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BIOTHRAX (ANTHRAX VACCINE ADSORBED) SUSPENSION FOR INJECTION 50μG/DOSE (NOMINAL) [SIN13967P]

Active ingredients: BIOTHRAX (ANTHRAX VACCINE ADSORBED) SUSPENSION FOR INJECTION 50μG/DOSE (NOMINAL)

Last updated 26 October 2025

Product Info

BIOTHRAX (ANTHRAX VACCINE ADSORBED) SUSPENSION FOR INJECTION 50μG/DOSE (NOMINAL)

[SIN13967P]

Product information

Active Ingredient and Strength

ANTHRAX ANTIGEN PROTEIN - 50 MCG/DOSE (NOMINAL)

Dosage Form

INJECTION, SUSPENSION

Manufacturer and Country

HOLLISTER-STIER LABORATORIES LLC (FILLING) - UNITED STATES
EMERGENT BIODEFENSE OPERATIONS LANSING LLC - UNITED STATES

Registration Number

SIN13967P

Licence Holder

EMERGENT SALES AND MARKETING SINGAPORE PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J07AC01

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.

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.

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.