FrancophonIA/ELRC3.0 huggingface dataset:
English: Other NRTIs (abacavir, emtricitabine, lamivudine, stavudine and zidovudine)
Danish: Andre NRTI'er (abacavir, emtricitabin, lamivudin, stavudin og zidovudin)
English: In patients with severe renal impairment or end-stage renal disease, the combination of rilpivirine with a strong CYP3A inhibitor (e.g., ritonavir-boosted HIV protease inhibitor) should only be used if the benefit outweighs the risk (see section 5.2).
Danish: Til patienter med svært nedsat nyrefunktion eller terminal nyresygdom bør kombinationen af rilpivirin og en stærk CYP3A-hæmmer (f.eks. en ritonavir-boostet hiv-proteasehæmmer) kun anvendes, hvis fordelen opvejer risikoen (se pkt.
English: The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was 104.3 and 104.1 weeks, respectively.
Danish: Medianvarigheden af eksponering var henholdsvis 104,3 og 104,1 uger hos patienterne i rilpivirin-gruppen og efavirenz-gruppen.
English: For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) taken once daily.
Danish: Hos patienter i samtidig behandling med rifabutin skal dosis af EDURANT øges til 50 mg (to tabletter a 25 mg) 1 gang dagligt.
English: More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Danish: Der var flere patienter, som svigtede virologisk med rilpivirin, end patienter som svigtede virologisk med efavirenz, der udviklede lamivudin/emtricitabin associeret resistens (se pkt.
English: It is not recommended to co-administer rilpivirine with other NNRTIs.
Danish: Rilpivirin bør ikke indgives samtidig med andre NNRTI.
English: Common: - abnormal dreams - rash - stomach pain - depression - tiredness - vomiting - drowsiness - decreased appetite - sleep disorders - stomach discomfort - depressed mood - dry mouth
Danish: Almindelige: - unormale drømme - udslæt - mavesmerter - depression - træthed - opkastning
English: - clarithromycin, erythromycin (antibiotics) - cimetidine, famotidine, nizatidine, ranitidine (H2-receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux).
Danish: - cimetidin, famotidin, nizatidin, ranitidin (H2-receptorantagonister til behandling af mavesår eller sår på tarmen eller til lindring af halsbrand, der skyldes tilbageløb af syre).
English: As rilpivirine 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 rilpivirin i høj grad er bundet til plasmaproteiner, er det usandsynligt, at stoffet vil kunne elimineres signifikant ved hæmodialyse eller peritonealdialyse (se pkt.
English: In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.
Danish: Hvis du har taget for mange tabletter, kan du få hovedpine, kvalme, svimmelhed og/eller unormale drømme.
English: Take the H2-receptor antagonist at least 12 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
Danish: Tag H2-receptorantagonisten mindst 12 timer før eller mindst 4 timer efter EDURANT (se "Brug af anden medicin sammen med EDURANT" under pkt.
English: In the pooled efficacy analysis from the Phase III trials in adults through 96 weeks, patients treated with rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/ml had a greater risk of virologic failure (18.2% with rilpivirine versus 7.9% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/ml (5.7% with rilpivirine versus 3.6% with efavirenz).
Danish: I den puljede effektanalyse efter 96 uger i fase III-studierne hos voksne havde patienter behandlet med rilpivirin, som havde en viral load på > 100.000 hiv 1-RNA-kopier/ml ved baseline, en større risiko for virologisk svigt (18,2 % med rilpivirin versus 7,9 % med efavirenz) sammenlignet med patienter med en viral load på ≤ 100.000 hiv 1-RNA-kopier/ml ved baseline (5,7 % med rilpivirin versus 3,6 % med efavirenz).
English: The evidence of efficacy of rilpivirine is based on the analyses of 96 week data from 2 randomised, double-blinded, active-controlled, Phase III trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE).
Danish: Behandlingsnaive hiv 1-inficerede voksne patienter Evidensen for effekten af rilpivirin er baseret på analyserne af data efter 96 uger fra 2 randomiserede, dobbeltblinde, aktivt kontrollerede fase III-studier, TMC278-C209 (ECHO) og TMC278-C215 (THRIVE).
English: Taking EDURANT in fasted condition or with only a nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of EDURANT (see section 4.2).
Danish: Indtagelse af EDURANT i fastende tilstand eller kun sammen med en ernæringsdrik kan reducere plasmakoncentrationen af rilpivirin, hvilket muligvis kan reducere den terapeutiske effekt af EDURANT (se pkt.
