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TRACTOCILE Solution for injection (2019)

Active ingredients: Atosiban

Product Name and Form

Tractocile 6.75 mg/0.9 ml solution for injection.

Pharmaceutical form

Solution for injection (injection).

Clear, colourless solution without particles.

Qualitative and Quantitative Composition

Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).

For a full list of excipients, see section 6.1.

Chemical substance
Description
Atosiban

Atosiban is a synthetic peptide which is a competitive antagonist of human oxytocin at receptor level. In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.

List of excipients

Mannitol
Hydrochloric acid 1M
Water for injections

Pack sizes and Marketing

One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.

Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.

Marketing authorization holder
Authorization dates

Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, KĂžbenhavn S, Denmark, Tel: +45 88 33 88 34

Date of first authorisation: 20 January 2000
Date of latest renewal: 20 January 2010

Marketing authorization number:

EU/1/99/124/001