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).

USA - engelsk - NLM (National Library of Medicine)

rebel distributors corp - 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.

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

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).

USA - engelsk - NLM (National Library of Medicine)

akorn - strides, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - injection - 40 mg in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin injection usp and other antibacterial drugs, tobramycin injection usp 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 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 pediatric patient and adult caused by p. aeruginosa, e. coli., and klebsiella spp lower respiratory tract infections caused by p. aeruginosa, klebsiella spp, enterobacter spp, serratia spp, e. coli, and s. aureus (penicillinase and non-penicillinase-producing strains) serious ce

USA - engelsk - 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.

USA - engelsk - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 1.2 g in 30 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 s

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.

USA - engelsk - NLM (National Library of Medicine)

h.j. harkins company, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 3 mg in 1 ml - tobramycin ophthalmic solution 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 is contraindicated in patients with known hypersensitivity to any of its components.

USA - engelsk - NLM (National Library of Medicine)

somerset therapeutics, llc - 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 0.3%. 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.