País: Israel
Idioma: anglès
Font: Ministry of Health
FACTOR VIII (HUMAN); VON WILLEBRAND FACTOR
DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL
B02BD02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VON WILLEBRAND FACTOR 1000 IU/VIAL; FACTOR VIII (HUMAN) 1000 IU/VIAL
I.V
Required
OCTAPHARMA AG, SWITZERLAND
COAGULATION FACTOR VIII
Von Willebrand disease (VWD) :Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated.Haemophilia A :Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency).
2018-11-30
_ _ _Page 1/13 _ The format of this leaflet has been defined by the MOH and its content has been checked and approved 12.2013 1 NAME OF THE MEDICINAL PRODUCT WILATE 500, 500 IU FVIII/500 IU VWF, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION WILATE 1000, 1000 IU FVIII/1000 IU VWF, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Wilate, produced from the plasma of human donors, is presented as a powder and solvent for solution for injection containing nominally 500 IU/1000 IU human coagulation factor VIII and human von Willebrand factor (VWF) per vial. The product contains approximately 100 IU/ml human von Willebrand factor when reconstituted with 5 ml/10 ml Water for Injections with 0.1 % Polysorbat 80. The specific activity of Wilate is 67 IU VWF:RCo/mg protein. The VWF potency (IU) is measured according to ristocetin cofactor activity (VWF:RCo) compared to the International Standard for von Willebrand Factor Concentrate (WHO). The product contains approximately 100 IU/ml human coagulation factor VIII when reconstituted with 5 ml/10 ml Water for Injections with 0.1% Polysorbate 80. The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Wilate is 67 IU FVIII:C/mg protein. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Freeze-dried powder: white or pale yellow powder or crumbly solid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Von Willebrand disease (VWD) Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated. Haemophilia A Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency). _ _ _Page 2/13 _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. The product is of single us Llegiu el document complet