Ginet 63

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Cyproterone acetate 2mg;  ;  ; Ethinylestradiol 0.035mg;  

Fáanlegur frá:

REX Medical Ltd

INN (Alþjóðlegt nafn):

Cyproterone acetate 2 mg

Lyfjaform:

Film coated tablet

Samsetning:

Active: Cyproterone acetate 2mg     Ethinylestradiol 0.035mg   Excipient: Hypromellose Lactose monohydrate Magnesium stearate Povidone Propylene glycol Purified talc   Quinoline yellow Starch Titanium dioxide

Einingar í pakka:

Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 (63) tablets per carton, 63 tablets

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Cipla Ltd

Ábendingar:

Androgen-dependent diseases in women are an indication for treatment with GINET-63. These diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. Oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with GINET-63. However GINET-63 is not recommended in women solely for contraception.

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 (63) tablets per carton - 63 tablets - 36 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2002-05-03

Vara einkenni

NEW ZEALAND DATASHEET
1 PRODUCT NAME
GINET
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cyproterone Acetate 2.00 mg and Ethinylestradiol
Tablets 35 mcg.
3 PHARMACEUTICAL FORM
Each blister tray contains 21 yellow active tablets and 7 larger white
inactive tablets. Each
active tablet is a yellow, biconvex, film-coated tablet, containing
cyproterone acetate 2 mg
and ethinylestradiol 35 micrograms (0.035 mg) with a diameter of 5.7
mm. Each inactive
tablet is a white, round, biconvex, tablet, plain on both sides with a
diameter of 7.1 mm.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Androgen-dependent diseases in women are an indication for treatment
with GINET. These
diseases may include: acne (where local treatment or oral antibiotics
alone have not been
successful), especially pronounced forms of acne that may be
accompanied by inflammation
or formation of nodes (acne nodulocystica, acne papulopustulosa),
seborrhea, mild forms of
hirsutism and/or androgenic alopecia.
Oral contraception in women requiring treatment for these
androgen-dependent diseases is
an indication for treatment with GINET. However, GINET is not
recommended in women
solely
for
contraception.
It
should
not
be
used
in
combination
with
other
hormonal
contraceptives.
GINET is indicated for the relief of symptoms of polycystic ovary
syndrome.
4.2 Dose and method of administration
Any previously used hormonal contraception should be discontinued. To
achieve therapeutic
efficacy and the required contraceptive protection, GINET needs to be
taken regularly. The
dose
regimen
of
GINET
is
similar
to
the
usual
regimen
for
most
combined
oral
contraceptives. Thus, the same administration rules for most combined
oral contraceptives
(COC’s) must be considered.
Intermenstrual bleeding and eventual deterioration of the therapeutic
and contraceptive
reliability may be caused by not taking GINET regularly at about the
same time each day.
HOW TO TAKE GINET
Tablets must be taken in the order directed on the blister each day at
about the same