FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, Stevens-Johnson Syndrome and erythema multiforme have been rarely (< 0.1%) reported.
Danish: I kliniske forsøg er der i sjældne tilfælde (< 0,1 %) rapporteret Stevens-Johnsons-syndrom og erythema multiforme.
English: Treatment with INTELENCE should be discontinued if a severe cutaneous reaction develops.
Danish: Behandling med INTELENCE bør seponeres, hvis der opstår svær kutan reaktion.
English: Very common side effects (may affect more than 1 in 10 people) - skin rash.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - hududslæt.
English: Pooled DUET Studies ≥ 18 years ETR N = 599
Danish: Poolede DUETstudier ≥ 18 år ETR N = 599
English: If you have stopped treatment due to a hypersensitivity reaction, you should not restart therapy with INTELENCE.
Danish: Hvis du er stoppet med behandlingen på grund af en overfølsomhedsreaktion, må du ikke begynde behandling med INTELENCE igen.
English: Proportion of subjects with HIV-1 RNA < 50 copies/ml at week 48
Danish: Andel af patienter med hiv-1 RNA < 50 kopier/ml i uge 48
English: Patients should be instructed to swallow the tablet(s) whole with a liquid such as water.
Danish: Patienterne skal have besked om at synke tabletten/tabletterne hele med væske, f.eks. vand.
English: INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Danish: INTELENCE er en type medicin, der anvendes til behandling af hiv-infektion (dvs. smitte med humant immundefektvirus).
English: The dosages of some medicines might need to be changed since their therapeutic effect or side effects may be influenced when combined with INTELENCE.
Danish: Visse lægemidler skal måske dosereres anderledes, da deres virkning eller bivirkninger kan blive påvirket, hvis de kombineres med INTELENCE.
English: • HIV-1 plasma viral load > 5,000 HIV-1 RNA copies/ml at screening
Danish: • hiv-1-virusmængde i plasma > 5.000 hiv-1 RNA kopier/ml ved screening
English: Always take the tablet following a meal.
Danish: Tabletten skal altid tages efter et måltid.
English: Etravirine is expected to decrease plasma concentrations of cyclosporine, sirolimus and tacrolimus.
Danish: Etravirin forventes at reducere plasmakoncentrationen af ciclosporin, sirolimus og tacrolimus.
English: Not studied, but no interaction expected based on the primary renal elimination route for other NRTIs (e.g., abacavir, emtricitabine, lamivudine, stavudine and zidovudine).
Danish: Ikke undersøgt, men der forventes ingen interaktion, eftersom andre NRTI-midler primært elimineres via nyrerne (f.eks. abacavir, emtricitabin, lamivudin, stavudin og zidovudin).
English: CCR5 Antagonists Maraviroc 300 mg twice daily
Danish: CCR5-antagonister Maraviroc 300 mg to gange dagligt
English: INTELENCE contains sodium
Danish: INTELENCE indeholder natrium
English: At week 12, virologic response was greater in the control-PI arm (-2.2 log10 copies/ml from baseline; n = 53) compared to the etravirine arm (-1.4 log10 copies/ml from baseline; n = 40).
Danish: I uge 12 var det virologiske respons større i PI-kontrolgruppen (-2,2 log10 kopier/ml fra baseline, n = 53) end i etravirin-gruppen (-1,4 log10 kopier/ml fra baseline, n = 40).
English: In rats, there was no effect on mating or fertility with etravirine treatment (see section 5.3).
Danish: Hos rotter blev der ikke observeret nogen virkning på parring eller fertilitet ved behandling med etravirin (se pkt.
English: Exploratory head to head comparison with protease inhibitor in protease inhibitor naïve patients (trial TMC125-C227)
Danish: Eksplorativ”head to head”-sammenligning med proteasehæmmer (PI) hos PI-naive patienter (forsøg TMC125-C227)
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for initiering af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener.
English: Note: Imputations according to the TLOVR algorithm (TLOVR = Time to Loss of Virologic Response)
Danish: Bemærk: Imputeringer i henhold til TLOVR-algoritmen (TLOVR = tid til tab af virologisk respons).
English: Median CD4 cell count
Danish: Mediant CD4-celletal
English: 6 cells/l
Danish: 6 celler/l
English: Table 4: DUET-1 and DUET-2 pooled data
Danish: Tabel 4: Poolede data fra DUET-1 og DUET-2
English: The recommended dose of INTELENCE is 200 mg twice a day.
Danish: Den anbefalede dosis INTELENCE er 200 mg to gange dagligt.
