DEXMEDETOMIDINE HYDROCHLORIDE INJECTION SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Disponível em:

OMEGA LABORATORIES LIMITED

Código ATC:

N05CM18

DCI (Denominação Comum Internacional):

DEXMEDETOMIDINE

Dosagem:

400MCG

Forma farmacêutica:

SOLUTION

Composição:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400MCG

Via de administração:

INTRAVENOUS

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2023-07-11

Características técnicas

_Dexmedetomidine Hydrochloride Injection _
_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Solution, 4 mcg/mL dexmedetomidine (as dexmedetomidine hydrochloride),
intravenous infusion
(Ready to use, 50 mL and 100 mL vials)
Alpha2-adrenergic agonist
Omega Laboratories Limited
11177 Hamon Street
Montreal, Canada
H3M 3E4
Submission Control Number: 280635
Date
of
Initial
Authorization:
JUL 11, 2023
Date
of
Revision:
NOV
27, 2023
_Dexmedetomidine Hydrochloride Injection _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
11/2023
7.0 Warnings and Precautions
11/2023
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
.............................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....