FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment paradigms for several protease inhibitors, which are subject to this interaction, require the co-administration of low-dose ritonavir (‘boosting') in order to enhance plasma levels and optimise antiviral efficacy.
Danish: Behandlingsregimerne for flere proteasehæmmere, som er subjekt for denne interaktion, kræver samtidig administration af lavdosis ritonavir (“boosting”) for at øge plasmakoncentrationerne og optimere den antivirale virkning.
English: Chronic nelfinavir treatment of rats has been demonstrated to produce effects consistent with enzyme induction, which predisposed rats, but not humans, to thyroid neoplasms.
Danish: Det er vist at kronisk behandling af rotter med nelfinavir fremkalder effekter, som er konsistente med enzyminduktion, som prædisponerer rotter, men ikke mennesker for thyreoidea-neoplasmer.
English: Elimination: oral clearance estimates after single doses (24-33 l/h) and multiple doses (26-61 l/h) indicate that nelfinavir exhibits medium to high hepatic bioavailability.
Danish: Elimination: Clearance efter enkelt oral indgift (24-33 l/t) og gentagen indgift (26-61 l/t) indicerer, at nelfinavir udviser medium til høj hepatisk biotilgængelighed.
English: Adverse reactions in clinical studies are summarised in Table 2.
Danish: Bivirkninger fra kliniske studier er anført i tabel 2.
English: Patients older than 13 years: VIRACEPT 250 mg tablets are recommended for adults and older children (see Summary of Product Characteristics for VIRACEPT 250 mg tablets).
Danish: Patienter over 13 år: VIRACEPT 250 mg tabletter anbefales til voksne og større børn (se produktresumé for VIRACEPT 250 mg tabletter).
English: The safety of the combination indinavir + nelfinavir has not been established
Danish: Sikkerheden ved kombinationen indinavir og nelfinavir er ikke fastlagt
English: The glass should be rinsed with a half cup of water and the rinse should be swallowed to ensure that the entire dose is consumed.
Danish: Glasset bør skylles med en halv kop vand og vandet, som er blevet brugt til at skylle med, skal drikkes for at sikre, at hele dosis indtages.
English: Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with nelfinavir is not recommended.
Danish: Siden forhøjede koncentrationer af HMG-CoAreduktasehæmmere kan forårsage myopati inklusiv rhabdomyolyse anbefales det ikke at kombinere disse lægemidler med nelfinavir.
English: Nelfinavir was found to be active against a broad range of laboratory strains and clinical isolates of HIV-1 and the HIV-2 strain ROD.
Danish: Nelfinavir viste sig at være aktiv over for en lang række laboratoriestammer og kliniske rendyrkninger af hiv-1- og hiv-2-stammen ROD.
English: The cause and long-term health effects of these conditions are not known at this time.
Danish: Årsagen til og den langsigtede effekt af disse tilstande på helbredet kendes ikke på nuværende tidspunkt.
English: Food increases nelfinavir exposure and decreases nelfinavir pharmacokinetic variability relative to the fasted state.
Danish: Føde øger nelfinavirs eksponering og formindsker nelfinavirs farmakokinetiske variabilitet i forhold til fastende tilstand.
English: Coadministration of nelfinavir with omeprazole may lead to a loss of virologic response and therefore concomitant use is contraindicated.
Danish: Samtidig administration af nelfinavir og omeprazol kan forårsage tab af virologisk respons og derfor er samtidig brug kontraindiceret.
English: There are not sufficient data from patients with liver impairment and therefore specific dose recommendations cannot be made (see section 5.2).
Danish: Der findes ingen specifikke data for patienter med leverinsufficiens, og der kan derfor ikke gives specifikke doseringsanbefalinger (se pkt.
English: Medicinal product by therapeutic areas (dose of nelfinavir used in study)
Danish: Lægemiddel opdelt efter terapeutiske områder (dosering af nelfinavir anvendt i studie)
English: Excipients: VIRACEPT oral powder contains aspartame (E951) as a sweetening agent.
Danish: Hjælpestoffer: VIRACEPT oralt pulver indeholder aspartam (E951) som sødemiddel.
English: Therefore nelfinavir should not be co-administered with orally administered midazolam.
Danish: Nelfinavir bør derfor ikke administreres sammen med oralt administreret midazolam.
English: This can lead to an increased risk of many types of infections.
Danish: Det kan føre til en øget risiko
English: These children will be given a different number of tablets with each meal.
Danish: Disse børn skal ikke have det samme antal tabletter ved hvert måltid.
English: The overall incidence of other mutations associated with primary PI resistance was 9.6 % for the L90M substitution where as substitutions at 48, 82 and 84 were not observed.
Danish: Den overordnede hyppighed af andre mutationer relateret til primær PI resistens var 9,6 % for L90M-substitution, mens substitutioner ikke blev set ved
English: Antiviral activity in vitro: the antiviral activity of nelfinavir in vitro has been demonstrated in both HIV acute and chronic infections in lymphoblastoid cell lines, peripheral blood lymphocytes and monocytes/macrophages.
Danish: Antiviral aktivitet in vitro: Nelfinavirs antivirale aktivitet in vitro er demonstreret i både akutte og kroniske hiv-infektioner i lymfoblastoide cellelinjer, perifere blodlymfocyter og monocyter/makrofager.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION The bottle contains 144 g of oral powder.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Flasken indeholder 144 g oralt pulver.
English: The following adverse events with an at least possible relationship to nelfinavir (i.e. adverse reactions) were reported most frequently: diarrhoea, nausea, and rash.
Danish: Følgende uønskede hændelser, der i det mindste har en mulig sammenhæng med nelfinavir (dvs. bivirkninger) og som rapporteredes hyppigst var: Diarré, kvalme og udslæt.
English: The pharmacokinetics of nelfinavir have been investigated in 5 studies in paediatric patients from birth to 13 years of age.
Danish: Nelfinavirs farmakokinetik er blevet undersøgt i 5 studier med pædiatriske patienter, der spænder aldersmæssigt fra nyfødte og op til 13 år.
English: Children with weights between 10.5-12 kg, 12-14 kg and 18-22 kg will receive a different number of tablets with each meal.
Danish: Børn, som vejer mellem 10,5 og 12 kg, 12 og 14 kgsamt 18 og 22 kg vil ikke få det samme antal tabletter ved hvert måltid.
English: Overdoses of nelfinavir could theoretically be associated with prolongation of the QT-interval of the ECG (see also section 5.3).
Danish: Overdosering af nelfinavir kan teoretisk være associeret med forlængelse af QT intervallet i EKG´et (se også pkt.
English: Clinically significant interactions have not been observed between nelfinavir and nucleoside analogues.
Danish: Der er ikke observeret klinisk signifikante interaktioner mellem nelfinavir og nukleosidanaloger.
English: Median baseline HIV-1 RNA was 4.8 log10 copies/ml in both treatment groups.
Danish: Den mediane baseline hiv-1-RNA var 4,8 log10 kopier/ml i begge behandlingsgrupper.
English: Metabolism: In vitro studies demonstrated that multiple cytochrome P-450 isoforms including CYP3A, CYP2C19/C9 and CYP2D6 are responsible for the metabolism of nelfinavir.
Danish: Metabolisme: In vitro studier viste, at forskellige isoformer af cytokrom P450 inklusive CYP3A, CYP2C19/C9 og CYP2D6 er ansvarlige for metabolisering af nelfinavir.
English: One major and several minor oxidative metabolites were found in plasma.
Danish: I plasma blev der fundet én hovedmetabolit og flere mindre oxidative metabolitter.
English: Table 1: Interactions and dose recommendations with other medical products Medicinal product by therapeutic areas (dose of nelfinavir used in study)
Danish: Tabel 1: Interaktioner og dosisanbefalinger med andre lægemidler Lægemiddel opdelt efter terapeutiske områder (dosering af nelfinavir anvendt i studie)
English: One or more viral protease mutations at amino acid positions 30, 35, 36, 46, 71, 77 and 88 were detected in > 10 % of patients with assessable isolates.
