CISPLATIN INJECTION BP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CISPLATIN

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

L01XA01

INN (International Name):

CISPLATIN

Dosering :

1MG

Legemiddelform:

SOLUTION

Sammensetning:

CISPLATIN 1MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

10ML/50ML/100ML

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2007-06-05

Preparatomtale

_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