TachoSil sealant matrix

Country: European Union

Language: English

Source: myHealthbox

Active ingredient:

Human fibrinogen / human thrombin

Available from:

Takeda Austria GmbH

ATC code:

B02BC30

INN (International Name):

Human fibrinogen / human thrombin

Dosage:

5.5 mg Human Fibrinogen and 2.0 IU Human Thrombin per cm²

Pharmaceutical form:

Sealant matrix

Administration route:

For epilesional use only. Do not use intravascularly

Units in package:

1 of 9.5 cm x 4.8 cm, 2 of 4.8 cm x 4.8 cm, 1 of 3.0 cm x 2.5 cm, 5 of 3.0 cm x 2.5 cm,1 pre-rolled matrix of 4.8 cm x 4.8 cm

Prescription type:

The use of TachoSil is restricted to experienced surgeons

Manufactured by:

Takeda Austria GmbH

Therapeutic group:

Local haemostatics

Therapeutic area:

Hemostasis, Surgical

Therapeutic indications:

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

Authorization status:

Authorized

Authorization date:

2004-06-08

Patient Information leaflet

17
PACKAGE LEAFLET: INFORMATION FOR THE USER
TACHOSIL SEALANT MATRIX
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 you get any side effects talk to your doctor. This includes any
possible side effects not listed in this 
leaflet.
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.
2.
WHAT YOU NEED TO KNOW 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 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 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 s

Summary of Product characteristics

2
1.
NAME OF THE MEDICINAL PRODUCT
TachoSil sealant matrix
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TachoSil contains per cm2:
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 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 7 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 and route of administration_
For epilesional use only. Do not use intravascularly.
See section 6.6 for more detailed instructions.

3
_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 intrava