roku 1849 na majora. Během revoluce 1848-1849 v Rakouském císařství se účastnil tažení polního maršála Josefa Václava Radeckého z Radče v severní Itálii. Za své zásluhy získal roku 1850 Vojenský řád Marie Terezie. Po válce proti Piemontu byl jmenován náčelníkem štábu rakouské armády v Toskánsku. Od roku 1852 zastával post náčelníka štábu 8. sboru v Bologni. Nadále stoupal v hierarchii rakouské armády. Roku 1859 se účastnil války proti Francouzskému císařství a Piemontu coby náčelník štábu 6. sboru v jižním Tyrolsku. Po válce nastoupil jako náčelník štábu 2. armády ve Veroně, kde po něm byla postavena nová pevnost Fort John. Během války v roce 1866 působil coby náčelník štábu jižní armády a byl vyznamenán za své působení v bitvě u Custozy opět řádem Marie Terezie. V červenci 1866 usedl do funkce náčelníka generálního štábu celé armády.

Po konci války se stal v září 1866 náčelníkem generálního štábu. Zároveň byl od 6. září 1866 do 15. prosince 1867 ministrem války Rakouského císařství, přičemž pak v souvislosti s rakousko-uherským vyrovnáním zastával až do 18. ledna 1868 post ministra války Rakouska-Uherska. Politické funkce byl na vlastní žádost zproštěn. Vypracoval plán reformy ozbrojených sil počítající s všeobecnou brannou povinností. Důvodem pro rezignaci byly neshody s Uherskem ohledně nového branného zákona, stejně jako s vládami obou částí monarchie ohledně armádního rozpočtu.

Následně působil jako generál v Štýrském Hradci a roku 1873 získal hodnost polního zbrojmistra (Feldzeugmeister). V letech 1874–1876 opětovně zastával funkci náčelníka generálního štábu. Od roku 1867 také zasedal v Panské sněmovně (horní jmenovaná komora Říšské rady).

Rodina
Byl dvakrát ženat. Jeho první manželka byla Antonia Margareta Carolina von Weihse, se kterou se oženil v roce 1849 a měl s ní pět dětí. Jedním ze synů byl viceadmirál Friedrich Albert von John. Jeho druhou manželkou byla Anna hraběnka Orsini-Rosenberg, se kterou měl dceru Idu.

Odkazy

Externí odkazy

Reference

Narození v roce 1815
Úmrtí v roce 1876
Ministři války Rakouska-Uherska
Ministři války Rakouského císařství
Rakousko-uherští generálové
Rakouští generálové
Rakouští válečníci
Nositelé Vojenského řádu Marie Terezie
Náčelníci generálního štábu rakousko-uherské armády
Náčelníci generálního štábu armády Rakouského císařství
Členové Panské sněmovny
Muži
Narození 20. listopadu
Úmrtí 25. května
Absolventi Tereziánské vojenské akademie


text:
Reasonable Modifications for the Disabled- Do I have to pay for it?
Since handicap/disability has become a protected class, there has been much said and discussed about what modifications should or must be done for those that request such accommodations. Buildings made available for occupancy after March of 1991 must have been constructed in such a way as to meet the design and construction requirements established under the provisions of Fair Housing Act to aid the handicap/disabled protected class.
However, HUD failed to provide any real guidance on these design and construction issues for over a decade. Many builders, developers, and operators of multi-family housing units were left to guess what was required. It wasn't until a few years after the turn of the century that the uniform building codes caught up to the anticipated guidelines for Fair Housing.
But what of the many units that were built prior to March of 1991. What are the requirements to provide modifications to those units for the handicapped/disabled? Do modifications have to be made that change the esthetics of a multi-family community? Who bears the cost of those changes? Do common areas and amenities have to be modified in communities built prior to 1991?


text:
Palaeorhincodon é um gênero fóssil de tubarões-baleia que data do Paleoceno (Norte da África e América do Norte) e do Eoceno (África Ocidental, América do Norte e Ásia). Quatro espécies foram descritas, conhecidas apenas por restos de dentes.

Espécies
P. daouii Noubhani & Cappetta, 1997
P. dartvellei (Arambourg, 1952)
P. wardi Herman, 1974
P. ypresiensis

Peixes pré-históricos
Tubarões


text:
Women's Basketball Goes Cold in Home Loss
Herkimer College (2-2) 16 13 16 25 70
Tompkins Cortland Community College (1-2) 8 15 10 7 40
Shantasia Jeffrey
Pts: Lexi DeBeatham - 22
Reb: Markia Peak - 17
Ast: 4 Players (#2, #4, #13, #21) - 2
Pts: Taylor Day - 11
Reb: Reyanah Brown - 8
A cold night inside the gym cost the Tompkins Cortland Community College women's basketball team as the Panthers lost to Herkimer College 70-40 Tuesday. The Panthers are now 1-2 overall and 1-1 in Region III play. Herkimer is 2-2 overall and in region.
It was a slow start for the Panthers, with Herkimer scoring the first six points of the game. A three-pointer by Taylor Day (Brooktondale/Ithaca H.S.) broke the ice with 4:30 left in the quarter, but the cold shooting continued. The Panthers were held to just eight points in the first quarter on 2-of-13 shooting and trailed 16-8. Herkimer's lead grew to 11 points at 21-10 before the Panthers showed some signs of life, scoring 13 points over the final six minutes to send the game to the half with Herkimer leading 29-23.
Any hopes of momentum carrying over to the second half were quickly dashed as the third quarter opened with another cold spell. Over the first four minutes, Herkimer outscored the Panthers 10-1 to extend the lead to 39-24. A three-pointer by Macy Boice (Homer/Homer H.S.) sparked a spurt that saw the Panthers pull within ten points at 43-33 in the closing seconds of the quarter, but a last second basket by Herkimer made the margin 45-33 heading into the final quarter. It was the last real threat mounted by the Panthers as Herkimer scored the first seven points of the fourth and continued to extend the lead to the final horn.
The final numbers weren't good for the Panthers, with the team shooting below 16% in three of the four quarters and just 19.7% for the game. Day was the lone Panther to reach double figures, scoring 11 points to go with 5 rebounds. Shantasia Jeffrey (Harlem/Curtis H.S.) was next with 9 points, 7 rebounds, and 7 steals. Boice had 7 points, 4 boards, 3 steals, and 2 assists. Reyanah Brown (Syracuse/Syracuse Academy of Science) had a team-best with 8 rebounds.
The Panthers are back on the road this weekend, with games at North Country Community College on Friday and Clinton Community College on Saturday.


