Crinone Gel

Crinone™ Gel
Generic Name Progesterone gel

Document last updated on the eMC: Mon 20 August 2001

1. NAME OF THE MEDICINAL PRODUCT
CRINONE* 8% PROGESTERONE VAGINAL GEL.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient	mg/dose	% w/w
Progesterone	90	8.0

3. PHARMACEUTICAL FORM
Vaginal gel.

4. CLINICAL PARTICULARS

4.1 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.

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.

When used during in-vitro fertilisation, daily application of Crinone 8% gel should be continued for 30 days if there is laboratory evidence of pregnancy.

Children: Not applicable.

The Elderly: Not applicable.

4.3 Contraindications
Known allergy to any of the excipients.

Undiagnosed uterine bleeding.

Porphyria

4.4 Special warnings and precautions for use
Cautious use in severe hepatic insufficiency.

The product should not be used concurrently with other local intravaginal therapy.

4.5 Interaction with other medicinal products and other forms of Interaction
No interaction reported

4.6 Pregnancy and lactation[/b]
In case of corpus luteum deficiency, CRINONE can be used during the first month of pregnancy.

Do not use during lactation.

4.7 Effects on ability to drive and use machines
Drivers and users of machines are warned that risk of somnolence may occur.

4.8 Undesirable effects
Rare cases of somnolence.

Occasional spotting.

4.9 Overdose
Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
The pharmacological particulars of the product are those of the naturally occurring progesterone with induction of a full secretory endometrium.

5.2 Pharmacokinetic properties
The progesterone vaginal gel is based on a polycarbophil delivery system which attaches to the vaginal mucosa and provides a prolonged release of progesterone for at least three days.

5.3 Preclinical safety data
In rabbits, Crinone was an eye irritant categorised class IV (minimal effects clearing in less than 24 hours), but not a dermal irritant.

A moderate vaginal irritation was found in rabbits after application of 2.0ml/day of 8% gel for 5 days.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipient(s)
Glycerin, Light Liquid Paraffin, Hydrogenated Palm Oil Glyceride, Carbopol 974P, Sorbic acid, Polycarbophil, Sodium hydroxide, Purified water.

6.2 Incompatibilities
No incompatibilities were found with the usual contraceptive devices.

6.3 Shelf-life
36 months.

6.4 Special precautions for storage
Store below 25?C.

6.5 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 1.45 g 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.

6.6 Instructions for use and handling
Crinone is applied directly from the specially designed sealed applicator into the vagina. Remove the applicator from the sealed wrapper. DO NOT remove the twist-off cap at this time.Grip the applicator firmly by the thick end. Shake down like a thermometer to ensure that the contents are at the thin end. Twist off the tab and discard. The applicator may be inserted while you are in a sitting position or when lying on your back with the knees bent. Gently insert the thin end of applicator well into the vagina. Press the thick end of the applicator firmly to deposit gel. Remove the applicator and discard in a waste container. CRINONE coats the vaginal mucosa to provide long-lasting release of progesterone.

7. MARKETING AUTHORISATION HOLDER
Serono Pharmaceuticals Ltd

Bedfont Cross

Stanwell Road

Feltham

Middlesex TW14 8NX

United Kingdom

Tel: 020 8818 7200

8. MARKETING AUTHORISATION NUMBER(S)
PL 03400/0081

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26 January 2000

10. DATE OF REVISION OF THE TEXT
November 2000