DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

זמין מ:

OMEGA LABORATORIES LIMITED

קוד ATC:

N05CM18

INN (שם בינלאומי):

DEXMEDETOMIDINE

כמות:

100MCG

טופס פרצבטיות:

SOLUTION

הרכב:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

100

סוג מרשם:

Prescription

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2023-06-28

מאפייני מוצר

dexmedeTOMidine Hydrochloride for Injection, USP
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_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
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
_ _
_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
...............................