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 caution in handling this 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 and maternal status should be taken into consideration in order to minimise the risk of uterine hyperstimulation, uterine rupture and uterine haemorrhage. Careful and regular monitoring of uterine activity should be conducted during use of dinoprostone. Patients who Page 2 of 8                                                   2023-0087262 develop uterine hypertonus or hypercontractility should be managed in a manner that addresses the welfare of the mother.


It is advised that Prostin E2 10 mg/ml should not be administered by the intramyometrial route since there have been reports of a possible association between this route of administration and cardiac arrest in severely ill patients.


Caution should be exercised in the administration of Prostin E2 10 mg/ml 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.


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.


Excipient information:

Ethanol (alcohol)
Each 0.5 ml ampoule of Prostin E2 Sterile Solution 10 mg/ml contains 400 mg anhydrous ethanol (see section 2), which is equivalent to less than 10 ml beer or 4 ml wine.

The small amount of ethanol in this medicine will not have any noticeable effects.


Page 3 of 8                                                    2023-0087262 Depending on the daily dose administered this medicinal product will deliver varying amounts of ethanol.

Effects on Driving

4.7     Effects on ability to drive and use machines

In view of the indication for Prostin E2 10 mg/ml, this section is not applicable.