New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - cefuroxime sodium 1578mg equivalent to cefuroxime 1500 mg;   - powder for injection - 1.5 g - active: cefuroxime sodium 1578mg equivalent to cefuroxime 1500 mg   - cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most ?-lactamases and is active against a wide range of gram-positive and gram-negative organisms. it is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria. susceptibility to cefuroxime sodium will vary with geography and time and local susceptibility data should be consulted where available. indications include:

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - cefuroxime sodium 789mg equivalent to cefuroxime 750 mg;   - powder for injection - 750 mg - active: cefuroxime sodium 789mg equivalent to cefuroxime 750 mg   - cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most ?-lactamases and is active against a wide range of gram-positive and gram-negative organisms. it is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria. susceptibility to cefuroxime sodium will vary with geography and time and local susceptibility data should be consulted where available. indications include:

Malta - English - Medicines Authority

villerton invest s.a. rue edward steichen 14, 2540, luxembourg - cefuroxime - powder for solution for injection powder for suspension for injection - cefuroxime 250 mg - antibacterials for systemic use

Canada - English - Health Canada

pharmaceutical partners of canada inc - cefuroxime (cefuroxime sodium) - powder for solution - 750mg - cefuroxime (cefuroxime sodium) 750mg - second generation cephalosporins

Canada - English - Health Canada

pharmaceutical partners of canada inc - cefuroxime (cefuroxime sodium) - powder for solution - 1.5g - cefuroxime (cefuroxime sodium) 1.5g - second generation cephalosporins

Canada - English - Health Canada

pharmaceutical partners of canada inc - cefuroxime (cefuroxime sodium) - powder for solution - 7.5g - cefuroxime (cefuroxime sodium) 7.5g - second generation cephalosporins

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - cefuroxime sodium - powder for solution for injection/infusion - 750 milligram(s) - second-generation cephalosporins; cefuroxime

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - cefuroxime sodium - powder for solution for injection/infusion - 1.5 gram(s) - second-generation cephalosporins; cefuroxime

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

remedyrepack inc. - cefuroxime axetil (unii: z49qdt0j8z) (cefuroxime - unii:o1r9fj93ed) - cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of streptococcus pyogenes . limitations of use - the efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials. - the efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of streptococcus pyogenes has not been demonstrated in clinical trials. cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of streptococcus pneumoniae, haemophilus influenzae (including β-lactamase–producing strains), moraxella catarrhalis (including β-lactamase–producing strains), or streptococcus pyogenes . cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of streptococcus pneumoniae or haemophilus influenzae (non -β -lactamase–producing strains only). limitations of use the effectiveness of cefuroxime axetil for sinus infections caused by β-lactamase–producing haemophilus influenzae or moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see clinical studies ( 14.1)] . cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of streptococcus pneumoniae , haemophilus influenzae (β-lactamase–negative strains), or haemophilus parainfluenzae (β-lactamase–negative strains). cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of staphylococcus aureus (including β - lactamase–producing strains) or streptococcus pyogenes. cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of escherichia coli or klebsiella pneumoniae . cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase–producing susceptible strains of neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing susceptible strains of neisseria gonorrhoeae . cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early lyme disease (erythema migrans) caused by susceptible strains of borrelia burgdorferi. to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil 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. cefuroxime axetil is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). risk summary available data from published epidemiologic studies, case series, and case reports over several decades with cephalosporin use, includingcefuroxime axetil, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . in studies in pregnant mice and rats administered oral cefuroxime axetil during organogenesis at 14 and 9 times the maximum recommended human dose (mrhd) based on body surface area, respectively, there were no adverse developmental outcomes (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defects, 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: maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age, and premature rupture of membranes. perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. data human data: while available studies cannot definitively establish the absence of risk, published data from epidemiologic studies, case series, and case reports over several decades have not identified an association with cephalosporin use (includingcefuroxime axetil) 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: studies performed with oral cefuroxime axetil administered to pregnant mice during organogenesis (gestation days 7 through 16) at doses up to 3,200 mg/kg/day (14 times the mrhd based on body surface area); and in rats dosed during organogenesis and lactation (gestation days 7 through 16 and gestation days 17 through lactation day 21, respectively) at doses up to 1,000 mg/kg/day (9 times the mrhd based on body surface area) have revealed no adverse developmental outcomes. risk summary based on several published case reports describing multiple lactating women who received cefuroxime via intravenous, intramuscular, and oral routes, cefuroxime is present in human milk. the highest maternal milk concentration described occurred in lactating women 8 hours after an intramuscular administration of cefuroxime 750 mg. allowing for an infant milk consumption of 150 ml/kg/day, the estimated breastfed infant dose would be less than 1% of the adult dose . no data are available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefuroxime and any potential adverse effects on the breastfed infant from cefuroxime or from the underlying maternal condition. the safety and effectiveness of cefuroxime axetil have been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults. use of cefuroxime axetil in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well-controlled trials of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients. it is also supported by postmarketing adverse events surveillance. [see indications and usage ( 1), dosage and administration ( 2), adverse reactions (6), clinical pharmacology ( 12.3).] of the total number of subjects who received cefuroxime axetil in 20 clinical trials, 375 were aged 65 and older while 151 were aged 75 and older. no overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. cefuroxime is substantially excreted by the kidney, and the risk of adverse reactions 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 it may be useful to monitor renal function. reducing the dosage of cefuroxime axetil is recommended for adult patients with severe renal impairment (creatinine clearance <30 ml/min) [see dosage and administration ( 2.5), clinical pharmacology ( 12.3)] .

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - cefuroxime sodium 1578 mg - eq. cefuroxime 1500 mg - powder for solution for injection - 1500 mg - cefuroxime sodium 1578 mg - cefuroxime