CLINOLEIC 20% EMULSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLIVE OIL; SOYBEAN OIL

Available from:

BAXTER CORPORATION

ATC code:

B05BA02

INN (International Name):

FAT EMULSIONS

Dosage:

16%; 4%

Pharmaceutical form:

EMULSION

Composition:

OLIVE OIL 16%; SOYBEAN OIL 4%

Administration route:

INTRAVENOUS

Units in package:

100/250/350/500/1000ML

Prescription type:

Ethical

Therapeutic area:

CALORIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0252693001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-03-08

Summary of Product characteristics

_Product Monograph _
_Template Date: September 2020 _
_CLINOLEIC 20% (Refined Olive Oil and Refined Soybean Oil Lipid
Emulsion) _
_Page 20 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CLINOLEIC 20%
Refined Olive Oil and Refined Soybean Oil Lipid Emulsion
Emulsion, approximately 16%/4% w/w
Lipid Emulsion for Intravenous Nutrition
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Initial Authorization:
MAR 28, 2012
Date of Revision:
AUG 1, 2023
Submission Control Number: 273081
Baxter and Clinoleic are registered trademarks of Baxter International
Inc.
_ _
_Product Monograph _
_Template Date: September 2020 _
_CLINOLEIC 20% (Refined Olive Oil and Refined Soybean Oil Lipid
Emulsion) _
_Page 30 of 30_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICTIONS
08/2023
6 WARNINGS AND PRECAUTIONS, Immune
08/2023
5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND
PACKAGING
08/2023
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
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
................................