DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

זמין מ:

EUGIA PHARMA INC.

קוד ATC:

N05CM18

INN (שם בינלאומי):

DEXMEDETOMIDINE

כמות:

100MCG

טופס פרצבטיות:

SOLUTION

הרכב:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

100

סוג מרשם:

Prescription

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2022-07-08

מאפייני מוצר

_Page 1 of 32_
PRODUCT MONOGRAPH
PR DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
CONCENTRATE
DEXMEDETOMIDINE (AS DEXMEDETOMIDINE HYDROCHLORIDE)
200 MCG/2 ML (100 MCG/ML)
Alpha
2
-adrenergic agonist
EUGIA PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario
L4L 8K8 Canada
SUBMISSION CONTROL NO.: 264435
Date of
Preparation:
July 8, 2022
_Page 2 of 32_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
13
OVERDOSAGE
........................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
16
STORAGE AND STABILITY
.................................................................................................
19
SPECIAL HANDLING
INSTRUCTION...................................................................................19
DOSAGE FORM, COMPOSITION AND
PACKAGING………………………………….20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
...................