natgillin/translations-raw huggingface dataset:
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). 
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.
Hver filmovertrukket tablet indeholder rilpivirin-hydrochlorid svarende til 25 mg rilpivirin. 
Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Der er observeret levertoksicitet forbundet med leverenzyminduktion hos gnavere. 
Liver toxicity associated with liver enzyme induction was observed in rodents.
Hvis du tager et antacidum (medicin, der bruges til behandling af sygdomme, der forbindes med mavesyre; f.eks. aluminium-/magnesiumhydroxid, calciumcarbonat). 
If you take an antacid (a medicine to treat diseases related to the acid in the stomach such as aluminium / magnesium hydroxide, calcium carbonate).
Brug af anden medicin sammen med EDURANT Du skal tage EDURANT sammen med anden hiv-medicin. 
You must take EDURANT together with other HIV medicines.
Der sås sammenlignelige responsrater (konfirmeret udetekterbar viral load < 50 hiv 1-RNAkopier/ml) i uge 96 i rilpivirin-gruppen og efavirenz-gruppen. 
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.
I ECHO blev baggrundsregimet fastsat til N(t)RTIpræparaterne tenofovirdisoproxilfumarat plus emtricitabin. 
In ECHO, the BR was fixed to the N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine.
Nervesystemet meget almindelige hovedpine svimmelhed 
Nervous system disorders very common headache dizziness common somnolence
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. 
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).
I den poolede analyse for ECHO og THRIVE var demografiske karakteristika og baselinekarakteristika afbalanceret mellem rilpivirin-gruppen og efavirenz-gruppen. 
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.
raltegravir AUC ↑ 9 % raltegravir Cmin ↑ 27 % raltegravir Cmax ↑ 10 % rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔ 
raltegravir AUC ↑ 9% raltegravir Cmin ↑ 27% raltegravir Cmax ↑ 10% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Hver EDURANT tablet indeholder rilpivirinhydrochlorid svarende til 25 mg rilpivirin. 
Each tablet of EDURANT contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Lægemidler, som påvirker eksponeringen for rilpivirin Rilpivirin metaboliseres primært af cytokrom P450 (CYP)3A. 
Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A.
ANALGETIKA Paracetamol* 500 mg enkeltdosis paracetamol AUC ↔ paracetamol Cmin IR paracetamol Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↑ 26 % rilpivirin Cmax ↔ 
ANALGESICS Paracetamol* 500 mg single dose paracetamol AUC ↔ paracetamol Cmin NA paracetamol Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↑ 26% rilpivirine Cmax ↔
rifabutin AUC ↔ rifabutin Cmin ↔ rifabutin Cmax ↔ 25-O-desacetylrifabutin AUC ↔ 25-O-desacetylrifabutin Cmin ↔ 25-O-desacetylrifabutin Cmax ↔ 
25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
300 mg x 1 (+ 25 mg rilpivirin x 1) 
300 mg once daily (+ 25 mg once daily rilpivirine)
Samtidig behandling med rilpivirin og antacida bør ske med ekstra forsigtighed. 
The combination of rilpivirine and antacids should be used with particular caution.
Samtidig indgift af rilpivirin og lægemidler, der øger gastrisk pH, kan reducere plasmakoncentrationen af rilpivirin, hvilket muligvis kan reducere den terapeutiske effekt af EDURANT. 
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.
BR bestod af 2 investigatorvalgte N(t)RTI: zidovudin plus lamivudin eller tenofovirdisoproxilfumarat plus emtricitabin. 
The BR consisted of 2 investigator-selected N(t)RTIs: zidovudine plus lamivudine or tenofovir disoproxil fumarate plus emtricitabine.
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). 
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
ketoconazol AUC ↓ 24 % ketoconazol Cmin ↓ 66 % ketoconazol Cmax ↔ 
400 mg once daily ketoconazole AUC ↓ 24% ketoconazole Cmin ↓ 66% ketoconazole Cmax ↔
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). 
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).
rilpivirin AUC ↓ 42 % rilpivirin Cmin ↓ 48 % rilpivirin Cmax ↓ 31 % 
rilpivirine AUC ↓ 42% rilpivirine Cmin ↓ 48% rilpivirine Cmax ↓ 31%
- antacida (bruges til behandling af sygdomme forårsaget af for meget mavesyre; f.eks. aluminium-/magnesiumhydroxid, calciumcarbonat). 
