TACHOSIL

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

HUMAN FIBRINOGEN; THROMBIN

Beschikbaar vanaf:

CTS LTD

ATC-code:

B02BB01

farmaceutische vorm:

SEALANT MATRIX

Samenstelling:

THROMBIN 2 IU/CM2; HUMAN FIBRINOGEN 5.5 MG/CM2

Toedieningsweg:

TOPICAL IN SURGERY, EPILESIONAL, EPILESIONAL

Prescription-type:

Required

Geproduceerd door:

TAKEDA AUSTRIA GMBH

Therapeutische categorie:

HUMAN FIBRINOGEN

Therapeutisch gebied:

HUMAN FIBRINOGEN

therapeutische indicaties:

Tachosil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for sutute support in vascular surgery where standard techniques are insufficient.

Autorisatie datum:

2023-09-30

Bijsluiter

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
_____________ ךיראת
51.2.51
__________ םושירה רפסמו תילגנאב רישכת םש
:
TACHOSIL 139-51-31704-00
םושירה לעב םש
________
טצכ
מ"עב
__________________
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ב קרפ
ןולע
יחכונ טסקט
שדח טסקט
SPECIAL WARNINGS
AND SPECIAL
PRECAUTIONS FOR
USE
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.
For epilesional use only.
Do not use intravascularly. Life threatening
thromboembolic complications may occur if
the preparation is 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-containing 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.
To prevent the development of tissue
adhesions at undesired sites, ensure tissue
areas outside the desired application area
are adequately cleansed before
ad

Productkenmerken

1
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
TachoSil sealant matrix.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TachoSil sealant matrix 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 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The use of TachoSil is restricted to experienced surgeons.
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 trials, the individual dosages 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 minimal invasive surgery the smaller size matrices
(4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) are
recommended.
Method and route of administration
For epilesional 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.
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
For epilesional use only.
Do not use intravascularly. Life threatening thromboembolic
complications may occur if the preparation is applied
intravascularly
2
Specific data have not