United States - English - NLM (National Library of Medicine)

novo nordisk - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - norditropin is indicated for the treatment of pediatric patients with: norditropin is indicated for the replacement of endogenous gh in adults with growth hormone deficiency (ghd) norditropin is contraindicated in patients with: risk summary limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous norditropin during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see data). the estimated background risk of birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in an embryo-fetal development s

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (gh). norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature associated with noonan syndrome. norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature associated with turner syndrome. norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature born small for gestational age (sga) with no catch-up growth by age 2-4 years. norditropin [somatropin (rdna origin) injection] is indicated for the replacement of endogenous gh in adults with growth hormone deficiency (ghd) who meet either of the following two criteria: - adult onset (ao): patients who have ghd, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease

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

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

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

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

novo nordisk pharmaceuticals pty ltd - somatropin -

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

novo nordisk pharmaceuticals pty ltd - somatropin -

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

novo nordisk pharmaceuticals pty ltd - somatropin -

Israel - English - Ministry of Health

novo nordisk ltd., israel - somatropin - solution for injection - somatropin 10 mg / 1 ml - somatropin - somatropin - children: * short stature due to inadequate or failed secretion of pituitary growth hormone or turner`s syndrome. * short stature in children with renal insufficiency. * growth disturbance (current height sds < - 2.5 and parental adjusted height sds < - 1) in short children born small for gestational age (sga) with a birth weight and/or length below - 2 sd who failed to show catch-up growth (hv sds < during the last year) by 4 years of age or later.* children with short stature associated with noonan syndrome.adults: treatment of adults with hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of g.h. deficiency.

Israel - English - Ministry of Health

novo nordisk ltd., israel - somatropin - solution for injection - somatropin 10 mg / 1.5 ml - somatropin - somatropin - children: * short stature due to inadequate or failed secretion of pituitary growth hormone or turner`s syndrome. * short stature in children with renal insufficiency. * growth disturbance (current height sds < - 2.5 and parental adjusted height sds < - 1) in short children born small for gestational age (sga) with a birth weight and/or length below - 2 sd who failed to show catch-up growth (hv sds < during the last year) by 4 years of age or later.* children with short stature associated with noonan syndrome.adults: treatment of adults with hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of g.h. deficiency.