VUMON LIQUID

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

TENIPOSIDE

Beszerezhető a:

BRISTOL-MYERS SQUIBB CANADA

ATC-kód:

L01CB02

INN (nemzetközi neve):

TENIPOSIDE

Adagolás:

10MG

Gyógyszerészeti forma:

LIQUID

Összetétel:

TENIPOSIDE 10MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

5ML

Recept típusa:

Prescription

Terápiás terület:

ANTINEOPLASTIC AGENTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0115885001; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2018-05-31

Termékjellemzők

PRODUCT MONOGRAPH
VUMON*
(TENIPOSIDE)
INJECTION, 10 MG
ANTINEOPLASTIC AGENT
Bristol-Myers Squibb Canada
DATE OF REVISION
:
Montreal, Canada
May 27, 2011
*
TM of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
CONTROL NO.: 145466
1
PRODUCT MONOGRAPH
NAME OF DRUG
VUMON*
(TENIPOSIDE)
Injection, 10 mg
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION: VUMON (TENIPOSIDE) IS A POTENT DRUG AND SHOULD BE USED ONLY
BY
PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE
WARNINGS
AND PRECAUTIONS). BLOOD COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION
TESTS
MUST
BE
DONE
REGULARLY.
DISCONTINUE
THE
DRUG
IF
ABNORMAL
DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS
SEEN.
ACTION AND CLINICAL PHARMACOLOGY
VUMON
(teniposide)
is
a
semi-synthetic
derivative
of
podophyllotoxin
used
in
the
treatment
of
neoplastic diseases.
VUMON is a phase-specific cytotoxic drug, acting in the late S
2
or G
2
phase of the cell cycle preventing
cells from entering mitosis. VUMON also produces single and
double-strand breaks in DNA. The
mechanism of action appears to be due to inhibition of type II
topoisomerases.
Teniposide produces a dose dependent inhibition of thymidine uptake
after 2.5 hours. This however is
not accompanied by a comparable reduction in DNA synthesis.
PHARMACOKINETICS
The pharmacokinetics of teniposide appear to be linear over a range of
doses. Drug accumulation does
not occur after daily administration for 3 days.
No major differences in the disposition of the drug in
2
adults and children have been identified.
Following intravenous infusion, initial clearance from the central
compartment is rapid with a distribution
half-life of approximately 1 hour. Teniposide is highly protein bound,
>99%. Levels of teniposide in
CSF are low relative to simultaneously measured plasma levels. Mean
terminal half-life has ranged
from approximately 6 to 20 hours with renal clearance accounting for
only about 10% of total clearance.
While metabolic pathways for teniposide have not been ch