DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP 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:

100MCG

Pharmaceutical form:

SOLUTION

Composition:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0152679003; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-06-28

Summary of Product characteristics

dexmedeTOMidine Hydrochloride for Injection, USP
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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
Omega Laboratories Limited
11177 Hamon
Montreal, Canada
H3M 3E4
Submission Control Number: 277599
Date
of
Initial
Authorization:
June 28, 2023
Date
of
Revision:
August 21, 2023
dexmedeTOMidine Hydrochloride for Injection, USP
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_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
08/2023
7.0 Warnings and Precautions
08/2023
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
...............................