XIAPEX Powder and solvent for solution for injection Ref.[7195] Active ingredients: Collagenase

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

Product name and form

Xiapex 0.9 mg powder and solvent for solution for injection.

Pharmaceutical Form

Powder and solvent for solution for injection.

The powder is a white lyophilised powder.

The solvent is a clear colourless solution.

Qualitative and quantitative composition

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

Powder:

Sucrose
Trometamol
Hydrochloric acid 2.4% w/w (for pH adjustment)

Solvent:

Calcium chloride dihydrate
Sodium chloride
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

Marketing authorization dates and numbers

EU/1/11/671/001

Date of first authorisation: 28 February 2011
Date of latest renewal: 18 January 2016

Drugs

Drug Countries
XIAPEX Estonia, Lithuania, Poland

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