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

norditropin flexpro somatropin (rbe) 10mg (6.67mg/ml) injection-solution multidose cartridge

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)

norditropin flexpro somatropin (rbe) 5mg (3.33mg/ml) injection-solution multidose cartridge

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.