국가: 아르메니아
언어: 영어
출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cyproterone (cyproterone acetate)
Bayer Weimer GmbH und Co.KG
G03HA01
cyproterone (cyproterone acetate)
10mg
tablets
(15/1x15/) blister
Prescription
Registered
2015-04-14
spcde-androcur-10-mg-tabletten-de7-may12-english Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Androcur ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Cyproterone acetate One tablet contains 10 mg cyproterone acetate (CPA). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to pale yellow tablets with a breaking score line on one side and embossed with ‘BW’ in a regular hexagon on the other. The score line is to break the tablet for ease of swallowing; not to divide the tablet into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of pronounced signs of virilisation in women, which make hormone therapy necessary: - severe forms of acne, when it is accompanied by inflammation and the formation of nodes (Acne papulopustulosa, Acne nodulocystica) or if there is a risk of scarring, - moderate to severe forms of hirsutism, - moderate to severe forms of androgenic alopecia, when CPA has not proved to be effective from a medical point of view at a lower dose as part of a low-dose cyproterone acetate-oestrogen combination 2 mg/0.030 mg or 2 mg/0.035 mg (combined oral contraceptive ‘pill’) or when another anti-androgen therapy has not been effective. When treating acne, hormone treatment should be weighed against systemic antibiotic treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Method of administration _ Oral administration spcde-androcur-10-mg-tabletten-de7-may12-english Page 2 of 11 _Dosage _ Pregnant women may not take Androcur. Consequently, pregnancy has to be excluded prior to the start of therapy (see section 4.4). Androcur 10 mg has to be used in combination with a suitable oestrogen or a suitable progestogen-oestrogen combination (combined oral contraceptive ‘pill’), in order to ensure necessary contraceptive protection and to avoid irregular bleeding. This combination therapy shall be carried out as follows: Both products have to be started on day 1 of the cycle (day 1 of menstruatio 전체 문서 읽기