FEMARA

País: Indonesia

Idioma: indonesio

Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredientes activos:

LETROZOLE

Disponible desde:

NOVARTIS INDONESIA - Indonesia

Designación común internacional (DCI):

LETROZOLE

Dosis:

2.5 MG

formulario farmacéutico:

TABLET SALUT SELAPUT

Unidades en paquete:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Fabricado por:

NOVARTIS PHARMA STEIN AG - Switzerland

Fecha de autorización:

2021-10-21

Ficha técnica

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