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:

Dormant

Current status date:

2018-08-07

Original market date: See footnote 1

1987-12-31

Product name:

AMINOSYN II

Description:

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:

00742619

Product Monograph/Veterinary Labelling:

Date: 2017-12-21 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ICU MEDICAL CANADA INC
2600 Boul Alfred-Nobel, Suite 100
Saint Laurent
Quebec
Canada H4S 0A9

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

17

Schedule(s):

Ethical

 

American Hospital Formulary Service (AHFS): See footnote 3

40:20.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B05BA01 AMINO ACIDS

Active ingredient group (AIG) number:See footnote5

1750888002

List of active ingredient(s)
Active ingredient(s) Strength
GLUTAMIC ACID 738 MG / 100 ML
GLYCINE 500 MG / 100 ML
HISTIDINE 300 MG / 100 ML
L-ALANINE 993 MG / 100 ML
L-ARGININE 1018 MG / 100 ML
L-ASPARTIC ACID 700 MG / 100 ML
L-ISOLEUCINE 660 MG / 100 ML
L-LEUCINE 1000 MG / 100 ML
L-LYSINE (L-LYSINE ACETATE) 1050 MG / 100 ML
L-PHENYLALANINE 298 MG / 100 ML
L-PROLINE 722 MG / 100 ML
L-THREONINE 400 MG / 100 ML
L-VALINE 500 MG / 100 ML
METHIONINE 172 MG / 100 ML
N-ACETYL-L-TYROSINE 270 MG / 100 ML
SERINE 530 MG / 100 ML
TRYPTOPHAN 200 MG / 100 ML
Version 4.0.2
Date modified: