Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221 Vienna, Austria
CEPROTIN 500 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. White or cream coloured powder or friable solid. After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg. |
Protein C from human plasma purified by mouse monoclonal antibodies. CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container. The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard.
Excipients with known effect: Sodium chloride: 44 mg/vial, Sodium citrate. 2H2O: 22 mg/vial
For the full list of excipients see section 6.1.
* One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.
| Active Ingredient | Description | |
|---|---|---|
| Protein C |
Protein C is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. Protein C exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation. Protein C has also been shown to have profibrinolytic effects. |
| List of Excipients |
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Powder: Human albumin Solvent: Sterilised Water for Injections |
500 IU and 1000 IU: CEPROTIN powder comes in vials of neutral glass of either hydrolytic type I (500 IU) or hydrolytic type II (1000 IU). The solvent comes in vials of neutral glass of hydrolytic type I. The product and the solvent vials are closed with butyl rubber stoppers.
Each pack also contains:
Not all pack sizes may be marketed.
Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221 Vienna, Austria
EU/1/01/190/001
Date of first authorisation: 16 July 2001
Date of last renewal: 16 July 2006
| Drug | Countries | |
|---|---|---|
| CEPROTIN | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, South Africa |
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