PROPOFOL INJECTION EMULSION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

PROPOFOL

متاح من:

FRESENIUS KABI CANADA LTD

ATC رمز:

N01AX10

INN (الاسم الدولي):

PROPOFOL

جرعة:

10MG

الشكل الصيدلاني:

EMULSION

تركيب:

PROPOFOL 10MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

20/50/100ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS GENERAL ANESTHETICS

ملخص المنتج:

Active ingredient group (AIG) number: 0121833001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2015-02-19

خصائص المنتج

_PROPOFOL INJECTION (Propofol Injectable Emulsion) _
_Page 1 of 36_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROPOFOL INJECTION
Propofol Injectable Emulsion
Emulsion, 10 mg / mL, Intravenous
Mfr. Std.
General Anesthetic
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
FEB 23, 2015
Date of Revision:
MAR 25, 2022
Submission Control Number: 260435
_PROPOFOL INJECTION (Propofol Injectable Emulsion) _
_Page 2 of 36_
_ _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing Considerations
03/2022
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
.....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1
Dosing Considerations
......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................... 6
4.3
Reconstitution
...............................................................................................
11
4.4
Administration