BENDAMUSTINE HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

JAMP PHARMA CORPORATION

ATC code:

L01AA09

INN (International Name):

BENDAMUSTINE

Dosage:

25MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

BENDAMUSTINE HYDROCHLORIDE 25MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0153268001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-02-25

Summary of Product characteristics

_Bendamustine Hydrochloride for Injection_ Page 1 of 48
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION
(BENDAMUSTINE HYDROCHLORIDE FOR INJECTION)
Lyophilized powder for injection, for intravenous infusion
25 mg / vial and 100 mg / vial
House Standard
Antineoplastic
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
February 25, 2021
Date of Revision:
August 29, 2023
Submission Control Number: 273497
_Bendamustine Hydrochloride for Injection_ Page 2 of 48
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Carcinogenesis and Mutagenesis
08/2023
7 Warnings and Precautions, Immune
08/2023
7 Warnings and Precautions, Monitoring and Laboratory Tests
08/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
...........................................................