FrancophonIA/ELRC3.0 huggingface dataset:
English: Small, non-statistically significant differences were observed in other pharmacokinetic parameters with no trend favouring one regimen over the other.
Danish: Små, ikke statistisk signifikante forskelle blev observeret for andre farmakokinetiske parametre uden tendens til at favorisere det ene regime fremfor det andet.
English: In mice, administration of up to 1000 mg/kg/day did not result in any evidence for an oncogenic effect.
Danish: Hos mus viste administration af op til 1000 mg/kg/dag ikke tegn på nogen onkogen effekt.
English: The virological failure was greater in the nelfinavir group (17 %) than in the fosamprenavir/ritonavir group (7 %).
Danish: Virologisk svigt var større i nelfinavirgruppen (17 %) end i fosamprenavir/ritonavirgruppen (7 %).
English: OUTER CARTON TEXT
Danish: TEKST PÅ YDRE KARTON
English: LOCF= Last observation carried forward ITT = Intention to Treat NC = F: non-completers = failures
Danish: LOCF= Last observation carried forward ITT = Intention to Treat
English: AG1343-524 20 (19-28) mg/kg TID
Danish: AG1343-524 20 (19-28) mg/kg
English: Proportion of patients with HIV RNA below LOQ (sensitive and ultrasensitive assays) at Week 48 Assay
Danish: Antal patienter med hiv RNA under LOQ (sensitive og ultrasensitive assays) ved uge 48 Assay
English: How much to give each time (in grams)
Danish: Hvor meget du giver hver gang (i gram)
English: When used with nelfinavir, the lowest possible dose of atorvastatin should be administered.
Danish: Når det administreres sammen med nelfinavir bør den lavest mulige dosis af atorvastatin administreres.
English: Administration of activated charcoal may also be used to aid removal of unabsorbed nelfinavir.
Danish: Administration af aktivt kul kan også anvendes som hjælp til at fjerne det uabsorberede nelfinavir.
English: Your doctor should monitor the number of HIV particles and the number of CD4 white blood cells in your child's blood to assure the medicine works as well as it can.
Danish: Din læge vil måle antallet af hiv- partikler og antallet af CD4 hvide blodceller i dit barns blod for at sikre, at
English: Overall, use of VIRACEPT in the paediatric population is associated with highly variable drug exposure.
Danish: Overordnet er brugen af VIRACEPT i den pædiatriske population forbundet med stærkt varierende lægemiddeleksponering.
English: The adverse reaction profile seen during paediatric clinical trials was similar to that for adults.
Danish: Bivirkningsprofilen set under pædiatriske kliniske studier var tilsvarende den for voksne.
English: • Ask your doctor or pharmacist for advice before taking any medicine.
Danish: • Spørg dig læge eller apoteket til råds, før du tager nogen form for medicin.
English: Always take Viracept exactly as your doctor has told you.
Danish: Tag altid Viracept nøjagtigt efter lægens anvisning.
English: Mutagenicity: in vitro and in vivo studies with and without metabolic activation have shown that nelfinavir has no mutagenic or genotoxic activity.
Danish: Mutagenicitet: In vitro og in vivo undersøgelser med og uden metabolisk aktivering har vist at nelfinavir ikke har nogen mutagen eller genotoksisk aktivitet.
English: Monitoring of overdosed patients is warranted.
Danish: Overdoserede patienter skal derfor overvåges.
English: Viracept is not a cure for HIV infection.
Danish: Viracept kan ikke helbrede hiv-infektionen.
English: Follow the instructions carefully to get the most benefit from Viracept.
Danish: Følg instruktionerne omhyggeligt for at få det fulde udbytte af Viracept.
English: The pharmacokinetics of nelfinavir are similar during BID and TID administration.
Danish: Nelfinavirs farmakokinetik er den samme for BID- og TID-administration.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og Pneumocystis carinii pneumoni.
English: Ultrasensitive
Danish: Ultrasensitiv
English: • This medicine is essentially ‘potassium-free' as it contains less than 1 mmol (39 milligrams) of potassium per dose.
Danish: • Dette lægemiddel er i det væsentlige kaliumfri, idet det indeholder mindre end 1 mmol (39 mg)
English: How much to take Adults and children older than 13 years Viracept powder can be taken either two or three times a day with a meal.
Danish: Hvor meget skal indtages Voksne og børn ældre end 13 år Viracept-pulver kan indtages enten to eller tre gange daglig med et måltid.
