VINORELBINE INJECTION, USP SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

VINORELBINE (VINORELBINE TARTRATE)

Dostupné s:

MYLAN PHARMACEUTICALS ULC

ATC kód:

L01CA04

INN (Mezinárodní Name):

VINORELBINE

Dávkování:

10MG

Léková forma:

SOLUTION

Složení:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Podání:

INTRAVENOUS

Jednotky v balení:

1/5ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2022-02-28

Charakteristika produktu

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
Following