PROSTIN E2 Vaginal tablet Ref.[9746] Active ingredients: Dinoprostone

Posology

Adults

One tablet to be inserted high into the posterior fornix. A second tablet may be inserted after six to eight hours if labour is not established. Maximum dose 6 mg.

Elderly

Not applicable.

Paediatric population

Not applicable.

Method of administration

Vaginally. The tablets should be inserted high into the posterior fornix.

Overdosage 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.

Where the tablets are packed in a bottle, the tablets should be used within one month of opening the bottle.

Amber glass bottle with screw cap and tac seal. Each bottle contains a desiccant capsule and 4 tablets.

Aluminium foil strip of 4 tablets, each box containing 4 or 8 tablets.

Not all pack sizes may be marketed.

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.