Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)
TEVA CANADA LIMITED
L01XG01
BORTEZOMIB
3.5MG
POWDER FOR SOLUTION
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 3.5MG
INTRAVENOUS
I.V.:3.5ML/S.C:1.4ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0150433001; AHFS:
APPROVED
2014-12-18
Bortezomib for Injection Page 1 of 95 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BORTEZOMIB FOR INJECTION Sterile Lyophilized Powder for Injection, 3.5 mg / vial bortezomib as the mannitol boronic ester, Intravenous or subcutaneous injection Antineoplastic Agent Teva Canada Limited 30 Novopharm Court, Toronto, Ontario M1B 2K9 Canada www.tevacanada.com Date of Initial Authorization: December 18, 2014 Date of Revision: December 14, 2022 Submission Control No. 265970 Bortezomib for Injection Page 2 of 95 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neurologic 12/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .............................................................................................. 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 .................................................................................................... Baca dokumen lengkapnya