Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
CYPROTERONE ACETATE
BAYER ISRAEL LTD
G03HA01
TABLETS
CYPROTERONE ACETATE 50 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
CYPROTERONE
CYPROTERONE
For antiandrogen therapy in men: sexual disorders, inoperable prostatic carcinoma.
2011-10-31
PACKAGING TECHNOLOGY BERLIN GF page 1 Bayer Pharma AG client: GV04 itemno.: 81203571 PZ: 9307A-4A code-no.: 131 name: LF-ANDROCUR 50MG TAB H6 country: IL BPH colors: BLACK version: 20.12.2012/02 approval: replaces: 80816546 ANDROCUR ® 50 TABLETS 81203571_02.indd 1 81203571_02.indd 1 20.12.2012 11:57:48 20.12.2012 11:57:48 সম্পূর্ণ নথি পড়ুন
1 1. NAME OF THE MEDICINAL PRODUCT Androcur 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg cyproterone acetate. Excipient with known effect: Lactose 108.75 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Round tablet. White to faintly yellowish tablets, scored on one side, with an embossed "BV" in a regular hexagon on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For antiandrogen therapy in men: sexual disorders, inoperable prostatic carcinoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The maximum daily dose is 300 mg. _Adults _ _ _ _REDUCTION OF DRIVE IN SEXUAL DEVIATIONS IN MEN _ Generally, treatment is started with 1 tablet Androcur 50 mg twice daily. It may be necessary to increase the dose to 2 tablets twice daily, or even 2 tablets three times daily for a short period of time. When a satisfactory result has been achieved, one should try to maintain the therapeutic effect with the lowest possible dose. Quite often 1/2 tablet twice daily is sufficient. When establishing the maintenance dose or when discontinuing the preparation, one should not reduce the dosage abruptly, but gradually. To this end, the daily dose should be reduced by 1 tablet, or better 1/2 tablet, at intervals of several weeks. To stabilize the therapeutic effect it is necessary to take Androcur over a protracted period of time, if possible with the simultaneous use of psychotherapeutic measures. _ANTIANDROGEN TREATMENT IN INOPERABLE CARCINOMA OF THE PROSTATE_ 2 tablets Androcur 50 mg twice to three times daily (= 200 - 300 mg). 2 Treatment should not be interrupted nor the dosage reduced after improvement or remissions have occurred. • To reduce the initial increase of male sex hormones in combination therapy with GnRH agonists. Initially 2 tablets Androcur 50 mg twice daily (= 200 mg) alone for 5 - 7 days, followed by 2 tablets Androcur 50 mg twice daily (= 200 mg) for 3 - 4 weeks together with a GnRH agonist in the dosage recommended সম্পূর্ণ নথি পড়ুন