FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or pharmacist if you are not sure.
Danish: Tal med din læge eller apotekspersonalet, hvis du er i tvivl.
English: At the lowest tested doses in the carcinogenicity studies, the systemic exposures (based on AUC) to rilpivirine were 21-fold (mice) and 3-fold (rats), relative to those observed in humans at the recommended dose (25 mg once daily).
Danish: Ved de laveste testede doser i karcinogenicitetsstudierne var de systemiske eksponeringer (baseret på AUC) for rilpivirin 21 gange højere (mus) og 3 gange højere (rotter) end dem, der er observeret hos mennesker ved den anbefalede dosis (25 mg x 1).
English: The mean increase from baseline in CD4+ counts was 146 × 10
Danish: Den gennemsnitlige stigning i forhold til baseline i CD4+ tal var 146 x 10
English: What you need to know before you take EDURANT
Danish: Det skal du vide, før du begynder at tage EDURANT
English: # to emtricitabine/lamivudine % (n/N)
Danish: # over for emtricitabin/lamivudin % (n/N)
English: No clinically relevant drug-drug interaction is expected.
Danish: Der forventes ingen klinisk relevant lægemiddelinteraktion.
English: The median baseline plasma HIV-1 RNA was 4.8 log10 copies per ml, and the median baseline CD4+ cell count was 414 × 10
Danish: Median hiv 1-RNA i plasma ved baseline var 4,8 log10 kopier/ml, og median CD4+-celletal ved baseline var 414 x 10
English: For those patients failing therapy with rilpivirine and who developed resistance to rilpivirine, cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen.
Danish: Hos de patienter, der oplevede behandlingssvigt med rilpivirin og som udviklede resistens over for rilpivirin, sås der generelt krydsresistens over for andre godkendte NNRTI (etravirin, efavirenz, nevirapin).
English: The film-coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 and triacetin.
Danish: Filmovertrækket indeholder lactosemonohydrat, hypromellose 2910 6 mPa.s, titandioxid E171, macrogol 3000 og triacetin.
English: In the Phase III studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
Danish: I fase III-studier har lavere rilpivirin-eksponering svarende til den, der ses under graviditet, været forbundet med øget risiko for virologisk svigt, og viral load skal derfor overvåges nøje (se pkt.
English: 75 ml high density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant closure and induction seal liner.
Danish: 75 ml HDPE-beholder (polyethylen med høj densitet) med børnesikret PP-låg (polypropylen) og induktionsforsegling.
English: 6 cells/l Percentage of subjects with: hepatitis B/C virus co-infection Percentage of patients with the following background regimens: tenofovir disoproxil fumarate plus emtricitabine zidovudine plus lamivudine abacavir plus lamivudine
Danish: 6 celler/l ved baseline Procentdel af forsøgspersoner med: hepatitis B-/C-virus co-infektion Procentdel af patienter med følgende baggrundsregimer: tenofovirdisoproxilfumarat plus emtricitabin zidovudin plus lamivudin abacavir plus lamivudin
English: In treatment-naïve adult subjects
Danish: Hos behandlingsnaive voksne forsøgspersoner
English: Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Danish: Rilpivirin inducerede ikke kromosomskader i in vivo-mikronukleustesten hos mus.
English: If a patient misses a dose of EDURANT by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule.
Danish: Hvis en patient glemmer en dosis EDURANT i mere end 12 timer, skal patienten ikke tage den glemte dosis, men genoptage den sædvanlige behandlingsplan.
English: The recommended dose of EDURANT is one 25 mg tablet taken once daily.
Danish: Den anbefalede dosis af EDURANT er én 25 mg tablet 1 gang dagligt.
English: Six subjects discontinued due to virological failure up to week 48 and 3 subjects discontinued beyond week 48.
Danish: Seks forsøgspersoner afbrød behandlingen på grund af virologisk svigt op til uge 48, og 3 forsøgspersoner afbrød behandlingen efter uge 48.
English: The EDURANT tablet must be taken with a meal.
Danish: EDURANT-tabletten skal tages i forbindelse med et måltid.
English: EDURANT has not been studied in patients with severe hepatic impairment (Child-Pugh score C).
Danish: EDURANT er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-score C).
English: Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, reported in EDURANT treated patients were increased pancreatic amylase (3.8%), increased AST (2.3%), increased ALT (1.6%), increased LDL cholesterol (fasted, 1.5%), decreased white blood cell count (1.2%), increased lipase (0.9%), increased bilirubin (0.7%), increased triglycerides (fasted, 0.6%), decreased haemoglobin (0.1%), decreased platelet count (0.1%), and increased total cholesterol (fasted, 0.1%).
