البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Cyproterone acetate 2mg; ; Ethinylestradiol 0.035mg;
Douglas Pharmaceuticals Limited
Cyproterone acetate 2 mg
Film coated tablet
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
Blister pack, PVC/PVDC/Al blister 3x21 tabs, 63 tablets
Prescription
Prescription
Sicor de Mexico SA de CV
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.
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
2000-11-23
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 اقرأ الوثيقة كاملة