Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
coagulation factor VIII; Von Willebrand Factor
Pharmaniaga Marketing Sdn Bhd
coagulation factor VIII; Von Willebrand Factor
1vial Vials
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H.
Not Applicable Διαβάστε το πλήρες έγγραφο
XXXXXXX-XX XXXXXXX-XX XXXXXXX-XX Mat-No./CAN/DataMatrix: XXXXXXX-XX (CODE IS A SAMPLE) / Version: 09 / 2020-09-28 / Product code: 189 / WILATE / MALAYSIA / 520 X 270 MM / BLACK / SATZSTUDIO BORNGRÄBER / font size: 9PT INSTRUCTION FOR USE (SUMMARY OF PRODUCT CHARACTERISTICS) 1 NAME OF THE MEDICINAL PRODUCT WILATE 500, 500 IU VWF/500 IU FVIII, powder and solvent for solution for injection WILATE 1000, 1000 IU VWF/1000 IU FVIII, powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Wilate is presented as a powder and solvent for solution for injection. Each vial contains nominally 500 IU/1000 IU human von Willebrand factor (VWF ) and human coagulation factor VIII (FVIII). The product contains approximately 100 IU/ml human von Willebrand factor when reconstituted with 5 ml/10 ml Water for Injections with 0.1 % Polysorbate 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 potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Wilate is ≥ 67 IU FVIII:C/ mg protein. Produced from the plasma of human donors. Excipient(s) with known effect: Wilate 500: 11.7 mg sodium per ml reconstituted solution (58.7 mg sodium per vial). Wilate 1000: 11.7 mg sodium per ml reconstituted solution (117.3 mg per vial). For the full list of excipients, see section 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 Διαβάστε το πλήρες έγγραφο