PROPOFOL INJECTION EMULSION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PROPOFOL

Boleh didapati daripada:

MARCAN PHARMACEUTICALS INC

Kod ATC:

N01AX10

INN (Nama Antarabangsa):

PROPOFOL

Dos:

10MG

Borang farmaseutikal:

EMULSION

Komposisi:

PROPOFOL 10MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2022-03-21

Ciri produk

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_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