Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
IMATINIB (IMATINIB MESYLATE)
NOVARTIS PHARMACEUTICALS CANADA INC
L01EA01
IMATINIB
100MG
TABLET
IMATINIB (IMATINIB MESYLATE) 100MG
ORAL
120
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0145503002; AHFS:
APPROVED
2004-06-02
_GLEEVEC_ _®_ _ (imatinib) Product Monograph _ _Page 1 of 70 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR GLEEVEC® Imatinib Mesylate Tablets, 100 mg and 400 mg, Oral Protein kinase inhibitor (ATC code: L01EA01) Novartis Pharmaceuticals Canada Inc. 385 Bouchard Blvd., Dorval, Quebec H9S 1A9 www.novartis.ca Date of Initial Authorization: September 19, 2001 Submission Control Number: 264052 Date of Revision: August 31, 2022 GLEEVEC is a registered trademark _GLEEVEC_ _®_ _ (imatinib) Product Monograph _ _Page 2 of 70_ RECENT MAJOR LABEL CHANGES Section 7 Warnings and Precautions, Musculoskeletal 08/2022 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 .................................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................ 5 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 Soma hati kamili