AJ-VINORELBINE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VINORELBINE (VINORELBINE TARTRATE)

Available from:

AGILA JAMP CANADA INC

ATC code:

L01CA04

INN (International Name):

VINORELBINE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Administration route:

INTRAVENOUS

Units in package:

1/5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2015-11-03

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
AJ-VINORELBINE
VINORELBINE INJECTION USP
SOLUTION FOR INJECTION
10 MG / ML VINORELBINE (AS VINORELBINE TARTRATE)
Antineoplastic Agent
AGILA-JAMP CANADA INC.
1380 – 203 Newton
Boucherville, QC
Canada J4B 5H2
DATE OF PREPARATION:
November 5, 2012
Submission Control No.: 159565
AJ-VINORELBINE (Vinorelbine Injection USP) – Product Monograph
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PRODUCT MONOGRAPH
PR
AJ-VINORELBINE
VINORELBINE INJECTION USP
SOLUTION FOR INJECTION
10 MG / ML VINORELBINE (AS VINORELBINE TARTRATE)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION
VINORELBINE INJECTION 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 LABELLED "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 multi ringed units,
vindoline and catharanthine.
Vinorelbine 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 antitumour activity of
vinorelbine is thought to be due primarily
to inhibition of mitosis at metaphase through its interaction with
tubulin. Vinorelbine may also interfere
with amino acid, cyclic AMP, and glutathione metabolism;
calmodulin-dependent Ca
++
-transport ATPase
activity; cellular respiration; and nucleic acid and lipid
biosynthesis.
AJ-VINORELBINE (Vinorelbine Injection USP) – Product Monograph
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PHARMACOKINETICS
Following intrave