English: Co-administration with systemic immunosuppressants should be done with caution because plasma concentrations of cyclosporin, sirolimus and tacrolimus may be affected when co-administered with INTELENCE.
Danish: Forsigtighed tilrådes ved samtidig indgift med systemiske immunsuppressiva, fordi plasmakoncentrationen af ciclosporin, sirolimus og tacrolimus kan blive påvirket ved indgift sammen med INTELENCE.
English: 4.8 log10 copies/ml
Danish: 4,8 log10kopier/ml 4,8 log10kopier/ml
English: Experience in geriatric patients is limited: in the Phase III trials, 6 patients aged 65 years or older and 53 patients aged 56-64 years received etravirine.
Danish: I fase III-forsøgene blev etravirin givet til seks patienter i alderen 65 år eller derover og 53 patienter i alderen 56-64 år.
English: Ear and labyrinth disorders uncommon vertigo
Danish: Øre og labyrint ikke almindelig vertigo
English: Co-administration of Intelence and daclatasvir is not recommended.
Danish: Samtidig administration af INTELENCE og daclatasvir frarådes.
English: In view of the limited data available in hepatitis B and/or C co-infected patients, particular caution should be paid when INTELENCE is used in these patients (see sections 4.4 and 4.8).
Danish: I betragtning af de begrænsede tilgængelige data vedrørende samtidig infektion med hepatitis B og/eller C bør der udvises særlig forsigtighed, når INTELENCE gives til disse patienter (se pkt.
English: The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of the combination therapy with HIV antiretroviral medicines which also affect the pharmacokinetics of etravirine and/or boceprevir has not been directly assessed.
Danish: Der er ikke udført direkte evaluering af den kliniske betydning af reduktionerne i etravirins farmakokinetiske parametre og boceprevir Cmin i forbindelse med kombinationsbehandling med antiretrovirale midler mod hiv, som også påvirker farmakokinetikken af etravirin og/eller boceprevir.
English: Subgroups
Danish: Undergrupper
English: HIV Protease Inhibitors (PIs) - Unboosted (i.e. without co-administration of low-dose ritonavir) Indinavir
Danish: Ikke-boostede hiv-proteasehæmmere (PI'er) (dvs. uden samtidig indgift af lavdosis ritonavir) Indinavir
English: Confidence interval around observed difference of response rates; P-value from CMH test controlling for stratification factors = 0.0199 for de novo, and < 0.0001 for not de novo.
Danish: P-værdi fra CMH-test, der kontrollerer for stratificeringsfaktorer = 0,0199 for de novo, og < 0,0001 for ikke de novo.
English: Paediatric population (6 years to less than 18 years of age)
Danish: Pædiatrisk population (i alderen 6 år til yngre end 18 år)
English: The pharmacokinetics of etravirine have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Etravirins farmakokinetik er ikke undersøgt til patienter med svært nedsat leverfunktion (Child-Pugh-klasse C).
English: Virologic parameters
Danish: Virologiske parametre
English: Etravirine exhibits activity against wild type HIV-1 in T-cell lines and primary cells with median EC50 values ranging from 0.9 to 5.5 nM. Etravirine demonstrates activity against HIV-1 group M (subtypes A, B, C, D, E, F, and G) and HIV-1 group O primary isolates with EC50 values ranging from 0.3 to 1.7 nM and from 11.5 to 21.7 nM, respectively.
Danish: Etravirin udviser aktivitet mod vild-type hiv-1 i T-cellelinjer og primære celler med mediane EC50-værdier på 0,9-5,5 nM. Etravirin udviser aktivitet mod hiv-1 gruppe M (undertype A, B, C, D, E, F og G) og hiv-1 gruppe O primære isolater med EC50-værdier på henholdsvis 0,3-1,7 nM og
English: Change from baseline in CD4 cell count (x 10
Danish: Ændring fra baseline i CD4celletal (x 10
English: Etravirine + BR N = 599
Danish: Etravirin + BR N = 599
English: ANTIMALARIALS Artemether/ Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether
Danish: 80/480 mg, 6 doser efter 0, 8, 24, 36, 48 og 60 timer artemeter
English: INTELENCE is expected to decrease plasma concentrations of these antiarrhythmics.
Danish: INTELENCE forventes at reducere plasmakoncentrationen af disse antiarytmika.
English: Pivotal studies
Danish: Pivotale forsøg
English: Imputations according to the TLOVR algorithm (TLOVR = Time to Loss of Virologic Response).
Danish: Imputeringer i henhold til TLOVR-algoritmen (TLOVR = tid til tab af virologisk respons).