text:
Pages Tagged With: "environmental violations"
The Department of Natural Resources and Environmental Control signed an agreement with Mountaire Farms of Delaware, Inc. Dec. 13 to resolve spray irrigation and land application permit violations cited by DNREC in a Nov. 2, 2017 Notice of Violation (NOV). DNREC first took action against Mountaire for these violations via the filing of a complaint in Delaware Superior Court against Mountaire in June 2018. The complaint was stayed by Superior Court pending resolution of a parallel action in Federal Court. To formalize ongoing and required corrective actions resulting from the September 2017 wastewater treatment plan failure, DNREC and Mountaire have finalized an agreement based on the consent decree proposed in June 2018. The agreement includes three major components – mitigation, environmentally-beneficial offset, and an administrative penalty and costs. Mountaire is required to mitigate damage to the environment through short-term and long-term corrective measures. In the short term, Mountaire must continue the interim corrective measures required by DNREC that have been ongoing since October 2017. Mountaire must also make long-term system upgrades to the plant, including the requirement for environmental mitigation through the relocation of Mountaire's production wells within the spray fields to establish a pump and treat system.
DNREC determines deluge water used to contain Croda, Inc.'s 2018 ethylene oxide release did not impact the environment
The Department of Natural Resources and Environmental Control has concluded that there was no increased risk to human health or safety from deluge water used to contain the Nov. 25, 2018 ethylene oxide (EO) release at Croda's Atlas Point facility. DNREC's conclusion was made from a soil and groundwater sampling report required of Croda by the Department as part of a settlement agreement with DNREC in the aftermath of the EO incident.
DNREC announces availability of Community Environmental Project Fund grant applications
DNREC Secretary Shawn M. Garvin has announced the availability of grants under the Community Environmental Project Fund. The grant program, created by the general Assembly in 2004, enables DNREC to withhold 25 percent of all civil or administrative penalties collected by the Department as funds to benefit communities where civil or administrative violations occurred, and provides for the restoration of these affected communities.


text:
Ett vinghjul, även kallat bevingat hjul, är en symbol för järnvägen. I dess moderna form kan vinghjulet härledas från Tyskland; det började användas flitigt i Sverige kring mitten av 1860-talet.

Bakgrund
I de svenska järnvägarnas tidiga historia dominerade lokomotivet som symbol, inspirerat av England, men det ersattes snart av vinghjulet. Vinghjulet kom snart att bli den allmängiltiga symbolen för järnvägen och användes både av staten och privata aktörer som symbol för sin verksamhet. Statens Järnvägar kom att använda det bevingade hjulet i kombination med en kunglig krona, för att visa att det rörde sig om ett statligt verk. Denna symbol kom sedermera att bli statens järnvägars logotyp, och inte bara en symbol för själva järnvägen.

Dagens SJ har fortfarande detta som symbol om än i moderniserad, stiliserad form. För privata järnvägar i Sverige användes det bevingade hjulet som symbol men då ofta krönt av järnvägsföretagets signatur (monogram) i form av en kunglig krona. Även Nohab hade det som logotyp för sin loktillverkning.

Exempel

Externa länkar

Järnväg


text:
Q: Specify Windows Service Name on install with Setup Project Objective: In support of a Windows Service that may have multiple instances on a single machine, use a Setup Project to create an MSI capable of:

*

*Receiving user input for Service Name

*Installing service

*Serializing Service Name from 1 (so that the proper name can be used in logging and uninstall)

My initial hope was to set Service Name in App.config (and then retrieve it during uninstall upon instantiation of the ServiceInstaller.  This seems to have been naive, because it is not accessible during the install.
If MyInstaller extends Installer, it can call base.Install(); however, my attempts to write to app.config (within MyInstaller.Install() and after base.Install()) are inneffective.
So while the service can be installed with a custom Service Name, that name is not serialized and the installer is most displeased upon uninstall.
How should this be done?

A: You can specify parameters to installer actions, so collect the service name, and pass it as a parameter to the action.  Then, in the Installer class, you can override Install() and access it via base.Context.Parameters.  That's how you get the value.  Having obtained that value and used it, you put it in the stateSaver IDictionary parameter so that if you override Uninstall() you can find out what value was used on install.

