Takeda Products Ireland Ltd
TachoSil sealant matrix
Package leaflet: Information for the user
TachoSil sealant matrix
Human fibrinogen/Human thrombin
Read all of this leaflet carefully.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What TachoSil is and what it is used for
2. What you need to know before TachoSil is used.
3. How to use TachoSil
4. Possible side effects
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 the active components: fibrinogen and thrombin. The yellow side of TachoSil is therefore the active side. When the active side comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the thrombin are activated and form a fibrin network. This means that the TachoSil sticks to the tissue surface, the blood coagulates (local haemostasis) and the tissue is sealed. In the body TachoSil will dissolve and disappear completely.
What is TachoSil used for?
TachoSil is used during surgery to stop local bleeding (haemostasis) and to seal tissue surfaces on internal organs.
2. What you need to know before TachoSil is used
Do not use TachoSil
- if you are allergic (hypersensitive) to human fibrinogen, human thrombin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
TachoSil is for local use only and should not be applied inside a blood vessel. Blood clots may occur if TachoSil is unintentionally applied inside a blood vessel.
It is possible that you could suffer an allergic reaction after TachoSil has been applied. You may suffer hives, or a rash similar to nettle rash, chest discomfort or tightness, wheezing or low blood pressure. You should contact your doctor immediately if you discover any of these symptoms.
After abdominal surgery and if TachoSil sticks to nearby tissues, it is possible that scar tissues can develop in the operated area. Scar tissues can cause surfaces in your bowel to stick together, which can lead to blockage of the bowel.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to the patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or 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 and hepatitis C virus, and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant woman (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia, (e.g. sickle cell disease or haemolytic anaemia).
It is strongly recommended that when you receive TachoSil the name and batch number of the product are recorded at the hospital in order to maintain a record of the batches used.
Other medicines and TachoSil
Tell your doctor if you are taking, have recently taken or might take any other medicines.
3. How to use TachoSil
The doctor treating you will apply TachoSil during surgery. The quantity of TachoSil used depends on the size of the wound. The doctor will place TachoSil on the internal organ to stop the bleeding or to seal the tissue. During the following time 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 of protein-containing components. The active components are made from human blood. All medicines based on human blood may uncommonly cause allergic reactions. In isolated cases these allergic reactions may progress to anaphylactic shock.
These allergic reactions may occur especially if TachoSil is used repeatedly or if you are allergic to any of the ingredients in TachoSil.
A clinical study has shown that some patients produced antibodies against the components of TachoSil, however, no side effects were reported resulting from the development of these antibodies.
Scar tissues may develop in some patients after surgery and use of TachoSil. Bowel obstruction and pain following abdominal surgeries can also occur. The frequency of these types of events is not known (cannot be estimated from available data). Your surgeon will make sure to clean the operating area when applying TachoSil to reduce this risk.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
Ireland
United Kingdom
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store TachoSil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What TachoSil contains
- The active substances are human fibrinogen (5.5 mg per cm2) and human thrombin (2.0 IU per cm2).
- The other ingredients are equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium citrate (E331) and L-arginine-hydrochloride.
What TachoSil looks like and contents of the pack
TachoSil is a sealant matrix made of collagen, which is coated on the yellow side with human fibrinogen and human thrombin.
The product is available in different sizes and comes in packages with up to 5 units:
Package with 1 matrix of 9.5 cm x 4.8 cm
Package with 2 matrices of 4.8 cm x 4.8 cm
Package with 1 matrix of 3.0 cm x 2.5 cm
Package with 5 matrices of 3.0 cm x 2.5 cm
Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: