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Norditropin to Children: Growth retardation due to growth hormone deficiency (GHD), growth retardation in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal children due to chronic renal disease and short children born small for gestational age (SGA) who failed to show catch-up growth by 2 years of age.
Adults: Childhood onset growth hormone deficiency: Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after growth completion. Testing is not required for those with more than three pituitary hormone deficits, with severe GHD due to a defined genetic cause, due to structural hypothalamic pituitary abnormalities, due to central nervous system tumours or due to high-dose cranial irradiation, or with GHD secondary to a pituitary/hypothalamic disease or insult if measurements of insulin-like growth factor (IGF-I) is <-2 SDS after at least four weeks off growth hormone treatment. MORE ON HGH
In all other patients an IGF-I measurement and one growth hormone stimulation test is required.
Adult onset growth hormone deficiency: Pronounced GHD in known hypothalamic-pituitary disease, cranial irradiation and traumatic brain injury.
GHD should be associated with one other deficient axis, other than prolactin.
GHD should be demonstrated by one provocative test after institution of adequate replacement therapy for any other deficient axis.
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-growth hormone releasing hormone is recommended. An arginine or glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test. RELATED PRODUCTS
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Dosage/Direction for Use
Norditropin NordiFlex is a pre-filled pen designed to be used with NovoFine or NovoTwist needles. The device delivers a maximum of 1.5 mg, 3.0 mg and 4.5 mg somatropin per dose, in increments of 0.025 mg, 0.050 mg and 0.075 mg somatropin, respectively.
The dosage is individual and must always be adjusted in accordance with individual’s clinical and biochemical response to therapy. Generally, daily subcutaneous injection in the evening is recommended. The injection site should be varied to prevent lipoatrophy.
For the injection procedure, please see the instruction manual for Norditropin NordiFlex 5 mg/1.5 ml and Norditropin NordiFlex 10 mg/5 ml.
Patients should be reminded to wash their hands thoroughly with soap and water and/or disinfectant prior to any contact with Norditropin NordiFlex.
Norditropin NordiFlex should not be shaken vigorously at any time.
General recommendations for dosages are shown as follows.
Children: Growth hormone deficiency: 0.025 to 0.035 mg/kg/day or 0.7 to 1.0 mg/m2/day.
When GHD persists after growth completion, growth hormone treatment should be continued to achieve full somatic adult development including lean body mass and bone mineral accrual.
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In children with Turner syndrome: 0.045 to 0.067 mg/kg/day or 1.3 to 2.0 mg/m2/day.
In children with Chronic renal disease: 0.050 mg/kg/day or 1.4 mg/m2/day.
In children born small for gestational age (SGA): 0.033 to 0.067 mg/kg/day or 1.0 to 2.0 mg/m2/day.
Adults: Replacement therapy: The dosage must be adjusted to the need of the individual patient.
In patients with childhood onset GHD, the recommended dose to restart is 0.2-0.5 mg/day with subsequent dose adjustment on the basis of IGF-I concentration determination.
In patients with adult onset GHD, it is recommended to start treatment with a low dose 0.1-0.3 mg/day and to increase the dosage gradually at monthly intervals in order to meet the need of the individual patient. Serum IGF-I can be used as guidance for the dose titration. Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement, are undertreated while men are over-treated. Dose requirements decline with age.
Maintenance dosages vary from person to person, but seldom exceed 1.0 mg/day (equal to 3 IU/day).
Acute overdosage can initially lead to hypoglycaemia and subsequently to hyperglycaemia. The hypoglycaemia was only detected biochemically (i.e. without clinical signs). Long-term overdose could result in signs and symptoms consistent with known effects of human growth hormone excess.
Hypersensitivity to the active substance or to any of the excipients.
Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive, and antitumour therapy must be completed prior to starting growth hormone therapy. Treatment should be discontinued if there is evidence of tumour growth.
Somatropin should not be used for longitudinal growth promotion in children with closed epiphyses. Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated with Norditropin NordiFlex.
For children with chronic renal disease, treatment with Norditropin NordiFlex should be discontinued at renal transplantation.
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