Biothrax

For intramuscular or subcutaneous injection only.

2.1 Dose and Schedule

Administer BioThrax as a three-dose primary series of intramuscular injections of 0.5 mL each at 0, 1, and 6 months. Administer booster injections of 0.5 mL intramuscularly at 12 and 18 months after initiation of the series. For those who remain at risk, administer booster injections at 1-year intervals thereafter.

Individuals are not considered protected until they have completed the three-dose primary immunization series.

BioThrax may be administered by the subcutaneous route (for example, in persons who are at risk for hematoma formation following intramuscular injection). The schedule for BioThrax administered subcutaneously is 0, 2, 4 weeks, and 6 months with booster doses at 12 and 18 months, and at 1 year intervals thereafter.

Select a different injection site (e.g. alternating arms) for each sequential injection of this vaccine. Do not mix with any other product in the syringe.

The optimal schedule for catch up of missed or delayed booster doses is unknown. [See Clinical Studies (14)]

2.2 Preparation for Administration

Shake the vial thoroughly to ensure that the suspension is homogeneous during withdrawal. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For intramuscular administration, use a 1- or 1½ -inch 23- or 25-gauge sterile needle and syringe.

BioThrax may be administered by the subcutaneous route using a ⅝-inch, 25- to 27-gauge sterile needle and syringe.

Use a separate sterile needle and syringe to withdraw a single dose for each patient.