CISPLATIN INJECTION BP SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CISPLATIN

Boleh didapati daripada:

HIKMA CANADA LIMITED

Kod ATC:

L01XA01

INN (Nama Antarabangsa):

CISPLATIN

Dos:

1MG

Borang farmaseutikal:

SOLUTION

Komposisi:

CISPLATIN 1MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2023-03-17

Ciri produk

PRODUCT MONOGRAPH
PR
CISPLATIN INJECTION BP
Sterile solution 1 mg / mL
(50 mg and 100 mg cisplatin per vial)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Date of Preparation:
March 16, 2023
Submission Control No.: 263374
_Pr_
_Cisplatin Injection BP Product Monograph _
_Page 2 of 20 _
PRODUCT MONOGRAPH
PR
CISPLATIN INJECTION BP
Sterile solution 1 mg / 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 of
intracerebral tumors, platinum