TACHOSIL Adhesive Matrix

Introduction

Package Leaflet: Information for the User

TachoSil, Adhesive Matrix

Human Fibrinogen/Human Thrombin

Read the entire package leaflet carefully before starting to use the medicine

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience side effects, consult your doctor, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is TachoSil and what is it used for
2. What you need to know before using TachoSil
3. How to use TachoSil
4. Possible side effects
5. Storage of TachoSil
6. Package Contents and Further Information

1. What is TachoSil and what is it used for

How does TachoSil work?

The yellow side of TachoSil contains two active substances: fibrinogen and thrombin. The yellow side of TachoSil is therefore the active side. When the active side comes into contact with a fluid (e.g., blood, lymph, or saline solution), the fibrinogen and thrombin are activated and form a fibrin network. This means that TachoSil adheres to the tissue surface, the blood coagulates (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 the surfaces of internal organ tissues.

2. What you need to know before using TachoSil

Do not use TachoSil

Warnings and Precautions

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

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

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

When medicines are manufactured from human blood or plasma, certain measures are taken to prevent the transmission of infections to other patients. These measures include careful selection of blood and plasma donors to ensure the exclusion of individuals who may be carriers of infections, as well as testing of each donation and plasma pools for signs of viruses or infections. Additionally, manufacturers of these types of products include steps in the processing of blood or plasma that can inactivate or eliminate viruses. Despite these measures, when administering a medicine prepared from human blood or plasma, it is not possible to completely exclude the risk of transmission of an infection. This also applies to unknown or newly emerging viruses, or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), as well as for the non-enveloped hepatitis A virus (HAV). These measures may have a limited effect on non-enveloped viruses such as parvovirus B19. Infection with parvovirus B19 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 medicines, the name and batch number of the administered medicine should be clearly recorded.

Using TachoSil with other medicines

Tell your doctor if you are using, have recently used, or might use other medicines.

3. How to use TachoSil

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

TachoSil is made from components that contain proteins. The active substances are made from human blood. All medicines based on human blood can cause allergic reactions in rare cases. In isolated cases, these allergic reactions can lead to anaphylactic shock.

Such allergic reactions can occur especially if TachoSil is used repeatedly or if you are allergic to one of the components of the medicine.

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

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

Reporting side effects

If you experience side effects, consult your doctor, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TachoSil

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Further Information

Composition of TachoSil

• The active substances 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 and Package Contents

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

The product is available in different sizes and is packaged in packs of 5 units:

Package of 1 matrix, 9.5 cm x 4.8 cm

Package of 2 matrices, 4.8 cm x 4.8 cm

Package of 1 matrix, 3 cm x 2.5 cm

Package of 5 matrices, 3 cm x 2.5 cm

Package of 1 pre-rolled matrix, 4.8 cm x 4.8 cm

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Takeda Austria GmbH

St. Peter Strasse, 25

A-4020 Linz, Austria

Date of last revision of this package leaflet:{month YYYY}

Other sources of information

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

The package leaflet for this medicine can be found on the European Medicines Agency website in all EU/EEA languages.

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This information is intended only for healthcare professionals:

INSTRUCTIONS FOR USE

Read the following before opening the packaging:

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

• to use only intact packaging that has not been opened (it is not possible to re-sterilize).
• that a person in non-sterile conditions opens the outer aluminum covering
• that a person in sterile conditions opens the inner sterile packaging
• to use TachoSil shortly after opening the outer aluminum 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 should completely cover the wound, leaving a gap 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 should overlap. For smaller wounds, such as in minimally invasive surgery, the use of smaller sizes (4.8 x 4.8 cm or 3 x 2.5 cm) or pre-rolled TachoSil (4.8 cm x 4.8 cm) is recommended. TachoSil can be cut to the appropriate size and shaped to fit the wound.

1. Carefully clean the wound surface before placing TachoSil on it. Profuse bleeding (uninterrupted) should be surgically intervened.

1. Open the inner sterile packaging and remove the matrix. Moisten the flat surface of the TachoSil matrix with a saline solution beforehand and place it in the wound immediately after (if the wound is completely moistened by blood and other fluids, it will not be necessary to moisten the matrix before application). Pre-rolled TachoSil should not be 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 important to note that not thoroughly cleaning the adjacent tissues can cause adhesions.

1. If a trocar is used to access the wound, the inside of the trocar should be dry. It is recommended to remove the top part of the trocar before passing the pre-rolled TachoSil through the trocar.

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

1. After the specified time (3 to 5 minutes), slowly release the pressure. To ensure that TachoSil does not adhere to the glove or damp compress and thus does not separate from the wound, you can hold it by one end, for example, with the help of forceps. It is not necessary to remove any residual component, as the entire matrix dissolves (is reabsorbed).

Traceability

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