PROSTIN E2 Concentrate for solution for infusion Ref.[9748] Active ingredients: Dinoprostone

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.

It is advised that Prostin E2 Sterile Solution 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 Sterile Solution 1 mg/ml 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.

As with any oxytocic agent, Prostin E2 Sterile Solution should be used with caution in patients with compromised (scarred) uteri.

In labour induction, cephalopelvic relationships should be carefully evaluated before use of Prostin E2 Sterile Solution. 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.

Ethanol (alcohol)

Depending on the daily dose administered this medicinal product will deliver varying amounts of ethanol.

This product contains 86.96% v/v ethanol (alcohol).

Once diluted with appropriate diluent this medicinal product contains 0.13% v/v ethanol (alcohol) i.e. up to 515 mg per maximum daily dose (infusion rate of 0.5 microgram/min per 24 hrs), equivalent to 19 ml of a 3.5% vol beer, 5 ml of a 14% vol wine per maximum daily dose. Harmful for those suffering from alcoholism. It should also be taken into account when considering using this medicine in children and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines.

Since it has been found that prostaglandins potentiate the effect of oxytocin, it is not recommended that these drugs are used together. If used in sequence, the patient’s uterine activity should be carefully monitored.

Pregnancy

Prostin E2 Sterile Solution 1 mg/ml is only used during pregnancy, to induce labour.

Breast-feeding

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

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

Cardiac disorders: Cardiac arrest

Vascular disorders: Hypertension

Gastrointestinal disorders: Diarrhoea, nausea, vomiting

General disorders and administration site conditions: Fever, local tissue irritation/erythema (injection site)

Immune system disorders: Hypersensitivity reactions such as anaphylactoid reactions and anaphylactic reactions including anaphylactic shock

Investigations: Elevated WBC

Musculoskeletal and connective tissue disorders: Back pain

Nervous system disorders: Transient vasovagal symptoms (flushing, shivering, headache, dizziness)

Pregnancy, puerperium and perinatal conditions:

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

Respiratory, thoracic and mediastinal disorders: Asthma, bronchospasm

Blood and lymphatic system disorders: 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 (see section 4.4). The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labours).

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.