What is it and how is it used?

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 (Fibrinogen and Thrombin respectively) Human Fibrinogen and Human Thrombin.
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.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

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 administration has to be discontinued immediately.

Take special care with EVICEL

When EVICEL is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue. EVICEL must not be injected into tissue or blood vessels because it would cause clots which could be fatal. The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective gluing tissues together surgery to the brain or spinal cord

controlling bleeding in the stomach or intestines by applying the product through an endoscope tube sealing surgical repairs to the intestines. Apply EVICEL as a thin layer. Excessive clot thickness may negatively interfere with the products efficacy and the wound healing process. Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer EVICEL. This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. When applying EVICEL using a spray device, be sure to use the pressure within the range recommended by the spray device manufacturer. In the absence of a specific recommendation avoid using pressure above 1.4-1.7 bars. Do not spray at a distance closer than the recommended by the spray device manufacturer. In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the tissue surface. When spraying EVICEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism. When using accessory tips with this product, be sure to follow carefully the instructions for use.

Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated. As with any product containing proteins, allergic type hypersensitivity reactions are possible. Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and anaphylaxis. If these symptoms occur, the administration has to be discontinued immediately.

When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virusesinfections. Manufacturers of these products also include steps in the processing of the blood and plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses, or other types of infections.

The measures taken in the manufacture of Fibrinogen and Thrombin are considered effective for lipid coated viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus and the non-enveloped virus, hepatitis A. The measures taken may be of limited value against parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

The healthcare professionals will record the name and batch number of the medicinal product in order to trace any possible infection source.

Using other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Pregnancy and breast-feeding

There is not enough information available to know whether any particular risks are associated with the use of EVICEL during pregnancy or whilst breast-feeding. However, since EVICEL is used during a surgical operation, if you are pregnant or breast-feeding you should discuss the overall risks of the operation with your doctor.

Pediatric use

Data are too limited to support the safety and effectiveness of EVICEL in children.

How is it used?

The doctor treating you will administer EVICEL during surgery.
During your operation, your doctor will drip or spray EVICEL onto raw tissue during operations, using an application device. This device allows equal amounts of the two components of EVICEL to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to have its optimal effect.
The amount of EVICEL that will be applied depends on the surface area of tissue to be treated during the operation. It will be dripped onto the tissue in short bursts or sprayed in very small amounts (0.1-0.2 ml), to produce a thin, even layer. If application of a single layer of EVICEL does not completely stop the bleeding, a second layer may be applied.

What are possible side effects?

Like all medicines, EVICEL can have side effects, although not everybody gets them.
EVICEL is a fibrin sealant. Fibrin sealants in general may, in rare cases (1 to 10 patients in 10,000), cause an allergic reaction. If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting or wheezing. No allergic reactions have so far been reported in patients treated with EVICEL.

There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.

If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. In clinical studies with EVICEL some undesired events occurred for which a causal relation to the application of EVICEL could not be excluded. After abdominal surgery some patients presented with an abscess, and in vascular surgery some cases of an occluded graft occurred which had do be re-operated.

How should it be stored?

Keep out of the reach and sight of children.

Store in a freezer at -18°C or colder.

Do not use EVICEL after the expiry date which is stated on the label as well as the carton after EXP. The expiry date refers to the last day of that month.

Keep the vials in the outer carton in order to protect from light. Do not refreeze. After thawing, unopened vials can be stored at 2-8°C and protected from light, for up to 25 days.
The Fibrinogen and Thrombin components are stable at room temperature for up to 24 hours but once drawn up into the application device, they must be used immediately.

Further information

What EVICEL contains

The active ingredients are as follows:

Component 1: Human clottable protein (50 - 90 mg/ml)
Component 2: Human thrombin (800 - 1,200 IU/ml)

Other ingredients are:

Component 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride and water for injections.

Component 2: calcium chloride, human albumin, mannitol, sodium acetate and water for injections.

Pack sizes

EVICEL is available in the following sizes: 2 x 1 ml, 2 x 2 ml and 2 x 5 ml.
All packs sizes may not be marketed in all countries.

What EVICEL looks like and contents of the pack

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 solution of Human Fibrinogen and Human Thrombin, respectively.

An application device and appropriate accessory tips are supplied separately.

Fibrinogen and Thrombin are packaged together as two vials each containing the same volume (1ml, 2ml or 5ml) of frozen, sterile solution, which is colourless or yellowish when thawed. 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.

Marketing Authorisation Holder:

Omrix Biopharmaceuticals S.A.
200 Chaussée de Waterloo
B-1640 Rhode-St-Genèse
Belgium
Tel: +32 2 359 91 23
Fax: +32 2 359 91 27

For any information about this medicine, please contact the Manufacturer:

Pharmacovigilance Department
Omrix Biopharmaceuticals Ltd
Plasma Fractionation Institute
Sheba Hospital, Tel Hashomer
Ramat Gan 52621, Israel
Tel: +972-3-5316512
Fax: +972-3-5316590

This leaflet was last approved in {MM/YYYY}

The following information is intended for medical or healthcare professionals only.

INSTRUCTIONS FOR USE

Read this before you open the package

EVICEL comes in sterile packages and therefore it is important to use only undamaged packages which have not been opened (post-sterilisation is not possible).

Preparation

No needles are involved in the preparation of EVICEL for administration. Draw the contents of the two vials into the administration device following the instructions for use in the device package.. Both syringes should be filled with equal volumes, and should not contain air bubbles. Any unused product or waste material should be disposed of in accordance with local requirements. The solutions should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

STORAGE OF EVICEL

Do not use after the expiry date stated on the carton and label.
Keep out of reach and sight of children.

Fibrinogen and Thrombin:

Long term storage
Store in a freezer at -18°C or colder. Do not use after the expiry date stated on the carton.

Short term storage
Store at 2-C-8-C (in a refrigerator) for no more than 25 days. The date on which refrigerator storage was started should be marked on the carton in the space provided. Do not re-freeze.

Fibrinogen and Thrombin are stable at room temperature for 24 hours but when they have been drawn up into the administration device, they must be used immediately.

Application Device:

Store separately from the Fibrinogen and Thrombin, at room temperature.

Thawing

The vials should be thawed in one of the following ways:
2-8°C (refrigerator): vials thaw within 1 day, or
20-25°C (room temperature): vials thaw within 1 hour, or
37ºC (e.g. water bath, using aseptic technique, or by warming vials in the hand): vials should be thawed within 10 minutes and must not be left at this temperature for longer than 10 minutes or until fully thawed. The temperature must not exceed 37ºC.

Before use, the product must reach 20-30°C.

Preparation

The solutions are clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

EVICEL should be applied using the CE-marked EVICEL application device and optional use of a tip accessory to the device. Leaflets giving detailed instructions for use of EVICEL in conjunction with the application device and optional accessory are provided with the package of the application device and of the accessory.
The accessory tips should only be used by persons adequately trained in laparoscopic, laparoscopic assisted, thoracoscopic or open surgical procedures.
Draw the contents of the two vials into the application device, following the instructions for use in the device package. Both syringes should be filled with equal volumes, and should not contain air bubbles. No needles are involved in the preparation of EVICEL for administration.

Application by dripping

Keeping the tip of the applicator as close to the tissue surface as possible, but without touching the tissue during application, apply individual drops to the area to be treated. If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.

Spray application

EVICEL can be sprayed usingpressurised CO 2 or compressed air.
Connect the short tube on the application device to the male luer-lock end of the long gas tube. Connect the female luer lock of the gas tube (with the 0.2 ?m bacteriostatic filter) to a pressure regulator. The pressure regulator should be used in accordance with the manufacturer?s instructions.
Information about the distance and pressure to be used is provided in the device and tip Assembly Guides. The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer. EVICEL forms a clear film over the area of application.
When applying EVICEL using a spray device, be sure to use only the pressure within the range recommended by the spray device manufacturer. Do not spray at a distance closer than the recommended by the spray device manufacturer. When spraying EVICEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO 2 should be monitored because of the possibility of occurrence of air or gas embolism.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

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