FrancophonIA/ELRC3.0 huggingface dataset:
English: Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Danish: Emtricitabin udskilles primært gennem nyrerne med komplet genfinding af dosis opnået i urinen (ca. 86 %) og fæces (ca. 14 %).
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thiolandelen til at danne 3'-sulfoxid-diastereomere (ca. 9 % af dosen) og forbindelse med glucuronsyre til at danne 2'-O-glucuronid (ca. 4 % af dosen).
English: As a precautionary measure, it is preferable to avoid the use of Eviplera during pregnancy.
Danish: For en sikkerheds skyld bør brug af Eviplera undgås under graviditeten.
English: See section 4.8, Description of selected adverse reactions.
Danish: 4.8, Beskrivelse af udvalgte bivirkninger.
English: 3 Phenotypic resistance (Antivirogram).
Danish: 2 Fænotype-resistens (Antivirogram).
English: Table 7: Outcomes of randomised treatment in study GS-US-264-0106 at week 24a
Danish: Tabel 7: Resultater af randomiseret behandling i studie GS-US-264-0106 ved uge 24a
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Danish: Den terminale eliminationshalveringstid for rilpivirin er ca. 45 timer.
English: Ethnicity No clinically important pharmacokinetic differences due to ethnicity have been identified.
Danish: Etnisk oprindelse Der er ikke blevet identificeret klinisk vigtige farmakokinetiske forskelle på grund af etnicitet.
English: During the time period of declining efavirenz plasma levels and increasing rilpivirine plasma levels after switching, none of the patients had efavirenz or rilpivirine levels below their respective IC90 levels at the same time.
Danish: I løbet af perioden med faldende efavirenz-plasmaniveau og stigende rilpivirinplasmaniveau efter skiftet havde ingen af patienterne på samme tidspunkt efavirenz- henholdsvis rilpivirin-niveau under de respektive IC90-niveauer.
English: The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 µM.
Danish: De 50 % effektive koncentrationsværdier (EC50) for emtricitabin var i intervallet fra 0,0013 til 0,64 µM.
English: Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Danish: Der blev kun detekteret spors af uomdannet rilpivirin (< 1 % af dosis) i urinen.
English: A negative impact by NNRTI mutations other than those listed above (e.g. mutations K103N or L100I as single mutations) cannot be excluded, since this was not studied in vivo in a sufficient number of patients.
Danish: En negativ indvirkning af NNRTI-mutationer bortset fra dem, der er anført ovenfor (f.eks. mutationerne K103N eller L100I som enkelte mutationer), kan ikke udelukkes, da dette ikke er undersøgt in vivo hos et tilstrækkeligt antal patienter.
English: If you have a history of liver disease, or chronic hepatitis B infection, your doctor may conduct blood tests in order to monitor liver function.
Danish: Hvis De har haft en leversygdom eller kronisk hepatitis B-infektion, kan Deres læge tage blodprøver for at overvåge leverfunktionen.
English: Stayed on Baseline Regimen (SBR) arm n = 159
Danish: Forblev på baseline-programarm (SBR) n = 159
English: Emtricitabine exposures were not affected by food.
Danish: Eksponeringen for emtricitabin blev ikke påvirket af mad.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect of some HIV medicines.
Danish: • Laktatacidose (for meget mælkesyre i blodet) er en sjælden, men muligvis livstruende bivirkning ved nogle former for hiv-medicin.
English: There were also reclassifications in the week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Danish: Der var også reklassifikationer i den primære analyse ved uge 48, hvor den hyppigste reklassifikation var fra virologisk svigt til seponering af andre årsager end AE'er.
English: Talk to your doctor about an alternative regimen (see section 3, How to take Eviplera).
Danish: Tal med lægen om et alternativt program (se punkt 3, Sådan skal De tage Eviplera).
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three active substances of Eviplera).
Danish: Nogle patienter har fået taget blodprøver eller har symptomer, som viser, at deres hepatitis er forværret efter ophør med emtricitabin eller tenofovirdisoproxil (to af de tre aktive stoffer i Eviplera.
