VINORELBINE TARTRATE INJECTION USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VINORELBINE (VINORELBINE TARTRATE)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

L01CA04

INN (Διεθνής Όνομα):

VINORELBINE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2018-08-01

Αρχείο Π.Χ.Π.

_Vinorelbine Tartrate Injection 10 mg/mL Page 1 of 26_
PRODUCT MONOGRAPH
PR VINORELBINE TARTRATE INJECTION USP
VINORELBINE TARTRATE USP
SOLUTION FOR INJECTION, 10 MG/ML
ANTINEOPLASTIC AGENT
Sandoz Canada Inc.
Date of Preparation:
145 Jules-Léger
June 15, 2009
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 119033
_Vinorelbine Tartrate Injection 10 mg/mL Page 2 of 26_
VINORELBINE TARTRATE INJECTION USP
10 MG/ML
VINORELBINE TARTRATE USP
VINORELBINE TARTRATE INJECTION USP IS A CYTOTOXIC DRUG AND SHOULD BE
USED ONLY BY
PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS. BLOOD
COUNTS SHOULD BE
TAKEN PRIOR TO THE NEXT DOSE. DISCONTINUE OR REDUCE THE DOSAGE UPON
EVIDENCE OF
ABNORMAL DEPRESSION OF THE BONE MARROW.
THIS PREPARATION IS FOR INTRAVENOUS ADMINISTRATION ONLY. INTRATHECAL
ADMINISTRATION OF
OTHER VINCA ALKALOIDS 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
multiringed 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.
P
HARMACOKINETICS
Following intravenous administration, vinorelbine concentration in
plasma decays in a
triphasic manner. The initial rapid decline represents distribution of
drug to peripheral
compartments and metabolism of the drug. The pro