CERVAGEM Vaginal pessary Ref.[11079] Active ingredients: Gemeprost

Adults

Softening & dilatation of cervix

One pessary to be inserted into the posterior vaginal fornix 3 hours before surgery.

Therapeutic termination of pregnancy

One pessary to be inserted into the posterior vaginal fornix at 3 hourly intervals to a maximum of 5 administrations. A second course of treatment may be instituted starting 24 hours after the initial commencement of treatment. If abortion is not well established after 10 pessaries, a further course of Gemeprost treatment is not recommended and alternative means should be employed to effect uterine emptying.

Intra-uterine foetal death

One pessary to be inserted into the posterior vaginal fornix at 3 hourly intervals up to a maximum of 5 administrations.

Elderly

Not applicable.

Children

Not applicable.

The toxic dose of gemeprost in women has not been established. Cumulative dosage of 10mg in 24 hours was accompanied by a significant increase in incidence and severity of side-effects. In animals the acute toxic effects are similar to those of prostaglandin E1 and include relaxation of smooth muscle, leading to hypotension and depression of the CNS. Clinically valuable signs of impending toxicity are likely to be sedation; tremor; convulsion; dyspnoea; abdominal pain and diarrhoea, which may be bloody; palpitations or bradycardia. Treatment should be symptomatic. A vaginal douche may be of value depending on elapsed time since insertion of the pessary.

The shelf-life of Gemeprost pessaries is 3 years. Once the foil sachet has been opened, any pessary not used within 12 hours should be destroyed.

Store below minus 10°C in the original pack. Temperature cycling should be avoided.

Container of 5 or 10 unit dose foil pessaries.

Before administration, the pessary should be allowed to warm to room temperature for 30 minutes away from direct heat and sunlight in the unopened foil sachet.