USA - engelsk - NLM (National Library of Medicine)

teva parenteral medicines, inc. - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 2 mg in 1 ml

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg - linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. linezolid is not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [ see warnings and precautions (5.4)]. nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [ see clinical studies (14 )]. community-acquired pneumonia caused by streptococcus pneumoniae, including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [ see clinical studies (14) ]. complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus pyogenes , or strept

USA - engelsk - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg - linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. linezolid tablets are not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [see warnings and precautions (5.4) ]. nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14) ]. community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14) ]. complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis , caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus py

USA - engelsk - NLM (National Library of Medicine)

novel laboratories, inc. - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg - linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. linezolid tablets are not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [see warnings and precautions (5.4)] . nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14)] . community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14)] . complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus pyo

USA - engelsk - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg - linezolid tablet is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. linezolid tablet is not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [see warnings and precautions (5.4) ]. nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14) ]. community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14) ]. complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis , caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus pyogen

USA - engelsk - NLM (National Library of Medicine)

allergan, inc. - ceftazidime (unii: 9m416z9qnr) (ceftazidime anhydrous - unii:dzr1ent301), avibactam sodium (unii: 9v824p8tai) (avibactam - unii:7352665165) - ceftazidime anhydrous 2 g - avycaz (ceftazidime and avibactam) in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (ciai) in adult and pediatric patients (at least 31 weeks gestational age) caused by the following susceptible gram-negative microorganisms: escherichia coli ,   klebsiella pneumoniae ,   proteus mirabilis, enterobacter cloacae, klebsiella oxytoca, citrobacter freundii complex, and pseudomonas aeruginosa . avycaz (ceftazidime and avibactam) is indicated for the treatment of complicated urinary tract infections (cuti) including pyelonephritis in adult and pediatric patients (at least 31 weeks gestational age) caused by the following susceptible gram-negative microorganisms: escherichia coli ,   klebsiella pneumoniae, enterobacter cloacae, citrobacter freundii complex, proteus mirabilis , and pseudomonas aeruginosa . avycaz (ceftazidime and avibactam) is indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (habp/vabp) in adult and pediatric patients (at least 31 weeks gestational age) caused by the following susceptible gram-negative microorganisms: klebsiella pneumoniae, enterobacter cloacae, escherichia coli, serratia marcescens, proteus mirabilis, pseudomonas aeruginosa, and haemophilus influenzae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of avycaz and other antibacterial drugs, avycaz 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. avycaz is contraindicated in patients with known serious hypersensitivity to the components of avycaz (ceftazidime and avibactam), avibactam containing products, or other members of the cephalosporin class [see warnings and precautions ( 5.2)] . risk summary there are no adequate and well-controlled studies of avycaz, ceftazidime, or avibactam in pregnant women. neither ceftazidime nor avibactam were teratogenic in rats at doses 40 and 9 times the recommended human clinical dose. in the rabbit, at twice the exposure as seen at the human clinical dose, there were no effects on embryofetal development with avibactam. the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population. because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. data animal data ceftazidime reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and showed no evidence of harm to the fetus due to ceftazidime. avibactam avibactam was not teratogenic in rats or rabbits. in the rat, intravenous studies with 0, 250, 500 and 1000 mg/kg/day avibactam during gestation days 6-17 showed no embryofetal toxicity at doses up to 1000 mg/kg/day, approximately 9 times the human dose based on exposure (auc). in a rat pre- and post-natal study at up to 825 mg/kg/day intravenously (11 times the human exposure based on auc), there were no effects on pup growth and viability. a dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups that was not associated with pathological changes to renal parenchyma or renal function, with renal pelvic dilatation persisting after female weaning pups became adults. rabbits administered intravenous avibactam on gestation days 6-19 at 0, 100, 300 and 1000 mg/kg/day showed no effects on embryofetal development at a dose of 100 mg/kg, twice the human exposure (auc). at higher doses, increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies were observed. risk summary ceftazidime is excreted in human milk in low concentrations. it is not known whether avibactam is excreted into human milk, although avibactam was shown to be excreted in the milk of rats. no information is available on the effects of ceftazidime and avibactam on the breast-fed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for avycaz and any potential adverse effects on the breastfed child from avycaz or from the underlying maternal conditions. data in a rat pre- and post-natal study at doses up to 825 mg/kg/day intravenously (11 times the human exposure based on auc), the exposure to avibactam was minimal in the pups in comparison to the dams. exposure to avibactam was observed in both pups and milk on pnd 7. the safety and effectiveness of avycaz in the treatment of cuti, ciai, and habp/vabp have been established in pediatric patients at least 31 weeks gestational age and older. use of avycaz is supported by evidence from adequate and well-controlled studies of avycaz in adults with cuti, ciai, and habp/vabp and additional pharmacokinetic and safety data from pediatric trials [see clinical pharmacology ( 12.3), clinical studies ( 14.1 and  14.2)] . the safety profile of avycaz in pediatric patients was similar to adults with ciai, cuti, and habp/vabp treated with avycaz [see adverse reactions ( 6.1) ] . the safety and effectiveness of avycaz in the treatment of cuti, ciai, and habp/vabp have not been established in pediatric patients less than 31 weeks gestational age. of the 1809 patients treated with avycaz in the phase 2 and phase 3 clinical trials 621 (34.5%) were 65 years of age and older, including 302 (16.7 %) patients 75 years of age and older. in the pooled phase 2 and phase 3 ciai avycaz clinical trials, 20% (126/630) of patients treated with avycaz were 65 years of age and older, including 49 (7.8%) patients 75 years of age and older. the incidence of adverse reactions in both treatment groups was higher in older patients (≥ 65 years of age) and similar in both treatment groups; clinical cure rates for patients 65 years of age or older were 73.0% (73/100) in the avycaz plus metronidazole arm and 78.6% (77/98) in the meropenem arm. in the phase 3 cuti trial, 30.7% (157/511) of patients treated with avycaz were 65 years of age or older, including 78 (15.3%) patients 75 years of age or older. the incidence of adverse reactions in both treatment groups was lower in older patients (≥ 65 years of age) and similar between treatment groups. among patients 65 years of age or older in the phase 3 cuti trial, 66.1% (82/124) of patients treated with avycaz had symptomatic resolution at day 5 compared with 56.6% (77/136) of patients treated with doripenem. the combined response (microbiological cure and symptomatic response) observed at the test-of-cure (toc) visit for patients 65 years of age or older were 58.1% (72/124) in the avycaz arm and 58.8% (80/136) in the doripenem arm. in the phase 3 habp/vabp trial, 54.1% (236/436) of patients treated with avycaz were 65 years of age or older, including 129 (29.6%) patients 75 years of age or older. the incidence of adverse reactions in patients ≥ 65 years of age was similar to patients < 65 years of age. the 28-day all-cause mortality was similar between treatment groups for patients 65 years of age or older (12.7% [29/229] for patients in the avycaz arm and 11.3% [26/230] for patients in the meropenem arm). ceftazidime and avibactam are known to be substantially excreted by the kidney; therefore, the risk of adverse reactions to ceftazidime and avibactam may be greater in patients with decreased renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. healthy elderly subjects had 17% greater exposure relative to healthy young subjects when administered the same single dose of avibactam, which may have been related to decreased renal function in the elderly subjects. dosage adjustment for elderly patients should be based on renal function [ see dosage and administration ( 2.2) and clinical pharmacology ( 12.3) ]. dosage adjustment is required in adult patients with moderately or severely impaired renal function (crcl 50 ml/min or less). for patients with changing renal function, crcl should be monitored at least daily, particularly early in treatment, and dosage of avycaz adjusted accordingly. both ceftazidime and avibactam are hemodialyzable; thus, avycaz should be administered after hemodialysis on hemodialysis days [ see dosage and administration ( 2.2) and clinical pharmacology ( 12.3) ] . dosage adjustment is also required in pediatric patients with renal impairment from 2 years to less than 18 years of age with egfr 50 ml/min/1.73 m2 or less. there is insufficient information to recommend a dosing regimen for pediatric patients younger than 2 years of age with renal impairment [see dosage and administration ( 2.3) and clinical pharmacology ( 12.3)] .

