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

accord healthcare pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin accord is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin accord is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin accord therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin accord is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin accord is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

dr reddys laboratories australia pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age) complicated skin and skin structure infections,daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

dr reddys laboratories australia pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age) complicated skin and skin structure infections,daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

wockhardt bio pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

wockhardt bio pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age) complicated skin and skin structure infections,daptomycin wockhardt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wockhardt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age) daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wockhardt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wockhardt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

wockhardt bio pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

wockhardt bio pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age) complicated skin and skin structure infections,daptomycin wockhardt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wockhardt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age) daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wockhardt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wockhardt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

alphapharm pty ltd - vancomycin hydrochloride, quantity: 1.026 g (equivalent: vancomycin, qty 1 g) - injection, powder for - excipient ingredients: nitrogen; hydrochloric acid; water for injections - vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg enterococcus faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

alphapharm pty ltd - vancomycin hydrochloride, quantity: 513 mg (equivalent: vancomycin, qty 500 mg) - injection, powder for - excipient ingredients: hydrochloric acid; water for injections; nitrogen - vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg enterococcus faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

pfizer australia pty ltd - vancomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide; hydrochloric acid - indications as at 31 october 2003: vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg strep. faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.