Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)
TARO PHARMACEUTICALS INC
L01XG01
BORTEZOMIB
1MG
POWDER FOR SOLUTION
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 1MG
INTRAVENOUS
100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0150433003; AHFS:
APPROVED
2021-11-01
Taro-Bortezomib (Bortezomib for Injection) Page 1 of 86 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TARO-BORTEZOMIB Bortezomib for Injection Sterile Lyophilized Powder for Injection, 1 mg, 2.5 mg and 3.5 mg / vial bortezomib, as the mannitol boronic ester, Intravenous or subcutaneous Antineoplastic Agent Taro Pharmaceuticals Inc. 130 East Drive Brampton, Ontario Canada, L6T 1C1 Date of Initial Authorization: May 14, 2020 Date of Revision: September 21, 2022 Submission Control Number: 263204 Taro-Bortezomib (Bortezomib for Injection) Page 2 of 86 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neurologic 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS 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 .......................................................................... Soma hati kamili