Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
BENDAMUSTINE HYDROCHLORIDE
MYLAN PHARMACEUTICALS ULC
L01AA09
BENDAMUSTINE
100MG
POWDER FOR SOLUTION
BENDAMUSTINE HYDROCHLORIDE 100MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0153268002; AHFS:
APPROVED
2021-02-25
_ _ _Product Monograph _ _BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (bendamustine hydrochloride) _ _Page 1 of 48 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BENDAMUSTINE HYDROCHLORIDE FOR INJECTION Lyophilized Powder for Injection, 25 mg / vial and 100 mg / vial, for intravenous infusion Mylan std. Antineoplastic agent Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: February 25, 2021 Date of Revision: June 21, 2023 Submission Control Number: 273642 _ _ _Product Monograph _ _ _ _BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (bendamustine hydrochloride) _ _Page 2 of 48_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis 12/2022 7 WARNINGS AND PRECAUTIONS, Immune 12/2022 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 12/2022 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 ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4 Baca dokumen lengkap