CSL Influenza A H1N1 2009 Monovalent Vaccine 5mL Multi-Dose Vial Mercury Levels: Thimerosal preservative Recipient's Age: 36 months and older Shot or Mist: shot Manufacturer: CSL Influenza A (H1N1) 2009 Monovalent Vaccine, for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. Influenza A (H1N1) 2009 Monovalent Vaccine is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using a continuous flow zonal centrifuge. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a "split virion". The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) per 0.5 mL dose of influenza A/California/7/2009 (H1N1)v-like virus. Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury. A single 0.5 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). A single 0.25 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine contains half of these quantities. From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≥ 10 ppm), ovalbumin (≥ 1 mcg), neomycin sulfate (≥ 0.2 picograms [pg]), polymyxin B (≥ 0.03 pg), and beta-propiolactone (< 25 nanograms). The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex. Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months and older against influenza disease caused by pandemic (H1N1) 2009 virus. This indication is based on the immune response elicited by the seasonal trivalent Influenza Virus Vaccine manufactured by CSL (AFLURIA®). CSL’s Influenza A (H1N1) 2009 Monovalent Vaccine and AFLURIA are manufactured by the same process. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA. Available data show that children 9 years of age and younger are largely serologically naive to the pandemic (H1N1) 2009 virus. Based upon these data Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as follows: Children Children 6 months through 35 months of age should receive two 0.25 mL doses approximately 4 weeks apart. Children 36 months through 9 years of age should receive two 0.5 mL doses approximately 4 weeks apart. Children 10 years of age and older should receive a single 0.5 mL intramuscular dose. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in toddlers and young children. Adults Persons 18 years of age and older should receive a single 0.5 mL intramuscular injection, preferably in the deltoid muscle of the upper arm. CONTRAINDICATIONS Influenza A (H1N1) 2009 Monovalent Vaccine is contraindicated in individuals with known hypersensitivity to eggs, neomycin, or polymyxin, or in anyone who has had a life-threatening reaction to previous influenza vaccination. WARNINGS AND PRECAUTIONS Guillain-Barre Syndrome (GBS) - If 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. Altered Immunocompetence - If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished. Preventing and Managing Allergic Reactions - Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. Limitations of Vaccine Effectiveness - Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals. ADVERSE REACTIONS CSL’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (AFLURIA) are manufactured by the same process. The data in this section were obtained from clinical studies and postmarketing experience with AFLURIA. Overall Adverse Reactions - 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 and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches. 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. Postmarketing Experience Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. These adverse reactions reflect experience in both children and adults and include those identified during post-approval use of AFLURIA outside the US since 1985. Blood and lymphatic system disorders Transient thrombocytopenia Immune system disorders Allergic reactions including anaphylactic shock and serum sickness Nervous system disorders Neuralgia, paresthesia, and convulsions; encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS Vascular disorders Vasculitis with transient renal involvement Skin and subcutaneous tissue disorders Pruritus, urticaria, and rash Other Adverse Reactions Associated With Influenza Vaccination Anaphylaxis has been reported after administration of AFLURIA. Although AFLURIA and Influenza A (H1N1) 2009 Monovalent Vaccine contain only a limited quantity of egg proteins, these proteins can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, asthma, and systemic anaphylaxis The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated. Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported. Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination. Concurrent Use With Immunosuppressive Therapies The immunological response to Influenza A (H1N1) 2009 Monovalent Vaccine may be diminished in individuals receiving corticosteroid or immunosuppressive therapies. USE IN SPECIFIC POPULATIONS CSL’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (AFLURIA) are manufactured by the same process. Available information for AFLURIA is provided in this section. Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed. Nursing Mothers Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman. Pediatric Use Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine and AFLURIA in children below 6 months of age have not been established. The safety and immunogenicity of AFLURIA was evaluated in 298 children between the ages of 6 months and 9 years. Geriatric Use In four clinical studies, 343 subjects ages 65 years and older received AFLURIA. Hemagglutination-inhibiting antibody responses in geriatric subjects were lower after administration of AFLURIA in comparison to younger adult subjects. Adverse event rates were generally similar in frequency to those reported in subjects ages 18 to less than 65 years, although some differences were observed. Dosage Information: 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 Pregnant Safe: Consult your physician