NAT-BENDAMUSTINE POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

BENDAMUSTINE HYDROCHLORIDE

Tilgængelig fra:

NATCO PHARMA (CANADA) INC

ATC-kode:

L01AA09

INN (International Name):

BENDAMUSTINE

Dosering:

100MG

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

BENDAMUSTINE HYDROCHLORIDE 100MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2021-02-25

Produktets egenskaber

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-BENDAMUSTINE
(BENDAMUSTINE HYDROCHLORIDE FOR INJECTION)
Lyophilized Powder for Injection, 25 mg / vial and 100 mg / vial, for
intravenous infusion
USP
Antineoplastic agent
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
MAR 04, 2020
Date of Revision:
MAY 05, 2023
Submission Control Number: 273010
_ _
_NAT-BENDAMUSTINE (bendamustine hydrochloride) _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
05/2022
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
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing
Considerations......................................................................................
5