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
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.
Children: Not applicable
The Elderly: 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.
4.3 Contraindications
1. Known hypersensitivity to progesterone or any of the excipients
2. Undiagnosed vaginal bleeding
3. Known or suspected progesterone-sensitive malignant tumours
4. Porphyria
4.4 Special Warnings And Precautions For Use
Cautious use in severe hepatic insufficiency.
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.
Crinone is not indicated in threatened abortion. Treatment should be discontinued in the event of a missed abortion.
Although risk of thromboembolism has been associated with estrogens, a link with progestins remains questionable. Therefore, in women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with Crinone may further increase the risk. In these women, the benefits of Crinone administration need to be weighed against the risks. It should be noted however, that pregnancy itself carries an increased risk of thrombo-embolic events.
Avoid concurrent use with other intravaginal preparations. See section 4.5.
The excipient sorbic acid may cause local skin reactions (e.g. contact dermatitis) or vaginal irritation.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Crinone is not recommended for use concurrently with other vaginal preparations.
Although there is evidence of interaction between oral progestogens and CYP3A4 inducers, resulting in a decrease of serum progestogen levels, no significant consequences on progesterone levels is expected from concurrent administration of CRINONE® vaginal gel with CYP3A inducers
4.6 Pregnancy And Lactation
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
Common (>1/100 – 1/10)
Headache, Somnolence, Breast Tenderness, Vaginal irritation, Itching or Burning
Post Marketing Reports
In addition, intermenstrual bleeding (spotting) and other mild application site reactions have been reported post-marketing.
Rare events of urticaria and pruritis were noted.
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 2.0 ml/day of 8% gel for 5 days.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerin, Light 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 1.45g 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.
6.6 Special Precautions For Disposal And Other Handling
No special requirements
7. Marketing Authorisation Holder
Serono 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
Date of first authorisation: 26th January 2000
Date of last renewal: 26th June 2004
10. Date Of Revision Of The Text
19th May 2010
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