Pays: Indonésie
Langue: indonésien
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PROGESTERONE
MERCK TBK - Indonesia
PROGESTERONE
90 MG
VAGINAL GEL
DUS, 15 SINGLE USE PRE-FILLED APPLICATOR @ 1,125 G
FLEET LABORATORIES LIMITED - United Kingdom
2019-10-30
Page 1 of 4 CRINONE® 8% PROGESTERONE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT mg/dose % w/w Progesterone 90 8.0 Excipients with known effect: Contains sorbic acid 0.08% w/w (0.9 mg/1.125 g dose). For the full list of excipients, see section 5.1 List of excipients. 2. PHARMACEUTICAL FORM Vaginal gel 3. CLINICAL PARTICULARS 3.1 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. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Intravaginal application. TREATMENT OF INFERTILITY DUE TO INADEQUATE LUTEAL PHASE One application (1.125 g 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. 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. DISETUJUI OLEH BPOM: 1/12/2021 EREG10014912100135 Page 2 of 4 3.3 CONTRAINDICATIONS 1. Hypersensitivity to progesterone or to any of the excipients listed in section 5.1 List of excipients 2. Und Lire le document complet