DIANE 35

البلد: أندونيسيا

اللغة: الإندونيسية

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

الوحدات في الحزمة:

DUS, 1 BLISTER @ 21 TABLET SALUT GULA

تاريخ الترخيص:

2022-08-30

خصائص المنتج

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