redpajama_set_name: RedPajamaStackExchange


text:
Escobedo & Cardenas LLP
Attorney's at Law
1602 Dulcinea • Edinburg, Texas 78539 • (956) 630-2222
Banking Litigation
Joe Escobedo Jr.
Luis M. Cardenas
CLE Papers
March 13th, 2015 by mpc_admin | Type: Standard Comments are off for this post
Mar, 13
Accident investigation and evidence preservation in trucking cases
THE PLAINTIFF'S PERSPECTIVE
JOE ESCOBEDO
Escobedo, Tippit & Cardenas, L.L.P
McAllen, Texas 78501
Prosecuting or Defending a Trucking or Auto Accident Case
September 27-28, 2007 – San Antonio
ACCIDENT INVESTIGATION AND EVIDENCE PRESERVATION IN AUTO AND TRUCKING CASES
PLAINTIFFS' PERSPECTIVE
Here's the situation – you've either signed up or have been referred a serious trucking case. WHAT NOW? This paper is designed to answer some of those vital questions. While I do not mean to sound presumptuous in saying that this paper will answer all your questions, it should provide the necessary information to assure that you do what is necessary to preserve your new client's rights in this action. One thing you can be certain, the trucking company will hire the best counsel they can find to defend its interests.
II. ACCIDENT INVESTIGATION
Once the case has been opened, you must actively investigate the claim and put into motion all that is required to preserve all relevant evidence.
A. The Defense's Rapid Response Team
With sophisticated trucking companies, it will be difficult to beat the defense to the scene. These trucking companies typically have in-house risk management personnel and the truck driver will have been trained on what to do in case of an accident. I have encountered cases where we have proven that the trucker's second phone call went to the police; his first phone call was placed to his employer's risk management personnel. Once the employer is notified about the incident, the defense's rapid response is put into motion. Risk management personnel and/or defense attorneys are whisked to the scene to assure that their side of the story is reported to the investigating officers. A retained accident reconstruction expert is called in as soon as possible to start their reconstruction of the incident. Within a matter of a few days, the evidence is taken under their control, all witnesses have been spoken to and the investigating officers have been properly lobbied.
Getting to the scene a few days before plaintiffs counsel are even hired is a huge advantage which should not be underestimated. This advantage can be overcome only by taking an active and aggressive role toward investigating the incident and preserving the evidence.
B. Notice Letter and Temporary Restraining Order (TRO)
Immediately upon retaining the clients, an investigation must be undertaken to determine the potentially responsible parties. The investigating officers must be contacted to determine the identity of the trucking company and the driver. Once the trucking company is identified, contact information must be ascertained. This can now be easily accomplished via the Internet. Once the trucking company's address is ascertained, there are numerous sources to ascertain service and citation information. First and foremost, search for a company website; a lot of trucking companies have them and they usually provide a plethora of information. Further, a quick search of the secretary of state's website for the company's home state will reveal the information required for service of citation.
Once the contact information is known, a notice or spoliation letter should be sent out immediately.[Examples of notice letters are attached hereto in Appendix A] The notice letter should advise the trucking company whom you represent and that all further contact with your clients should be directed to your office. You do not want to give the trucking company's adjusters any excuse to try to contact your clients directly. The notice letter should also request that all relevant evidence be preserved. Specific examples of evidence and documents should be listed in the notice letter. While these items will be different from case to case, the following items should be considered in any trucking case:
First, and foremost, the tractor-trailer and all of its component parts
Everything that was in the vehicle at the time of the incident
Driver's logbooks required pursuant to 49 C.F.R. 395
Documents relating to the subject trip including the driver's daily log, fuel receipts, dispatch records, trip sheets, bills of lading, pay checks
Post-trip inspection reports
Maintenance and repair records for the subject tractor-trailer
Electronic Control Module (ECM), black box and related data [NOTE: Some of this information will be lost if the ignition is activated after the incident. All information will be lost after tractor is put back in service. ECMs should be removed and retained by qualified experts]
Satellite communication, GPS tracking devices and related data
Radar systems and related data (Eaton VORAD® system)
Onboard communication systems and related data
Truck driver's driving record and personnel file, including the driver qualification file (49 C.F.R.391), physical examinations, and drug tests
49 C.F.R 390.15 "accident register" for the truck driver and the company
Company training and safety manuals
Post-accident alcohol and drug tests on driver
Once the notice letter is sent out, plaintiffs' counsel should seek a Temporary Restraining Order (TRO) seeking the preservation of all the items listed in your notice letter. Whether to rely solely on the notice letter to ensure the preservation of the evidence can only be made on a case by case basis. However, deciding that the notice letter is sufficient to preserve relevant evidence can be a dangerous proposition. See Ordonez v. M.W. McCurdy & Co., infra. Numerous factors will affect your decision. A notice letter requesting that all relevant evidence be preserved may be sufficient in a situation where the investigating officers have control over the evidence, as is often the case where criminal charges may be brought against the truck driver. Also, if your notice letter gets a quick response from defense counsel which results in a Rule 11 agreement on the evidence preservation issue, a TRO might not be required. Regardless of the situation, the decision to pursue or not to pursue a TRO to preserve the evidence is one that should not be made lightly.
C. Other Documents Related to the Incident
In addition to the evidence and documents that should be requested be preserved by the trucking company, Plaintiffs' counsel should begin gathering other relevant documents relating to the incident. These documents generally include the following:
Investigative reports from law enforcement, including photographs, measurements, witness statements
Documents relating to the investigation by other insurance companies
Medical records relating to your clients
Autopsy report(s)
Death certificate(s)
EMS records
Wrecker records
Emergency or 911 call data
Criminal and civil case history for all drivers
Media reports including print, television and radio
D. Documentation of the Scene and the Vehicles
