Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 2.5 mg - injection, solution - excipient ingredients: water for injections; mannitol - bortezomib intas, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib intas, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib intas is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib intas in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: water for injections; mannitol - bortezomib intas, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib intas, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib intas is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib intas in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Austrálie - angličtina - 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 intas 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 intas 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 intas 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 intas 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 intas 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.

Austrálie - angličtina - 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 intas 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 intas 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 intas 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 intas 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 intas 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - topotecan hydrochloride, quantity: 4.346 mg (equivalent: topotecan, qty 4 mg) - injection, concentrated - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; tartaric acid - topotecan intas is indicated as single agent therapy for the treatment of patients with:,? small cell lung carcinoma after failure of first line chemotherapy.,? metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.,topotecan intas is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - topotecan hydrochloride, quantity: 1.09 mg (equivalent: topotecan, qty 1 mg) - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections; tartaric acid; sodium hydroxide - topotecan intas is indicated as single agent therapy for the treatment of patients with:,? small cell lung carcinoma after failure of first line chemotherapy.,? metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.,topotecan intas is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levothyroxine sodium, quantity: 137 microgram - tablet, uncoated - excipient ingredients: light magnesium oxide; microcrystalline cellulose; sodium starch glycollate; sodium stearylfumarate; brilliant blue fcf aluminium lake - levothyroxine intas is indicated for the management of demonstrated thyroid hormone deficiency.,levothyroxine intas is also used to suppress thyrotropin (tsh) for the management of tsh-responsive tumours of the thyroid.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levothyroxine sodium, quantity: 100 microgram - tablet, uncoated - excipient ingredients: microcrystalline cellulose; light magnesium oxide; sodium stearylfumarate; sodium starch glycollate; sunset yellow fcf aluminium lake; tartrazine aluminium lake - levothyroxine intas is indicated for the management of demonstrated thyroid hormone deficiency.,levothyroxine intas is also used to suppress thyrotropin (tsh) for the management of tsh-responsive tumours of the thyroid.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levothyroxine sodium, quantity: 25 microgram - tablet, uncoated - excipient ingredients: light magnesium oxide; sodium stearylfumarate; sodium starch glycollate; microcrystalline cellulose; sunset yellow fcf aluminium lake - levothyroxine intas is indicated for the management of demonstrated thyroid hormone deficiency.,levothyroxine intas is also used to suppress thyrotropin (tsh) for the management of tsh-responsive tumours of the thyroid.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levothyroxine sodium, quantity: 112 microgram - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; sodium starch glycollate; light magnesium oxide; allura red ac aluminium lake; carmine - levothyroxine intas is indicated for the management of demonstrated thyroid hormone deficiency.,levothyroxine intas is also used to suppress thyrotropin (tsh) for the management of tsh-responsive tumours of the thyroid.