Atosiban 7.5 mg/ml

Solution for injection

Atosiban 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 3 cm (0-3 for nulliparas) and effacement of ≥ 50%
− a gestational age from 24 until 33 completed weeks
− a normal foetal heart rate

Treatment with Atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.

Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Atosiban therapy should preferably not exceed 330.75 mg of atosiban.

Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour. Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Atosiban 37.5 mg/5 ml, concentrate for solution for infusion). In the case of persistence of uterine contractions during treatment with Atosiban, alternative therapy should be considered.