VeraSeal
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
12-01-2023
Charakterystyka produktu
(SPC)
12-01-2023
Sprawozdanie z oceny publicznego
(PAR)
03-02-2020
Składnik aktywny:
human fibrinogen, human thrombin
Dostępny od:
Instituto Grifols, S.A.
Kod ATC:
B02BC
INN (International Nazwa):
human fibrinogen, human thrombin
Grupa terapeutyczna:
Antihemorrhagics
Dziedzina terapeutyczna:
Hemostasis, Surgical
Wskazania:
Supportive treatment in adults where standard surgical techniques are insufficient:for improvement of haemostasisas suture support in vascular surgery
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Authorised
Data autoryzacji:
2017-11-10
Ulotka dla pacjenta
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERASEAL SOLUTIONS FOR SEALANT
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 VeraSeal is and what it is used for
2.
What you need to know before you are treated with VeraSeal
3.
How VeraSeal is used
4.
Possible side effects
5.
How VeraSeal is stored
6.
Contents of the pack and other information
1.
WHAT VERASEAL IS AND WHAT IT IS USED FOR
VeraSeal contains human fibrinogen and human thrombin, two proteins
extracted from the blood that
form a clot when they are mixed together.
VeraSeal is used as a sealant during surgical operations in adults. It
is applied to the surface of
bleeding tissue to reduce bleeding during and after the operation when
standard surgical techniques are
not sufficient.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH VERASEAL
_ _
YOUR SURGEON MUST NOT TREAT YOU WITH VERASEAL
-
if you are allergic to human fibrinogen or human thrombin or any of
the other ingredients of this
medicine (listed in section 6).
VeraSeal must not be applied inside blood vessels.
VeraSeal must not be used to treat severe or rapid bleeding from an
artery.
WARNINGS AND PRECAUTIONS
Allergic reactions are possible. Signs of such reactions include
hives, rash, tightness of the chest,
wheezing, drop in blood pressure (e.g. light-headedness, fainting,
blurred vision), and anaphylaxis (a
severe reaction with a rapid onset). If these symptoms occur during
surgery, the use of the medicine
should be stopped immediately.
VeraSeal spray application should only be used if it is possible to
accurately judge the spray distance.
The spray device should not be used closer than the recommend
Przeczytaj cały dokument
Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VeraSeal solutions for sealant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
Human fibrinogen
80 mg/ml
Component 2:
Human thrombin
500 IU/ml
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solutions for sealant.
Frozen solutions. After thawing, the solutions are clear or slightly
opalescent and colourless or pale
yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supportive treatment in adults where standard surgical techniques are
insufficient:
- for improvement of haemostasis.
- as suture support: in vascular surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of VeraSeal is restricted to experienced surgeons who have
been trained in the use of this
medicinal product.
Posology
The volume of VeraSeal to be applied and the frequency of application
should always be oriented
towards the underlying clinical needs for 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.
Application of the product must be individualised by the treating
physician. In clinical trials, the
individual doses have typically ranged from 0.3 to 12 ml. For other
procedures, larger volumes may be
required.
3
The initial volume of the product to be applied at a chosen anatomic
site or target surface area should
be sufficient to entirely cover the intended application area. The
application can be repeated, if
necessary.
_Paediatric population _
The safety and efficacy of VeraSeal in children aged 0 to 18 years has
not yet been established.
Currently available data are described in section 5.1, but no
recommendation on a posology can be
made.
Method of administration
For epilesional use.
For instructions on preparation of the medicinal product before
administration, see section 6.6. The
product should only be admin
Przeczytaj cały dokument
