- Approval Id
- 530901aa0b638da0
- Drug Name
- CERVAGEM VAGINAL PESSARY 1 MG
- Product Name
- CERVAGEM VAGINAL PESSARY 1 MG
- Approval Number
- SIN02475P
- Approval Date
- 1989-03-08
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SUPPOSITORY
- Dosage
- <p><strong>ADMINISTRATION AND DOSAGE</strong><br>
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.</p>
<ol>
<li><p><strong>Softening and dilatation of the cervix in the first trimester of gestation.</strong><br>
<strong>Adults:</strong> One pessary to be inserted into the posterior vaginal fornix 3 hours before surgery.</p></li>
<li><p><strong>Therapeutic termination of pregnancy in the second trimester of gestation.</strong><br>
<strong>Adults:</strong> One pessary to be inserted into the posterior vaginal fornix at <strong>3-hourly</strong> intervals to a maximum of 5 administrations.<br>
If abortion is not established after 5 pessaries, a second course of treatment may be instituted starting 24 hours after the initial commencement of treatment.<br>
Vaginal bleeding and uterine contractions may start after the administration of the first or second pessary, but treatment should be continued for the full course unless complete abortion occurs earlier.<br>
The embryopathic hazards of gemeprost have not been determined. Every effort should be made to ensure that once treatment has started termination of the pregnancy is completed.<br>
<strong>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.</strong></p></li>
<li><p><strong>Intrauterine foetal death in the second trimester of gestation.</strong><br>
One pessary to be inserted into the posterior vaginal fornix at 3-hourly intervals up to a maximum of 5 administrations.<br>
Elderly: Not applicable.<br>
Children: Not applicable.</p></li>
</ol>
- Route Of Administration
- VAGINAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<ol>
<li>Softening and dilatation of the <em>cervix uteri</em> prior to trans-cervical intrauterine operative procedures in pregnant patients in the first trimester of gestation.</li>
<li>Therapeutic termination of pregnancy in patients in the second trimester of gestation, in licensed institutions.</li>
<li>Induction of abortion of second trimester pregnancies complicated by intrauterine foetal death.</li>
</ol>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
GEMEPROST should not be administered to women with known hypersensitivity to prostaglandins or to women with renal function disturbances. GEMEPROST is also contraindicated in women experiencing uterine fragility related to uterine scarring, and in placenta previa.<br>
GEMEPROST pessaries should not be used for the induction of labour or cervical softening at term as foetal effects have not been ascertained.</p>
- Atc Code
- G02AD03
- Atc Item Name
- gemeprost
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
