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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crinone 8% w/w progesterone vaginal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: Contains sorbic acid 0.08% w/w (0.9mg/1.125g dose)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel
White to off white gel contained in a white plastic applicator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infertility due to inadequate luteal phase.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravaginal application.
Treatment of infertility due to inadequate luteal phase:
One application (1.125g 8% gel) every day, starting after documented ovulation or arbitrarily on the 18th-21st day of
the cycle.
Children: not applicable.
4.3 CONTRAINDICATIONS
Crinone should not be used in individuals with any of the following conditions:
Active Ingredient
Mg/dose % w/w
Progesterone
90
8.0
1. Known hypersensitivity to progesterone or to any of the other excipients of Crinone.
2. Undiagnosed vaginal bleeding.
3. Known or suspected malignancy of the breast or genital organs.
4. Acute porphyria.
5. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or patients with a history of these conditions.
6. Missed abortion.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/11/2010_
_CRN 2091414_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, non-functional causes should be
considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken.
Sorbic acid may cause local skin reactions, (e.g. contact dermatitis).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Although
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