DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Pieejams no:

BAXTER CORPORATION

ATĶ kods:

N05CM18

SNN (starptautisko nepatentēto nosaukumu):

DEXMEDETOMIDINE

Deva:

100MCG

Zāļu forma:

SOLUTION

Kompozīcija:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2021-03-19

Produkta apraksts

_Dexmedetomidine Hydrochloride for Injection, USP Product Monograph _
Page 1 of 37
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)
Alpha
2
-adrenergic agonist
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
L5N 0C2
Submission Control Number: 266549
Baxter is a registered trademark of Baxter
International Inc.
Date of Initial Authorization:
March 17, 2021
Date of Revision:
November 29, 2022
_Dexmedetomidine Hydrochloride for Injection, USP Product Monograph _
Page 2 of 37
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
11/2022
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
.................................................................................................
5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstitution