CISPLATIN INJECTION BP SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CISPLATIN

Boleh didapati daripada:

PFIZER CANADA ULC

Kod ATC:

L01XA01

INN (Nama Antarabangsa):

CISPLATIN

Dos:

1MG

Borang farmaseutikal:

SOLUTION

Komposisi:

CISPLATIN 1MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

10ML/50ML/100ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2007-06-05

Ciri produk

_Pr_
_Cisplatin Injection BP – Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CISPLATIN INJECTION BP
(Cisplatin injection)
Sterile solution
1 mg / mL
(50 mg and 100 mg cisplatin per vial)
Antineoplastic Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
AUG 18, 1986
Date of Revision:
OCT 24, 2023
Submission Control Number: 275069
_ _
_Pr_
_Cisplatin Injection BP – Product Monograph _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2023
7 WARNINGS AND PRECAUTIONS
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Reconstitution
........................................................................................................
5