ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
TachoSil medicated sponge
Human Fibrinogen
5.5 mg
For a full list of excipients, see section 6.1.
2.0 IU
TachoSil is an off-white sponge. The active side of the sponge, which is coated with fibrinogen and
thrombin, is marked by a yellow colour.
TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis,to
promote tissue sealing, and for suture support in vascular surgery where standard techniques are
insufficient (see section 5.1).
Posology
The use of TachoSil is restricted to experienced surgeons.
The number of TachoSil sponges to be applied should always be oriented towards the underlying
clinical need for the patient. The number of TachoSil sponges to be applied is governed by the size of
the wound area.
Application of TachoSil must be individualised by the treating surgeon. In clinical trials, the individual
dosages have typically ranged from 1-3 sponges (9.5 cm x 4.8 cm); application of up to 7 sponges has
been reported. For smaller wounds, e.g. in minimal invasive surgery the smaller size sponges (4.8 cm
x 4.8 cm or 3.0 cm x 2.5 cm) are recommended.
Method and route of administration
For local use only. Do not use intravascularly.
See section 6.6 for more detailed instructions.
Paediatric patients
TachoSil is not recommended for use in children below age 18 years due to insufficient data on safety
and efficacy.
2
Human Thrombin
Hypersensitivity to the active substances or to any of the excipients.
For local use only.
Do not use intravascularly. Life threatening thromboembolic complications may occur if the
preparation is unintentionally applied intravascularly.
Specific data have not been obtained on the use of this product in neurosurgery or in gastrointestinal
anastomoses surgery.
As with any protein product, allergic type hypersensitivity reactions are possible. Signs of
hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing,
hypotension and anaphylaxis. If these symptoms occur, the administration has to be discontinued
immediately.
In case of shock, the current medical standards for shock treatment should be observed.
Standard measures to prevent infections resulting from the use of medicinal products prepared from
human blood or plasma include selection of donors, screening of individual donations and plasma
pools for specific markers of infection and the inclusion of effective manufacturing steps for the
inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or
plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and
for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped
viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal
infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic
anaemia).
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.
No formal interaction studies have been performed.
Similar to comparable products or thrombin solutions, the sealant may be denatured after exposure to
solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions). Such substances should
be removed to the greatest possible extent before applying the sealant.
The safety of TachoSil for use in human pregnancy or breastfeeding has not been established in
controlled clinical trials. Experimental animal studies are insufficient to assess the safety with respect
to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal
development.
Therefore, TachoSil should be administered to pregnant and breastfeeding women only if clearly
needed.
3
Not relevant.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the
application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension,
lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may
occur in rare cases in patients treated with fibrin sealants/haemostatics. In isolated cases, these
reactions may progress to severe anaphylaxis. Such reactions may especially be seen, if the
preparation is applied repeatedly, or administered to patients known to be hypersensitive to
constituents of the product.
Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly
(see section 4.4).
For viral safety see section 4.4
Frequency of undesirable effects for TachoSil based on all adverse event data from six clinical trials,
two post-authorisation safety studies and spontaneous reporting.
Summary of the safety profile
The safety data of TachoSil generally reflect the type of post-operative complications related to the
surgical settings in which the trials were conducted and the underlying disease of the patients.
Tabulated summary of adverse reactions
Data from the six controlled clinical trials conducted by the MAH has been pooled into an integrated
dataset and the frequencies of occurrence in this SmPC originate from this integrated dataset. In the
integrated analyses, 521 patients were treated with TachoSil and 511 patients were treated with
comparator treatment. Due to practical reasons (comparison to standard surgical and standard
haemostatic treatment), blinding was not possible in the TachoSil trials. Therefore the studies were
performed as open-label studies.
The following categories are used to rank the undesirable effects by frequency of occurrence: very
common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
<1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
Frequency
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Very rare
(<1/10,000), not
known (cannot be
estimated from the
available data)
Organ class
Immune system
disorders
Hypersensitivity
Vascular disorders
Thromboembolism
(if applied
intravascularly)
General disorders and
administration site
conditions
Pyrexia*
*Pyrexia occurred in 6.3% of the patients treated with TachoSil and in 5.9% of the patients treated
with comparator treatment.
4
No case of overdose has been reported
.
