Tractocile

Posology Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour. 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. 75 mg of atosiban. Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour. 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. 5 mg/5 ml, concentrate for solution for infusion. Patients with renal or hepatic impairment There 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 population The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established.

No data are available. 6.

Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials. In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials. The observed adverse reactions were generally of a mild severity.

The most commonly reported adverse reaction in the mother is nausea (14 %). For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban. The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta- mimetic group incidences.

The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

5 MedDRA System Organ Class (SOC) Very common Common Uncommon Rare Immune system disorders Allergic reaction Metabolism and nutrition disorders Hyperglycaemia Psychiatric disorder Insomnia Nervous system disorders Headache, Dizziness Cardiac disorders Tachycardia Vascular disorders Hypotension, Hot flush Gastrointestinal disorders Nausea Vomiting Skin and subcutaneous tissue disorders Pruritis, Rash Reproductive system and breast disorder Uterine haemorrhage, uterine atony General disorders and administration site conditions Injection site reaction Pyrexia Post-marketing experience Respiratory 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 national reporting system listed in Appendix V.

When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis. There 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. 2). There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.

The benefit of atosiban in these subgroups is therefore uncertain. 2). In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Tractocile depends on the assessment of fetal maturity. Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.

As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored. However, inadequate uterus contraction postpartum was not observed during the clinical trials.

Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta- mimetics are known to be associated with increased risk of pulmonary oedema. 8).

1.