CRINONE Vaginal gel Ref.[7856] Active ingredients: Progesterone

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

Therapeutic indications

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.

Posology and method of administration

Posology

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.

Use during in-vitro fertilisation

Daily application of Crinone 8% gel should be continued for 30 days if there is laboratory evidence of pregnancy.

Paediatric population

Not applicable.

Older people

Not applicable.

Method of Administration

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.

  1. The applicator should be gripped firmly by the thick end. It should be shaken down like a thermometer to ensure that the contents are at the thin end.
  2. The tab should be twisted off and discarded.
  3. The applicator may be inserted while patient is in a sitting position or when lying on her back with the knees bent. The thin end of applicator should be gently inserted well into the vagina.
  4. The thick end of the applicator should be pressed firmly to deposit gel. The applicator should be removed and discarded in a waste container.

Overdose

Not applicable.

Shelf life

36 months.

Special precautions for storage

Store below 25°C.

Nature and contents of container

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.

Special precautions for disposal and other handling

No special requirements.

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