VINORELBINE TARTRATE FOR INJECTION SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

VINORELBINE (VINORELBINE TARTRATE)

Предлага се от:

PFIZER CANADA ULC

АТС код:

L01CA04

INN (Международно Name):

VINORELBINE

дозиране:

10MG

Лекарствена форма:

SOLUTION

Композиция:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

1ML/5ML

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2021-04-06

Данни за продукта

PRODUCT MONOGRAPH
PR
VINORELBINE TARTRATE FOR INJECTION
(10 mg / 1 mL, 50 mg / 5 mL)
10 MG VINORELBINE PER ML
Antineoplastic Agent
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
July 21, 2017
Control # 206491
_Product Monograph - _
_Pr_
_Vinorelbine Tartrate for Injection _
_Page 2 of 31 _
PRODUCT MONOGRAPH
PR
VINORELBINE TARTRATE FOR INJECTION
(10 mg/ 1 mL, 50 mg/ 5 mL)
10 MG VINORELBINE PER ML
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION
VINORELBINE TARTRATE 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 respiration; and nucleic acid and lipid biosynthesis.
PHARMACOKINETICS
Following intravenous administration, vinorelbine tartrate
concentration in plasma decays in a
triphasic
manner.
The
initial
rapid
decline