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. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. In all the trials, blood samples were taken prior to vaccination and approximately three weeks after vaccination to assess the immunogenic response to vaccination by measurement of anti-HA antibodies.Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6-48 months). For more information about this message, please visit this page: How do I view different file formats (PDF, DOC, PPT, MPEG) on this site? In one child, the tenderness was also accompanied by redness at the site of injection for two days. 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. This season, vaccines to protect against the 2009 H1N1 virus (sometimes called “swine flu”) have been produced. If Influenza A (H1N1) 2009 Monovalent Vaccine is to be given at the same time as another injectable vaccine(s), the vaccines should always be administered at different injection sites.Influenza A (H1N1) 2009 Monovalent Vaccine should not be mixed with any other vaccine in the same syringe or vial.Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Influenza A (H1N1) 2009 Monovalent Vaccine.Novartis’ Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (FLUVIRIN) are manufactured by the same process. Just six months after the first case of the flu variant was detected on US soil, doctors had a vaccine … Subjects were instructed to complete a diary card for three days following immunization (i.e. The influenza virus strain is harvested and clarified by centrifugation and filtration prior to inactivation with betapropiolactone. All participants received a single 0.5-mL dose of FLUVIRIN.Immunogenicity results were obtained for 19 of the 38 subjects enrolled in the study. When educating vaccine recipients and guardians regarding the potential side effects, clinicians should emphasize that Influenza A (H1N1) 2009 Monovalent Vaccine contains non-infectious particles and cannot cause influenza. The 2009 H1N1 swine flu vaccine is made exactly the same way as the seasonal flu vaccine, by the same manufacturers using the same materials -- except for one shiny new piece.


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. At least 49% of subjects showed a ≥4-fold increase in HI antibody titer to all three strains. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.Neither FLUVIRIN nor the Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.Novartis’ Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (FLUVIRIN) are manufactured by the same process.

The most common solicited local and systemic adverse events were injection site pain, and headache (The most common overall events in elderly subjects (≥65 years of age) were headache and fatigue.Only 11 serious adverse events in adult and geriatric subjects (18 years and older) have been reported to date from all the trials performed.

Data in this section were obtained in clinical studies conducted with FLUVIRIN.Between 1982 and 1991, twelve clinical studies were conducted in healthy adult and geriatric subjects and one in children between 4 and 12 years of age who were considered to be ‘at risk’. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.Influenza A (H1N1) 2009 Monovalent Vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of Influenza A (H1N1) 2009 Monovalent Vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see DESCRIPTION (If Guillain-Barré 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.If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.Prior to administration of any dose of Influenza A (H1N1) 2009 Monovalent Vaccine, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with Influenza A (H1N1) 2009 Monovalent Vaccine and to allow an assessment of benefits and risks.

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