Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).The multidose vial stopper and the syringe stopper/plunger do not contain latex.Influenza illness and its complications follow infection with influenza viruses. Available information for FLUVIRIN is provided in this section.Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.Novartis’ Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (FLUVIRINSerious allergic reactions, including anaphylactic shock, have been observed in individuals receiving FLUVIRIN during postmarketing surveillance.Adverse event information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis [see CONTRAINDICATIONS (The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). All studies have been conducted in the UK, apart from a study run in the US in 2005-2006 where FLUVIRIN was used as a comparator for an unlicensed vaccine.After vaccination, the subjects were observed for 30 minutes for hypersensitivity or other immediate reactions. FLUVIRIN was also used as a control in a US clinical trial in adults (18-49 years of age).

The \"2009\" in the name only relates to the year the virus was first identified; it does not have to do with how long the vaccine will work or the year in which it should be administered. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Available for Android and iOS devices. Types of vaccine.

Because these reactions are reported voluntarily 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 anterolateral thigh can be used, but the needle should be longer, usually 1 inch.The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.Influenza A (H1N1) 2009 Monovalent Vaccine is a sterile suspension for intramuscular injection. Yes, the vaccine to protect against the 2009 H1N1 influenza virus will be the same for the entire 2009-2010 influenza season, which extends into the spring of 2010. Since 1991 an annual clinical study has been conducted in the UK in healthy adults aged 18 years or older. 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).2) Multidose vial, 5-mL. No serious adverse events were reported.FLUVIRIN and Influenza A (H1N1) 2009 Monovalent Vaccine should only be used for the immunization of persons aged 4 years and over.The following additional adverse reactions have been reported during post-approval use of FLUVIRIN.

HI antibody titers of 1:40 or greater were seen in at least 71% of the subjects for all three influenza strains, with increases in geometric mean titer of 6.0-fold or greater to all three strains.Two clinical studies (1999-2000 and 2004) indicated a lower immunogenicity profile for FLUVIRIN compared with two commercial split vaccines; in a study in the age group 6-48 months the comparator was a US licensed vaccine, FluzoneInfluenza A (H1N1) 2009 Monovalent Vaccine should only be used for the immunization of persons aged 4 years and older.Influenza A (H1N1) 2009 Monovalent Vaccine is supplied as a 0.5-mL prefilled single dose syringe, package of 10 syringes per carton.

The influenza virus strain is harvested and clarified by centrifugation and filtration prior to inactivation with betapropiolactone. Vaccine recipients and guardians should be instructed to report any severe or unusual adverse reactions to their healthcare provider.Vaccine recipients should be advised that there are two influenza vaccine formulations for this influenza season, the monovalent pandemic (H1N1) 2009 influenza vaccine and seasonal trivalent influenza vaccine.Manufactured by:     Novartis Vaccines and Diagnostics Limited, Speke, Liverpool, UKAn affiliate of:            Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139 USAThe easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Like seasonal flu vaccines, there are two kinds of 2009 H1N1 vaccines: a "To receive weekly email updates about this site, enter your email address: Note: Javascript is disabled or is not supported by your browser. NDC 66521-200-10Store Influenza A (H1N1) 2009 Monovalent Vaccine refrigerated between 2º and 8ºC (36º and 46ºF).Store in the original package to protect from light.Between uses, return the multidose vial to the recommended storage conditions.Vaccine recipients and guardians should be informed by their health care provider of the potential benefits and risks of immunization with Influenza A (H1N1) 2009 Monovalent Vaccine.

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