Name of the medicinal product Norditropin Simplexx 45IU Pre-filled pen,
solution for injection
Norditropin Simplexx 45IU is a solution for injection into the skin in a multi-dose disposable pre-filled pen. Norditropin contains biosynthetic human growth hormone (somatropin), which is the active substance. Other ingredients are: Mannitol, histidine, poloxamer 188, phenol and water for injections.
Somatropin is an endocrine hormone with metabolic and growth promoting effects.
Growth failure due to growth hormone insufficiency, growth failure 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).
Pronounced growth hormone deficiency in known hypothalamicpituitary disease (one other deficient axis, other than prolactin), demonstrated by one provocative test after institution of adequate replacement therapy for any other deficient axis. Childhood onset growth hormone insufficiency, reconfirmed by two provocative tests. 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 arginineor glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.
Dosage and administration
Norditropin NordiLet is a pre-filled pen, which is designed to be used with NovoFine needles. The dose is delivered in clicks. Norditropin Simplexx 45IU delivers 1–29 clicks in increments of 1 click for each injection. In the package leaflet for each strength a range of doses in mg per number of clicks is given in a conversion table. The dosage is individual. Generally, daily subcutaneous injection in the evening is recommended. The injection site should be varied to prevent lipoatrophy. Prescription only. For the injection procedure, please
see the instruction manual for Norditropin .Patients should be reminded to wash their hands thoroughly with soap and water and/or disinfectant
prior to any contact with Norditropin . Norditropin Simplexx 45IU should not be shaken vigorously at any time. General recommendations for dosages are shown
Growth hormone insufficiency:
25 to 35 microgram/kg/day or 0.7 to 1.0mg/m²/day In children with Turner syndrome: 45 to 67 microgram/kg/day or 1.3 to 2.0mg/m²/day In children with Chronic renal disease: 50 microgram/kg/day or 1.4mg/m²/day In children born small for gestational age (SGA): 33 to 67 microgram/kg/day or 1.0 to 2.0mg/m²/day
Replacement therapy: It is recommended to start treatment with a low dose 0.1–0.3mg/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. Dose requirementsdecline with age. Maintenance dosages vary from person to person, but seldom exceed 1.0mg/day (equal to 3 IU/day).
Any evidence of active malignant tumours. Intracranial neoplasm must be inactive and antitumour therapy should be completed prior to institution of therapy. Pregnancy and lactation. 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. Hypersensitivity to any of the ingredients in the preparation. In children with chronicrenal disease treatment with Norditropin NordiLet should be discontinued
at renal transplantation.
All pens come prefilled and preloaded and use some of the thinnest needles available.a The pens can even be stored outside of the refrigerator for up to 21 days after first use