Australië - Engels - 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.

Australië - Engels - 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.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

panpharma australia pty ltd - linezolid, quantity: 600 mg - injection, solution - excipient ingredients: glucose monohydrate; sodium citrate dihydrate; citric acid; hydrochloric acid; sodium hydroxide; water for injections - linezolid is indicated for the treatment of suspected or proven infections due to gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant staphylococcus species and vancomycin resistant enterococcus species. linezolid is active against gram-positive bacteria only. linezolid has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram-negative pathogen is documented or suspected.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

panpharma australia pty ltd - linezolid, quantity: 400 mg - injection, solution - excipient ingredients: glucose monohydrate; sodium citrate dihydrate; citric acid; hydrochloric acid; sodium hydroxide; water for injections - linezolid is indicated for the treatment of suspected or proven infections due to gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant staphylococcus species and vancomycin resistant enterococcus species. linezolid is active against gram-positive bacteria only. linezolid has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram-negative pathogen is documented or suspected.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

panpharma australia pty ltd - linezolid, quantity: 200 mg - injection, solution - excipient ingredients: glucose monohydrate; sodium citrate dihydrate; citric acid; hydrochloric acid; sodium hydroxide; water for injections - linezolid is indicated for the treatment of suspected or proven infections due to gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant staphylococcus species and vancomycin resistant enterococcus species. linezolid is active against gram-positive bacteria only. linezolid has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram-negative pathogen is documented or suspected.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - ketorolac trometamol, quantity: 30 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; ethanol - ketorolac trometamol solution for injection is indicated for the short-term management of moderately severe, acute pain following surgical procedures. the total duration of ketorolac use should not exceed five days.,it is recommended that ketorolac parenteral be used in the immediate post-operative period.,patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in the "dosage and administration" section (refer to "conversion from parenteral to oral therapy"). the total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days. note that oral dosage form can be available from other brand/s.,general,ketorolac trometamol solution for injection is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation.,there is no satisfactory evidence for the use of ketorolac trometamol solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - sumatriptan, quantity: 12 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - clustran injection is indicated for the acute relief of migraine attacks with or without aura., clustran injection is also indicated for the acute treatment of cluster headaches.,there is no information available on the use of sumatriptan in the treatment of basilar or hemiplegic migraine.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - radium (223ra) dichloride, quantity: 6600 kbq - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; sodium citrate dihydrate - xofigo is indicated for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - water for injections, quantity: 4.2 ml - injection - excipient ingredients: - firmagon is a gnrh receptor blocker indicated for treatment of patients with prostate cancer in whom androgen deprivation is warranted.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - water for injections, quantity: 3 ml - injection - excipient ingredients: - firmagon is a gnrh receptor blocker indicated for treatment of patients with prostate cancer in whom androgen deprivation is warranted.