USA - engelsk - NLM (National Library of Medicine)

celltrion, inc. - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. linezolid is not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [see warnings and precautions (5.4) ]. nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14) ]. community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14) ]. complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis , caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus pyogenes , or strept

USA - engelsk - NLM (National Library of Medicine)

xellia pharmaceuticals usa llc - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli , enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae , streptococcus anginosus grp. (includes s. anginosus , s. intermedius , and s. constellatus ), streptococcus pyogenes , enterobacter cloacae , klebsiella pneumoniae , and bacteroides fragilis . tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii , enterobacter cloacae , escherichia coli , klebsiella oxytoca , klebsiella pneumoniae , enterococcus faecalis (vancomycin-susceptible isolates) staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus , s. int

USA - engelsk - NLM (National Library of Medicine)

fresenius kabi usa, llc - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline 50 mg in 5 ml - tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), streptococcus pyogenes, enterobacter cloacae, klebsiella pneumoniae, and bacteroides fragilis.  tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), bacteroides fragilis, bacteroides thetaiotaomicron, bacteroides uniformis, bacteroides vulgatus, clostridium perfringens, and peptostreptococcus micros. tigecycline for injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of  streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, haemophilus influenzae , and legionella pneumophila . tigecycline for injection is not indicated for the treatment of diabetic foot infections.  a clinical trial failed to demonstrate non-inferiority of tigecycline for injection for treatment of diabetic foot infections. tigecycline for injection is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia.  in a comparative clinical trial, greater mortality and decreased efficacy were reported in tigecycline-treated patients [see warnings and precautions (5.2)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline and other antibacterial drugs, tigecycline for injection should be used only to treat  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. appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline.  tigecycline for injection may be initiated as empiric monotherapy before results of these tests are known.  tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline. reactions have included anaphylactic reactions [see  warnings and precautions (5.3) and adverse reactions (6.2)] . teratogenic effects—pregnancy category d [see warnings and precautions (5.6)] tigecycline was not teratogenic in the rat or rabbit.  in preclinical safety studies, 14 c-labeled tigecycline crossed the placenta and was found in fetal tissues, including fetal bony structures.  the administration of tigecycline was associated with reductions in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 times and 1 times the human daily dose based on auc in rats and rabbits, respectively (28 mcg•hr/ml and 6 mcg•hr/ml at 12 and 4 mg/kg/day).  an increased incidence of fetal loss was observed at maternotoxic doses in the rabbits with exposure equivalent to human dose. there are no adequate and well-controlled studies of tigecycline in pregnant women.  tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. results from animal studies using 14 c-labeled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats.  consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. it is not known whether this drug is excreted in human milk.  because many drugs are excreted in human milk, caution should be exercised when tigecycline is administered to a nursing woman [see warnings and precautions (5.7)] . use in patients under 18 years of age is not recommended.  safety and effectiveness in pediatric patients below the age of 18 years have not been established.  because of the increased mortality observed in tigecycline-treated adult patients in clinical trials, pediatric trials of tigecycline to evaluate the safety and efficacy of tigecycline were not conducted. in situations where there are no other alternative antibacterial drugs, dosing has been proposed for pediatric patients 8 to 17 years of age based on data from pediatric pharmacokinetic studies  [see dosage and administration (2.3) and clinical pharmacology (12.3)] . because of effects on tooth development, use in patients under 8 years of age is not recommended [see warnings and precautions (5.7)] . of the total number of subjects who received tigecycline in phase 3 clinical studies (n=2,514), 664 were 65 and over, while 288 were 75 and over.  no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out. no significant difference in tigecycline exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg dose of tigecycline [see clinical pharmacology (12.3) ]. no dosage adjustment is warranted in patients with mild to moderate hepatic impairment (child pugh a and child pugh b).  in patients with severe hepatic impairment (child pugh c), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours.  patients with severe hepatic impairment (child pugh c) should be treated with caution and monitored for treatment response [see clinical phar macology (12.3) and dosage and administration (2.2)] .

USA - engelsk - NLM (National Library of Medicine)

sandoz inc - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline 50 mg in 10 ml - tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), streptococcus pyogenes , enterobacter cloacae , klebsiella pneumoniae , and bacteroides fragilis. tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus, s. intermedius,