国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
progesterone
Central Pharma (Contract Packing) Limited
progesterone
80mg/g
gel vaginal
Prescription
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 完全なドキュメントを読む