Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Xiapex 0.9 mg powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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Powder and solvent for solution for injection. The powder is a white lyophilised powder. The solvent is a clear colourless solution. |
Each vial of powder contains 0.9 mg of collagenase clostridium histolyticum*.
* A formulation of two collagenase enzymes co-expressed and harvested from anaerobic fermentation of a phenotypically selected strain of Clostridium histolyticum bacterium.
Excipients with known effect:
Sodium injected per joint in the treatment of Dupuytren’s contracture:
Metacarpophalangeal (MP) joints: 0.9 mg.
Proximal interphalangeal (PIP) joints: 0.7 mg.
Sodium injected per plaque in the treatment of Peyronie’s disease: 0.9 mg.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Collagenase |
Collagenases are proteinases that hydrolyze collagen under physiological conditions. Collagenase clostridium histolyticum is comprised of a mixture of Class I (AUX-I) and Class II (AUX-II) clostridial collagenases in a defined mass ratio. Both collagenases effectively cleave interstitial collagen but at different sites on the molecule; additionally, they prefer different conformations (triple helical versus denatured or cleaved). |
| List of Excipients |
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Powder: Sucrose Solvent: Calcium chloride dihydrate |
Xiapex powder is supplied in a clear glass vial (3 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene).
Solvent: 3 ml solution supplied in a clear glass vial (5 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene).
Pack of 1 vial of powder and 1 vial of solvent.
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
EU/1/11/671/001
Date of first authorisation: 28 February 2011
Date of latest renewal: 18 January 2016
| Drug | Countries | |
|---|---|---|
| XIAPEX | Estonia, Lithuania, Poland |
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