País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 2 POUCH @ 1 BLISTER @ 14 TABLET
2022-06-09
Visanne/Dienogest/Tablet/BEC 16202 - VIPOS 1 VISANNE ® TABLETS Important information, please read carefully! COMPOSITION Each tablet contains 2 mg dienogest. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Progestogens ATC code: G03D Pharmacodynamic effects Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic activity of approximately one third of that of cyproterone acetate. Dienogest binds to the progesterone receptor of the human uterus with only 10% of the relative affinity of progesterone. Despite its low affinity to the progesterone receptor, dienogest has a strong progestogenic effect in vivo. Dienogest has no significant androgenic, mineralocorticoid or glucocorticoid activity in vivo. Mechanism of action Dienogest acts on endometriosis by reducing the endogenous production of estradiol and thereby suppressing the trophic effects of estradiol on both the eutopic and ectopic endometrium. When given continuously, dienogest leads to a hypoestrogenic, hypergestagenic endocrine environment causing initial decidualization of endometrial tissue followed by atrophy of endometriotic lesions. Additional properties, like immunologic and antiangiogenic effects, seem to contribute to the inhibitory action of dienogest on cell proliferation. CLINICAL EFFICACY AND SAFETY • DATA ON EFFICACY: Superiority of Visanne over placebo with regard to reduction of endometriosis-associated pelvic pain (EAPP) and clinically meaningful reduction of pain compared to baseline were demonstrated in a 3-month study including 102 patients on Visanne. The open-label extension to this placebo-controlled study showed a continued improvement of endometriosis-associated pelvic pain for a treatment duration of up to 15 months. In addition, efficacy on endometriosis-associated pelvic pain was shown in a 6-month comparative trial of Visanne versus the GnRH analogue leuprorelin acetate (LA) including 120 patients on Visanne. A clinically meaningful reduction of pain compared t Leer el documento completo