Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Cyproterone acetate 2mg; ; ; Ethinylestradiol 0.035mg;
REX Medical Ltd
Cyproterone acetate 2 mg
Film coated tablet
Active: Cyproterone acetate 2mg Ethinylestradiol 0.035mg Excipient: Hypromellose Lactose monohydrate Magnesium stearate Povidone Propylene glycol Purified talc Quinoline yellow Starch Titanium dioxide
Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 (63) tablets per carton, 63 tablets
Prescription
Prescription
Cipla Ltd
Androgen-dependent diseases in women are an indication for treatment with GINET-63. These diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. Oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with GINET-63. However GINET-63 is not recommended in women solely for contraception.
Package - Contents - Shelf Life: Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 (63) tablets per carton - 63 tablets - 36 months from date of manufacture stored at or below 25°C
2002-05-03
NEW ZEALAND DATASHEET 1 PRODUCT NAME GINET 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Cyproterone Acetate 2.00 mg and Ethinylestradiol Tablets 35 mcg. 3 PHARMACEUTICAL FORM Each blister tray contains 21 yellow active tablets and 7 larger white inactive tablets. Each active tablet is a yellow, biconvex, film-coated tablet, containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms (0.035 mg) with a diameter of 5.7 mm. Each inactive tablet is a white, round, biconvex, tablet, plain on both sides with a diameter of 7.1 mm. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Androgen-dependent diseases in women are an indication for treatment with GINET. These diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. Oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with GINET. However, GINET is not recommended in women solely for contraception. It should not be used in combination with other hormonal contraceptives. GINET is indicated for the relief of symptoms of polycystic ovary syndrome. 4.2 Dose and method of administration Any previously used hormonal contraception should be discontinued. To achieve therapeutic efficacy and the required contraceptive protection, GINET needs to be taken regularly. The dose regimen of GINET is similar to the usual regimen for most combined oral contraceptives. Thus, the same administration rules for most combined oral contraceptives (COC’s) must be considered. Intermenstrual bleeding and eventual deterioration of the therapeutic and contraceptive reliability may be caused by not taking GINET regularly at about the same time each day. HOW TO TAKE GINET Tablets must be taken in the order directed on the blister each day at about the same Les hele dokumentet