English: Once mixed, the entire contents must be consumed in order to obtain the full dose.
Danish: Når det er blandet, skal hele blandingen indtages for at få den fulde dosis.
English: The pharmacokinetic data from Study AG1343-556 were more variable than data from other studies conducted in the paediatric population; the 95% confidence interval for AUC24 was 9 to 121 mg.hr/L.
Danish: De farmakokinetiske data fra studie AG1343-556 varierede mere end data fra andre studier, som blev udført i den pædiatriske population; 95 % konfidensintervallet for AUC24 var 9 til 121 mg.t/l.
English: In subjects with normal CYP2C19 activity, plasma levels of this metabolite are approximately 25 % of the total plasma nelfinavir-related concentration.
Danish: Hos patienter med normal CYP2C19-aktivitet er plasmakoncentrationer af denne metabolit ca. 25 % af den totale nelfinavirrelaterede plasmakoncentration.
English: The EC95 (95 % effective concentration) of nelfinavir ranged from 7 to 111 nM (mean of 58 nM).
Danish: EC95 (95 % effektiv koncentration) for nelfinavir var fra 7 til 111 nM (middelværdi på 58 nM).
English: Nausea, flatulence,
Danish: Kvalme, flatulens
English: Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandling med VIRACEPT skal påbegyndes af en læge med erfaring i behandling af hiv-infektion.
English: The signs include severe pains in your stomach that spread to your back.
Danish: Symptomerne inkluderer stærke smerter i maven, der stråler over
English: The cleavage of these viral polyproteins is essential for the maturation of infectious virus.
Danish: Spaltningen af disse virus-polyproteiner er essentiel for modning af en smitsom virus.
English: Viracept tablets can be taken either two or three times a day with a meal.
Danish: Viracept-tabletter kan indtages enten to eller tre gange daglig med et måltid.
English: With milk
Danish: Med føde Med mælk Med mælk
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1, dated 30 July 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version 1, dateret 30. juli 2007,,modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: If you forget to take Viracept If you forget to take a dose, take it as soon as you remember it.
Danish: Hvis du har glemt en dosis, så tag den, så snart du kommer i tanker om det.
English: The usual doses are described below.
Danish: De sædvanlige doser er beskrevet nedenunder.
English: Although study 542 showed no statistically significant differences between the two regimens in efficacy in a predominantly antiretroviral naïve patient population, the significance of these findings for antiretroviral experienced patients is unknown.
Danish: Selvom undersøgelse 542 ikke viste statistisk signifikante forskelle mellem de to regimer med hensyn til effekt i en overvejende antiretroviral naiv population, kendes signifikansen af disse fund for antiretrovirale behandlede patienter ikke.
English: HMG-CoA reductase inhibitors (Statins)
Danish: HMG-CoA-reduktasehæmmere (statiner)
English: The safety of the VIRACEPT 250 mg tablet was studied in controlled clinical trials with over 1300 patients.
Danish: Sikkerheden af VIRACEPT 250 mg tabletter blev undersøgt i kontrollerede kliniske studier, som omfattede mere end 1300 patienter.
English: Check with your doctor or pharmacist before taking Viracept if:
Danish: Tjek med din læge før du tager Viracept hvis:
English: St. John's wort may persist for at least 2 weeks after cessation of treatment.
Danish: Den inducerende effekt af perikon kan vare ved i mindst 2 uger efter ophør af behandling.
English: A total of approximately 400 patients received nelfinavir in paediatric treatment trials (Studies 524, 556, PACTG 377/725, and PENTA-7) for up to 96 weeks.
Danish: Et samlet antal på cirka 400 patienter fik nelfinavir i pædiatriske behandlingsforsøg (studie 524, 556, PACTG377/725 og PENTA-7) i op til 96 uger.
English: • Pimozide (used for mental health problems)
Danish: • Pimozid (anvendt mod psykiske sygdomme)
English: This medicinal product must not be mixed with acidic substances due to taste (see section 4.2).
Danish: Dette lægemiddel må ikke blandes med syreholdige substanser på grund af smagen (se pkt.
English: Nelfinavir must not be administered concurrently with terfenadine, astemizole or cisapride because of the potential for serious and/or life-threatening cardiac arrhythmias.
Danish: Nelfinavir må ikke administreres samtidig med terfenadin, astemizol eller cisaprid på grund af muligheden for alvorlige og/eller livstruende hjertearytmier.
