- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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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
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Dosages
| 5q spinal muscle atrophy (SMA) |
|---|
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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
Infantile SMA (type 1):
Very common (>10%): Diarrhea, rash, maculopapular rash, erythema, dermatitis, allergic dermatitis, papular rash, folliculitis, pyrexia (including hyperpyrexia)
Common (1-10%): Oral and aphthous ulcers, urinary tract infections (including cystitis)
Frequently (1-10%).
In addition, in late-onset SMA (types 2 and 3):
Very common (>10%): Headache
Common (1-10%): nausea, arthralgia
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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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| Other drugs for disorders of the musculo-skeletal system | ||
|---|---|---|
| M09AX03 | ||
| M09AX07 | ||
| M09AX09 | ||
| M09AX09 | ||
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References
- Roche Registration GmbH, SmPC Evrysdi 0.75 mg/mL powder for oral solution, (EU/1/21/1531/001) Rev 9, 2-10-2024, www.ema.europa.eu
- Roche Registration GmbH, SmPC Evrysdi 0.75 mg/mL powder for oral solution, (EU/1/21/1531/001) Rev 9, 2-10-2024, www.ema.europa.eu
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Changes
Changes
