This medication is an active immunization agent 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.
Adults- 0.5 mL as 5 intramuscular doses at day 0, week 4, then 6, 12, and 18 months. Yearly booster injections of 0.5 mL are recommended for those who remain at risk.
It comes as a solution for injection, to be administered by a healthcare provider into the large muscle.
• Caution needed for elderly, children, pregnant and breastfeeding women. Select a different injection site for each sequential injection of this vaccine.
• BioThrax may be administered by the subcutaneous route for the persons with coagulation disorders.
• Most Common :
Injection site tenderness, pain, warmth, muscle pain, arm motion limitation, fatigue and headache.
• Central Nervous System : Tingling, tremor, nerve disease, dizziness, seizures, tremors, aseptic meningitis, encephalitis, transverse myelitis, cerebrovascular accident, facial palsy, hearing and visual disorders, Guillain-Barre Syndrome, and multiple sclerosis have been reported rarely; however, causality has not been established.
• Skin : Itching, rash, hair loss, subcutaneous nodule, induration, and local pruritus.
• Eye and ENT : Throat pain.
• Gastrointestinal : Nausea, anorexia, diarrhea.
• Hypersensitivity : Angioedema, rash, hives, itching, redness of the skin, and Stevens-Johnson syndrome.
• Musculoskeletal : Back pain, neck pain, joint sprain, rigors, joint pain, damaged skeletal muscle.
• Respiratory : Upper respiratory tract infection, transient respiratory difficulty.
• Miscellaneous : Painful menstrual cycle, fever, chills, and influenza-like illness.
Avoid excess dosage.
Store at 2°C to 8°C (36°F to 46°F). Do not freeze.
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