Evicel

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

human fibrinogen, human thrombin

Saadav alates:

Omrix Biopharmaceuticals N. V.

ATC kood:

B02BC

INN (Rahvusvaheline Nimetus):

human fibrinogen, human thrombin

Terapeutiline rühm:

Antihemorrhagics

Terapeutiline ala:

Hemostasis, Surgical

Näidustused:

Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.Evicel is also indicated as suture support for haemostasis in vascular surgery.

Toote kokkuvõte:

Revision: 18

Volitamisolek:

Authorised

Loa andmise kuupäev:

2008-10-05

Infovoldik

23
B. PACKAGE LEAFLET
24
Package Leaflet: Information for the patient
EVICEL 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, pharmacist, or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What EVICEL is and what it is used for
2.
What you need to know before you use EVICEL
3.
How to use EVICEL
4.
Possible side effects
5
How to store EVICEL
6.
Contents of the pack and other information
1.
What EVICEL is and what it is used for
EVICEL is a Human Fibrin Sealant which is supplied as a package
containing two separate vials, each
containing 1 ml, 2 ml or 5 ml of solution (Human Fibrinogen and Human
Thrombin respectively).
An application device and appropriate accessory tips are supplied
separately.
Fibrinogen is a concentrate of clottable protein and thrombin is an
enzyme that causes clottable protein to
coalesce. Thus, when the two components are mixed together they clot
instantly.
EVICEL is applied in adults during surgical operations to reduce
bleeding and oozing during and after the
operation.
EVICEL can be used in blood vessel surgery and in surgery taking place
on the posterior abdominal wall.
EVICEL can also be used to support the watertight closure of the
cerebral envelopes (dura mater) during
neurosurgery when other surgical techniques are insufficient.
It is dripped or sprayed onto cut tissue where it forms a thin layer
that seals the tissue and/or stops bleeding.
2.
What you need to know before you use EVICEL
Do not use EVICEL

If you are hypersensitive (allergic) to products made from human blood
or to any of the other ingredients
of EVICEL (listed in section 6). Signs of allergic reactions include
hives, rash, tightness of the chest,
wheezing, drop in b

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EVICEL solutions for sealant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients are as follows:
1 ml vial
2 ml vial
5 ml vial
Component 1
Human clottable protein containing
mainly fibrinogen and fibronectin *
50 – 90 mg
100 – 180 mg
250 – 450 mg
Component 2
Human thrombin
800 – 1,200 IU
1,600 – 2,400 IU
4,000 – 6,000 IU
* Total quantity of protein is 80 - 120 mg/ml
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solutions for sealant.
Clear or slightly opalescent solutions.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
EVICEL is indicated in adults as supportive treatment in surgery where
standard surgical techniques are
insufficient, for improvement of haemostasis (see section 5.1).
EVICEL is also indicated in adults as suture support for haemostasis
in vascular surgery and for suture line
sealing in dura mater closure.
4.2
Posology and method of administration
The use of EVICEL is restricted to experienced surgeons who have been
trained in the use of EVICEL.
Posology
The volume of EVICEL 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.
Application of the product must be individualised by the treating
physician. In controlled clinical trials in
vascular surgery, the individual dosage used was up to 4 ml; for
suture line sealing in dura mater closure,
doses of up to 8 ml were used, whereas in retroperitoneal or
intra-abdominal surgery the individual dosage
used was up to 10 ml. However, for some procedures (e.g., liver
traumata) 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 i