国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
DESOGESTREL ETHINYLESTRADIOL
Organon (Ireland) Limited
DESOGESTREL ETHINYLESTRADIOL
Unknown
Film Coated Tablet
Withdrawn
2008-12-04
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Novial, film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION o Each yellow tablet contains 0.050 mg desogestrel and 0.035 mg ethinylestradiol; o Each red tablet contains 0.100 mg desogestrel and 0.030 mg ethinylestradiol; o Each white tablet contains 0.150 mg desogestrel and 0.030 mg ethinylestradiol. Excipient: Lactose < 65mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. The tablets are round, biconvex and 5 mm in diameter. They are coded on one side “VR4” (yellow tablets), “VR2” (red tablets), “TR5” (white tablets) and on the reverse side all tablets are coded “Organon” and an asterix “*”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HOW TO TAKE NOVIAL 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 21 consecutive days, starting with the yellow tablets for 7 days, followed by the red for 7 days and finally the white for 7 days. Each subsequent pack is started after a 7-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. HOW TO START TAKING NOVIAL _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 完全なドキュメントを読む