- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Children generally have a lower rufinamide clearance than adults, a difference that is related to body size.
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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
| Adjuvant treatment for episodes in Lennox-Gastaut syndrome: IN COMBINATION WITH VALPROATE |
|---|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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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
Paediatric Population (age 1 to less than 4 years):
Very common (≥ 10%): upper respiratory tract infection, vomiting, pneumonia, somnolence, sinusitis, otitis media, diarrhoea, cough, pyrexia, bronchitis, constipation, nasal congestion, rash, irritability and decreased appetite
The frequency, type and severity of these adverse reactions were similar to that in children 4 years of age and older, adolescents and adults. [SmPC Inovelon]
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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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| Barbiturates and derivatives | ||
|---|---|---|
| N03AA02 | ||
| N03AA03 | ||
| Hydantoin derivatives | ||
|---|---|---|
| N03AB02 | ||
| Succinimide derivatives | ||
|---|---|---|
| N03AD01 | ||
| Benzodiazepine derivatives | ||
|---|---|---|
| N03AE01 | ||
| Carboxamide derivatives | ||
|---|---|---|
| N03AF01 | ||
| N03AF02 | ||
| Fatty acid derivatives | ||
|---|---|---|
| N03AG01 | ||
| N03AG04 | ||
| Other antiepileptics | ||
|---|---|---|
| N03AX23 | ||
| N03AX24 | ||
| N03AX10 | ||
| N03AX26 | ||
| N03AX18 | ||
| N03AX09 | ||
| N03AX14 | ||
| N03AX22 | ||
| N03AX16 | ||
| N03AX17 | ||
| N03AX03 | ||
| N03AX11 | ||
| N03AX15 | ||
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Reference
- Eisai Limited, SPC Inovelon (EU/1/06/378/017) Rev 22, 17-08-2021, www.ema.europa.eu
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Changes
Changes
