natgillin/translations-raw huggingface dataset:
Rilpivirin kombineret med et baggrundsregimen blev evalueret i et klinisk studie med 19 gravide kvinder i løbet af andet og tredje trimester og postpartum. 
Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Fortæl det til lægen, hvis du tager: - rifabutin (medicin til behandling af visse infektioner, der skyldes bakterier). 
Tell your doctor if you take: - rifabutin (a medicine to treat some bacterial infections).
Der kan ikke gives dosisanbefalinger for pædiatriske patienter under 12 år på grund af utilstrækkelige data (se pkt. 
Dosing recommendations for paediatric patients less than 12 years of age cannot be made due to insufficient data (see section 4.2).
I fæces udgjorde uforandret rilpivirin gennemsnitligt 25 % af den indgivne dosis. 
In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Bivirkninger, som er rapporteret hos voksne patienter i behandling med rilpivirin, er opsummeret i tabel 2. 
ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.
EDURANT indeholder lactose 
EDURANT contains lactose
Der var god tolerans over for rilpivirin under graviditet og postpartum. 
Rilpivirine was well tolerated during pregnancy and postpartum.
Rilpivirin er blevet vurderet med hensyn til karcinogent potentiale ved tvangsfodring per os af mus og rotter i op til 104 uger. 
Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Poolede data fra studierne ECHO og THRIVE 
Pooled data from the ECHO and THRIVE trials
Graviditet og postpartum 
Pregnancy and Postpartum
De observerede hepatocellulære fund hos mus kan være gnaverspecifikke. 
The observed hepatocellular findings in mice may be rodent-specific.
Abacavir/lamivudin 
Abacavir/lamivudine
Du må ikke holde op med at tage EDURANT 
Do not stop using EDURANT
Når du stopper med at tage rifabutin, skal du kun tage én tablet EDURANT en gang dagligt. 
When you stop taking rifabutin, take one tablet of EDURANT once a day.
I ECHO blev randomiseringen stratificeret ud fra viral load ved screening. 
In ECHO, randomisation was stratified by screening viral load.
Det er ukendt, om rilpivirin udskilles i human mælk. 
It is not known whether rilpivirine is excreted in human milk.
Kun unge, der må formodes at kunne overholde den antiretrovirale behandling, bør behandles med rilpivirin, eftersom suboptimal behandlingsoverholdelse kan føre til resistensudvikling og tab af fremtidige behandlingsmuligheder. 
Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
Tag ikke EDURANT, hvis du er allergisk over for rilpivirin eller et af de øvrige indholdsstoffer i EDURANT (angivet i punkt 6). 
Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Der var ingen patienter, som afbrød behandlingen på grund af bivirkninger. 
There were no patients who discontinued treatment due to ADRs.
Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager EDURANT. 
Warnings and precautions Talk to your doctor or pharmacist before taking EDURANT.
Hos disse patienter blev der observeret fænotypekrydsresistens over for andre NNRTI med følgende hyppighed: etravirin 32/42, efavirenz 30/42 og nevirapin 16/42. 
In these patients, phenotypic cross-resistance to other NNRTIs was noted as follows: etravirine 32/42, efavirenz 30/42, and nevirapine 16/42.
Rilpivirins terminale elimineringshalveringstid er ca. 45 timer. 
The terminal elimination half-life of rilpivirine is approximately 45 hours.
CCR5-hæmmere Maraviroc 
CCR5 Antagonists Maraviroc
BR = baggrundsregime N = antal forsøgspersoner 
BR=background regimen N=number of subjects
Behandling med rilpivirin førte til en tidlig mindre stigning i gennemsnitligt serumkreatinin, som forblev stabilt over tid og ikke anses for klinisk relevant (se pkt. 
Treatment with rilpivirine 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).
6 celler/l i efavirenz-gruppen i den poolede analyse af studierne ECHO og THRIVE [estimeret behandlingsforskel (95 % CI): 11,3 (-6,8; 29,4)]. 
6 cells/l in the efavirenz arm in the pooled analysis of the ECHO and THRIVE trials [estimated treatment difference (95% CI): 11.3 (-6.8; 29.4)].
Symptomer på en overdosis kan omfatte hovedpine, kvalme, svimmelhed og/eller unormale drømme. 
Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams.
Alle forsøgspersoner med rilpivirin-RAM havde også mindst 1 behandlingsrelateret NRTI RAM på det sidste tidspunkt efter baseline med genotypedata. 
All subjects with rilpivirine RAMs also had at least 1 treatment-emergent NRTI RAM at the last post-baseline time point with genotypic data.
Eftersom rilpivirin i høj grad er bundet til plasmaproteiner, er det usandsynligt, at dialyse kan medføre signifikant eliminering af det aktive stof. 
Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
EDURANT anvendes sammen med andre former for hiv-medicin til behandling af voksne og unge over 12 år med hiv-infektion, som aldrig tidligere har fået behandling med hiv-medicin. 
EDURANT is used in combination with other HIV medicines to treat adolescents and adults 12 years of age and older who are infected with HIV and who have never been treated before with HIV medicines.
Tal med lægen, hvis du er i tvivl om, hvad du skal gøre, hvis du har glemt en dosis eller kastet op. 
Contact your doctor if uncertain about what to do if you miss a dose or vomit.
K103Nsubstitutionen alene medførte ikke nedsat følsomhed for rilpivirin, men kombinationen af K103N og L100I medført en syvdobbelt reduktion af følsomheden for rilpivirin. 
The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Erfaringen med overdosering af rilpivirin er begrænset. 
Human experience of overdose with rilpivirine is limited.
Der foreligger begrænsede oplysninger om brug af EDURANT til patienter med let til moderat nedsat leverfunktion (Child-Pugh-score A eller B). 
There is limited information regarding the use of EDURANT in patients with mild or moderate hepatic impairment (Child-Pugh score A or B).
I disse studier blev respons ikke påvirket af tilstedeværelsen af mutationerne V90I og V189I ved baseline. 
In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Rilpivirin hæmmer ikke humane cellulære DNApolymeraser α, β og γ. 
Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Dyrestudier har ikke vist tegn på relevant embryonal eller føtal toksicitet eller påvirkning af den reproduktive funktion. 
Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
- Fortæl det straks til lægen, hvis du mærker symptomer på infektion (f.eks. feber, kulderystelser, svedeture). 
- Tell your doctor immediately if you notice any symptoms of infections (for example, fever, chills, sweats).
Ligesom for andre antiretrovirale lægemidler bør resistensundersøgelser være vejledende for brugen af EDURANT. 
As with other antiretroviral medicinal products, resistance testing should guide the use of EDURANT.
EDURANT er hovedsageligt undersøgt hos patienter med normal nyrefunktion. 
EDURANT has mainly been studied in patients with normal renal function.
Rilpivirin hæmmer P-glykoprotein in vitro ((IC50 er 9,2 μM). 
Rilpivirine inhibits P-glycoprotein in vitro (IC50 is 9.2 μM).
De farmakokinetiske data påviste, at den samlede eksponering (AUC) for rilpivirin som en del af et antiretroviralt regimen var ca. 30 % lavere under graviditet sammenlignet med postpartum (6-12 uger). 
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).
På grund af både den potentielle risiko for hiv-smitte og risikoen for bivirkninger hos det ammede barn bør mødre informeres om, at de ikke bør amme, hvis de er i behandling med rilpivirin. 
Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breast-feed if they are receiving rilpivirine.
Disse resistensassocierede mutationer blev udledt fra in vivo-data, der kun vedrørte behandlingsnaive forsøgspersoner, og de kan derfor ikke anvendes til at forudsige virkningen af rilpivirin hos personer der har haft virologisk svigt i et antiretroviralt behandlingsregime. 
These resistance-associated mutations were derived from in vivo data involving treatment-naïve subjects only and therefore cannot be used to predict the activity of rilpivirine in subjects who have virologically failed an antiretroviral-containing regimen.
Forventet forskel i responsrater (95 % CI) for analysen i uge 48: 1,6 % (-2,2 %; 5,3 %) og for analysen i uge 96: -0,4 % (-4,6 %; 3,8 %); begge p-værdi < 0,0001 (noninferioritet ved en margin på 12 %) fra logistisk regressionsmodel, herunder stratificeringsfaktorer og studie. 
