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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1238677
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Name of medicinal product:
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OMNITROPE
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Active substances:
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ATC code:
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H01AC01
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Dosage form:
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powder and solvent for solution for injection
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Route of administration:
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subcutaneous use
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Strengh:
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1,3mg
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Amount in package:
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1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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lahusti 1 ml
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Indication:
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Infants, children and adolescents
- Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD).
- Growth disturbance associated with Turner syndrome.
- Growth disturbance associated with chronic renal insufficiency.
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
- Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.
Adults
- Replacement therapy in adults with pronounced growth hormone deficiency.
- Adult onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency.
- Childhood onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.
All other patients will require IGF-I assay and one growth hormone stimulation test.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Sandoz GmbH
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Marketing authorization number:
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EU/1/06/332
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Marketing authorization issued on:
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May 20, 2006
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
September 3, 2014
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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