SPC, UK: Tractocile 7.5 mg/ml Solution for Injection
||Ferring Pharmaceuticals Ltd
||Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
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Name of the medicinal product
TRACTOCILE 7.5 mg/ml solution for injection.
Qualitative and quantitative composition
One ml solution contains 7.5 mg atosiban free-base in the form of atosiban acetate. For excipients, see ...
Solution for injection. Visual appearance: clear, colourless solution without particles.
TRACTOCILE is indicated to delay imminent pre-term birth in pregnant women with: regular uterine contractions ...
Posology and method of administration
Treatment with TRACTOCILE should be initiated and maintained by a physician experienced in the treatment ...
TRACTOCILE should not be used in the following conditions: Gestational age below 24 or over 33 completed ...
Special warnings and precautions for use
When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits ...
Interaction with other medicinal products and other forms of interaction
It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro ...
Pregnancy and lactation
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks ...
Effects on ability to drive and use machines
Possible undesirable effects of atosiban were described for the mother during the use of atosiban in ...
Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms. ...
Pharmacotherapeutic group: Other gynecologicals ATC code: G02CX01 TRACTOCILE contains atosiban (INN), ...
In healthy non-pregnant subjects receiving atosiban infusions (10 to 300 micrograms/min over 12 hours), ...
Preclinical safety data
No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and ...
List of excipients
Mannitol Hydrochloric acid 1M Water for injections
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...
2 years. Once the vial has been opened, the product must be used immediately.
Special precautions for storage
Store in a refrigerator (2°C 8°C). Store in the original package.
Nature and contents of container
One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban. Colourless ...
Special precautions for disposal and other handling
The vials should be inspected visually for particulate matter and discoloration prior to administration. ...
Marketing authorization holder
Ferring AB Soldattorpsvägen 5 Box 30 047 SE 20061 Limhamn Sweden
Marketing authorization number(s)
Date of first authorization / renewal of the authorization
20 January 2005.
Date of revision of the text
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.