- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Treatment with the recommended doses of delamanid for adolescents and children with a body weight of at least 10 kg resulted in a plasma exposure similar to that of adults. [SmPC Deltyba]
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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
| Multi-drug resistant tuberculosis |
|---|
|
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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 frequency, type and severity of adverse reactions are similar in children and adults with the exception of halluzinations which were more frequently reported in children (5.4% vs. 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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| Antibiotics | ||
|---|---|---|
| J04AB02 | ||
| Hydrazides | ||
|---|---|---|
| J04AC01 | ||
| Other drugs for treatment of tuberculosis | ||
|---|---|---|
| J04AK05 | ||
| J04AK02 | ||
| J04AK01 | ||
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Reference
- Otsuka Novel Products GmbH, SmPC Deltyba (EU/1/13/875), 07/2023
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Changes
Changes