English: Virologic failure in efficacy analysis: includes subjects who were rebounder (confirmed viral load ≥ 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load < 50 copies/ml, either ongoing or discontinued due to lack or loss of efficacy).
Danish: Virologisk svigt i effektanalyse: Omfatter forsøgspersoner med rebound (konfirmeret viral belastning ≥ 50 kopier/ml efter respons) eller som aldrig var supprimerede (ingen konfirmeret viral belastning < 50 kopier/ml, enten i behandling eller efter seponering af behandling pga. manglende eller tabt virkning).
English: Non-response Virologic failure
Danish: Manglende respons Virologisk svigt I alt
English: In the week 48 pooled resistance analysis from the Phase III trials, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
Danish: I den poolede resistensanalyse fra uge 48 i fase III-studierne havde 62 (ud af i alt 72) med virologiske svigt i rilpivirin-gruppen resistensdata ved baseline og på tidspunktet for svigt.
English: Lactose monohydrate Croscarmellose sodium Povidone K30
Danish: Lactosemonohydrat Croscarmellosenatrium Povidon K30
English: Study TMC278-C204 enrolled 368 HIV-1 infected treatment-naïve adult patients who had a plasma HIV-1 RNA ≥ 5,000 copies/ml, previously received ≤ 2 weeks of treatment with an N(t)RTI or protease inhibitor, had no prior use of NNRTIs and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Danish: I studie TMC278-C204 blev der inkluderet 368 hiv 1-inficerede behandlingsnaive voksne patienter, som havde hiv 1-RNA ≥ 5.000 kopier/ml i plasma, tidligere havde fået ≤ 2 ugers behandling med en N(t)RTI eller proteasehæmmer, ikke tidligere havde taget NNRTI og blev screenet for følsomhed over for N(t)RTI og for fravær af specifikke NNRTI-resistensassocierede mutationer.
English: Pharmacokinetic Results of Total Rilpivirine After Administration of Rilpivirine 25 mg Once Daily as Part of an Antiretroviral Regimen, During the 2
Danish: Farmakokinetiske resultater for total-rilpivirin efter administration af rilpivirin 25 mg én gang daglig som del af et antiretroviralt regimen under graviditetens 2. trimester, 3. trimester og postpartum
English: Tenofovir disoproxil fumarate*
Danish: Tenofovirdisoproxilfumarat*
English: The safety assessment is based on the week 48 analysis of the single-arm, open-label, Phase II trial, TMC278-C213, in which 36 antiretroviral treatment-naïve HIV-1 infected adolescent patients weighing at least 32 kg received rilpivirine (25 mg once daily) in combination with other antiretroviral agents (see section 5.1).
Danish: Sikkerhedsvurderingen er baseret på analysen efter 48 uger af det åbne, enkeltarmede fase II-studie TMC278-C213, i hvilket 36 antiretroviral-naive hiv 1-inficerede unge patienter, der vejede mindst 32 kg, fik rilpivirin (25 mg én gang dagligt) i kombination med andre antiretrovirale midler (se pkt.
English: Virologic failure in pooled efficacy analysis: includes subjects who were rebounder (confirmed viral load ≥ 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load < 50 copies/ml, either ongoing or discontinued due to lack or loss of efficacy).
Danish: Virologisk svigt i poolet effektanalyse: Omfatter forsøgspersoner med rebound (konfirmeret viral load ≥ 50 kopier/ml efter respons) eller som aldrig var supprimerede (ingen konfirmeret viral load < 50 kopier/ml, enten i behandling eller efter seponering af behandling pga. manglende eller tab af virkning).
English: The virologic response was generally preserved throughout the study: of the 12 subjects that completed the study, 10 subjects were suppressed at the end of the study; in the other 2 subjects an increase in viral load was observed only postpartum, for at least 1 subject due to suspected suboptimal adherence.
Danish: Det virologiske respons blev generelt bevaret under hele studiet: Ud af de 12 forsøgspersoner, der gennemførte studiet, var der viral hæmning hos 10 forsøgspersoner ved slutningen af studiet.
English: If you notice after 12 hours, then skip that dose and take the next doses as usual.
Danish: Hvis du bemærker det efter 12 timer, skal du springe denne dosis over og derefter blot fortsætte med den sædvanlige dosis.
