EVICEL Fibrin Sealant (Human) Solution 50-90 mgml 800-1200 IUml

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Clottable Protein (Human Fibrinogen); Human Thrombin

Հասանելի է:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC կոդը:

B02BC

Դոզան:

50-90 mg/ml

Դեղագործական ձեւ:

SOLUTION

Կազմը:

Clottable Protein (Human Fibrinogen) 50-90 mg/ml; Human Thrombin 800-1200 IU/ml

Կառավարման երթուղին:

OTHERS

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

OMRIX biopharmaceuticals Ltd

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2011-02-23

Տեղեկատվական թերթիկ

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVICEL® FIBRIN SEALANT (HUMAN)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What EVICEL® is and what it is used for
2.
Before you are treated with EVICEL®
3.
How to use EVICEL®
4.
Possible side effects
5.
How to store EVICEL®
6.
Further 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 sterile solution of Human Fibrinogen
and Human Thrombin.
The Human Thrombin component appears as a white to slightly yellowish
opaque mass when frozen and as a
clear to slightly opalescent and colourless to slightly yellowish
solution when thawed. The solution contains
no preservative.
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 during surgical operations, to reduce bleeding and
oozing during and after the
operation. It is dripped or sprayed onto cut tissue where it forms a
thin layer that seals the tissue and stops
bleeding.
EVICEL® can also be used in blood vessels surgery and in surgery
taking place in the area between the
bowels and the posterior abdominal wall.
2.
BEFORE YOU ARE TREATED WITH 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®. Signs of such reactions include hives, rash,
tightness of the chest,
wheezing,
drop
in
blood
pressure
and
breathing
difficulties.
If
these
symptoms
occur,
the
administrati

Ապրանքի հատկությունները

1
1.
NAME OF THE MEDICINAL PRODUCT
EVICEL Fibrin Sealant (Human)
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 a 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.
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, 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.
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.
_ _
Method and route of administration
2
Evicel is for epilesional use.
For instructions on preparati