5.1. Pharmacodynamic properties
Pharmaco-therapeutic group: Local haemostatics, ATC code: B02BC30
TachoSil contains fibrinogen and thrombin as a dried coating on the surface of a collagen sponge. In
contact with physiological fluids, e.g. blood, lymph or physiological saline solution the components of
the coating dissolve and partly diffuse into the wound surface. This is followed by the fibrinogen-
thrombin reaction which initiates the last phase of physiological blood coagulation. Fibrinogen is
converted into fibrin monomers which spontaneously polymerise to a fibrin clot, which holds the
collagen sponge tightly to the wound surface. The fibrin is then cross linked by endogenous factor
XIII, creating a firm, mechanically stable network with good adhesive properties and therefore
provides sealing as well.
Clinical studies demonstrating haemostasis were conducted in a total of 240 patients (119 TachoSil,
121 argon beamer) undergoing partial liver resection surgery and 185 patients (92 TachoSil, 93
standard surgical treatment) undergoing surgical resection of superficial renal tumour. A further
controlled study in 119 patients (62 TachoSil, 57 haemostatic fleece) demonstrated sealing,
haemostasis and suture support in patients undergoing cardiovascular surgery. Tissue sealing in lung
surgery was investigated in two controlled trials in patients undergoing lung surgery. The first
controlled clinical trial investigating tissue sealing in lung surgery failed to document superiority over
standard treatment measured by air leakage due to the inclusion of a large group of patients (53%)
without air leakage. However, the second study investigating tissue sealing in 299 patients (149
TachoSil, 150 standard surgical treatment) with demonstrated intraoperative air leakage showed the
superiority of TachoSil compared to standard treatment.
5.2. Pharmacokinetic properties
TachoSil is intended for local application only. Intravascular administration is not possible.
As a consequence, intravascular pharmacokinetic studies were not performed in man.
In animal studies TachoSil shows a progressive biodegradation. The fibrin clot is metabolised in the
same way as endogenous fibrin by fibrinolysis and phagocytosis. The collagen sponge is degraded by
resorptive granulation tissue. Approximately 24 weeks after application only a few remnants were
present without any signs of local irritation.
5.3 Preclinical safety data
Single dose toxicity studies in different species of animals have shown no signs of acute toxic effect.
6
6.1 List of excipients
Equine collagen
Human albumin
Riboflavine (E 101)
Sodium chloride
Sodium citrate (E331)
L-arginine-hydrochloride.
5
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
Once the foil sachet is opened, TachoSil must be used immediately.
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
Each sponge is packed in a PET-GAG blister sealed with a coated PE foil. The blister is packed in an
aluminium-bonded foil sachet with a desiccant bag included and packed in a folding carton.
Pack sizes:
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.
6.6 Special precautions for disposal and other handling
TachoSil comes ready to use in sterile packages and must be handled accordingly. Use only
undamaged packages. Once the package is opened post-sterilisation is not possible. The outer
aluminium foil sachet may be opened in a non-sterile operating area. The inner sterile blister must be
opened in a sterile operating room area. TachoSil should be used immediately after opening the inner
sterile cover.
Pressure is applied with moistened gloves or a moist pad. Due to the strong affinity of collagen to
blood, TachoSil may also stick to surgical instruments or gloves covered with blood. This can be
avoided by pre-moistening surgical instruments and gloves with physiological saline solution. After
pressing TachoSil to the wound, the glove or the pad must be removed carefully. To avoid the sponge
from being pulled loose it may be held in place at one end, e.g. with a pair of forceps.
Alternatively, e.g. in case of stronger bleeding, TachoSil may be applied without pre-moistening,
while also pressing gently to the wound for 3-5 minutes.
The TachoSil sponge should be applied so that it extends 1-2 cm beyond the margins of the wound. If
more than one sponge is used the sponges should overlap. The sponge can be cut to the correct size
and shaped if too large.
Any unused product or waste material should be disposed of in accordance with local requirements.
7
6
TachoSil is used under sterile conditions. Prior to application the wound area should be cleansed, e.g.
from blood, disinfectants and other fluids.
After removal of TachoSil from the sterile package the
sponge should be pre-moistened in saline solution and then applied immediately. The yellow, active
side of the sponge is applied to the bleeding/leaking surface and held against it with a gentle pressure
for 3-5 minutes. This procedure enables an easy adhesion of TachoSil to the wound surface.
