CERVAGEM Vaginal pessary (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
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.
4.1. Therapeutic indications
Softening and dilatation of the cervix uteri to trans-cervical intra-uterine operative procedures in pregnant patients in the first trimester of gestation. Therapeutic termination of pregnancy conducted ...
4.2. Posology and method of administration
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 ...
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 ...
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 ...
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 ...
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 ...
5.1. Pharmacodynamic properties
Gemeprost (16, 16-dimethyl-trans-delta<sup>2</sup> PGE1 methyl ester) is a prostaglandin E1 analogue. Both in pregnant and non-pregnant animals, it causes contraction of the uterus and causes softening ...
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 ...
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 ...
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 authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
8. Marketing authorization number(s)
PL 04425/0373
9. Date of first authorization / renewal of the authorization
16 September 2005
10. Date of revision of the text
14 August 2019
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