- antacids (used to treat diseases related to the acid in the stomach; for example, aluminium / magnesium hydroxide, calcium carbonate).
300 mg x 1 (+ 50 mg rilpivirin x 1) 
300 mg once daily (+ 50 mg once daily rilpivirine)
(induktion af CYP3A-enzymer) 
(induction of CYP3A enzymes)
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. 
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.
Rilpivirin i supra-terapeutiske doser (75 og 300 mg x 1) er blevet associeret med forlængelse af QTcintervallet på elektrokardiogrammet (EKG) (se pkt. 
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).
Udtrådt på grund af bivirkning/uønsket hændelse 
Discontinued due to adverse event (AE)
Incidensen af virologisk svigt var højere i rilpivirin-gruppen end i efavirenz-gruppen i uge 96. 
Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm.
I uge 96 var den gennemsnitlige ændring fra baseline i CD4+ celletal +228 x 10 6 celler/l i rilpivirin gruppen og +219 x 10 
At week 96, the mean change from baseline in CD4+ cell count was +228 × 10
Ved seponering af rifabutin skal dosis af EDURANT nedsættes til 25 mg 1 gang dagligt (se pkt. 
When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily (see section 4.5).
Hos kvinder, der fik rilpivirin 25 mg én gang daglig under graviditetens 2. trimester, var de gennemsnitlige intra-individuelle værdier for Cmax, AUC24h og Cmin for total-rilpivirin henholdsvis 21 %, 29 % og 35 % lavere ved sammenligning med postpartum. 
nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3
Tabel 4: Virologisk resultat hos voksne forsøgspersoner i studierne ECHO og THRIVE (puljede data i uge 48 (primær analyse) og uge 96; ITT-TLOVR 
Virologic outcome in adult subjects in the ECHO and THRIVE trials (pooled data in the week 48 (primary) and week 96 analysis; ITT-TLOVR*) Outcome in the week 48 analysis
Hvis du er gravid, skal du spørge din læge til råds vedrørende brugen af EDURANT. 
Pregnant women should discuss the use of EDURANT with their doctor.
rilpivirin AUC ↑ 49 % rilpivirin Cmin ↑ 76 % rilpivirin Cmax ↑ 30 % 
rilpivirine AUC ↑ 49% rilpivirine Cmin ↑ 76% rilpivirine Cmax ↑ 30%
I THRIVE bestod baggrundsregimet af 2 investigatorvalgte N(t)RTI: tenofovirdisoproxilfumarat plus emtricitabin eller zidovudin plus lamivudin eller abacavir plus lamivudin. 
In THRIVE, the BR consisted of 2 investigator-selected N(t)RTIs: tenofovir disoproxil fumarate plus emtricitabine or zidovudine plus lamivudine or abacavir plus lamivudine.
rilpivirin AUC ↑ 16 % rilpivirin Cmin ↔* rilpivirin Cmax ↑ 43 % 
rilpivirine AUC ↑ 16%* rilpivirine Cmin ↔* rilpivirine Cmax ↑ 43%*
EDURANT skal anvendes med forsigtighed sammen med lægemidler, der er kendt for at indebære en risiko for torsades de pointes. 
EDURANT should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
I tilfælde af opkastning inden for 4 timer efter indtagelse af lægemidlet skal patienten tage en tablet til i forbindelse med et måltid. 
If a patient vomits within 4 hours of taking the medicine, another EDURANT tablet should be taken with a meal.
3 "Vejledning i brug til voksne og unge (fra 12 til under 18 år)". 
please carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18 years of age)”.
Der kræves ingen dosisjustering af rilpivirin til patienter med let eller moderat nedsat nyrefunktion. 
No dose adjustment of rilpivirine is required in patients with mild or moderate renal impairment.
6 celler/l hos patienter, der fik rilpivirin 25 mg, og 160 x 10 6 celler/l hos patienter, der fik efavirenz. 
