Special Warning : אזהרת שימוש

4.4.   Special Warnings and Precautions for Use

• EVICEL is for epilesional use only. It must not be applied intravascularly.
• Life-threatening thromboembolic complications may occur if the product is unintentionally applied intravascularly.
• Life-threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer EVICEL. This event appears to be related to the use of the spray device at higher than indicated pressures and/or in close proximity to the tissue surface.
• In order to avoid the risk of air or gas embolism:
- EVICEL should be sprayed using pressurised CO2 gas only.
- EVICEL spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy. Spray distance from tissue and CO2 pressure should be within the ranges indicated by the manufacturer (see table in Section 6.6 for pressures and distances).
- 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, the instructions for use of the tips should be followed.
• EVICEL should be applied as a thin layer. Excessive clot thickness may negatively interfere with the product’s efficacy and the wound healing process.
• Adequate data are not available to support the use of this product in tissue gluing, through an endoscope for treatment of bleeding or in gastrointestinal anastomoses.
• The concomitant use of EVICEL for dural suture line sealing with implants from synthetic materials or dural patches has not been evaluated in clinical studies.
• The use of EVICEL in patients undergoing radiotherapy within 7 days after surgery has not been evaluated. It is not known whether radiation therapy could affect the efficacy of fibrin sealant when used for suture line sealing in dura mater closure.
• Complete haemostasis should be achieved before application of EVICEL to seal the dural suture line.
• The use of EVICEL as a sealant in transsphenoidal and otoneurosurgical procedures has not been studied.
• Before administration of EVICEL, care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.


• As with any protein product, allergic-type hypersensitivity reactions are possible. Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, the administration should be discontinued immediately.
• In case of shock, standard medical treatment for shock should be implemented.
• Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, hepatitis C virus and hepatitis B virus and for the non- enveloped virus hepatitis A virus.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g., haemolytic anaemia).
• It is strongly recommended that every time that EVICEL is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

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