Dinoprostone

Επειδή έχει βρεθεί ότι οι προσταγλανδίνες είναι δυνατό να ενισχύσουν τη δράση της ωκυτοκίνης δε συνιστάται τα φάρμακα αυτά να χρησιμοποιούνται ταυτόχρονα. Η ακόλουθη χρήση ωκυτοκίνης μετά τη χορήγηση κολπικών δισκίων δινοπροστόνης συνιστάται με ένα μεσοδιάστημα μεταξύ των δόσεων τουλάχιστον 6 ωρών.

Caution should be exercised in the administration of dinoprostone 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
• hypertension.

Dinoprostone is only used during pregnancy, to induce labour.

Prostaglandins are excreted in breast milk. This is not expected to be a hazard given the circumstances in which the product is used.

Vaginal application

Not relevant.

IV administration

The amount of alcohol (ethanol) in this medicinal product may impair the patient’s ability to drive or use machines.

Cardiac disorders: Vaginal / IV administration: Cardiac arrest

Vascular disorders: Vaginal / IV administration: Hypertension

Gastrointestinal disorders: Vaginal / IV administration: Diarrhoea, nausea, vomiting

General disorders and administration site conditions:

Vaginal administration: Fever

IV administration: Fever, local tissue irritation/erythema (injection site)

Immune system disorders: Vaginal / IV administration: Hypersensitivity reactions such as anaphylactoid reactions and anaphylactic reactions including anaphylactic shock

Musculoskeletal and connective tissue disorders: Vaginal / IV administration: Back pain

Pregnancy, puerperium and perinatal conditions:

Vaginal / IV administration:

Maternal-related conditions: Uterine hypertonus, uterine rupture, abruptio placenta, pulmonary amniotic fluid embolism, rapid cervical dilatation

Foetus-related conditions: Uterine hypercontractility with/without foetal bradycardia foetal distress/altered foetal heart rate (FHR)

Neonatal conditions: Neonatal distress, neonatal death, stillbirths, low Apgar score

Reproductive system and breast disorders: Vaginal administration: Warm feeling in vagina, irritation, pain

Respiratory, thoracic and mediastinal disorders: Vaginal / IV administration: Asthma, bronchospasm

Skin and subcutaneous tissue disorders: Vaginal administration: Rash

Blood and lymphatic system disorders: Vaginal / IV administration: An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labour was induced by pharmacological means, either with dinoprostone or oxytocin. The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labours).