Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, København S, Denmark, Tel: +45 88 33 88 34
Tractocile 6.75 mg/0.9 ml solution for injection.
| Pharmaceutical Form |
|---|
|
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.
| Active Ingredient |
|---|
|
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 |
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
EU/1/99/124/001
Date of first authorisation: 20 January 2000
Date of latest renewal: 20 January 2010
| Drug | Countries | |
|---|---|---|
| TRACTOCILE | Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Mexico, Nigeria, Netherlands, Poland, Romania, Turkey, United Kingdom, South Africa |
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