Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
CYPROTERONE ACETATE; ETHINYLESTRADIOL
BAYER (SOUTH EAST ASIA) PTE LTD
G03HB01
2 mg
TABLET, SUGAR COATED
CYPROTERONE ACETATE 2 mg; ETHINYLESTRADIOL 0.035 mg
ORAL
Prescription Only
BAYER WEIMAR GMBH UND CO. KG
ACTIVE
1990-06-11
Diane 35 PI_SG_CCDS 12, 15 &16_23 May 2014 1. NAME OF THE MEDICINAL PRODUCT Diane-35 tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 hormone-containing beige coated tablets: Each coated tablet contains 0.035 mg ethinylestradiol, 2.0 mg cyproterone acetate. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL PARTICULARS 4.1 INDICATIONS For the treatment of androgen-dependent diseases in women, such as moderate to severe acne, and mild forms of hirsutism. When used for the treatment of acne, Diane-35 should only be used after topical therapy or systemic antibiotic treatments have failed. If the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis. Diane-35 should not be prescribed for the purpose of contraception alone. 4.2 DOSAGE AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION _ Oral use. _DOSAGE REGIMEN _ _How to take Diane-35 _ Diane-35 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 Diane-35 is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administration rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of Diane-35 can lead to intermenstrual bleedings and could deteriorate the therapeutic and contracept Lire le document complet
Diane 35 PI_SG_CCDS 17_5 Dec 2016 1. NAME OF THE MEDICINAL PRODUCT Diane-35 tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 hormone-containing beige coated tablets: Each coated tablet contains 0.035 mg ethinylestradiol, 2.0 mg cyproterone acetate. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL PARTICULARS 4.1 INDICATIONS For the treatment of androgen-dependent diseases in women, such as moderate to severe acne, and mild forms of hirsutism. When used for the treatment of acne, Diane-35 should only be used after topical therapy or systemic antibiotic treatments have failed. If the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis. Diane-35 should not be prescribed for the purpose of contraception alone. 4.2 DOSAGE AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION _ Oral use. _DOSAGE REGIMEN _ _How to take Diane-35 _ Diane-35 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 Diane-35 is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administration rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of Diane-35 can lead to intermenstrual bleedings and could deteriorate the therapeutic and contraceptive reliability. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. Diane 35 PI_SG_CCDS 17_5 Dec 2016 _How to start Diane-35 _ Lire le document complet