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

novartis pharmaceuticals australia pty ltd - tobramycin, quantity: 3 mg/ml - eye drops, solution - excipient ingredients: sodium chloride; boric acid; benzalkonium chloride; sodium hydroxide; tyloxapol; hydrochloric acid; sodium sulfate; purified water - tobrex(tobramycin) eye drops are topical antibiotics 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 tobrex.

Australia - engelsk - 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).

Australia - engelsk - 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).

Australia - engelsk - 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).

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

juno pharmaceuticals pty ltd - tobramycin, quantity: 60 mg/ml - inhalation, conventional - excipient ingredients: sulfuric acid; sodium hydroxide; water for injections; sodium chloride - tobramycin solution for inhalation 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).

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

pfizer australia pty ltd - tobramycin, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; sulfuric acid; sodium metabisulfite; disodium edetate - 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 cefalosporin 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 in the product information document.

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

pfizer australia pty ltd - tobramycin, quantity: 80 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium metabisulfite; phenol; water for injections; sulfuric acid; disodium edetate - for the treatment of serious infections of the following type where they are caused by susceptible organisms: skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. if susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should be instituted.,note that bacterial cultures should bo obtained before and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if the organisms are resistant, 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 cefalosporin 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, the severity of infection and the important additional concepts discussed in the product information leaflet.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 300 mg in 5 ml - tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with pseudomonas aeruginosa . safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (fev1 ) < 25% or > 75% predicted, or patients colonized with burkholderia cepacia [see clinical studies (14)]. tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. risk summary aminoglycosides can cause fetal harm. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [see warnings and precautions (5.5)]. although there are no available data on tobramycin use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inha

USA - engelsk - NLM (National Library of Medicine)

mwi - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 3 mg in 1 ml - tobramycin ophthalmic solution 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. clinical studies have shown tobramycin to be safe and effective for use in children. tobramycin ophthalmic solution 0.3% is contraindicated in patients with known hypersensitivity to any of its components.