Product information

From Health Canada

New search

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:

2015-09-15

Original market date: See footnote 1

2015-09-15

Product name:

SMOFKABIVEN

Description:

CONTAINS (W/V): 5.1% AMINO ACIDS, 0.7% ELECTROLYTES, 12.7% DEXTROSE & 3.8% LIPID. SINGLE USE.

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02440695

Product Monograph/Veterinary Labelling:

Date: 2020-07-09 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):

28

Schedule(s):

Ethical  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

40:12.00   REPLACEMENT PREPARATIONS ,  40:20.00   CALORIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

B05BA10  COMBINATIONS

Active ingredient group (AIG) number:See footnote 5

2856870001

List of active ingredient(s)
Active ingredient(s) Strength
ALANINE 0.71 G / 100 ML
ARGININE 0.61 G / 100 ML
CALCIUM CHLORIDE 0.028 G / 100 ML
DEXTROSE 12.7 G / 100 ML
FISH OIL 0.57 G / 100 ML
GLYCINE 0.56 G / 100 ML
HISTIDINE 0.15 G / 100 ML
ISOLEUCINE 0.25 G / 100 ML
LEUCINE 0.38 G / 100 ML
LYSINE (LYSINE ACETATE) 0.34 G / 100 ML
MAGNESIUM SULFATE 0.061 G / 100 ML
MEDIUM CHAIN TRIGLYCERIDES (MCT) 1.14 G / 100 ML
METHIONINE 0.22 G / 100 ML
NITROGEN 0.8 G / 100 ML
OLIVE OIL 0.95 G / 100 ML
PHENYLALANINE 0.26 G / 100 ML
POTASSIUM CHLORIDE 0.23 G / 100 ML
PROLINE 0.57 G / 100 ML
SERINE 0.33 G / 100 ML
SODIUM ACETATE TRIHYDRATE 0.17 G / 100 ML
SODIUM GLYCEROPHOSPHATE 0.21 G / 100 ML
SOYBEAN OIL 1.14 G / 100 ML
TAURINE 0.05 G / 100 ML
THREONINE 0.22 G / 100 ML
TRYPTOPHAN 0.10 G / 100 ML
TYROSINE 0.02 G / 100 ML
VALINE 0.31 G / 100 ML
ZINC SULFATE HEPTAHYDRATE 0.00066 G / 100 ML

Application information

Related information

Contact us

Version 3.8.0
Date modified: