CARBOPLATIN INJECTION SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CARBOPLATIN

Beschikbaar vanaf:

OMEGA LABORATORIES LIMITED

ATC-code:

L01XA02

INN (Algemene Internationale Benaming):

CARBOPLATIN

Dosering:

10MG

farmaceutische vorm:

SOLUTION

Samenstelling:

CARBOPLATIN 10MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

5/15/45/60ML

Prescription-type:

Prescription

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0117892002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-03-30

Productkenmerken

PRODUCT MONOGRAPH
Pr
CARBOPLATIN INJECTION
OMEGA STANDARD
(CARBOPLATIN)
10 mg/mL
Antineoplastic
Omega Laboratories, Ltd.
Preparation date:
11 177, Hamon
March 24, 2011
Montréal, Canada
H3M 3E4
Control No. 135287
2
Pr
CARBOPLATIN INJECTION
10 MG/ML
OMEGA STANDARD
THERAPEUTIC CLASSIFICATION
Antineoplastic
CAUTION:
CARBOPLATIN 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
Carboplatin is a synthetic analogue of cisplatin. Like cisplatin,
carboplatin interferes with DNA
intrastrand and interstrand crosslinks in cells exposed to the drug.
DNA reactivity has been
correlated with cytotoxicity.
Following administration of carboplatin in man, linear relationships
exist between dose and
plasma concentrations of total and free ultrafilterable platinum.
The area under the plasma concentration versus time curve for total
platinum also shows a linear
relationship with the dose.
Repeated dosing during four consecutive days did not produce an
accumulation of platinum in
plasma.
3
Following administration of carboplatin, reported values for the
terminal elimination half-lives of
free ultrafilterable platinum and carboplatin in man were
approximately 6 hours and 1.5 hours,
respectively. During the initial phase, most of the free
ultrafilterable platinum is present as
carboplatin. The terminal half-life for total plasma platinum is 24
hours. Approximately 87% of
the plasma platinum is protein bound within 24 hours following
administration. Carboplatin is
excreted primarily in the urine with recovery of approximately 70% of
the administered platinum
within 24 hours. Most of the drug is excreted in the first 6 hours.
Excretion of carboplatin is by glomerular filtration. Patients with
poor renal function have a
higher area under curve (AUC) for total platinu