Predicted difference of response rates (95% CI) for the week 48 analysis: 1.6% (-2.2%; 5.3%) and for the week 96 analysis: -0.4% (-4.6%; 3.8%); both p-value < 0.0001 (non-inferiority at 12% margin) from logistic regression model, including stratification factors and study.
Der blev ikke indberettet nogen grad 3-4 abnorme laboratorieværdier for ASAT/ALAT eller grad 3-4 bivirkninger med relation til forhøjede aminotransferaser. 
No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
Eksponeringen for rilpivirin var ca. 40 % lavere, når EDURANT blev taget i fastende tilstand sammenlignet med et måltid med et normalt kalorieindhold (533 kcal) eller et måltid med et højt fedtindhold og et højt kalorieindhold (928 kcal). 
The exposure to rilpivirine was approximately 40% lower when EDURANT was taken in a fasted condition as compared to a normal caloric meal (533 kcal) or high-fat high-caloric meal (928 kcal).
Interaktioner mellem rilpivirin og samtidigt indgivne lægemidler er angivet i tabel 1 (forhøjelse angives med "↑", reduktion angives med "↓", ingen ændring angives med "↔", ikke relevant angives med "IR", konfidensinterval angives med "CI"). 
Interactions between rilpivirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not applicable as “NA”, confidence interval as “CI”).
FOSFODIESTERASE-5-HÆMMERE (PDE5-HÆMMERE) Sildenafil* 
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil*
Farmakokinetik for totalrilpivirin (gennemsnit ± SD, tmax: median [interval]) 
Pharmacokinetics of total rilpivirine (mean ± SD, tmax: median [range])
H2-receptorantagonister bør ikke tages to gange dagligt. 
H2-receptor antagonists should not be taken in a twice a day regimen.
Rilpivirin bibeholdt sensitivitet (FC ≤ BCO) over for 62 % af 4.786 hiv 1-rekombinante kliniske isolater, der var resistente over for efavirenz og/eller nevirapin. 
Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4,786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Aktiviteten af rilpivirin medieres af ikke-kompetitiv hæmning af hiv 1 revers transcriptase (RT). 
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Der findes ingen data om rilpivirins virkning på fertiliteten hos mennesker. 
No human data on the effect of rilpivirine on fertility are available.
Der er ikke set klinisk relevante virkninger på fertiliteten i dyrestudier (se pkt. 
No clinically relevant effects on fertility were seen in animal studies (see section 5.3).
Reduktionen i de farmakokinetiske parametre for ubundet (dvs. aktiv) rilpivirin under graviditet sammenlignet med postpartum var mindre udtalt end for total-rilpivirin. 
The decrease in unbound (ie, active) rilpivirine pharmacokinetic parameters during pregnancy compared to postpartum was less pronounced than for total rilpivirine.
ANDRE LÆGEMIDLER ANTIEPILEPTIKA Carbamazepin Oxcarbazepin Phenobarbital Phenytoin 
OTHER AGENTS ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Det kan dog ikke helt udelukkes, at rilpivirin kan øge eksponeringen for andre lægemidler, der transporteres af P-glykoprotein, og som er mere følsomme for hæmning af P-glykoprotein i tarmen, f.eks. dabigatranetexilat. 
However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate.
- Fortæl det til lægen, hvis du tager lægemidler, der kan give livstruende uregelmæssig hjerterytme (torsades de pointes). 
- Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsade de Pointes).
Meget almindelige: - hovedpine - kvalme - vanskelighed ved at falde i søvn (søvnløshed) - svimmelhed - ændringer i resultatet af dine rutinemæssige leverprøver (aminotransferaser) - stigning i blodets indhold af kolesterol og/eller pancreas-amylase 
Very common: - headache - nausea - difficulty falling asleep (insomnia) - dizziness - changes in one of your routine liver tests (transaminase) - increase in cholesterol and/or pancreatic amylase in your blood
Rilpivirin-resistente stammer blev selekterede i cellekultur startende fra vildtype hiv 1 af forskellig oprindelse og undertyper samt NNRTI-resistent hiv 1. 
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI resistant HIV-1.
EDURANT er ikke blevet evalueret hos patienter, som tidligere har oplevet virologisk svigt af anden retroviral behandling. 
EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Patienterne i kontrolgruppen fik efavirenz 600 mg x 1 som tillæg til BR i begge dele af studiet. 
Patients in the control arm received efavirenz 600 mg once daily in addition to a BR in both parts of the study.
Det tilhører en gruppe af hiv-medicin, som kaldes non-nukleosid reverse transcriptasehæmmere (NNRTI). 
It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Disse rilpivirin resistensassocierede mutationer bør kun anvendes til at vejlede brug af EDURANT i den behandlingsnaive population. 
These rilpivirine resistance-associated mutations should only guide the use of EDURANT in the treatment-naïve population.
Hvis du tager ribabutin (medicin til behandling af visse infektioner, der skyldes bakterier): Tag to tabletter EDURANT en gang dagligt. 
If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day.
De hyppigste bivirkninger (samtlige grader, over eller lig med 10 %) var hovedpine (19,4 %), depression (19,4 %), døsighed (13,9 %) og kvalme (11,1 %). 
The most common ADRs (all grades, greater than or equal to 10%) were headache (19.4%), depression (19.4%), somnolence (13.9%), and nausea (11.1%).
Hvis du bemærker det inden for 12 timer efter det tidspunkt, hvor du normalt tager EDURANT, skal du tage tabletten snarest muligt. 
If you notice within 12 hours of the time you usually take EDURANT, you must take the tablet as soon as possible.
MAKROLIDANTIBIOTIKA Clarithromycin 
MACROLIDE ANTIBIOTICS Clarithromycin
Respons (konfirmeret < 50 hiv-1 RNA kopier/ml) 
Response (confirmed < 50 HIV-1 RNA copies/ml)
Rilpivirin er testet negativt ved fravær og tilstedeværelse af et metabolisk aktiveringssystem i in vitro-Ames revers mutationstest og in vitro-clastogenicitetsanalysen af muselymfomer. 
Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay.
Rilpivirin udskilles i mælk hos rotter. 
Rilpivirine is excreted in the milk of rats.
Der blev ikke identificeret nye sikkerhedsproblemer i analysen i uge 240 i TMC278-C213-studiet hos unge. 
There were no new safety concerns identified in the Week 240 analysis of the TMC278-C213 trial in adolescents.
Af disse virologiske svigt forekom henholdsvis 9 ud af 24 og 4 ud af 14 hos forsøgspersoner med en viral load på < 100.000 kopier/ml ved baseline. 
Of these virologic failures, 9 out of 24 and 4 out of 14 were in subjects with a baseline viral load < 100,000 copies/ml, respectively.
Eksponeringen for rilpivirin var generelt lavere hos hiv 1-inficerede patienter end hos raske forsøgspersoner. 
Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Bivirkningerne er opført efter systemorganklasse og frekvens. 
The ADRs are listed by system organ class (SOC) and frequency.
ANTIINFEKTIVA Antiretrovirale midler Hiv-NRTI/N[t]RTI Didanosin* 
ANTI-INFECTIVES Antiretrovirals HIV NRTIs/N[t]RTIs
Hvis du har glemt at tage EDURANT 
If you forget to take EDURANT
Den større risiko for virologisk svigt hos patienter i rilpivirin-gruppen blev observeret i løbet af de først 48 uger af disse studier (se pkt. 
The greater risk of virologic failure for patients in the rilpivirine arm was observed in the first 48 weeks of these trials (see section 5.1).
Lægemidler, som påvirkes af rilpivirin 
Medicinal products that affect rilpivirine exposure
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med rilpivirin i en eller flere undergrupper af den pædiatriske population til behandling af humant immundefektvirus type 1-(hiv 1-) infektion (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with rilpivirine in one or more subsets of the paediatric population in the treatment of Human Immunodeficiency Virus (HIV-1) infection (see section 4.2 for information on paediatric use).
Sammenlignelig effekt blev påvist for rilpivirin i hvert af studierne, hvilket påviste noninferioritet i forhold til efavirenz. 
Similar efficacy for rilpivirine was seen in each trial demonstrating non-inferiority to efavirenz.
EDURANT indeholder: - Aktivt stof: rilpivirin i form af rilpivirinhydrochlorid. 
