CARBOPLATIN INJECTION, BP SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CARBOPLATIN

Saatavilla:

STRIDES PHARMA CANADA INC

ATC-koodi:

L01XA02

INN (Kansainvälinen yleisnimi):

CARBOPLATIN

Annos:

10MG

Lääkemuoto:

SOLUTION

Koostumus:

CARBOPLATIN 10MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-05-20

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
CARBOPLATIN INJECTION, BP
CONCENTRATED STERILE SOLUTION FOR INJECTION
10 MG/ML CARBOPLATIN
ANTINEOPLASTIC AGENT
Concentrate – must be diluted before use
Strides Pharma Canada Inc.
Date of revision:
1565, Boul. Lionel-Boulet May 20, 2020
Varennes, Quebec
Canada J3X 1P7
Submission Control No.: 237832
2
PR
CARBOPLATIN INJECTION, BP
10
MG/ML
STERILE
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION
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.
ACTIONS AND CLINICAL PHARMACOLOGY
Carboplatin
has
biochemical
properties
similar
to
that
of
cisplatin,
thus
producing
predominantly interstrand DNA, crosslinks. In patients with creatinine
clearances of 60
mL/min or greater given Carboplatin injection at doses of 300 to 500
mg/m
2
, the plasma
concentrations of Carboplatin decline in a biphasic manner with mean
alpha and beta half-
lives of 1.6 h and 3.0 h. respectively. The total body clearance,
apparent volume of
distribution, and mean residence time for Carboplatin is 73 mL/min, 16
L, and 3.5 h.
respectively. The Cmax and AUC increase linearly with dose. Therefore,
over the range of
doses studied, Carboplatin exhibits
linear, pharmacokinetics in patients with creatinine
clearances ≥ 60 mL /min.
Repeated dosing during four consecutive days did not produce an
accumulation of platinum
in
plasma.
Following
administration
of
carboplatin,
reported
values
for
the
terminal
elimination
half-lives
of
free
ultrafilterable
platinum
and
carboplatin
in
man
are
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 plasma platinum is protein
bound w