Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use


This product is only available to hospitals and clinics with specialised obstetric units and should only be used where 24-hour resident medical cover is provided.


Use the total contents of the syringe for one patient only. Discard after use. Use caution in handling the product to prevent contact with skin. Wash hands thoroughly with soap and water after administration.

As with any oxytocic agent, the risk of uterine rupture should be considered. Concomitant medication, maternal and foetal status should be taken into consideration in order to minimise the risk of uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal and neonatal death. Careful and regular monitoring of uterine activity and foetal heart rate should be Pfleet 2023-0087262                       Page 2 of 7
conducted during use of dinoprostone. Patients who develop uterine hypertonus or hypercontractility, or in whom unusual foetal heart rate patterns develop, should be managed in a manner that addresses the welfare of the foetus and mother.

Prostin E2 Vaginal Gel and Prostin E2 Vaginal Tablets are not bioequivalent.

Caution should be exercised in the administration of Prostin E2 Vaginal Gel for the induction of labour in patients with:
•   asthma or a history of asthma
•   epilepsy or a history of epilepsy
•   glaucoma or raised intra-ocular pressure
•   compromised cardiovascular, hepatic, or renal function
•   hypertension
•   ruptured chorioamniotic membranes.


Dinoprostone should be used with caution in patients with multiple pregnancy.

In labour induction, cephalopelvic relationships should be carefully evaluated before use of Prostin E2 Vaginal Gel. During use, uterine activity, foetal status and the progression of cervical dilation should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus, sustained uterine contractions, or foetal distress.
In cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the foetus (where applicable) should be continuously monitored throughout labour. The possibility of uterine rupture should be borne in mind where high-tone uterine contractions are sustained.
Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who received prostaglandin E1 during prolonged treatment. There is no evidence that short-term administration of prostaglandin E2 can cause similar bone effects.
Women aged 35 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labour induction (see section 4.8). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase.

Effects on Driving

4.7      Effects on ability to drive and use machines

Not relevant.