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 Pre Market
Current status date:
2020-03-27
Original market date: See footnote 1
Product name:
ACTACEL
DIN:
02238683
Product Monograph/Veterinary Labelling:
Date:
2012-02-28
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SANOFI PASTEUR LIMITED
1755 Steeles Avenue West
Toronto
Ontario
Canada
M2R 3T4
Class:
Human
Dosage form(s):
Liquid
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
8
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07AG52 HEMOPHILUS INFLUENZAE B, COMBINATIONS WITH PERTUSSIS AND TOXOIDS
Active ingredient group (AIG) number:See footnote5
0834460003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DIPHTHERIA TOXOID | 15 LF / 0.5 ML |
| FILAMENTOUS HAEMAGGLUTININ | 5 MCG / 0.5 ML |
| FIMBRIAE | 5 MCG / 0.5 ML |
| PERTACTIN | 3 MCG / 0.5 ML |
| PERTUSSIS TOXOID | 10 MCG / 0.5 ML |
| POLYRIBOSE RIBITOL PHOSPHATE POLYSACCHARIDE (PRP) | 10 MCG / 0.5 ML |
| TETANUS PROTEIN | 30 MCG / 0.5 ML |
| TETANUS TOXOID | 5 LF / 0.5 ML |