Nycomed Austria GmbH
St. Peter Strasse 25
A-4020 Linz
Austria
8
EU/1/04/277/001-004
9
Date of first authorisation: 8 June 2004
Date of latest renewal: 8 June 2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu/
7
ANNEX II
A.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE
SUBSTANCES AND MANUFACTURING
AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
8
A
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturers of the biological active substances
CSL Behring GmbH
P.O. Box 1230
D-35002 Marburg/Lahn
Germany
Name and address of the manufacturer responsible for batch release
Nycomed Austria GmbH
St. Peter Strasse 25
A-4020 Linz
Austria
B
CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Characteristics, section 4.2)
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented
in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP
agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the
updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
In addition, an updated RMP should be submitted
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reached
•
At the request of the EMEA
Official batch release: in accordance with Article 114 of Directive 2001/83/EC as amended, the
official batch release will be undertaken by a state laboratory or a laboratory designated for that
purpose.
9
ANNEX III
LABELLING AND PACKAGE LEAFLET
10
A
LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.
TachoSil
,
medicated sponge
Human fibrinogen/Human thrombin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each sponge contains per cm
2
Human fibrinogen 5.5 mg
Human thrombin 2.0 IU
3.
LIST OF EXCIPIENTS
Equine collagen, human albumin, riboflavine (E101), sodium chloride, sodium citrate (E331), L-
arginine-hydrochloride
4.
Medicated sponge
1 sponge of 9.5 cm x 4.8 cm
2 sponges of 4.8 cm x 4.8 cm
1 sponge of 3.0 cm x 2.5 cm
5 sponges of 3.0 cm x 2.5 cm
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For local use.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Once the foil sachet is opened, use immediately. Do not resterilise.
8.
EXPIRY DATE
EXP {MM/YYYY}
9.
SPECIAL STORAGE CONDITIONS
12
Do not store above 25°C
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Any unused product or waste material should be disposed of in accordance with local requirements.
NYCOMED Austria GmbH
St.Peter Strasse 25
A- 4020 Linz, Austria
EU/1/04/277/001 1 sponge of 9.5 cm x 4.8 cm
EU/1/04/277/002 2 sponges of 4.8 cm x 4.8 cm
EU/1/04/277/003 1 sponge of 3.0 cm x 2.5 cm
EU/1/04/277/004 5 sponges of 3.0 cm x 2.5 cm
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
ALUMINIUM-BONDED FOIL SACHET
1.
TachoSil, medicated sponge
Human fibrinogen/Human thrombin
For local use
2.
METHOD OF ADMINISTRATION
Read the package leaflet before use
3.
EXPIRY DATE
EXP {MM/YYYY}
4.
BATCH NUMBER
Batch
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
1 sponge of 9.5 cm x 4.8 cm
1 sponge of 4.8 cm x 4.8 cm
1 sponge of 3.0 cm x 2.5 cm
6.
OTHER
14
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
POLYETHYLENE TEREPHTHALATE BLISTER
1.
TachoSil
2.
NYCOMED
3.
EXPIRY DATE
EXP {MM/YYYY}
4.
BATCH NUMBER
Batch
5.
OTHER
15
B. PACKAGE LEAFLET
16
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 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 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.
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.
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
17
-
If you have any further questions, ask your doctor.
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.
3.
HOW TO USE TACHOSIL
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.
4.
POSSIBLE SIDE EFFECTS
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
5.
HOW TO STORE TACHOSIL
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.
18
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.
6.
FURTHER INFORMATION
What TachoSil contains
-
The active substances are human fibrinogen (5.5 mg per cm
2
) and human thrombin (2.0 IU per
cm
2
).
-
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:
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.
Népfürdő u. 22.
H-1138 Budapest
Tel.: +36 1 270 7030
Česká republika
Nycomed s.r.o.
Malta
Nycomed
19
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 (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 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
Portugal
Nycomed Portugal – Produtos Farmacêuticos, Lda.
Quinta da Fonte – Edifício Gil Eanes
P – 2770-192 Paço de Arcos
Tel: + 351 214 460 200
France
Nycomed France SAS
13 rue Watt
F-75013 Paris
Tél: + 33 1 56 61 48 48
România
Nycomed Pharma România
Strada Episcop Chesarie, nr.15, Corp C, city Center
Bucureşti, 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
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.
Suomi/Finland
Oy Leiras Finland Ab
20
Via Libero Temolo 4
I-20126 Milano
Tel: +39 02 641601
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 {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.
21
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.
22
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/tachosil.html
Copyright © 1995-2021 ITA all rights reserved.