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

baxter healthcare corporation - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin in dextrose injection is indicated for the treatment of respiratory tract infections due to streptococcus pneumoniae, staphylococcus aureus and streptococcus pyogenes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . limitations of use injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin in dextrose injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available. cefazolin in dextrose injection is indicated for the treatment of urinary tract infections due to escherichia coli, and proteus mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of skin and skin structure infections due to s. aureus , s. pyogenes , and streptococcus agalactiae in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of biliary infections due to e. coli , various isolates of streptococci, p. mirabilis, and s. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of bone and joint infections due to s. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of genital infections due to e. coli, and p. mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)]. cefazolin in dextrose injection is indicated for the treatment of septicemia due to s. pneumoniae, s. aureus , p. mirabilis, and e. coli in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of endocarditis due to s. aureus and s. pyogenes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)]. cefazolin in dextrose injection is indicated is indicated for perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.3, 2.4, 2.5) and use in specific populations (8.4)]. the perioperative use of cefazolin in dextrose injection is indicated in adult and pediatric patients (aged 10 to 17 years old) surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). the prophylactic administration of cefazolin in dextrose injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin in dextrose injection and other antibacterial drugs, cefazolin in dextrose injection 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. cefazolin in dextrose injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefazolin or the cephalosporin class of antibacterial drugs, penicillins, or other beta-lactams [see warnings and precautions (5.1) ]. risk summary available data from published prospective cohort studies, case series and case reports over several decades with cephalosporin use, including cefazolin, in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. cefazolin crosses the placenta. animal reproduction studies with rats, mice and rabbits administered cefazolin during organogenesis at doses 1 to 3 times the maximum recommended human dose (mrhd) did not demonstrate adverse developmental outcomes. in rats subcutaneously administered cefazolin prior to delivery and throughout lactation, there were no adverse effects on offspring at a dose approximately 2 times the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, 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. data human data while available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use 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 reproduction studies have been performed in rats, mice and rabbits administered cefazolin during organogenesis at doses of 2000, 4000 and 240 mg/kg/day (approximately 1 to 3 times the maximum recommended human dose on a body surface area comparison). there was no evidence of any adverse effects on embryofetal development due to cefazolin. in a peri‑postnatal study in rats, cefazolin administered subcutaneously up to 1200 mg/kg/day (approximately 2 times the mrhd based on body surface area comparison) to pregnant dams prior to delivery and through lactation caused no adverse effects on offspring. risk summary data from published literature report that cefazolin is present in human milk, but is not expected to accumulate in a breastfed infant. there are no data on the effects of cefazolin on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefazolin in dextrose injection and any potential adverse effects on the breastfed child from cefazolin in dextrose injection or from the mother’s underlying condition. cefazolin in dextrose injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis in pediatric patients for whom appropriate dosing with this formulation can be achieved and for perioperative prophylaxis in pediatric patients aged 10 to 17 years old [see indications and usage (1.1 to 1.8)] . safety and effectiveness of cefazolin in dextrose injection in premature infants and neonates have not been established and is not recommended for use in this age group of pediatric patients. dosing for cefazolin in pediatric patients younger than one month old has not been established. because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of cefazolin in dextrose injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of cefazolin in dextrose injection that does not equal 1 gram or 2 grams is required and an alternative formulation of cefazolin should be considered [see dosage and administration (2.2, 2,3, 2.4 and 2.5)] . the safety and effectiveness of cefazolin in dextrose injection for perioperative prophylaxis have not been established in pediatric patients younger than 10 years old. the safety and effectiveness of cefazolin in dextrose injection for perioperative prophylaxis have been established in pediatric patients aged 10 to 17 years old. use of cefazolin in dextrose injection in these age groups is supported by evidence from adults with additional safety and pharmacokinetic data in pediatric patients aged 10 to 17 years old. safety and pharmacokinetics were evaluated in two multicenter, non-comparative studies (study 1 and study 2). these studies were conducted to assess the safety and pharmacokinetics of a single 30-minute infusion of either 1 gram or 2 grams (based on weight) of cefazolin in dextrose injection for perioperative prophylaxis in pediatric patients. study 1 evaluated the safety and pharmacokinetics of 1 g of cefazolin for injection in pediatric patients aged 10 to 17 years old scheduled for surgery with a weight of at least 25 kg but less than 60 kg and, 2 g in pediatric patients with a weight of at least 60 kg. study 2 evaluated 1 g of cefazolin for injection in pediatric patients aged 10 to 12 years old scheduled for surgery with a weight of at least 25 kg but less than 50 kg and, 2 g in pediatric patients with a weight of at least 50 kg to less than 85 kg [see dosage and administration (2.3), adverse reactions (6.1) and clinical pharmacology (12.3)] . the safety and effectiveness of cefazolin in dextrose injection for perioperative prophylaxis have not been established in pediatric patients younger than 10 years old. of the 920 subjects who received cefazolin in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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 it may be useful to monitor renal function [see dosage and administration (2.3) and warnings and precautions (5.2) ]. when cefazolin in dextrose injection is administered to adult and pediatric patients with low urinary output because of impaired renal function (creatinine clearance less than 55 ml/min and 70 ml/min for adults and pediatric patients, respectively), lower daily dosage is required [see dosage and administration (2.4) and warnings and precautions (5.2) ].