As I mentioned earlier, it will be a rare occurrence indeed where the plaintiffs will beat the trucking company's representatives to the scene. That being said, it is imperative that the scene and subject vehicles be inspected immediately.
1. Investigators
In-house investigators or retained private investigators should be sent to the scene immediately. These investigators can assist plaintiff's counsel by ascertaining the names and contact information of all witnesses (occupants, eyewitnesses, post-collision witnesses, investigating law enforcement). Photographs of the scene should also be taken in that it may be a few days before accident reconstruction experts may be able to go to the scene. Photographs should also be taken of the vehicles involved. Further, the investigators can interview witnesses. Special caution should be exercised in the recording of witness statements, either by audio/video or written statements. The only person that should determine whether recorded statements are taken is the Plaintiff's attorney.
2. Plaintiff's Counsel Should Go to the Scene
As I mentioned earlier, it is quite common that the trucking lawyer will be sent to the scene immediately after being notified of the incident. Having a qualified trial lawyer at the scene is a considerable advantage for the defense which can be somewhat alleviated by plaintiff's counsel going to the scene to coordinate the scene and vehicle inspections. Plaintiff's counsel's presence at the scene can also assure a fair and unbiased investigation. Further, plaintiff's counsel would then be able to direct accident reconstruction experts upon their arrival at the scene.
3. Accident Reconstruction Experts
Ideally, the accident reconstruction expert should be retained and taken to the scene within 24-48 after counsel is retained in this case. The sooner the accident reconstruction expert arrives at the scene the better; tire marks on the roadway can begin to fade within 1-2 days after the incident. Rain and excessive travel over the roadway will impact how long the tire marks remain on the roadway. Just as importantly, marks unrelated to the incident may begin to appear on the roadway. A complete discussion of what accident reconstruction experts should do at the scene is beyond the scope of this paper. Suffice it to say, that a competent accident reconstruction expert will know what must be done to completely document the scene. It is imperative that the expert also inspect the vehicles involved in the incident before any changes or repairs are made to them. A Rule 11 agreement via a Notice Letter or a TRO will assure that the expert has access to the tractor-trailer. Accident reconstruction experts can also sometimes interact with the local law enforcement authorities investigating the incident.
4. Retention of Truck Safety and Other Liability Experts
Often times, in trucking litigation, other liability experts will be needed in the case. There are numerous issues that arise exclusively in trucking cases. These include applicable Federal Motor Carrier Safety Regulations found in the Code of Federal Regulations ( Title 49, Parts 383-399) and the Texas Administrative Code found at Title 37 (Sections 4.11 and 4.12). Often, accident reconstruction experts will not be intimately familiar with these specific trucking issues. A trucking safety expert should be retained to ascertain the trucking company's compliance with applicable safety regulations relating to logbook requirements, driver hour requirements and the like.
In other cases, maintenance issues relating to the tractor or the trailer may require the retention of an trucking maintenance expert. The discovery of faulty maintenance on behalf of the trucking company amounts to an independent negligence claim in addition to the respondeat superior claim relating to the truck driver's negligence. The trucking maintenance expert should be retained and be available for inspection of the tractor and the trailer before the vehicle is put back into service or is repaired.
Other experts may be required to assure the proper downloading of ECMs, black boxes, and similar electronics related to both the tractor-trailer and the other vehicles involved in the collision. As mentioned supra, valuable data may be lost unless qualified experts are retained to preserve and download the data typically produced by these electronic items.
III. EVIDENCE PRESERVATION & SPOLIATION
A party's duty to preserve evidence in a civil case has received a lot of attention from
Texas courts recently. In 2003, the Texas Supreme Court addressed the issue of whether a party has a duty to preserve material evidence in Wal-Mart Stores, Inc. v. Johnston, 106 S.W3d, 718, 722 (Tex. 2003). In that case, a Wal-Mart employee accidently knocked one or more decorative reindeer from a high shelf onto Johnson's head and arm. Id. at 720. During the course of the investigation of the incident by Wal-Mart, a Wal-mart supervisor took notes, photographed the reindeer and obtained a written statement from the employee who caused the accident. Id. During the course of the litigation, Johnson asked whether Wal-Mart still possessed the reindeer that fell on him. Wal-Mart responded that they did not have possession of that reindeer but offered to provide a reasonable facsimile. Id. At the trial, the court granted the Johnson's request for a spoliation instruction to be given the jury based upon Wal-Mart's failure to keep the reindeer. The Supreme Court held that the trial court had abused its discretion in giving a spoliation instruction because Johnson failed to prove the Wal-Mart "knew, or should have known, that there was a substantial chance there would be litigation and that the reindeer would be material to it." Id. at 723. See also Trevino v. Ortega, 969 S.W.2d 950, 955 (Tex. 1998) (a trial judge has broad discretion in determining whether to provide a jury with a spoliation presumption instruction.)
In addition to these cases, there have been published opinions relating to spoliation in trucking cases. In Texas Electric Cooperative v. Dillard, 171 S.W.3d 201, 209 (Tex. App.–Tyler, 2005), the appellate court held that the trial judge did not abuse his discretion in instructing the jury on a spoliation presumption. In the Dillard case, the truck driver hit a cow on the roadway; the cow fell dead in the eastbound lane. Thereafter, the plaintiffs collided with the cow which caused their death. Id. at 203-204. The trucking company "admitted that it had destroyed [the truck driver's] logbook and all other documents regarding" the subject trip. Id. at 209. Plaintiffs established that shortly after the incident plaintiffs' counsel sent a letter to the defendant advising of their representation. [NOTE: The opinion is silent on whether the letter from plaintiffs' counsel requested that all evidence be preserved.] The appellate court held that the "record before the trial judge indicated that [the defendant] had knowledge of Dillard's claim and understood its severity before [it] destroyed [the truck driver's] logbook and other documents." Id.