English: • Increased bleeding if you have haemophilia.
Danish: • Øget blødning, hvis du har hæmofili.
English: The weight of evidence indicates that nelfinavir is unlikely to be a carcinogen in humans.
Danish: Vægten af evidens tyder på, at det er usandsynligt, at nelfinavir vil være carcinogent hos mennesker.
English: Cross-resistance between nelfinavir and reverse transcriptase inhibitors is unlikely because different enzyme targets are involved.
Danish: Krydsresistens mellem nelfinavir og reverse transkriptasehæmmere er usandsynlig på grund af de forskellige involverede enzymers angrebspunkt.
English: • You have a rare blood problem which runs in families called ‘haemophilia'.
Danish: • Du har en sjælden blodsygdom, som findes i nogle familier, som kaldes hæmofili.
English: Physicians should not use potent inducers of CYP 3A4 in combination with Viracept and should consider using alternatives when a patient is taking VIRACEPT (see section 4.5).
Danish: Læger bør ikke bruge potente CYP3A4-induktorer i kombination med VIRACEPT, og bør overveje at bruge alternativer, hvis en patient får VIRACEPT (se pkt.
English: Cmax fold increase Increase in Tmax (hr)
Danish: Stigning i Cmax Stigning i Tmax (timer)
English: (Very common (≥ 10 %); common (≥ 1 % and < 10 %) Body System
Danish: (Meget almindelige (≥ 10 %); almindelige (≥ 1 % og < 10 %)) Organklasser
English: For adults or children unable to take tablets, Viracept tablets may be put into water and taken as follows:
Danish: Til voksne eller børn, som ikke kan tage tabletter, kan Viracept-tabletter opløses i vand og indtages på følgende måde:
English: If you notice any of these symptoms please inform your doctor immediately.
Danish: Hvis du bemærker nogle af disse symptomer, skal du omgående informere din læge.
English: VIRACEPT is administered orally and should always be ingested with food (see section 5.2).
Danish: VIRACEPT administreres oralt og bør altid indtages sammen med et måltid (se pkt.
English: In children between the ages of 2 and 13 years, the clearance of orally administered nelfinavir is approximately 2 to 3 times higher than in adults, with large intersubject variability.
Danish: Hos børn mellem 2 og 13 år er nelfinavirs clearance efter oral indgift ca. 2 til 3 gange højere end hos voksne med stor variabilitet mellem individer.
English: Diarrhoea was the most commonly reported adverse event in children.
Danish: Diarré var den mest almindelige rapporterede bivirkning hos børn.
English: The absorption of nelfinavir may be reduced in situations where the gastric pH is increased irrespective of cause.
Danish: Absorptionen af nelfinavir kan være nedsat i situationer, hvor det gastriske pH er øget uden hensynstagen til årsagen.
English: ↑ Fluticasone
Danish: ↑ Fluticason
English: When administered concomitantly with nelfinavir, the patient's tolerability of bosentan should be monitored.
Danish: Ved samtidig administration af nelfinavir, bør patientens bosentan-tolerabilitet overvåges.
English: There is no specific antidote for overdose with nelfinavir.
Danish: Der er ingen specifik modgift for overdosering af nelfinavir.
English: Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Danish: Måling af fastende serumlipider og blodglukose bør overvejes.
English: VIRACEPT oral powder should not be reconstituted with water in its original container.
Danish: VIRACEPT oralt pulver bør ikke rekonstitueres med vand i dets orginale beholder.
English: This may lead to a loss of virologic response and possible resistance to VIRACEPT (see section 4.5).
Danish: Dette kan medføre et tab af virologisk respons og mulig resistens over for VIRACEPT (se pkt.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C Store in the original container
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C Opbevares i den originale beholder
English: In the absence of such studies, caution should be exercised, as increases in nelfinavir levels and/or increases in liver enzymes may occur.
Danish: Der bør i mangel på sådanne studier, udvises forsigtighed, idet stigninger i nelfinavirniveauer og/eller stigninger i lever-enzymer kan forekomme.
English: • This medicine contains aspartame, which is a source of phenylalanine.
Danish: • Dette lægemiddel indeholder aspartam, som er en fenylalaninkilde.
English: No substantial differences have been observed between healthy volunteers and HIV-infected patients.
Danish: Der blev ikke observeret nogen væsentlige forskelle mellem raske frivillige og hiv-smittede patienter.
English: Studies in lactating rats showed that nelfinavir is excreted in breast milk.
