BENDAMUSTINE HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

MYLAN PHARMACEUTICALS ULC

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

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_Product Monograph _
_BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (bendamustine hydrochloride)
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_Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION
Lyophilized Powder for Injection, 25 mg / vial and 100 mg / vial, for
intravenous infusion
Mylan std.
Antineoplastic agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
February 25, 2021
Date of Revision:
June 21, 2023
Submission Control Number: 273642
_ _
_Product Monograph _
_ _
_BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (bendamustine hydrochloride)
_
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis
12/2022
7 WARNINGS AND PRECAUTIONS, Immune
12/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
12/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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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
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4
DOSAGE AND ADMINISTRATION
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5
4