TachoSil adhesive matrix

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TachoSil, adhesive matrix

Human fibrinogen/Human thrombin

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse reactions, consult your doctor, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What TachoSil is and what it is used for
2. What you need to know before using TachoSil
3. How to use TachoSil
4. Possible adverse reactions
5. How to store TachoSil
6. Contents of the pack and other information

1. What TachoSil is and what it is 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 any fluid (for example, blood, lymph, or saline solution), fibrinogen and thrombin are activated and form a fibrin network. This means that TachoSil adheres to the tissue surface, 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 tissue surfaces of internal organs in adults and children aged 1 month and older.

TachoSil is also indicated in adults for neurosurgery to promote sealing of the dura mater and prevent postoperative cerebrospinal fluid leakage.

2. What you need to know before using TachoSil

Do not use TachoSil

• if you are allergic to human fibrinogen, human thrombin, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

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

After administration of TachoSil, you may experience an allergic reaction. Symptoms may include flushing, a rash similar to hives, discomfort or tightness in the chest, 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 surrounding tissues, scar tissue may develop at the surgical site. Scar tissue may cause parts of the intestine to stick together, potentially leading to intestinal obstruction.

When medicines are manufactured from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These measures include careful selection of blood and plasma donors to exclude individuals who may carry infections, testing each donation and plasma pools for signs of viruses or infections, and including manufacturing steps that can inactivate or remove viruses. Despite these measures, it cannot be completely ruled out that administration of a medicine prepared from human blood or plasma may result in transmission of infection. This also applies to unknown or newly emerging viruses and other types of infections.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), as well as the non-enveloped hepatitis A virus (HAV). However, these measures may have limited effect against 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 certain types of anemia (such as sickle cell anemia or hemolytic anemia).

Use of TachoSil with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

3. How to use TachoSil

Your treating physician will apply TachoSil during the procedure. The amount of TachoSil used depends on the size of the lesion. The physician will place TachoSil onto the internal organ to stop bleeding or to seal the tissue. Subsequently, TachoSil will dissolve and disappear.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

TachoSil is manufactured from components containing proteins. The active substances are derived from human blood. All medicines derived from human blood may rarely cause allergic reactions. In isolated cases, these allergic reactions may progress to anaphylactic shock.

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

A clinical trial has shown that some patients develop antibodies against the components of TachoSil, although adverse effects related to antibody development have not been reported.

In some patients, scar tissue formation may occur after surgery and use of TachoSil. Intestinal obstruction and pain may also occur after abdominal surgeries. Granuloma formation due to foreign bodies has been identified as a potential risk. The frequency of such events is unknown (cannot be estimated from the available data). Your surgeon will ensure that the surgical site is thoroughly cleaned when applying TachoSil to reduce this risk.

There have been some reports of problems with product adherence/lack of efficacy. Proper handling and application of the product are required (see section 6 Instructions for use) when applying TachoSil to reduce this risk.

Reporting of adverse effects

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

5. Storage of TachoSil

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the container following "EXP". The expiry date refers to 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 and containers you no longer need. This helps protect the environment.

6. Package contents and other 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 of the product and contents of the pack

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

The product is available in different sizes and is supplied in packs containing a total of 5 units:

Pack containing 1 matrix of 9.5 cm x 4.8 cm

Pack containing 2 matrices of 4.8 cm x 4.8 cm

Pack containing 1 matrix of 3 cm x 2.5 cm

Pack containing 5 matrices of 3 cm x 2.5 cm

Pack containing 1 pre-rolled matrix of 4.8 cm x 4.8 cm

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Corza Medical GmbH
Speditionstraße 21
40221 Düsseldorf,
Germany

Manufacturer

Corza Medical Distribution GmbH, Austria Branch
St. Peter Strasse, 25
A-4020 Linz, Austria

Date of the most recent review of this leaflet:

Other sources of information

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

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

This information is intended for healthcare professionals only:

INSTRUCTIONS FOR USE

Read the following before opening the packaging:

TachoSil is supplied in sterile packaging, therefore it is important:

• to use only undamaged, unopened packaging (post-sterilization is not possible).
• that a person in non-sterile conditions opens the outer aluminium wrapping.
• that a person in sterile conditions opens the inner sterile packaging.
• to use TachoSil shortly after opening the outer aluminium wrapping.
• to use TachoSil immediately after opening the inner sterile packaging.

Instructions

Use TachoSil only under sterile conditions.

Determine the required size of TachoSil. The size of the adhesive matrix depends on the size of the wound. Note that the matrix must completely cover the wound, with a margin of 1 to 2 cm between the wound edges and the edges of the sponge. If two or more matrices are required, they should overlap. For smaller wounds, such as in minimally invasive surgery, 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) are recommended. TachoSil can be trimmed to the appropriate size and shaped to fit the wound.

1. Carefully clean the wound surface before placing TachoSil on it. Profuse (uncontrolled) bleeding must be surgically managed.

2. Open the inner sterile packaging and remove the matrix. Moisten the flat surface of the TachoSil matrix with saline solution prior to application and place it immediately onto the wound (if the wound is already thoroughly moistened by blood and other fluids, pre-moistening of the matrix is not necessary). Pre-rolled TachoSil should not be pre-moistened before passing it through the trocar or port.

3. Clean instruments, surgical gloves, and adjacent tissues, if necessary. TachoSil may adhere to instruments, surgical gloves, or adjacent tissues that are covered with blood. It is important to note that inadequate cleaning of adjacent tissues may cause adhesions.

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

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

6. After the recommended time (3 to 5 minutes), slowly release pressure. To ensure that TachoSil does not adhere to the moistened glove or compress and thus detach from the wound, it may be held at one end, for example with forceps. It is not necessary to remove any residual components, as the entire matrix dissolves (is reabsorbed). However, there have been reports of some product residue which could potentially cause a foreign body granulomatous reaction.

Traceability

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