- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Geen informatie
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
< 2 jaar: Off-label
≥ 2 jaar: On-label
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Available formulations
Per ml oordr.:
Hydrocortison 10 mg, Neomycinesulfaat 5 mg, Polymyxine-B-sulfaat 10000 IE, 10 ml
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Dosages
| Otorrhoea in middle ear inflammation with the presence of perforation or tube |
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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
Adult Side Effects
Stekend en branderig gevoel bij geperforeerd trommelvlies. Overgevoeligheidsverschijnselen. Neomycine kan frequent en polymyxine in mindere mate sensibilisatie veroorzaken. Ototoxiciteit (bij systemische resorptie). Langdurig gebruik van corticosteroïden in het oor kan leiden tot atrofie en perforatie van het trommelvlies.
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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 in adults
Beschadiging/perforatie van het trommelvlies of vermoeden hiervan. Aandoeningen, primair veroorzaakt door een bacterie, virus, schimmel, gist of parasiet. Ulcereuze aandoeningen, wonden. Neonaten. Overgevoeligheid voor aminoglycosiden en polymyxinen.
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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| Corticosteroids and antiinfectives in combination | ||
|---|---|---|
| S02CA03 | ||
| S02CA03 | ||
| S02CA06 | ||
| S02CA07 | ||
| S02CA07 | ||
| S02CA03 | ||
| S02CA04 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- GlaxoSmithKline BV, SPC Otosporin (RVG 00855) 8-3-2016, www.geneesmiddeleninformatiebank.nl, Geraadpleegd 28 okt 2016
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Changes
Changes
