Source: European Medicines Agency (EU) Revision Year: 2014 Publisher: Canyon Pharmaceuticals Limited, 7th Floor, 52-54 Gracechurch Street, London, EC3V 0EH, United Kingdom
Revasc 15mg/0.5ml powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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White powder and clear, colourless solvent for solution for injection. |
Each vial contains 15 mg desirudin. After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml.
Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges.
* produced by recombinant DNA technology in yeast cells.
** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of desirudin with reference to the WHO Second International Standard for alpha-thrombin.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Desirudin |
Desirudin is a highly potent and selective inhibitor of free circulating and clot-bound thrombin. The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time of human or rat plasma whether induced directly (thrombin time) or via the intrinsic (aPTT) or extrinsic (PT) pathways. |
| List of Excipients |
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Powder: Magnesium chloride Solvent: Mannitol (E421) |
15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass).
Pack size of 1, 2 or 10.
Not all pack sizes may be marketed.
Canyon Pharmaceuticals Limited, 7th Floor, 52-54 Gracechurch Street, London, EC3V 0EH, United Kingdom
2 vials/2 ampoules of solvent: EU/l/97/043/001
10 vials/10 ampoules of solvent: EU/1/97/043/002
1 vial/1 ampoule of solvent: EU/1/97/043/003
Date of first authorisation: 9 July 1997
Date of latest renewal: 9 July 2007
| Drug | Countries | |
|---|---|---|
| REVASC | Estonia |
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