English: In virologically suppressed HIV-1 infected patients Study GS-US-264-0106
Danish: Hos virologisk supprimerede hiv 1-inficerede patienter Studie GS-US-264-0106
English: 4 The predominant circulating metabolite of sofosbuvir.
Danish: 4 Den primære cirkulerende af sofosbuvir metabolit.
English: 5 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in hepatitis C virus
Danish: 5 Studiet blev udført med yderligere voxilaprevir 100 mg for at opnå de forventede voxilaprevir-eksponeringer hos patienter inficeret med hepatitis C-virus (HCV).
English: If Eviplera is stopped your doctor may recommend that you resume hepatitis B treatment.
Danish: Hvis Eviplera stoppes, kan Deres læge anbefale, at De igen påbegynder hepatitis B-behandling.
English: Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics is not different across the age range (18 to 78 years) evaluated, with only 2 patients aged 65 years of age or older.
Danish: En populationsfarmakokinetisk analyse hos hiv-inficerede patienter viste, at farmakokinetikken af rilpivirin ikke er forskellig i de aldersintervaller (18 til 78 år), der blev evalueret, med kun 2 patienter i alderen 65 år og derover.
English: De novo resistance to emtricitabine/lamivudine was seen in 4 cases, and also to rilpivirine in 2 cases, with a consequent cross-resistance to efavirenz (2/2), nevirapine (2/2) and etravirine (1/2).
Danish: De novo resistens over for emtricitabin/lamivudin blev set i 4 tilfælde, og i 2 tilfælde tillige over for rilpivirin med en konsekvent krydsresistens over for efavirenz (2/2), nevirapin (2/2) og etravirin (1/2).
English: After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Danish: Efter oral administration af en enkelt dosis [14C-]rilpivirin kunne der i gennemsnit genfindes hhv. 85 % og 6,1 % af radioaktiviteten i fæces og urin.
English: If Eviplera is co-administered with an NSAID, renal function should be monitored adequately.
Danish: Hvis Eviplera administreres sammen med et NSAID, skal nyrefunktionen monitoreres på tilstrækkelig vis.
English: Interactions between Eviplera or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
Danish: Interaktioner mellem Eviplera eller dets individuelle komponent(er) og lægemidler, der administreres samtidigt, ses i tabel 1 nedenfor (stigning er angivet som „↑”, fald som „↓” og ingen ændring som
English: • Increased levels of creatine kinase in the blood that may result in muscle pain and weakness
Danish: • Forhøjet kreatinkinase-niveau i blodet, hvilket kan resultere i muskelsmerter og muskelsvaghed
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor (PI).
Danish: I andre studier (prospektive studier og tværsnitsstudier) sås de mest udtalte reduktioner i BMD hos patienter, der blev behandlet med tenofovirdisoproxil som del af et regime indeholdende en boostet proteasehæmmer (PI).
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Tilfælde af osteonekrose er rapporteret, specielt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig behandling med CART.
English: d Includes patients who discontinued due to AE or death at any time point from day 1 through the week 24 window resulting in no virologic data on treatment during the specified window.
Danish: d Inkluderer patienter, som seponerede pga. bivirkninger eller død på et hvilket som helst tidspunkt fra dag 1 til og med uge 24-perioden, hvilket resulterede i ingen virologiske data for behandlingen i løbet af den angivne periode.
English: • Abnormal dreams, sleep disorders
Danish: • Unormale drømme, søvnforstyrrelser
English: e Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc.
Danish: e Inkluderer patienter, som seponerede af andre årsager end bivirkninger, død eller manglende virkning/tab af virkning, f.eks. tilbagetrækning af samtykke, manglende opfølgning osv.
English: If you have hepatitis B infection, liver problems may become worse after you stop taking Eviplera.
Danish: Hvis De har en hepatitis B-infektion, kan Deres leverproblemer blive værre, efter De holder op med at tage Eviplera.
English: The efficacy of Eviplera is based on the analyses of 96 week data from two randomised, double-blind, controlled studies C209 and C215.
