Pays: Canada
Langue: anglais
Source: Health Canada
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)
ACCORD HEALTHCARE INC
N05CM18
DEXMEDETOMIDINE
100MCG
SOLUTION
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG
INTRAVENOUS
2ML
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0152679003; AHFS:
APPROVED
2019-01-03
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION Solution, 100 mcg / mL dexmedetomidine (as dexmedetomidine hydrochloride), intravenous infusion (Concentrate, 2 mL vial) USP Alpha 2 -adrenergic agonist Accord Healthcare Inc. 3535 boul. St. Charles, Suite 704 Kirkland, QC H9H 5B9 Canada Date of Initial Authorization: JAN 03, 2019 Date of Revision: November 1, 2023 SUBMISSION CONTROL NUMBER: 275584 Dexmedetomidine Hydrochloride for Injection _Page 2 of 34_ RECENT MAJOR LABEL CHANGES 4.1 Dosing Considerations 02-2023 7 Warnings and Precautions 11-2023 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 4 DOSAGE AND ADMINISTRATION ............................................................................. 5 4.1 Dosing Considerations .................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ............................................................... 5 4.3 Reconstitution ......................................................................................... Lire le document complet