Humatrope ® (somatropin (rDNA ursprung) för injektion)

För fullständig produktresumé för Humatrope® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Humatrope® (somatropin): Terapeutiska indikationer

Humatrope är indicerat för behandling av barn som har tillväxtfel i samband med hälsoförhållanden och för ersättningsterapi hos vuxna med uttalad tillväxthormonbrist

Paediatric patients

Humatrope is indicated for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone.

Humatrope is also indicated for the treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.

Humatrope is also indicated for the treatment of growth retardation in prepubertal children with chronic renal insufficiency.

Humatrope is also indicated for the treatment of patients who have growth failure associated with SHOX deficiency, as confirmed by DNA analysis.

Humatrope is also indicated for 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 (height velocity SDS < 0 during the last year) by 4 years of age or later.



Adult patients

Humatrope is indicated for replacement therapy in adults with pronounced growth hormone deficiency.

Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. In patients with childhood onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low IGF-I concentrations <-2 SDS, who may be considered for one test. The cut-off point of the dynamic test should be strict.

Reference

Humatrope Summary of Product Characteristics

Datum fӧr senaste ӧversyn 2019 M02 01


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