Description

FLUSURE™ is a freeze-dried preparation containing 2 type-A field isolates, subtypes H1N1 and H3N2, of inactivated swine influenza viruses grown on an established cell line. A sterile diluent containing Amphigen^®, a unique oil-in-water adjuvant to enhance the immune response, is used to rehydrate the freeze-dried vaccine.

Approved Uses

FLUSURE is approved for:

• Vaccination of healthy swine 3 weeks of age or older as an aid in preventing respiratory disease caused by swine influenza virus (SIV) subtypes H1N1 and H3N2.

• Proven, effective, bivalent swine-flu protection. FLUSURE aids in the prevention of respiratory disease caused by swine influenza (SIV) subtypes H1N1 and H3N2 — the two subtypes most often diagnosed in U.S. swine herds.



• FLUSURE bivalent vaccine is an important tool in fighting swine influenza, since immunity against H1N1 does not protect against viruses of the H3N2 subtype. This is especially important since virus typing conducted between 1998 and 2000 at leading swine diagnostics laboratories found both subtypes almost equally prevalent.



• FLUSURE was developed to cross-react with H1N1 and H3N2 field isolates currently circulating in major pig population centers of the U.S.



• In safety studies on hundreds of pigs and pregnant sows, animals vaccinated with FLUSURE showed no systemic reactions. Pigs vaccinated with FLUSURE were 100% injection-site-reaction-free and sows were 99.5% injection-site-reaction-free. Pregnant sows vaccinated with FLUSURE farrowed at similar rates and had pigs born live, born dead and born mummies similar to saline-vaccinated control sows.



• Serologic studies showed that SIV-negative pigs vaccinated with FLUSURE exhibited very high H1N1 and H3N2 titers.



• In a separate study using highly virulent challenge viruses, swine influenza virus titers in the lungs of pigs vaccinated with FLUSURE showed 97.1% improvement over the controls for H1N1 and 99.97% improvement for H3N2. No pigs vaccinated with FLUSURE were observed to have signs of clinical illness. Lung lesion scores improved 92% versus controls given the H1N1 challenge, and 99.41% versus controls given the H3N2 challenge.



• The freeze-dried formulation provides for greater flexibility when dosing.



• Amphigen, the adjuvant in FLUSURE, provides for a prolonged immune response, a high degree of safety, ease of use and excellent syringability.

• General Directions: Vaccination of all pigs on the premises is recommended to enhance herd immunity. Shake diluent before use. Aseptically rehydrate the freeze-dried vaccine with the accompanying adjuvant-containing sterile diluent, shake well, and administer 2 mL intramuscularly.



• Primary Vaccination: Healthy swine 3 weeks of age or older should receive two 2-mL doses administered approximately 3 weeks apart. In young pigs, vaccinate after maternally derived antibodies to SIV have declined.



• Revaccination: Semiannual revaccination with a single dose is recommended.



• Good animal husbandry and herd health management practices should be employed.

• Store at 2°–7° C. Prolonged exposure to higher temperatures may adversely affect potency. Do not freeze.



• Use entire contents when first opened or rehydrated.



• Sterilized syringes and needles should be used to administer this vaccine.



• Do not vaccinate within 21 days before slaughter.



• As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.



• This product has been shown to be efficacious in healthy animals. A protective immune response may not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.