DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

متاح من:

ACCORD HEALTHCARE INC

ATC رمز:

N05CM18

INN (الاسم الدولي):

DEXMEDETOMIDINE

جرعة:

100MCG

الشكل الصيدلاني:

SOLUTION

تركيب:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

2ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2019-01-03

خصائص المنتج

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
Solution, 100 mcg / mL dexmedetomidine (as dexmedetomidine
hydrochloride), intravenous infusion
(Concentrate, 2 mL vial)
USP
Alpha
2
-adrenergic agonist
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC H9H 5B9
Canada
Date of Initial Authorization:
JAN 03, 2019
Date of Revision:
November 1, 2023
SUBMISSION CONTROL NUMBER: 275584
Dexmedetomidine Hydrochloride for Injection
_Page 2 of 34_
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
02-2023
7 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
.............................................................................
5
4.1
Dosing Considerations
....................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................... 5
4.3
Reconstitution
.........................................................................................