Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: LFB-BIOMEDICAMENTS, 3, avenue des Tropiques, BP 40305 LES ULIS, 91958 Courtabœuf Cedex, FRANCE
Willfact 1000 IU Powder and solvent for solution for injection.
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Powder and solvent for solution for injection. The powder should be white or pale yellow lyophilised powder or friable solid. The solvent should be clear and colourless. |
Willfact is presented as powder and solvent for solution for injection containing nominally 1000 IU human von Willebrand factor per vial.
The product contains approximately 100 IU/ml human von Willebrand factor when reconstituted with 10 ml water for injection.
Before the addition of albumin, the specific activity of Willfact is ≥50 IU VWF:RCo/mg protein.
The von Willebrand factor potency (IU) is measured according to ristocetin cofactor activity (VWF:RCo) compared to the International Standard for von Willebrand factor concentrate.
The quantity of human factor VIII in Willfact is ≤10 IU/100 IU VWF:RCo. The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Excipient with known effect:
This medicinal product contains sodium: One 10 ml vial (1000 IU) of Willfact contains 0.3 mmol (6.9 mg) sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Von Willebrand factor |
Administration of von Willebrand factor allows correction of the haemostatic abnormalities exhibited by patients who suffer from von Willebrand factor deficiency. |
| List of Excipients |
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Powder: Human albumin Solvent: water for injections |
1 pack contains: powder in a vial (Type I glass) with a bromobutyl stopper, solvent in an injection vial (Type I glass) with a chlorobutyl stopper, and a transfer system.
LFB-BIOMEDICAMENTS, 3, avenue des Tropiques, BP 40305 – LES ULIS, 91958 Courtabœuf Cedex, FRANCE
PL 28315/0005
Date of first authorisation: 12/01/2011
Date of last renewal: 15/05/2014
| Drug | Countries | |
|---|---|---|
| WILLFACT | Austria, Estonia, Spain, Lithuania, Poland, United Kingdom |
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