DEXMEDETOMIDINE HYDROCHLORIDE INJECTION SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Beszerezhető a:

FRESENIUS KABI CANADA LTD

ATC-kód:

N05CM18

INN (nemzetközi neve):

DEXMEDETOMIDINE

Adagolás:

4MCG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4MCG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

100

Recept típusa:

Prescription

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2023-03-22

Termékjellemzők

_DEXMEDETOMIDINE HYDROCHLORIDE INJECTION (dexmedetomidine
hydrochloride) _
_Page 1 of 36 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Solution, 4 mcg/mL dexmedetomidine (as dexmedetomidine hydrochloride),
intravenous infusion
(Ready to use, 20 mL, 50 mL and 100 mL vials)
Manufacturer’s Standard
Alpha
2
-adrenergic agonist
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON
M9W 0C8
Date of Initial Authorization:
MAR 10, 2023
Date of Revision:
MAR 21, 2023
Submission Control Number: 261178
_DEXMEDETOMIDINE HYDROCHLORIDE INJECTION (dexmedetomidine
hydrochloride) _
_Page 2 of 36 _
RECENT MAJOR LABEL CHANGES
Not Applicable
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...................................................................................5
4.1
Dosing Considerations
..........................................................................................5
4.2
Recommended Dose and Dosage Adjustment
.......................................................5
4.3
Reconstitution....................