somatropin
Genotropin · Humatrope · Norditropin
1 INDICATIONS AND USAGE NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome ( 1.1 ) • Adult : Replacement of endogenous GH in adults with growth hormone deficiency ( 1.2 ) 1.1 Pediatric Patients NORDITROPIN is indicated for the treatment of pediatric patients with: • growth failure due to inadequate secretion of endogenous growth hormone (GH), • short stature associated with Noonan syndrome, • short stature associated with Turner syndrome, • short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, • growth failure due to Prader-Willi syndrome (PWS). 1.2 Adult Patients NORDITROPIN is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
Mechanism. 12.1 Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glucose output, protein synthesis and lipolysis. Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.
What stands out in the reports.
ROR = reporting odds ratio (log-schaal). Een waarde boven 1 betekent dat het symptoom vaker wordt gemeld voor dit product dan voor alle andere producten samen. Dit meet hoeveel het opvalt in meldingen — geen causaliteit, geen risico.
Se notifican desproporcionadamente problemas relacionados con el dispositivo de administración de somatropina, como "DEVICE MECHANICAL ISSUE" (ROR 509.1) y "DEVICE DIFFICULT TO USE" (ROR 6.3). También errores de uso, como "WRONG TECHNIQUE IN DEVICE USAGE PROCESS" (ROR 38.1). Esto es lógico, ya que la somatropina se administra mediante dispositivos inyectables. Las reacciones en el lugar de inyección, como hematomas, también están desproporcionadamente notificadas. "Notificado con frecuencia" no es lo mismo que "causado con frecuencia". Esto no sustituye el consejo médico.
Dit vervangt geen medisch advies.
No signals currently mapped to the label.
Report volume per quarter.
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 27, 2016 | II | Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step | Novo Nordisk Inc |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm. Source: openFDA enforcement.