كينيا - الإنجليزية - Pharmacy and Poisons Board

kopran limited c/o. surgilinks ltd parijat house, 1076, dr,e.moses road, worli, - cefepime for injection usp - powder for injection - cefepime 1000mg (as cefepime hydrochloride) - cefepime

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - cefepime dihydrochloride monohydrate 1 g - powder for injection - 1 g - active: cefepime dihydrochloride monohydrate 1 g excipient: arginine - indicated for the treatment of lower respiratory tract infections, including pneumonia and bronchitis, when caused by susceptible bacteria.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - cefepime dihydrochloride monohydrate 2 g - powder for injection - 2 g - active: cefepime dihydrochloride monohydrate 2 g excipient: arginine - indicated for the treatment of lower respiratory tract infections, including pneumonia and bronchitis, when caused by susceptible bacteria.

بنما - الإنجليزية - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

vesalius pharma, s.a. - cefepime (hidrocloruro estÉril) - cefepime (hidrocloruro estÉril) ....1,00 g

بنما - الإنجليزية - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

shandong luoxin pharmaceutical group stock co.,ltd - cefepime - cefepime....1.0 g

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allecra therapeutics sas - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3), enmetazobactam (unii: 80vun7l00c) (enmetazobactam - unii:80vun7l00c) - exblifep® is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cuti) including pyelonephritis, caused by the following susceptible microorganisms: escherichia coli, klebsiella pneumoniae, pseudomonas aeruginosa, proteus mirabilis, and enterobacter cloacae complex. to reduce the development of drug-resistant bacteria and maintain the effectiveness of exblifep and other antibacterial drugs, exblifep 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. exblifep is contraindicated in patients with a history of serious hypersensitivity reactions to the components of exblifep (cefepime and enmetazobactam) or other beta-lactam antibacterial drugs [see warnings and precautions (5.1)] . risk summary there are no available data with the use of exblifep, or enmetazobactam during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. available data from published observational studies and case reports over several decades with cephalosporin use, including cefepime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data ). cefepime cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during organogenesis. the doses used in these studies were 1.6 (rats), approximately equal to (mice), and 0.3 times (rabbits) the maximum recommended human dose (mrhd) (see data ). enmetazobactam intravenous administration of enmetazobactam to pregnant rats and rabbits during organogenesis was associated with maternal toxicity and reduced fetal weights, but not fetal malformations at approximately 7 times and 11 times, respectively, the mrhd (1.5 g/day). intravenous administration of enmetazobactam to pregnant rats during organogenesis through lactation resulted in reduction of maternal body weights and reduced fetal body weights and delayed pinna detachment in first-generation offspring in the absence of any other adverse effects on the survival, growth, and development of first- and second-generation offspring at exposures 7-times the mrhd (see data ). the background risk of major birth defects and miscarriage for the indicated population is 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. data human data cefepime while available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use, including cefepime, during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data cefepime cefepime was not embryocidal and did not cause fetal malformations when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day. these doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the maximum recommended clinical dose based on body surface area. enmetazobactam enmetazobactam was administered to pregnant rats in intravenous doses of 125, 250, and 500 mg/kg/day during the period of organogenesis from gestation day (gd) 6 through gd 17. maternal weight gain was reduced at 500 mg/kg/day (approximately 7 times the mrhd based on plasma auc comparison). no fetal malformations were observed with any dose of enmetazobactam, but fetal weights were reduced in the high-dose group. the dose at which no maternal or fetal toxicity occurred was 250 mg/kg/day (approximately 3 times the mrhd based on plasma auc comparison). enmetazobactam was administered intravenously to pregnant rabbits in doses of 50, 150, and 300 mg/kg/day during the period of organogenesis from gd 7 through gd 19. maternal body weight gains were reduced in the mid- and high-dose groups (approximately 11 and 25 times the mrhd respectively based on plasma auc comparison). no fetal malformations were observed, but the mean values for total litter weights and fetal weights were decreased in the mid- and high-dose groups, and mean placental weights were decreased in the high-dose group. the dose at which no maternal or fetal toxicity occurred was 50 mg/kg/day (approximately 3-times the mrhd based on plasma auc comparison). in a pre-postnatal study, enmetazobactam was administered intravenously to pregnant rats from gd 6 through the lactation period until lactation day 20 in maternal doses of 125, 250, and 500 mg/kg/day. maternal body weights and the body weights of first-generation offspring were reduced, and pinna detachment in first-generation off-spring was delayed with the maternal dose of 500 mg/kg/day (approximately 7-times the mrhd based on plasma auc comparison). no other adverse effects on the survival, development, behavior, or reproduction of first-generation offspring occurred with any of the maternal enmetazobactam doses up to 500 mg/kg/day. the survival, growth and development of second-generation offspring were not adversely affected by maternal enmetazobactam doses up to 500 mg/kg/day (approximately 7-times the mrhd based on plasma auc comparison). the dose at which no maternal toxicity or toxicity in first-generation offspring occurred was 250 mg/kg/day (approximately 3-times the mrhd based on plasma auc comparison). no adverse effects occurred in second-generation offspring at 500 mg/kg/day (approximately 7-times the mrhd based on plasma auc comparison). risk summary cefepime cefepime is present in human breast milk at low concentrations (approximately 0.5 mcg/ml) following a single intravenous dose of 1000 mg. a nursing infant consuming approximately 1000 ml of human milk per day would receive approximately 0.5 mg of cefepime per day (see data) . enmetazobactam enmetazobactam was present in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. there is no information regarding the effects of cefepime, enmetazobactam or their combination on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for exblifep and any potential adverse effects on the breastfed child from exblifep or from the underlying maternal condition. data human data cefepime a pharmacokinetic study was conducted in 9 healthy lactating women to evaluate the concentrations of cefepime in plasma and breast milk following a single intravenous dose of 1000 mg. the mean breast milk concentrations of cefepime during the first 8 hours post-dose were approximately 0.5 mcg/ml and then declined and became undetectable between 12- and 24-hours post-dose. the mean cumulative breast milk excretion of cefepime over 24 hours was 0.01% of the administered dose. the pharmacokinetics of cefepime are similar between lactating and non-lactating women. animal data enmetazobactam in a pharmacokinetic study in rats intended to assess the potential for enmetazobactam secretion into milk, 5 pregnant rats were administered 500 mg/kg/day enmetazobactam by intravenous bolus from gestation day (gd) 6 through the day of birth and the subsequent lactation period until lactation day (ld) 20. on ld 14, lactation milk was collected 30 minutes after dosing from the 5 maternal rats, and enmetazobactam was measured. concentrations of enmetazobactam in rat milk ranged from 34 to 317 mcg/ml which is approximately equivalent to 2.6% to 24% of the highest plasma concentrations. the concentration of enmetazobactam in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of exblifep in pediatric patients (younger than 18 years of age) have not been established. of the 516 patients treated with exblifep in the cuti trial (trial 1), 204 (40%) patients were 65 years of age and older, while 78 (15%) patients were 75 years of age and older. no overall differences in safety or effectiveness were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. serious neurologic adverse reactions have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, a component of exblifep including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [see warnings and precautions (5.2) and adverse reactions (6.2)] . no dosage adjustment based on age is required. exblifep 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, care should be taken in dose selection, and renal function should be monitored as appropriate. dosage adjustment for elderly patients should be based on renal function. [see dosage and administration (2.2), use in specific populations (8.6), and clinical pharmacology (12.3) . cefepime and enmetazobactam, the components of exblifep, are primarily renally excreted. plasma exposures of both cefepime and enmetazobactam increase with decreasing renal function, therefore dosage adjustments are recommended to compensate for the slower rate of renal clearance in patients with egfr less than 60 ml/min [see dosage and administration (2.2) and clinical pharmacology (12.3)] . in patients with egfr greater than or equal to 130 ml/min, plasma exposures of cefepime and enmetazobactam are decreased. therefore, dosage adjustments are recommended to compensate for the higher rate of renal clearance in these patients [see dosage and administration (2.2) and clinical pharmacology (12.3)] . both cefepime and enmetazobactam are hemodialyzable; thus, exblifep should be administered after intermittent hemodialysis on hemodialysis days [see dosage and administration (2.2) and clinical pharmacology (12.3)] . monitor renal function regularly and adjust the dosage of exblifep accordingly as renal function may change during the course of therapy.

جنوب أفريقيا - الإنجليزية - South African Health Products Regulatory Authority (SAHPRA)

aurogen south africa (pty) ltd - injection - see ingredients - each vial contains cefepime hydrochloride equivaqlent to cefepime 500,0 mg

جنوب أفريقيا - الإنجليزية - South African Health Products Regulatory Authority (SAHPRA)

aurogen south africa (pty) ltd - injection - see ingredients - each vial contains cefepime hydrochloride equivaqlent to cefepime 1000,0 mg

جنوب أفريقيا - الإنجليزية - South African Health Products Regulatory Authority (SAHPRA)

aurogen south africa (pty) ltd - injection - see ingredients - each vial contains cefepime hydrochloride equivaqlent to cefepime 2000,0 mg

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

united italian trading corporation (private) limited - cefepime hydrochloride 2.3784g eqv cefepime - injection, powder, for solution - cefepime hydrochloride 2.3784g eqv cefepime 2g per vial