Canada - English - Health Canada

qilu pharmaceutical co., ltd. - cefepime (cefepime hydrochloride) - powder for solution - 2g - cefepime (cefepime hydrochloride) 2g - fourth generation cephalosporins

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

samson medical technologies llc - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime 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 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 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 infection is severe, or caused by escherichia coli, klebsiella pneumoniae , or proteus mirabilis , when the infection is mild to moderate, including cases associated with concurrent bacteremia with these bacteria. cefepime is indicated in the treatment of uncomplicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes . cefepime is indicated in the treatment of complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible isolates of escherichia coli , viridans group streptococci, pseudomonas aeruginosa, klebsiella pneumoniae, enterobacter species or bacteroides fragilis .  [see clinical studies (14.2) ]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime for injection, usp and other antibacterial drugs, cefepime for injection, usp 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. cefepime for injection, usp is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics. pregnancy category b there are no adequate and well-controlled studies of cefepime use 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. cefepime was not teratogenic or embryocidal when administered during the period of organogenesis to rats at doses up to 1000 mg/kg/day (1.6 times the recommended human dose calculated on a body surface area basis) or to mice at doses up to 1200 mg/kg (approximately equal to the recommended maximum human dose calculated on a body surface area basis) or to rabbits at a dose level of 100 mg/kg (0.3 times the recommended maximum human dose calculated on a body surface area basis). cefepime has not been studied for use during labor and delivery. treatment should only be given if clearly indicated. cefepime is excreted in human breast milk.  caution should be exercised when cefepime is administered to a nursing woman [see clinical pharmacology (12.3) ]. cefepime for injection, pharmacy bulk package bag smartpak® should not be used in pediatric patients who require less than a 500 mg dose of cefepime. the safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years.  use of cefepime in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials [see clinical pharmacology (12.3) ]. safety and effectiveness in pediatric patients below the age of 2 months have not been established.  there are insufficient clinical data to support the use of cefepime in pediatric patients for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is h. influenzae type b.  in those patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented, an alternate agent with demonstrated clinical efficacy in this setting should be used. of the more than 6400 adults treated with cefepime in clinical studies, 35% were 65 years or older while 16% were 75 years or older.  when geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in non-geriatric adult patients. serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [ see warnings and precautions (5.2), adverse reactions (6.2) ]. this drug is known to be substantially excreted by the kidney, and the risk of toxic 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 [ see clinical pharmacology (12.3), warnings and precautions (5.2), dosage and administration (2.3) ]. cefepime for injection, pharmacy bulk package bag smartpak® should not be used in patients with renal impairment who require less than a 500 mg dose of cefepime. adjust the dose of cefepime in patients with creatinine clearance less than or equal to 60 ml/min to compensate for the slower rate of renal elimination. [see dosage adjustments in patients with renal impairment (2.3) ]

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

apotex corp. - 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

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - cefepime dihydrochloride monohydrate 1.1518 g equivalent to 1 g cefepime free base; cefepime dihydrochloride monohydrate 1.189 g equivalent to 1 g cefepime free base - powder for injection - 1 g - active: cefepime dihydrochloride monohydrate 1.1518 g equivalent to 1 g cefepime free base excipient: arginine active: cefepime dihydrochloride monohydrate 1.189 g equivalent to 1 g 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - cefepime dihydrochloride monohydrate 2.30368 g equivalent to 2 g cefepime free base; cefepime dihydrochloride monohydrate 2.378 g equivalent to 2 g cefepime free base - powder for injection - 2 g - active: cefepime dihydrochloride monohydrate 2.30368 g equivalent to 2 g cefepime free base excipient: arginine active: cefepime dihydrochloride monohydrate 2.378 g equivalent to 2 g 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.

New Zealand - English - 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.

Australia - English - 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.

Australia - English - 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.

Canada - English - Health Canada

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

Canada - English - Health Canada

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