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

sandoz pty ltd - somatropin, quantity: 3.3 mg/ml - injection - excipient ingredients: poloxamer; dibasic sodium phosphate heptahydrate; benzyl alcohol; sodium hydroxide; monobasic sodium phosphate; mannitol; water for injections; phosphoric acid - omnitrope is intended for long term treatment of children (above three years of age with growth disturbance due to insufficient secretion of pituitary growth hormone; growth disturbance associated with gonadal dysgenesis (turner's syndrome); & growth disturbance associated with chronic renal insufficiency.

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

sandoz pty ltd - somatropin, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; phenol; phosphoric acid; water for injections; sodium chloride; monobasic sodium phosphate dihydrate; dibasic sodium phosphate heptahydrate; poloxamer - omnitrope is intended for the long term treatment of children (above three years of age) with:,- growth disturbance due to insufficient secretion of pituitary growth hormone,- growth disturbance associated with gonadal dysgenesis (turner syndrome),- growth disturbance associated with chronic renal insufficiency.

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

scigen australia pty ltd - somatropin, quantity: 6.67 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; monobasic sodium phosphate dihydrate; poloxamer; phenol; glycine; phosphoric acid; sodium hydroxide; water for injections - omnitrope is intended for the long term treatment of children (above three years of age) with, growth disturbance due to insufficient secretion of pituatary growth hormone, growth disturbance associated with gonadal dysgenesis (turner syndrome), growth disturbance associated with chronic renal insufficiency.

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

sandoz pty ltd - somatropin, quantity: 10 mg - injection, solution - excipient ingredients: phenol; poloxamer; sodium hydroxide; phosphoric acid; monobasic sodium phosphate dihydrate; dibasic sodium phosphate heptahydrate; water for injections; glycine - omnitrope is intended for the long term treatment of children (above three years of age) with, growth disturbance due to insufficient secretion of pituatary growth hormone, growth disturbance associated with gonadal dysgenesis (turner syndrome), growth disturbance associated with chronic renal insufficiency.

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

pfizer australia pty ltd - somatropin, quantity: 5 mg/ml - diluent, not applicable - excipient ingredients: metacresol; water for injections - short stature due to decreased or failed secretion of pituitary growth hormone. indications as at 20 march 2001: short stature due to decreased or failed secretion of pituitary hormone. growth distrubances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. indications as at 26 november 2001: short stature due to decreased or failed secretion of pituitary growth hormone. 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 nanograms/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. indications as at 13 june 2003: short stature due to decreased or failed secretion of pituitary growth hormone. 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. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

pfizer australia pty ltd - somatropin, quantity: 12 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - short stature due to decreased or failed secretion of pituitary growth hormone. 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. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

pfizer australia pty ltd - somatropin, quantity: 5 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - short stature due to decreased or failed secretion of pituitary growth hormone. 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. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

Australia - English - 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.

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.