PACKAGE LEAFLET : INFORMATION FOR THE USER

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

In this leaflet:

1. What TachoSil is and what it is used for
2. Before TachoSil is used.
3. How to use TachoSil
4. Possible side effects
5. How to store TachoSil
6. Further information

1. WHAT TACHOSIL IS AND WHAT IT IS USED FOR

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 disappears completely.

What is TachoSil used for?
TachoSil is used during surgery to stop local bleeding (haemostasis) on internal organs.

2. 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 TachoSil.

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

Important information about some of the ingredients of TachoSil
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.

3. HOW TO USE TACHOSIL

The doctor treating you will administer TachoSil during surgery. The doctor will place the sponge on the organ to stop the bleeding. During the following time the sponge will dissolve and disappear completely.

4. POSSIBLE SIDE EFFECTS

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

TachoSil is made on the basis of human blood. All medicines based on human blood may in rare cases cause allergic reactions. In isolated cases these allergic reactions may progress to anaphylactic shock.

The above allergic reactions may especially occur 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 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

5. HOW TO STORE TACHOSIL

You will not be required to store this product.

6. FURTHER 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 and L-arginin-hydrochloride.

What TachoSil looks like and contents of the pack

TachoSil is a sponge made of collagen, which is coated on the yellow side with human fibrinogen and human thrombin.

Pack sizes
The product is available in different sizes and 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.

België/Belgique/Belgien Nycomed Belgium Chaussée de Gand 615 Gentsesteenweg B-1080 Brussels Tél/Tel: + 32 2 464 06 11	Luxembourg/Luxemburg Nycomed Belgium Chaussée de Gand 615 Gentsesteenweg B-1080 Brussels Belgique/Belgien Tél/Tel: + 32 2 464 06 11
България Nycomed Langebjerg 1 DK-4000 Roskilde Дания Teл.: + 45 46 77 11 11	Magyarország Nycomed Pharma Kft. Hermina út 17. H-1146 Budapest Tel.: +36 1 471 9930
Česká republika Nycomed s.r.o. Novodvorská 994 142 21 Praha 4 Tel: +420 239 044 244	Malta Nycomed 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 (0)1 815 0202-0
Ελλάδα Nycomed Hellas S.A. Λεωφ. Κηφισίας 196 GR-152 31 Χαλάνδρι, Αθήνα Tηλ: + 30 210 672 9570	Polska Nycomed 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	Portugal Nycomed Langebjerg 1 DK-4000 Roskilde Dinamarca Tel: + 45 46 77 11 11
France Nycomed France SAS 28 rue Pages F-92150 Suresnes Tél: + 33 1 42 04 85 50	România Nycomed România Strada Despot Vodă nr.32A, Sect.2 Bucureşti, Cod 020656-RO Tel: + 40212123848
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
Ísland Nycomed Langebjerg 1 DK-4000 Roskilde Danmörk Sími: + 45 46 77 11 11	Slovenská republika Nycomed s.r.o. Plynárenská 7B SK-821 02 Bratislava Tel: + 421 2060 2600
Italia Nycomed Italia S.r.l. Via Libero Temolo 4 I-20126 Milano Tel: +39 02 641601	Suomi/Finland Oy Leiras Finland Ab P O Box 1406 FIN-00101 Helsinki Puh/Tel: + 358 20 746 5000
Κύπρος Nycomed Langebjerg 1 DK-4000 Roskilde Δανία Tηλ: + 45 46 77 11 11	Sverige Nycomed AB Box 27264 S-102 53 Stockholm Tel: + 46 8 731 28 00
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 Gynėjų 16 LT-01109 Vilnius Tel: +370 521 09 070

This leaflet was last approved on 11/2007

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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

Use TachoSil soon after opening the outer aluminium cover.
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 that TachoSil is administered to a patient, the name and batch number of the product are recorded in the order to maintain a link between the patient and the batch of the product.

Storage of TachoSil
Do not store above 25°C.
Do not use after the expiry date stated on the label and carton.
Keep out of the reach and sight of children.