Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2016-02-09
Original market date: See footnote 1
2013-05-08
Product name:
SMOFLIPID 20%
Description:
LIPID INJECTABLE EMULSION, MFR STD.
DIN:
02396963
Product Monograph/Veterinary Labelling:
Date:
2023-07-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
FRESENIUS KABI CANADA LTD
165 Galaxy Blvd, Suite 100
Toronto
Ontario
Canada
M9W 0C8
Class:
Human
Dosage form(s):
Emulsion
Route(s) of administration:
Intravenous
Number of active ingredient(s):
4
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
40:20.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
B05BA02 FAT EMULSIONS
Active ingredient group (AIG) number:See footnote5
0453432001
| Active ingredient(s) | Strength |
|---|---|
| FISH OIL | 3 % / W/V |
| MEDIUM CHAIN TRIGLYCERIDES (MCT) | 6 % / W/V |
| OLIVE OIL | 5 % / W/V |
| SOYBEAN OIL | 6 % / W/V |