Država: Kanada
Jezik: engleski
Izvor: Health Canada
BLINATUMOMAB
AMGEN CANADA INC
L01FX07
BLINATUMOMAB
38.5MCG
POWDER FOR SOLUTION
BLINATUMOMAB 38.5MCG
INTRAVENOUS
265ML TO 275ML (STARTING VOL)
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0157670001; AHFS:
APPROVED
2015-12-22
_ _ _BLINCYTO (blinatumomab) _ _Page 1 of 65_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BLINCYTO ® blinatumomab for injection Lyophilized powder for solution for infusion, 38.5 mcg Professed Standard Anti-neoplastic Agent ATC code: L01FX07 Submission Control Number: 269288 © 2015-2023 Amgen Canada Inc., All Rights Reserved. Amgen Canada Inc. 6775 Financial Drive, Suite 300 Mississauga, Ontario L5N 0A4 Date of Initial Authorization: December 22, 2015 Date of Revision: August 29, 2023 _ _ _BLINCYTO (blinatumomab) _ _Page 2 of 65_ RECENT MAJOR LABEL CHANGES 1.1 Pediatrics XX/2023 4.2 Recommended Dose and Dosage Adjustment XX/2023 4.4 Administration XX/2023 7.1.3 Pediatrics XX/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 ...................................................................................................... 11 4.4 Administration ..................................... Pročitajte cijeli dokument