Influenza A (H1N1) 2009 Monovalent Vaccine

Influenza A 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by pandemic 2009 virus. It has been discontinued.

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

• Children 4 through 9 years of age: Two 0.5 mL intramuscular injections approximately 1 month apart.
• Children 10 through 17 years of age: A single 0.5 mL intramuscular injection.

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 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.

Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers or in children less than 4 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.

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

• 0.5 mL single-dose, pre-filled syringe. Thimerosal is removed to a trace amount (≤ 1 mcg mercury per 0.5 mL dose).
• 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.

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.