MELIANE SUGAR-COATED TABLETS

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

Gestodene; ETHINYLESTRADIOL

可用日期:

BAYER CO. (MALAYSIA) SDN. BHD.

INN（国际名称）:

Gestodene; ETHINYLESTRADIOL

每包单位数:

21Tablet Tablets

厂商:

Delpharm Lille SAS

资料单张

Not Applicable

产品特点

Reference: Meliane 0.02/0.075 mg coated tablets / CCDS / Version 14.0/ 9 Aug 2016 , Meliane 0.02/0.075 mg coated tablets / expanded CCDS / Vers ion 14.0/ 9 Aug 2016 , Directive 13 2018
Meliane ®
Coated Tablet 1. NAME OF THE MEDICINAL PRODUCT Meliane 0.02 mg / 0.075 mg coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 hormone -containing white coated tablets: Each coated tablet contains 0.02 mg ethinylestradiol, 0.075 mg gestodene
3. PHARMACEUTICAL FORM Coated tablet
4. CLINICAL PARTICULARS
4.1 Indication Oral contraception.
4.2 Dosage and method of administration Method of administration Oral use Dosage regimen How to take Meliane Combined oral contr aceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. Tablets must be taken in the order directed on the package every day at about the same time with s ome liquid as needed. One tablet is to be taken daily for 21 consecutive 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 coated tab let and may not have finished before the next pack is started. How to start Meliane ► 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 transderm al patch The woman should start with Meliane preferably on the day after the last hormone -containing tablet of her previous COC, but at the latest on the day following the usual tablet -free or hormone -free tablet interval of her previous COC. In case a vag inal ring or transdermal patch has been used, the woman should start using