Medicine information TRACTOCILE 7.5mg / ml concentrate for solution for injection

Product code:
W53605001
Quantity:
1
Indicated for:
delay of preterm labor
Route of administration:
injectable
Substance:
atosiban (tocolytic)
ATC
G02CX01 — Genito urinary system and sex hormones | Other gynecologicals | Other gynecologicals
Atosiban is an oxytocin receptor antagonist used to halt preterm labor in pregnant women with a gestational age between 24 and 33 weeks. It works by blocking the effects of oxytocin on the uterus, reducing uterine contractions and preventing premature birth.

Atosiban is administered intravenously in three stages: an initial bolus dose followed by a continuous infusion for up to 48 hours. It is indicated for women showing signs of preterm labor, such as regular uterine contractions and cervical changes.

Common side effects include nausea, headache, dizziness, and injection site reactions. In rare cases, severe allergic reactions or cardiovascular complications may occur. Careful monitoring of the mother's and fetus's condition is essential during treatment.

Atosiban is an effective and well-tolerated therapeutic option for managing preterm labor, helping to reduce the risk of complications associated with premature birth.

General data about TRACTOCILE 7.5mg / ml

Substance:
atosiban
Date of latest medicines list:
01-10-2026
Product code:
W53605001
Strength:
7.5mg / ml
Pharmaceutical form:
concentrate for solution for injection
Quantity:
1
Product type:
Original
Price:
209.96 RON
Prescription status:
S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

Manufacturer:
FERRING AB - SUEDIA
Holder:
FERRING PHARMACEUTICALS A/S - DANEMARCA
Number:
124/2000/01
Shelf life:
2 years

Strengths available for atosiban

  • 37.5mg/5ml
  • 6.75mg/0.9ml
  • 7.5mg/ml

Official documents

The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.

Added to database:
07/07/2009
Source record updated:
30/03/2022