VINORELBINE TARTRATE FOR INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

VINORELBINE (VINORELBINE TARTRATE)

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

L01CA04

INN (nume internaţional):

VINORELBINE

Dozare:

10MG

Forma farmaceutică:

SOLUTION

Compoziție:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

1ML/5ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2021-04-06

Caracteristicilor produsului

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