The Anthrax Vaccine Is It Safe? Does It Work? (2002) / Chapter Skim
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Appendix D Anthrax Vaccine Adsorbed Package Inserts
Appendix D Anthrax Vaccine Adsorbed Package Inserts
Pages 227-238
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CLINICAL PHARMACOLOGY Anthrax Vaccine Adsorbed is used in man to promote increased resistance to Bacillus anthracis by active immunization (1,2~.
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DOES IT STORK? INDICATIONS AND USAGE Immunization with Anthrax Vaccine Adsorbed is recommended for individuals who may come in contact with animal products such as hides, hair, or bones which come from anthrax endemic areas and may be contaminated with Bacillus anthracis spores; and for individuals engaged in diagnostic or investigational activities which may bring them into contact with B
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ADVERSE REACTIONS Local Reactions: Mild local reactions occur in approximately thirty per cent of recipients and consist of a small ring of erythema, 1-2 cm in diameter, plus slight local tenderness/l)
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1. Use a separate sterile needle and syringe for each patient to avoid transmission of viral hepatitis and other infectious agents.
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License No. 1260 All rights reserved ~ 1999 BioPort Corporation
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In humans, anthrax disease can result from contact with animal hides, leather or hair products from contaminated animals, or from other exposures to Bacillus anthracis spores. It occurs in three forms depending upon the route of infection: cutaneous anthrax, gastrointestinal anthrax and inhalation anthrax.
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Most of these exposures occurred in industrial settings, i.e., textile mills.3 From October 4, 2001, to December 5, 2001, a total of 11 cases of inhalation anthrax linked to intentional dissemination of Bacillus anthracis spores were identified in the U.S. Five of these cases were fatal.4 Mechanism of Action Virulence components of Bacillus anthracis include an antiphagocytic polypeptide capsule and three proteins known as protective antigen (PA)
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Of those, 28 were enrolled into the study arm to receive the licensed schedule (initial injections at 0, 2 and 4 weeks followed by additional doses at 6, 12 and 18 months) and were subsequently monitored for the occurrence of local and systemic adverse events.
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Geriatric Use No data regarding the safety of BioThrax are available for persons aged ~ 65 years. ADVERSE REACTIONS Pre Licensure Local Reactions- In an open-label safety study, 15,907 doses of BioThrax were administered to approximately 7,000 textile employees, laboratory workers and other at risk individuals (See Clinical Studies)
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Post Licensure Adverse Event Surveillance Data regarding potential adverse events following anthrax vaccination are available from the Vaccine Adverse Event Reporting System (VAERS) .8 The report of an adverse event to VAERS is not proof that a vaccine caused the event.
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Reporting Adverse Events Adverse events following immunization with BioThrax should be reported to the Medical Affairs Division of BioPort Corporation (517) 327-1675 during regular working hours and (517)
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Chen, R.T., et al., 1994. The Vaccine Adverse Event Reporting System (VAERS)
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