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Cervagem

SPC Table of Contents
1. Name of the medicinal product

Cervagem 1mg Pessary

2. Qualitative and quantitative composition

Each pessary contains gemeprost 1.0mg.

3. Pharmaceutical form

White to yellowish-white spindle shaped vaginal pessary.

4. Clinical particulars
4.1 Therapeutic indications

1. Softening and dilatation of the cervix uteri to trans-cervical intra-uterine operative procedures in pregnant patients in the first trimester of gestation.

2. Therapeutic termination of pregnancy conducted in licensed premises during the second trimester of pregnancy.

3. Induction of abortion of second trimester pregnancy complicated by intrauterine foetal death.

Gemeprost is not indicated in the induction of labour or for cervical dilatation at term as foetal effects have not yet been sufficiently studied.

4.2 Posology and method of administration

Adults:

1. Softening & dilatation of cervix

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

2. 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.

3. 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.

4.3 Contraindications

Known hypersensitivity to prostaglandins, renal function disturbances. Gemeprost is also contraindicated in women experiencing uterine fragility related to uterine scarring, and in placenta previa.

Gemeprost pessaries should be not be used for the induction of labour or cervical softening at term as foetal effects have not been ascertained.

4.4 Special warnings and precautions for use

Gemeprost should be used with caution in patients with obstructive airways disease, those with cardiovascular insufficiency, elevated intraocular pressure, cervicitis or vaginitis. Serious, potentially fatal, cardiovascular accidents (myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported with prostaglandins including gemeprost. Cardiac and vascular parameters should be monitored by taking regular measurements of the patients pulse and blood pressure.

Coagulopathy may occur following intra-uterine foetal death and should be monitored and managed actively according to current clinical standard practice.

Adequate follow up of a patient having a pregnancy terminated is essential to ensure that the process has been completed, as the embryopathic hazards of gemeprost have not been determined.

Patients with the following diseases have not been studied: ulcerative colitis; diabetes mellitus; sickle-cell anaemia; epilepsy; disorders of blood coagulation; cardiovascular or pulmonary disease.

When used for cervical dilatation, if it is necessary to postpone surgery much beyond the recommended 3 hour interval patients should be kept under observation, as there is a possibility that spontaneous abortion may occur.

4.5 Interaction with other medicinal products and other forms of interaction

Oxytocin and other labour inducers or accelerators can potentiate the action of Gemeprost..

4.6 Pregnancy and lactation

Not applicable.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Vaginal bleeding and mild uterine pain, similar to menstrual pain, may occur in the interval between the administration of the pessary and surgery, especially if this interval is prolonged beyond the recommended 3 hours. Nausea, vomiting, loose stools or diarrhoea may occur but are rarely severe enough to require treatment. However, standard anti-emetic or anti-diarrhoeal agents may be administered if required. Other reported side effects include: headache, muscle weakness; dizziness; flushing; chills; backache; dyspnoea; chest pain; palpitations and mild pyrexia. Uterine rupture has been reported on rare occasions, most commonly in multiparous women and in those women with a history of uterine surgery. Anaphylactic reactions have not occurred with gemeprost but such reactions have very rarely been noted with other prostaglandins. In very rare cases, severe hypotension and coronary spasms with subsequent myocardial infarctions have been reported.

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

4.9 Overdose

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Gemeprost (16, 16-dimethyl-trans-delta2 PGE1 methyl ester) is a prostaglandin E1 analogue. Both in pregnant and non-pregnant animals, it causes contraction of the uterus and causes softening and decreases resistance of cervical tissue. Gemeprost depresses placental and uterine blood flow but those actions are secondary to the main uterine stimulation. In women, Gemeprost is an effective cervical dilator in the first trimester in pregnancy, Gemeprost is also effective at terminating pregnancy in the second trimester of gestation.

5.2 Pharmacokinetic properties

In pregnant women, although plasma levels of both the active drug and the main metabolite (de-esterified gemeprost) are very low, Gemeprost induces cervical softening within three hours of insertion. Between 12 and 28% of the vaginal dose is eventually absorbed into the circulation, and 50% of this is excreted in the urine. The unabsorbed dose is largely recovered from the genital area, either washed out in the urine or from pads used to absorb post-operative blood loss.

5.3 Preclinical safety data

No drug related toxicity has been observed in rodents given 6 times the therapeutic dose (3.2mmol Kg-1 daily) for up to 26 weeks.

In cynomolgus monkeys subcutaneous administration of doses up to 40 times the human therapeutic dose for 1 month caused effects such as muscular tremor, excessive salivation, poorly formed faeces and mild local reactions at injection sites.

No teratogenic effects observed in either rats or rabbits receiving intra vaginal doses 10 to 40 times the human therapeutic dose.

No mutagenic effects have been observed.

6. Pharmaceutical particulars
6.1 List of excipients

Witepsol S 52

Dehydrated Ethanol

6.2 Incompatibilities

None known.

6.3 Shelf life

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.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Container of 5 or 10 unit dose foil pessaries.

6.6 Special precautions for disposal and other handling

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.

7. Marketing authorisation holder

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

or trading as

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing authorisation number(s)

PL 04425/0373

9. Date of first authorisation/renewal of the authorisation

16 September 2005

10. Date of revision of the text

9 January 2014

Legal classification

POM

Company Information

SANOFI

Address : 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK

Telephone : +44 (0)1483 505 515

Fax : +44 (0)1483 535 432

Medical Information Direct Line : +44 (0)845 372 7101

Medical Information e-mail :

More information about this medicine

Legal categories

  • POM

Active ingredients/generics

  • gemeprost
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