- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
| Paediatric patients (2.5-14 years) | |
| Caverage with a dose of 0,16 mg/kg/week | 80,2 ng/mL |
| Tmax with doses of 0,02-0,16 mg/kg/week | 4-25,5 hour (median) |
| Vd* | 1,7 l |
| T1/2 * | 34 hour |
* Estimated based on pop PK-analyses
[SmPC Sogroya]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Growth disorders resulting from growth hormone deficiency, neonatal hypoglycemia due to GH deficiency |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Very common (> 10%): headache.
Common (1-10%): hypothyroidism, adrenal cortex insufficiency. Hyperglycemia. Joint pain, pain in extremities. Peripheral edema, fatigue, reactions at the injection site (hematoma, pain, swelling).
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
Promotion of longitudinal growth in children with closed epiphyseal joints [SmPC Sogroya]
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| ACTH | ||
|---|---|---|
| H01AA02 | ||
| Somatropin and somatropin agonists | ||
|---|---|---|
| H01AC09 | ||
| H01AC03 | ||
| H01AC08 | ||
| H01AC01 | ||
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Reference
- Novo Nordisk A/S, SmPC Sogroya (EU/1/20/1501/001) Rev 2; 31-7-2023, www.ema.europa.eu
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Changes
Changes
