Tractocile 7.5 mg/ml Solution for injection (2005)
Active ingredients: Atosiban
Product Name and Form
TRACTOCILE 7.5 mg/ml solution for injection.
Solution for injection.
Visual appearance: clear, colourless solution without particles.
Qualitative and Quantitative Composition
One ml solution contains 7.5 mg atosiban free-base in the form of atosiban acetate.
For 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.
Box 30 047
SE – 20061 – Limhamn
20 January 2005.