Страна: Индонезия
Язык: индонезийский
Источник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CYPROTERONE ACETATE; ETHINYLESTRADIOL
BAYER INDONESIA - Indonesia
CYPROTERONE ACETATE; ETHINYLESTRADIOL
2/0.035 MG
TABLET SALUT GULA
DUS, 1 BLISTER @ 21 TABLET SALUT GULA
BAYER WEIMAR Gmbh & Co KG - Germany
2017-12-29
PACKAGING TECHNOLOGY BERLIN SGLRH page 1 Bayer AG client: 0021,GV15 material-no.: 87232549 PZ: 2688A-3A code-no.: name: LF-INS-DIANE 35 SCT 21 country: ID/-/BAG colors: BLACK version: 11.05.2020/03 Restricted Document dimension: 355 X 594 MM Important information, please read carefully! COMPOSITION Each tablet of Diane-35 contains 2 mg Cyproterone acetate and 0.035 mg Ethinylestradiol PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES The substance cyproterone acetate contained in Diane-35 inhibits the influence of the androgens which are also produced by the female organism. It is thus possible to treat diseases the cause of which is either an increased production of androgens or a particular sensitivity to these hormones. Post Authorization Safety Studies (PASS) have shown that the frequency of VTE diagnosis ranges between 7-10 per 10,000 woman years in low estrogen dose (< 50 μg ethinylestradiol) COC users. The most recent data suggest that the frequency of VTE diagnosis is approximately 4 per 10,000 woman years in non-pregnant non-COC users, and ranges between 20 to 30 per 10,000 pregnant women or post partum. While Diane-35 is being taken, the increased sebaceous gland function, which plays an important role in the development of acne and seborrhea, is reduced. This leads-usually after 3 to 4 months of therapy-to the healing of existing acne efflorescences. The excessive greasiness of the hair and skin generally disappears earlier. Treatment with Diane-35 is indicated in women of child-bearing age who exhibit mild forms of hirsutism, and in particular in slightly increased facial hair; results do not, however, become apparent until after several months of use. Apart from the described antiandrogen effect, cyproterone acetate has also a pronounced progestational action. The sole administration of cyproterone acetate would thus lead to cycle disturbances which are avoided by its combination with ethinylestradiol in Diane-35. This holds true as long as the preparation is taken cyclically according to the in Прочитать полный документ