• FLUAD^® is contraindicated in individuals with a known hypersensitivity to the active substances, to any of the excipients and to eggs, chicken proteins, kanamycin and neomycin sulphate, hydrocortisone, formaldehyde, and cetyltrimethylammonium bromide (CTAB), or in anyone who has had a life-threatening reaction to previous influenza vaccination²
• Do not administer by any other route than intramuscularly²
• The immune response to FLUAD^® in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient²
• Prior to administration of any dose of FLUAD^®, the vaccine recipient should be asked about personal medical history, family medical history, recent and current health status, including immunization history, main allergies and any adverse events associated with previous immunizations²
• Before the injection of any biological product, such as vaccines, the person responsible for administration should take all precautions known for the prevention of allergic or any other reactions. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine²
• Immunization should be postponed in patients with febrile illness or acute infections²
• As with other intramuscular injections, administration of FLUAD^® requires careful consideration in patients with clinically significant bleeding disorders²
• If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD^® should be based on careful consideration of the potential benefits and risks²
• Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, hepatitis C and, especially HTLV1 have been observed. The Western Blot technique disproves the results. The transient false positive reactions could be due to the IgM response by the vaccine²

Immunosuppressive therapies may reduce the immune response to FLUAD^®.²

According to FLUAD^®’s pharmacodynamic profile:^2*

• The antibody response to FLUAD^® is increased when compared to the response to vaccines without adjuvant, and is most pronounced for A/H3N2 and B influenza antigens. Seroprotection is generally obtained within 2 to 3 weeks after vaccination
• This increased immune response is seen particularly in elderly subjects with low pre-immunization titers and/or with underlying diseases (diabetes, cardiovascular and respiratory diseases) who are at increased risk of complications of influenza infection. A similar immunogenicity profile has been noted after a second and third immunization with FLUAD^®

* Clinical significance and comparative clinical significance have not been established.