BIOTHRAX Suspension for injection Ref.[9978] Active ingredients: Anthrax antigen

Source: FDA, National Drug Code (US)  Revision Year: 2015 

Product description

BioThrax (Anthrax Vaccine Adsorbed) is a sterile, milky-white suspension for intramuscular or subcutaneous injections made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis. The production cultures are grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins, inorganic salts, and sugars. The final product, prepared from the sterile filtrate culture fluid contains proteins, including the 83kDa protective antigen (PA) protein, released during the growth period and contains no dead or live bacteria. The final product is formulated to contain 1.2 mg/mL aluminum, added as aluminum hydroxide in 0.85% sodium chloride. The final product is formulated to contain 25 mcg/mL benzethonium chloride and 100 mcg/mL formaldehyde, added as preservatives.

Dosage Forms and Strengths

BioThrax is a suspension for injection (0.5 mL dose) in 5 mL multidose vials. See Description (11) for the complete listing of ingredients.

How Supplied

BioThrax is supplied in 5 mL multidose vials containing ten 0.5 mL doses.

NDC 64678-211-05 (vial), 64678-211-01 (carton)


Drug Countries
BIOTHRAX Poland, Singapore, United Kingdom, United States

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