Evarrest
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
03-04-2018
Produktets egenskaber
(SPC)
03-04-2018
Offentlige vurderingsrapport
(PAR)
03-04-2018
Aktiv bestanddel:
human fibrinogen, human thrombin
Tilgængelig fra:
Omrix Biopharmaceuticals N. V.
ATC-kode:
B02BC30
INN (International Name):
human fibrinogen, human thrombin
Terapeutisk gruppe:
Local hemostatics
Terapeutisk område:
Hemostasis
Terapeutiske indikationer:
Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1):- for improvement of haemostasis.
Produkt oversigt:
Revision: 4
Autorisation status:
Withdrawn
Autorisation dato:
2013-09-25
Indlægsseddel
21
B. PACKAGE LEAFLET
Medicinal product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVARREST SEALANT MATRIX
Human Fibrinogen / Human Thrombin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS USED TO
TREAT YOU, 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 EVARREST is and what it is used for
2.
What you need to know before you are treated with EVARREST
3.
How EVARREST is used
4.
Possible side effects
5.
How to store EVARREST
6.
Contents of the pack and other information
1.
WHAT EVARREST IS AND WHAT IT IS USED FOR
EVARREST is a combination product made from an absorbable material
(Matrix) coated with human
fibrinogen and human thrombin.
Fibrinogen is a protein extracted from the blood that forms a fibrin
clot when acted upon by the
enzyme thrombin. When the dry powder coating of EVARREST is wetted,
the thrombin acts on the
fibrinogen to rapidly form a clot. The fibrin clot becomes embedded in
the Matrix which enables
EVARREST to stick firmly to the surrounding tissue.
EVARREST is applied during surgical operations in adult subjects, to
stop bleeding and oozing during
the operation. It is applied directly onto tissue where it sticks
firmly and stops bleeding. It is left in
place after the operation and is absorbed by the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH EVARREST:
YOUR SURGEON MUST NOT TREAT YOU WITH EVARREST IN THE FOLLOWING
CIRCUMSTANCES:
EVARREST must not be applied inside blood vessels.
You must not be treated with EVARREST if you are allergic to human
fibr
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
EVARREST Sealant Matrix
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
Human Fibrinogen
8.1 mg/cm
2
Component 2
Human Thrombin
40 IU/cm
2
Excipient(s) with known effect:
Contains up to 3.0 mmol (68.8 mg) sodium per sealant matrix.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sealant Matrix
EVARREST is a white-to-yellow bio-absorbable combination product made
from a flexible composite
Matrix, coated with Human Fibrinogen and Human Thrombin. The active
side of the sealant matrix is
powdery, and the non-active side has an embossed wave pattern.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supportive treatment in adult surgery where standard surgical
techniques are insufficient (see section
5.1):
-
for improvement of haemostasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of EVARREST is restricted to experienced surgeons.
Posology
The amount of EVARREST to be applied and the frequency of application
should always be oriented
towards the underlying clinical needs of the patient.
The dose to be applied is governed by variables including, but not
limited to, the type of surgical
intervention, the size of the area and the mode of intended
application, and the number of applications.
The quantity of EVARREST to be applied depends upon the area and
location of the bleeding area to
be treated. EVARREST should be applied so it extends approximately 1
to 2 cm beyond the margins
of the target bleeding area. It can be cut to the size and shape
required to fit the size of the bleeding
area.
Medicinal product no longer authorised
3
Bleeding areas larger than those which can be covered by a single unit
of EVARRES
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