Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

Tractocile 7.5 mg/ml Solution for injection (2005)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Ferring Pharmaceuticals Ltd
Διεύθυνση :
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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 section 6.1.

Pharmaceutical form

Solution for injection. Visual appearance: clear, colourless solution without particles.

Therapeutic indications

TRACTOCILE is indicated to delay imminent pre-term birth in pregnant women with: regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes a cervical dilation of 1 to ...

Posology and method of administration

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: an initial ...

Contraindications

TRACTOCILE should 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 Intrauterine growth retardation and ...

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 ...

Pregnancy and lactation

Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation. In atosiban clinical trials no effects were observed on lactation. Small amounts of ...

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

Possible undesirable effects of atosiban were described for the mother during the use of atosiban in clinical trials. The observed undesirable effects were generally of a mild severity. In total 48% of ...

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

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 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 AB Soldattorpsvägen 5 Box 30 047 SE 20061 Limhamn Sweden

Marketing authorization number(s)

EU/1/99/124/001

Date of first authorization / renewal of the authorization

20 January 2005.

Date of revision of the text

January 2005.
Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.