מדינה: אינדונזיה
שפה: אינדונזית
מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LEVONORGESTREL
TUNGGAL IDAMAN ABDI- Indonesia
LEVONORGESTREL
0,75 MG
TABLET
DUS, 1 BLISTER @ 2 TABLET
GEDEON RICHTER
2015-11-30
SUMMARY OF PRODUCT CHARACTERISTICS POSTINOR-2 TABLETS DISETUJUI OLEH BPOM: 06/10/2021 ID REG: EREG10015512000004; EREG10015512000066 1. NAME OF THE MEDICINAL PRODUCT Postinor - 2 tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Levonorgestrel 0.75 mg per each tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Postinor-2 is an emergency contraceptive which can be used to prevent pregnancy if taken within 72 hours (three days) following unprotected intercourse or a contraceptive accident. As an emergency contraceptive, Postinor-2 is indicated following any unprotected act of sexual intercourse, including: • when no contraceptive has been used • when a contraceptive method may have failed, including – condom rupture, slippage or misuse – diaphragm or cap dislodgement, breakage or early removal – failed coitus interruptus – miscalculation of periodic abstinence method – IUD expulsion – missed regular oral contraceptive pills for three or more days in a cycle • in cases of sexual assault 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration: Two tablets should be taken together, as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse (see section 5.1). Postinor-2 can be used at any time during the menstrual cycle unless menstrual bleeding is overdue. If vomiting occurs within three hours of taking the tablets, another two tablets should be taken immediately. Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 4 tablets together at the same time) for those women unable or unwilling to use Cu- IUD (see section 4.5). After a single act of unprotected intercourse, the treatment fails in about 1-2% of women who use it within 72 hours (3 days) after unprotected intercourse 4.3 CONTRAINDICATIONS Hypersensitivity קרא את המסמך השלם