国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
von Willebrand factor; Factor VIII
Bio Products Laboratory Ltd
B02BD06
von Willebrand factor; Factor VIII
500unit ; 250unit
Powder and solvent for solution for injection
Intravenous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 02110000; GTIN: 5019943000232
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. 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 _ _8Y contains’)_ SPECIAL CARE MUST BE TAKEN WITH 8Y IF YOU: • DEVELOP AN ALLERGIC REACTION _(see Section 4 _ _‘Possible side effects’ for a list of these)_ STOP THE TREATMENT IMMEDIATELY AND TELL YOUR DOCTOR. • ARE BLOOD GROUP A, B OR AB and need large doses of the medicine. Your doctor will carry out regular blood tests to check your red blood cells because this medicine contains small amounts of blood group antibodies which are present in the plasma that the medici 阅读完整的文件
OBJECT 1 DRIED FACTOR VIII FRACTION, TYPE 8Y Summary of Product Characteristics Updated 15-Jul-2013 | Bio Products Laboratory Limited 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. The vials also contain at least 260 IU or 520 IU von Willebrand Factor. The product contains approximately 25 IU/mL human coagulation factor VIII per mL (measured by activity assay) and at least 26 IU/mL human von Willebrand Factor (measured by VWF:RCo) when reconstituted with 10 mL (250 IU) or 20 mL (500 IU) of Sterilised Water for Injections, (Ph.Eur.). 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. 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 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 deficie 阅读完整的文件