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:
2015-08-11
Original market date: See footnote 1
2015-08-11
Product name:
OCTAPLEX
Description:
HUMAN PROTHROMBIN COMPLEX. 40ML RECONSTITUTED.
DIN:
02434970
Product Monograph/Veterinary Labelling:
Date:
2024-11-21
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H
Oberlaaer Strasse 235
Vienna
Vienne
Austria
1100
Class:
Human
Dosage form(s):
Powder For Solution , Kit
Route(s) of administration:
Intravenous
Number of active ingredient(s):
6
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
20:28.16
Anatomical Therapeutic Chemical (ATC): See footnote 4
B02BD01 COAGULATION FACTOR IX, II, VII AND X IN COMB
Active ingredient group (AIG) number:See footnote5
0652205005
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| COAGULATION FACTOR II (HUMAN) | 1520 UNIT / VIAL |
| COAGULATION FACTOR IX (HUMAN) | 1000 UNIT / VIAL |
| COAGULATION FACTOR VII (HUMAN) | 960 UNIT / VIAL |
| COAGULATION FACTOR X (HUMAN) | 1200 UNIT / VIAL |
| PROTEIN C | 1240 UNIT / VIAL |
| PROTEIN S | 1280 UNIT / VIAL |