Important Risk Information
- Do not apply Tachosil® fibrin sealant patch intravascularly. Intravascular application of Tachosil® can result in life-threatening thromboembolic events. Thrombosis can occur if Tachosil® is exposed intravascularly. Ensure that Tachosil® is applied to the surface of cardiac, vascular or hepatic tissue only.
- Do not use Tachosil® in individuals with known hypersensitivity to human blood products or horse proteins.
- Can cause hypersensitivity or allergic/anaphylactoid reactions with first-time or repetitive application.
- Avoid application to contaminated areas of the body or in the presence of active infection.
- Tachosil® contains collagen which may adhere to bleeding surface. May carry a risk of gastrointestinal obstruction in abdominal surgery due to tissue adhesions. To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the application area are adequately cleansed before administration of Tachosil®.
- Avoid packing in cavities or closed spaces because this may cause compression of underlying tissue. Use the least number of patches required to cover the entire bleeding area. Do not pack. Remove any unattached pieces of Tachosil® fibrin sealant patch.
- May carry a risk of transmitting infectious agents, such as viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent and the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission.
- The most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection and post-procedural bile leakage in hepatic surgery.
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