Ország: Kanada
Nyelv: angol
Forrás: Health Canada
RAVULIZUMAB
ALEXION PHARMA GMBH
L04AJ02
RAVULIZUMAB
300MG
SOLUTION
RAVULIZUMAB 300MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0161710002; AHFS:
APPROVED
2022-12-13
ULTOMIRIS ® (ravulizumab) Product Monograph Page 1 of 58 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ULTOMIRIS ® RAVULIZUMAB FOR INJECTION 10 mg/mL & 100 mg/mL concentrate for solution for intravenous infusion Selective immunosuppressant Submission Control Number: 269852 Alexion Pharma GmbH Neuhofstrasse 34 Baar, Switzerland 6340 Imported by: Alexion Pharma Canada Corp. 1004 Middlegate Road, Suite #5000 Mississauga, ON L4Y 1M4 Date of Initial Authorization: AUG 28, 2019 Date of Revision: OCT 30, 2023 ULTOMIRIS ® (ravulizumab) Product Monograph Page 2 of 58 RECENT MAJOR LABEL CHANGES [1 Indications] [12/2022] [4 Dosage & Administration], [4.2 Recommended Dose & Dosage Adjustment] [12/ 2022] [7 Warnings & Precautions] [11/2022] 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 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations ................................................................. Olvassa el a teljes dokumentumot