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

xellia pharmaceuticals aps - polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - polymyxin b 500000 - acute infections caused by susceptible strains of pseudomonas aeruginosa. polymyxin b sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of ps. aeruginosa . it may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of ps. aeruginosa . it may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: h influenzae , specifically meningeal infections. escherichia coli , specifically urinary tract infections. aerobacter aerogenes , specifically bacteremia. klebsiella pneumoniae , specifically bacteremia. note: in meningeal infections, polymyxin b sulfate should be administered only by the intrathecal route. to reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin b and other antibacterial drugs, polymyxin b should be used

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

general injectables & vaccines, inc - gentamicin sulfate (unii: 8x7386qrlv) (gentamicin - unii:t6z9v48ikg) - gentamicin 40 mg in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. gentamicin sulfate injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: pseudomonas aeruginosa, proteus species (indole-positive and indole-negative), escherichia coli, klebsiella-enterobacter-serratia species, citrobacter species, and staphylococcus species (coagulase-positive and coagulase-negative). clinical studies have shown gentamicin sulfate injection, usp to be effective in bacterial neonatal sepsis; bacter

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

phebra pty ltd - tobramycin sulfate, quantity: 762.24 mg (equivalent: tobramycin, qty 500 mg) - injection, concentrated - excipient ingredients: sulfuric acid; water for injections; sodium hydroxide - tobra-day is indicated for once daily intravenous use in the treatment of cystic fibrosis patients (greater than 5 years old) with acute pulmonary exacerbations caused by susceptible organisms.

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

hospira, inc. - gentamicin sulfate (unii: 8x7386qrlv) (gentamicin - unii:t6z9v48ikg) - gentamicin 40 mg in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. gentamicin sulfate injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: pseudomonas aeruginosa , proteus species (indole-positive and indole-negative), escherichia coli , klebsiella-enterobacter-serratia species, citrobacter species, and staphylococcus species (coagulase-positive and coagulase-negative). clinical studies have shown gentamicin sulfate injection, usp to be effective in bacterial neonatal seps

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

hospira australia pty ltd - amikacin sulfate, quantity: 333.65 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium metabisulfite - short term treatment of serious infections caused by susceptible strains of gram-negative bacteria, including pseudomonas species.

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

insmed incorporated - amikacin (unii: 84319sgc3c) (amikacin - unii:84319sgc3c) - limited population: arikayce® is indicated in adults, who have limited or no alternative treatment options, for the treatment of mycobacterium avium complex (mac) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. as only limited clinical safety and effectiveness data for arikayce are currently available, reserve arikayce for use in adults who have limited or no alternative treatment options. this drug is indicated for use in a limited and specific population of patients. this indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6. clinical benefit has not yet been established [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitati

Israel - English - Ministry of Health

truemed ltd, israel - amikacin as sulfate - suspension for inhalation - amikacin as sulfate 70 mg/ml - amikacin - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis. consideration should be given to official guidance on the appropriate use of antibacterial agents.

Ireland - English - HPRA (Health Products Regulatory Authority)

hospira uk ltd - amikacin sulfate - solvent for parenteral use - 250mg/ml mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

bristol-myers squibb (holdings) limited - amikacin sulfate - solution for injection - 250 %v/v

Israel - English - Ministry of Health

medic trim healthcare ltd - amikacin as sulfate 100 mg / 2 ml - solution for injection - amikacin - treatment of serious nosocomial gram-negative bacillary and in some gram-positive infections in hospitals where resistance to gentamicin and tobramycin has been found