Danish: Virkningen af Eviplera er baseret på analyserne af 96-ugers data fra to randomiserede, dobbeltblinde, kontrollerede studier, C209 og C215.
English: The triple combination of emtricitabine, rilpivirine, and tenofovir demonstrated synergistic antiviral activity in cell culture.
Danish: Trippelkombinationen af emtricitabin, rilpivirin og tenofovir viste synergistisk antiviral aktivitet i cellekultur.
English: • Tell your doctor immediately and stop taking Eviplera if you develop a skin rash with the following symptoms: fever, blisters, redness in your eyes and swelling of your face, mouth or body.
Danish: • Fortæl det straks til lægen og hold op med at tage Eviplera, hvis De udvikler hududslæt med følgende symptomer: feber, blærer, røde øjne og hævelse af ansigt, mund eller krop.
English: Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Danish: Eviplera er ikke blevet evalueret hos patienter med tidligere virologisk svigt over for anden antiretroviral behandling.
English: In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system.
Danish: In vitro-eksperimenter indikerer, at rilpivirinhydrochlorid primært gennemgår oxidativ metabolisme medieret af CYP3A-systemet.
English: At a dose of 25 mg of rilpivirine, no dose adjustment is required.
Danish: Ved en dosis på 25 mg rilpivirin kræves ingen dosisjustering.
English: 2 Adverse reaction identified for rilpivirine hydrochloride.
Danish: 2 Bivirkning identificeret for rilpivirinhydrochlorid.
English: Do not stop taking Eviplera Do not stop taking Eviplera without talking to your doctor.
Danish: Hold ikke op med at tage Eviplera Hold ikke op med at tage Eviplera uden at tale med Deres læge.
English: The decrease in the unbound free fraction of rilpivirine exposure (i.e. active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
Danish: Faldet i den ubundne frie fraktion ved eksponering for rilpivirin (dvs. aktiv) under graviditet sammenlignet med postpartum var mindre udtalt end for samlet eksponering for rilpivirin.
English: • Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
Danish: • Methadon, medicin til behandling af opiat-afhængighed, da det kan være nødvendigt, at lægen ændrer Deres methadondosis.
English: • Joint aches and pains (especially of the hip, knee and shoulder)
Danish: • Smerter (især i hofter, knæ og skuldre)
English: In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Danish: I fæces udgjorde uomdannet rilpivirin i gennemsnit 25 % af den administrerede dosis.
English: Possible side effects: tell a doctor immediately
Danish: Mulige bivirkninger: Fortæl det straks til lægen
English: Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine.
Danish: En populationsfarmakokinetisk analyse indikerede, at samtidig infektion med hepatitis B og/eller hepatitis C-virus ikke havde nogen klinisk relevant virkning på eksponeringen for rilpivirin.
English: • H2-antagonists (famotidine, cimetidine, nizatidine or ranitidine) These medicines can decrease the amount of rilpivirine (a component of Eviplera) in your blood.
Danish: • H2-antagonister (famotidin, cimetidin, nizatidin eller ranitidin) Disse former for medicin kan nedsætte mængden af rilpivirin (en komponent i Eviplera) i Deres blod.
English: Following oral administration of tenofovir disoproxil to HIV infected patients, tenofovir disoproxil is rapidly absorbed and converted to tenofovir.
Danish: Efter oral administration af tenofovirdisoproxil til hiv-inficerede patienter, absorberes tenofovirdisoproxil hurtigt og omdannes til tenofovir.
English: Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Danish: Da rilpivirin i høj grad er proteinbundet, er det usandsynligt, at dialyse resulterer i en betydelig fjernelse af det aktive stof.
English: 1 Adverse reaction identified for emtricitabine.
Danish: 1 Bivirkning identificeret for emtricitabin.
English: The absolute bioavailability of rilpivirine is unknown.
Danish: Den absolutte biotilgængelighed af rilpivirin er ikke kendt.
English: Insufficient safety data are available for children under the age of 18 years.
Danish: Der foreligger utilstrækkelig dokumentation vedrørende sikkerhed for børn under 18 år.
English: Both emtricitabine and tenofovir have activity that is specific to HIV-1, HIV-2 and, HBV.
Danish: Både emtricitabin og tenofovir har aktivitet, som er specifik mod hiv 1, hiv 2 og HBV.
English: As soon as serious skin and/or mucosal reactions are observed, Eviplera must be discontinued and appropriate therapy should be initiated.
Danish: Så snart der observeres alvorlige hud- og/eller slimhindereaktioner, skal Eviplera seponeres og passende behandling iværksættes.
English: Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Danish: Endvidere hæmmede emtricitabin ikke uridin-5'diphosphoglucuronyl-transferase, det enzym, som er ansvarlig for glukuronidering.
English: No patients discontinued from the study due to a TEAE in the SBR arm.
Danish: Ingen patienter i SBR-armen udgik af studiet pga. TEAE.
English: • Increased fatty acids (triglycerides), bilirubin or sugar in the blood
Danish: • Forhøjet niveau af fedtsyrer (triglycerider), bilirubin eller sukker i blodet
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Danish: De farmakokinetiske data viser, at samlet eksponering (AUC) for rilpivirin som del af et antiretroviralt program var cirka 30 % lavere under graviditet sammenlignet med postpartum (612 uger).
English: Cmin: N/A Emtricitabine:
Danish: Cmin: N/A Emtricitabin:
English: However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Danish: Det bør imidlertid ikke udelukkes, at eksponering for den farmakologisk aktive, ubundne rilpivirin er signifikant øget ved moderat nedsat leverfunktion.
English: Not enough patients over the age of 65
Danish: Der er ikke undersøgt tilstrækkeligt mange patienter over 65 år.
English: Some patients taking combination antiretroviral medicines such as Eviplera may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der tager antiretroviral kombinationsmedicin, såsom Eviplera, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød, forårsaget af manglende blodforsyning til knoglerne).
English: • Medicines containing didanosine (for HIV infection): Taking Eviplera with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4+ cell counts.
Danish: • Medicin, som indeholder didanosin (mod hiv-infektion): Hvis De tager Eviplera sammen med anden antiviral medicin, som indeholder didanosin, kan det øge indholdet af didanosin i blodet og reducere CD4+-celletallet.
English: The incidence of virologic failure was higher in the rilpivirine arm than in the efavirenz arm at week 96; however, most of the virologic failures occurred within the first 48 weeks of treatment.
Danish: Forekomsten af virologisk svigt var højere i rilpivirin-armen end i efavirenz-armen ved uge 96, men de fleste virologiske svigt forekom imidlertid i løbet af de første 48 behandlingsuger.
English: • Softening of the bones (with bone pain and sometimes resulting in fractures)
Danish: • Kalktab fra knoglerne (med knoglesmerter; kan nogle gange resultere i knoglebrud)
English:  Tell your doctor if you are taking any of these medicines.
Danish:  Fortæl det til lægen, hvis De tager nogle af disse former for medicin.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling af hepatitis B eller C henvises der også til de relevante produktresuméer til disse lægemidler.
English: Your doctor may do blood tests to see if your kidneys are working properly
Danish: Deres læge kan tage blodprøver for at se, om Deres nyrer fungerer ordentligt.
English: The K65R, M184V, and K65R+M184V mutants of HIV-1 remain fully susceptible to rilpivirine.
Danish: K65R, M184V og K65R+M184V-mutanter af hiv 1 forbliver fuldt ud følsomme for rilpivirin.
English: Randomisation was stratified by use of tenofovir disoproxil and/or lopinavir/ritonavir in the baseline regimen.
Danish: Randomisering blev stratificeret med anvendelse af tenofovirdisoproxil og/eller lopinavir/ritonavir i baseline-programmet.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system (human organic anion transporter 1 [hOAT1]) with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Danish: Tenofovir udskilles primært af nyrerne både ved filtration og et aktivt tubulært transportsystem (human organisk anion-transporter 1 [hOAT1]), hvor ca. 70-80 % af dosen udskilles uomdannet i urinen efter intravenøs indgivelse.
