DEXMEDETOMIDINE HYDROCHLORIDE INJECTION SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

MAH:

JUNO PHARMACEUTICALS CORP.

ATC_code:

N05CM18

INN:

DEXMEDETOMIDINE

dosage:

400MCG

pharmaceutical_form:

SOLUTION

composition:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400MCG

administration_route:

INTRAVENOUS

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

leaflet_short:

Active ingredient group (AIG) number: 0152679004; AHFS:

authorization_status:

APPROVED

authorization_date:

2019-04-12

SPC

_Dexmedetomidine Hydrochloride Injection _
_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Solution, 4 mcg/mL dexmedetomidine (as dexmedetomidine hydrochloride),
intravenous infusion
(Ready to use, 50 mL and 100 mL vials)
Alpha2-adrenergic agonist
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, ON L5N 2X7
Date of Initial Authorization:
April 12, 2019
Date of Revision:
October 12, 2023
Submission Control Number: 274740
_Dexmedetomidine Hydrochloride Injection _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
10/2023
7.0 Warnings and Precautions
10/2023
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
.............................................................................................................
5
4.2
Recommended Dose and Dosage Adjust