দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
LUMASIRAN (LUMASIRAN SODIUM)
ALNYLAM NETHERLANDS B.V.
A16AX18
LUMASIRAN
94.5MG
SOLUTION
LUMASIRAN (LUMASIRAN SODIUM) 94.5MG
SUBCUTANEOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0163440001; AHFS:
APPROVED
2022-03-07
_OXLUMO_ _®_ _(lumasiran injection) _ _Page 1 of 27 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR OXLUMO® Lumasiran Injection Solution, 94.5 mg/0.5 mL lumasiran (as lumasiran sodium), subcutaneous injection Various alimentary tract and metabolism products Alnylam Netherlands B.V. Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands Imported / Distributed by: Innomar Strategies Inc. Oakville, ON L6L 0C4 Date of Initial Authorization: MAR 03, 2022 Date of Revision: DEC 01, 2023 Submission Control Number: 277966 _ _ _OXLUMO_ _®_ _(lumasiran injection) _ _Page 2 of 27_ RECENT MAJOR LABEL CHANGES 1. INDICATIONS 05/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 4 4.1 Dosing Considerations ............................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment ....................................................... 4 4.3 Reconstitution ........................................................................................................ 5 4.4 Administration ............................................................ সম্পূর্ণ নথি পড়ুন