Country: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
BENDAMUSTINE HYDROCHLORIDE
TEVA CANADA LIMITED
L01AA09
BENDAMUSTINE
25MG
POWDER FOR SOLUTION
BENDAMUSTINE HYDROCHLORIDE 25MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0153268001; AHFS:
APPROVED
2018-01-10
_ _ _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... সম্পূর্ণ নথি পড়ুন