TREANDA POWDER FOR SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

BENDAMUSTINE HYDROCHLORIDE

Disponível em:

TEVA CANADA LIMITED

Código ATC:

L01AA09

DCI (Denominação Comum Internacional):

BENDAMUSTINE

Dosagem:

25MG

Forma farmacêutica:

POWDER FOR SOLUTION

Composição:

BENDAMUSTINE HYDROCHLORIDE 25MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

ANTINEOPLASTIC AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2018-01-10

Características técnicas

_ _
_Product Monograph _
_ _
_TREANDA_
_® _
_bendamustine hydrochloride _
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TREANDA
®
(BENDAMUSTINE HYDROCHLORIDE FOR INJECTION)
Lyophilized Powder for Injection, for intravenous infusion
25 mg/ vial and 100 mg/ vial
Antineoplastic agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Manufactured for:
Teva Canada Innovation
H2Z 1S8
Date of Initial Authorization:
August 24, 2012
Date of Revision:
January 25, 2023
Submission Control Number: 268351
_ _
_Product Monograph _
_ _
_TREANDA_
_® _
_bendamustine hydrochloride _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Carcinogenesis and Mutagenesis
08/2021
7 Warnings and Precautions, Immune
08/2021
7 Warnings and Precautions, Monitoring and Laboratory Tests
08/2021
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...