Product Information for the User

TachoSil, Adhesive Matrix

Human Fibrinogen/Human Thrombin

Read the entire product information carefully before starting to use the medication

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this product information.

How does TachoSil work?

The yellow side of TachoSil contains two active principles: fibrinogen and thrombin. The yellow side of TachoSil is therefore the active side.yellowside of TachoSil is therefore the active side. When the active side comes into contact with any fluid (for example, blood, lymph or a saline solution) the fibrinogen and thrombin are activated and form a fibrin network. This means that TachoSil adheres to the surface of the tissue, the blood clots (local hemostasis) and the tissue is sealed. TachoSil dissolves in the body and disappears completely.

What is TachoSil used for?

TachoSil is used during surgery to stop local bleeding (hemostasis) and to seal surfaces of internal organ tissues.

No use TachoSil

• if you are allergic (hypersensitive) to human fibrinogen, human thrombin, or any other component of this medication (listed in section 6).

Warnings and precautions

TachoSil is only for local use and should not be administered into a blood vessel. If TachoSil is administered accidentally into a blood vessel, blood clots may appear.

It is possible that, after administration of TachoSil, you may experience an allergic reaction. You may suffer from flushing, or a rash similar to urticaria, chest discomfort or tightness, wheezing, or a drop in blood pressure. You should immediately contact your doctor if any of these symptoms appear.

After abdominal surgery and if TachoSil adheres to nearby tissues, it is possible that scar tissue may develop in the operated area. Scar tissue may cause some surfaces of your intestine to adhere to each other, which can lead to intestinal obstruction.

When medications are made from human blood or plasma, certain measures are taken to prevent the transmission of infections to other patients. These measures include the careful selection of blood and plasma donors to ensure the exclusion of individuals who may be carriers of infections, as well as the testing of each donation and plasma reserves to detect possible signs of viruses or infections. Additionally, manufacturers of this type of product include steps in the processing of blood or plasma that may inactivate or eliminate viruses. Despite these measures, when administering a medication prepared from human blood or plasma, it is not possible to completely rule out the possibility of transmission of some infection. This also applies to unknown or recently emerging viruses, or other types of infections.

The measures taken are considered effective for viruses with a envelope such as the human immunodeficiency virus (HIV), the hepatitis B virus (HBV), and the hepatitis C virus (HCV), as well as for the non-enveloped hepatitis A virus (HAV). These measures may have a limited effect for non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be severe in pregnant women (fetal infection) and in individuals with weakened immune systems or those suffering from certain types of anemia (such as sickle cell anemia or hemolytic anemia).

Traceability

In order to improve the traceability of biological medications, the name and batch number of the administered medication must be clearly recorded.

Use of TachoSil with other medications

Inform your doctor if you are using, have recently used, or may need to use other medications.

The doctor treating you will apply TachoSil during the procedure. The amount of TachoSil used depends on the size of the injury. The doctor will place TachoSil over the internal organ to stop bleeding or to seal the tissue. Subsequently, TachoSil will dissolve and disappear.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

TachoSil is manufactured with components that contain proteins. The active principles are manufactured with human blood. All medications based on human blood may cause allergic reactions in rare cases. In isolated cases, these allergic reactions may lead to anaphylactic shocks.

Such allergic reactions may occur mainly if TachoSil is used repeatedly or if you are allergic to any of the medication's components.

A clinical trial has shown that some patients produce antibodies against TachoSil components, although no adverse effects have been reported due to the development of antibodies.

In some patients, scar tissue may develop after surgery and the use of TachoSil. Intestinal obstruction and pain may also occur after abdominal surgeries. The frequency of this type of event is unknown (cannot be estimated from available data). Your surgeon will ensure the surgical area is cleaned when applying TachoSil to reduce this risk.

Reporting Adverse Effects

If you experience adverse effects, consult your doctor, even if they are not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “EXP”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of TachoSil

• The active principles are human fibrinogen (5.5 mg per cm2) and human thrombin (2.0 IU per cm2).

• The other components are equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium citrate (E331), and L-arginine hydrochloride.

Appearance of the product and contents of the packaging

TachoSil is a collagen adhesive matrix covered on the yellow side with human fibrinogen and human thrombin.

The product is available in different sizes and is presented in packaging containing a total of 5 units:

Package of 1 matrix of 9.5 cm x 4.8 cm

Package of 2 matrices of 4.8 cm x 4.8 cm

Package of 1 matrix of 3 cm x 2.5 cm

Package of 5 matrices of 3 cm x 2.5 cm

Package of 1 pre-enrolled matrix of 4.8 cm x 4.8 cm

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Takeda Austria GmbH

St. Peter Strasse, 25

A-4020 Linz, Austria

Last review date of this leaflet:{month YYYY}

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

This leaflet is available on the website of the European Medicines Agency in all languages of the European Union/European Economic Area.

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This information is intended solely for medical professionals or healthcare professionals:

INSTRUCTIONS FOR USE

Read the following before opening the packaging:

TachoSil is presented in sterile packaging and it is therefore essential:

• to useonlyintact packaging that has not been opened (sterilization after opening is not possible).
• for aperson in non-sterile conditionsto open the outer aluminium covering
• for aperson in sterile conditionsto open the inner sterile packaging
• to use TachoSil shortly after opening the outer aluminium covering.
• to use TachoSil immediately after opening the inner sterile packaging.

Instructions

Use TachoSil only in sterile conditions.

Determine the size of TachoSil needed. The size of the adhesive matrix depends on the size of the wound. Note that the matrix must cover the wound completely, leaving a separation of 1 or 2 cm between the edges of the wound and the edges of the sponge. If two or more matrices are needed, they must be overlapped. For smaller wounds, for example in minimally invasive surgery, it is recommended to use smaller sizes (4.8 x 4.8 cm or 3 x 2.5 cm) or pre-enrolled TachoSil (4.8 cm x 4.8 cm). TachoSil can be cut to the required size and shaped to fit the wound.

1. Carefully clean the surface of the wound before placing TachoSil on it. Prolonged (uninterrupted) bleeding must be surgically intervened.

1. Open the inner sterile packaging and remove the matrix. Moisten the flat surface of the TachoSil matrix beforehand with a saline solution and place it on the wound immediately afterwards (if the wound is completely moistened with blood and other fluids, it will not be necessary to moisten the matrix before application). Pre-enrolled TachoSilmust notbe moistened beforehand before passing it through the trocar or port.

1. Clean the instruments, surgical gloves, and adjacent tissues, if necessary. TachoSil may adhere to instruments, surgical gloves, or adjacent tissues that are covered in blood. It is essential to note that insufficient cleaning of adjacent tissues may cause adhesions.

1. If a trocar is used to access the wound, the interior of the trocar must be dry. It is recommended to remove the top of the trocar before passing pre-enrolled TachoSil through the trocar.

1. Place theyellow active side of TachoSilon the wound. Hold TachoSil in place with gentle pressure for 3 to 5 minutes. Use a moistened glove or a damp compress to keep TachoSil in place. In minimally invasive surgery, the pre-enrolled matrix can be unrolled with the instrument at the application site. Once unrolled, TachoSil must be moistened at the application site with a damp compress and held in place with gentle pressure for 3 to 5 minutes.

1. After the indicated time (3 to 5 minutes), release the pressure slowly. To ensure that TachoSil does not adhere to the moistened glove or compress and therefore does not separate from the wound, it may be held by one end, for example with the help of a forceps. It is not necessary to remove any residual components, as the entire matrix (is absorbed).

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.