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:
2016-08-04
Original market date: See footnote 1
2016-08-04
Product name:
PH 12 STERILE DILUENT FOR FLOLAN
DIN:
02443651
Product Monograph/Veterinary Labelling:
Date:
2024-03-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GLAXOSMITHKLINE INC
800
100 Milverton Drive
Mississauga
Ontario
Canada
L5R 4H1
Class:
Human
Dosage form(s):
Liquid
Route(s) of administration:
Intravenous
Number of active ingredient(s):
3
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
40:50.00* See footnote6
Anatomical Therapeutic Chemical (ATC): See footnote 4
V07AB SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT
Active ingredient group (AIG) number:See footnote5
0357090001
| Active ingredient(s) | Strength |
|---|---|
| GLYCINE | 94 MG / VIAL |
| SODIUM CHLORIDE | 73.3 MG / VIAL |
| WATER | 50 ML / VIAL |