- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Population pharmacokinetics modeling was performed based on sparse plasma concentration data (n=232, leeftijd 2 mnd-17 jaar). The analysis indicated that doses of 5.0 (body weights 10- 20 kg) and 4.0 mg/kg/day (body weights 20-50 kg) provide the same steady-state average plasma concentration as in adults receiving 200 mg/day.
| Bodyweight | Cl (l/hour) |
| 10 kg | 0,96 |
| 20 kg | 1,61 |
| 30 kg | 2,18 |
| 50 kg | 3,19 |
| 70 kg | 3,58 |
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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
| As an adjuvant in partial epilepsy with or without secondary generalization |
|---|
|
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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
Psychomotor hyperactivity. Behavioural disorders and suicidal thoughts have been reported more often in children than in adults.
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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 | ||
| N03AF03 | ||
| Fatty acid derivatives | ||
|---|---|---|
| N03AG01 | ||
| N03AG04 | ||
| Other antiepileptics | ||
|---|---|---|
| N03AX24 | ||
| N03AX10 | ||
| N03AX26 | ||
| N03AX18 | ||
| N03AX09 | ||
| N03AX14 | ||
| N03AX22 | ||
| N03AX16 | ||
| N03AX17 | ||
| N03AX03 | ||
| N03AX11 | ||
| N03AX15 | ||
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References
- UCB Pharma S.A., SmPC Briviact Drank ( EU/1/15/1073/021) Rev 15. 17-03-2022, www.ema.europa.eu
- UCB Pharma S.A., SmPC Briviact ( EU/1/15/1073/022) Rev 15. 17-03-2022
- UCB, SmPC Briviact 10mg/25mg/50mg/75mg/100mg Filmtabletten (EU/1/15/1073/001), 07/2018
- UCB, SmPC Briviact 10mg/ml Injektions-/Infusionslösung (EU/1/15/1073/022), 07/2018
- UCB, SmPC Briviact 10mg/ml Lösung zum Einnehmen (EU/1/15/1073/021), 07/2018
- Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed April 15, 2019
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Changes
Changes
