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

sandoz inc - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: * efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. data animal data oral administration of gatifloxacin to pregnant rats throughout organogenesis produ

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

pacific pharma, inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: - aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group* streptococcus oralis* streptococcus pneumoniae - aerobic gram-negative bacteria: haemophilus influenzae *efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution 0.5% is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions ( 5.1 )] . risk summary there are no available data on the use of gatifloxacin ophthalmic solution 0.5% in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of ga

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

akorn - gatifloxacin anhydrous (unii: 81485y3a9a) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin anhydrous 5 mg in 1 ml - gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: *efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. data animal data oral administration of gatifloxacin to pregnant rats throughout organogenesis produced t

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

lupin limited - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group* streptococcus oralis * streptococcus pneumoniae aerobic gram-negative bacteria: haemophilus influenzae * efficacy for this organism was studied in fewer than 10 infections. none pregnancy category c teratogenic effects: there were no teratogenic effects observed in rats or rabbits following oral gatifloxacin doses up to 50 mg/kg/day (approximately 1000-fold higher than the maximum recommended ophthalmic dose). however, skeletal/craniofacial malformations or delayed ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats given ≥150 mg/kg/day (approximately 3000-fold higher than the maximum recommended ophthalmic dose). in a perinatal/postnatal study, increased late post-implantation loss and neonatal/perinatal m

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

lupin pharmaceuticals, inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: - aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group*   streptococcus oralis* streptococcus pneumoniae - aerobic gram-negative bacteria: haemophilus influenzae * efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution, 0.5% is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution, 0.5% in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats

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

allergan, inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - zymaxid® is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:    - aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group* streptococcus oralis * streptococcus pneumoniae - aerobic gram-negative bacteria: haemophilus influenzae *efficacy for these organisms were studied in fewer than 10 infections.   zymaxid®  is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions ( 5.1 )] . risk summary there are no available data on the use of zymaxid® in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats during late gestation through lactation did not produce a

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

physicians total care, inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin - unii:l4618bd7kj) - gatifloxacin 5 mg in 1 ml - zymaxid® (gatifloxacin ophthalmic solution) 0.5% solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group* streptococcus oralis * streptococcus pneumoniae aerobic gram-negative bacteria: haemophilus influenzae * efficacy for this organism was studied in fewer than 10 infections. none pregnancy category c teratogenic effects: there were no teratogenic effects observed in rats or rabbits following oral gatifloxacin doses up to 50 mg/kg/day (approximately 1000-fold higher than the maximum recommended ophthalmic dose). however, skeletal/craniofacial malformations or delayed ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats given ≥150 mg/kg/day (approximately 3000-fold higher than the maximum recommended ophthalmic dose). in a perinatal/postnatal study, increased late post-implantation l

Canada - English - Health Canada

apotex inc - gatifloxacin (gatifloxacin hemihydrate) - solution - 0.3% - gatifloxacin (gatifloxacin hemihydrate) 0.3% - antibacterials

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

mylan pharmaceuticals inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: * efficacy for these organisms were studied in fewer than ten infections. gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)] . there are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. oral administration of gatifloxacin to pregnant rats throughout organogenesis produced teratogenic effects in rat

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

torrent pharmaceuticals limited - gatifloxacin anhydrous (unii: 81485y3a9a) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin ophthalmic solution 0.5 % is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: •    aerobic gram-positive bacteria:             staphylococcus aureus             staphylococcus epidermidis             streptococcus mitis group *             streptococcus oralis*             streptococcus pneumoniae •    aerobic gram-negative bacteria:             haemophilus influenzae *efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution 0.5% is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions ( 5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution 0.5% in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout