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:

2016-12-13

Original market date: See footnote 1

2011-12-18

Product name:

ARTISS

Description:

FROZEN(SYNTHETIC APROTININ),SLOW SET(4IU)-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:

02326167

Product Monograph/Veterinary Labelling:

Date: 2022-01-28 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

 

American Hospital Formulary Service (AHFS): See footnote 3

20:28.16 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B02BC30 COMBINATIONS

Active ingredient group (AIG) number:See footnote5

0452577004

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) 4 UNIT / ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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