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.

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 in 50 ml - tice® bcg is indicated for: - the treatment and prophylaxis of carcinoma in situ (cis) of the urinary bladder - the prophylaxis of primary or recurrent stage ta and/or t1 papillary tumors following transurethral resection (tur) limitations of use: - tice bcg is not recommended for stage tag1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. - tice bcg is not indicated for papillary tumors of stages higher than t1. tice® bcg should not be used in immunosuppressed patients with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., aids, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids). treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. seven to 14 days should elapse before bcg is administered following biopsy, tur, or traumatic catheterization. tice bcg should not be administered to persons with active tuberculosis. active tuberculosis should be ruled out in individuals who are ppd positive before starting treatment with tice bcg.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pencef pharma gmbh - amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate) - powder for oral suspension - 1000mg+ 125mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pencef pharma gmbh - amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate) - powder for oral suspension - 1000mg+ 125mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

serum institute of india pvt. ltd. - bcg vaccine(bacillus calmette guerin strain) - powder lyophilized for solution for injection - between 2x10^5 and 8x10^5 cfu/0,1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance pharmaceuticals ltd - connaught strain bacillus of calmette-guerin - powder for reconstitution for instillation - 81mg

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

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - bacillus calmette-guerin 500 mcfu (range: 2-8x10e8 cfu) - powder for injection - 500 mcfu - active: bacillus calmette-guerin 500 mcfu (range: 2-8x10e8 cfu) excipient: ammonia solution asparagine citric acid monohydrate dibasic potassium phosphate ferric ammonium citrate glycerol zinc formate lactose magnesium sulfate - oncotice is used as a treatment of flat urothelial cell carcinoma in situ (cis) of the bladder, and as an adjuvant therapy after transurethral resection (tur) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage ta (grade 2 or 3) or t1 (grade 1, 2 or 3). oncotice is only recommended for stage ta grade 1 papillary tumours when there is judged to be a high risk of tumour recurrence.

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft für klinische spezialpräparate mbh - bacillus calmette guérin (bcg) - powder and solvent for intravesical suspension - unknown - other immunostimulants; bcg vaccine

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme (uk) ltd - tice strain bacillus of calmette-guerin - powder for reconstitution for instillation - 12.5mg