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil/Emtricitabine
Danish: PHOSPHODIESTERASE TYPE 5 (PDE-5)-HÆMMERE Sildenafil/Emtricitabin
English: Treatment with Eviplera resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant (see section 4.8).
Danish: Behandling med Eviplera resulterede i en tidlig lille forhøjelse af gennemsnitlige serumkreatininniveauer, hvilket var stabilt over tid, og ikke anses for at være klinisk relevant (se pkt.
English: No other pathways of resistance to emtricitabine or tenofovir have been identified.
Danish: Der er ikke identificeret andre veje for resistens over for emtricitabin eller tenofovir.
English: The pharmacokinetics of rilpivirine and tenofovir disoproxil in children and adolescents are under investigation.
Danish: Farmakokinetikken af rilpivirin og tenofovirdisoproxil hos børn og teenagere er i gang med at blive undersøgt.
English: Following intravenous administration the volume of distribution of the single components emtricitabine and tenofovir was approximately 1,400 mL/kg and 800 mL/kg, respectively.
Danish: Efter intravenøs indgivelse blev de enkelte komponenter emtricitabins og tenofovirs fordelingsvolumen vurderet til at være henholdsvis 1.400 ml/kg og 800 ml/kg.
English: Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (IC50 is 9.2 µM).
Danish: Rilpivirin hæmmer P-glykoprotein (P-gp) in vitro (IC50 er 9,2 μM).
English: Findings in repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use included kidney and bone changes and a decrease in serum phosphate concentration.
Danish: Fund fra toksicitetsstudier efter gentagne doser hos rotter, hunde og aber vedeksponeringsniveauer højere end eller lig med kliniske eksponeringsniveauer og med mulig relevans for den kliniske anvendelse omfatter nyre- og knogleændringer og et fald i serum-phosphatkoncentrationen.
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Danish: Efter oral indgivelse er tenofovirs eliminationshalveringstid ca. 12-18 timer.
English: There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil.
Danish: Der var ingen forskel i ændringen fra baseline af helkrops-BMD eller -BMC for rilpivirin sammenlignet med kontrollen, for den samlede population, eller hos de patienter, der behandles med et baggrundsprogram, der omfatter tenofovirdisoproxil.
English: The EC50 values for tenofovir were in the range of 0.04 to 8.5 µM.
Danish: EC50-værdierne for tenofovir var i intervallet fra 0,04 til 8,5 µM.
English: Rilpivirine does not inhibit the human cellular DNA polymerases α, β and mitochondrial DNA polymerase γ.
Danish: Rilpivirin hæmmer ikke humane cellulære dna-polymeraser α, β og mitokondriel dna-polymerase γ.
English: The administration of Eviplera to healthy adult subjects with either a light meal (390 kcal) or a standard meal (540 kcal) resulted in increased exposures of rilpivirine and tenofovir relative to fasting conditions.
Danish: Administrationen af Eviplera til raske, voksne forsøgspersoner, enten sammen med et let måltid (390 kcal) eller et standardmåltid (540 kcal) førte til øgede eksponeringer for rilpivirin og tenofovir i forhold til fastende tilstand.
English: • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Danish: • non-steroide antiinflammatoriske midler (NSAID'er, til at lindre knogle- eller muskelsmerter)
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Danish: Hyppighed er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) eller sjælden (≥ 1/10.000 til < 1/1.000).
English: The safety profile of emtricitabine and tenofovir disoproxil in these studies was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Danish: Emtricitabins og tenofovirdisoproxils sikkerhedsprofiler i disse studier svarede til de tidligere erfaringer med disse stoffer, når disse var blevet administreret sammen med andre antiretrovirale stoffer.
English: Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
Danish: Der er observeret lavere eksponeringer for rilpivirin, når rilpivirin 25 mg blev taget én gang dagligt under graviditet.