CISPLATIN INJECTION SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CISPLATIN

Dostupné z:

OMEGA LABORATORIES LIMITED

ATC kód:

L01XA01

INN (Medzinárodný Name):

CISPLATIN

Dávkovanie:

1MG

Forma lieku:

SOLUTION

Zloženie:

CISPLATIN 1MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

50ML/100ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2014-03-06

Súhrn charakteristických

Cisplatin Injection
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sur
15
PRODUCT MONOGRAPH
PR
CISPLATIN INJECTION
CONCENTRATED STERILE SOLUTION FOR INJECTION
1.0 MG/ML
(50 mg/50 mL, 100 mg/100 mL)
Omega Standard
Antineoplastic Agent
MUST BE DILUTED BEFORE ADMINISTRATION
Omega Laboratories, Ltd.
11 177, Hamon
Montréal, Canada
H3M 3E4
CONTROL # : 152337_ _
Date of Preparation:
March 5, 2014
Cisplatin Injection
Page 2
sur
15
PRODUCT MONOGRAPH
PR CISPLATIN INJECTION
1.0 MG/ML
(50 mg/50 mL, 100 mg/100 mL)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION:
CISPLATIN 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 of
intracerebral