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TICOVAC Warnings and Precautions (tick-borne encephalitis vaccine,whole virus, inactivated)

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TICOVAC.

5.2 Altered Immunocompetence

Some individuals with altered immunocompetence may have reduced immune responses to TICOVAC.

5.3 Human Albumin

TICOVAC contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

5.4 Limitation of Vaccine Effectiveness

Vaccination with TICOVAC may not protect all individuals.

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