AFINITOR TABLET 10 MG

Country: Indónesía

Tungumál: indónesíska

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

Virkt innihaldsefni:

EVEROLIMUS

Fáanlegur frá:

NOVARTIS INDONESIA - Indonesia

INN (Alþjóðlegt nafn):

EVEROLIMUS

Skammtar:

10 MG

Lyfjaform:

TABLET

Einingar í pakka:

DUS, 1 BLISTER @ 10 TABLET

Framleitt af:

NOVARTIS PHARMA STEIN A.G., STEIN, SWISS

Leyfisdagur:

2015-09-03

Vara einkenni

Novartis
Page 1
Leaflet
Afinitor
AFINITOR
®
(EVEROLIMUS)
2.5 mg*, 5 mg and 10 mg tablets
LEAFLET
_* Disclaimer: Afinitor 2.5 mg tablet is not registered and marketed
in Indonesia_
DISETUJUI OLEH BPOM : 08/09/2021
ID : EREG10000512100100
EREG10000512100101
Novartis
Page 2
Leaflet
Afinitor
TRADE NAME(S)
2.5 MG TABLETS*
Afinitor 2.5 mg tablets
5 MG TABLETS
Afinitor 5 mg tablets
10 MG TABLETS
Afinitor 10 mg tablets
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
TABLET
White to slightly yellow, elongated tablets with a bevelled edge and
no score.
•
2.5 MG*: The tablets are engraved with “LCL” on one side and
“NVR” on the other.
•
5 MG: The tablets are engraved with “5” on one side and “NVR”
on the other.
•
10 MG: The tablets are engraved with “UHE” on one side and
“NVR” on the other.
ACTIVE SUBSTANCE
TABLET
•
2.5 MG*: Each tablet contains 2.5 mg everolimus.
•
5 MG: Each tablet contains 5 mg everolimus.
•
10 MG: Each tablet contains 10 mg everolimus
EXCIPIENTS
TABLET:
Butylated
hydroxytoluene
(E321),
magnesium
stearate,
lactose
monohydrate,
hypromellose, crospovidone and lactose anhydrous.
INDICATIONS
•
AFINITOR

is indicated for the treatment of patients with advanced renal cell
carcinoma
after failure of treatment with sunitinib or sorafenib.
•
ADVANCED NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET)
AFINITOR

is indicated for the treatment of progressive neuroendocrine tumors of
pancreatic origin (PNET) in patients with unresectable, locally
advanced or metastatic
DISETUJUI OLEH BPOM : 08/09/2021
ID : EREG10000512100100
EREG10000512100101
Novartis
Page 3
Leaflet
Afinitor
disease. The safety and effectiveness of AFINITOR

in the preatment of patients with
carcinoid tumors have not been established.
•
ADVANCED NEUROENDOCRINE TUMORS OF GASTROINTESTINAL (GI) OR LUNG ORIGIN
AFINITOR

is
indicated
for
the
treatment
of
unresectable
or
metastatic,
well-
differentiated (grade 1 or 2), non-functional neuroendocrine tumors of
gastrointestinal or
lung origin in adults