Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, SUSPENSION
**2 DOSAGE AND ADMINISTRATION** **2.1 Preparation for Administration** Use a separate 1- or 1½ -inch 23- or 25-gauge sterile needle and syringe for each patient to avoid transmission of viral hepatitis and other infectious agents. Shake the bottle thoroughly to ensure that the suspension is homogeneous during withdrawal. Inspect visually for particulate matter and discoloration prior to administration. If the product appears discolored or has visible particulate matter, DISCARD THE VIAL. **2.2 Dose and Schedule** Immunization consists of a series of 5 intramuscular doses administered at 0 and 4 weeks and 6, 12 and 18 months. Select a different injection site for each sequential injection of this vaccine. Do not mix with any other product in the syringe. Individuals should not be considered protected until they have received the full series of vaccinations. Do not inject BioThrax intravenously or intradermally. Yearly booster injections of 0.5 mL intramuscularly are recommended for those who remain at risk. When medically indicated, such as in persons with coagulation disorders or receiving medications that affect coagulation (e.g. warfarin), BioThrax may be administered by the subcutaneous route.
INTRAMUSCULAR
Medical Information
**1 INDICATIONS AND USAGE** BioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by _Bacillus anthracis_, in persons between 18 and 65 years of age whose occupation or other activities place them at high risk of exposure. Since the risk of anthrax infection in the general population is low, routine immunization is not recommended. The safety and efficacy of BioThrax in a post-exposure setting have not been established.
**4 CONTRAINDICATIONS** The use of BioThrax is contraindicated in persons with a history of anaphylactic or anaphylactic-like reaction following a previous dose if BioThrax.
J07AC01
anthrax antigen
Manufacturer Information
EMERGENT SALES AND MARKETING SINGAPORE PTE. LTD.
Hollister-Stier Laboratories LLC (Filling)
Emergent BioDefense Operations Lansing LLC
Active Ingredients
Documents
Package Inserts
Bio Thrax suspension for injection 100ug per ml PI.pdf
Approved: June 8, 2011