Tachosil Fibrin Sealant Patch

Indications and Detailed Important Risk Information

TachoSil® Fibrin Sealant Patch

Indications and Usage

Indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. Not for use in children under one month of age.

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® Fibrin Sealant Patch 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® Fibrin Sealant Patch contains collagen which may adhere to bleeding surfaces. 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 over-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.

Baxter is a registered trademark of Baxter International Inc.
Tachosil and the Tachosil logo are registered trademarks of Takeda AS, and are used under license. All rights reserved. USBS/421/14-0003(1)a(1) 4/2017

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