Danish: Der blev opdaget en eller flere virale proteasemutationer ved aminosyrepositionerne 30, 35, 36, 46, 71, 77 og 88 hos >10 % af patienterne med vurderbare isolater.
English: Lipodystrophy: Combination antiretroviral therapy has been associated with the redistribution of body fat (acquired lipodystrophy) in HIV patients.
Danish: Lipodystrofi: Antiretroviral kombinationsbehandling er blevet associeret med omfordeling af kropsfedt (erhvervet lipodystrofi) hos patienter med hiv.
English: • When your child weighs 18 kg or less, you must provide the tablets three times a day.
Danish: • Hvis dit barn vejer 18 kg eller mindre, skal du give tabletterne tre gange dagligt.
English: Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Danish: Baseret på data fra andre CYP3A4-hæmmere forventes midazolams plasmakoncentrationer at være signifikant højere, når midazolam administreres oralt.
English: The prescriber should also advise the caregiver about the importance of adhering to the dosing instructions and that the appropriate number of tablets should be taken at each dose with a meal.
Danish: Den ordinerende læge skal også rådgive pårørende om vigtigheden af at overholde doseringsvejledningen, og at det rette antal tabletter indtages ved hver dosis med et måltid.
English: It is supplied in plastic bottles with plastic child resistant lids.
Danish: Det leveres i plastikflasker med børnesikrede plastiklåg.
English: Frequency of Reaction
Danish: Bivirkningsfrekvens
English: The table also shows the recommended total number of Viracept tablets that children will be given each day based on their weight.
Danish: Tabellen viser også det anbefalede totale antal Viracept tabletter, som børn skalhave, ud fra deres vægt.
English: The efficacy of the BID regimen has been evaluated versus the TID regimen with VIRACEPT 250 mg tablets primarily in patients naïve to PIs.
Danish: Effekten af BID-regimet er evalueret overfor TID-regimet med VIRACEPT 250 mg tabletter, hovedsageligt hos PI-naive patienter.
English: There were no significant differences between low doses of ritonavir (either 100 or 200 mg BID) for effects on AUCs of nelfinavir and M8.
Danish: Der var ikke signifikant forskel mellem de påvirkninger de lave doser af ritonavir (hverken 100 eller 200 mg 2 gange daglig) havde på nelfinavir og M8´s AUC.
English: After multiple dosing with 750 mg every 8 hours for 28 days (steady-state), peak plasma concentrations (Cmax) averaged 3-4 µg/ml and plasma concentrations prior to the next dose (trough) were 1-3 µg/ml.
Danish: Efter multipel dosering med 750 mg hver 8. time i 28 dage (steady-state), var gennemsnittet for peak-plasmakoncentrationer (Cmax) 3-4 µg/ml og plasmakoncentrationerne inden næste dosis (trough) var 1-3 µg/ml.
English: If treatment with HMG-CoA reductase inhibitors is indicated in combination with nelfinavir, pravastatin or fluvastatin are recommended.
Danish: Hvis behandling med HMGCoA-reduktasehæmmere er indiceret i kombination med nelfinavir, anbefales pravastatin eller fluvastatin.
English: Therefore the potential for QT prolongation should be considered in cases of overdose (see section 4.9).
Danish: Derfor skal potentialet for forlængelse af QT intervallet overvejes ved overdosering (se pkt.
English: This is because Viracept can affect the way some other medicines work.
Danish: Det skyldes, at Viracept kan påvirke behandlingen med anden medicin, og anden medicin kan påvirke behandlingen med
English: Nelfinavir demonstrated additive to synergistic effects against HIV in combination with reverse transcriptase inhibitors zidovudine (ZDV), lamivudine (3TC), didanosine (ddI), zalcitabine (ddC) and stavudine (d4T) without enhanced cytotoxicity.
