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

accord healthcare pty ltd - olanzapine, quantity: 10 mg - tablet, film coated - excipient ingredients: hypromellose; crospovidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; hyprolose; titanium dioxide; polysorbate 80; macrogol 400 - olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. ,olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

accord healthcare pty ltd - olanzapine, quantity: 2.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hyprolose; lactose monohydrate; microcrystalline cellulose; crospovidone; hypromellose; titanium dioxide; polysorbate 80; macrogol 400 - olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. ,olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

accord healthcare pty ltd - olanzapine, quantity: 7.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; magnesium stearate; hypromellose; hyprolose; titanium dioxide; polysorbate 80; macrogol 400 - olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. ,olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

accord healthcare pty ltd - quetiapine fumarate -

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

accord healthcare pty ltd - quetiapine fumarate -

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

accord healthcare pty ltd - quetiapine fumarate -

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

accord healthcare pty ltd - doxorubicin hydrochloride -

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

accord healthcare pty ltd - doxorubicin hydrochloride -

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

accord healthcare 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 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 - English - 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.