Danish: Udvalgte behandlingsrelaterede klinisk abnorme laboratorieværdier (af grad 3 eller 4), der blev betragtet som bivirkninger, og som blev rapporteret hos EDURANT-behandlede patienter, var forhøjede pankreas-amylaser (3,8 %), forhøjet ASAT (2,3 %), forhøjet ALAT (1,6 %), forhøjet LDLkolesterol (fastende, 1,5 %), fald i leukocyttal (1,2 %), forhøjet lipase (0,9 %), forhøjet bilirubin (0,7 %), forhøjede triglycerider (fastende, 0,6 %), fald i hæmoglobin (0,1 %), fald i trombocyttal (0,1 %) og forhøjet totalkolesterol (fastende, 0,1 %).
English: Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Danish: Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italien
English: Resistance to rilpivirine % (n/N)
Danish: Resistens over for rilpivirin % (n/N)
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Danish: I analysen af uge 48 til uge 96 forekom der yderligere 24 (3,5 %) og 14 (2,1 %) tilfælde af virologisk svigt i henholdsvis rilpivirin- og efavirenzgruppen.
English: ANTIDIABETICS Metformin* 850 mg single dose metformin AUC ↔ metformin Cmin NA metformin Cmax ↔
Danish: ANTIDIABETIKA Metformin * 850 mg enkeltdosis metformin AUC ↔ metformin Cmin NA metformin Cmax ↔
English: EDURANT at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Danish: EDURANT ved den anbefalede dosis 25 mg x 1 er ikke forbundet med en klinisk relevant effekt på QTc.
English: In the week 96 pooled resistance analysis, lower rates of virologic failure were observed in the second 48 weeks than in the first 48 weeks of treatment.
Danish: I den poolede resistensanalyse efter 96 uger sås en lavere hyppighed af virologisk svigt i behandlingens sidste 48 uger end i de førte 48 uger.
English: * compared to 25 mg once daily rilpivirine alone
Danish: * sammenlignet med 25 mg rilpivirin x 1 alene
English: If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the medicine with a meal as soon as possible and resume the normal dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis EDURANT inden for 12 timer efter det tidspunkt, hvor lægemidlet normalt tages, skal patienten tage lægemidlet sammen med et måltid snarest muligt og derefter genoptage den sædvanlige behandlingsplan.
English: Increased exposure of rilpivirine is expected.
Danish: Der forventes øget eksponering for rilpivirin.
English: If you vomit less than 4 hours after taking EDURANT, take another tablet with a meal.
Danish: Hvis du kaster op mindre end 4 timer efter, at du har taget EDURANT, skal du tage en tablet til sammen med et måltid.
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2).
Danish: Der er utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af rilpivirin til gravide kvinder (se pkt.
English: digoxin AUC ↔ digoxin Cmin NA digoxin Cmax ↔
Danish: ANTIARYTMIKA Digoxin digoxin AUC ↔ digoxin Cmin NA digoxin Cmax ↔
English: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Danish: Tabel 1: INTERAKTIONER OG DOSISANBEFALINGER MED ANDRE LÆGEMIDLER Lægemidler efter terapeutisk område
English: Most of these discontinuations occurred in the first 48 weeks of treatment.
Danish: De fleste af sådanne seponeringer forekom i løbet af de første 48 ugers behandling.
English: HIV PIs - with co-administration of low dose ritonavir Darunavir/ritonavir*
Danish: Hiv-proteasehæmmere - med samtidig indgift af lavdosis ritonavir Darunavir/ritonavir*
English: A strict dosing schedule, with intake of H2-receptor antagonists at least 12 hours before or at least 4 hours after rilpivirine should be used.
Danish: Der skal foreligge en stringent behandlingsplan, hvor H2receptorantagonisten skal tages mindst 12 timer før eller mindst 4 timer efter rilpivirin.
English: Table 6 summarizes the week 48 and week 240 virologic outcome results for trial TMC278-C213.
Danish: Tabel 6 viser en oversigt over de virologiske resultater i uge 48 og uge 240 for TMC278-C213-studiet.
English: EDURANT should be used with caution in patients with moderate hepatic impairment.
Danish: EDURANT bør anvendes med forsigtighed til patienter med moderat nedsat leverfunktion.
