can affect reproduction capacity. Anthrax Vaccine Adsorbed should be given to pregnant women only if clearly needed.

  1. Pediatric Use: This antigen should be administered only to healthy men and women from 18 to 65 years of age because investigations to date have been conducted exclusively in that population.

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(1). This reaction usually occurs within 24 hours and begins to subside by 48 hours. Occasionally, the erythema increases to 3 to 5 cm in diameter. Local reactions tend to increase in severity by the 5th injection and then may decrease in severity with subsequent doses.

Moderate local reactions which occur in 4 per cent of recipients of a second injection are defined by an inflammatory reaction greater than 5 cm diameter.

These may be pruritic. Subcutaneous nodules may occur at the injection site and persist for several weeks in a few persons. A moderate local reaction can occur if the vaccine is given to anyone with a past history of anthrax infection.

More severe local reactions are less frequent and consist of extensive edema of the forearm in addition to the local inflammatory reaction. All local reactions have been reversible.

Systemic Reactions: Systemic reactions which occur in fewer than 0.2 per cent of recipients have been characterized by malaise and lassitude. Chills and fever have been reported in only a few cases. In such instances, immunization should be discontinued.

All adverse reactions thought by a physician possibly to have been related to this product should be directed to the BioPort Corporation (517) 327-1500 during regular working hours and (517) 327-7200 during off hours.

DOSAGE AND ADMINISTRATION
Dosage

Primary immunization consists of three subcutaneous injections, 0.5 mL each, given 2 weeks apart followed by three additional subcutaneous injections, 0.5 mL each, given at 6, 12 and 18 months(1).

If immunity is to be maintained, subsequent booster injections of 0.5 mL of anthrax vaccine at one year intervals are recommended.



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