Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
progesterone
Central Pharma (Contract Packing) Limited
G03DA04
progesterone
80mg/g
gel vaginal
(6) pre-filled plastic applicators 1,125g, (15) pre-filled plastic applicators 1,125g
Prescription
Registered
2018-12-27
2 SUMMARY OF PRODUCT CHARACTERISTICS 1.3.1 PAGE 2 OF 16 3 1. NAME OF THE MEDICINAL PRODUCT Crinone 8% w/w Progesterone Vaginal Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Progesterone mg/dose 90 % w/w 8.0 Excipient with known effect: Contains Sorbic acid 0.08% w/w (0.9mg/1.125 g dose) For the full list of excipients, see section 6.1. 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 18 th – 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. _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 a p p l i c a t o r s h o u l d b e r e m o v e d f r o m t h e s e a l e d w r a p p e r . T h e tw i s t - o f f c a p s h o u ld n o t b e 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. 1.3.1 PAGE 3 OF 16 4 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 applicato Прочитать полный документ