CISPLATIN INJECTION BP SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CISPLATIN

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

L01XA01

INN (Algemene Internationale Benaming):

CISPLATIN

Dosering:

1MG

farmaceutische vorm:

SOLUTION

Samenstelling:

CISPLATIN 1MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

10/50/100ML

Prescription-type:

Prescription

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0113245002; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2022-07-25

Productkenmerken

PRODUCT MONOGRAPH
PR
CISPLATIN INJECTION BP
Sterile solution
1 MG/ML
(10mg, 50mg, 100mg cisplatin per vial)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
Sandoz Canada Inc.
Date of Revision: September 29, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission Control No: 240523
________________________________________________________________________
_Cisplatin Injection BP_
_Page 2 of 21 _
PRODUCT MONOGRAPH
PR
CISPLATIN INJECTION BP
Sterile solution
1MG/ML
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION
CISPLATIN INJECTION BP 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
SHOULD BE TAKEN REGULARLY. DISCONTINUE THE DRUG IF
ABNORMAL DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR
HEPATIC FUNCTION IS SEEN.
ACTION AND CLINICAL PHARMACOLOGY
Cisplatin has biochemical properties similar to those of bifunctional
alkylating agents
producing inter-strand and intra-strand cross-links in DNA. It is
apparently not cell-cycle
specific.
PHARMACOKINETICS
Following bolus injection, or intravenous infusion over 2 to 7 hours,
of doses ranging
from 50 to 100 mg/m
2
, plasma cisplatin half-life is approximately 30 minutes. The ratios
of cisplatin to total, free (ultrafilterable) platinum in the plasma
range from 0.4 to 1.1
after a dose of 100 mg/m
2
.
Cisplatin does not undergo instantaneous and reversible binding to
plasma proteins
characteristic of normal drug-protein binding. However, the platinum
from cisplatin
becomes bound to plasma proteins. These complexes are slowly
eliminated with a half-
life of 5 days or more.
Following cisplatin doses of 20 to 120 mg/m
2
, the concentrations of platinum are highest
in liver, prostate and kidney, somewhat lower in bladder, muscle,
testicle, pancreas and
spleen and lowest in bowel, adrenal, heart, lung, cerebrum and
cerebellum. Platinum is
present in tissues for as long as 180 days after the last
administration. With the exception
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