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.