This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is TachoSil?

TachoSil is a sponge that is coated with the active substances human fibrinogen and human thrombin.

What is TachoSil used for?

TachoSil is used during an operation to stop bleeding and to seal the surfaces of internal organs. TachoSil also acts as a support to stitching during surgery on the blood vessels. TachoSil is used in adults, when standard techniques are not sufficient.

The medicine can only be obtained with a prescription.

How is TachoSil used?

TachoSil should only be used by an experienced surgeon under sterile conditions.

TachoSil should only be applied directly onto the treatment site. The sponge should be applied so that it covers 1 to 2 cm beyond the edge of the wound. The number of TachoSil sponges used depends on the size of the wound. In studies, one to three sponges were usually used (9.5 × 4.8 cm), although up to seven sponges were used in some cases. For smaller wounds, the smaller sponges are recommended (4.8 × 4.8 cm or 3.0 × 2.5 cm). Sponges can be cut to size if needed. TachoSil must not be applied inside a blood vessel.

How does TachoSil work?

TachoSil consists of a sponge made out of collagen, with fibrinogen and thrombin as a dried coating on one surface. Thrombin and fibrinogen are natural substances that are obtained from human blood. On contact with fluid such as blood, the coating on the sponge that contains the active substances dissolves. This activates the fibrinogen and thrombin, causing the fibrinogen to be converted into the protein fibrin. This forms a clot that holds the collagen sponge tightly to the wound surface, preventing bleeding and sealing the tissue. The sponge is left in the body, where it dissolves and disappears completely.

How has TachoSil been studied?

TachoSil has been studied in six studies:

• Two of the studies looked at the effects of TachoSil in stopping bleeding. The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in a total of 240 adults having liver surgery. The main measure of effectiveness was the time until the blood stopped flowing. A third study compared TachoSil with standard stitching in 185 patients having kidney surgery.
• Two studies were carried out to see if TachoSil could be used as a tissue sealant. The studies compared TachoSil and standard surgical techniques such as stitching and stapling in a total of 490 patients having lung surgery. Effectiveness was measured by looking at whether air leaked from the lungs after surgery.
• The final study looked at the effectiveness of TachoSil in surgery on the heart or major blood vessels. The study compared TachoSil with standard materials to aid clotting in 120 patients, around three-quarters of whom also had stitches to help stop the bleeding. The main measure of effectiveness was the number of patients whose bleeding had stopped after three minutes.

What benefit has TachoSil shown during the studies?

TachoSil was more effective than the argon beamer at stopping blood flow during liver surgery. In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively. TachoSil was more effective than stitching in the kidney surgery patients.

The first study looking at lung surgery patients was not sufficient to support the use of TachoSil in sealing tissue, because very few patients in the study had any air leakage. However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with standard techniques.

TachoSil was also more effective than standard materials at stopping bleeding during surgery on the heart or blood vessels. After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).

What is the risk associated with TachoSil?

Thromboembolic complications (blood clots) may occur if TachoSil is unintentionally applied inside a blood vessel. As for other sealants, TachoSil may cause an allergic reaction. In rare cases, patients may also develop antibodies to the proteins in TachoSil, which could interfere with blood clotting.

The most common side effect with TachoSil (seen in between 1 and 10 patients in 100) is pyrexia (fever). For the full list of all side effects reported with TachoSil, see the Package Leaflet.

TachoSil should not be used in people who may be hypersensitive (allergic) to fibrinogen, thrombin or any of the other ingredients.

TachoSil has not been studied in neurosurgery (surgery on the nervous system, including the brain) or surgery to connect up two sections of the gut, such as a stomach bypass.

Why has TachoSil been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that TachoSil’s benefits are greater than its risks for supportive treatment in surgery for the improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. The Committee recommended that TachoSil be given marketing authorisation.

Other information about TachoSil

The European Commission granted a marketing authorisation valid throughout the European Union for TachoSil to Nycomed Austria GmbH on 8 June 2004. The marketing authorisation was renewed on 8 June 2009.

This EPAR was last updated on 11/08/2011 .

More detail is available in the Summary of Product Characteristics

Product details

Publication details

Product information

25/07/2011  TachoSil -EMEA/H/C/000505 -N/0033

Contents

• Annex I - Summary of product Characteristics
• Annex IIA - Manufacturing Authorisation Holder responsible for Batch Release
• Annex IIB - Conditions of the Marketing Authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package Leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmaco-therapeutic Group

Antihemorrhagics

Therapeutic Indication

TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis,to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient.

Changes since initial authorisation of medicine

Initial Marketing authorisation documents