Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
ANASTRAZOLE
Docpharma BVBA
ANASTRAZOLE
1 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-11-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anastrozole Docpharma 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole as active substance. Excipients: Each tablet contains 95 mg of lactose monohydrate (see section 4.4). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film-coated tablets. Debossed with ‘1’ on one side and plain on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anastrozole is indicated for the : Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration : Posology : Adults including the elderly: The recommended dose of anastrozole is one 1 mg tablet once a day. For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years. Special populations Paediatric population: Not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.4 and 5.1). Renal impairment: No dose change is recommended in patients with mild or moderate renal impairment. In patients with severe renal impairment, administration of Anastrozole should be performed with caution (see section 4.4 and 5.2) Hepatic impairment: No dose change is recommended in patients with mild hepatic disease. Caution is advised in patient with moderate to severe hepatic impairme Lugege kogu dokumenti