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 Cardiovascular Surgery?

Watch examples of TISSEEL application over broad, oozing cardiac surfaces

Mammary Bed

Epicardium
  • Clinically proven efficacy in challenging cardiovascular reoperations1,2
    • Data reflects an earlier formulation of TISSEEL
  • Effective in fully heparinized patients undergoing cardiopulmonary bypass2
  • Spray application option for even distribution across broad surfaces
  • Pre-filled syringe eliminates mixing and reconstitution

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 occur1
  • Do not use in individuals with a known hypersensitivity to aprotinin. Apply only as a thin layer1
  • Do not use for the treatment of severe or brisk arterial or venous bleeding1
  • 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 supply1

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References:

  1. TISSEEL [Fibrin Sealant] full Prescribing Information, 10/2010.
  2. Rousou J, Gonzalez-Lavin L, Cosgrove D, et al. Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. J Thorac Cardiovasc Surg. 1989;97:194-203.