Influenza A 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic 2009 virus.

Influenza A (H1N1) 2009 Monovalent Vaccine should not be used in patients who have hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or life-threatening reaction to previous influenza vaccination.

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks.

Immunocompromised persons may have a diminished immune response to Influenza A (H1N1) 2009 Monovalent Vaccine.

Based on currently available information, the vaccination regimen is as follows:

Adults 18 years of age and older:

• A single 0.5 mL intramuscular injection.

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated vaccine that cannot cause influenza but rather stimulates the immune system to produce antibodies.

Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in two presentations:

• 0.5 mL preservative-free, single-dose, pre-filled syringe.

• 5 mL multi-dose vial containing ten doses. Thimerosal, a mercury derivative, is added as a preservative; each 0.5 mL dose contains 24.5 micrograms (mcg) of mercury.

Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers or in persons less than 18 years of age.

The most common (= 10%) local (injection-site) adverse reactions were tenderness, pain, redness, and swelling. The most common (= 10%) systemic adverse reactions were headache, malaise, and muscle aches.

Any severe or unusual adverse reactions should be reported to the healthcare provider.

To report SUSPECTED ADVERSE REACTIONS, contact VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

Do not mix Influenza A (H1N1) 2009 Monovalent Vaccine with any other vaccine in the same syringe or vial.

Immunosuppressive therapies may diminish the immune response to Influenza A (H1N1) 2009 Monovalent Vaccine.