Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
Desogestrel
MSD PHARMA (SINGAPORE) PTE. LTD.
G03AC09
0.075mg
TABLET, FILM COATED
ORAL
Prescription Only
N.V. Organon
2013-06-19
RA 0390 EU S6 (REF 5.0) CERAZETTE® 75 MICROGRAM FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT Cerazette 75 microgram film-coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 microgram desogestrel. Excipient: lactose < 65 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side Organon*. 4. CLINICAL PARTICULARS 4.1 Therapeutic indication Contraception. 4.2 Posology and method of administration 4.2.1 How to take Cerazette Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. 1.4.3_Proposed Cerazette PI_Clean_20 Nov 2013 4.2.2 How to start Cerazette No preceding hormonal contraceptive use [in the past month] Tablet-taking has to start on day 1 of the woman’s natural cycle (day 1 is the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking. Following first-trimester abortion After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception. Following delivery or second-trimester abortion Contraceptive treatment with Cerazette after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed pregnancy ought to be ruled out and an additional met Прочитать полный документ