BENDAMUSTINE HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BENDAMUSTINE HYDROCHLORIDE

Disponibil de la:

ACCORD HEALTHCARE INC

Codul ATC:

L01AA09

INN (nume internaţional):

BENDAMUSTINE

Dozare:

25MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

BENDAMUSTINE HYDROCHLORIDE 25MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-02-25

Caracteristicilor produsului

_Bendamustine Hydrochloride for Injection _
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_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION
Lyophilized Powder for Injection, for Intravenous Infusion
25 mg/vial and 100 mg/vial
Antineoplastic agent
Accord Healthcare Inc.
Date of Initial Authorization:
3535 boul. St. Charles, Suite 704
March 5, 2020
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
June 16, 2023
SUBMISSION CONTROL NUMBER: 273477
_Bendamustine Hydrochloride for Injection _
_ _
_Page 2 of 47 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis
05/2022
7 WARNINGS AND PRECAUTIONS, Immune
05/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
05/2022
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
4.1
Dosing
Considerations........................................................................................