English: Rarely, during INTELENCE treatment, you can experience severe skin rash with blisters or peeling skin, particularly around the mouth or eyes or hypersensitivity reaction (allergic reaction including rash and fever but also swelling of the face, tongue or throat, difficulty in breathing or swallowing) which could be potentially life-threatening.
Danish: Under behandlingen med INTELENCE kan du i sjældne tilfælde opleve et alvorligt hududslæt med blærer eller afskalning af huden, især omkring munden eller øjnene, eller en overfølsomhedsreaktion (allergisk reaktion med udslæt og feber, men også hævelse af ansigt, tunge eller svælg, besvær med vejrtrækning eller med at synke), som kan være livstruende.
English: In healthy subjects, the absorption of etravirine is not affected by co-administration of oral ranitidine or omeprazole, medicinal products that are known to increase gastric pH.
Danish: Hos raske forsøgspersoner påvirkes absorptionen af etravirin ikke af samtidig indgift af oral ranitidin eller omeprazol, som er kendt for at øge den gastriske pH-værdi.
English: (Hypericum perforatum)
Danish: NATURLÆGEMIDLER Perikon (Hypericum perforatum)
English: Table 3: DUET-1 and DUET-2 pooled 48-week data Etravirine + BR N = 599
Danish: Tabel 3: Poolede 48 ugers-data fra DUET-1 og DUET-2 Etravirin + BR N = 599
English: Population pharmacokinetic analysis in HIV infected patients showed that etravirine pharmacokinetics are not considerably different in the age range (18 to 77 years) evaluated, with 6 subjects aged 65 years or older (see sections 4.2 and 4.4).
Danish: En farmakokinetisk populationsanalyse af hiv-inficerede patienter har vist, at etravirins farmakokinetiske egenskaber ikke er væsentligt forskellige i den evaluerede aldersgruppe (18-77 år), hvor seks patienter var 65 år eller derover (se pkt.
English: Co-administration of Intelence and simeprevir is not recommended.
Danish: Samtidig administration af INTELENCE og simeprevir frarådes.
English: Simultaneously, plasma concentrations of itraconazole or ketoconazole may be decreased by etravirine.
Danish: Samtidig kan plasmakoncentrationen af itraconazol eller ketoconazol blive reduceret af etravirin.
English: Etravirine is a weak inhibitor of CYP2C9 and CYP2C19.
Danish: Etravirin er en svag hæmmer af CYP2C9 og CYP2C19.
English: 6 weeks after opening the bottle.
Danish: 6 uger efter åbning af beholderen.
English: The pharmacokinetics of etravirine in paediatric patients less than 6 years of age are under investigation.
Danish: Etravirins farmakokinetiske egenskaber hos børn under 6 år er ved at blive undersøgt.
English: SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) Paroxetine
Danish: SELEKTIVE SEROTONINGENOPTAGSHÆMMERE (SSRI) Paroxetin
English: 8 weeks after opening the bottle.
Danish: 8 uger efter åbning af beholderen.
English: The observed hepatocellular findings in female mice are generally considered to be rodent specific, associated with liver enzyme induction, and of limited relevance to humans.
Danish: De hepatocellulære observervationer i hunmus anses generelt for værende specifikke for gnavere forbundet med leverenzyminduktion og er af begrænset betydning for mennesker.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In the pooled analysis for DUET-1 and DUET-2, the incidence of hepatic events tended to be higher in co-infected subjects treated with etravirine compared to co-infected subjects in the placebo group.
Danish: Patienter, som samtidig er inficeret med hepatitis B- og/eller hepatitis C-virus I den poolede analyse af DUET-1 og DUET-2 var der tendens til, at incidensen af leverpåvirkning var højere hos de co-inficerede patienter, som blev behandlet med etravirin, end hos co-inficerede patienter i placebogruppen.
English: There are insufficient data at this time to recommend a dose in paediatric patients less than 6 years of age or weighing less than 16 kg (see section 4.2).
Danish: For øjeblikket er dokumentationen utilstrækkelig til at anbefale en dosis hos pædiatriske patienter, som er under 6 år eller vejer mindre end 16 kg (se pkt.
English: Other NRTIs
Danish: Andre NRTI-midler
English: Exposure in mice was equivalent to human exposure while in rats it was below the clinical exposure at the recommended dose.
Danish: Eksponeringen hos mus svarede til eksponeringen hos mennesker, mens den hos rotter lå under den kliniske eksponering ved den anbefalede dosis.
English: The safety and efficacy of etravirine in children less than 6 years of age and weighing less than 16 kg have not yet been established (see section 5.2).