English: Table 2: ADRs reported in antiretroviral treatment-naïve HIV-1 infected adult patients treated with Rilpivirine (pooled data from the week 96 analysis of the Phase III ECHO and THRIVE trials) N=686 System Organ Class (SOC) Frequency Category ADRs (Rilpivirine + BR)
Danish: Tabel 2: Bivirkninger rapporteret hos antiretroviral-naive hiv 1-inficerede voksne patienter behandlet med rilpivirin (poolede data fra analysen i uge 96 i fase III-studierne ECHO og THRIVE) N = 686 Systemorganklasse
English: Rilpivirine + BR N=686
Danish: Rilpivirin + BR N = 686
English: The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Danish: Rilpivirins farmakokinetiske egenskaber er ikke undersøgt hos patienter med nyreinsufficiens.
English: Medicinal products that are affected by the use of rilpivirine Rilpivirine at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
Danish: Det er ikke sandsynligt, at rilpivirin i en dosis på 25 mg x 1 vil have en klinisk relevant effekt på eksponeringen for lægemidler, der metaboliseres af CYP-enzymer.
English: EDURANT should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes.
Danish: EDURANT bør anvendes med forsigtighed, når det indgives samtidigt med et lægemiddel med kendt risiko for torsades de pointes.
English: After single dose oral administration of
Danish: Efter indgift som en enkelt peroral dosis af
English: Median baseline CD4+ cell count (range), x 10
Danish: Median CD4+ celletal (interval), x 10
English: In mice, rilpivirine was positive for hepatocellular neoplasms in both males and females.
Danish: Hos både han- og hunmus var rilpivirin positivt for hepatocellulære neoplasmer.
English: What EDURANT looks like and contents of the pack White to off-white, film-coated, round, biconvex tablet, with “TMC” on one side and “25” on the other side.
Danish: Hvide til offwhite, filmovertrukne, runde, bikonvekse tabletter præget med "TMC" på den ene side og "25" på den anden side.
English: The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation.
Danish: Der pågår undersøgelser af rilpivirins farmakokinetiske egenskaber hos pædiatriske patienter under 12 år.
English: PROTON PUMP INHIBITORS Omeprazole*
Danish: PROTONPUMPEHÆMMERE Omeprazol*
English: Take the antacid either at least 2 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
Danish: Tag medicinen enten mindst 2 timer før eller mindst 4 timer efter EDURANT (se "Brug af anden medicin sammen med EDURANT" under pkt.
English: Increase in CD4+ cell count (mean)
Danish: Stigning i CD4+ celletal (middel)
English: Antacids should only be administered either at least 2 hours before or at least 4 hours after rilpivirine.
Danish: Antacida bør kun indgives enten mindst 2 timer før eller mindst 4 timer efter rilpivirin.
English: Baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in the ECHO and THRIVE trials (pooled analysis)
Danish: Tabel 3: Sygdomskarakteristika ved baseline for antiretroviralnaive hiv 1-inficerede voksne forsøgspersoner i studierne ECHO og THRIVE (poolet analyse)
English: Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/ml
Danish: Sygdomskarakteristika ved baseline Median hiv 1-RNA (interval), log10 kopier/ml i plasma ved baseline
English: Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48/96.
Danish: Forsøgspersonerne opnåede virologisk respons (to konsekutive viral loads < 50 kopier/ml) og opretholdt respons til og med uge 48.
English: Dose dependent decreases in rilpivirine plasma concentrations are expected.
Danish: Der forventes dosisafhængige fald i rilpivirins plasmakoncentration.
English: In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
Danish: I denne analyse var de resistensassocierede mutationer (RAM) forbundet med NNRTI-resistens, der blev udviklet i mindst 2 af tilfældene med virologisk svigt af rilpivirin, V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y og F227C.
English: Didanosine should be administered at least two hours before or at least four hours after rilpivirine.
Danish: Didanosin bør indgives mindst 2 timer før eller mindst 4 timer efter rilpivirin.
English: If you vomit more than 4 hours after taking EDURANT you do not need to take another tablet until your next regularly scheduled tablet.
Danish: Hvis du kaster op over 4 timer efter, at du har taget EDURANT, behøver du ikke at tage en tablet, før du skal tage den næste dosis til sædvanlig tid.
English: Antiretroviral treatment-naïve HIV-1 infected patients were enrolled who had a plasma HIV-1 RNA ≥ 5,000 copies/ml and were screened for susceptibility to N(t)RTIs and for absence of specific NNRTI resistance-associated mutations.
