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

alphapharm pty ltd - ceftriaxone sodium -

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

alphapharm pty ltd - ceftriaxone sodium -

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

a-s medication solutions - ceftriaxone sodium (unii: 023z5br09k) (ceftriaxone - unii:75j73v1629) - ceftriaxone 500 mg - before instituting treatment with ceftriaxone for injection, usp, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, usp and other antibacterial drugs, ceftriaxone 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. ceftriaxone for injection, usp is indicated for the treatment of the following infections when caused by susceptible organisms: lower respiratory tract infections caused

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

a-s medication solutions - ceftriaxone sodium (unii: 023z5br09k) (ceftriaxone - unii:75j73v1629) - ceftriaxone 250 mg - before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, usp and other antibacterial drugs, ceftriaxone 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. ceftriaxone for injection, usp is indicated for the treatment of the following infections when caused by susceptible organisms: caused by streptococcus pneumoniae , staphylococcus aureus, haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, escherichia coli, enterobacter aerogenes, proteus mirabilis or serratia marcescens . caused by streptococcus pneumoniae, haemophilus influenzae (including beta-lactamase producing strains) or moraxella catarrhalis (including beta-lactamase producing strains). note: in one study lower clinical cure rates were observed with a single dose of ceftriaxone compared to 10 days of oral therapy. in a second study comparable cure rates were observed between single dose ceftriaxone and the comparator. the potentially lower clinical cure rate of ceftriaxone should be balanced against the potential advantages of parenteral therapy (see clinical studies ). caused by staphylococcus aureus, staphylococcus epidermidis, streptococcus pyogenes , viridans group streptococci , escherichia coli, enterobacter cloacae, klebsiella oxytoca, klebsiella pneumoniae, proteus mirabilis, morganella morganii*, pseudomonas aeruginosa, serratia marcescens, acinetobacter calcoaceticus, bacteroides fragilis * or peptostreptococcus species. caused by escherichia coli, proteus mirabilis, proteus vulgaris, morganella morganii or klebsiella pneumoniae . caused by neisseria gonorrhoeae , including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of neisseria gonorrhoeae . caused by neisseria gonorrhoeae . ceftriaxone sodium, like other cephalosporins, has no activity against chlamydia trachomatis . therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, haemophilus influenzae or klebsiella pneumoniae . caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, proteus mirabilis, klebsiella pneumoniae or enterobacter species. caused by escherichia coli, klebsiella pneumoniae, bacteroides fragilis, clostridium species (note: most strains of clostridium difficile are resistant) or peptostreptococcus species. caused by haemophilus influenzae, neisseria meningitidis or streptococcus pneumoniae . ceftriaxone has also been used successfully in a limited number of cases of meningitis and shunt infection caused by staphylococcus epidermidis * and escherichia coli* . * efficacy for this organism in this organ system was studied in fewer than ten infections. the preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. when administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone provides protection from most infections due to susceptible organisms throughout the course of the procedure. ceftriaxone for injection is contraindicated in patients with known hypersensitivity to ceftriaxone, any of its excipients or to any other cephalosporin. patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to ceftriaxone (see warnings – hypersensitivity reactions ). premature neonates: ceftriaxone for injection is contraindicated in premature neonates up to a post-menstrual age of 41 weeks (gestational age + chronological age). hyperbilirubinemic neonates: hyperbilirubinemic neonates should not be treated with ceftriaxone for injection. ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a risk of bilirubin encephalopathy in these patients. ceftriaxone for injection is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing iv solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see clinical pharmacology, warnings and dosage and administration ). cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone for injection and calcium-containing fluids. in some of these cases, the same intravenous infusion line was used for both ceftriaxone for injection and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. there have been no similar reports in patients other than neonates. intravenous administration of ceftriaxone solutions containing lidocaine is contraindicated. when lidocaine solution is used as a solvent with ceftriaxone for intramuscular injection, exclude all contraindications to lidocaine. refer to the prescribing information of lidocaine.

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

wg critical care, llc - ceftazidime (unii: 9m416z9qnr) (ceftazidime anhydrous - unii:dzr1ent301) - ceftazidime anhydrous 1 g in 20 ml - ceftazidime for injection, usp is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1. lower respiratory tract infections, including pneumonia, caused by pseudomonas aeruginosa and other pseudomonas spp.; haemophilus influenzae, including ampicillin-resistant strains; klebsiella spp.; enterobacter spp.; proteus mirabilis; escherichia coli; serratia spp.; citrobacter spp.; streptococcus pneumoniae; and staphylococcus aureus (methicillin-susceptible strains). 2. skin and skin-structure infections caused by pseudomonas aeruginosa; klebsiella spp.; escherichia coli; proteus spp., including proteus mirabilis and indole-positive proteus; enterobacter spp.; serratia spp.; staphylococcus aureus (methicillin-susceptible strains); and streptococcus pyogenes (group a beta-hemolytic streptococci). 3. urinary tract infections, both complicated and uncomplicated, caused by pseudomonas aeruginosa; enterobacter spp.; proteus spp., including proteus mirabilis and indole-positive proteus; klebsiella spp.; and escherichia coli. 4. bacterial septicemia caused by pseudomonas aeruginosa, klebsiella spp., haemophilus influenzae, escherichia coli, serratia spp., streptococcus pneumoniae, and staphylococcus aureus (methicillin-susceptible strains). 5. bone and joint infections caused by pseudomonas aeruginosa, klebsiella spp., enterobacter spp., and staphylococcus aureus (methicillin-susceptible strains). 6. gynecologic infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by escherichia coli. 7. intra-abdominal infections, including peritonitis caused by escherichia coli, klebsiella spp., and staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and bacteroides spp. (many strains of bacteroides fragilis are resistant). 8. central nervous system infections, including meningitis, caused by haemophilus influenzae and neisseria meningitidis. ceftazidime has also been used successfully in a limited number of cases of meningitis due to pseudomonas aeruginosa and streptococcus pneumoniae. ceftazidime for injection, usp may be used alone in cases of confirmed or suspected sepsis. ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibacterial drugs have been used. ceftazidime for injection, usp may also be used concomitantly with other antibacterial drugs, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. when such concomitant treatment is appropriate, prescribing information in the labeling for the other antibacterial drugs should be followed. the dose depends on the severity of the infection and the patient’s condition. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftazidime for injection, usp and other antibacterial drugs, ceftazidime 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. ceftazidime for injection is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibacterial drugs.

Israel - English - Ministry of Health

vitamed pharmaceutical industries ltd - ceftazidime as pentahydrate - powder for solution for injection - ceftazidime as pentahydrate 1.000 g/vial - ceftazidime - ceftazidime-vit is indicated for the treatment of the infections listed below in adults and children including neonates (from birth).• nosocomial pneumonia• broncho-pulmonary infections in cystic fibrosis• bacterial meningitis• chronic suppurative otitis media• malignant otitis externa• complicated urinary tract infections• complicated skin and soft tissue infections• complicated intra-abdominal infections• bone and joint infections• peritonitis associated with dialysis in patient on capd.treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing trans-urethral resection of the prostate (turp).the selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic gram negative bacteria.ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causive bacteria would not fall within its spectrum of activity.consideration should be given to official guidelines on the appropriate use of antibacterial agents.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - avibactam sodium 543.5mg equivalent to avibactam 500mg;  ; ceftazidime pentahydrate 2329.7mg equivalent to ceftazidime 2000mg;   - powder for infusion concentrate - active: avibactam sodium 543.5mg equivalent to avibactam 500mg   ceftazidime pentahydrate 2329.7mg equivalent to ceftazidime 2000mg   excipient: sodium carbonate - zavicefta is indicated for the treatment of the following infections in adult and paediatric (aged 3 months and older) patients: - complicated intra-abdominal infection (ciai), in combination with metronidazole. - complicated urinary tract infection (cuti), including pyelonephritis. - hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap). treatment of adult patients with bacteraemia that occurs in association with or is suspected to be associated with any of the infections listed above zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adult and paediatrics (3 months and older) patients with limited treatment options.

European Union - English - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - antibacterials for systemic use, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options.consideration should be given to official guidance on the appropriate use of antibacterial agents.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - ceftriaxone sodium 1079.3mg (present as 1.193g ceftriaxone na*3.5h2o. eq 1.0793g of ceftriaxone na anhyd or 1g ceftriaxone anhyd) - powder for injection - 1000 mg - active: ceftriaxone sodium 1079.3mg (present as 1.193g ceftriaxone na*3.5h2o. eq 1.0793g of ceftriaxone na anhyd or 1g ceftriaxone anhyd)

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - ceftriaxone sodium 2158.6mg (present as 2.386g ceftriaxone na*3.5h2o. eq 2.158g of ceftriaxone na anhyd or 2g ceftriaxone anhyd) - powder for injection - 2000 mg - active: ceftriaxone sodium 2158.6mg (present as 2.386g ceftriaxone na*3.5h2o. eq 2.158g of ceftriaxone na anhyd or 2g ceftriaxone anhyd)