Danish: Undersøgelser på lakterende rotter viste, at nelfinavir udskilles i maternel mælk.
English: Decreases in HIV RNA observed with nelfinavir monotherapy were less pronounced and of shorter duration.
Danish: Fald i hiv-RNA observeret ved nelfinavir-monoterapi var mindre udpræget og af kortere varighed.
English: • Immunosuppressant medicines such as tacrolimus or ciclosporin
Danish: • Lægemidler, som undertrykker immunforsvaret, såsom tacrolimus eller ciclosporin
English: If you notice any of the above, contact your doctor straight away.
Danish: Hvis du bemærker noget af ovenstående, skal du kontakte din læge med det samme.
English: • Rifampicin (for tuberculosis (TB))
Danish: • Rifampicin (mod tuberkulose)
English: VIRACEPT has no or negligible influence on the ability to drive and use machines.
Danish: VIRACEPT påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The difference between morning and afternoon or evening trough concentrations for the TID and BID regimens was also observed in healthy volunteers who were dosed at precise 8- or 12-hour intervals.
Danish: Forskellen mellem trough-koncentrationerne om morgenen og om eftermiddagen eller aftenen efter behandling to eller tre gange daglig blev også observeret hos raske frivillige, hos hvem dosisintervallerne var præcis 8 eller 12 timer.
English: Treatment emergent NRTI resistance was significantly less frequent with fosamprenavir/ritonavir compared to nelfinavir (13 % versus 57 %; p<0.001).
Danish: Behandlingsfremkaldt NRTI resistens var signifikant mindre hyppigt med fosamprenavir/ritonavir sammenlignet med nelfinavir (13 % mod 57 %; p<0,001).
English: • High blood sugar (diabetes) or diabetes get worse.
Danish: • Højt blodsukker (diabetes) eller forværring af diabetes.
English: If you stop taking Viracept
Danish: Hvis du holder op med at tage Viracept
English: For other substrates of CYP3A4 a dose reduction or consideration of an alternative may be required (Table 1).
Danish: For andre substrater for CYP3A4 kan dosisreduktion være nødvendig, eller alternativer bør overvejes (tabel 1).
English: Dose adjustment for midazolam should be considered if more than a single dose is administered (Table 1)
Danish: Dosisjustering af midazolam bør overvejes, hvis der administreres mere end en enkelt dosis (tabel 1).
English: Total grams of Powder per dose
Danish: Total mængde pulver pr. dosis
English: Mechanism of action: HIV protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors to the individual proteins found in infectious HIV.
Danish: Virkningsmekanisme: Hiv-protease er et enzym, som er nødvendigt for den proteolytiske spaltning af virus-polyproteinprækursorer til de individuelle proteiner, som findes i smitsom hiv.
English: This could be a sign of a liver problem such as hepatitis or jaundice.
Danish: Dette kan være symptomer på leverproblemer som f.eks. hepatitis
English: In vitro: HIV isolates with reduced susceptibility to nelfinavir have been selected in vitro.
Danish: In vitro: Hiv-isolater med reduceret følsomhed over for nelfinavir er blevet isoleret in vitro.
English: This includes medicines that you buy without a prescription and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, og naturlægemidler.
English: Pharmacokinetic data are also available for 86 patients (age 2 to 12 years) who received VIRACEPT 25-35 mg/kg TID in Study AG1343-556.
Danish: Farmakokinetiske data er også tilgængelige fra 86 patienter (i alderen 2 til 12 år), som fik VIRACEPT 25-35 mg/kg 3 gange daglig i studie AG1343-556.
English: Nelfinavir is principally metabolised and eliminated by the liver.
Danish: Nelfinavir omsættes og elimineres hovedsageligt i leveren.
English: Sensitive
Danish: Sensitiv
English: Acute and chronic toxicity: oral acute and chronic toxicity studies were conducted in the mouse (500 mg/kg/day), rat (up to 1,000 mg/kg/day) and monkey (up to 800 mg/kg/day).
Danish: Akut og kronisk toksicitet: Akutte og kroniske toksikologiske undersøgelser med oral indgift blev udført på mus (500 mg/kg/dag), rotte (op til 1.000 mg/kg/dag) og abe (op til 800 mg/kg/dag).
English: Human experience of acute overdose with VIRACEPT is limited.
Danish: Erfaring med akut overdosering af VIRACEPT hos mennesket er begrænset.
