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:
Cancelled Post Market
Current status date:
2016-07-29
Original market date: See footnote 1
1987-12-31
Product name:
AMINOSYN II 8.5% INJECTION
DIN:
00742627
Product Monograph/Veterinary Labelling:
Date:
2012-06-01
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
HOSPIRA HEALTHCARE ULC
17300 Trans-Canada Highway
Kirkland
Quebec
Canada
H9J 2M5
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
1750888003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GLUTAMIC ACID | 627 MG / 100 ML |
| GLYCINE | 425 MG / 100 ML |
| HISTIDINE | 255 MG / 100 ML |
| L-ALANINE | 844 MG / 100 ML |
| L-ARGININE | 865 MG / 100 ML |
| L-ASPARTIC ACID | 595 MG / 100 ML |
| L-ISOLEUCINE | 561 MG / 100 ML |
| L-LEUCINE | 850 MG / 100 ML |
| L-LYSINE (L-LYSINE ACETATE) | 893 MG / 100 ML |
| L-PHENYLALANINE | 253 MG / 100 ML |
| L-PROLINE | 614 MG / 100 ML |
| L-THREONINE | 340 MG / 100 ML |
| L-VALINE | 425 MG / 100 ML |
| METHIONINE | 146 MG / 100 ML |
| N-ACETYL-L-TYROSINE | 230 MG / 100 ML |
| SERINE | 450 MG / 100 ML |
| TRYPTOPHAN | 170 MG / 100 ML |