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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:

2017-02-14

Original market date: See footnote 1

2017-02-14

Product name:

SMOFKABIVEN PERIPHERAL

Description:

AMINO ACIDS WITH ELECTROLYTES (3.2% & 0.4%); DEXTROSE 7.1% ; LIPIDS 2.8%

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:

02456206

Product Monograph/Veterinary Labelling:

Date: 2016-07-04 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):

27

Schedule(s):

Ethical  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

92:92.00   OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

V06DX  OTHER COMBINATIONS OF NUTRIENTS

Active ingredient group (AIG) number:See footnote 5

2758251001

List of active ingredient(s)
Active ingredient(s) Strength
ALANINE 440 MG / 100 ML
ARGININE 380 MG / 100 ML
CALCIUM CHLORIDE 18 MG / 100 ML
DEXTROSE 7.1 G / 100 ML
FISH OIL 420 MG / 100 ML
GLYCINE 350 MG / 100 ML
HISTIDINE 93 MG / 100 ML
ISOLEUCINE 160 MG / 100 ML
LEUCINE 230 MG / 100 ML
LYSINE (LYSINE ACETATE) 210 MG / 100 ML
MAGNESIUM SULFATE 38 MG / 100 ML
MEDIUM CHAIN TRIGLYCERIDES (MCT) 850 MG / 100 ML
METHIONINE 130 MG / 100 ML
OLIVE OIL 700 MG / 100 ML
PHENYLALANINE 160 MG / 100 ML
POTASSIUM CHLORIDE 140 MG / 100 ML
PROLINE 350 MG / 100 ML
SERINE 210 MG / 100 ML
SODIUM ACETATE TRIHYDRATE 110 MG / 100 ML
SODIUM GLYCEROPHOSPHATE 130 MG / 100 ML
SOYBEAN OIL 850 MG / 100 ML
TAURINE 32 MG / 100 ML
THREONINE 140 MG / 100 ML
TRYPTOPHAN 63 MG / 100 ML
TYROSINE 12 MG / 100 ML
VALINE 200 MG / 100 ML
ZINC SULFATE HEPTAHYDRATE 0.4 MG / 100 ML

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