Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK
Treatment of infertility due to inadequate luteal phase.
For use during in-vitro fertilisation, where infertility is mainly due to tubal, idiopathic or endometriosis linked sterility associated with normal ovulatory cycles.
Intravaginal application.
One application (1.125g 8% gel) every day, starting after documented ovulation or arbitrarily on the 18th – 21st day of the cycle.
Daily application of Crinone 8% gel should be continued for 30 days if there is laboratory evidence of pregnancy.
Not applicable.
Not applicable.
Crinone is applied directly from the specially designed sealed applicator into the vagina. The applicator should be removed from the sealed wrapper. The twist-off cap should not be removed at this time.
Not applicable.
36 months.
Store below 25°C.
A single use, one piece, white polyethylene applicator with a twist-off top, designed for intravaginal application.
Each applicator contains 1.45g of gel and delivers 1.125g of gel. Each one is wrapped up and sealed in a paper/aluminium/polyethylene foil overwrap.
The applicators are packed in cardboard boxes containing 6 or 15 units of Crinone 8% progesterone vaginal gel.
No special requirements.
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