Omnitrope 15 mg/1.5 ml solution for injection
Qualitative and quantitative composition
Each ml of solution contains 10 mg of somatropin* (corresponding to 30 IU). One cartridge contains 1.5 ml, corresponding to 15 mg somatropin* (45 IU).
Produced by Escherichia coli using recombinant DNA techniques. For the complete list of excipients, see section 6.1.
Pharmaceutical form Omnitrop Sandoz 15 IU
Solution injectable in one cartridge for SurePal 15 The solution is clear and colourless.
- Infants, children and adolescents
- Growth disorders due to insufficient secretion of growth hormone (GH).
- Growth disorders associated with Turner's syndrome.
- Growth disorders associated with chronic renal failure.
Growth disorders (standard deviation score (SDS) of current height
Prader-Willi syndrome (PWS) for the improvement of growth and body structure.
The diagnosis of PWS must be confirmed by appropriate genetic testing.
Adults Omnitrop Sandoz 15 IU
Replacement therapy in adults with marked growth hormone deficiency. Adult patients with severe growth hormone deficiency are patients with known hypothalamic-pituitary pathology who are deficient in at least one known pituitary hormone other than prolactin. These patients must perform a single dynamic test for confirmation of diagnosis or exclusion of growth hormone deficiency. In patients with isolated growth hormone deficiency arising in childhood (who show no sign of hypothalamic-pituitary disease or who have not undergone cranial radiotherapy), two dynamic tests should be performed, except where patients have low concentrations of IGF-I (SDS
|Active ingredient, IU||15|
|Active ingredient, mg||5|
|1 bottle, ml||1,5|
|Ampoules per package, pcs||5|
|Packing||Packing (5 ampoules), Ampoule|
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