Virus VaccineWARNINGS AND PRECAUTIONS

Fluarix should not be administered in persons with bleeding disorders (i.e. hemophilia, thrombocytopenia), patients receiving anticoagulant therapy, or persons in whom Guillain-Barre syndrome has occurred within six weeks of prior influenza vaccination unless the potential benefit outweighs the risk of vaccination.

The tip cap and rubber plunger of the prefilled syringes contain dry, natural latex rubber, which may potentiate an allergic reaction in people with latex sensitivities. Therefore, epinephrine injections (1:1,000) and other agents used in the control of immediate allergic reactions must be readily available in the case of this reaction or any potential ana-phylactic reaction following the administration of Fluarix.
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Fluarix is a pregnancy category C agent. It is not known whether this vaccine causes fetal harm when administered to pregnant women or whether it affects reproduction capacity. It is also unknown whether Fluarix is excreted in human milk; therefore, nursing women should exercise careful consideration and caution with this drug.

DOSAGE AND ADMINISTRATION

Fluarix is available as a colorless to slightly opalescent suspension in pre-filled syringes containing single 0.5-ml doses. The syringes should be kept in their original packaging, protected from light, and should be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) without freezing. Each 0.5-ml prefilled syringe should be shaken well and inspected for any particulate material or discoloration prior to administration.

Fluarix should be injected intra­muscularly, preferably in the deltoid muscle region of the arm. The vaccine should not be injected in the gluteal area or areas where a major nerve trunk may exist.

CONCLUSION

Disruptions in the manufacturing or delays in the distribution of influenza vaccines have occurred during three of the last five influenza seasons in the U.S. In October 2004, the Chiron Corporation notified the U.S. Centers for Disease Control and Prevention (CDC) that none of its influenza vaccine (Fluvirin) would be available for distribution during the 2004-2005 influenza season, thereby reducing the anticipated supply of trivalent inactivated vaccine by approximately 50% in the U.S. In response to this urgent situation, the CDC, in coordination with its Advisory Committee for Immunization Practices (ACIP), issued interim recommendations for influenza vaccinations to ensure appropriate prioritization of vaccine administration to those at greatest risk of infection, complications, and death.

To prevent future shortages of influenza vaccines, steps to ensure adequate supply are necessary. One step was the approval of Fluarix influenza virus vaccine using the accelerated approval process of the Food and Drug Administration (FDA). This process allows products that treat serious or life-threatening illnesses to be approved based on successfully achieving an end-point that is reasonably likely to predict ultimate clinical benefit. canadian pharmacy online

Fluarix is the first vaccine to be approved by this accelerated process. As a result, its manufacturer (GlaxoSmith-Kline) will continue to conduct clinical studies to assess and verify the benefits of the vaccine.