Another case involving trucking cases and spoliation is Whiteside v. Watson, 12 S.W.3d 614 (Tex.App.–Eastland 2000) (vacated pursuant to settlement Jan. 18, 2001). In that case, Watson sued the driver of a dump truck and his employer. Id. at 617. The original of the Driver's Daily Logs and the Vehicle Inspection Reports were turned in by the driver and the driver would keep a carbon copy for his own records. Id. at 620. The driver's copies were introduced into evidence and indicated problems with brakes and steering. Id. at 621. After receiving notice of the lawsuit, the president of the trucking company "ordered the originals of these documents…burned pursuant to an unwritten document retention policy." Id. Based upon this evidence, the trial court allowed an instruction to the jury on the spoliation presumption. Id. The trucking company argued that the spoliation instruction should not have been granted given the fact that copies of the logs and reports had been admitted into evidence. The appellate court countered that given the fact that the president of the trucking company testified at trial that the copies introduced at trial had been "doctored", the plaintiffs were prejudiced by the destruction of the documents. Id. at 622. See also Union Transports, Inc. V. Braun, 318 S.W.2d 927, 932 (Tex. Civ. App.–Eastland 1958) (defendant's failure to produce a tacometer which recorded evidence of the speed of the truck was of some probative force on the question of excessive speed of the truck)
In Ordonez v. M.W. McCurdy & Co., Inc., 984 S.W.2d 264, 273-74 (Tex. App.–Houston [1st Dist.]1998), the appellate court held that the trial court did not err in refusing his instruction on spoliation of evidence. A truck driven by an employee of M.W. McCurdy collided with the rear end of a van driven by the plaintiff. Id. at 267. Plaintiffs "presented some evidence showing that McCurdy intentionally destroyed [the truck] driver's log reflecting his off-duty and on-duty hours." Id. at 273. McCurdy's corporate representative testified that driver's logs were kept for only six months and then thrown away. Id. It should be specifically noted that McCurdy's corporate representative was questioned at the trial relating the receipt of a notice letter sent by plaintiff's counsel four days after the incident. The corporate representative testified that it was "possible" that he would have received the notice letter. Id. The court notes in a footnote that the "record does not contain a copy of this letter, and no witness testified that such a letter was actually sent to McCurdy." Id. at FN12. The appellate court was persuaded by the fact that the logs were destroyed pursuant to "normal business practice" and held that there was "no evidence that the log books were destroyed for the purpose of concealing them from Ordonez." Id. at 274. The moral of this story is that a notice letter sent without any evidence of receipt will not suffice for spoliation grounds. As I have mentioned earlier in this paper, plaintiff's counsel should tread very carefully when deciding whether a notice letter will suffice relating to the preservation of evidence.
Critical evidence may be lost or destroyed unless Plaintiff's counsel does everything within his or her power to assure that the incident is thoroughly investigated and all pertinent evidence is inspected and secured. In a typical trucking case, as opposed to the typical auto accident case, the roles are reversed; the defense will typically arrive at the scene first and the plaintiff's counsel will be playing catch-up. Once again, this is a huge advantage which should not be underestimated. Only by promptly inspecting the scene and the vehicles and assuring that the evidence is preserved can the plaintiff's counsel assure that his clients interests will be protected.
About mpc_admin
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text:
Rizatriptan 10mg Orodispersible Tablets
Accord-UK Ltd contact details
Last updated on emc: 18 Sep 2020
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
This information is intended for use by health professionals
Each Rizatriptan 10mg Orodispersible Tablet contains 10mg rizatriptan as 14.53mg of rizatriptan benzoate.
Excipients: Each tablet contains 8.8mg aspartame.
For the full list of excipients see section 6.1.
Orodispersible tablets.
Rizatriptan 10 mg Orodispersible Tablets are white, round, 9 mm in diameter, flat, bevel-edged tablets, with "IZ 10" engraved on one side.
Acute treatment of the headache phase of migraine attacks, with or without aura.
Posology
Adults 18 years of age and older
Redosing: Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period.
- for headache recurrence within 24 hours: If headache returns after relief of the initial attack, one further dose may be taken. The above dosing limits should be observed.
- after non-response: The effectiveness of a second dose for treatment of the same attack, when an initial dose is ineffective, has not been examined in controlled trials. Therefore, if a patient does not respond to the first dose, a second dose should not be taken for the same attack.
Clinical studies have shown that patients who do not respond to treatment of an attack are still likely to respond to treatment for subsequent attacks.
Some patients should receive the lower (5 mg) dose of Rizatriptan orodispersible tablets, in particular the following patient groups:
• patients on propranolol. Administration of rizatriptan should be separated by at least two hours from administration of propranolol (see section 4.5).
• patients with mild or moderate renal insufficiency.
• patients with mild to moderate hepatic insufficiency.
Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period.
Paediatric population
Children and Adolescents (under 18 years of age)
The safety and efficacy of Rizatriptan 10mg orodispersible tablets in children and adolescents under 18 years of age has not yet been established. Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
The safety and effectiveness of rizatriptan in patients older than 65 years have not been systematically evaluated.
Method of administration
Rizatriptan 10mg Orodispersible Tablets should not be used prophylactically.
Rizatriptan 10mg Orodispersible Tablets need not be taken with liquid.
Patients should be instructed not to remove the orodispersible tablet from the aluminium blister until just prior to dosing. The blister should be peeled open with dry hands and the orodispersible tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.
Orodispersible tablets can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Concurrent administration of monoamine oxidase (MAO) inhibitors or use within two weeks of discontinuation of MAO inhibitor therapy (see section 4.5).
- Severe hepatic or severe renal insufficiency.
- Previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
- Moderately severe or severe hypertension, or untreated mild hypertension.
- Established coronary artery disease, including ischaemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischaemia), signs and symptoms of ischaemic heart disease, or Prinzmetal's angina.
- Peripheral vascular disease.
- Concomitant use of rizatriptan and ergotamine, ergot derivatives (including methysergide), or other 5-HT1B/1D receptor agonists (see section 4.5).
Rizatriptan 10mg Orodispersible Tablets should only be administered to patients in whom a clear diagnosis of migraine has been established. Rizatriptan 10mg Orodispersible Tablets should not be administered to patients with basilar or hemiplegic migraine.
Rizatriptan 10mg Orodispersible Tablets should not be used to treat "atypical" headaches, i.e. those that might be associated with potentially serious medical conditions, (e.g. CVA, ruptured aneurysm) in which cerebrovascular vasoconstriction could be harmful.
Rizatriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat (see section 4.8). Where such symptoms are thought to indicate ischaemic heart disease, no further dose should be taken and appropriate evaluation should be carried out.
As with other 5-HT1B/1D receptor agonists, rizatriptan should not be given, without prior evaluation, to patients in whom unrecognised cardiac disease is likely or to patients at risk for coronary artery disease (CAD) (e.g. patients with hypertension, diabetics, smokers or users of nicotine substitution therapy, men over 40 years of age, post-menopausal women, patients with bundle branch block, and those with strong family history for CAD). Cardiac evaluations may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease when 5-HT1 agonists have been administered. Those in whom CAD is established should not be given Rizatriptan 10mg Orodispersible Tablets. (see section 4.3).
5-HT1B/1D receptor agonists have been associated with coronary vasospasm. In rare cases, myocardial ischaemia or infarction have been reported with 5-HT1B/1D receptor agonists including rizatriptan (see section 4.8).
Other 5-HT1B/1D agonists, (e.g. sumatriptan) should not be used concomitantly with Rizatriptan 10mg Orodispersible Tablets (see section 4.5).
It is advised to wait at least six hours following use of rizatriptan before administering ergotamine-type medications, (e.g. ergotamine, dihydro-ergotamine or methysergide). At least 24 hours should elapse after the administration of an ergotamine-containing preparation before rizatriptan is given.
Although additive vasospastic effects were not observed in a clinical pharmacology study in which 16 healthy males received oral rizatriptan and parenteral ergotamine, such additive effects are theoretically possible (see section 4.3).
Serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been reported following concomitant treatment with triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs). These reactions can be severe. If concomitant treatment with rizatriptan and an SSRI or SNRI is clinically warranted, appropriate observation of the patient is advised, particularly during treatment initiation, with dose increases, or with addition of another serotonergic medication (see section 4.5).
Undesirable effects may be more common during concomitant use of triptans (5HT1B/1D agonists) and herbal preparations containing St John's wort (Hypericum perforatum).
Angioedema (e.g. facial oedema, tongue swelling and pharyngeal oedema) may occur in patients treated with triptans, among which is rizatriptan. If angioedema of the tongue or pharynx occurs, the patient should be placed under medical supervision until symptoms have resolved. Treatment should promptly be discontinued and replaced by an agent belonging to another class of drugs.
Rizatriptan orodispersible tablets contain aspartame, a source of phenylalanine. Each Rizatriptan 10mg Orodispersible Tablet contains 8.8 mg aspartame, corresponding to 4.9 mg phenylalanine. It may be harmful for patients with phenylketonuria.
The potential for interaction should be considered when rizatriptan is administered to patients taking CYP 2D6 substrates (see section 4.5).
Medication overuse headache (MOH)
Prolonged use of any painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Rizatriptan orodispersible tablets contain mannitol which may have a mild laxative effect.
Ergotamine, ergot derivatives (including methysergide), other 5HT1B/1D receptor agonists: Due to an additive effect, the concomitant use of rizatriptan and ergotamine, ergot derivatives (including methysergide), or other 5 HT1B/1D receptor agonists (e.g. sumatriptan, zolmitriptan, naratriptan) increase the risk of coronary artery vasoconstriction and hypertensive effects. This combination is contraindicated (see section 4.3).
Monoamine oxidase inhibitors: Rizatriptan is principally metabolised via monoamine oxidase, 'A' subtype (MAO-A). Plasma concentrations of rizatriptan and its active N-monodesmethyl metabolite were increased by concomitant administration of a selective, reversible MAO-A inhibitor. Similar or greater effects are expected with non-selective, reversible (e.g. linezolid) and irreversible MAO inhibitors. Due to a risk of coronary artery vasoconstriction and hypertensive episodes, administration of Rizatriptan 10mg Orodispersible Tablets to patients taking MAO inhibitors is contraindicated (see section 4.3).
Beta-blockers: Plasma concentrations of rizatriptan may be increased by concomitant administration of propranolol. This increase is most probably due to first-pass metabolic interaction between the two drugs, since MAO-A plays a role in the metabolism of both rizatriptan and propranolol. This interaction leads to a mean increase in AUC and Cmax of 70-80%. In patients receiving propranolol, the 5 mg dose of Rizatriptan Orodispersible Tablets should be used (see section 4.2).
In a drug-interaction study, nadolol and metoprolol did not alter plasma concentrations of rizatriptan.
Selective Serotonin Reuptake Inhibitors (SSRIs) /Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) and Serotonin Syndrome: There have been reports describing patients with symptoms compatible with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans (see section 4.4).
In vitro studies indicate that rizatriptan inhibits cytochrome P450 2D6 (CYP 2D6). Clinical interaction data are not available. The potential for interaction should be considered when rizatriptan is administered to patients taking CYP 2D6 substrates.
Effects on human fertility have not been investigated. Animal studies only revealed minimal effects on fertility at plasma concentrations far in excess of human therapeutic concentrations (more than 500-fold).
The safety of rizatriptan for use in human pregnancy has not been established. Animal studies do not indicate harmful effects at dose levels that exceed therapeutic dose levels with respect to the development of the embryo or foetus, or the course of gestation, parturition and post-natal development.
Because animal reproductive and developmental studies are not always predictive of human response, Rizatriptan 10mg Orodispersible Tablets should be used during pregnancy only if clearly needed.
Studies in rats indicated very high milk transfer of rizatriptan occurred. Transient, very slight decreases in pre-weaning pup body weights were observed only when the mother's systemic exposure was well in excess of the maximum exposure level for humans. No data exist in humans.
