BENDAMUSTINE HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BENDAMUSTINE HYDROCHLORIDE

Dostupné s:

HIKMA CANADA LIMITED

ATC kód:

L01AA09

INN (Mezinárodní Name):

BENDAMUSTINE

Dávkování:

25MG

Léková forma:

POWDER FOR SOLUTION

Složení:

BENDAMUSTINE HYDROCHLORIDE 25MG

Podání:

INTRAVENOUS

Jednotky v balení:

100

Druh předpisu:

Prescription

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2022-05-02

Charakteristika produktu

_Product Monograph _
_Bendamustine Hydrochloride for Injection _
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_Page 1 of 44 _
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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
USP
Antineoplastic agent
Hikma Canada Limited
5995 Avebury Road,
Suite 804, Mississauga,
Ontario L5R 3P9
Date of Initial Authorization:
April 28, 2022
Submission Control Number: 238015
_Product Monograph _
_Bendamustine Hydrochloride for Injection _
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_ _
_Page 2 of 44 _
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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
CHANGE…………………………………………………………………………………………..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
4.1
Dosing Considerations
.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................. 5
4.3
Recons