Danish: Nelfinavir demonstrerede additive til synergistiske virkninger over for hiv i kombination med de reverse transkriptasehæmmere zidovudin (ZDV), lamivudin (3TC), didanosin (ddI), zalcitabin (ddC) og stavudin (d4T) uden øget cytotoksicitet.
English: Powder with milk, formula, pudding, or water, as part of a light meal or tablet taken with a light meal
Danish: Pulver med mælk, modermælkserstatning, budding eller vand som en del af et let måltid eller tablet indtaget med et let måltid
English: The use of nelfinavir in patients with moderate hepatic impairment has not been studied.
Danish: Anvendelse af nelfinavir hos patienter med moderat nedsat leverfunktion har ikke været undersøgt.
English: For patients unable to swallow the tablets, VIRACEPT tablets may be dispersed in a half cup of water while thoroughly stirring with a spoon.
Danish: Til patienter, som ikke er i stand til at sluge VIRACEPT tabletter, kan tabletterne opløses i en halv kop vand under omhyggelig omrøring med en ske.
English: • Midazolam given by injection or diazepam (for anxiety or to help you sleep)
Danish: • Midazolam administreret som injektion eller diazepam (mod angst eller til at hjælpe dig sove)
English: n=22 n=22
Danish: n=22
English: • Do not mix the powder with orange juice, apple sauce or other acidic liquids or foods.
Danish: • Bland ikke pulveret med appelsinjuice, æblemos eller andre syreholdige væsker og madvarer.
English: • Rifabutin, erythromycin or clarithromycin (for bacterial infections)
Danish: • Rifabutin, erythromycin eller clarithromycin (mod bakterielle infektioner)
English: No treatment-related adverse reactions were seen in animal reproductive toxicity studies in rats at doses providing systemic exposure comparable to that observed with the clinical dose.
Danish: Der er ikke set behandlingsrelaterede bivirkninger i reproduktionstoksikologiske undersøgelser på rotter i doser, som medfører systemisk eksponering for lægemidlet svarende til den kliniske dosis.
English: Some patients taking combination anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, som tager antiretroviral kombinationsbehandling, kan udvikle en knoglesygdom, som kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: Weight loss and general physical decline was observed in monkeys together with general evidence of gastrointestinal toxicity.
Danish: Hos aber blev der observeret vægttab og generel fysisk svækkelse sammen med generelle tegn på gastrointestinal
English: In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history.
Danish: Hos patienter, som tidligere har været behandlet med proteasehæmmere (PI), bør valget af nelfinavir baseres på individuel viral resistenstestning og resultatet af tidligere behandling.
English: You will either give the medicine to your child two or three times a day with a
Danish: Du skal give lægemidlet til dit barn enten to eller tre gange daglig i forbindelse
English: PDE5 inhibitors: particular caution should be used when prescribing sildenafil, tadalafil or vardenafil for the treatment of erectile dysfunction in patients receiving VIRACEPT.
Danish: PDE-5-hæmmere: Der bør udvises særlig forsigtighed ved ordination af sildenafil, tadalafil eller vardenafil til behandling af erektil dysfunktion hos patienter, som får VIRACEPT.
English: Only 1-2 % of the dose was recovered in urine, of which unchanged nelfinavir was the major component.
Danish: Kun 1-2 % af dosis blev genfundet i urinen og hovedsagelig som uomdannet
English: Dose to be taken by adults and children older than 13 years
Danish: Dosis som tages af voksne og børn ældre end 13 år
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt
English: On rare occasions these muscle problems have been serious causing muscle degeneration
Danish: Muskellidelserne har i sjældne tilfælde været alvorlige og forårsaget muskeldegeneration
English: • A severe form of rash (erythema multiforme).
Danish: • Alvorligt hududslæt (erythema multiforme).
English: • Oral contraceptives (the pill).
Danish: • Orale præventionsmidler (p-piller).
English: The cause and long-term health effects of these conditions are not
Danish: Årsagen og den langsigtede effekt af disse tilstande på helbredet kendes ikke på
English: • Calcium channel blockers such as bepridil (for heart problems)
Danish: • Calciumantagonister såsom bepridil (mod hjerteproblemer)
English: Patients should be instructed that VIRACEPT is not a cure for HIV infection, that they may continue to develop infections or other illnesses associated with HIV disease, and that VIRACEPT has not been shown to reduce the risk of transmission of HIV disease through sexual contact or blood contamination.
Danish: Patienterne skal instrueres om at VIRACEPT ikke helbreder en hiv-infektion, at de fortsat kan få infektioner eller andre sygdomme, som er relateret til hiv-sygdommen samt at det ikke er vist at VIRACEPT nedsætter risikoen for overførsel af hiv-sygdommen ved seksuel kontakt eller smittet
English: • When new information is received that may impact on the current Safety Specification,
Danish: • når der modtages ny information, som kan have indflydelse på den gældende sikkerhedsspecifikation, pharmacovigilance-plan eller risikominimeringsaktiviteter
English: • Fluoxetine, paroxetine, imipramine, amitriptyline or trazodone (for depression)
Danish: • Fluoxetin, paroxetin, imipramin, amitriptylin eller trazodon (mod depression)
English: AUC fold increase
Danish: Stigning i AUC
English: All patients older than 13 years should take either 5 level scoops of the blue 5 gram spoon twice daily or 3 level scoops of the blue 5 gram spoon three times daily.
Danish: Alle patienter, der er ældre end 13 år, bør indtage enten 5 strøgede skefulde af den blå måleske på 5 gram to gange daglig eller 3 strøgede skefulde af den blå måleske på 5 gram 3 gange daglig.
English: Two studies have compared the safety and efficacy of nelfinavir (unboosted) with ritonavir- boosted protease inhibitors, each in combination with other antiretroviral agents.
Danish: To studier har sammenlignet sikkerhed og effekt af nelfinavir (ikke-boostet) med ritonavir-boostede proteasehæmmere, begge i kombination med andre antiretrovirale stoffer.
English: • When your child weighs 18 kg or more, you may provide the tablets either two or three times a day.
Danish: • Hvis dit barn vejer 18 kg eller mere kan du give tabletterne enten to eller tre gange dagligt.
English: • Put the tablets in a half cup of water and stir with a spoon.
Danish: • Læg tabletterne ned i et halvt glas vand og rør med en ske
English: Delavirdine AUC ↓ 31 % Nelfinavir AUC ↑ 107 %
Danish: Delavirdin AUC ↓ 31 % Nelfinavir AUC ↑ 107 %
English: • You are allergic to nelfinavir or to any of the other ingredients (listed in Section 6 ‘Further information').
Danish: • Du er overfølsom (allergisk) over for nelfinavir eller et af de øvrige indholdsstoffer (anført i
English: Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
Danish: Aspartam er en phenylalaninkilde og kan være skadelig for patienter med phenylketonuri.
English: AUC24 (mg.hr/L) Arithmetic mean ± SD
Danish: AUC24 (mg.t/l) Aritmetisk gennemsnit ± standardafvigelse
English: • Viracept can stop oral contraceptives (the pill) from working, so you should use other contraception methods (such as condoms) while you are taking Viracept.
Danish: • Viracept kan forhindre orale præventionsmidler (p-piller) i at virke, så du bør bruge andre præventionsmetoder (som f.eks. kondom), mens du tager Viracept.
English: • Table 3: if you give the medicine three times a day, you will give 25-35 mg nelfinavir each time for each kg of body weight, except for children who weigh from 10.5 to 12 kg, from 12 to 14 kg and from 18 to 22 kg.
Danish: • Tabel 3: Hvis du giver lægemidlet tre gange daglig, skal du give 25-35 mg nelfinavir hver gang for hvert kg kropsvægt, undtagen for børn, som vejer mellem 10,5 og 12 kg, mellem 12 og 14 kg og mellem 18 og 22 kg.
