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TACHOSIL® Fibrin Sealant Patch

TACHOSIL® Patch helps control mild to moderate intraoperative bleeding in cardiovascular and hepatic tissue. It combines the effectiveness of a fibrin sealant in the convenience of a surgical patch to provide targeted bleeding coverage.
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Tachosil Product

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. Please see accompanying full Prescribing Information

Proven and Effective in Cardiovascular Surgery

In cardiovascular surgery, bleeding was controlled at 3 minutes in approximately 75% of patients with TachoSil® Patch.

The ability of TachoSil® Patch to control bleeding in cardiovascular surgery was evaluated in an open-label, 1:1 randomized, parallel-group study comparing TachoSil® Patch with a comparator treatment.* ITT population = 119 patients. The most common ARs in the TachoSil® Patch (N=62) vs. comparator (N=57) groups, respectively, of the CV trial were atrial fi brillation (29% vs. 25%), pleural effusion (23% vs. 19%) and pyrexia (6% vs. 5%).

 

Proven and Effective in Hepatic Surgery

In hepatic surgery, bleeding was controlled at 3 minutes in approximately 81% of patients with TachoSil® Patch.

The ability of TachoSil® Patch to control bleeding in hepatic resection surgery was evaluated in a randomized, open label, parallel-group, multi-center trial to compare the efficacy and safety of TachoSil® Patch versus a comparator treatment.* ITT population = 224 patients. The most common ARs in the TachoSil® Patch (N=114) vs. comparator (N=109) groups, respectively, of the hepatic resection trial were nausea (30% vs. 27%) and anemia (23% vs. 21%).

 

Mechanism of Action

TachoSil® Patch harnesses the efficacy of a fibrin sealant in the convenience of a surgical patch for targeted bleeding coverage. The coating of active biological ingredients fibrinogen and thrombin on one side of the collagen patch promote hemostasis by triggering the last stage of the coagulation cascade to create a fibrin clot

Additional Product Benefits

Ready to use

  • No mixing
  • No thawing
  • No refrigeration
  • No special apparatus

Conformable

  • Maintains flexibility that accommodates tissue and organ movement
  • Can be cut to size and shape of wound
  • Wet or dry field application

Staying power

  • High adhesive strength shown to withstand pressures up to 61.4 hPa (46.1 mmHg)1
  • Does not have to be removed
  • TachoSil® Patch was applied to swine liver wounds and showed progressive degradation. Remnants of the patch may remain present up to 12 months*

 

*Preclinical results may not correlate with results in humans.

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® 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.

 

TachoSil and the TachoSil logo are registered trademarks of Takeda AS, and are used under license.