Danish: Antiretroviralnaive hiv 1-inficerede patienter, som havde hiv 1-RNA ≥ 5.000 kopier/ml i plasma og blev screenet for følsomhed over for N(t)RTI-præparater og for fravær af specifikke NNRTIresistensassocierede mutationer, blev inkluderet.
English: If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of EDURANT until the next regularly scheduled dose.
Danish: Hvis opkastningen finder sted over 4 timer efter indtagelse af lægemidlet, behøver patienten ikke at tage en til dosis EDURANT før den næste planlagte dosis.
English: Zidovudine/lamivudine
Danish: Zidovudin/lamivudin
English: Alternatively, switching to another ART regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Danish: 4.4, 4.6, 5.1 og 5.2).
English: Rilpivirine-treated Resistance
Danish: Behandling med rilpivirin Resistens
English: 50 mg single dose sildenafil AUC ↔ sildenafil Cmin NA sildenafil Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Danish: 50 mg enkeltdosis sildenafil AUC ↔ sildenafil Cmin IR sildenafil Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: Interaction Geometric mean change (%)
Danish: Interaktion Geometrisk middelværdi ændring
English: Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 56 mg lactosemonohydrat.
English: Concomitant use of rilpivirine with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Danish: Samtidig indgift af rilpivirin og ritonavir-boostede PI øger plasmakoncentrationen af rilpivirin, men dosisjustering er ikke nødvendig.
English: There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial TMC278-C213 (33 to 93 kg), similar to what was observed in adults.
Danish: Svarende til det, der observeredes hos voksne, havde legemsvægten ingen indflydelse på rilpivirins farmakokinetiske egenskaber hos pædiatriske patienter i TMC278-C213-studiet (33 til 93 kg).
English: Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Danish: Hver filmovertrukket tablet indeholder rilpivirin-hydrochlorid svarende til 25 mg rilpivirin.
English: Liver toxicity associated with liver enzyme induction was observed in rodents.
Danish: Der er observeret levertoksicitet forbundet med leverenzyminduktion hos gnavere.
English: If you take an antacid (a medicine to treat diseases related to the acid in the stomach such as aluminium / magnesium hydroxide, calcium carbonate).
Danish: Hvis du tager et antacidum (medicin, der bruges til behandling af sygdomme, der forbindes med mavesyre; f.eks. aluminium-/magnesiumhydroxid, calciumcarbonat).
English: You must take EDURANT together with other HIV medicines.
Danish: Brug af anden medicin sammen med EDURANT Du skal tage EDURANT sammen med anden hiv-medicin.
English: The response rate (confirmed undetectable viral load < 50 HIV-1 RNA copies/ml) at week 96 was comparable between the rilpivirine arm and the efavirenz arm.
Danish: Der sås sammenlignelige responsrater (konfirmeret udetekterbar viral load < 50 hiv 1-RNAkopier/ml) i uge 96 i rilpivirin-gruppen og efavirenz-gruppen.
English: In ECHO, the BR was fixed to the N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine.
Danish: I ECHO blev baggrundsregimet fastsat til N(t)RTIpræparaterne tenofovirdisoproxilfumarat plus emtricitabin.
English: Nervous system disorders very common headache dizziness common somnolence
Danish: Nervesystemet meget almindelige hovedpine svimmelhed
English: In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
Danish: I et studie med raske forsøgspersoner har det vist sig, at supraterapeutiske doser af rilpivirin (75 mg x 1 og 300 mg x 1) forlænger QTc-intervallet på EKG'et (se pkt.
English: In the pooled analysis for ECHO and THRIVE, demographics and baseline characteristics were balanced between the rilpivirine arm and the efavirenz arm. Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms.
Danish: I den poolede analyse for ECHO og THRIVE var demografiske karakteristika og baselinekarakteristika afbalanceret mellem rilpivirin-gruppen og efavirenz-gruppen.
English: raltegravir AUC ↑ 9% raltegravir Cmin ↑ 27% raltegravir Cmax ↑ 10% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Danish: raltegravir AUC ↑ 9 % raltegravir Cmin ↑ 27 % raltegravir Cmax ↑ 10 % rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: Each tablet of EDURANT contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Danish: Hver EDURANT tablet indeholder rilpivirinhydrochlorid svarende til 25 mg rilpivirin.
English: Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A.
Danish: Lægemidler, som påvirker eksponeringen for rilpivirin Rilpivirin metaboliseres primært af cytokrom P450 (CYP)3A.