Danish: Etravirins sikkerhed og virkning hos børn under 6 år og med legemsvægt under 16 kg er endnu ikke klarlagt (se pkt.
English: The total etravirine exposure after intake of etravirine 200 mg twice daily as part of an antiretroviral regimen was generally higher during pregnancy compared with postpartum (see Table 9).
Danish: Eksponering for total-etravirin efter indtagelse af 200 mg etravirin to gange dagligt som del af et antiretroviralt regime var generelt højere under graviditet i forhold til post partum (se tabel 9).
English: Paediatric population (6 years to less than 18 years of age) The recommended dose of etravirine for paediatric patients (6 years to less than 18 years of age and weighing at least 16 kg) is based on body weight (see table below).
Danish: Pædiatrisk population (i alderen 6 år til yngre end 18 år) Den anbefalede dosis etravirin til pædiatriske patienter (der er 6 år til yngre end 18 år og som vejer mindst 16 kg) er baseret på legemsvægt (se tabellen nedenfor).
English: Cases of severe hypersensitivity syndromes, including DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and TEN (toxic epidermal necrolysis), sometimes fatal, have been reported with the use of etravirine (see section 4.8).
Danish: Svære overfølsomhedsreaktioner, inklusive lægemiddelrelateret udslæt med eosinofili og systemiske symptomer (DRESS - Drug Rash with Eosinophilia and Systemic Symptoms) og toksisk epidermal nekrolyse (TEN), i nogle tilfælde letale, er rapporteret ved brug af etravirin (se pkt.
English: Rash was most frequently mild to moderate, generally macular to maculopapular or erythematous, mostly occurred in the second week of therapy, and was infrequent after week 4.
Danish: Udslæt var hyppigst let til moderat, generelt makulært til makulopapulært eller erytematøst, opstod som oftest i anden behandlingsuge og forekom sjældent efter uge 4. uge.
English: Table 8: Population pharmacokinetic estimates for etravirine (all doses combined) in treatment-experienced HIV-1 infected paediatric patients 6 years to less than 18 years of age (PIANO 48 week analysis)
Danish: Tabel 8: Populationsfarmakokinetiske estimater af etravirin (alle doser) hos behandlingserfarne pædiatriske patienter med hiv-1-infektion i alderen 6 år til yngre end 18 år (PIANO - analyse i uge 48)
English: Renal and urinary disorders common renal failure, blood creatinine increased
Danish: Nyrer og urinveje almindelig nyresvigt, forhøjet kreatinin i blodet
English: Skin and subcutaneous tissue disorders very common rash common night sweats, dry skin, prurigo uncommon angioneurotic oedema a, swelling face, hyperhidrosis rare
Danish: Hud og subkutane væv meget almindelig udslæt almindelig nattesved, tør hud, prurigo ikke almindelig angioneurotisk ødem a, hævelser i ansigtet, hyperhidrose sjælden
English: 800 mg 3 times daily + etravirine 200 mg every 12 hours boceprevir
Danish: Boceprevir 800 mg tre gange dagligt + etravirin 200 mg hver 12. time boceprevir
English: As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Danish: Eftersom etravirin er stærkt bundet til plasmaproteiner, er det usandsynligt, at stoffet vil kunne fjernes i væsentlig grad ved hæmodialyse eller peritonealdialyse (se pkt.
English: Blood and lymphatic system disorders common thrombocytopaenia, anaemia, decreased neutrophils uncommon decreased white blood cell count
Danish: Blod og lymfesystem almindelig trombocytopeni, anæmi, reduktion i neutrofiler ikke almindelig reduktion i antallet af hvide blodlegemer
English: Patients who have stopped treatment due to hypersensitivity reactions should not restart therapy with INTELENCE.
Danish: Patienter, der er seponeret på grund af overfølsomhedsreaktioner, bør ikke påbegynde behandling med INTELENCE igen.
English: Co-administration with medicinal products primarily metabolised by CYP2C9 or CYP2C19, or transported by P-glycoprotein, may result in increased plasma concentrations of such medicinal products, which could increase or prolong their therapeutic effect or alter their adverse events profile.
Danish: Samtidig indgift af lægemidler, som primært metaboliseres af CYP2C9 eller CYP2C19, eller som transporteres af P-glykoprotein, kan resultere i en øget plasmakoncentration af disse lægemidler, hvilket kan øge eller forlænge deres terapeutiske virkning eller ændre deres bivirkningsprofil.
English: The patient should be instructed to do the following: - place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medicine, - stir well until the water looks milky, - if desired, add more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water), - drink it immediately, - rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.
