- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information is present at this moment.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
No information is present at this moment.
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Dosages
| Pulmonary arterial hypertension |
|---|
|
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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
The safety profile in children aged 2-18 years corresponds to that in adults.
The following adverse reactions occurred with a different frequency than in adults: upper respiratory tract infection (31.9%), rhinitis (8.3%) and gastroenteritis (11.1%).
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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
No information available on specific contra indications in children.
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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| Serotonin antagonists | ||
|---|---|---|
| C02KD01 | ||
| Antihypertensives for pulmonary arterial hypertension | ||
|---|---|---|
| C02KX02 | ||
| C02KX01 | ||
| C02KX05 | ||
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Reference
- Janssen-Cilag International NV, SmPC Opsumit (EU/1/13/893/004) 26-11-2024 Rev 24, www.ema.europa.eu
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Changes
Changes
