Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Human factor viii; Von willebrand factor human
Octapharma (IP) SPRL
B02BD; B02BD06
Human factor viii; Von willebrand factor human
500/500 international unit(s)
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
Blood coagulation factors; von Willebrand factor and coagulation factor VIII in combination
Marketed
2012-03-16
Wilate can be stored at room temperature (max. +25°C) for 2 months. In this case the shelf-life expires 2 months after the product has been taken out of the refrigerator for the first time. The new shelf-life has to be noted on the outer carton by you. The powder should be dissolved only directly before injection. The stability of the solution has been demonstrated for 4 hours at room temperature. Nevertheless, to prevent contamination, the solution should be used immediately and on one occasion only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT WILATE CONTAINS − The active substances are human von Willebrand factor and human coagulation factor VIII − The other ingredients are sodium chloride, glycine, sucrose, sodium citrate and calcium chloride. Solvent: water for injections with 0.1% Polysorbate 80 WHAT WILATE LOOKS LIKE AND CONTENTS OF THE PACK Freeze-dried powder: white or pale yellow powder or crumbly solid Reconstituted solution: should be clear or slightly opalescent Wilate is supplied as a powder and solvent for solution for injection. It comes in 2 pack sizes: • Wilate, 500 IU VWF and 500 IU FVIII, powder and solvent for solution for injection, contains nominally 500 IU human von Willebrand factor and 500 IU human coagulation factor VIII per vial. The product contains approximately 100 IU/ml human von Willebrand factor and 100 IU/ml human coagulation factor VIII when reconstituted with 5 ml of Water for Injections with 0.1% Polysorbate 80 (Solvent). • Wilate, 1000 IU VWF and 1000 IU FVIII, powder and solvent for solution for injection, contains nominally 1000 IU human von Willebrand factor and 1000 IU human coagulation factor VIII per vial. The product contains approximately 100 IU/ml human von Willebrand factor and 100 IU/ml human coagulation factor VIII when reconstituted with 10 ml of Water for Injections Read the complete document
Health Products Regulatory Authority 14 December 2022 CRN00D55X Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Wilate, 500 IU VWF/500 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 ³ 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 ³ 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 sodium 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 is ineffective or contra-indicated. Haemophilia A Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be under the supervision of a physi Read the complete document