NAT-BENDAMUSTINE POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

BENDAMUSTINE HYDROCHLORIDE

Dostopno od:

NATCO PHARMA (CANADA) INC

Koda artikla:

L01AA09

INN (mednarodno ime):

BENDAMUSTINE

Odmerek:

25MG

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

BENDAMUSTINE HYDROCHLORIDE 25MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2021-02-25

Lastnosti izdelka

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