البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Factor VIII high purity; von Willebrand factor
Grifols UK Ltd
B02BD06
Factor VIII high purity; von Willebrand factor
1000unit ; 1200unit
Powder and solvent for solution for injection
Intravenous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 02110000; GTIN: 00368516792223
OBJECT 1 ALPHANATE Summary of Product Characteristics Updated 25-May-2016 | Grifols UK Ltd 1. Name of the medicinal product Alphanate ® , powder for injection. 2. Qualitative and quantitative composition Alphanate ® is a high purity solvent detergent and heat treated preparation of human coagulation factor VIII, freeze-dried, Ph. Eur. Alphanate ® also contains human von Willebrand factor at pharmacologically effective levels. Alphanate ® is presented as a powder and solvent for solution for injection containing nominally 250 IU, 500 IU, 1000 IU or 1500 IU human coagulation factor VIII and 300, 600, 1200 or 1800 IU of human von Willebrand factor per vial. Alphanate ® 250 IU contains approximately 50 IU/ml human coagulation factor VIII and 60 IU/ml human von Willebrand factor when reconstituted with 5 ml sterile Water for Injections, Ph. Eur. Alphanate ® 500 IU contains approximately 100 IU/ml human coagulation factor VIII and 120 IU/ml human von Willebrand factor activity when reconstituted with 5 ml sterile Water for Injections, Ph. Eur. Alphanate ® 1000 IU contains approximately 100 IU/ml human coagulation factor VIII and 120 IU/ml human von Willebrand factor activity when reconstituted with 10 ml sterile Water for Injections, Ph. Eur. Alphanate ® 1500 IU contains approximately 150 IU/ml human coagulation factor VIII and 180 IU/ml human von Willebrand factor activity when reconstituted with 10 ml sterile Water for Injections, Ph. Eur. Each container is labelled with the number of International Units of factor VIII and von Willebrand factor activity. The factor VIII potency is determined using the Activated Partial Thromboplastin Time method, which gives results comparable to the European Pharmacopoeia chromogenic assay, and a reference standard calibrated against the WHO International Standard (FVIII:C IU). The von Willebrand factor potency is determined by measuring the ristocetin cofactor activity using a reference standard calibrated against the WHO International Standard (VWF:RCo IU). The specific ac اقرأ الوثيقة كاملة