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Tractocile 7.5 mg/ml Solution for injection (2005)

Active ingredients: Atosiban

Product Name and Form

TRACTOCILE 7.5 mg/ml solution for injection.

Pharmaceutical form

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.

Chemical substance
Description

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 AB
Soldattorpsvägen 5
Box 30 047
SE – 20061 – Limhamn
Sweden

20 January 2005.

Marketing authorization number:

EU/1/99/124/001