DEXMEDETOMIDINE HYDROCHLORIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Available from:

OMEGA LABORATORIES LIMITED

ATC code:

N05CM18

INN (International Name):

DEXMEDETOMIDINE

Dosage:

400MCG

Pharmaceutical form:

SOLUTION

Composition:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400MCG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-07-11

Summary of Product characteristics

_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
Omega Laboratories Limited
11177 Hamon Street
Montreal, Canada
H3M 3E4
Submission Control Number: 280635
Date
of
Initial
Authorization:
JUL 11, 2023
Date
of
Revision:
NOV
27, 2023
_Dexmedetomidine Hydrochloride Injection _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
11/2023
7.0 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
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4
2
CONTRAINDICATIONS
..............................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................................
4
4.1
Dosing Considerations
.............................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....