WILLFACT Powder and solvent for solution for injection Ref.[9434] Active ingredients: Von Willebrand factor

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

Product name and form

Willfact 1000 IU Powder and solvent for solution for injection.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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

Powder:

Human albumin
Arginine hydrochloride
Glycine
Sodium citrate
Calcium chloride dihydrate

Solvent:

water for injections

Pack sizes and marketing

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.

Marketing authorization holder

LFB-BIOMEDICAMENTS, 3, avenue des Tropiques, BP 40305 – LES ULIS, 91958 Courtabœuf Cedex, FRANCE

Marketing authorization dates and numbers

PL 28315/0005

Date of first authorisation: 12/01/2011
Date of last renewal: 15/05/2014

Drugs

Drug Countries
WILLFACT Austria, Estonia, Spain, Lithuania, Poland, United Kingdom

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