(PEG) precipitation (20% PEG 4000, pH 5.8), pasteurisation (10 hours at 60.5 ± 1.0 ºC) and 15 nm filtration to remove the smallest known viral particles (a process not utilized by all other currently available C1 esterase inhibitor products). Collectively, these processes result in reduction of at least 16.7 log10 for the enveloped viruses tested (HIV, Bovine Viral Diarrhea Virus (BVDV), Pseudorabies Virus (PRV)), at least 8.8 log10 for the non-enveloped viruses (HAV, Canine Parvovirus (CPV)), and >10 log10 reduction in prion-like material. Thus, while the infection-related risk with any plasma-derived product will never be zero, the manufacturing process for CINRYZE provides substantial protection against infections of C1 esterase inhibitor products to date and represents an important improvement in product safety. Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived C1 esterase inhibitor product. It is strongly recommended that every time CINRYZE is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. Sodium Each vial of CINRYZE contains approximately 11.5 mg of sodium. To be taken into account by patients on a controlled sodium diet. Effects on fertility No studies on fertility or early embryonic and postnatal development were conducted because chronic dosing in animals would be expected to be associated with development of neutralising antibodies to the human protein. Effects in pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of CINRYZE in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. The use of CINRYZE may be considered during pregnancy, if necessary. Use in lactation It is unknown whether C1 esterase inhibitor is excreted in milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from CINRYZE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Paediatric use
(PEG) precipitation (20% PEG 4000, pH 5.8), pasteurisation (10 hours at 60.5 ± 1.0 ºC) and 15 nm filtration to remove the smallest known viral particles (a process not utilized by all other currently available C1 esterase inhibitor products). Collectively, these processes result in reduction of at least 16.7 log10 for the enveloped viruses tested (HIV, Bovine Viral Diarrhea Virus (BVDV), Pseudorabies Virus (PRV)), at least 8.8 log10 for the non-enveloped viruses (HAV, Canine Parvovirus (CPV)), and >10 log10 reduction in prion-like material. Thus, while the infection-related risk with any plasma-derived product will never be zero, the manufacturing process for CINRYZE provides substantial protection against infections of C1 esterase inhibitor products to date and represents an important improvement in product safety. Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived C1 esterase inhibitor product. It is strongly recommended that every time CINRYZE is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. Sodium Each vial of CINRYZE contains approximately 11.5 mg of sodium. To be taken into account by patients on a controlled sodium diet. Effects on fertility No studies on fertility or early embryonic and postnatal development were conducted because chronic dosing in animals would be expected to be associated with development of neutralising antibodies to the human protein. Effects in pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of CINRYZE in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. The use of CINRYZE may be considered during pregnancy, if necessary. Use in lactation It is unknown whether C1 esterase inhibitor is excreted in milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from CINRYZE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Paediatric use
auspar-c1-esterase-inhibitor-130729-pi.docx