TRACTOCILE Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Tractocile 6.75 mg/0.9 ml solution for injection.
Qualitative and quantitative composition
Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate). For a full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection (injection). Clear, colourless solution without particles.
Therapeutic indications
Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of ≥4 per 30 minutes a cervical dilation of ...
Posology and method of administration
Posology Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour. Tractocile is administered intravenously in three successive stages: ...
Contraindications
Tractocile must not be used in the following conditions: Gestational age below 24 or over 33 completed weeks. Premature rupture of the membranes >30 weeks of gestation. Abnormal foetal heart rate. Antepartum ...
Special warnings and precautions for use
When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis. There is ...
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 investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does ...
Fertility, pregnancy and lactation
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation. If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials. In total 48% of the patients treated with atosiban experienced adverse reactions during ...
Overdose
Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms. There is no known specific treatment in case of an overdose.
Pharmacodynamic properties
Pharmacotherapeutic group: Other gynecologicals ATC code: G02CX01 Tractocile contains atosiban (INN), a synthetic peptide ([Mpa<sup>1</sup>,D-Tyr(Et)<sup>2</sup>,Thr<sup>4</sup>,Orn<sup>8</sup>]-oxytocin) ...
Pharmacokinetic properties
In healthy non-pregnant subjects receiving atosiban infusions (10 to 300 micrograms/min over 12 hours), the steady state plasma concentrations increased proportionally to the dose. The clearance, volume ...
Preclinical safety data
No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during ...
List of excipients
Mannitol Hydrochloric acid 1M Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 4 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 in order to protect from light. For storage conditions after first opening of the medicinal product, see section 6.3.
Nature and contents of container
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, ...
Special precautions for disposal and other handling
The vials should be inspected visually for particulate matter and discoloration prior to administration. Preparation of the initial intravenous injection: Withdraw 0.9 ml of a 0.9 ml labelled vial of Tractocile ...
Marketing authorization holder
Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, København S, Denmark, Tel: +45 88 33 88 34
Marketing authorization number(s)
EU/1/99/124/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 January 2000 Date of latest renewal: 20 January 2010
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