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atosiban

Tractocile · ATC code G02CX01

Key facts
Active substance
atosiban
ATC code
G02CX01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Tractocile 6.75 mg/0.9 ml solution for injection · Tractocile 37.5 mg/5 ml concentrate for solution for infusion
Marketing authorisation holder
Ferring Pharmaceuticals A/S
Information as of
2026-10-29

Key facts

Atosiban is an oxytocin antagonist (tocolytic). It is used to delay imminent pre-term birth in pregnant adult women.

What it is used for

  • To delay imminent pre-term birth in pregnant adult women with regular uterine contractions of at least 30 seconds at a rate of ≥ 4 per 30 minutes, cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement ≥ 50%, gestational age from 24 until 33 completed weeks, and a normal foetal heart rate (Tractocile).

Dosing

  • Intravenously in three stages: bolus 6.75 mg (Tractocile 6.75 mg/0.9 ml solution for injection) over 1 minute, then loading infusion 300 micrograms/min for 3 hours (54 mg), then subsequent infusion 100 micrograms/min for up to 45 hours (up to 270 mg) using Tractocile 37.5 mg/5 ml concentrate.
  • Treatment should not exceed 48 hours; the total dose of a full course should preferably not exceed 330.75 mg.
  • Re-treatment also starts with a bolus; experience with up to 3 re-treatments is limited.
  • Renal impairment: dose adjustment unlikely to be needed; hepatic impairment: use with caution. If contractions persist, consider alternative therapy.

Contraindications

  • Gestational age below 24 or over 33 completed weeks; premature rupture of membranes > 30 weeks.
  • Abnormal foetal heart rate, intrauterine foetal death, suspected intrauterine infection.
  • Antepartum uterine haemorrhage requiring immediate delivery, eclampsia and severe pre-eclampsia requiring delivery, placenta praevia, abruptio placenta.
  • Any other maternal or foetal condition in which continuing pregnancy is hazardous; hypersensitivity to the active substance or excipients.

Important warnings

  • If premature rupture of membranes cannot be excluded, balance the benefit against the risk of chorioamnionitis.
  • Limited experience in multiple pregnancies and between 24 and 27 weeks.
  • Increased risk of pulmonary oedema with multiple pregnancy or other tocolytics (e.g. calcium channel blockers, beta-mimetics); use with caution.
  • Monitoring of uterine contractions and foetal heart rate should be considered.

Side effects

  • Overall 48% of patients had adverse reactions, generally mild; the most common was nausea (14%, very common).
  • Others: headache, dizziness, tachycardia, hypotension, hot flush, vomiting, hyperglycaemia, injection site reaction, pyrexia, insomnia, pruritus, rash, uterine haemorrhage, uterine atony, allergic reaction.
  • Post-marketing: dyspnoea and pulmonary oedema, particularly with other tocolytics or in multiple pregnancy.
  • No specific adverse reactions in the newborn.

Interactions

  • Atosiban is not a substrate or inhibitor of CYP450; CYP450-mediated interactions are unlikely.
  • No clinically relevant interaction with labetalol or betamethasone.

Pregnancy and breastfeeding

  • Use only when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
  • If an earlier child is being breast-fed, breast-feeding should be stopped during treatment, as oxytocin release may increase contractions.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Atosiban SUN · genericSun Pharmaceutical Industries Europe B.V. · EMEA/H/C/002329
  • TractocileFerring Pharmaceuticals A/S · EMEA/H/C/000253

Source: European Medicines Agency (EMA), product information

Austria

  • Atosiban AltanAltan Pharmaceuticals S.A. · 1 register entry
  • Atosiban Ever PharmaEver Valinject Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Atosiban Ever PharmaEver Valinject Gmbh · 2 register entries
  • Atosiban IbisqusIbigen Srl · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • TractocileFERRİNG İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 21 more European countries
Belgium
Atosiban Ever Pharma
Bulgaria
Атозибан Ever Pharma
Croatia
Atosiban Ever Pharma, Atosiban Makpharm
Czechia
Atosiban Avmc, Atosiban Ever Pharma
Denmark
Atosiban Ever Pharma
Finland
Atosiban Ever Pharma
France
Atosiban Altan, Atosiban Ever Pharma
Greece
Atosiban Ever Pharma
Iceland
Atosiban Sun, Tractocile
Italy
Atosiban Ever Pharma, Atosiban Ibisqus
Latvia
Atosiban Pharmidea
Liechtenstein
Tractocile
Luxembourg
Atosiban Ever Pharma
Netherlands
Atosiban Accord, Atosiban Ever Pharma
Norway
Atosiban Ever Pharma, Atosiban Sun, Tractocile
Poland
Atosiban Ever Pharma
Portugal
Atosiban Ever Pharma, Atosibano Altan
Slovakia
Atosiban Ardez
Slovenia
Atoziban Ever Pharma
Spain
Atosiban Altan Pharmaceuticals S.A., Atosiban Ever Pharma
Sweden
Atosiban Accord, Atosiban Ever Pharma

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Tractocile – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/tractocile-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.