*Available in a pre-filled,
pre-mixed syringe.
TISSEEL Important Risk Information
For Topical Use Only. Do not inject TISSEEL directly into the circulatory system. Intravascular application of TISSEEL may result in life-threatening thromboembolic events. Caution should be exercised to minimize any risk of inadvertent intravascular application.
Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
Do not use TISSEEL for the treatment of severe or brisk arterial bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.
Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Symptoms associated with allergic reactions include: flush, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnea, severe hypotension and anaphylactic shock. Such reactions may also occur in patients receiving TISSEEL for the first time.
Discontinue administration of TISSEEL in the event of hypersensitivity reactions.
Apply as a thin layer. Excessive clot thickness may negatively interfere with the product?s efficacy and the wound healing process.
Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. This event appears to be related to use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.
When applying fibrin sealants using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer.
Exposure to solutions containing alcohol, iodine or heavy metals may cause TISSEEL to be denatured. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.
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; its use in this setting is not FDA approved.
There have been reports of serious adverse events such as paralysis and other compressive complications possibly related to the use of fibrin sealant in combination with resorbable hemostatic agents.
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.
Please see accompanying full Prescribing Information.
