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TISSEEL [Fibrin Sealant] |
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TISSEEL consists of a two-component fibrin biomatrix that offers highly concentrated human fibrinogen to seal tissue and stop diffuse bleeding.1
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For full prescribing information, please view the package insert (pdf 105k). |
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- TISSEEL is indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature and cautery, is ineffective or impractical.
- TISSEEL is not indicated for the treatment of massive and brisk arterial or venous bleeding.
- TISSEEL has been shown to be an effective sealant as an adjunct in the closure of colostomies.
- TISSEEL is a satisfactory hemostatic agent in fully heparinized patients undergoing cardiopulmonary bypass.
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- Sealing of bleeding tissue starts with fibrin formation, the end stages of natural blood coagulation2,3
- Fibrinogen is converted to fibrin strands that join into net-like matrices2
- Tensile strength- Provides greater tensile strength- four times stronger than a high salt, non-physiologic fibrin sealant clot2,4
- The relatively high fibrinogen and relatively low thrombin concentration in TISSEEL increases the elastic properties of this fibrin sealant1,4,5
- TISSEEL has a coarse clot structure which is easier to see6
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- Manufactured using thoroughly screened plasma1
- Satisfactory for use in fully heparinized patients undergoing cardiopulmonary bypass1
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| Important Safety Information |
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Do not inject TISSEEL directly into blood vessels. Intravascular application of TISSEEL may result in life-threatening, thromboembolic events.
TISSEEL is contraindicated in individuals who are known to be hypersensitive to bovine proteins.
TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
As with any other protein products, hypersensitivity or allergic/anaphylactoid reactions may occur in very rare cases.
Especially in coronary bypass surgery, TISSEEL should be applied with caution to minimize any risk of inadvertent intravascular application. The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated.
Please see accompanying full Prescribing Information. |
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- TISSEEL [Fibrin Sealant] Full Prescribing Information, 0707074.
- Sierra D., Fibrin sealant adhesive systems: a review of their chemistry, material properties and clinical applications. Journal of Biomaterial Applications. Vol 7. 1993: 309-352.
- Carr M., Martin E., et al. Fibrin sealants. Encyclopedia of Biomaterials and Biomedical Engineering. 2004:611-620.
- Redl H, Schlag G. Properties of Different Tissue Sealants with Special Emphasis on Fibrinogen-Based Preparations. Fibrin Sealant in Operative Medicine, Otohinolaryngology. Vol 1. Berlin, Heidelberg: Springer-Verlag; 1986:27-38.
- Data on file. Baxter Healthcare Corporation
- Goessl A., Redl H. Optimized thrombin dilution protocol for a slowly setting fibrin sealant in surgery. Eur Surg (2005) 37/1: 43-51.
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TISSEEL is a trademark of Baxter International Inc. |
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