Danish: Patienten bør vejledes i at gøre som følger: - læg tabletten/tabletterne i 5 ml (1 teske) vand, eller mindst nok til at medicinen dækkes - rør godt rundt i vandet, indtil blandingen har et mælkeagtigt udseende - tilsæt evt. mere vand, eller tilsæt i stedet appelsinjuice eller mælk (patienten bør ikke lægge tabletterne i appelsinjuice eller mælk uden først at tilsætte vand) - drik med det samme - skyl glasset grundigt flere gange med vand, appelsinjuice eller mælk, og drik al skyllevandet hver gang for at sikre, at hele dosen indtages.
English: The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reaction cannot be excluded (see section 4.4).
Danish: De kliniske data er begrænsede, og en øget risiko for kutane reaktioner hos patienter med NNRTI-associerede kutane reaktioner i anamnesen kan ikke udelukkes (se pkt.
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDFØRINGSTILLADELSESNUMMER (-NUMRE)
English: Etravirine was not carcinogenic in rats and in male mice.
Danish: Etravirin havde ingen karcinogen virkning hos rotter og hanmus.
English: What INTELENCE contains - The active substance is etravirine.
Danish: INTELENCE indeholder - Aktivt stof: etravirin.
English: Geometric Mean ± Standard Deviation Median (Range)
Danish: Geometrisk gennemsnitsratio ± standardafvigelse Median (interval)
English: NARCOTIC ANALGESICS Methadone individual dose ranging from 60 mg to 130 mg once daily
Danish: NARKOTISKE ANALGETIKA Metadon individuel dosering 60-130 mg en gang dagligt
English: Norethindrone
Danish: Norethindron
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
English: Medicinal products that affect etravirine exposure
Danish: Lægemidler, som påvirker etravirineksponeringen
English: Raltegravir 400 mg twice daily raltegravir
Danish: Raltegravir 400 mg to gange dagligt raltegravir
English: Concomitant systemic use of itraconazole or ketoconazole and etravirine may increase plasma concentrations of etravirine.
Danish: Samtidig systemisk brug af itraconazol eller ketoconazol og etravirin kan øge plasmakoncentrationen af etravirin.
English: Some patients taking combination antiretroviral 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 er i behandling med antiretroviral kombinationsterapi, dvs. flere typer hivmedicin samtidig, kan udvikle knoglesygdommen osteonekrose, hvor knoglevævet går til grunde på grund af manglende blodforsyning til knoglen.
English: Itraconazole and ketoconazole are potent inhibitors as well as substrates of CYP3A4.
Danish: Itraconazol og ketoconazol er potente CYP3A4-hæmmere og -substrater.
English: If you vomit less than 4 hours after taking INTELENCE, take another dose following a meal.
Danish: Hvis du kaster op mindre end 4 timer efter, at du har taget INTELENCE, skal du tage en ny dosis efter et måltid.
English: 300/100 mg once daily atazanavir
Danish: 300/100 mg en gang dagligt atazanavir
English: Therefore, the pharmacokinetic parameter estimates shown in the table account for reductions in the pharmacokinetic parameters of etravirine due to co-administration of etravirine with darunavir/ritonavir.
Danish: Derfor forklarer tabellens estimater af etravirins farmakokinetiske parametre de reduktioner i parametrene, der skyldes samtidig administration af etravirin og darunavir/ritonavir.
English: A subgroup analysis of the virologic response (defined as a viral load < 50 HIV-1 RNA copies/ml) at week 48 by baseline viral load and baseline CD4 count (pooled DUET data) is presented in table 4.
Danish: En undergruppeanalyse af det virologiske respons (defineret som en virusmængde på < 50 hiv-1 RNA kopier/ml) i uge 48 efter virusmængde ved baseline og CD4-celletal ved baseline (poolede DUET-data) vises i tabel 4.
English: In the rat, the key target organs identified were the liver, the thyroid and the coagulation system.
Danish: Hos rotter var de identificerede primære målorganer leveren, skjoldbruskkirtlen og koagulationssystemet.
English: - Keep this leaflet.
Danish: - Fjern låget.
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for opstart af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværre allerede tilstedeværende symptomer.
English: Etravirine had no effect on offspring development during lactation or post weaning at maternal exposures equivalent to those observed at the recommended clinical dose.
Danish: Etravirin havde ingen effekt på afkommets udvikling under amning eller efter afvænning ved eksponeringsniveauer hos mødrene, som svarede til dem, som observeres ved den anbefalede kliniske dosis.