Australia - Kiingereza - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - cefotaxime sodium, quantity: 2.096 g - injection, powder for - excipient ingredients: - indications: cefotaxime is indicated for the treatment of the following types of infection when caused by susceptible micro-organisms: infections of the respiratory tract (upper and lower). infections of the urinary tract. septicaemia - concomitant therapy with an aminoglycoside may be instituted prior to isolation of the causative organism. intra-abdominal infection. gonorrhoea (including gonorrhoea caused by beta lactamase producing strains of n.gonorrhoeae). ear, nose and throat infections. skin and skin structure infections. bone and joint infections. meningitis - cefotaxime should be combined with an appropriate alternative antibiotic (ampicillin, chloramphenicol or penicillin g) for initial therapy in children, (excluding neonates) pending the availabiliy of culture and sensitivity results. in adults, the empirical use of cefotaxime should be restricted to patients suspected of having meningitis caused by gram negative enteric bacilli. cefotaxime may be used for the prevention of post-operative infe

Marekani - Kiingereza - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - cefotaxime sodium (unii: 258j72s7tz) (cefotaxime - unii:n2gi8b1gk7) - cefotaxime 1 g - cefotaxime for injection, usp is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) lower respiratory tract infections, including pneumonia, caused by streptococcus pneumoniae (formerly diplococcus pneumoniae ), streptococcus pyogenes* (group a streptococci) and other streptococci (excluding enterococci, e.g., enterococcus faecalis ), staphylococcus aureus (penicillinase and non-penicillinase producing), escherichia coli , klebsiella species, haemophilus influenzae (including ampicillin resistant strains), haemophilus parainfluenzae , proteus mirabilis , serratia marcescens* , enterobacter species, indole positive proteus and pseudomonas species (including p. aeruginosa ). (2) genitourinary infections . urinary tract infections caused by enterococcus species, staphylococcus epidermidis , staphylococcus aureus* , (penicillinase and non-penicillinase producing), citrobacter species, enterobacter species, escherichia coli , klebsiella species, proteus mirabilis , proteus vulgaris* , providencia stuartii , morganella morganii* , providencia rettgeri* , serratia marcescens and pseudomonas species (including p. aeruginosa ). also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by neisseria gonorrhoeae , including penicillinase producing strains. (3) gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by staphylococcus epidermidis , streptococcus species, enterococcus species, enterobacter species*, klebsiella species*, escherichia coli , proteus mirabilis , bacteroides species (including bacteroides fragilis* ), clostridium species, and anaerobic cocci (including peptostreptococcus species and peptococcus species) and fusobacterium species (including f. nucleatum* ). cefotaxime for injection, usp, like other cephalosporins, has no activity against chlamydia trachomatis . therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and c. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) bacteremia/septicemia caused by escherichia coli , klebsiella species, and serratia marcescens , staphylococcus aureus and streptococcus species (including s. pneumoniae ). (5) skin and skin structure infections caused by staphylococcus aureus (penicillinase and non-penicillinase producing), staphylococcus epidermidis , streptococcus pyogenes (group a streptococci) and other streptococci, enterococcus species, acinetobacter species*, escherichia coli , citrobacter species (including c. freundii* ), enterobacter species, klebsiella species, proteus mirabilis , proteus vulgaris* , morganella morganii , providencia rettgeri* , pseudomonas species, serratia marcescens , bacteroides species, and anaerobic cocci (including peptostreptococcus* species and peptococcus species). (6) intra-abdominal infections including peritonitis caused by streptococcus species*, escherichia coli , klebsiella species, bacteroides species, and anaerobic cocci (including peptostreptococcus* species and peptococcus* species) proteus mirabilis* , and clostridium species*. (7) bone and/or joint infections caused by staphylococcus aureus (penicillinase and non-penicillinase producing strains), streptococcus species (including s. pyogenes* ), pseudomonas species (including p. aeruginosa* ), and proteus mirabilis* . (8) central nervous system infections, e.g., meningitis and ventriculitis, caused by neisseria meningitidis , haemophilus influenzae , streptococcus pneumoniae , klebsiella pneumoniae* and escherichia coli* . (*) efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. although many strains of enterococci (e.g., s. faecalis ) and pseudomonas species are resistant to cefotaxime sodium in vitro , cefotaxime for injection, usp has been used successfully in treating patients with infections caused by susceptible organisms. specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime. therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. in certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, usp may be used concomitantly with an aminoglycoside. the dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. it is possible that nephrotoxicity may be potentiated if cefotaxime for injection, usp is used concomitantly with an aminoglycoside. the administration of cefotaxime for injection, usp preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. in patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of cefotaxime for injection, usp may also reduce the incidence of certain postoperative infections. see dosage and administration section. effective use for elective surgery depends on the time of administration. to achieve effective tissue levels, cefotaxime for injection, usp should be given 1/2 or 1 1/2 hours before surgery. see dosage and administration section. for patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. if there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection, usp and other antibacterial drugs, cefotaxime for injection, usp 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. cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.

