Crinone

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

progesterone

Beschikbaar vanaf:

Central Pharma (Contract Packing) Limited

INN (Algemene Internationale Benaming):

progesterone

Dosering:

80mg/g

farmaceutische vorm:

gel vaginal

Prescription-type:

Prescription

Productkenmerken

Certificate Number: PP10127267
SUMMARY OF PRODUCT CHARACTERISTICS
PRINTED FOR CERTIFICATE OF PHARMACEUTICAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCT
CRINONE® 8% Progesterone Vaginal Gel.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Progesterone
mg/dose
90
%w/w
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
- 21
st
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
Certificate Number: PP10127267
SUMMARY OF PRODUCT CHARACTERISTICS
Printed for Certificate of Pharmaceutical Product
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 Contra indications
1.
Known hypersensitivity to progesterone or any of the excipients
2.
Undiagnosed v