TachoSil medicated sponge

How does TachoSil work?
The yellow side of the TachoSil sponge contains the active components: fibrinogen and thrombin. The yellow side of the sponge is therefore the active side. When the sponge 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 sponge 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.

Do not use TachoSil

• if you are allergic (hypersensitive) to human fibrinogen, human thrombin or any of the other ingredients of TachoSil.

Take special care with TachoSil

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.

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.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The doctor treating you will administer TachoSil during surgery. The number of TachoSil sponges used depends on the size of the wound. The doctor will place the sponge on the internal organ to stop the bleeding or to seal the tissue. During the following time the sponge will dissolve and disappear completely.

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

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)

TachoSil is made on the basis of 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.

In rare cases you may produce antibodies against the active substances of TachoSil. You may experience a fever when taking TachoSil.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor

Keep out of the reach and sight of children.

Do not use TachoSil 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 medicated sponge made of collagen, which is coated on the yellow side with human fibrinogen and human thrombin.

The product is available in different sizesand comes in packages with up to 5 sponges: Package with 1 sponge of 9.5 cm x 4.8 cm
Package with 2 sponges of 4.8 cm x 4.8 cm
Package with 1 sponge of 3.0 cm x 2.5 cm
Package with 5 sponges of 3.0 cm x 2.5 cm

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Nycomed Austria GmbH
St. Peter Strasse 25
A-4020 Linz, Austria

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Nycomed Belgium Chaussée de Gand 615 Gentsesteenweg B-1080 Brussels TélTel 32 2 464 06 11 LuxembourgLuxemburg Nycomed Belgium Chaussée de Gand 615 Gentsesteenweg B-1080 Brussels BelgiqueBelgien TélTel 32 2 464 06 11

Magyarország Nycomed Pharma Kft. Népfürd u. 22. H-1138 Budapest Tel. 36 1 270 7030 Nycomed Langebjerg 1 DK-4000 Roskilde Te. 45 46 77 11 11

eská republika Nycomed s.r.o. Malta Nycomed

Novodvorská 994 142 21 Praha 4 Tel 420 239 044 244 Langebjerg 1 DK-4000 Roskilde Id-Danimarka Tel 45 46 77 11 11

Danmark Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Tlf 45 46 77 11 11 Nederland Nycomed bv Postbus 31, NL-2130AA Hoofddorp Tel 023 566 8777

Deutschland Nycomed Deutschland GmbH Moltkestr. 4 D-78467 Konstanz Tel 49 7531-36660 Norge Nycomed Pharma AS Drammensveien 852 N-1372 Asker Tlf 47 6676 3030

Eesti Nycomed SEFA AS Pirita tee 20T EE-10127 Tallinn Tel 372 6112 569 Österreich Nycomed Pharma GmbH EURO PLAZA, Gebäude F Technologiestraße 5 A-1120 Vienna Tel 43 01 815 0202-0

Nycomed Hellas S.A. . 196 GR-152 31 , T 30 210 672 9570 Polska Nycomed Pharma Sp. z o.o. Al. Jerozolimskie 146A PL 02-305 Warszawa Tel. 48 22 608 13 00

España Nycomed Pharma, S.A. Calle Alsasua 20 E-28023 Madrid Tlf 34 91 714 99 00 France Nycomed France SAS 13 rue Watt F-75013 Paris Tél 33 1 56 61 48 48 Portugal Nycomed Portugal Produtos Farmacêuticos, Lda. Quinta da Fonte Edifício Gil Eanes P 2770-192 Paço de Arcos Tel 351 214 460 200 România Nycomed Pharma România Strada Episcop Chesarie, nr.15, Corp C, city Center Bucureti, Cod 020656-RO Tel 40213350391

Ireland Nycomed Products Limited 2051 Castledrive Citywest Business Campus IRL-Dublin 24 Tel 353 1 642 0021 Slovenija Nycomed GmbH Podruznica Ljubljana Dalmatinova ulica 2 SI-1000 Ljubljana Tel 386 1 23 96 110

Slovenská republika Nycomed s.r.o. Plynárenská 7B SK-821 02 Bratislava Tel 421 2060 2600 Ísland Nycomed Langebjerg 1 DK-4000 Roskilde Danmörk Sími 45 46 77 11 11

Italia Nycomed Italia S.r.l. SuomiFinland Oy Leiras Finland Ab

Via Libero Temolo 4 I-20126 Milano Tel 39 02 641601 P O Box 1406 FIN-00101 Helsinki PuhTel 358 20 746 5000

Sverige Nycomed AB Box 27264 S-102 53 Stockholm Tel 46 8 731 28 00 Nycomed Langebjerg 1 DK-4000 Roskilde T 45 46 77 11 11

Latvija Nycomed Latvija SIA Duntes 6 LV-1013 Riga Tel 371 784 0082 United Kingdom Nycomed UK Ltd. Three Globeside Business Park Fieldhouse Lane Marlow Bucks SL7 1HZ- UK Tel 44 1628 646400

Lietuva

?Nycomed?, UAB
Gyn-j- 16
LT-01109 Vilnius
Tel: +370 521 09 070

This leaflet was last approved on {MM/YYYY}

------------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:

INSTRUCTIONS FOR USE

Read this before you open the package:
TachoSil comes in sterile packages and therefore it is important:

• only to use undamaged packages which have not been opened (post-sterilisation is not possible).
• to have a non-sterile person open the outer aluminium cover
• to have a sterile person open the inner sterile package
• to use TachoSil soon after opening the outer aluminium cover.
• to use TachoSil immediately after opening the inner sterile package.

Instructions

Use the TachoSil sponge under sterile conditions only.

Find out which sponge size is needed. The size of the sponge depends on the size of the wound. But please note that the sponge should cover 1-2 cm beyond the margins of the wound. If more than one sponge is needed, the sponges should overlap. For smaller wounds, the sponge can be cut to the appropriate size and shaped if too large.

1. Wipe the wound surface gently before placing the sponge on the wound. Strong (pulsating) bleeding should be stopped surgically.

2. Open the inner sterile package and remove the sponge. Pre-moisten the sponge in saline solution and place it on the wound immediately (if the wound is completely wetted by blood and other fluids, there is no need to moisten the sponge before application).

3. Pre-moisten surgical instruments or gloves with a saline solution, if necessary. TachoSil may stick to surgical instruments or gloves covered with blood.

4. Place the yellow,active side of the sponge against the wound. Hold down the sponge with a gentle pressure for 3-5 minutes. Use a moistened glove or a moist pad to keep the sponge in place.

5. Remove the light pressure carefully after 3-5 minutes. To make sure that the sponge does not cling to the moistened glove or swab, and loosens itself from the wound, the sponge can be held down at one end e.g. by using a pair of forceps. There is no residual product which needs to be removed, the entire sponge is dissolved (resorbed).

It is strongly recommended that every time TachoSil is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.