BENDAMUSTINE HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

BENDAMUSTINE HYDROCHLORIDE

Tillgänglig från:

MYLAN PHARMACEUTICALS ULC

ATC-kod:

L01AA09

INN (International namn):

BENDAMUSTINE

Dos:

25MG

Läkemedelsform:

POWDER FOR SOLUTION

Sammansättning:

BENDAMUSTINE HYDROCHLORIDE 25MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

15G/50G

Receptbelagda typ:

Prescription

Terapiområde:

ANTINEOPLASTIC AGENTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2021-02-25

Produktens egenskaper

_ _
_Product Monograph _
_BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (bendamustine hydrochloride)
_
_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
...........................................................................................
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
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4