VINORELBINE INJECTION, USP SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

VINORELBINE (VINORELBINE TARTRATE)

Disponível em:

GENERIC MEDICAL PARTNERS INC

Código ATC:

L01CA04

DCI (Denominação Comum Internacional):

VINORELBINE

Dosagem:

10MG

Forma farmacêutica:

SOLUTION

Composição:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

1ML/5ML

Tipo de prescrição:

Prescription

Área terapêutica:

ANTINEOPLASTIC AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0126071001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2014-09-04

Características técnicas

_Page 1 of 32_
PRODUCT MONOGRAPH
PR
VINORELBINE INJECTION, USP
(10 mg/1 mL and 50 mg/5 mL)
10 mg/mL vinorelbine (as vinorelbine tartrate)
Sterile Solution for Injection
Concentrate: Solution Must Be Diluted Before Use
Antineoplastic Agent
Generic Medical Partners Inc.
251 Consumers Road, Suite 1200
Date of Preparation:
Toronto, Ontario
September 03, 2014
M2J 4R3
Control # 163682
_Page 2 of 32_
PRODUCT MONOGRAPH
PR
VINORELBINE INJECTION, USP
(10 mg/1 mL and 50 mg/5 mL)
10 mg/mL vinorelbine (as vinorelbine tartrate)
Sterile Solution for Injection
Concentrate: Solution Must Be Diluted Before Use THERAPEUTIC
CLASSIFICATION
Antineoplastic Agent
CAUTION
VINORELBINE INJECTION, USP IS A CYTOTOXIC DRUG AND SHOULD BE USED
ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC
DRUGS.
BLOOD
COUNTS
SHOULD
BE
TAKEN
PRIOR
TO
EACH
DOSE.
THE
DOSAGE
SHOULD
BE
REDUCED
OR
THE
DRUG
DISCONTINUED
UPON
EVIDENCE OF ABNORMAL DEPRESSION OF THE BONE MARROW.
THIS PREPARATION IS FOR INTRAVENOUS ADMINISTRATION ONLY. INTRATHECAL
ADMINISTRATION OF OTHER
VINCA ALKALOIDS HAS RESULTED IN DEATH. SYRINGES CONTAINING THIS
PRODUCT SHOULD BE LABELED
"WARNING - FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN INTRATHECALLY”.
CLINICAL PHARMACOLOGY
Vinorelbine tartrate is a novel vinca alkaloid which interferes with
microtubule assembly. Vinca
alkaloids are structurally similar compounds comprising two
multiringed units, vindoline and
catharanthine. Vinorelbine tartrate is a vinca alkaloid in which the
catharanthine unit is the site of
structural modification. This structural change imparts unique
pharmacologic properties which
may translate into clinical benefits for patients with various
malignancies. The antitumor activity
of vinorelbine tartrate is thought to be due primarily to inhibition
of mitosis at metaphase through
its interaction with tubulin. Vinorelbine tartrate may also interfere
with amino acid, cyclic AMP
and
glutathione
metabolism;
calmodulin-dependent
Ca
++
-transport
ATPase
activity;
cellular
_Page 3 of 32_
respiration; and nucleic acid a