Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
DARATUMUMAB
JANSSEN INC
L01FC01
DARATUMUMAB
100MG
SOLUTION
DARATUMUMAB 100MG
INTRAVENOUS
5ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0158231001; AHFS:
APPROVED
2016-06-29
_~db5_Oac54e46c9e98425794855d4eadebbcc0.docx_ _ _ _ EDMS-RIM-746978 v12.0 _ _Darzalex (daratumumab for injection) _ _Page 1 of 95_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DARZALEX® daratumumab for injection 20 mg/mL Concentrate for Solution for Infusion Professed Standard Antineoplastic, monoclonal antibody ATC Code L01FC01 Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen.com/canada Date of Initial Authorization: June 29, 2016 Date of Revision: May 29, 2023 Submission Control Number: 265459 All trademarks used under license. © 2023 Janssen Inc. _~db5_Oac54e46c9e98425794855d4eadebbcc0.docx_ _ _ _ EDMS-RIM-746978 v12.0 _ _Darzalex (daratumumab for injection) _ _Page 2 of 95_ RECENT MAJOR LABEL CHANGES 1 Indications 12/2022 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 12/2022 7 Warnings and Precautions 12/2022 7 Warnings and Precautions, 7.1.1 Pregnant Women 12/2022 7 Warnings and Precautions, 7.1.2 Breast-Feeding 12/2022 7 Warnings and Precautions, 7.1.4 Geriatrics 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 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 SER Կարդացեք ամբողջական փաստաթուղթը