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).

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).

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)

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).

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

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin for injection is indicated for the treatment of septicemia caused by susceptible isolates of p. aeruginosa, e. coli, and klebsiella spp., in adult and pediatric patients. tobramycin for injection is indicated for the treatment of lower respiratory tract infections caused by susceptible isolates of p. aeruginosa, klebsiella spp., enterobacter spp., serratia spp., e. coli, and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bacterial meningitis caused by susceptible bacteria in adult and pediatric patients. tobramycin for injection is indicated for the treatment of intra-abdominal infections, including peritonitis, caused by susceptible isolates of e. coli, klebsiella spp., and enterobacter spp. in adult and pediatric patients. tobramycin for injection is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bone infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients tobramycin for injection is indicated for the treatment of complicated urinary tract infections caused by susceptible isolates of p. aeruginosa, proteus spp., (indole-positive and indole-negative), e. coli, klebsiella spp., enterobacter spp., serratia spp., s. aureus, providencia spp., and citrobacter spp. in adult and pediatric patients to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin for injection and other antibacterial drugs, tobramycin for injection 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. tobramycin for injection is contraindicated in patients with a history of hypersensitivity to tobramycin or any other aminoglycoside [see warnings and precautions (5.4)] . risk summary aminoglycosides, including tobramycin for injection, can cause fetal harm when administered to a pregnant woman. 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 (5.3)]. in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, there were no adverse developmental outcomes at doses up to 3.2 times and 1.3 times the maximum recommended clinical dose based on body surface area; however, ototoxicity was not evaluated in the offspring from these studies (see data). advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. data animal data subcutaneous administration of tobramycin at doses of up to 100 mg/kg/day (rat) or 20 mg/kg/day (rabbit) during organogenesis was not associated with adverse developmental outcomes. these doses are 3.2 and 1.3 times the maximum recommended clinical daily dose of 5 mg/kg based on body surface area. doses of tobramycin ≥40 mg/kg/day were maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. ototoxicity was not evaluated in offspring during nonclinical reproductive toxicity studies with tobramycin. risk summary limited published data with tobramycin for injection in lactating women indicate that tobramycin is present in human milk. there are no data on the effects of tobramycin for injection on milk production. tobramycin may cause alteration in the intestinal flora of the breastfeeding infant. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin for injection and any potential adverse effects on the breastfed infant from tobramycin for injection or from the underlying maternal condition. use tobramycin for injection with caution in premature infants and neonates because of their renal immaturity and the resulting prolongation of serum half-life. for pediatric dosing information [see dosage and administration (2.3)]. similar to adults, monitor renal function and serum tobramycin concentrations in pediatric patients receiving tobramycin for injection. elderly patients may be at a higher risk of developing nephrotoxicity and ototoxicity while receiving tobramycin for injection [see warnings and precautions (5.1)]. tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function and serum tobramycin levels [see dosage and administration (2.6) and warnings and precautions (5.1)]. the dosage schedule of tobramycin for injection should be adjusted according to the degree of renal impairment and serum concentration [see dosage and administration (2.6)]. in patients undergoing hemodialysis, 25% to 70% of the administered dose may be removed, depending on the duration and type of dialysis.

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

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin for injection is indicated for the treatment of septicemia caused by susceptible isolates of p. aeruginosa, e. coli, and klebsiella spp., in adult and pediatric patients. tobramycin for injection is indicated for the treatment of lower respiratory tract infections caused by susceptible isolates of p. aeruginosa, klebsiella spp., enterobacter spp., serratia spp., e. coli, and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bacterial meningitis caused by susceptible bacteria in adult and pediatric patients. tobramycin for injection is indicated for the treatment of intra-abdominal infections, including peritonitis, caused by susceptible isolates of e. coli, klebsiella spp., and enterobacter spp. in adult and pediatric patients. tobramycin for injection is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bone infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients tobramycin for injection is indicated for the treatment of complicated urinary tract infections caused by susceptible isolates of p. aeruginosa, proteus spp., (indole-positive and indole-negative), e. coli, klebsiella spp., enterobacter spp., serratia spp., s. aureus, providencia spp., and citrobacter spp. in adult and pediatric patients to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin for injection and other antibacterial drugs, tobramycin for injection 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. tobramycin for injection is contraindicated in patients with a history of hypersensitivity to tobramycin or any other aminoglycoside [see warnings and precautions (5.4)] . risk summary aminoglycosides, including tobramycin for injection, can cause fetal harm when administered to a pregnant woman. 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 (5.3)]. in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, there were no adverse developmental outcomes at doses up to 3.2 times and 1.3 times the maximum recommended clinical dose based on body surface area; however, ototoxicity was not evaluated in the offspring from these studies (see data). advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. data animal data subcutaneous administration of tobramycin at doses of up to 100 mg/kg/day (rat) or 20 mg/kg/day (rabbit) during organogenesis was not associated with adverse developmental outcomes. these doses are 3.2 and 1.3 times the maximum recommended clinical daily dose of 5 mg/kg based on body surface area. doses of tobramycin ≥40 mg/kg/day were maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. ototoxicity was not evaluated in offspring during nonclinical reproductive toxicity studies with tobramycin. risk summary limited published data with tobramycin for injection in lactating women indicate that tobramycin is present in human milk. there are no data on the effects of tobramycin for injection on milk production. tobramycin may cause alteration in the intestinal flora of the breastfeeding infant. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin for injection and any potential adverse effects on the breastfed infant from tobramycin for injection or from the underlying maternal condition. use tobramycin for injection with caution in premature infants and neonates because of their renal immaturity and the resulting prolongation of serum half-life. for pediatric dosing information [see dosage and administration (2.3)]. similar to adults, monitor renal function and serum tobramycin concentrations in pediatric patients receiving tobramycin for injection. elderly patients may be at a higher risk of developing nephrotoxicity and ototoxicity while receiving tobramycin for injection [see warnings and precautions (5.1)]. tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function and serum tobramycin levels [see dosage and administration (2.6) and warnings and precautions (5.1)]. the dosage schedule of tobramycin for injection should be adjusted according to the degree of renal impairment and serum concentration [see dosage and administration (2.6)]. in patients undergoing hemodialysis, 25% to 70% of the administered dose may be removed, depending on the duration and type of dialysis.

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

mylan institutional llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - 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 citrobacter s

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

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - tobramycin 300mg - solution for inhalation - 300 mg/5ml - active: tobramycin 300mg excipient: sodium chloride sodium hydroxide sulfuric acid water for injection - tobramycin bnm 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 >75% predicted, or patients colonised with burkholderia cepacia.

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

gland pharma limited - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin injection 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. au