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:
Marketed
Current status date:
2014-12-19
Original market date: See footnote 1
1997-11-14
Product name:
PRIMENE 10%
Description:
AMINO ACID INJECTION
DIN:
02236875
Product Monograph/Veterinary Labelling:
Date:
2019-12-23
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BAXTER CORPORATION
7125 Mississauga Road
Mississauga
Ontario
Canada
L5N 0C2
Class:
Human
Dosage form(s):
Liquid
Route(s) of administration:
Intravenous
Number of active ingredient(s):
20
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
2050895002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GLUTAMIC ACID | 1 G / 100 ML |
| GLYCINE | 400 MG / 100 ML |
| HISTIDINE | 380 MG / 100 ML |
| L-ALANINE | 800 MG / 100 ML |
| L-ARGININE | 840 MG / 100 ML |
| L-ASPARTIC ACID | 600 MG / 100 ML |
| L-CYSTEINE | 189 MG / 100 ML |
| L-ISOLEUCINE | 670 MG / 100 ML |
| L-LEUCINE | 1 G / 100 ML |
| L-LYSINE | 1.1 G / 100 ML |
| L-ORNITHINE DIHYDROCHLORIDE | 318 MG / 100 ML |
| L-PHENYLALANINE | 420 MG / 100 ML |
| L-PROLINE | 300 MG / 100 ML |
| L-THREONINE | 370 MG / 100 ML |
| L-TYROSINE | 45 MG / 100 ML |
| L-VALINE | 760 MG / 100 ML |
| METHIONINE | 240 MG / 100 ML |
| SERINE | 400 MG / 100 ML |
| TAURINE | 60 MG / 100 ML |
| TRYPTOPHAN | 200 MG / 100 ML |