VINORELBINE INJECTION, USP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

VINORELBINE (VINORELBINE TARTRATE)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

L01CA04

DCI (Dénomination commune internationale):

VINORELBINE

Dosage:

10MG

forme pharmaceutique:

SOLUTION

Composition:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

1/5ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2022-02-28

Résumé des caractéristiques du produit

Vinorelbine Injection, USP – Product Monograph
Page 1 of 30
PRODUCT MONOGRAPH
PR
VINORELBINE INJECTION, USP
(Solution for Injection: 10 mg/mL)
10 MG/ML VINORELBINE (AS VINORELBINE TARTRATE)
Antineoplastic Agent
Mylan Pharmaceuticals ULC
Date of Preparation: June 23, 2014
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No: 174320
Vinorelbine Injection, USP – Product Monograph
Page 2 of 30
PRODUCT MONOGRAPH
PR
VINORELBINE INJECTION, USP
(Solution for Injection: 10 mg/mL)
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.
Vinorelbine Injection, USP – Product Monograph
Page 3 of 30
PHARMACOKINETICS
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