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BACILLE CALMETTE-GUERIN (BCG) - TUBERCULOSIS

Tuberculosis (TB) is a potentially serious infectious disease caused by the bacteria Mycobacterium tuberculosis. The bacteria spread from person to person through tiny droplets released during coughs and sneezes. Tuberculosis is rare in developed countries, mainly occurring as co-infection in people with HIV/AIDS. Tuberculosis is treatable with a combination of antibiotics, typically isoniazid and rifampicin, pyrazinamide, and ethambutol. The treatment typically lasts six months or more. Many tuberculosis strains are antibiotic-resistant, and other regimens must be used (Merck Manual). Bacille Calmette-Guerin (BCG) is a vaccine for tuberculosis disease. It is used in many countries with a higher prevalence of tuberculosis. In the United States, the BCG vaccine is only recommended for high-risk persons. It is administered to newborns at about four weeks of age (CDCNHS, ACIP). 

Proprietary name Product label Application number Labeler name
BCG Vaccine – TICE Strain DailyMed BLA103050 Merck Sharp & Dohme LLC
BCG Vaccine AJV – Danish Strain 1331 Medicines.org.uk PL 46796/0001 AJ Vaccines A/S
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