English: • Colchicine (for gout-flares or Mediterranean fever)
Danish: • Colchicin (mod podagraanfald eller familiær middelhavsfeber)
English: • Terfenadine or astemizole (for allergy)
Danish: • Terfenadin eller astemizol (mod allergi)
English: For younger children able to take tablets, Viracept tablets may be taken instead of the oral powder.
Danish: Yngre børn, som er i stand til at tage tabletter, kan tage Viracept-tabletter i stedet for det orale pulver.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Der er rapporteret om tilfælde af osteonekrose, især hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig kombinationsbehandling med antiretroviral lægemidler (CART).
English: VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to nelfinavir and its active metabolite M8 (Tert-butyl hydroxy nelfinavir).
Danish: VIRACEPT bør ikke administreres samtidig med omeprazol på grund af nedsat eksponering af nelfinavir og nelfinavirs aktive metabolit M8 (tert-butyl hydroxynelfinavir).
English: • There have been rare reports of muscle pain, tenderness or weakness, particularly with combination anti-retroviral therapy including protease inhibitors and nucleoside analogues.
Danish: • I sjældne tilfælde er der rapporteret om smerter eller ømhed i musklerne samt muskelsvækkelse, især efter antiretroviral kombinationsbehandling med proteasehæmmere og nukleosidanaloger.
English: Also contains colourant indigocarmine (E132) and other constituents.
Danish: Tabletten indeholder også farvestoffet indigotin (E132) og andre indholdsstoffer.
English: The further degradation of M8 appears to be catalysed by CYP3A4.
Danish: Den videre nedbrydning af M8 ser ud til at blive katalyseret af CYP3A4.
English: Skin and subcutaneous tissue disorders: Very rare (≤ 0.01 %), including isolated reports: Erythema multiforme.
Danish: Hud og subkutane væv: Meget sjælden (≤ 0,01 %), herunder enkeltstående indberetninger: Erythema multiforme
English: At present, there is no evidence of inadequate efficacy of zidovudine in the CNS that could be associated with the modest reduction in plasma levels of zidovudine when coadministered with nelfinavir.
Danish: For øjeblikket er der ikke påvist utilstrækkelig virkning af zidovudin i centralnervesystemet, som kan sættes i forbindelse med den beskedne reducering i zidovudins plasmakoncentrationer, når det administreres sammen med nelfinavir.
English: • Medicines that lower stomach acid such as lansoprazole
Danish: • Lægemidler, som hæmmer mavesyren, såsom lansoprazol
English: The prescriber should assure that the caregiver understands the importance of monitoring adherence and the appropriate method to prepare and administer Viracept tablets to children in each weight band.
Danish: Den ordinerende læge skal sikre, at de pårørende forstår vigtigheden af at overvåge overholdelse og den korrekte metode til at forberede og administrere VIRACEPT-tabletter til børn i de enkelte
English: Pharmacokinetics of nelfinavir after a single dose of 750 mg was studied in patients with liver impairment and healthy volunteers.
Danish: Nelfinavirs farmakokinetik efter en enkeltdosis på 750 mg blev undersøgt hos patienter med leverinsufficiens og hos raske frivillige.
English: 7.5 to 8.5 kg
Danish: 7,5 til 8,5 kg
English: The majority (87 %) of an oral 750 mg dose containing 14C-nelfinavir was recovered in the faeces; total faecal radioactivity consisted of nelfinavir (22 %) and numerous oxidative metabolites (78 %).
Danish: Størstedelen (87 %) af en oral 750 mg dosis indeholdende 14C-nelfinavir blev genfundet i fæces; total fækal radioaktivitet bestod af nelfinavir (22 %) og en række oxidative metabolitter (78 %).
English: Nelfinavir exposure increases with increasing calorie or fat content of meals taken with VIRACEPT.
Danish: Nelfinavirs eksponering øges med stigende kalorie- eller fedtindhold i måltiderne, der indtages sammen med VIRACEPT.