Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2005 Publisher: Ferring AB Soldattorpsvägen 5 Box 30 047 SE 20061 Limhamn Sweden
TRACTOCILE 7.5 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Visual appearance: clear, colourless solution without particles. |
One ml solution contains 7.5 mg atosiban free-base in the form of atosiban acetate.
For excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Atosiban |
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 AB
Soldattorpsvägen 5
Box 30 047
SE – 20061 – Limhamn
Sweden
EU/1/99/124/001
20 January 2005.
| Drug | Countries | |
|---|---|---|
| TRACTOCILE | Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, United Kingdom, South Africa |
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