VISANNE

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

DIENOGEST

Disponible depuis:

BAYER INDONESIA - Indonesia

DCI (Dénomination commune internationale):

DIENOGEST

Dosage:

2 MG

forme pharmaceutique:

TABLET

Unités en paquet:

DUS, 2 POUCH @ 1 BLISTER @ 14 TABLET

Fabriqué par:

BAYER WEIMAR Gmbh & Co KG - Germany

Date de l'autorisation:

2017-12-07

Résumé des caractéristiques du produit

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