Marekani - Kiingereza - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - cefotaxime sodium (unii: 258j72s7tz) (cefotaxime - unii:n2gi8b1gk7) - cefotaxime 10 g - cefotaxime for injection, usp is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) lower respiratory tract infections, including pneumonia, caused by streptococcus pneumoniae (formerly diplococcus pneumoniae ), streptococcus pyogenes* (group a streptococci) and other streptococci (excluding enterococci, e.g., enterococcus faecalis ), staphylococcus aureus (penicillinase and non-penicillinase producing), escherichia coli , klebsiella species, haemophilus influenzae (including ampicillin resistant strains), haemophilus parainfluenzae , proteus mirabilis , serratia marcescens* , enterobacter species, indole positive proteus and pseudomonas species (including p. aeruginosa ). (2) genitourinary infections . urinary tract infections caused by enterococcus species, staphylococcus epidermidis , staphylococcus aureus* , (penicillinase and non-penicillinase producing), citrobacter species, enterobacter species, escherichia coli , klebsiella species, proteus mirabilis , proteus vulgaris* , providencia stuartii , morganella morganii* , providencia rettgeri* , serratia marcescens and pseudomonas species (including p. aeruginosa ). also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by neisseria gonorrhoeae , including penicillinase producing strains. (3) gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by staphylococcus epidermidis , streptococcus species, enterococcus species, enterobacter species*, klebsiella species*, escherichia coli , proteus mirabilis , bacteroides species (including bacteroides fragilis* ), clostridium species, and anaerobic cocci (including peptostreptococcus species and peptococcus species) and fusobacterium species (including f. nucleatum* ). cefotaxime for injection, usp, like other cephalosporins, has no activity against chlamydia trachomatis . therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and c. trachomatis is one of the suspected pathogens, appropriate anti‑chlamydial coverage should be added. (4) bacteremia/septicemia caused by escherichia coli , klebsiella species, and serratia marcescens , staphylococcus aureus and streptococcus species (including s. pneumoniae ). (5) skin and skin structure infections caused by staphylococcus aureus (penicillinase and non-penicillinase producing), staphylococcus epidermidis , streptococcus pyogenes (group a streptococci) and other streptococci, enterococcus species, acinetobacter species*, escherichia coli , citrobacter species (including c. freundii* ), enterobacter species, klebsiella species, proteus mirabilis , proteus vulgaris* , morganella morganii , providencia rettgeri* , pseudomonas species, serratia marcescens , bacteroides species, and anaerobic cocci (including peptostreptococcus* species and peptococcus species). (6) intra-abdominal infections including peritonitis caused by streptococcus species*, escherichia coli , klebsiella species, bacteroides species, and anaerobic cocci (including peptostreptococcus* species and peptococcus* species) proteus mirabilis* , and clostridium species*. (7) bone and/or joint infections caused by staphylococcus aureus (penicillinase and non‑penicillinase producing strains), streptococcus species (including s. pyogenes* ), pseudomonas species (including p. aeruginosa* ), and proteus mirabilis* . (8) central nervous system infections, e.g., meningitis and ventriculitis, caused by neisseria meningitidis , haemophilus influenzae , streptococcus pneumoniae , klebsiella pneumoniae* and escherichia coli* . (*) efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. although many strains of enterococci (e.g., s. faecalis ) and pseudomonas species are resistant to cefotaxime sodium in vitro , cefotaxime for injection, usp has been used successfully in treating patients with infections caused by susceptible organisms. specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime. therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. in certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, usp may be used concomitantly with an aminoglycoside. the dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient’s condition. renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. it is possible that nephrotoxicity may be potentiated if cefotaxime for injection, usp is used concomitantly with an aminoglycoside. the administration of cefotaxime for injection, usp preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. in patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of cefotaxime for injection, usp may also reduce the incidence of certain postoperative infections. see dosage and administration   section. effective use for elective surgery depends on the time of administration. to achieve effective tissue levels, cefotaxime for injection, usp should be given 1/2 or 1 1/2 hours before surgery. see dosage and administration   section. for patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non- absorbable antibiotic (e.g., neomycin) is recommended. if there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection, usp and other antibacterial drugs, cefotaxime for injection, usp 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. cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.

Marekani - Kiingereza - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - cefotaxime sodium (unii: 258j72s7tz) (cefotaxime - unii:n2gi8b1gk7) - cefotaxime 500 mg - cefotaxime for injection usp is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - lower respiratory tract infections , including pneumonia, caused bystreptococcus pneumoniae (formerlydiplococcus pneumoniae ),streptococcus pyogenes * (group a streptococci) and other streptococci (excluding enterococci, e.g.,enterococcus faecalis ),staphylococcus aureus (penicillinase and non-penicillinase producing),escherichia coli ,klebsiella species,haemophilus influenzae (including ampicillin resistant strains),haemophilus parainfluenzae ,proteus mirabilis ,serratia marcescens *,enterobacter species, indole positiveproteus andpseudomonas species (includingp. aeruginosa ). - genitourinary infections . urinary tract infections caused byenterococcus species,staphylococcus epidermidis ,staphylococcus aureus *, (penicillinase and non-penicillinase producing),citrobacter species,enterobacter species,escherichia coli ,kl

