Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
FACTOR VIII, HUMAN
Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom
B02BD06
FACTOR VIII, HUMAN 25 IU/ml
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FACTOR VIII, HUMAN 25 IU/ml
POM
ANTIHEMORRHAGICS
Suspended
2006-03-24
B. PACKAGE LEAFLET PATIENT INFORMATION LEAFLET DRIED FACTOR VIII FRACTION, TYPE 8Y Human Factor VIII and von Willebrand Factor (VWF) PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. -Keep this leaflet. You may need to read it again. -If you have any further questions, please ask your doctor. -This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. -If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. -Is this leaflet hard to see or read? Phone +44 (0)20 8957 2200. IN THIS LEAFLET: 1. What Dried Factor VIII Fraction (8Y) is and what it is used for 2. Before you use 8Y 3 .How to use 8Y 4 .Possible side effects 5 .How to store 8Y 6. Further Information 1. WHAT DRIED FACTOR VIII FRACTION (8Y) IS AND WHAT IT IS USED FOR Dried Factor VIII fraction (8Y) is a concentrate of Factor VIII and von Willebrand Factor (VWF) prepared from blood plasma from screened donors and then heat-treated. 8Y is given by injection into a vein (intravenously) and is used to prevent and treat bleeding in patients with haemophilia A (an inherited shortage of Factor VIII in the blood) or von Willebrand disease (VWD). Your doctor will explain further why this medicine has been given to you. SUMMARY OF CONTENTS VIAL SIZE OF 8Y FACTOR VIII POTENCY 2 VWF POTENCY 3 250 IU 1 250 IU/Vial 500 IU/ Vial 500 IU 1 500 IU/Vial 1000 IU/ Vial 1 After reconstitution with appropriate amount of Sterile Water for Injections (see Dissolving your medicine before use) 2Potency complies with Ph.Eur. for Human Coagulation Factor VIII 3 Potency complies with Ph.Eur. for Human Coagulation Factor VIII for preparations intended for the treatment of von Willebrand’s disease 2. BEFORE YOU USE 8Y YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU ARE: • ALLERGIC (hypersensitive) to Factor VIII or von Willebrand Factor (VWF) or to any of the other ingredients in the product (See Section 6 ‘What Leggi il documento completo
_ _ _Page 1 of 12 _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _Page 2 of 12 _ SUMMARY OF PRODUCT CHARACTERISTICS DRIED FACTOR VIII FRACTION, TYPE 8Y ® Human Factor VIII and von Willebrand Factor (VWF) 1. NAME OF THE MEDICINAL PRODUCT Dried Factor VIII Fraction, Type 8Y ® , 25 IU/mL powder for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dried Factor VIII Fraction, Type 8Y ® , is presented as a powder for injection containing nominally 250 IU or 500 IU of FVIII per vial. Dried Factor VIII Fraction, Type 8Y contains approximately 25 IU/mL human coagulation factor VIII per mL (measured by activity assay) and human von Willebrand Factor (measured by VWF:RCo) at a potency of approximately 50 IU/mL. The FVIII potency is determined using the European Pharmacopoeia chromogenic assay. The specific activity of FVIII in 8Y ® is not less than 2 IU/mg protein. Product from the plasma of human donors. The VWF potency (IU) is measured according to Ristocetin Cofactor activity (VWF:RCo), and ELISA antigen method, compared to an in-house standard calibrated against the International Standard for von Willebrand Factor concentrate (WHO). The ratio of FVIII to VWF antigen is approximately 1 IU:3 IU. The specific activity of VWF:RCo in 8Y ® is not less than 2 IU/mg protein. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra- indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Page 3 of 12 _ POSOLOGY Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and other haemostatic disorders. _HAEMOPHILIA A _ The dosage and duration of the substitution therapy depend on the severity of the factor VIII d Leggi il documento completo