PROPOFOL EMULSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-10-2017
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Active ingredient:
PROPOFOL
Available from:
BAXTER CORPORATION
ATC code:
N01AX10
INN (International Name):
PROPOFOL
Dosage:
10MG
Pharmaceutical form:
EMULSION
Composition:
PROPOFOL 10MG
Administration route:
INTRAVENOUS
Units in package:
20ML/50ML/100ML
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS GENERAL ANESTHETICS
Product summary:
Active ingredient group (AIG) number: 0121833001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2024-01-30
Summary of Product characteristics
_PROPOFOL Product Monograph _
_Page 1 of 48_
_ _
PRODUCT MONOGRAPH
PR
PROPOFOL
Propofol Injectable Emulsion, BP
1% w/v
10 mg/mL
Intravenous Emulsion – Anaesthetic - Sedative
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
L5N 0C2
Date of Revision:
September 29, 2017
Submission Control No: 207653
_PROPOFOL Product Monograph _
_Page 2 of 48_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
DETAILED PHARMACOLOGY
.....................................................................................27
TOXICOLOGY
..................
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