Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom
Optivate 100 IU/ml powder and solvent for solution for injection.
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Powder and solvent for solution for injection. Powder: White or pale yellow powder. Solvent: Clear colourless liquid. |
High purity human factor VIII and human von Willebrand factor concentrate
Each vial contains nominally 250 IU human coagulation factor VIII.
Optivate contains approximately 100 IU/ml of human coagulation factor VIII after reconstitution.
Each vial contains nominally 500 IU human coagulation factor VIII.
Optivate contains approximately 100 IU/ml of human coagulation factor VIII after reconstitution.
Each vial contains nominally 1000 IU human coagulation factor VIII.
Optivate contains approximately 100 IU/ml of human coagulation factor VIII after reconstitution.
The factor VIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The factor VIII specific activity of Optivate is approximately 800 IU/mg protein when von Willebrand factor (VWF) is discounted and approximately 43 IU/mg protein when the presence of VWF is considered in the calculation.
Optivate contains approximately 172 IU VWF:RCo per ml after reconstitution.
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 specific activity of Optivate is approximately 75 IU of VWF:RCo/mg protein.
Produced from the plasma of human donors.
Excipient with known effect:
After reconstitution Optivate contains approximately 320 mmol/1 (7.4 mg/ml) sodium, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
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. |
| List of Excipients |
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Powder |
Optivate 250 IU powder and solvent for solution for injection:
Optivate 500 IU powder and solvent for solution for injection:
Optivate 1000 IU powder and solvent for solution for injection:
Not all pack sizes may be marketed.
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom
PL 08801/0055
Date of first authorisation: 27 May 2010
Date of latest renewal: 26 May 2015
| Drug | Countries | |
|---|---|---|
| OPTIVATE | Cyprus, Estonia, Israel, Lithuania, Malta, Poland, Romania, Singapore, United Kingdom |
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