TRACTOCILE Solution for injection (2019)
Active ingredients: Atosiban
Product Name and Form
Tractocile 6.75 mg/0.9 ml solution for injection.
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.
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.
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