English: In patients with severe renal impairment or end-stage renal disease, the combination of EDURANT with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk.
Danish: Til patienter med svært nedsat nyrefunktion eller terminal nyresygdom bør kombinationen af EDURANT og en stærk CYP3A-hæmmer kun anvendes, hvis fordelen opvejer risikoen.
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved initiering af CART opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller symptomforværring.
English: In the week 240 resistance analysis of the TMC278-C213 trial, rilpivirine resistance-associated mutations (RAMs) were observed in 46.7% (7/15) of subjects with virologic failure and post-baseline genotypic data.
Danish: I resistensanalysen i uge 240 i TMC278-C213-studiet sås der rilpivirin-resistensassocierede mutationer (RAM) hos 46,7 % (7/15) af forsøgspersonerne med virologisk svigt og genotypedata efter baseline.
English: As with other antiretroviral medicinal products, resistance testing should guide the use of rilpivirine (see section 5.1).
Danish: Ligesom for andre antiretrovirale lægemidler bør undersøgelser for resistens være vejledende for brugen af rilpivirin (se pkt.
English: The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy subjects and in antiretroviral treatment-naïve HIV-1 infected patients 12 years of age and older.
Danish: Rilpivirins farmakokinetiske egenskaber er blevet evalueret hos raske voksne forsøgspersoner og hos antiretroviralnaive hiv 1-inficerede patienter fra 12 år og derover.
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin*
Danish: HMG-COA-REDUKTASEHÆMMERE Atorvastatin*
English: In patients with severe renal impairment or end-stage renal disease, EDURANT should be used with caution, as plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Danish: EDURANT bør anvendes med forsigtighed til patienter med svært nedsat nyrefunktion eller terminal nyresygdom, da plasmakoncentrationen kan øges som følge af ændring i lægemiddeloptagelse, -fordeling og/eller -metabolisme, der er sekundær til nyredysfunktion.
English: The safety and efficacy of EDURANT in children aged < 12 years have not yet been established.
Danish: Pædiatrisk population EDURANTs sikkerhed og virkning hos børn < 12 år er endnu ikke klarlagt.
English: The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Danish: Effekten af rilpivirin ved den anbefalede dosis 25 mg x 1 på QTcF-intervallet blev vurderet i et randomiseret, placebokontrolleret og aktivt kontrolleret (moxifloxacin 400 mg x 1) overkrydsningsstudie med 60 raske voksne, hvor der blev udført 13 målinger i løbet af 24 timer ved steady state.
English: The pharmacokinetics of rilpivirine in antiretroviral treatment-naïve HIV-1 infected adolescent subjects receiving EDURANT 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving EDURANT 25 mg once daily.
Danish: Rilpivirins farmakokinetiske egenskaber hos antiretroviral-naive hiv 1-inficerede unge patienter, der fik EDURANT 25 mg én gang dagligt, var sammenlignelige med de farmakokinetiske egenskaber hos behandlingsnaive hiv 1-inficerede voksne patienter, der fik EDURANT 25 mg én gang dagligt.
English: One subject discontinued due to an adverse event at week 48, and no additional subjects discontinued due to adverse events in the week 240 analysis.
Danish: Én forsøgsperson afbrød behandlingen på grund af en bivirkning i uge 48, mens der i analysen i uge 240 ikke var yderligere forsøgspersoner, der afbrød behandlingen på grund af bivirkninger.
English: At 96 weeks, the proportion of patients with < 50 HIV-1 RNA copies/ml receiving rilpivirine 25 mg (N=93) compared to patients receiving efavirenz (N=89) was 76% and 71%, respectively.
Danish: Efter 96 uger var andelen af patienter med < 50 hiv 1-RNA-kopier/ml, der fik rilpivirin 25 mg (N = 93), sammenlignet med patienter, der fik efavirenz (N = 89), henholdsvis 76 % og 71 %.
English: In the rilpivirine arm in the week 96 analysis of the Phase III ECHO and THRIVE trials, mean change from baseline in total cholesterol (fasted) was 5 mg/dl, in HDL cholesterol (fasted) 4 mg/dl, in LDL cholesterol (fasted) 1 mg/dl, and in triglycerides (fasted) -7 mg/dl.
Danish: I rilpivirin-gruppen viste analysen fra uge 96 i fase III-studierne ECHO og THRIVE en gennemsnitlig ændring fra baseline i total-kolesterol (fastende) på 5 mg/dl, i HDL-kolesterol (fastende) på 4 mg/dl, i LDL-kolesterol (fastende) på 1 mg/dl og i triglycerider (fastende) på -7 mg/dl.
