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The Anthrax Vaccine: Is It Safe? Does It Work? (2002)
Institute of Medicine (IOM)

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. "Appendix D Anthrax Vaccine Adsorbed Package Inserts." The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press, 2002.

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The Anthrax Vaccine: Is it Safe? Does it Work?
HOW SUPPLIED/STORAGE

Anthrax Vaccine Adsorbed (BioThraxTM) is supplied in 5 mL multidose vials.

THIS PRODUCT IS TO BE STORED AT 2ºC TO 8ºC (36 TO 46ºF). Do not freeze. Do not use after the expiration date given on the package.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to ascertain whether BioThrax has carcinogenic action, or any effect on fertility.

REFERENCES

1. Meselson, M., et al., 1994. The Sverdlosk anthrax outbreak of 1979. Science 266:1201-8.

2. Henderson, D.W., Peacock, S., Belton, F.C., 1956. Observations on the prophylaxis of experimental pulmonary anthrax in the monkey. J. Hygiene, 54:28-36.

3. Brachman, P.S., 1980. Inhalation Anthrax. Ann. NY Acad. Science, 353:83-93.

4. Update: Investigation of bioterrorism-related anthrax—Connecticut, 2001. MMWR. 2001; 50:1077-9.

5. Brachman, P.S., & A. M. Friedlander. 1999. Anthrax. In Vaccines, Third Edition, Plotkin & Orenstein (eds.), pp. 629-637.

6. Brachman, P.S., et al., 1962. Field Evaluation of a Human Anthrax Vaccine. Amer. J. Public Health, 52:632-645.

7. Centers for Disease Control and Prevention. General recommendations on immunization recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1994; Vol. 43 (No. RR-1).

8. Chen, R.T., et al., 1994. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 12(6): 542-550.

Revision: January 31, 2002

Rx Only---Federal (U.S.A.) law prohibits dispensing without a prescription.

Manufactured by

BIOPORT CORPORATION

Lansing, Michigan 48906

U.S. License No. 1260

50483-04

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