Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LETROZOLE
NOVARTIS INDONESIA - Indonesia
LETROZOLE
2.5 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
NOVARTIS PHARMA STEIN AG - Switzerland
2021-10-21
FEMARA ® (LETROZOLE) 2.5 mg Film-coated Tablets LEAFLET DISETUJUI OLEH BPOM: 04/10/2021 EREG100005VR12100132 2 TRADE NAME FEMARA 2,5 mg film-coated tablets. 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). CLINICAL PARTICULARS THERAPEUTIC INDICATIONS • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. • Extended adjuvant treatment of early breast cancer in post-menopausal women who have received prior standard adjuvant tamoxifen therapy. • Treatment in postmenopausal women with hormone-dependent advanced breast cancer. • Treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status, who have previously been treated with antiestrogens. • Pre-operative therapy in postmenopausal women with localised hormone receptor positive breast cancer, to allow subsequent breast-conserving surgery in women not originally considered candidates for this type of surgery. Subsequent treatment after surgery should be in accordance with standard of care. DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN GENERAL TARGET POPULATION 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 3 years or until tumour relapse DISETUJUI OLEH BPOM: 04/10/2021 EREG100005VR12100132 3 occurs, whichever comes first. In patients with metastatic disease, treatment with Femara should continue until tumour pro Baca dokumen lengkapnya