Therefore, caution should be exercised when administering rizatriptan to women who are breast-feeding. Infant exposure should be minimised by avoiding breast-feeding for 24 hours after treatment.
Migraine or treatment with Rizatriptan 10mg Orodispersible Tablets may cause somnolence in some patients. Dizziness has also been reported in some patients receiving Rizatriptan 10mg Orodispersible Tablets, Patients should, therefore, evaluate their ability to perform complex tasks during migraine attacks and after administration of Rizatriptan 10mg Orodispersible Tablets.
Rizatriptan (as the tablet and orodispersible tablet formulation) was evaluated in 8630 adult patients for up to one year in controlled clinical studies. The most common side effects evaluated in clinical studies were dizziness, somnolence, and asthenia/fatigue. The following side effects have been evaluated in clinical studies and/or reported in post-marketing experience:
Very common [≥ 1/10]; Common [≥ 1/100, <1/10]; Uncommon: [≥ 1/1,000, <1/100]; Rare [≥ 1/10,000 <1/1,000]; Very rare [≤ 1/10,000], not known (cannot be estimated from the available data).
Immune system disorders:
Rare: hypersensitivity reaction, anaphylaxis/anaphylactoid reaction.
Psychiatric disorders:
Common: insomnia.
Uncommon: disorientation, nervousness.
Nervous system disorders:
Common: dizziness, somnolence, paraesthesia, headache, hypoaesthesia, decreased mental acuity.
Uncommon: ataxia, vertigo, dysgeusia/bad taste, tremor, syncope.
Not known: seizure, serotonin syndrome.
Eye disorders:
Uncommon: blurred vision.
Cardiac disorders:
Common: palpitation.
Uncommon: arrhythmia, tachycardia.
Rare: cerebrovascular accident (most of these adverse reactions have been reported in patients with risk factors predictive of coronary artery disease), bradycardia.
Not known: myocardial ischaemia or infarction (most of these adverse reactions have been reported in patients with risk factors predictive of coronary artery disease).
Vascular disorders:
Uncommon: hypertension, hot flushes/flashes.
Not known: peripheral vascular ischaemia.
Respiratory, thoracic and mediastinal disorders:
Common: pharyngeal discomfort.
Uncommon: dyspnoea.
Rare: wheezing.
Gastro-intestinal disorders:
Common: nausea, dry mouth, vomiting, diarrhoea, dyspepsia.
Uncommon: thirst.
Not known: ischemic colitis.
Skin and subcutaneous tissue disorders:
Common: flushing.
Uncommon: pruritus, urticaria, angioedema (e.g. facial oedema, tongue swelling, pharyngeal oedema) (for angioedema see also section 4.4), rash, sweating.
Not known: toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders:
Common: regional heaviness, neck pain, stiffness.
Uncommon: regional tightness, muscle weakness, facial pain, myalgia.
General disorders and administration site conditions:
Common: asthenia/fatigue, pain in abdomen or chest.
Investigations:
Uncommon: ECG abnormalities.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Rizatriptan 40 mg (administered as either a single tablet dose or as two doses with a two-hour interdose interval) was generally well tolerated in over 300 patients; dizziness and somnolence were the most common drug-related adverse effects.
In a clinical pharmacology study in which 12 subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. One subject, a female aged 29 years, developed vomiting, bradycardia, and dizziness beginning three hours after receiving a total of 80 mg rizatriptan (administered over two hours). A third-degree AV block, responsive to atropine, was observed an hour after the onset of the other symptoms. The second subject, a 25 year-old male, experienced transient dizziness, syncope, incontinence, and a five-second systolic pause (on ECG monitor) immediately after a painful venipuncture. The venipuncture occurred two hours after the subject had received a total of 80 mg rizatriptan (administered over four hours).
In addition, based on the pharmacology of rizatriptan, hypertension or other more serious cardiovascular symptoms could occur after an overdose. Gastro-intestinal decontamination (e.g. gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with Rizatriptan 10mg OrodispersibleTablets. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of haemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.
Pharmacotherapeutic group: antimigraine preparations, selective serotonin (5HT1) agonists, ATC-code: N02C C04
Rizatriptan binds selectively with high affinity to human 5-HT1B and 5-HT1D receptors and has little or no effect or pharmacological activity at 5-HT2, 5-HT3; adrenergic alpha1, alpha2 or beta; D1, D2, dopaminergic, histaminic H1; muscarinic; or benzodiazepine receptors.
The therapeutic activity of rizatriptan in treating migraine headache may be attributed to its agonist effects at 5-HT1B and 5-HT1D receptors on the extracerebral intracranial blood vessels that are thought to become dilated during an attack and on the trigeminal sensory nerves that innervate them. Activation of these 5-HT1B and 5-HT1D receptors may result in constriction of pain-producing intracranial blood vessels and inhibition of neuropeptide release that leads to decreased inflammation in sensitive tissues and reduced central trigeminal pain signal transmission.
Pharmacodynamic effects
The efficacy of rizatriptan orodispersible tablets in the acute treatment of migraine attacks was established in two multicentre, randomised, placebo-controlled trials that were similar in design to the trials of regular rizatriptan tablets. In one study (n=311), by two hours post-dosing, relief rates in patients treated with rizatriptan orodispersible tablets were approximately 66% for rizatriptan 5 mg and 10 mg, compared to 47% in the placebo group. In a larger study (n=547), by 2 hours post-dosing, relief rates were 59% in patients treated with rizatriptan 5 mg orodispersible tablets, and 74% after 10 mg, compared to 28% in the placebo group. Rizatriptan orodispersible tablets also relieved the disability, nausea, photophobia, and phonophobia which accompanied the migraine episodes. A significant effect on pain relief was observed as early as 30 minutes post-dosing in one of the two clinical trials for the 10 mg dose (see section 5.2).
Based on studies with the oral tablet, rizatriptan remains effective in treating menstrual migraine, i.e. migraine that occurs within 3 days before or after the onset of menses.
Adolescents (12-17 years of age)
The efficacy of rizatriptan orodispersible tablets in paediatric patients (12 to 17 years of age) was evaluated in a multicentre, randomised, double-blind, placebo-controlled, parallel group study (n=570). The patient population was required to be historically non-responsive to NSAIDs and acetaminophen therapy. Patients with a qualifying migraine headache initially administered placebo or rizatriptan within 30 minutes of onset. Following the 15 minute placebo run-in, subjects who did not respond to placebo then treated a single migraine attack with placebo or rizatriptan. Using a weight-based dosing strategy, patients 20 kg to <40 kg received 5 mg rizatriptan and patients ≥40 kg received 10mg rizatriptan.
