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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:

2016-04-22

Original market date: See footnote 1

2011-06-20

Product name:

TISSEEL

Description:

FROZEN(SYNTHETIC APROTININ),FAST SET(500 IU)-PRE-FILLED DOUBLE-CHAMBERED SYRINGE OF SEALER PROTEIN-APROTININ SOLN AND THROMBIN-CALCIUM CHLORIDE SOLN

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02326175

Product Monograph/Veterinary Labelling:

Date: 2020-10-27 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BAXTER CORPORATION
7125 Mississauga Road
Mississauga
Ontario
Canada  L5N 0C2

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Topical

Number of active ingredient(s):

4

Schedule(s):

Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

20:28.16   HEMOSTATICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

B02BC30  COMBINATIONS

Active ingredient group (AIG) number:See footnote 5

0452577003

List of active ingredient(s)
Active ingredient(s) Strength
APROTININ (SYNTHETIC) 3000 KIU / ML
CALCIUM CHLORIDE 40 MCMOL / ML
SEALER PROTEIN (HUMAN) 125 MG / ML
THROMBIN (HUMAN) 500 UNIT / ML

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