CISPLATIN INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

CISPLATIN

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

L01XA01

INN (Tarptautinis Pavadinimas):

CISPLATIN

Dozė:

1.0MG

Vaisto forma:

SOLUTION

Sudėtis:

CISPLATIN 1.0MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

50/100ML

Recepto tipas:

Prescription

Gydymo sritis:

ANTINEOPLASTIC AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2013-03-15

Prekės savybės

1
PRODUCT MONOGRAPH
PR
CISPLATIN INJECTION
Sterile solution
1 mg/mL
(10 mg, 50 mg, 100 mg cisplatin per vial)
Teva Standard
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Date of Revision: October 31, 2016
Control No.: 198585
2
PRODUCT MONOGRAPH
Pr
CISPLATIN INJECTION
Sterile solution
1 mg/mL
Teva Standard
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION
CISPLATIN INJECTION 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 tumors, platinum
concentrations in tumors are generally somewhat lower than th