Estelle-35

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Cyproterone acetate 2mg;  ; Ethinylestradiol 0.035mg;  

Beschikbaar vanaf:

Douglas Pharmaceuticals Limited

INN (Algemene Internationale Benaming):

Cyproterone acetate 2 mg

farmaceutische vorm:

Film coated tablet

Samenstelling:

Active: Cyproterone acetate 2mg   Ethinylestradiol 0.035mg   Excipient: Croscarmellose sodium Opaglos 6000 white Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry buff OY-3690 Opadry white Y-1R-7000B Povidone Purified water Quinoline yellow Sucrose

Eenheden in pakket:

Blister pack, PVC/PVDC/Al blister 3x21 tabs, 63 tablets

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Sicor de Mexico SA de CV

therapeutische indicaties:

ESTELLE-35 and ESTELLE-35 ED are indicated for the treatment of androgen dependent diseases in women, such as acne (where oral antibiotics or local treatment alone has not been successful), especially pronounced forms and those which are accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenic alopecia, mild forms of hirsutism. ESTELLE-35 and ESTELLE-35 ED are also indicated for oral contraception in women requiring treatment for these androgen-dependent diseases; it is not recommended in women solely for contraception. ESTELLE-35 and ESTELLE-35 ED are also indicated for treating the symptoms of polycystic ovary syndrome.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al blister 3x21 tabs - 63 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisatie datum:

2000-11-23

Productkenmerken

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Estelle-35® 2 mg/35 microgram film coated tablet
Estelle-35® ED 2 mg/35 microgram film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active tablet of Estelle-35 and Estelle-35 ED contains:
Cyproterone acetate
2 mg
Ethinylestradiol
35 micrograms
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
Sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ESTELLE-35
Film coated, yellowish buff, round, biconvex, active tablets that are
plain on both sides, with a
diameter of 5 mm.
ESTELLE-35 ED
Active tablets are film coated, yellowish buff, round, biconvex
tablets that are plain on both sides,
with a diameter of 5 mm.
Placebo tablets are white, round, biconvex tablets that are plain on
both sides, with a diameter of
7.1 mm.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ESTELLE-35/ESTELLE-35 ED IS NOT RECOMMENDED IN WOMEN SOLELY FOR
CONTRACEPTION.
Estelle-35/Estelle-35 ED is indicated for the treatment of
androgen-dependent diseases in women,
such as acne (where oral antibiotics or local treatment alone has not
been successful), especially
pronounced forms and those which are accompanied by seborrhoea or by
inflammation or
2 | P a g e
formation of nodes (acne papulopustulosa, acne nodulocystica),
androgenic alopecia, mild forms
of hirsutism.
Estelle-35/Estelle-35 ED is also indicated for oral contraception in
women requiring treatment for
these androgen-dependent diseases; it is not recommended in women
solely for contraception.
It should not be used in combination with other hormonal
contraceptives.
Estelle-35/Estelle-35 ED is also indicated for treating the symptoms
of polycystic ovary syndrome.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Estelle-35/Estelle-35 ED is to be taken regularly in order to achieve
the therapeutic efficacy and
the
required
contraceptive
protection.
Previously
used
hormonal
contraception
should
be
discontinued. The dose regimen of Estelle-35/Estelle-35 ED is similar
to the usual regimen of most
combi