VINORELBINE INJECTION, USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VINORELBINE (VINORELBINE TARTRATE)

Available from:

GENERIC MEDICAL PARTNERS INC

ATC code:

L01CA04

INN (International Name):

VINORELBINE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Administration route:

INTRAVENOUS

Units in package:

1ML/5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-09-04

Summary of Product characteristics

_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_
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