PROPOFOL INJECTION EMULSION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PROPOFOL

Commercializzato da:

FRESENIUS KABI CANADA LTD

Codice ATC:

N01AX10

INN (Nome Internazionale):

PROPOFOL

Dosaggio:

10MG

Forma farmaceutica:

EMULSION

Composizione:

PROPOFOL 10MG

Via di somministrazione:

INTRAVENOUS

Confezione:

20/50/100ML

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS GENERAL ANESTHETICS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-02-19

Scheda tecnica

_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