国家: 加拿大
语言: 英文
来源: Health Canada
IMATINIB (IMATINIB MESYLATE)
APOTEX INC
L01EA01
IMATINIB
100MG
TABLET
IMATINIB (IMATINIB MESYLATE) 100MG
ORAL
30/100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0145503002; AHFS:
APPROVED
2013-04-02
_APO-IMATINIB (Imatinib Mesylate) _ _Page 1 of 89_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr APO-IMATINIB Imatinib Mesylate Tablets Tablets, 100 mg and 400 mg imatinib (as imatinib mesylate), Oral Protein Kinase Inhibitor (ATC code: L01EA01) APOTEX INC. 150 Signet Drive Toronto, Ontario Canada M9L 1T9 Date of Initial Authorization: APR 02, 2013 Date of Revision: APR 18, 2023 Submission Control Number: 270347 _APO-IMATINIB (Imatinib Mesylate) _ _Page 2 of 89_ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Musculoskeletal 04/2023 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 ................................................................. 5 1 INDICATIONS .................................................................................................................... 5 1.1 Pediatrics ...................................................................................................................... 5 1.2 Geriatrics ...................................................................................................................... 6 2 CONTRAINDICATIONS ....................................................................................................... 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 6 4 DOSAGE AND ADMINISTRATION ....................................................................................... 7 4.1 Dosing Considerations .................................................................................................. 7 4.2 Recommended Dose and Dosage Adjustment .............................................................. 7 4.5 Missed Dose ..... 阅读完整的文件