PosologyTreatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour.Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 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 Tractocile 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 Tractocile 37.5 mg/5 ml, concentrate for solution for infusion). In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.The following table shows the full posology of the bolus injection followed by the infusion:
|0.9 ml intravenous bolus injection given over 1 minute
|3 hours intravenous loading infusion
|24 ml/hour (300 µg/min)
|Up to 45 hours subsequent intravenous infusion
|8 ml/hour (100 µg/min)
|Up to 270 mg
Patients with renal or hepatic impairmentThere is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution.
Paediatric populationThe safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established. No data are available.
Method of administrationFor instructions on preparation of the medicinal product before administration, see section 6.6.
|MedDRA System Organ Class (SOC)
|Immune system disorders
|Metabolism and nutrition disorders
|Nervous system disorders
|Hypotension, Hot flush
|Skin and subcutaneous tissue disorders
|Reproductive system and breast disorder
|Uterine haemorrhage, uterine atony
|General disorders and administration site conditions
|Injection site reaction
Post-marketing experienceRespiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and beta-mimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
MAH in GB:
Ferring Pharmaceuticals Ltd
MAH in EU:
Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
DK-2300 Copenhagen S
Tel: +45 88 33 88 34
1st January 2021