USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - moxifloxacin hydrochloride is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]) ,   haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies ( 14.3 )] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin hydrochloride is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes [see clinical studies ( 14.4 )]. moxifloxacin hydrochloride is indica

USA - engelsk - NLM (National Library of Medicine)

novel laboratories, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - moxifloxacin hydrochloride is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies (14.3)] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin hydrochloride is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes [see clinical studies (14.4)]. moxifloxacin hydrochloride is indicated in ad

USA - engelsk - NLM (National Library of Medicine)

redpharm drug, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - 1.1 community acquired pneumonia moxifloxacin hydrochloride is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies (14.3)]. mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. 1.2 uncomplicated skin and skin structure infections moxifloxacin hydrochloride is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyoge

USA - engelsk - NLM (National Library of Medicine)

fresenius kabi norge as - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg in 250 ml - moxifloxacin injection is indicated in adults (18 years of age or older) for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant isolates*), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae . * mdrsp, multi-drug resistant streptococcus pneumoniae includes isolates previously known as prsp (penicillin-resistant s. pneumoniae ), and are isolates resistant to two or more of the following antibiotics: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole [see  clinical studies (14.2)] . moxifloxacin injection is indicated in adu

USA - engelsk - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - moxifloxacin tablets are indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae , moraxella catarrhalis , methicillin-susceptible staphylococcus aureus , klebsiella pneumoniae , mycoplasma pneumoniae , or chlamydophila pneumoniae  [see clinical studies (14.3)] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes  [see clinical studies (14.4)] . moxifloxacin tablets are indicated in adult patie

USA - engelsk - NLM (National Library of Medicine)

avpak - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs, moxifloxacin hydrochloride tablets 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. moxifloxacin hydrochloride tablets are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible isolates of the designated microorganisms in the conditions listed below [see dosage and administration (2) and use in specific populations (8.5)] . culture and susceptibility testing  

USA - engelsk - NLM (National Library of Medicine)

fresenius kabi usa, llc - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg in 250 ml - moxifloxacin injection is indicated in adults (18 years of age or older) for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant isolates*), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae . * mdrsp, multi-drug resistant streptococcus pneumoniae includes isolates previously known as prsp (penicillin-resistant s. pneumoniae ), and are isolates resistant to two or more of the following antibiotics: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole [see clinical studies (14.2)] . moxifloxacin injection is indicated in adults (18 years of age or older) for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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