IRINOTECAN FOR INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IRINOTECAN HYDROCHLORIDE

Available from:

TEVA CANADA LIMITED

ATC code:

L01CE02

INN (International Name):

IRINOTECAN

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

IRINOTECAN HYDROCHLORIDE 20MG

Administration route:

INTRAVENOUS

Units in package:

2/5/25ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0132910001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-04-11

Summary of Product characteristics

IRINOTECAN FOR INJECTION
Page 1 of 71
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IRINOTECAN FOR INJECTION
Irinotecan Hydrochloride Injection
Solution, 20 mg / mL, Intravenous
USP
Antineoplastic Agent
ATC: L01XX19
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number: 269838
Date of Initial Authorization:
June 18, 2008
Date of Revision:
March 28, 2023
IRINOTECAN FOR INJECTION
Page 2 of 71
RECENT MAJOR LABEL CHANGES
N/A
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
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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
................................................................... 5
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1
Dosing Considerations
....................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................................ 6
4.3
Reconstitution
......................................