PROPOFOL INJECTION EMULSION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

PROPOFOL

Prieinama:

BAXTER CORPORATION

ATC kodas:

N01AX10

INN (Tarptautinis Pavadinimas):

PROPOFOL

Dozė:

10MG

Vaisto forma:

EMULSION

Sudėtis:

PROPOFOL 10MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

MISCELLANEOUS GENERAL ANESTHETICS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2001-10-02

Prekės savybės

_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