What EDURANT contains - The active substance is rilpivirine in the form of rilpivirine hydrochloride.
Hvis du tilhører denne aldersgruppe, skal du tale med lægen om, hvorvidt du kan tage EDURANT. 
If you belong to this age group, please discuss the use of EDURANT with your doctor.
Det kan ikke udelukkes, at der er risiko for øget dabigatran-plasmakoncentration. 
A risk for increases in dabigatran plasma concentrations cannot be excluded.
Resultaterne for unge (fra 12 til under 18 år) i TMC278-C213-studiet var generelt på linje med disse data (se pkt. 
Findings in adolescents (12 to less than 18 years of age) in trial TMC278-C213 were generally in line with these data (for details see section 5.1).
Selv om der med rilpivirin er påvist begrænset in vitro-aktivitet mod hiv-2 med EC50-værdier fra 2.510 til 10.830 nM (920 til 3.970 ng/ml), anbefales behandling af hiv-2-infektion med rilpivirin ikke, på grund af fraværet af kliniske data. 
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/ml), treatment of HIV-2 infection with rilpivirine is not recommended in the absence of clinical data.
Der blev observeret lavere eksponering for rilpivirin, når rilpivirin 25 mg blev taget én gang daglig under graviditet. 
Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
EDURANT indeholder rilpivirin, der anvendes til behandling af hiv-infektion (dvs. smitte med humant immundefektvirus). 
EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Andre boostede PI (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir) 
Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
QT-forlængende lægemidler 
QT prolonging medicinal products
Det kan dog ikke udelukkes, at eksponering for farmakologisk aktivt, ubundet rilpivirin øges signifikant ved moderat nedsat leverfunktion. 
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment.
Inddelt efter viral load ved baseline (kopier/ml) 
By baseline viral load (copies/ml)
Der er ikke observeret klinisk relevante forskelle i farmakokinetikken for rilpivirin mellem mænd og kvinder. 
No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women.
Under graviditetens 3. trimester var værdierne for Cmax, AUC24h og Cmin henholdsvis 20 %, 31 % og 42 % lavere ved sammenligning med postpartum. 
rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum.
Det samme blev observeret i efavirenz-gruppen. 
This observation was the same in the efavirenz arm.
- Øvrige indholdsstoffer i den filmovertrukne tabletkerne: lactosemonohydrat, croscarmellosenatrium, povidon K30, polysorbat 20, silicificeret mikrokrystallinsk cellulose og magnesiumstearat. 
- The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
Resistens over for rilpivirin blev fastsat som en ændring (i fold) i EC50-værdien over analysens biologiske skæringspunkt. 
Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay.
Rilpivirin har også vist antiviral aktivitet mod et bredt panel af hiv 1 gruppe M (undertype A, B, C, D, F, G, H) primære isolater med EC50-værdier fra 0,07 til 1,01 nM (0,03 til 0,37 ng/ml) og gruppe O primære isolater med EC50-værdier fra 2,88 til 8,45 nM (1,06 til 3,10 ng/ml). 
Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/ml) and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/ml).
Der kræves ingen dosisjustering ved påbegyndelse af samtidig indgift af methadon og rilpivirin. 
No dose adjustments are required when initiating co-administration of methadone with rilpivirine.
Der blev observeret lavere eksponering for rilpivirin under graviditet, og viral load skal derfor overvåges nøje. 
Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
I et klinisk studie sås ingen signifikant påvirkning af digoxins farmakokinetik. 
In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
EDURANT skal indtages oralt en gang dagligt i forbindelse med et måltid (se pkt. 
EDURANT must be taken orally, once daily with a meal (see section 5.2).
Lægemidler, der inducerer eller hæmmer CYP3A, kan således påvirke clearance af rilpivirin (se pkt. 
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Patienter, som er co-inficeret med hepatitis B- og/eller hepatitis C-virus Hos patienter, der var co-inficeret med hepatitis B- eller C-virus, og som fik rilpivirin, var forekomsten af forhøjede leverenzymer højere end hos patienter, der fik rilpivirin, og som ikke havde co-infektion. 
Patients co-infected with hepatitis B and/or hepatitis C virus In patients co-infected with hepatitis B or C virus receiving rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving rilpivirine who were not co-infected.