Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Letrozole
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
L02BG04
TABLET, FILM COATED
Letrozole 2.50mg
ORAL
Prescription Only
SAG Manufacturing S.L.U.
ACTIVE
2020-11-10
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Letrovitae 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg letrozole. Each tablet contains 45 mg of lactose monohydrate (see section 4.4) For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablets Yellow, circular, biconvex film-coated tablets plain on both sides. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Letrozole is not indicated in hormone receptor negative disease. Letrozole is indicated in: Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. Extended adjuvant treatment of invasive early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for five years. First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer. Treatment of advanced breast cancer after relapse or progression of the disease in women with natural or artificially induced postmenopausal endocrine state, who have been previously treated with anti-estrogens. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Adult The recommended dose of letrozole is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Letrovitae should continue for 5 years or until disease relapse/recurrence, whichever comes first. In patients with advanced or metastatic breast cancer, treatment with letrozole should continue until the progression of the tumor is evident. Special populations Paediatric population The use of Letrovitae in children and adolescents is not recommended. The safety and efficacy of Letrovitae in children and adolescents up to 17 years of age have not been established. Limited data are available and a dosage recommendation can not be made. Geriatric patients (65 years of age or older) No dose adjustment is required for elderly patients. Renal impairment No dose adjustment of Letrovitae is required f Přečtěte si celý dokument