English: Lactose monohydrate Hypromellose 2910 6 mPa.s Titanium dioxide E171 Macrogol 3000
Danish: Lactosemonohydrat Hypromellose 2910 6 mPa.s Titandioxid E171
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: Den populationsfarmakokinetiske analyse tydede på, at samtidig infektion med hepatitis B- og/eller Cvirus ikke havde nogen klinisk relevant effekt på eksponeringen for rilpivirin.
English: Uncommon: - signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome)
Danish: Ikke almindelige: - symptomer på betændelsestilstand eller infektion, f.eks. feber, kulderystelser, svedeture
English: Resistance outcome by background NRTI regimen used (pooled data from the ECHO and THRIVE trials in the week 96 resistance analysis) tenofovir/ emtricitabine zidovudine/ lamivudine abacavir/ lamivudine
Danish: Tabel 5: Resistensreultater ud fra det anvendte NRTI-baggrundsregime (poolede data fra studierne ECHO og THRIVE i resistensanalysen i uge 96) tenofovir/ emtricitabin zidovudin/ lamivudin abacavir/ lamivudin
English: In patients with a baseline viral load ≤ 100,000 copies/ml, 9 out of 27 patients with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis), with the following frequency of phenotypic cross-resistance: etravirine 4/9, efavirenz 3/9, and nevirapine 1/9.
Danish: Hos patienter med viral load ≤ 100.000 kopier/ml ved baseline udviste 9 ud af 27 patienter med virologisk svigt på rilpivirin behandlingsudviklet resistens over for rilpivirin (ved genotypeanalyse) med følgende hyppighed af fænotypekrydsresistens: etravirin 4/9, efavirenz 3/9 og nevirapin 1/9.
English: No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Danish: Der foreslås ikke dosisjustering, men forsigtighed tilrådes hos patienter med moderat nedsat leverfunktion.
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Danish: Rilpivirin hæmmer transportøren MATE-2K in vitro med en IC50 < 2,7 nM.
English: Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).
Danish: Genotypisk resistens bør være vejledende for brugen af EDURANT (se pkt.
English: EDURANT should be used with caution in this population (see section 4.2).
Danish: EDURANT bør anvendes med forsigtighed til denne population (se pkt.
English: ANTACIDS Antacids (e.g., aluminium or magnesium hydroxide, calcium carbonate)
Danish: ANTACIDA Antacida (f.eks. aluminium- eller magnesiumhydroxid, calciumcarbonat)
English: Significant decreases in rilpivirine plasma concentrations are expected.
Danish: Der forventes signifikante fald i rilpivirins plasmakoncentration.
English: In treatment-naïve adolescent subjects
Danish: Hos behandlingsnaive unge forsøgspersoner
English: The most commonly observed resistance-associated mutations that emerged included L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Danish: De hyppigst observerede resistensassocierede mutationer, der opstod, omfattede L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C og M230I.
English: EDURANT 25 mg film-coated tablets
Danish: EDURANT 25 mg filmovertrukne tabletter
English: Patients with a baseline viral load > 100,000 HIV-1 RNA copies/ml who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
Danish: Patienter med en viral load ved baseline på > 100.000 hiv 1-RNA-kopier/ml, som oplevede virologisk svigt, udviste en større rate af resistens opstået efter behandlingsstart over for klassen af non-nukleosid reverse transcriptasehæmmere (NNRTI).
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere behandlingstiltag bør bygge på de kliniske tegn eller følge anbefalingerne fra Giftlinjen, om muligt.
English: The combination of rilpivirine and dabigatran etexilate should be used with caution.
Danish: Samtidig behandling med rilpivirin og dabigatranetexilat bør ske med forsigtighed.
English: HIV NNRTIs NNRTIs (delavirdine, efavirenz, etravirine, nevirapine)
Danish: Hiv-NNRTI NNRTI (delavirdin, efavirenz, etravirin, nevirapin)
English: ANTIMYCOBACTERIALS Rifabutin*
Danish: ANTIBIOTIKA MED VIRKNING PÅ MYKOBAKTERIER Rifabutin*
English: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Danish: Der var ingen nye forekomster vedrørende sikkerhed sammenlignet med den kendte sikkerhedsprofil for rilpivirin hos hiv-1inficerede voksne (se pkt.
