देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Bicalutamide 50mg
Teva Pharma (New Zealand) Limited
Bicalutamide 50 mg
50 mg
Film coated tablet
Active: Bicalutamide 50mg Excipient: Hypromellose E-5 Lactose monohydrate Macrogol 400 Magnesium stearate Povidone Purified water Sodium starch glycolate Titanium dioxide
Blister pack, PVC/PVdC Al, 28 tablets, 28 tablets
Prescription
Prescription
Hetero Labs Limited
Treatment of advanced prostate cancer in combination with GnRH (LHRH) agonist therapy or surgical castration. Prevention of disease flare associated with the use of LHRH agonists.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC Al, 28 tablets - 28 tablets - 36 months from date of manufacture stored at or below 25°C
2009-09-16
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Bicalaccord, 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of Bicalutamide. 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in adult males aged 18 years and older in combination with GnRH (LHRH) agonist therapy or surgical castration. Prevention of disease flare associated with the use of LHRH agonists. 4.2 DOSE AND METHOD OF ADMINISTRATION AS COMBINATION THERAPY IN ADULT MALES INCLUDING THE ELDERLY One tablet (50 mg) once a day. Treatment with BICALACCORD should be started at the same time as treatment with a GnRH (LHRH) agonist or surgical castration. CHILDREN BICALACCORD is contraindicated in children. USE IN ADULT MALES WITH RENAL IMPAIRMENT No dosage adjustment is necessary for patients with renal impairment. USE IN ADULT MALES WITH 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 WARNINGS AND PRECAUTIONS). 4.3 CONTRAINDICATIONS BICALACCORD is contraindicated in females and children. BICALACCORD must not be given to any patient who has shown a hypersensitivity reaction to its use. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE BICALACCORD is extensively metabolised in the liver. On the basis of currently available investigations, there may be slower excretion and accumulation of bicalutimide in instances of severe hepatic impairment. Caution is therefore required with patients with moderate to severe hepatic impairment. In these cases regular liver function tests (bilirubin, transaminases, alkaline phosphatase) must be carried out. Severe hepatic changes and hepatic failure have been observed rarely with BICALACCORD (see ADVERSE EFFECTS). If there is clinical and/or biochemical evidence of severe hepatotoxicity, consideration should be given to discontinue BICALACCORD therapy पूरा दस्तावेज़ पढ़ें