Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Precautions for use

For epilesional use only. Do not apply intravascularly.
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.8).

VeraSealTM spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy. Spray distance from tissue should be within the range recommended by the marketing authorisation holder of VeraSealTM (see section 6.6).
When using accessory tips, the instructions for use of the tips should be followed.

Before administration of VeraSealTM, care must be taken that the parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.

VeraSealTM 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, neurosurgery, application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses.

Hypersensitivity reactions

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 must be discontinued immediately. In case of shock, standard medical treatment for shock should be implemented.

Transmissible agents

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 infective 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 human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non- enveloped 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).

Effects on Driving

4.7 Effects on ability to drive and use machines
VeraSealTM has no or negligible influence on the ability to drive and use machines.