Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)
JUNO PHARMACEUTICALS CORP.
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
dexmedeTOMidine Hydrochloride for Injection, USP _ _ _Page 1 of 33 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP Solution, 100 mcg/mL dexmedetomidine (as dexmedetomidine hydrochloride) intravenous infusion (Concentrate, 2 mL vial) Preservative free. The stopper is not made with natural rubber latex Alpha 2 -adrenergic agonist Juno Pharmaceuticals Corp. 402-2233 Argentia Road Mississauga, Ontario L5N 2X7 Date of Initial Authorization: August 25, 2017 Date of Revision: June 30, 2023 Submission Control Number: 271849 dexmedeTOMidine Hydrochloride for Injection, USP _ _ _Page 2 of 33 _ RECENT MAJOR LABEL CHANGES 4.1 Dosing Considerations 06/2023 7.0 Warnings and Precautions 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 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 ................ Izlasiet visu dokumentu