In this enriched population study, a difference of 9% between active treatment and placebo was observed for the primary efficacy endpoint of pain freedom (reduction from moderate or severe pain to no pain) 2 hours after treatment (31% under rizatriptan vs. 22% for placebo (p=0.025)). No significant difference for the secondary endpoint of pain relief (reduction from moderate or severe pain to mild or no pain) was found.
Children (6-11 years of age)
The efficacy of rizatriptan orodispersible tablets was also evaluated in paediatric patients 6 to 11 years of age in the same acute placebo-controlled clinical trial (n=200). The percentage of patients achieving pain freedom 2 hours after treatment was not statistically significantly different in patients who received rizatriptan orodispersible tablets 5 and 10 mg, compared with those who received placebo (39.8% vs. 30.4%, p=0.269).
Rizatriptan orodispersible tablets enable migraine patients to treat their migraine attacks without having to swallow liquids. This may allow patients to administer their medication earlier, for example, when liquids are not available, and to avoid possible worsening of GI symptoms by swallowing liquids.
Rizatriptan is rapidly and completely absorbed following oral administration.
The mean oral bioavailability of the orodispersible tablets is approximately 40-45%, and mean peak plasma concentrations (Cmax) are reached in approximately 1.58 hours (Tmax). The time to maximum plasma concentration following administration of rizatriptan as the orodispersible tablet formulation is delayed by 30-60 minutes relative to regular rizatriptan tablets.
Effect of food: The effect of food on the absorption of rizatriptan from orodispersible tablets has not been studied. For the rizatriptan tablets, Tmax is delayed by approximately 1 hour when the tablets are administered in the fed state. A further delay in the absorption of rizatriptan may occur when the orodispersible tablets are administered after meals.
Rizatriptan is minimally bound (14%) to plasma proteins. The volume of distribution is approximately 140 litres in male subjects, and 110 litres in female subjects.
The primary route of rizatriptan metabolism is via oxidative deamination by monoamine oxidase-A (MAO-A) to the indole acetic acid metabolite, which is not pharmacologically active. N-monodesmethyl-rizatriptan, a metabolite with activity similar to that of parent compound at the 5-HT1B/1D receptors, is formed to a minor degree, but does not contribute significantly to the pharmacodynamic activity of rizatriptan. Plasma concentrations of N-monodesmethyl-rizatriptan are approximately 14% of those of parent compound, and it is eliminated at a similar rate. Other minor metabolites include the N-oxide, the 6-hydroxy compound, and the sulfate conjugate of the 6-hydroxy metabolite. None of these minor metabolites is pharmacologically active. Following oral administration of 14C-labelled rizatriptan, rizatriptan accounts for about 17% of circulating plasma radioactivity.
Following intravenous administration, AUC in men increases proportionally and in women near-proportionally with the dose over a dose range of 10-60 µg/kg. Following oral administration, AUC increases near-proportionally with the dose over a dose range of 2.5-10 mg. The plasma half-life of rizatriptan in males and females averages 2-3 hours. The plasma clearance of rizatriptan averages about 1,000-1,500 mL/min in males and about 900-1,100 mL/min in females; about 20-30% of this is renal clearance. Following an oral dose of 14C-labelled rizatriptan, about 80% of the radioactivity is excreted in urine, and about 10% of the dose is excreted in faeces. This shows that the metabolites are excreted primarily via the kidneys.
Consistent with its first pass metabolism, approximately 14% of an oral dose is excreted in urine as unchanged rizatriptan while 51% is excreted as indole acetic acid metabolite. No more than 1% is excreted in urine as the active N-monodesmethyl metabolite.
If rizatriptan is administered according to the maximum dosage regimen, no drug accumulation in the plasma occurs from day to day.
Characteristics in patients
The following data are based on studies with regular rizatriptan tablets.
Patients with a migraine attack: A migraine attack does not affect the pharmacokinetics of rizatriptan.
Gender: The AUC of rizatriptan (10 mg orally) was about 25% lower in males as compared to females, Cmax was 11% lower, and Tmax occurred at approximately the same time. This apparent pharmacokinetic difference was of no clinical significance.
Elderly: The plasma concentrations of rizatriptan observed in elderly subjects (age range 65 to 77 years) after tablet administration were similar to those observed in young adults.
Paediatric population: A pharmacokinetics study of rizatriptan (as the orodispersible tablet formulation) was conducted in paediatric migraineurs 6 to 17 years of age. The mean exposures following a single dose administration of 5 mg rizatriptan orodispersible tablets to paediatric patients weighing 20-39 kg or 10 mg rizatriptan orodispersible tablets to paediatric patients weighing ≥40 kg were respectively 15% lower and 17% higher compared to the exposure observed following single dose administration of 10 mg rizatriptan orodispersible tablets to adults. The clinical relevance of these differences is unclear.
Hepatic impairment (Child-Pugh's score 5-6): Following oral tablet administration in patients with hepatic impairment caused by mild alcoholic cirrhosis of the liver, plasma concentrations of rizatriptan were similar to those seen in young male and female subjects. A significant increase in AUC (50%) and Cmax (25%) was observed in patients with moderate hepatic impairment (Child-Pugh's score 7). Pharmacokinetics were not studied in patients with Child-Pugh's score >7 (severe hepatic impairment).
Renal impairment: In patients with renal impairment (creatinine clearance 10-60 mL/min/1.73 m2), the AUC of rizatriptan after tablet administration was not significantly different from that in healthy subjects. In haemodialysis patients (creatinine clearance <10 mL/min/1.73 m2), the AUC for rizatriptan was approximately 44% greater than that in patients with normal renal function. The maximal plasma concentration of rizatriptan in patients with all degrees of renal impairment was similar to that in healthy subjects.
Preclinical data indicate no risk for humans based on conventional studies of repeat dose toxicity, genotoxicity, carcinogenic potential, reproductive and developmental toxicity, safety pharmacology, and pharmacokinetics and metabolism.
Mannitol (E421)
Microcrystalline cellulose (E460a)
Crospovidone type A (E1202)
Aspartame (E951)
Colloidal anhydrous silica
Peppermint flavour
Magnesium stearate (E470b)
OPA/Aluminium/PVC-Aluminium blister packs with push-through foil.
2, 3, 6, 12 and 18 orodispersible tablets.
Any unused product or waste material should be disposed of in accordance with local requirements.
Accord-UK Ltd
(Trading style: Accord)
Whiddon Valley
EX32 8NS
11. DOSIMETRY (IF APPLICABLE)
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
www.accord-healthcare.co.uk
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