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BioThraxAnthrax Vaccine Adsorbed

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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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Special warnings and precautions for useAs with other vaccines, administration of BioThrax should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in deferral of vaccination.Do not inject intravascularly.When administered subcutaneously there is a higher incidence of injection site adverse reaction compared to intramuscular administration.Before administration, the person’s medical immunisation history should be reviewed for possible vaccine sensitivities and/or previous vaccination-related adverse events, in order to determine the existence of any contraindications to immunisation.As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine.Persons with impaired immune responsiveness due to congenital or acquired immunodeficiency, or immunosuppressive therapy may have reduced antibody responses to active immunisation. Vaccination during chemotherapy, high dose corticosteroid therapy of greater than 2-week duration, or radiation therapy may result in a suboptimal response. Deferral of vaccination for 3 months after completion of such therapy may be considered.As with other vaccines, a protective immune response may not be elicited in all individuals. The safety and efficacy of BioThrax in children have not been established.The safety and efficacy of BioThrax in patients > 65 years have not been established. The vial stopper may contain natural rubber latex. Although the risk of developing allergic reactions is very small, healthcare professionals should consider the benefit-risk prior to administering this vaccine to subjects with known history of hypersensitivity to latex