BENDAMUSTINE HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

BENDAMUSTINE HYDROCHLORIDE

זמין מ:

AURO PHARMA INC

קוד ATC:

L01AA09

INN (שם בינלאומי):

BENDAMUSTINE

כמות:

25MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

BENDAMUSTINE HYDROCHLORIDE 25MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2021-02-25

מאפייני מוצר

BENDAMUSTINE HYDROCHLORIDE FOR INJECTION
PAGE 1 OF 47
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION
(Bendamustine hydrochloride for injection)
Lyophilized Powder for Injection, for intravenous infusion
25 mg / vial and 100 mg / vial
House Standard
Antineoplastic agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
August 24, 2012
Date of Revision:
June 20, 2023
Submission Control Number: 273261
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION
PAGE 2 OF 47
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Carcinogenesis and Mutagenesis
06/2023
7 Warnings and Precautions, Immune
06/2023
7 Warnings and Precautions, Monitoring and Laboratory Tests
06/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 PEDIATRICS
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4
1.2 GERIATRICS
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4
2 CONTRAINDICATIONS
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4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4 DOSAGE AND ADMINISTRATION
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5
4.1 DOSING CONSIDER