6 cells/l in patients receiving rilpivirine 25 mg and 160 × 10
Almindelige unormale drømme depression søvnforstyrrelser nedsat stemningsleje 
Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood
I effektanalysen efter 96 uger blev den virologiske responsrate (konfirmeret udetekterbar viral load (< 50 hiv 1-RNA-kopier/ml)) vurderet hos patienter behandlet med rilpivirin 25 mg x 1 ud over et baggrundsregime versus patienter behandlet med efavirenz 600 mg x 1 ud over et baggrundsregime. 
In the week 96 efficacy analysis, the virologic response rate [confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml)] was evaluated in patients receiving rilpivirine 25 mg once daily in addition to a BR versus patients receiving efavirenz 600 mg once daily in addition to a BR.
EDURANT anbefales derfor ikke til patienter med svært nedsat leverfunktion (se pkt. 
Therefore, EDURANT is not recommended in patients with severe hepatic impairment (see section 5.2).
Blod og lymfesystem Almindelige fald i leukocyttal fald i hæmoglobin fald i trombocyttal 
Blood and lymphatic system disorders common decreased white blood cell count decreased haemoglobin decreased platelet count
(hæmning af CYP3A enzymer) 
(inhibition of CYP3A enzymes)
40 mg enkeltdosis taget 2 timer før rilpivirin rilpivirin AUC ↓ 76 % rilpivirin Cmin IR rilpivirin Cmax ↓ 85 % 
Famotidine* 40 mg single dose taken 2 hours before rilpivirine rilpivirine AUC ↓ 76% rilpivirine Cmin NA rilpivirine Cmax ↓ 85%
Behandling med efavirenz Resistens over for emtricitabin/lamivudin % (n/N) 
Resistance to emtricitabine/lamivudine % (n/N)
Norethindron* 
Didanosine*
Sådan skal du tage EDURANT 
How to take EDURANT
Hiv-integrasehæmmere Raltegravir* 
HIV Integrase Strand Transfer Inhibitors Raltegravir*
Der er observeret nedsat plasmakoncentration af rilpivirin ved samtidig indgift af rilpivirin og lægemidler, der inducerer CYP3A, hvilket kan reducere den terapeutiske effekt af rilpivirin. 
Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine.
Rilpivirin bør ikke anvendes i kombination med systemisk dexamethason (undtagen som en enkeltdosis), da samtidig indgift kan medføre tab af terapeutisk effekt af rilpivirin (se pkt. 
Rilpivirine should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Ved samtidig administration af rilpivirin og rifabutin skal dosis af rilpivirin øges fra 25 mg x 1 til 50 mg x 1. 
Throughout co-administration of rilpivirine with rifabutin, the rilpivirine dose should be increased from 25 mg once daily to 50 mg once daily.
Studie TMC278-C204 var et randomiseret, aktivt kontrolleret, fase IIb-studie antiretroviralnaive hiv 1-inficerede voksne patienter bestående af 2 dele: en indledende delvist blindet dosisbestemmende del [doserne af (rilpivirin) er blindede] på op til 96 uger, efterfulgt af en langvarig, åben del. I den åbne del af studiet blev patienter, der oprindeligt var randomiseret til en af de tre doser af rilpivirin, alle behandlet med rilpivirin 25 mg x 1 som tillæg til BR, efter at dosis til fase III-studierne var valgt. 
Study TMC278-C204 was a randomised, active-controlled, Phase IIb trial in antiretroviral treatment-naïve HIV-1 infected adult patients consisting of 2 parts: an initial partially blinded dose-finding part [(rilpivirine) doses blinded] up to 96 weeks, followed by a long-term, open label part.
ethinylestradiol AUC ↔ ethinylestradiol Cmin ↔ ethinylestradiol Cmax ↑ 17 % norethindron AUC ↔ norethindron Cmin↔ norethindron Cmax ↔ rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * baseret på historiske kontroller 
ORAL CONTRACEPTIVES Ethinylestradiol* 0.035 mg once daily Norethindrone* 1 mg once daily ethinylestradiol AUC ↔ ethinylestradiol Cmin ↔ ethinylestradiol Cmax ↑ 17% norethindrone AUC ↔ norethindrone Cmin ↔ norethindrone Cmax ↔ rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
atorvastatin AUC ↔ atorvastatin Cmin ↓ 15 % atorvastatin Cmax ↑ 35 % rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↓ 9 % 
40 mg once daily atorvastatin AUC ↔ atorvastatin Cmin ↓ 15% atorvastatin Cmax ↑ 35% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↓ 9%
EDURANT skal indtages i forbindelse med et måltid (se pkt. 
EDURANT must be taken with a meal (see section 5.2).
omeprazol AUC ↓ 14 % omeprazol Cmin IR omeprazol Cmax ↓ 14 % rilpivirin AUC ↓ 40 % rilpivirin Cmin ↓ 33 % rilpivirin Cmax ↓ 40 % 
20 mg once daily omeprazole AUC ↓ 14% omeprazole Cmin NA omeprazole Cmax ↓ 14% rilpivirine AUC ↓ 40% rilpivirine Cmin ↓ 33% rilpivirine Cmax ↓ 40%
rifampicin AUC ↔ rifampicin Cmin IR rifampicin Cmax ↔ 25-desacetylrifampicin AUC ↓ 9 % 25-desacetylrifampicin Cmin IR 25-desacetylrifampicin Cmax ↔ rilpivirin AUC ↓ 80 % rilpivirin Cmin ↓ 89 % rilpivirin Cmax ↓ 69 % 
Rifampicin* 600 mg once daily rifampicin AUC ↔ rifampicin Cmin NA rifampicin Cmax ↔ 25-desacetyl-rifampicin AUC ↓ 9% 25-desacetyl-rifampicin Cmin NA 25-desacetyl-rifampicin Cmax ↔ rilpivirine AUC ↓ 80% rilpivirine Cmin ↓ 89% rilpivirine Cmax ↓ 69%
Se yderligere oplysninger i indlægssedlen. 
See package leaflet for further information.
4.5): - følgende antiepileptika: carbamazepin, oxcarbazepin, phenobarbital, phenytoin - følgende antibiotika med virkning på mykobakterier: rifampicin, rifapentin - syrepumpehæmmere, f.eks. omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol - det systemiske glukokortikoid dexamethason (undtagen som enkeltdosis) - perikon (Hypericum perforatum) 
Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
tenofovir AUC ↑ 23 % tenofovir Cmin ↑ 24 % tenofovir Cmax ↑ 19 % rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔ 
300 mg once daily tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Beholderen er forsynet med et børnesikret låg. 
The bottle comes with a child resistant cap.
darunavir AUC ↔ darunavir Cmin ↓ 11 % darunavir Cmax ↔ rilpivirin AUC ↑ 130 % rilpivirin Cmin ↑ 178 % rilpivirin Cmax ↑ 79 % 
800/100 mg once daily darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79%
Der er ikke behov for dosisjustering til patienter med let eller moderat nedsat nyrefunktion. 
No dose adjustment is needed for patients with mild or moderate renal impairment.
Almindelige abdominalsmerter opkastning forhøjet lipase abdominalgener mundtørhed 
Gastrointestinal disorders very common nausea increased pancreatic amylase common abdominal pain vomiting increased lipase abdominal discomfort dry mouth
Doseringsanbefalingen gælder for den anbefalede dosis af rilpivirin på 25 mg x 1 
The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.
40 mg enkeltdosis taget 4 timer efter rilpivirin rilpivirin AUC ↑ 13 % rilpivirin Cmin IR rilpivirin Cmax ↑ 21 % 
Famotidine* 40 mg single dose taken 4 hours after rilpivirine rilpivirine AUC ↑ 13% rilpivirine Cmin NA rilpivirine Cmax ↑ 21%
(hæmning af P-gp i tarmen). 
(inhibition of intestinal P-gp)
- sløvhed - nedsat appetit - søvnforstyrrelser - mavegener - dårligt humør - mundtørhed - lavt antal hvide blodlegemer og/eller blodplader, fald i blodets indhold af hæmoglobin, stigning i blodets indhold af triglycerider, lipase og/eller bilirubin 
- low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides, lipase and/or bilirubin in your blood
5.1 er kun beregnet som vejledning til brug af EDURANT hos den behandlingsnaive population. 
The list of rilpivirine resistance-associated mutations presented in section 5.1 should only guide the use of EDURANT in the treatment-naïve population.
I analysen i uge 48 havde 31 ud af 62 forsøgspersoner med virologisk svigt af rilpivirin samtidig RAM forbundet med NNRTI og NRTI. 
