- 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)
< 3 jaar: Off-label
> 3 jaar: On-label
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Available formulations
Tablet filmomhuld (als mesilaat) 250 mg
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Dosages
| Treatment HIV infection |
|---|
|
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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%): diarree. Vaak (1-10%): flatulentie, misselijkheid, verhoogd ALAT en ASAT, afname aantal neutrofielen. Soms (0,1-1%): braken, pancreatitis, verhoogd amylase. Overgevoeligheidsreacties, waaronder bronchospasmen, koorts, pruritus, gezichtsoedeem, maculopapulaire of bulleuze uitslag. Zelden (0,01-0,1%): toename van het aantal spontane bloedingen bij hemofilie, ontstaan of verergering van diabetes mellitus, hepatitis. Verhoogde CPK-waarden, myalgie, myositis en rabdomyolyse. Anti-retrovirale combinatietherapie kan gepaard gaan met herverdeling van lichaamsvet (lipodystrofie) en metabole stoornissen (zoals hypertriglyceridemie, hypercholesterolemie, insulineresistentie, hyperglykemie, hyperlactatemie). Er zijn gevallen van osteonecrose gemeld, vooral bij patiënten met algemeen erkende risicofactoren, voortgeschreden hiv-infectie of langdurige blootstelling aan anti-retrovirale combinatietherapie.
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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 in children
Voedsel bevordert de biologische beschikbaar heid. Controle bloedspiegels. Voor sommige kinderen is het metabolisme onverwacht snel.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Alerts And Precautions Adults
Voorzichtigheid is geboden bij nier- of leverfunctiestoornissen. Bij verslechtering van een eerder bestaande leveraandoening, onderbreking of beëindiging van de behandeling overwegen. Bij een aantal hemofiliepatiënten die proteaseremmers gebruikten, zijn spontane bloedingen (subcutane of musculaire hematomen, hemartrosen) opgetreden. Houdt rekening met kruisresistentie met andere proteaseremmers, ondanks dat die tot nu toe niet is beschreven. Voorzichtigheid is geboden bij ernstige immuundeficiëntie omdat er meer kans is op een ontstekingsreactie op asymptomatische of nog aanwezige opportunistische pathogenen die tot ernstige klinische manifestaties kunnen leiden.
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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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| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | ||
|---|---|---|
| J05AB01 | ||
| J05AB12 | ||
| J05AB06 | ||
| J05AB16 | ||
| J05AB04 | ||
| J05AB11 | ||
| J05AB14 | ||
| Phosphonic acid derivatives | ||
|---|---|---|
| J05AD01 | ||
| Protease inhibitors | ||
|---|---|---|
| J05AE08 | ||
| J05AE10 | ||
| J05AE07 | ||
| J05AE02 | ||
| J05AE03 | ||
| J05AE01 | ||
| Nucleoside and nucleotide reverse transcriptase inhibitors | ||
|---|---|---|
| J05AF06 | ||
| J05AF02 | ||
| J05AF09 | ||
| J05AF10 | ||
| J05AF05 | ||
| J05AF04 | ||
| J05AF07 | ||
| J05AF13 | ||
| J05AF13 | ||
| J05AF01 | ||
| Non-nucleoside reverse transcriptase inhibitors | ||
|---|---|---|
| J05AG06 | ||
| J05AG03 | ||
| J05AG04 | ||
| J05AG01 | ||
| J05AG05 | ||
| Neuraminidase inhibitors | ||
|---|---|---|
| J05AH02 | ||
| J05AH01 | ||
| Antivirals for treatment of HIV infections, combinations | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Other antivirals | ||
|---|---|---|
| J05AX28 | ||
| J05AX12 | ||
| J05AX07 | ||
| J05AX09 | ||
| J05AX08 | ||
| J05AX24 | ||
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Integrase inhibitors | ||
|---|---|---|
| J05AJ04 | ||
| Antivirals for treatment of HCV infections | ||
|---|---|---|
| J05AP54 | ||
| J05AP57 | ||
| J05AP51 | ||
| J05AP08 | ||
| J05AP55 | ||
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References
- CBO, Richtlijn antiretrovirale therapie, www.cbo.nl, herziene versie december 2007
- Rudin C, et al, Long-term safety and effectiveness of ritonavir, nelfinavir, and lopinavir/ritonavir in antiretroviral-experienced HIV-infected children., Pediatr Infect Dis J, 2008, 27(5), 431-7
- Scherpbier HJ, et al, Long-term experience with combination antiretroviral therapy that contains nelfinavir for up to 7 years in a pediatric cohort, Pediatrics, 2006, 117(3), e528-36
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Changes
Changes
