AJ-VINORELBINE SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

VINORELBINE (VINORELBINE TARTRATE)

Предлага се от:

AGILA JAMP CANADA INC

АТС код:

L01CA04

INN (Международно Name):

VINORELBINE

дозиране:

10MG

Лекарствена форма:

SOLUTION

Композиция:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

1/5ML

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2015-11-03

Данни за продукта

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
Page 2 of 30
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
Page 3 of 30
PHARMACOKINETICS
Following intrave