Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tachosil

Document Subject

Generated Narrative: MedicinalProductDefinition mpdf6c7db31dd11bfbd41b9384e5297ec4

identifier: http://ema.europa.eu/identifier/EU/1/04/277/001-005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: TachoSil sealant matrix

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-df6c7db31dd11bfbd41b9384e5297ec4

identifier: http://ema.europa.eu/identifier/EU/1/04/277/001-005

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tachosil

Attesters

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

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 in adults and in children from 1 month of age. TachoSil is also indicated in adults in neurosurgery to support sealing of dura mater and prevent postoperative cerebrospinal leakage.

Do not use TachoSil

• if you are allergic 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 (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia, (e.g., sickle cell disease or haemolytic anaemia).

Other medicines and TachoSil Tell your doctor if you are taking, have recently taken or might take any other medicines.

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.

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. Foreign-body granuloma formation has been identified as a potential risk. 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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 after EXP . 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.

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

Corza Medical GmbH Speditionstra e 40221 D sseldorf Germany

Manufacturer

Takeda Austria GmbH
St. Peter Strasse A-4020 Linz, Austria

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: