দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
PATISIRAN (PATISIRAN SODIUM)
ALNYLAM NETHERLANDS B.V.
N07XX12
PATISIRAN
2MG
SOLUTION
PATISIRAN (PATISIRAN SODIUM) 2MG
INTRAVENOUS
15G/50G
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0161490001; AHFS:
APPROVED
2019-06-07
_ _ _Page 1 of 32_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr ONPATTRO® patisiran lipid complex for injection lipid complex solution; 2 mg/mL patisiran (as patisiran sodium); intravenous ATC Code N07XX12 Other nervous system drugs Alnylam Netherlands B.V. Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands Imported / Distributed by: Innomar-Strategies Oakville, ON L6L 0C4 Date of Initial Approval: June 07, 2019 Date of Revision: June 12, 2023 Submission Control No: 266240 _ _ _ONPATTRO (patisiran) Product Monograph _ _Page 2 of 32_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 06/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 4.3 Reconstitution .....................................................................................................6 4.4 Administration ................................................................ সম্পূর্ণ নথি পড়ুন