PROPOFOL INJECTION EMULSION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

PROPOFOL

Prieinama:

MARCAN PHARMACEUTICALS INC

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

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2022-03-21

Prekės savybės

_ _
_Page 1 of 38 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROPOFOL INJECTION
Propofol Injectable Emulsion, USP
Emulsion, 10 mg / mL (1% w / v), Intravenous
USP
General Anaesthetic
ATC CODE: N01AX10
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite#112,
Ottawa, ON, K2E1A2
Date of Initial
Authorization:
MAR 08, 2022
Submission Control No: 255332
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
1 INDICATIONS
.........................................................................................................................
4
1.1
P
EDIA TRICS
........................................................................................................................
4
1.2
G
ERIATRICS
........................................................................................................................
4
2 CONTRAINDICATIONS
..........................................................................................................
4
4 DOSAGE AND
ADMINISTRATION..........................................................................................
5
4.1
D
OSING CONSIDERA TIONS
..................................................................................................
5
4.2
R
ECOMMENDED
D
OSE AND
D
OSAGE
A
DJUSTMENT
............................................................... 6
INDUCTION OF GENERAL ANAESTHESIA
..............................................................................
6
4.3
R
ECONSTITUTION
............................................................................................................
12
4.4
A
DMINISTRA TION
............................................................................................................
12
5 OVERDOSAGE
..................................................................................................................
13
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................. 14
7