Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
BENDAMUSTINE HYDROCHLORIDE
ACCORD HEALTHCARE INC
L01AA09
BENDAMUSTINE
25MG
POWDER FOR SOLUTION
BENDAMUSTINE HYDROCHLORIDE 25MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0153268001; AHFS:
APPROVED
2021-02-25
_Bendamustine Hydrochloride for Injection _ _ _ _Page 1 of 47 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BENDAMUSTINE HYDROCHLORIDE FOR INJECTION Lyophilized Powder for Injection, for Intravenous Infusion 25 mg/vial and 100 mg/vial Antineoplastic agent Accord Healthcare Inc. Date of Initial Authorization: 3535 boul. St. Charles, Suite 704 March 5, 2020 Kirkland, QC, H9H 5B9 Canada Date of Revision: June 16, 2023 SUBMISSION CONTROL NUMBER: 273477 _Bendamustine Hydrochloride for Injection _ _ _ _Page 2 of 47 _ RECENT MAJOR LABEL CHANGES 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 ............................................................. 5 4 DOSAGE AND ADMINISTRATION.................................................................................. 5 4.1 Dosing Considerations........................................................................................ Přečtěte si celý dokument