NAVELBINE

Nazione: Indonesia

Lingua: indonesiano

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

Principio attivo:

VINORELBINE TARTRATE

Commercializzato da:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Nome Internazionale):

VINORELBINE TARTRATE

Dosaggio:

41.55 MG

Forma farmaceutica:

KAPSUL LUNAK

Confezione:

DUS, 1 BLISTER @ 1 KAPSUL LUNAK

Prodotto da:

CATALENT GERMANY EBERBACH GMBH - Federal Republic of Germany

Data dell'autorizzazione:

2021-05-26

Scheda tecnica

Instruction for use! Read carefully!
NAVELBINE®
20 mg — 30 mg
Soft capsule
Vinorelbine (as tartrate)
COMPOSITION
The active substance is vinorelbine (as tartrate) 20 or 30 mg.
The other ingredients are:
The solution contains: ethanol anhydrous; purified water; glycerol,
macrogol 400.
The capsule shell contains: gelatin; glycerol 85
0
%; sorbitol/sorbitan (anidrisorb 85/70);
triglycerides, medium chain and PHOSAL 53 MCT (phosphatidylcholine;
glycerides; ethanol
anhydrous) and colouring agents (El 71-titanium dioxide and E172 red
and/or yellow iron oxide
depending on the strength).
The edible printing ink contains: cochineal extract (E120),
hypromellose, propylene glycol.
PHARMACOTHERAPEUTIC GROUP
Cytostatic - Antineoplastic drug
MECHANISM OF ACTION
Navelbine is a cytostatic antineoplastic of the vinca alkaloid group.
The molecular target of its
activity is tubulin/microtubules dynamic equilibrium. Navelbine
inhibits the polymerization of
tubulin. It acts preferentially on mitotic microtubules and affects
axonal microtubules only at
high concentration.
The effects on tubulin spiralization are lower than with vincristine.
Navelbine blocks mitosis in
phase G2+M and induces cell death at interphase or at the following
mitosis.
INDICATION
1.
For
non-small-cell lung cancer: In combination
with platinum
based
therapy for the
treatment of inoperable or stage IIIb or IV non-small cell lung
cancer.
2.
For breast cancer
-
In mono-therapy for the treatment of metastatic or relapsed breast
cancer after of
refractory to an anthracycline containing regimen.
-
In combination with capecitabine for the treatment of metastatic or
relapsed breast
cancer after or refractory to an anthracycline containing regimen.
DISETUJUI OLEH BPOM: 18/02/2022
EREG10043712100054
EREG10043712100055
CONTRAINDICATIONS
•
Known
hypersensitivity
to
vinorelbine
or
other
vinca
alkaloids
or
to
any
of
the
constituents.
•
Disease significantly affecting absorption.
•
Previous significant surgical resection of stomach or small bowel.
•
Neutrophil coun