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

Posology

Adults

Directions for the Preparation of a Dilute Solution:

For use by IV drip (a drip set delivering 60 drops/per ml must be used) or constant rate infusion pump. Withdraw 0.75 ml from the ampoule using an aseptic technique and add to 500 ml sterile normal saline or 5% dextrose. Shake to ensure uniformity.

After dilution attach label provided. Use dilute solution within 24 hours of preparation and store in a refrigerator at 2-8°C.

The dose of Prostin E2 Sterile Solution used normally depends not only upon the indication but also on patient response.

The following is a guide to dosage:

Dilute with normal saline or 5% dextrose to produce a 1.5 micrograms/ml solution. The 1.5 micrograms/ml solution is infused at 0.25 micrograms/minute for 30 minutes and then maintained or increased. Cases of foetal death in utero may require higher doses. An initial rate of 0.5 micrograms/minute may be used with stepwise increases, at intervals of not less than one hour.

The appearance of foetal distress or uterine hypertonus requires cessation of therapy until the state returns to normal. The situation should be re-assessed and, if necessary, the infusion can be recommenced but at lower dosage rates, 50% of the last dose level used.

If no response is seen within the first 12-24 hours of treatment, the medication should be discontinued.

Elderly

Not applicable.

Paediatric population

Not applicable.

Method of administration

For intravenous administration only.

Over dosage may be expressed by uterine hypercontractility and uterine hypertonus. During use, uterine activity, fetal 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 fetal distress. Because of the transient nature of prostaglandin E₂ (PGE₂)-induced myometrial hyperstimulation, non-specific, conservative management was found to be effective in the vast majority of cases: i.e. maternal position change and administration of oxygen to the mother. If conservative management is not effective, β-adrenergic drugs may be used as a treatment of hyperstimulation following administration of PGE₂ for cervical ripening, in appropriate patients.

2 years.

Store in a refrigerator at 2-8°C.

Once diluted, the diluted solution should be stored in a refrigerator at 2-8°C and used within 24 hours.

Ph. Eur. Type I glass ampoule, containing 0.75 ml sterile solution, packed in a carton.

Use caution in handling this product to prevent contact with skin. Wash hands thoroughly with soap and water after administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.