TREANDA POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BENDAMUSTINE HYDROCHLORIDE

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

L01AA09

INN (nume internaţional):

BENDAMUSTINE

Dozare:

100MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

BENDAMUSTINE HYDROCHLORIDE 100MG

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: 0153268002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-01-10

Caracteristicilor produsului

_ _
_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...