English: ANALGESICS Paracetamol* 500 mg single dose paracetamol AUC ↔ paracetamol Cmin NA paracetamol Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↑ 26% rilpivirine Cmax ↔
Danish: ANALGETIKA Paracetamol* 500 mg enkeltdosis paracetamol AUC ↔ paracetamol Cmin IR paracetamol Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↑ 26 % rilpivirin Cmax ↔
English: 25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
Danish: rifabutin AUC ↔ rifabutin Cmin ↔ rifabutin Cmax ↔ 25-O-desacetylrifabutin AUC ↔ 25-O-desacetylrifabutin Cmin ↔ 25-O-desacetylrifabutin Cmax ↔
English: 300 mg once daily (+ 25 mg once daily rilpivirine)
Danish: 300 mg x 1 (+ 25 mg rilpivirin x 1)
English: The combination of rilpivirine and antacids should be used with particular caution.
Danish: Samtidig behandling med rilpivirin og antacida bør ske med ekstra forsigtighed.
English: Co-administration of rilpivirine with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of EDURANT.
Danish: Samtidig indgift af rilpivirin og lægemidler, der øger gastrisk pH, kan reducere plasmakoncentrationen af rilpivirin, hvilket muligvis kan reducere den terapeutiske effekt af EDURANT.
English: The BR consisted of 2 investigator-selected N(t)RTIs: zidovudine plus lamivudine or tenofovir disoproxil fumarate plus emtricitabine.
Danish: BR bestod af 2 investigatorvalgte N(t)RTI: zidovudin plus lamivudin eller tenofovirdisoproxilfumarat plus emtricitabin.
English: The exposure to total rilpivirine after intake of rilpivirine 25 mg once daily as part of an antiretroviral regimen was lower during pregnancy (similar for the 2
Danish: Eksponeringen for total-rilpivirin efter indtagelse af rilpivirin 25 mg én gang daglig som en del af et antiretroviralt regimen var lavere under graviditet (tilsvarende 2. og 3. trimester) sammenlignet med postpartum (se tabel 7).
English: 400 mg once daily ketoconazole AUC ↓ 24% ketoconazole Cmin ↓ 66% ketoconazole Cmax ↔
Danish: ketoconazol AUC ↓ 24 % ketoconazol Cmin ↓ 66 % ketoconazol Cmax ↔
English: In the week 96 pooled resistance analysis of the Phase III trials (ECHO and THRIVE), 42 out of 86 subjects with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis).
Danish: Behandlingsnaive hiv 1-inficerede voksne patienter I den poolede resistensanalyse efter 96 uger i fase III-studierne (ECHO og THRIVE) udviste 42 ud af 86 forsøgspersoner med virologisk svigt på rilpivirin behandlingsudviklet resistens over for rilpivirin (ved genotypeanalyse).
English: rilpivirine AUC ↓ 42% rilpivirine Cmin ↓ 48% rilpivirine Cmax ↓ 31%
Danish: rilpivirin AUC ↓ 42 % rilpivirin Cmin ↓ 48 % rilpivirin Cmax ↓ 31 %
English: - antacids (used to treat diseases related to the acid in the stomach; for example, aluminium / magnesium hydroxide, calcium carbonate).
Danish: - antacida (bruges til behandling af sygdomme forårsaget af for meget mavesyre; f.eks. aluminium-/magnesiumhydroxid, calciumcarbonat).
English: 300 mg once daily (+ 50 mg once daily rilpivirine)
Danish: 300 mg x 1 (+ 50 mg rilpivirin x 1)
English: (induction of CYP3A enzymes)
Danish: (induktion af CYP3A-enzymer)
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion, som tidligere har haft opportunistiske infektioner (dvs. infektioner, som raske mennesker er modstandsdygtige over for, og som kun angriber mennesker med nedsat immunforsvar), kan tegn og symptomer på betændelse fra tidligere infektioner vise sig kort efter påbegyndelse af hiv-behandling.
English: At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5, 4.8 and 5.2).
Danish: Rilpivirin i supra-terapeutiske doser (75 og 300 mg x 1) er blevet associeret med forlængelse af QTcintervallet på elektrokardiogrammet (EKG) (se pkt.
English: Discontinued due to adverse event (AE)
Danish: Udtrådt på grund af bivirkning/uønsket hændelse
English: Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm.
Danish: Incidensen af virologisk svigt var højere i rilpivirin-gruppen end i efavirenz-gruppen i uge 96.