Authorized Distributors
Afluria®
Influenza Virus Vaccine
Company |
Merck & Co., Inc. |
Important Safety Information
Afluria® is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
This indication is based on the immune response elicited by Afluria®; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Afluria®.
Afluria® is contraindicated in individuals with hypersensitivity to eggs, neomycin, or polymyxin, or in anyone who has had a life-threatening reaction to previous influenza vaccination.
Immunocompromised persons may have a diminished immune response. If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of prior influenza vaccination, the decision to give Afluria® should be based on careful consideration of the potential benefits and risks.
Administration of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years. Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving Afluria®.
In adults, the most common local (injection-site) adverse reactions observed in clinical studies with Afluria® were tenderness, pain, redness (erythema), and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches (myalgia).
In children, the most common local (injection-site) adverse reactions observed in a clinical study with AFLURIA were
pain, redness, and swelling. The most common systemic adverse reactions observed were irritability, rhinitis, fever,
cough, loss of appetite, vomiting/diarrhea, headache, muscle aches and sore throat.
Afluria® should be given to a pregnant woman only if clearly needed.
Safety and effectiveness of Afluria® in children below 6 months of age have not been established.
Antibody responses in geriatric subjects were lower after administration of AFLURIA in comparison to younger adult
subjects.
Vaccination with Afluria® may not protect all individuals.
See
full prescribing information
for Afluria® (updated July 2011).