- 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)
On-label
Licensed use Licensed useA second drug has not been selected yet.
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Available formulations
Focetria: Inj.susp. (influenzavirus A/Vietnam/1194/2004 (H5N1), subunit) 15 µg/ml 0.5 ml
Pandemrix: Inj.emulsie (influenzavirus A/Vietnam/1194/2004 (H5N1), gesplitst 7.5 μg/ml 0.5 ml
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Dosages
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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
Er zijn enkele gevallen van narcolepsie gerapporteerd.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Adult Side Effects
Bij meer dan 10% van de patiënten: pijn, erytheem, zwelling en verharding op de injectieplaats, koorts, vermoeidheid, hoofdpijn, spierpijn en gewrichtspijn. Bij 1-10%: ecchymosen en jeuk op de injectieplaats, malaise, rillingen, zweten, duizeligheid, nasofaryngitis, faryngolaryngale pijn en lymfadenopathie. Bij minder dan 1%: maagdarmstoornissen (zoals misselijkheid, braken, diarree en buikpijn), algemene huidreacties (waaronder huiduitslag, jeuk en urticaria), paresthesie, dysesthesie, slaperigheid, slapeloosheid, rusteloosheid, gehoorverlies, dyspneu, hoesten, rinorroe, verstopte neus, conjunctivitis en hypotensie; zelden neuralgie, convulsies, allergische reacties (in zeldzame gevallen tot anafylactische shock leidend), angio-oedeem, trombocytopenie, vasculitis en neurologische aandoeningen, zoals encefalomyelitis, neuritis en syndroom van Guillain-Barré.
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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
Pandemisch influenzavaccin is gecontraïndiceerd bij een anamnese van een anafylactische reactie op een van de bestanddelen (waaronder residuen, zoals kippenei-eiwit) van het vaccin; in een pandemische situatie kan het echter zinvol zijn het vaccin te geven, op voorwaarde dat faciliteiten voor reanimatie direct beschikbaar zijn.
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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| Encephalitis vaccines | ||
|---|---|---|
| J07BA02 | ||
| J07BA01 | ||
| Influenza vaccines | ||
|---|---|---|
| J07BB02 | ||
| Hepatitis vaccines | ||
|---|---|---|
| J07BC20 | ||
| J07BC02 | ||
| J07BC01 | ||
| Measles vaccines | ||
|---|---|---|
| J07BD52 | ||
| Poliomyelitis vaccines | ||
|---|---|---|
| J07BF03 | ||
| Rabies vaccines | ||
|---|---|---|
| J07BG01 | ||
| Rota virus diarrhea vaccines | ||
|---|---|---|
| J07BH01 | ||
| Varicella zoster vaccines | ||
|---|---|---|
| J07BK01 | ||
| Yellow fever vaccines | ||
|---|---|---|
| J07BL01 | ||
| Papillomavirus vaccines | ||
|---|---|---|
| J07BM03 | ||
| J07BM02 | ||
| Other viral vaccines | ||
|---|---|---|
| J07BX04 | ||
| Covid-19 vaccines | ||
|---|---|---|
| J07BN01 | ||
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References
- GlaxoSmithKline Biologicals BV, SPC Pandemrix, EU/1/08/452/001,, www.emea.europa.eu, http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/emea-combined-h832nl.pdf (Geraadpleegd 11 nov 2009)
- Novartis Vaccines and Diagnostics, SPC Focetria, EU/1/07/385/001-002, www.emea.europa.eu, http://www.emea.europa.eu/humandocs/PDFs/EPAR/focetria/emea-combined-h710nl.pdf (geraadpleegd 11 nnov 2009)
- Gezondheidsraad, Vaccinatie tegen pandemische influenza A/H1N1 2009: doelgroepen en prioritering (3), www.gezondheidsraad.nl, 2009, 3-5, http://www.gezondheidsraad.nl/sites/default/files/200616_0.pdf (geraadpleegd 11 nov 2009)
- LAREB, Kwartaalbericht 1, 2014
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Changes
Changes
