DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Disponível em:

JUNO PHARMACEUTICALS CORP.

Código ATC:

N05CM18

DCI (Denominação Comum Internacional):

DEXMEDETOMIDINE

Dosagem:

100MCG

Forma farmacêutica:

SOLUTION

Composição:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

Via de administração:

INTRAVENOUS

Unidades em pacote:

2ML

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2019-01-03

Características técnicas

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
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Initial Authorization:
August 25, 2017
Date of Revision:
June 30, 2023
Submission Control Number: 271849
dexmedeTOMidine Hydrochloride for Injection, USP
_ _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
06/2023
7.0 Warnings and Precautions
06/2023
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
................