- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Tmax en Cmax bij kinderen vanaf 7 jaar zijn vergelijkbaar met waarden volwassenen: na toediening van 0,15 E/kg: de Tmax 55 minuten en de Cmax 82 +/- 1,3 μE/ml.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
On-label
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Available formulations
Inj.vlst. 100 E/ml
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Dosages
| Diabetes mellitus, insulin-dependent |
|---|
|
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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
Adult Side Effects
Zeer vaak (> 10%): hypoglykemie. Vaak (1–10%): lokale overgevoeligheidsreacties, zoals roodheid, pijn, jeuk, zwelling, urticaria, ontsteking (meestal voorbijgaand na enkele dagen tot weken). Soms (0,1–1%): systemische overgevoeligheidsreacties, waaronder gegeneraliseerde huiduitslag, allergische huidontsteking en jeuk, benauwdheid op de borst, ademnood. Zelden (0,01–0,1%): lipodystrofie op de injectieplaats. Verder is gemeld: hyperglykemie, waaronder gevallen leidend tot diabetische ketoacidose bij het gebruik van pompsystemen.
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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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| Insulins and analogues for injection, fast-acting | ||
|---|---|---|
| A10AB04 | ||
| A10AB01 | ||
| A10AB04 | ||
| Insulins and analogues for injection, intermediate-acting | ||
|---|---|---|
| A10AC01 | ||
| Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting | ||
|---|---|---|
| A10AD06 | ||
| A10AD01 | ||
| Insulins and analogues for injection, long-acting | ||
|---|---|---|
| A10AE05 | ||
| A10AE04 | ||
| A10AE | ||
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Reference
- Sanofi-Aventis Deutschland GmbH, SPC Apidra (EU/1/04/285/001-004), www.ema.europa.eu, Geraadpleegd 4 juni 2010, http://www.ema.europa.eu/humandocs/PDFs/EPAR/apidra/emea-combined-h557nl.pdf
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Changes
Changes
