Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium
Wilate, 500 IU VWF/500 IU FVIII, powder and solvent for solution for injection.
Wilate, 1000 IU VWF/1000 IU FVIII, powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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Powder and solvent for solution for injection. Freeze-dried powder: white or pale yellow powder or crumbly solid. |
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 sodium per vial).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor VIII |
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. |
|
| 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: Sodium chloride, Glycine, Sucrose, Sodium citrate and Calcium chloride Solvent: Water for injections with 0.1% Polysorbate 80 |
Package sizes:
1 package contains:
1 package contains:
Not all pack sizes may be marketed.
Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium
Wilate 500 Reg.-No.: PA2219/008/001
Wilate 1000 Reg.-No.: PA2219/008/002
Date of First Authorisation: 16th March 2012
Date of last renewal: 25th August 2014
| Drug | Countries | |
|---|---|---|
| WILATE | Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Tunisia, United Kingdom, United States |
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