TachoSil
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
12-05-2023
Karatteristiċi tal-prodott
(SPC)
12-05-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
12-05-2023
Ingredjent attiv:
human fibrinogen, human thrombin
Disponibbli minn:
Corza Medical GmbH
Kodiċi ATC:
B02BC30
INN (Isem Internazzjonali):
human fibrinogen, human thrombin
Grupp terapewtiku:
Antihemorrhagics
Żona terapewtika:
Hemostasis, Surgical
Indikazzjonijiet terapewtiċi:
TachoSil is indicated in adults and children from 1 month of age 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. TachoSil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).
Sommarju tal-prodott:
Revision: 25
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2004-06-08
Fuljett ta 'informazzjoni
B. PACKAGE LEAFLET
Package leaflet: Information for the user
TachoSil sealant matrix
human fibrinogen/human thrombin
Read all of this leaflet carefully before you start using this
medicine because it contains
important information for you.
-
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. See section 4.
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 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.
2.
What you need to know before TachoSil is used
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 react
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Karatteristiċi tal-prodott
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TachoSil sealant matrix
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TachoSil contains per cm
2
:
Human fibrinogen 5.5 mg
Human thrombin 2.0 IU
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sealant matrix.
TachoSil is an off-white sealant matrix. The active side of the
matrix, which is coated with fibrinogen
and thrombin, is marked by a yellow colour.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
TachoSil is indicated in adults and children from 1 month of age 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.
TachoSil is indicated in adults for supportive sealing of the dura
mater to prevent postoperative
cerebrospinal leakage following neurological surgery (see section
5.1).
4.2
Posology and method of administration
The use of TachoSil is restricted to experienced surgeons.
Posology
The quantity of TachoSil to be applied should always be oriented
towards the underlying clinical need
for the patient. The quantity of TachoSil to be applied is governed by
the size of the wound area.
Application of TachoSil must be individualised by the treating
surgeon. In clinical studies, the
individual doses have typically ranged from 1-3 units (9.5 cm x 4.8
cm); application of up to 10 units
has been reported. For smaller wounds, e.g., in minimally invasive
surgery the smaller size matrices
(4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) or the pre-rolled matrix (based
on a matrix of 4.8 cm x 4.8 cm) is
recommended.
Method of administration
For epilesional use only. Do not use intravascularly.
See section 6.6 for more detailed instructions.
4.3
Contraindications
TachoSil must not be applied intravascularly.
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4
Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medi
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