Maa: Singapore
Kieli: englanti
Lähde: HSA (Health Sciences Authority)
LETROZOLE
NOVARTIS (SINGAPORE) PTE LTD
L02BG04
2.5 mg
TABLET, FILM COATED
LETROZOLE 2.5 mg
ORAL
Prescription Only
NOVARTIS PHARMA STEIN AG
ACTIVE
1998-07-28
FEMARA Non-steroidal aromatase inhibitor (inhibitor of oestrogen biosynthesis); antineoplastic agent. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablets Coated tablet, dark yellow, round, slightly biconvex with bevelled edges. One side bears the imprint “FV”, the other “CG”. ACTIVE SUBSTANCE 4,4'-[(1H-1,2,4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN= letrozole). Each film-coated tablet contains 2.5 mg letrozole. EXCIPIENTS Colloidal anhydrous silica, microcristalline cellulose, lactose monohydrate, magnesium stearate, maize starch, sodium starch glycollate, hydroxypropyl methylcellulose, polyethylene glycol 8000, talc, titanium dioxide (E 171), iron oxide yellow (E 172). Pharmaceutical formulations may vary between countries. 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 post menopausal 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 disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-estrogens DOSAGE AND ADMINISTRATION ADULTS The recommended dose of Femara is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Femara should continue for 5 years or until disease relapse/recurrence occurs, whichever Lue koko asiakirja
Femara Dec 2016.SINv2 Page 1 of 21 FEMARA Non-steroidal aromatase inhibitor (inhibitor of oestrogen biosynthesis); antineoplastic agent. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablets Coated tablet, dark yellow, round, slightly biconvex with bevelled edges. One side bears the imprint “FV”, the other “CG”. ACTIVE SUBSTANCE 4,4'-[(1H-1,2,4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN= letrozole). Each film-coated tablet contains 2.5 mg letrozole. EXCIPIENTS Colloidal anhydrous silica, microcristalline cellulose, lactose monohydrate, magnesium stearate, maize starch, sodium starch glycollate, hydroxypropyl methylcellulose, polyethylene glycol 8000, talc, Pigment suspension white, Pigment suspension yellow. Pharmaceutical formulations may vary between countries. 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 post menopausal 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 disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-estrogens DOSAGE REGIMEN AND ADMINISTRATION ADULTS The recommended dose of Femara is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Femara should continue for 5 years or until disease Femara Dec 2016.SINv2 Page 2 of 21 relapse/recurrence occurs, whichever comes first. In patients with metastatic disease, treatment with Femara should continue until tumor progression is evident. SPECIAL POPULATIONS HEPATIC IMPAIRMENT No dose adjustment of Femara is required for patients with mild to moderate hepatic insufficiency (Child-Pugh scor Lue koko asiakirja