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

remedyrepack inc. - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae, klebsiella species , h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci . injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection, usp is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection, usp in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis, klebsiella species, and some strains of enterobacter and enterococci . skin and skin structure infections:  due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strains of streptococci. biliary tract infections: due to e. coli, various strains of streptococci, p. mirabilis,  klebsiella species, and s. aureus. bone and joint infections: due to s. aureus. genital infections: (i.e., prostatitis, epididymitis) due to e. coli, p. mirabilis, klebsiella species, and some strains of enterococci . septicemia:  due to s. pneumoniae, s. aureus (penicillin-sensitive and penicillin-resistant), p. mirabilis, e. coli, and  klebsiella species. endocarditis:  due to s. aureus (penicillin-sensitive and penicillin-resistant) and group a beta-hemolytic streptococci . perioperative prophylaxis: the prophylactic administration of cefazolin for injection, usp preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). the perioperative use of cefazolin for injection, usp may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). the prophylactic administration of cefazolin for injection, usp should usually be discontinued within a 24-hour period after the surgical procedure.  in surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection, usp may be continued for 3 to 5 days following the completion of surgery. if there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (see dosage and administration.) to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin for injection, usp and other antibacterial drugs, cefazolin 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. cefazolin for injection, usp is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

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

henry schein, inc. - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae, klebsiella species, h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection, usp is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection, usp in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis , klebsiella species, and some strains of enterobacter and enterococci. skin and skin structure infections: due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strains

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

proficient rx lp - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae, klebsiella species, h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection, usp is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection, usp in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis, klebsiella species, and some strains of enterobacter and enterococci. skin and skin structure infections:  due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strain

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

apotex corp. - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae, klebsiella species, h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection, usp is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection, usp in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis, klebsiella species, and some strains of enterobacter and enterococci. skin and skin structure infections:  due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strains of streptococci. biliary tract infections: due to e. coli, various strains of streptococci, p. mirabilis,  klebsiella species, and s. aureus. bone and joint infections: due to s. aureus. genital infections: (i.e., prostatitis, epididymitis) due to e. coli, p. mirabilis, klebsiella species, and some strains of enterococci. septicemia:  due to s. pneumoniae, s. aureus (penicillin-sensitive and penicillin-resistant), p. mirabilis, e. coli, and klebsiella species. endocarditis:  due to s. aureus (penicillin-sensitive and penicillin-resistant) and group a beta-hemolytic streptococci. perioperative prophylaxis: the prophylactic administration of cefazolin for injection, usp preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). the perioperative use of cefazolin for injection, usp may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). the prophylactic administration of cefazolin for injection, usp should usually be discontinued within a 24-hour period after the surgical procedure.  in surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection, usp may be continued for 3 to 5 days following the completion of surgery. if there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (see dosage and administration.) to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin for injection, usp and other antibacterial drugs, cefazolin 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. cefazolin for injection, usp is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - cefazolin sodium 10.5 g;   - powder for injection - 10 g - active: cefazolin sodium 10.5 g  

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - cefazolin sodium 1.05 g;   - powder for injection - 1 g - active: cefazolin sodium 1.05 g  

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - cefazolin sodium 21 g;   - powder for injection - 20 g - active: cefazolin sodium 21 g  

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - cefazolin sodium 525mg equivalent to 500 mg cephazolin;   - powder for injection - 500 mg - active: cefazolin sodium 525mg equivalent to 500 mg cephazolin  

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

sandoz pty ltd - cefazolin sodium, quantity: 2096 mg (equivalent: cefazolin, qty 2000 mg) - injection, powder for - excipient ingredients: - treatment of the following serious infections due to susceptible organisms: respiratory tract infections due to strep. pneumoniae, klebsiella sp., h. influenzae, staph. aureus (penicillin sensitive and penicillin resistant) and group a beta-haemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cephazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cephazolin in the subsequent prevention of rheumatic fever are not available at present. genitourinary tract infections due to e. coli, p. mirabilis, and klebsiella sp. and some strains of enterobacter and enterococci. skin and skin structure infections due to staph. aureus (penicillin sensitive and penicillin resisant) and group a beta-haemolytic streptococci and other strains of streptococci. bone and joint infections due to staph. aureus. septicaemia due to strep. pneumoniae, staph. aureus (penicillin sensitive and penicillin resistant), e. coli, p. mirabilis, and klebsiella sp. endocarditis due to staph. aureus (penicillin sensitive and penicillin resistant) and group a beta-haemolytic streptococci. note: appropriate culture and susceptibility studies should be preformed to determine susceptibility of the causative organism to cephazolin.