País: Canadà
Idioma: anglès
Font: Health Canada
SUGAMMADEX (SUGAMMADEX SODIUM)
MERCK CANADA INC
V03AB35
SUGAMMADEX
100MG
SOLUTION
SUGAMMADEX (SUGAMMADEX SODIUM) 100MG
INTRAVENOUS
10X2ML/ 10X5ML
Prescription
ANTIDOTES
Active ingredient group (AIG) number: 0157810001; AHFS:
APPROVED
2016-02-05
_BRIDION_ _® _ _(sugammadex sodium)_ _ _ _Page 1 of 45_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION BRIDION ® sugammadex (as sugammadex sodium) 100 mg/mL solution for intravenous injection Selective Relaxant Binding Agent MERCK CANADA INC. 16750 route Transcanadienne Kirkland, QC H9H 4M7 www.merck.ca Date of Initial Authorization: FEB 04, 2016 Date of Revision: OCT 18, 2021 Submission Control Number: 234372 _ _ _BRIDION_ _® _ _(sugammadex sodium)_ _ _ _Page 2 of 45_ RECENT MAJOR LABEL CHANGES 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment, Obese Patients 02/2021 1 Indications, 1.1 Pediatrics 10/2021 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment, Pediatrics 10/2021 4 Dosage and Administration, 4.4 Administration 10/2021 7 Warnings and Precautions, 7.1.3 Pediatric 10/2021 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 ..................................................................... 5 1 INDICATIONS .............................................................................................................. 5 1.1 Pediatrics ......................................................................................................... 5 1.2 Geriatrics........................................................................................................... 5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION................................................................................. 6 4.1 Dosing Consi Llegiu el document complet