NAVELBINE

Krajina: Indonézia

Jazyk: indonézština

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

Aktívna zložka:

VINORELBINE TARTRATE

Dostupné z:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Medzinárodný Name):

VINORELBINE TARTRATE

Dávkovanie:

13.85 MG

Forma lieku:

INJEKSI

Počet v balení:

DUS, 1 VIAL @ 1 ML

Výrobca:

FAREVA PAU 1 - France

Dátum Autorizácia:

2021-04-22

Súhrn charakteristických

1
PRESENT – CURRENT INDONESIAN LEAFLET
Instruction for use! Read carefully!
NAVELBINE®
VINORELBINE TARTRATE
10 mg/1 ml & 50 mg/5 ml
Injectable solution in vial
COMPOSITION
INGREDIENTS
FORMULATION
10 mg/1 ml
50 mg/5 ml
_Active ingredient _
vinorelbine tartrate (mg)
equivalent to vinorelbine (INN)
base (mg)
13.85
10.00
69.25
50.00
_Other ingredient _
Water for injection (ml) qs
1.00
5.00
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/microtubule
dynamic equilibrium. Navelbine inhibits the polymerization of tubulin.
lt acts preferentially on mitotic microtubules and
affects axonal microtubules only at high concentration.
The effects on tubulin spiralization are Iower than with vincristine.
Navelbine blocks mitosis in phase G2+M and induces
cell death at interphase or at the following mitosis.
INDICATION
• Treatment of non small cell lung cancer.
• Treatment of advanced breast cancer in combination with standard
chemotherapy.
CONTRAINDICATIONS
Pregnancy, lactation, known hypersensitivity to vinorelbine or other
vinca alkaloids, or to any of the constituents, neutrophil
count <1500/mm
3
or severe infection current or recent (within 2 weeks), platelet count
< 100000/mm
3
in combination with
yellow fever vaccine.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
• Navelbine injection should be administered under the supervision
of a physician experienced in the use of chemotherapy.
The product is for intravenous (IV) use only. Intrathecal
administration of other vinca alkaloids has resulted in death.
• Severe granulocytopenia resulting in increased susceptibility to
infection may occur. Granulocyte counts should be ≥
1500 cells/mm3. Prior to the administration of Navelbine, the dosage
should be adjusted according to complete blood
counts with differentials obtained on the day of treatment.
• Navelbine must only be administered by the intravenous route.
• It