Novartis Influenza A H1N1 2009 Monovalent Vaccine Multi-Dose Mercury Levels: Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose). Recipient's Age: 4 years and older Shot or Mist: shot Manufacturer: Novartis Influenza A (H1N1) 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 (H1N1) 2009 virus. Dosage and Administration 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 Dosage Forms and Strengths Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in two presentations: Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose). Thimerosal is added as preservative. Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury derivative used during manufacture, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose) Contraindications History of systemic hypersensitivity reactions to egg proteins, or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reactions to previous influenza vaccinations. Warnings and Precautions If Guillain-Barre syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, 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 reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. Adverse Reactions Adverse Reaction information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by Novartis (FLUVIRIN). The most frequently reported adverse reactions are mild hypersensitivity reactions (such as rash), local reactions at the injection site, and influenza-like symptoms. To report SUSPECTED ADVERSE REACTIONS contact Novartis Vaccines at 1- 800-244-7668, or VAERS at 1-800-822-7967 and www.vaers.hhs.gov. Drug Interactions Do not mix with any other vaccine in the same syringe or vial. Immunosuppressive therapies may reduce immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. Use In Specific Populations Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers or children less than 4 years of age. Antibody responses to the trivalent seasonal Influenza Virus Vaccine manufactured by Novartis (FLUVIRIN) were lower in the geriatric population than in younger subjects. Dosage Information: Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose). Thimerosal is added as preservative. Pregnant Safe: Consult your physician