Land: Kanada
Sprache: Englisch
Quelle: Health Canada
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)
JUNO PHARMACEUTICALS CORP.
L01XG01
BORTEZOMIB
2.5MG
POWDER FOR SOLUTION
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 2.5MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0150433002; AHFS:
APPROVED
2020-07-03
BORTEZOMIB FOR INJECTION Page 1 of 83 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BORTEZOMIB FOR INJECTION Lyophilized powder, 1 mg, 2.5 mg and 3.5 mg/vial bortezomib (as the mannitol boronic ester), Intravenous or Subcutaneous Injection Antineoplastic Agent Juno Pharmaceuticals Corp. 402-2233 Argentia Road Mississauga,Ontario L5N 2X7 Date of Initial Authorization: January 29, 2019 Date of Revision: October 13, 2023 Submission Control Number: 277669 BORTEZOMIB FOR INJECTION Page 2 of 83 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neurologic 10/2023 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 .......................................................................................................... 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 ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................. 6 4.3 Reconstitution ................................................................................. Lesen Sie das vollständige Dokument