English: Table 4 below shows the results of the week 48 and the week 96 efficacy analysis for patients treated with rilpivirine and patients treated with efavirenz from the pooled data from the ECHO and THRIVE trials.
Danish: I nedenstående tabel 4 vises resultaterne af analyser efter 48 uger og 96 uger for patienter behandlet med rilpivirin og patienter behandlet med efavirenz fra de poolede data fra studierne ECHO og THRIVE.
English: Of those patients who were responders at week 96, 74% of patients receiving rilpivirine remained with undetectable viral load (< 50 HIV-1 RNA copies/ml) at week 240 compared to 81% of patients receiving efavirenz.
Danish: Af de patienter, der var responders i uge 96, havde 74 % af de patienter, der fik rilpivirin, fortsat udetekterbar viral load (< 50 hiv 1-RNA-kopier/ml) i uge 240 sammenlignet med 81 % af de patienter, der fik efavirenz.
English: The pharmacokinetics, safety, tolerability and efficacy of rilpivirine 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, was evaluated in trial TMC278-C213, a single-arm, open-label Phase II trial in antiretroviral treatment-naïve HIV-1 infected adolescent subjects weighing at least 32 kg.
Danish: Farmakokinetik, sikkerhed, tolerabilitet og virkning af rilpivirin 25 mg én gang dagligt i kombination med et investigator-valgt BR med to NRTI'er blev evalueret i TMC278-C213-studiet, et enkeltarmet, åbent fase II-studie med antiretroviral-naive hiv 1-inficerede unge forsøgspersoner, der vejede mindst
English: The combination of rilpivirine and H2-receptor antagonists should be used with particular caution.
Danish: Samtidig behandling med rilpivirin og en H2-receptorantagonist bør ske med ekstra forsigtighed.
English: HIV PIs - without co-administration of low dose ritonavir Unboosted PIs (atazanavir, fosamprenavir, indinavir, nelfinavir)
Danish: Hiv-proteasehæmmere - uden samtidig indgift af lavdosis ritonavir Ikke-boostede PI (atazanavir, fosamprenavir, indinavir, nelfinavir)
English: Considering all of the available in vitro and in vivo data in treatment-naïve subjects, the following resistance-associated mutations, when present at baseline, may affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, and M230L.
Danish: I betragtning af alle de tilgængelige in vitro- og in vivo-data hos behandlingsnaive forsøgspersoner kan følgende resistensassocierede mutationer påvirke aktiviteten af rilpivirin, når de er til stede ved baseline: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I og M230L.
English: EDURANT, please carefully read how to take EDURANT in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18 years of age)”.
Danish: 3 om, hvordan du skal tage EDURANT: "Vejledning i brug til voksne og unge (fra 12 til under 18 år)".
English: Concomitant use of EDURANT with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine.
Danish: Samtidig brug af EDURANT og azol-antimykotika kan øge plasmakoncentrationen af rilpivirin.
English: No dose adjustment of EDURANT is required in older patients (see section 5.2).
Danish: Der kræves ingen dosisjustering af EDURANT til ældre patienter (se pkt.
English: EDURANT 25 mg film-coated tablets rilpivirine
Danish: EDURANT 25 mg filmovertrukne tabletter rilpivirin
English: Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.
Danish: En populationsfarmakokinetisk analyse af rilpivirin hos hiv-inficerede patienter viste, at etnisk tilhørsforhold ikke havde nogen klinisk relevant effekt på eksponeringen for rilpivirin.
English: (reduced absorption due to gastric pH increase) H2-RECEPTOR ANTAGONISTS Famotidine* 40 mg single dose taken 12 hours before rilpivirine rilpivirine AUC ↓ 9% rilpivirine Cmin NA rilpivirine Cmax ↔
Danish: (reduceret absorption pga. stigning i gastrisk pH) H2-RECEPTORANTAGONISTER Famotidin* 40 mg enkeltdosis taget 12 timer før rilpivirin rilpivirin AUC ↓ 9 % rilpivirin Cmin IR rilpivirin Cmax ↔
English: Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48 and week 240.
Danish: Forsøgspersonerne opnåede virologisk respons (to konsekutive virale belastninger < 50 kopier/ml) og opretholdt respons til og med uge 48 og uge 240.
English: EDURANT must be taken with a meal.
Danish: EDURANT skal tages i forbindelse med et måltid.
English: 6 cells/l).
Danish: 6 celler/l).
English: 6 cells/l)
Danish: 6 celler/l)