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)

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

sandoz pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: sodium hydroxide; polysorbate 80; water for injections; glutamic acid; sorbitol - indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. ,indicated for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. ,indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies. ,indicated for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation.,in patients receiving myeloablative chemotherapy, is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation.,indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia.,indicated in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

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

sandoz pty ltd - filgrastim, quantity: 960 microgram/ml - injection, solution - excipient ingredients: sorbitol; polysorbate 80; sodium hydroxide; glutamic acid; water for injections - indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. ,indicated for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. ,indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies. ,indicated for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation.,in patients receiving myeloablative chemotherapy, is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation.,indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia.,indicated in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

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

novo nordisk pharmaceuticals pty ltd - somatropin, quantity: 10 mg/ml - injection, solution - excipient ingredients: histidine; phenol; poloxamer; mannitol; water for injections - children:treatment of growth failure in children due to pituitary growth hormone deficiency. treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2. treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 sd) without spontaneous catch up growth by 2 years of age). adults: treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. in order to establish childhood onset [co] growth hormone insufficiency, reconfirmation by one provocative test is recommended. in order to establish isolated growth hormone deficiency two provocative tests are recommended. in adults, the insulin tolerance test is the provocative test of choice. when the insulin tolerance test is contraindicated, alternative provocative tests must be used. the combined arginine or the glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.

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

novo nordisk pharmaceuticals pty ltd - somatropin, quantity: 6.67 mg/ml - injection, solution - excipient ingredients: poloxamer; mannitol; histidine; water for injections; phenol - children:treatment of growth failure in children due to pituitary growth hormone deficiency. treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2. treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 sd) without spontaneous catch up growth by 2 years of age). adults: treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. in order to establish childhood onset [co] growth hormone insufficiency, reconfirmation by one provocative test is recommended. in order to establish isolated growth hormone deficiency two provocative tests are recommended. in adults, the insulin tolerance test is the provocative test of choice. when the insulin tolerance test is contraindicated, alternative provocative tests must be used. the combined arginine or the glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.