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Human medicines European public assessment report (EPAR): Atosiban SUN, atosiban, Date of authorisation: 31/07/2013, Revision: 10, Status: Authorised

Atosiban SUN can only be obtained with a prescription. Treatment with Atosiban SUN should be carried out by a doctor who has experience in the treatment of pre-term labour.

Treatment should be started as soon as possible after diagnosis of pre-term labour. Atosiban SUN is available as a solution for injection and as a concentrate that is made up into a solution for infusion (drip) into a vein. It is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower-dose infusion (6 mg per hour) lasting up to 45 hours. If contractions come back, treatment with Atosiban SUN can be repeated up to three more times during the pregnancy.

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