Država: Južnoafriška republika
Jezik: angleščina
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
MINERVA-35 SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): MINERVA-35 Tablets COMPOSITION The 28-day pack (Every-Day pack) contains 21 hormonal tablets, each with cyproterone acetate (6-chloro-17-hydroxy- 1alpha,2alpha-methylene-pregna-4,6-diene-3,20-dione-acetate) 2 mg and ethinylestradiol (17alpha-ethinyl-estra- 1,3,5(10)-triene-3,17beta-diol) 0,035 mg, plus 7 non-hormonal tablets. PHARMACOLOGICAL CLASSIFICATION A. 21.8.2 Progesterones with estrogens. PHARMACOLOGICAL ACTION The substance cyproterone acetate contained in Minerva-35 blocks the effect of endogenously produced and exogenously administered androgens at the target organs by means of competitive inhibition. The stimulating effect of male sex hormones on androgen-dependent structures and functions is weakened or abolished by cyproterone acetate. Excessive sebaceous gland function is decreased. Apart from the described anti-androgen effect, cyproterone acetate also has a progestational action. The ethinylestradiol in the combination inhibits ovulation and changes the cervical mucus and the endometrium rendering them unfavourable for sperm penetration and nidation of a fertilised ovum, respectively. INDICATIONS Androgen-dependent acne, especially those forms which are accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgen-dependent alopecia and mild forms of hirsutism. Oral contraception in women requiring anti-androgen therapy. CONTRA-INDICATIONS Pregnancy; lactation; severe disturbances of liver function; recurrent cholestatic jaundice; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours; existing or previous thromboembolic processes in arteries or veins and states which predispose to such diseases (eg d Preberite celoten dokument