Country: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
DESOGESTREL (in blue tablet); DESOGESTREL (in white tablet); ETHINYLESTRADIOL (in blue tablet); ETHINYLESTRADIOL (in white tablet)
DCH AURIGA SINGAPORE
G03AA09
25 mcg
TABLET
DESOGESTREL (in blue tablet) 25 mcg; DESOGESTREL (in white tablet) 125 mcg; ETHINYLESTRADIOL (in blue tablet) 40 mcg; ETHINYLESTRADIOL (in white tablet) 30 mcg
ORAL
Prescription Only
ORGANON (IRELAND) LTD
ACTIVE
2004-02-10
Gracial ® Tablet 1. NAME OF THE MEDICINAL PRODUCT Gracial tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gracial is a combiphasic oral contraceptive of which: • each blue tablet contains 0.025mg desogestrel and 0.040mg ethinylestradiol. • each white tablet contains 0.125mg desogestrel and 0.030mg ethinylestradiol. Excipient: lactose <100mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets for oral use. Tablets are round, flat with beveled edges, and 6 mm in diameter. Tablets are coded on one side Organon* and on the reverse side TR above 8 (white tablets) or TR above 9 (blue tablets). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 HOW TO TAKE GRACIAL Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 22 consecutive days, starting with the blue tablet for 7 days, followed by the white tablets for 15 days. Each subsequent pack is started after a 6-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. 4.2.2 HOW TO START TAKING GRACIAL No preceding hormonal contraceptive use [in the past month] Tablet- taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking. Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transd Прочитајте комплетан документ
Gracial ® Tablet 1. NAME OF THE MEDICINAL PRODUCT Gracial tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gracial is a combiphasic oral contraceptive of which: • each blue tablet contains 0.025mg desogestrel and 0.040mg ethinylestradiol. • each white tablet contains 0.125mg desogestrel and 0.030mg ethinylestradiol. Excipient: lactose <100mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets for oral use. Tablets are round, flat with beveled edges, and 6 mm in diameter. Tablets are coded on one side Organon* and on the reverse side TR above 8 (white tablets) or TR above 9 (blue tablets). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 HOW TO TAKE GRACIAL Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 22 consecutive days, starting with the blue tablet for 7 days, followed by the white tablets for 15 days. Each subsequent pack is started after a 6-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. 4.2.2 HOW TO START TAKING GRACIAL No preceding hormonal contraceptive use [in the past month] Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking. Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start with Gracial preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case a vaginal ring or transdermal patch has Прочитајте комплетан документ