Feiba Warnings

Viral Safety: Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, [e.g., 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.
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.
The measures taken are considered effective for enveloped viruses such as HIV, HBV, and HCV and for the nonenveloped viruses HAV. 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. in hemolytic anaemia).
Appropriate vaccination (against hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived products including FEIBA.
It is recommended that every time FEIBA 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.