Land: Kanada
Språk: engelska
Källa: Health Canada
GIVOSIRAN (GIVOSIRAN SODIUM)
ALNYLAM NETHERLANDS B.V.
A16AX16
GIVOSIRAN
189MG
SOLUTION
GIVOSIRAN (GIVOSIRAN SODIUM) 189MG
SUBCUTANEOUS
15G/50G
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0162538001; AHFS:
APPROVED
2020-10-09
_GIVLAARI (givosiran) _ _ _ _ _ _Page 1 of 29_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr GIVLAARI® Givosiran Injection Solution, 189 mg/mL givosiran (as givosiran 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: OCT 08, 2020 Date of Revision: SEPT 18, 2023 Submission Control Number: 275066 _ _ _ _ _ _ _GIVLAARI (givosiran) _ _Page 2 of 29_ RECENT MAJOR LABEL CHANGES Not applicable. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES .......................................................................................... 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 4.4 Administration ......................................................................................................... 5 4.5 Missed Dose ............................................................................................................. 6 5 OVERDOSAGE ................................................................. Läs hela dokumentet