DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Sẵn có từ:

JUNO PHARMACEUTICALS CORP.

Mã ATC:

N05CM18

INN (Tên quốc tế):

DEXMEDETOMIDINE

Liều dùng:

100MCG

Dạng dược phẩm:

SOLUTION

Thành phần:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

2ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-01-03

Đặc tính sản phẩm

dexmedeTOMidine Hydrochloride for Injection, USP
_ _
_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
................