DEXMEDETOMIDINE HYDROCHLORIDE INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

제공처:

OMEGA LABORATORIES LIMITED

ATC 코드:

N05CM18

INN (International Name):

DEXMEDETOMIDINE

복용량:

400MCG

약제 형태:

SOLUTION

구성:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400MCG

관리 경로:

INTRAVENOUS

패키지 단위:

100

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2023-07-11

제품 특성 요약

_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
....