BENDAMUSTINE HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

BENDAMUSTINE HYDROCHLORIDE

Disponible desde:

ACCORD HEALTHCARE INC

Código ATC:

L01AA09

Designación común internacional (DCI):

BENDAMUSTINE

Dosis:

100MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

BENDAMUSTINE HYDROCHLORIDE 100MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0153268002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-02-25

Ficha técnica

_Bendamustine Hydrochloride for Injection _
_ _
_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........................................................................................