PROPOFOL INJECTION EMULSION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

PROPOFOL

متاح من:

BAXTER CORPORATION

ATC رمز:

N01AX10

INN (الاسم الدولي):

PROPOFOL

جرعة:

10MG

الشكل الصيدلاني:

EMULSION

تركيب:

PROPOFOL 10MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS GENERAL ANESTHETICS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2001-10-02

خصائص المنتج

_PROPOFOL INJECTION Product Monograph _
_ _
_Page 1 of 38_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROPOFOL INJECTION
Propofol Injection, BP
BP
Emulsion, 10 mg / mL (1% w / v), Intravenous
General Anaesthetic
ATC CODE: N01AX10
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
L5N 0C2
Date of Initial Authorization:
OCT 02, 2001
Date of Revision:
AUG 5, 2022
Submission Control No.: 261974
_PROPOFOL INJECTION Product Monograph _
_ _
_Page 2 of 38_
_ _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing Considerations
08/2022
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