Prescribing Information Important Risk Information

TISSEEL [Fibrin Sealant] Indications

Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of blunt or penetrating splenic injuries when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical. TISSEEL is a hemostatic agent that may be used in fully heparinized patients undergoing cardiopulmonary bypass.

Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Why TISSEEL in Colonic Anastomosis?

In a prospective, single-center, randomized trial TISSEEL was shown to be an effective tool for sealing colonic
anastomoses and for reducing the incidence of intra-abdominal abscesses and re-operation
following the closure of temporary colostomies.1

Watch an example of laparoscopic TISSEEL application to prevent colonic anastomosis leakage following the reversal of temporary colostomy

   Laparoscopic Procedure

 

TISSEEL provides leakage prevention through reinforcement

TISSEEL provides leakage prevention through reinforcement

Clinical Studies

Selected Important Risk Information for TISSEEL [Fibrin Sealant]

  • Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue; thromboembolic events can occur2
  • Do not use in individuals with a known hypersensitivity to aprotinin. Apply only as a thin layer2
  • Do not use for the treatment of severe or brisk arterial or venous bleeding2
  • Air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants. To achieve an optimal result, a spraying distance of 10-15 cm is recommended. DO NOT connect the spray set directly to the pressurized gas supply2

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References:

  1. Data on File, Baxter Healthcare Corporation.
  2. TISSEEL [Fibrin Sealant] full Prescribing Information, 10/2010.