VINORELBINE INJECTION, USP SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

VINORELBINE (VINORELBINE TARTRATE)

Beszerezhető a:

MYLAN PHARMACEUTICALS ULC

ATC-kód:

L01CA04

INN (nemzetközi neve):

VINORELBINE

Adagolás:

10MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

1/5ML

Recept típusa:

Prescription

Terápiás terület:

ANTINEOPLASTIC AGENTS

Termék összefoglaló:

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

Engedélyezési státusz:

CANCELLED PRE MARKET

Engedély dátuma:

2022-02-28

Termékjellemzők

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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