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Important Safety Information
Afluria® is indicated for active immunization of persons 18 years of age
and older against influenza disease caused by influenza virus subtypes
A and type B present in the vaccine. The indication is based on the
immune response elicited by Afluria®; no controlled clinical studies
have demonstrated a decrease in influenza disease after vaccination
with Afluria®.
Afluria® should not be administered to individuals with hypersensitivity to
eggs or chicken protein or other components of Afluria®, or to anyone who
has had a life-threatening reaction to previous influenza vaccination.
The most common injection-site adverse reactions were tenderness, pain,
redness, and swelling. The most common systemic adverse reactions
were headache, malaise, and muscle aches.
Vaccination with Afluria® may not protect all individuals.
Immunocompromised persons may have a diminished immune response.
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of
prior influenza vaccine, the decision to give Afluria® should be based
on careful consideration of the potential benefits and risks.
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