Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

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. In patients with impaired hepatic function, atosiban should be used with caution (see Sections 4.2 and 5.2).

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.

Re-treatment with Atosiban EVER Pharma is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see Section 4.2).
In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Atosiban EVER Pharma depends on the assessment of foetal maturity.
Monitoring of uterine contractions and foetal 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 delive1y 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. Therefore, atosiban should be used with caution in case of multiple pregnancy and/or concomitant administration of other medicinal products with tocolytic activity (see section 4.8).

Effects on Driving

4.7     Effects on ability to drive and use machines

Not relevant.