Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
BICALUTAMIDE
ASTRA ZENECA (ISRAEL) LTD
L02BB03
TABLETS
BICALUTAMIDE 150 MG
PER OS
Required
ASTRA ZENECA UK LIMITED
BICALUTAMIDE
BICALUTAMIDE
In patients with locally advanced prostate cancer (T3 - T4 any N M0 T1 -T2 N+ M0) Casodex 150 mg is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. The management of patients with locally advanced non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.
2010-09-30
" טמרופ ןולע הז עבקנ ע " י דרשמ תואירבה ונכותו קדבנ רשואו ." רשואמ ןולע : טסוגוא 2011 “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved.” Date of approval in August 2011: _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Casodex 150 mg Film-coated Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg Bicalutamide (INN) For excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. White. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Patients with locally advanced prostate cancer (T3-T4, any N, M0; T1-T2, N+, M0), Casodex 150mg is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. (See section Pharmacodynamic properties). Casodex 150 mg is also indicated for the management of patients with locally advanced, non- metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult males including the elderly: The dosage is one 150 mg tablet to be taken orally once a day. Casodex 150 mg should be taken continuously for at least 2 years or until disease progression. Renal Impairment: No dosage adjustment is necessary for patients with renal impairment. Hepatic Impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see Section Special warnings and precautions for use ). Page 2 of 8 2 4.3 CONTRAINDICATIONS Casodex 150 mg is contraindicated in females and children (see Section Pregnanacy and lactation). Casodex 150 mg must not be given to any patient who has shown a hypersensitivity to the active substance or any of the excipients. Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see Se Leggi il documento completo