United States - English - 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

United States - English - 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.

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

xellia pharmaceuticals aps - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 1200 mg in 30 ml - tobramycin for injection, usp 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 central-nervous-system infections (meningitis) caused by susceptible organisms intra-abdominal infections, including peritonitis, caused by e. coli, klebsiella   spp, and enterobacter spp skin, bone, and skin structure infections caused by p. aeruginosa , proteus spp, e. coli , klebsiella spp, enterobacter s pp, and s. aureus complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus spp (indole-positive and indole-negative), e. coli , klebsiella spp, enterobacter spp, serratia spp, s. aureus , p

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

sandoz inc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 300 mg in 5 ml - tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with p. 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). tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

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

teva pharmaceuticals usa, inc. - 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 inhalation solution use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramy

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

akorn - 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 inhalation solution use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramy

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

bausch & lomb incorporated - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - tobramycin 3 mg in 1 ml - tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye

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

nucare pharmaceuticals,inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - tobramycin 3 mg in 1 ml - tobramycin and dexamethasone ophthalmic suspension is indicated for steroid- responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye

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

physicians total care, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - tobramycin 3 mg in 1 ml - tobramycin and dexamethasone ophthalmic suspension is indicated for steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye

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

rebel distributors corp - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - tobramycin 3 mg in 1 ml - tobramycin and dexamethasone ophthalmic suspension is indicated for steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye