Australia - English - 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.

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

novo nordisk pharmaceuticals pty ltd - somatropin, quantity: 3.33 mg/ml - injection, solution - excipient ingredients: mannitol; histidine; water for injections; phenol; poloxamer - 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

1%) solution for injection vials (hameln pharma ltd - lidocaine hydrochloride - solution for injection - 10mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

2%) solution for injection vials (hameln pharma ltd - lidocaine hydrochloride - solution for injection - 20mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

base) 3.3mg/1ml solution for injection ampoules (hameln pharma ltd - dexamethasone sodium phosphate - solution for injection - 3.3mg/1ml

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; water for injections - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards.,actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx.,in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,polyarticular juvenile idiopathic arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.,subcutaneous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.,actemra iv and sc can be given alone or in combination with methotrexate (mtx).

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.