Leaflet ATOSIBAN EVER PHARMA 37.5mg / 5ml concentrate for solution for infusion

Indicated for: delay of preterm labor

Route of administration: infusion

Substance: atosiban (tocolytic)

ATC: G02CX01 (Genito urinary system and sex hormones | 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 ATOSIBAN EVER PHARMA 37.5mg / 5ml

  • Substance: atosiban
  • Product code: W71954001
  • Concentration: 37.5mg / 5ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Product type: Generic medicine
  • Prescription status: S - Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

  • Manufacturer: EVER PHARMA JENA GMBH - GERMANIA
  • Holder: EVER VALINJECT GMBH - AUSTRIA
  • Number: 16660/2026/01
  • Shelf life: 2 years-after packing for marketing;after the first opening of the bottle-it is used immediately

Concentrations available for atosiban

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