Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

viatris limited - cefepime dihydrochloride monohydrate 575.9mg equivalent to 500 mg cefepime free base;   - powder for injection - 500 mg - active: cefepime dihydrochloride monohydrate 575.9mg equivalent to 500 mg cefepime free base   excipient: arginine - cefepime mylan is indicated in adults for the treatment of the infections listed below when caused by susceptible bacteria. · lower respiratory tract infections, including pneumonia and bronchitis. · urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. · skin and skin structure infections. · septicaemia. · intra-abdominal infections, including peritonitis and biliary tract infections. · empiric treatment of febrile neutropenia.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - cefepime, quantity: 2000 mg - injection, powder for - excipient ingredients: arginine - adults:. cefepime is indicated in the treatment of the infections listed below when caused by susceptible bacteria.. - lower respiratory tract infections, including pneumonia and bronchitis;. - urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections;. - skin and skin structure infections;. - intra-abdominal infections, including peritonitis and biliary tract infections;. - gynaecological infections;. - septicaemia;. - empirical treatment in febrile neutropenic patients (see precautions).. cefepime is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. in this indication it is essential that metronidazole also be administered.. paediatrics:. cefepime is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria. . - urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections;. - skin and skin structure infections;. - septicaemia;. - empirical treatment in febrile neutropenic patients (see precautions).. culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. empirical therapy with cefepime may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.. because of its broad spectrum of bactericidal activity against gram positive and gram negative bacteria, cefepime can be used appropriately as monotherapy prior to identification of the causative organisms(s). in the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with cefepime. in patients who are at risk of mixed aerobic/ anaerobic infection, including infections in which bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - cefepime, quantity: 1000 mg - injection, powder for - excipient ingredients: arginine - adults:. cefepime is indicated in the treatment of the infections listed below when caused by susceptible bacteria.. - lower respiratory tract infections, including pneumonia and bronchitis;. - urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections;. - skin and skin structure infections;. - intra-abdominal infections, including peritonitis and biliary tract infections;. - gynaecological infections;. - septicaemia;. - empirical treatment in febrile neutropenic patients (see precautions).. cefepime is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. in this indication it is essential that metronidazole also be administered.. paediatrics:. cefepime is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria. . - urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections;. - skin and skin structure infections;. - septicaemia;. - empirical treatment in febrile neutropenic patients (see precautions).. culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. empirical therapy with cefepime may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.. because of its broad spectrum of bactericidal activity against gram positive and gram negative bacteria, cefepime can be used appropriately as monotherapy prior to identification of the causative organisms(s). in the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with cefepime. in patients who are at risk of mixed aerobic/ anaerobic infection, including infections in which bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

Kanāda - angļu - Health Canada

hikma canada limited - cefepime (cefepime hydrochloride) - powder for solution - 1g - cefepime (cefepime hydrochloride) 1g - fourth generation cephalosporins

Kanāda - angļu - Health Canada

hikma canada limited - cefepime (cefepime hydrochloride) - powder for solution - 2g - cefepime (cefepime hydrochloride) 2g - fourth generation cephalosporins

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

xellia pharmaceuticals usa llc - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime for injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of streptococcus pneumoniae , including cases associated with concurrent bacteremia, pseudomonas aeruginosa , klebsiella pneumoniae , or enterobacter species. cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14.1)] . cefepime for injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of escherichia coli or klebsiella pneumoniae , when the infec

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 400 mg - suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . suprax is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes. (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies (14)]. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. suprax is generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of suprax in the subsequent prevention of rheumatic fever is not available.) suprax is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of suprax and other antibacterial drugs, suprax 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. suprax  (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology (12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration (2.3)] .

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 100 mg in 5 ml - suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis .   suprax is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes. (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies (14)] . suprax is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 400 mg - suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . suprax is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes. (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies ( 14)]. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isol

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

lupin pharma - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 100 mg - to reduce the development of drug resistant bacteria and maintain the effectiveness of suprax (cefixime) chewable tablets and other antibacterial drugs, suprax (cefixime) chewable 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. suprax (cefixime) chewable tablets are indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: uncomplicated urinary tract infections caused by escherichia coli and proteus mirabilis . otitis media caused by haemophilus influenzae (beta-lactamase positive and negative strains), moraxella (branhamella) catarrhalis , (most of which are beta-lactamase positive) and s. pyogene