Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)
TARO PHARMACEUTICALS INC
L01XG01
BORTEZOMIB
2.5MG
POWDER FOR SOLUTION
BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 2.5MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0150433002; AHFS:
APPROVED
2021-01-29
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 .......................................................................... Přečtěte si celý dokument