In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
Almene symptomer og reaktioner på administrationsstedet 
General disorders and administration site conditions common fatigue
Inddelt efter CD4+ celletal (x 10 
By baseline CD4 count (× 10
Ved seponering af rifabutin skal dosis af rilpivirin nedsættes til 25 mg x 1. 
When rifabutin co-administration is stopped, the rilpivirine dose should be decreased to 25 mg once daily.
Tabletovertræk 
Cardiovascular
Der kræves ingen dosisjustering af EDURANT til patienter med let eller moderat nedsat leverfunktion. 
No dose adjustment of EDURANT is required in patients with mild or moderate hepatic impairment.
Ved undersøgelse af supraterapeutiske doser på 75 mg x 1 og 300 mg x 1 af rilpivirin til raske voksne var de højeste gennemsnitlige tidsmæssigt afstemte (95 % øvre konfidensgrænse) forskelle i QTcFinterval i forhold til placebo efter baselinekorrektion henholdsvis 10,7 (15,3) og 23,3 (28,4) ms. Steady state-indgift af rilpivirin 75 mg x 1 og 300 mg x 1 resulterede i et gennemsnitligt Cmax på henholdsvis ca. 2,6 og 6,7 gange højere end det gennemsnitlige Cmax ved steady state, der blev observeret med den anbefalede dosis på 25 mg x 1 af rilpivirin. 
When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Tag ikke EDURANT i kombination med et af følgende lægemidler, da de kan påvirke virkningen af EDURANT eller den anden medicin: - carbamazepin, oxcarbazepin, phenobarbital, phenytoin (medicin til behandling af epilepsi og til forebyggelse af krampeanfald). 
EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT (see section 4.5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifampicin, rifapentine - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole,
Lever og galdeveje meget almindelige forhøjede aminotransferaser 
Hepatobiliary disorders very common increased transaminases common increased bilirubin
Dosisjustering er ikke nødvendig, når rilpivirin (i den anbefalede dosis på 25 mg x 1) indgives sammen med ketoconazol. 
At the recommended dose of 25 mg once daily, no dose adjustment is required when rilpivirine is co-administered with ketoconazole.
Det skal du vide, før du begynder at tage EDURANT Sådan skal du tage EDURANT Bivirkninger 
What EDURANT is and what it is used for What you need to know before you take EDURANT How to take EDURANT
Andre antivirale midler Ribavirin 
ANTICOAGULANTS Dabigatran etexilate
Liste i tabelform over bivirkninger 
Tabulated summary of adverse reactions
Antallet af patienter med virologisk svigt og parrede genotyper (ved baseline og svigt) var henholdsvis 71, 11 og 4 i rilpivirin-gruppen og 30, 10 og 2 i efavirenz-gruppen for regimerne tenofovir/emtricitabin, zidovudin/lamivudin og abacavir/lamivudin. 
Resistance to efavirenz % (n/N) * The number of patients with virologic failure and paired genotypes (baseline and failure) were 71, 11, and 4 for rilpivirine and 30, 10,
Rilpivirin må ikke anvendes i kombination med disse antiepileptika, da samtidig indgift kan medføre tab af terapeutisk effekt af rilpivirin (se pkt. 
Rilpivirine must not be used in combination with these anticonvulsants as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
- produkter, som indeholder perikon (Hypericum perforatum) (et naturlægemiddel, som anvendes mod depression). 
- methadone (used to treat narcotic withdrawal and dependence) - dabigatran etexilate (anticoagulant).
Almindelige træthed 
Renal impairment
Der er observeret øget plasmakoncentration af rilpivirin ved samtidig indgift af rilpivirin og lægemidler, der hæmmer CYP3A. 
Co-administration of rilpivirine and medicinal products that inhibit CYP3A has been observed to increase the plasma concentrations of rilpivirine.
Rilpivirin må ikke anvendes i kombination med rifampicin, da samtidig indgift sandsynligvis vil medføre tab af terapeutisk effekt af rilpivirin (se pkt. 
Rilpivirine must not be used in combination with rifampicin as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Hvis du tager disse former for medicin, skal du omhyggeligt læse, hvordan du skal tage dem, i pkt. 
If you take these medicines,
Kontakt straks lægen eller apoteket. 
If you take more EDURANT than you should Contact your doctor or pharmacist immediately.