Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - bendamustine hydrochloride, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patient?s ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - bendamustine hydrochloride, quantity: 25 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patient?s ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - temozolomide, quantity: 5 mg - capsule, hard - excipient ingredients: indigo carmine; colloidal anhydrous silica; iron oxide yellow; stearic acid; titanium dioxide; lactose; purified water; gelatin; sodium starch glycollate; tartaric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,treatment of recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - dopamine hydrochloride, quantity: 200 mg - injection, concentrated - excipient ingredients: sodium chloride; potassium metabisulfite; water for injections; hydrochloric acid; sodium hydroxide - for the correction of haemodynamic imbalance present in: acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. as an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia. in chronic cardiac decompensation as in congestive failure.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: water for injections; dilute hydrochloric acid - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: dilute hydrochloric acid; water for injections - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 20 mg/ml - injection, solution - excipient ingredients: dilute hydrochloric acid; water for injections - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 20 mg/ml - injection, solution - excipient ingredients: water for injections; dilute hydrochloric acid - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide; water for injections; nitrogen - daptomycin is indicated for:,the treatment of adults and paediatric patients (1 to 17 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.,daptomycin is also indicated in adults 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,- 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 coadministered 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

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: water for injections; sodium hydroxide; nitrogen - daptomycin is indicated for:,the treatment of adults and paediatric patients (1 to 17 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.,daptomycin is also indicated in adults 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,- 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 coadministered 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