Estados Unidos - inglés - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - 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 pediatric patients. tobramycin ophthalmic solution usp, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Estados Unidos - inglés - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - 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

Estados Unidos - inglés - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution, usp 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 tobramycin following inhaled administration is expected to be minimal [see clinical pharmacology (12.3)] . there are risks to the mother associated with cystic fibrosis in pregnancy (see clinical considerations). in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, there were no adverse developmental outcomes; 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 defect, 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. clinical considerations disease-associated maternal and/or embryo/fetal risk cystic fibrosis may increase the risk for preterm delivery. data animal data no reproductive toxicity studies have been conducted with tobramycin inhalation solution (tobramycin administered by inhalation). however, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes. doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin. risk summary there are no data on the presence of tobramycin in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk. however, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see clinical pharmacology (12.3)] . tobramycin may cause alteration in the intestinal flora of the breastfeeding infant (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin and any potential adverse effects on the breastfed infant from tobramycin or from the underlying maternal condition. clinical considerations tobramycin may cause intestinal flora alteration. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). the safety and efficacy of tobramycin inhalation solution in pediatric patients under 6 years of age has not been established. the use of tobramycin inhalation solution is not indicated in children <6 years of age [see indications and usage (1) and dosage and administration (2)]. clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. 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, it may be useful to monitor renal function [see warnings and precautions (5.3,)].

Estados Unidos - inglés - NLM (National Library of Medicine)

dr. reddy's laboratories inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - 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 tobr

Estados Unidos - inglés - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - 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.

Nueva Zelanda - inglés - 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.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

maple healthcare limited - tobramycin 300mg - solution for inhalation - 300 mg/5ml - active: tobramycin 300mg excipient: sodium chloride sodium hydroxide sulfuric acid water for injection - tobramycin wockhardt 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.

Estados Unidos - inglés - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - 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 t

Estados Unidos - inglés - NLM (National Library of Medicine)

northstar rxllc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - 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 tob

Estados Unidos - inglés - NLM (National Library of Medicine)

prasco, llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with pseudomonas aeruginosa . safety and efficacy have not been demonstrated in patients under the age of six years, patients with fev1 less than 40% or greater than 80% 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 [warnings and precautions ( 5.6 )] . although there are no available data on use of tobramycin inhalation solution in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected