Active ingredients: Atosiban
Tractocile 6.75 mg/0.9 ml solution for injection.
Solution for injection (injection).
Clear, colourless solution without particles.
Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
For a full list of excipients, see section 6.1.
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.
Hydrochloric acid 1M
Water for injections
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.
Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, København S, Denmark, Tel: +45 88 33 88 34
Date of first authorisation: 20 January 2000
Date of latest renewal: 20 January 2010