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:
2018-09-01
Original market date: See footnote 1
1995-12-31
Lot number: See footnote 2
65042JT
Expiry date: See footnote 2
2017-08-31
Product name:
AMINOSYN II
DIN:
02126745
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
1750888001
| Active ingredient(s) | Strength |
|---|---|
| GLUTAMIC ACID | 1107 MG / 100 ML |
| GLYCINE | 750 MG / 100 ML |
| HISTIDINE | 450 MG / 100 ML |
| L-ALANINE | 1490 MG / 100 ML |
| L-ARGININE | 1527 MG / 100 ML |
| L-ASPARTIC ACID | 1050 MG / 100 ML |
| L-ISOLEUCINE | 990 MG / 100 ML |
| L-LEUCINE | 1500 MG / 100 ML |
| L-LYSINE (LYSINE ACETATE) | 1575 MG / 100 ML |
| L-PHENYLALANINE | 447 MG / 100 ML |
| L-PROLINE | 1083 MG / 100 ML |
| L-THREONINE | 600 MG / 100 ML |
| L-VALINE | 750 MG / 100 ML |
| METHIONINE | 258 MG / 100 ML |
| N-ACETYL-L-TYROSINE | 405 MG / 100 ML |
| SERINE | 795 MG / 100 ML |
| TRYPTOPHAN | 300 MG / 100 ML |