Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - tobramycin - nebuliser solution - tobramycin 300 ml/5ml - antibacterials for systemic use

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

alphapharm pty ltd - tobramycin, quantity: 40 mg/ml - injection, solution - excipient ingredients: sulfuric acid; sodium hydroxide; water for injections; disodium edetate; sodium bisulfite - tobramycin is indicated in the treatment of the following serious infections caused by susceptible micro-organisms: - central nervous system infections, including meningitis; septicaemia and neonatal sepsis; gastro-intestinal infections, including peritonitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis; lower respiratory tract infections, including pneumonia, bronchopneumonia and acute bronchitis; bone, skin and skin structure infections, including burns.,tobramycin may be considered in serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use. aminoglycosides, including tobramycin, are not indicated in uncomplicated initial episodes or urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.,bacterial cultures should be obtained prior to and during treatment to isolate and identify aetiologic organisms and to test their susceptibility to tobramycin. if susceptibility tests show that the causative organism is resistant to tobramycin, other appropriate therapy should be instituted. in patients in whom gram negative septicaemia, neonatal sepsis, or meningitis is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, tobramycin therapy may be initiated before results of susceptibility studies are obtained. the decision to continue tobramycin therapy should be based upon the results of susceptibility studies, severity of the infection, and the important additional concepts discussed under precautions.

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

juno pharmaceuticals pty ltd - tobramycin -

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

sun pharma anz pty ltd - tobramycin, quantity: 300 mg - inhalation, conventional - excipient ingredients: sodium hydroxide; sulfuric acid; nitrogen; water for injections; sodium chloride - tobramycin solution is indicated for the management of cystic fibrosis patients with p. aeruginosa infections.,safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with fev1 ? 25 % or ? 80 % predicted at screening, or patients colonized with burkholderia cepacia (see clinical trials).

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

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 40 mg in 1 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginos a, klebsiella sp, enterobacter sp, serratia sp, e. coli , and s. aureus (penicillinase- and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli , klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa , proteus sp, e. coli , klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus sp (indole-positive and indole-negative), e. coli , klebsiella sp, enterobacter sp, serratia sp, s. aureus , providencia sp, and citrobacter sp. aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. in patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. the decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the warnings box above. to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. a hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin. a history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.

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

teva parenteral medicines, inc. - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 40 mg in 1 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginosa , klebsiella sp, enterobacter sp, serratia sp, e. coli , and s. aureus (penicillinase and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli , klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa , proteus sp, e. coli , klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus sp (indole-positive and indole-negative), e. coli , klebsiella sp, enterobacter sp, serratia sp, s. aureus , providencia sp, and citrobacte

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

lake erie medical dba quaity care products llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 3 mg in 1 ml - tobramycin ophthalmic solution usp, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution usp, 0.3%. clinical studies have shown tobramycin to be safe and effective for use in children. tobramycin ophthalmic solution usp, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

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

maple healthcare pty ltd - tobramycin, quantity: 60 mg/ml - inhalation, conventional - excipient ingredients: sodium hydroxide; sodium chloride; sulfuric acid; water for injections - tobramycin wockhardt solution is indicated for the management of cystic fibrosis patients with p. aeruginosa infections.,safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with fev1 less than or equal to 25 percent or more than or equal to 80 percent predicted at screening, or patients colonized with burkholderia cepacia (see clinical trials).

Malta - English - Medicines Authority

viatris healthcare limited damastown industrial park, mulhuddart, dublin 15, dublin , ireland - nebuliser solution - tobramycin 300 ml/5ml - antibacterials for systemic use

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

luminarie pty ltd - tobramycin, quantity: 60 mg/ml - inhalation, conventional - excipient ingredients: sodium hydroxide; sulfuric acid; water for injections; sodium chloride - tobramycin wkt solution is indicated for the management of cystic fibrosis patients with p. aeruginosa infections.,safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with fev1 less than or equal to 25 percent or more than or equal to 80 percent predicted at screening, or patients colonized with burkholderia cepacia (see clinical trials).