CISPLATIN INJECTION BP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CISPLATIN

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

L01XA01

INN (nume internaţional):

CISPLATIN

Dozare:

1MG

Forma farmaceutică:

SOLUTION

Compoziție:

CISPLATIN 1MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

10/50/100ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2022-07-25

Caracteristicilor produsului

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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