United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - bacillus calmette-guerin substrain tice live antigen (unii: 2xq558l16z) (bacillus calmette-guerin substrain tice live antigen - unii:2xq558l16z) - bacillus calmette-guerin substrain tice live antigen 50 mg - bcg vaccine (tice® strain) is indicated for the prevention of tuberculosis in persons not previously infected with m. tuberculosis who are at high risk for exposure. as with any vaccine, immunization with bcg vaccine may not protect 100% of susceptible individuals. the advisory committee on immunization practices (acip) and the advisory committee for the elimination of tuberculosis has recommended that bcg vaccination be considered in the following circumstances.{3} bcg vaccination is recommended for infants and children with negative tuberculin skin tests who are (a) at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy, or (b) continuously exposed to persons with infectious pulmonary tuberculosis who have bacilli resistant to isoniazid and rifampin, and the child cannot be separated from the presence of the infectious patient.{3} bcg vaccination of hcws should be considered on an individual basis in settings where (a) a high percentage of tb patients are infected with m. tuberculosis strains resistant to both isoniazid and rifampin, (b) transmission of such drug resistant m. tuberculosis strains to hcws and subsequent infection are likely, and (c) comprehensive tb infection control precautions have been implemented and have not been successful. vaccination should not be required for employment or for assignment of hcws in specific work areas. hcws considered for bcg vaccination should be counseled regarding the risks and benefits associated with both bcg vaccinations and tb preventive therapy.{3} bcg vaccination is not recommended for hcws in settings in which the risk for m. tuberculosis transmission is low.{3} bcg vaccine for prevention of tuberculosis should not be given to persons (a) whose immunologic responses are impaired because of hiv infections, congenital immunodeficiency such as chronic granulomatous disease or interferon gamma receptor deficiency, leukemia, lymphoma, or generalized malignancy or (b) whose immunologic responses have been suppressed by steroids, alkylating agents, antimetabolites, or radiation.{3} bcg vaccine should not be administered to hiv-infected or immunocompromised infants, children, or adults. prior to administration, the possibility of allergic reactions should be assessed. allergy to any component of bcg vaccine or an anaphylactic or allergic reaction to a previous dose of bcg vaccine are contraindications for vaccination. bcg vaccine is not a vaccine for the treatment of active tuberculosis. bcg vaccine should not be used in infants, children, or adults with severe immune deficiency syndromes. children with a family history of immune deficiency disease should not be vaccinated; if they are, an infectious disease specialist should be consulted and anti-tuberculous therapy administered if clinically indicated.{18} please read this leaflet carefully before administering bcg vaccine. the vaccine is to be administered after fully explaining the risks and benefits to the vaccinee, parent, or guardian. bcg vaccination should not be given to individuals previously infected with m. tuberculosis. the sterile, single-use multiple puncture device is for use with the bcg vaccine only. figure 1 figure 2 figure 5 caution: federal law restricts this device to sale by or on the order of a physician. multiple puncture devices may be obtained separately from the order management center, merck sharp & dohme llc, 351 north sumneytown pike, north wales, pa 19454-2505, telephone number: 800-637-2579.

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - mycobacterium bovis (bacillus calmette and guerin (bcg) strain), quantity: 1.5 mg - injection, powder for - excipient ingredients: monosodium glutamate monohydrate - bcg vaccine is recommended for active immunisation in high risk groups. the nhmrc recommendation for bcg vaccination are: bcg is recommended for use in 3 groups of infants: . aboriginal and torres strait islander neonates in regions of high incidence; . neonates born to patients with leprosy; . children under the age of 5 years who will be travelling to live in countries of high tuberculosis prevalence for long periods. bcg vaccination should be considered for the following children and adolescents: .neonates who will be living in a household which includes immigrants or visitors recently arrived from countries of high prevalence (this also applies to neonates in families who have returned to visit the homes of relatives in countries of high prevalence); . children and adolescents aged less than 16 years who continue to be exposed to a patient with active tuberculosis, and where the child or adolescent cannot be placed on isoniazid therapy or the active case has organisms resistant to both isoniazid and rifampicin. in addition to the above categories, there are other groups of individuals who are at increased risk of tuberculosis, but for whom the value of bcg vaccine is less certain. these groups are: . health care workers with a high risk of exposure to tuberculosis, such as staff of chest clinics and tuberculosis wards, physiotherapists, diagnostic laboratory staff, autopsy room staff, and most medical and nursing staff of public hospitals; . travellers over the age of 5 years who will spend prolonged periods in countries of high tuberculosis prevalence. . a tuberculin test should be performed prior to bcg vaccination in all individuals, except in infants under 6 months of age. only subjects in whom a test dose of 10 units produces less than 5mm of induration should receive bcg. bcg vaccination has no value in the treatment of tuberculosis disease.

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية الرعاية الدوائية - pharma care drug store - bcg 2 x 10(8)-3x10(9) viable units - 2 x 10(8)-3x10(9) viable units

Uganda - English - National Drug Authority

serum institute of india ltd. - bcg vaccine(freeze dried) - parenteral ordinary dry vials - 1.33*100000 c.f.u/0.1ml

Kenya - English - Pharmacy and Poisons Board

final bulk for onco bcg 40 mg/ml” as the active… - intravesical solution/solution for injection - bacillus calmette-guerin strain: 40 mg/ml - bcg vaccine

Kenya - English - Pharmacy and Poisons Board

statens serum institut 5 artillerivej dk 2300 copenhagen s denmark - bcg vaccine danish strain 1331 - powder and solvent for suspension for injecti - 2-8 x 105 cfu - bacterial vaccines: tuberculosis vaccines

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

serum institute of india pvt. ltd. (siipl), india - bcg vaccine - live, freeze-dried vaccine - 2 x 105 and 8 x 105 cfu/ml

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

radiantaire sdn bhd - bcg live -

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - bacillus calmette-guerin 0.75 mg/ml (when reconstituted with diluted sauton ajv (danish strain 1331) (vaccine)) - suspension for injection - 0.75 mg/ml - active: bacillus calmette-guerin 0.75 mg/ml (when reconstituted with diluted sauton ajv (danish strain 1331) (vaccine)) excipient: monosodium glutamate asparagine citric acid monohydrate dibasic potassium phosphate ferric ammonium citrate glycerol magnesium sulfate water for injection - active immunisation against tuberculosis

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

radiantaire sdn bhd - bcg live -