Malta - Kiingereza - Medicines Authority

villerton invest s.a. rue edward steichen 14, 2540, luxembourg - cefotaxime sodium - powder for solution for injection/infusion - cefotaxime sodium 500/2.2 mci/ml - antibacterials for systemic use

Malta - Kiingereza - Medicines Authority

villerton invest s.a. rue edward steichen 14, 2540, luxembourg - cefotaxime sodium - solution for injection/infusion - cefotaxime sodium 1/4.4 g/ml - antibacterials for systemic use

Marekani - Kiingereza - NLM (National Library of Medicine)

wockhardt usa llc. - cefotaxime sodium (unii: 258j72s7tz) (cefotaxime - unii:n2gi8b1gk7) - cefotaxime 500 mg - treatment cefotaxime for injection, usp is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) lower respiratory tract infections , including pneumonia, caused by streptococcus pneumoniae (formerly diplococcus pneumoniae ), streptococcus pyogenes * (group a streptococci) and other streptococci (excluding enterococci, e.g., enterococcus faecalis ), staphylococcus aureus (penicillinase and non-penicillinase producing), escherichia coli , klebsiella species, haemophilus influenzae (including ampicillin resistant strains), haemophilus parainfluenzae , proteus mirabilis , serratia marcescens *, enterobacter species, indole positive proteus and pseudomonas species (including p. aeruginosa ). (2) genitourinary infections . urinary tract infections caused by enterococcus species, staphylococcus epidermidis , staphylococcus aureus *, (penicillinase and non-penicillinase producing), citrobacter species,

Australia - Kiingereza - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - cefotaxime sodium, quantity: 1.048 g - injection, powder for - excipient ingredients: - indications: cefotaxime is indicated for the treatment of the following types of injection when caused by susceptible micro-organisms: infections of the respiratory tract (upper and lower). infections of the urinary tract. septicaemia - concomitant therapy with an aminoglycoside may be instituted prior to isolation of the causative organism. intra-abdominal infection. gonorrhoea (including gonorrhoea caused by beta lactamase producing strains of n. gonorrhoeae). ear, nose and throat infections. skin and skin structure infections. bone and joint infections. meningitis - cefotaxime should be combined with an appropriate alternative antibiotic (ampicillin, chloramphenicol or pencillin g) for initial therapy in children, (excluding neonates) pending the availability of culture and sensitivity results. in adults, the empirical use of cefotaxime should be restricted to patients suspected of having meningitis caused by gram negative enteric bacilli. cefotaxime may be used for the prevention of post-operative infection in obstetrical surgery, vaginal and abdominal hysterectomy and biliary surgery. in serious cases, cefotaxime may be used, if considered appropriate,before the results of sensitivity tests become available. the emergency of resistance to cefotaxime may complicate treatment.

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - cefotaxime sodium 1.048 g equivalent to 1 g cefotaxime;  ;   - powder for injection - 1 g - active: cefotaxime sodium 1.048 g equivalent to 1 g cefotaxime     - dbl™ cefotaxime sodium for injection is indicated in the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity. septicaemia. respiratory tract infections: acute and chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and post-operative chest infections. urinary tract infections: acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. soft tissue infections: cellulitis, peritonitis and wound infections. bone and joint infections: osteomyelitis, septic arthritis. obstetric and gynaecological infections: pelvic inflammatory disease. gonorrhoea: particularly if penicillin-resistant. other bacterial infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy. the administration of dbl™ cefotaxime sodium for injection prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operations where infections would have serious effects. protection is best ensured by achieving adequate local tissue concentrations at the time contamination is likely to occur. dbl™ cefotaxime sodium for injection should therefore be administered immediately prior to surgery and if necessary continued in the immediate post-operative period. administration should usually be stopped within 24 hours since continuing use of any antibiotic in the majority of surgical procedures does not reduce the incidence of subsequent infections.

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - cefotaxime sodium 2.096 g equivalent to 2 g cefotaxime;  ;   - powder for injection - 2 g - active: cefotaxime sodium 2.096 g equivalent to 2 g cefotaxime     - dbl™ cefotaxime sodium for injection is indicated in the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity. septicaemia. respiratory tract infections: acute and chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and post-operative chest infections. urinary tract infections: acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. soft tissue infections: cellulitis, peritonitis and wound infections. bone and joint infections: osteomyelitis, septic arthritis. obstetric and gynaecological infections: pelvic inflammatory disease. gonorrhoea: particularly if penicillin-resistant. other bacterial infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy. the administration of dbl™ cefotaxime sodium for injection prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operations where infections would have serious effects. protection is best ensured by achieving adequate local tissue concentrations at the time contamination is likely to occur. dbl™ cefotaxime sodium for injection should therefore be administered immediately prior to surgery and if necessary continued in the immediate post-operative period. administration should usually be stopped within 24 hours since continuing use of any antibiotic in the majority of surgical procedures does not reduce the incidence of subsequent infections.