English: However, based on data from products known to prolong the QT-interval, a block of hERG potassium channels of > 20 % may be clinically relevant.
Danish: Data fra produkter, der forlænger QT intervallet indikerer dog, at en blokering af hERGkaliumkanaler med mere end 20 % kan være klinisk relevant.
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered
Danish: Dosisjustering af midazolam bør overvejes, særligt hvis der administreres mere end en enkeltdosis af midazolam.
English: There is no data available on nelfinavir excretion into human breast milk.
Danish: Der foreligger ingen data om udskillelse af nelfinavir i human modermælk.
English: D-79639 Grenzach-Wyhlen Germany
Danish: D-79639 Grenzach / Wyhlen
English: The BID regimen produced statistically significantly higher peak nelfinavir plasma levels versus the TID regimen.
Danish: BID-regimet viste statistisk signifikante højere peak nelfinavirplasmaværdier versus TID-regimet.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske
English: The major oxidative metabolite, M8 (tertbutyl hydroxy nelfinavir), has in vitro antiviral activity equal to the parent drug and its formation is catalysed by the polymorphic cytochrome CYP2C19.
Danish: Den oxidative hovedmetabolit M8 (tert-butyl hydroxynelfinavir) har in vitro antiviral aktivitet, som er lig moderstoffet, og dets dannelse er katalyseret af det polymorfe cytokrom CYP2C19.
English: By contrast, no effects suggesting prolongation of the QT-interval of the ECG were observed at similar doses in dogs or in isolated cardiac tissue.
Danish: I kontrast til dette blev der ikke observeret forhold, der tydede på forlængelsen af QT intervallet i EKG´et ved forsøg med lignende doser hos hunde eller i isoleret hjertevæv.
English: Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes or hyperglycaemia.
Danish: Mange patienter havde svære medicinske tilstande, som for nogles vedkommende nødvendiggjorde behandling med lægemidler, der er sat i forbindelse med udvikling af diabetes eller hyperglykæmi.
English: Very common (affect more than 1 in 10 people): • Diarrhoea.
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter): • Diarré.
English: Treatment with Viracept does not stop you giving HIV to others through contact with blood or sexual contact.
Danish: Selv om du er i behandling med Viracept, kan du give hiv videre til andre gennem kontakt med blod eller ved seksuel kontakt.
English: Increased alanine aminotransferase, increased aspartate aminotransferase, neutropenia, blood creatinine phosphokinase increased, neutrophil count decreased
Danish: Øget alanin-aminotransferase, øget aspartat-aminotransferase, neutropeni, øget blod-kreatin-phosphokinase, nedsat neutrofil antal.
English: The side effects only rarely resulted into having to stop taking Viracept.
Danish: Bivirkningerne resulterede kun sjældent i at behandlingen med Viracept skulle stoppes.
English: Parenteral midazolam should be coadministered with nelfinavir in an intensive care unit to ensure close clinical monitoring.
Danish: Parenteralt midazolam bør administreres samtidig med nelfinavir på en intensivafdeling for at sikre tæt klinisk overvågning.
English: Date of latest renewal: 23 January 2008
Danish: Dato for første markedsføringstilladelse: 22. januar 1998 Dato for seneste genregistrering: 23. januar 2008
English: If you take more Viracept than you should, talk to a doctor or pharmacist or go to a hospital straight away.
Danish: Hvis du har taget mere Viracept, end du burde, skal du tale med en læge eller apoteket eller tage til den nærmeste skadestue med det samme.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med allerede kendt leverdysfunktion, inklusive kronisk aktiv hepatitis, har en øget frekvens af leverfunktionsabnormaliteter i forbindelse med antiretroviral kombinationsterapi og bør monitoreres i henhold til standardpraksis.
English: Patients received VIRACEPT either three times daily or twice daily with food or with meals.
Danish: Patienterne fik VIRACEPT enten tre gange daglig eller to gange daglig med føde eller i forbindelse med måltider.
English: • Cisapride (for heart burn or problems with your digestive system)
Danish: • Cisaprid (mod halsbrand eller problemer med dit fordøjelsessystem)
English: 18 to 22 kg over 22 kg
Danish: 18 til 22 kg over 22 kg
English: It is recommended that the international normalized ratio (INR) be monitored carefully during treatment with VIRACEPT, especially when commencing therapy.
Danish: Det anbefales, at international normaliseret ratio (INR) monitoreres omhyggeligt under behandling