FrancophonIA/ELRC3.0 huggingface dataset:
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Danish: Aktiviteten af rilpivirin medieres af ikke-kompetitiv hæmning af hiv 1 revers transcriptase (RT).
English: No human data on the effect of rilpivirine on fertility are available.
Danish: Der findes ingen data om rilpivirins virkning på fertiliteten hos mennesker.
English: No clinically relevant effects on fertility were seen in animal studies (see section 5.3).
Danish: Der er ikke set klinisk relevante virkninger på fertiliteten i dyrestudier (se pkt.
English: The decrease in unbound (ie, active) rilpivirine pharmacokinetic parameters during pregnancy compared to postpartum was less pronounced than for total rilpivirine.
Danish: Reduktionen i de farmakokinetiske parametre for ubundet (dvs. aktiv) rilpivirin under graviditet sammenlignet med postpartum var mindre udtalt end for total-rilpivirin.
English: OTHER AGENTS ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Danish: ANDRE LÆGEMIDLER ANTIEPILEPTIKA Carbamazepin Oxcarbazepin Phenobarbital Phenytoin
English: 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.
Danish: 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.
English: - Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsade de Pointes).
Danish: - Fortæl det til lægen, hvis du tager lægemidler, der kan give livstruende uregelmæssig hjerterytme (torsades de pointes).
English: 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
Danish: 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
English: 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.
Danish: Rilpivirin-resistente stammer blev selekterede i cellekultur startende fra vildtype hiv 1 af forskellig oprindelse og undertyper samt NNRTI-resistent hiv 1.
English: EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Danish: EDURANT er ikke blevet evalueret hos patienter, som tidligere har oplevet virologisk svigt af anden retroviral behandling.
English: Patients in the control arm received efavirenz 600 mg once daily in addition to a BR in both parts of the study.
Danish: Patienterne i kontrolgruppen fik efavirenz 600 mg x 1 som tillæg til BR i begge dele af studiet.
English: It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Danish: Det tilhører en gruppe af hiv-medicin, som kaldes non-nukleosid reverse transcriptasehæmmere (NNRTI).
English: These rilpivirine resistance-associated mutations should only guide the use of EDURANT in the treatment-naïve population.
Danish: Disse rilpivirin resistensassocierede mutationer bør kun anvendes til at vejlede brug af EDURANT i den behandlingsnaive population.
English: If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day.
Danish: Hvis du tager ribabutin (medicin til behandling af visse infektioner, der skyldes bakterier): Tag to tabletter EDURANT en gang dagligt.
English: 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%).
Danish: De hyppigste bivirkninger (samtlige grader, over eller lig med 10 %) var hovedpine (19,4 %), depression (19,4 %), døsighed (13,9 %) og kvalme (11,1 %).
English: If you notice within 12 hours of the time you usually take EDURANT, you must take the tablet as soon as possible.
Danish: Hvis du bemærker det inden for 12 timer efter det tidspunkt, hvor du normalt tager EDURANT, skal du tage tabletten snarest muligt.
English: MACROLIDE ANTIBIOTICS Clarithromycin
Danish: MAKROLIDANTIBIOTIKA Clarithromycin
English: Response (confirmed < 50 HIV-1 RNA copies/ml)
Danish: Respons (konfirmeret < 50 hiv-1 RNA kopier/ml)
English: 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.
Danish: Rilpivirin er testet negativt ved fravær og tilstedeværelse af et metabolisk aktiveringssystem i in vitro-Ames revers mutationstest og in vitro-clastogenicitetsanalysen af muselymfomer.
English: Rilpivirine is excreted in the milk of rats.
Danish: Rilpivirin udskilles i mælk hos rotter.
English: There were no new safety concerns identified in the Week 240 analysis of the TMC278-C213 trial in adolescents.
Danish: Der blev ikke identificeret nye sikkerhedsproblemer i analysen i uge 240 i TMC278-C213-studiet hos unge.
English: 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.
Danish: 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.
English: Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Danish: Eksponeringen for rilpivirin var generelt lavere hos hiv 1-inficerede patienter end hos raske forsøgspersoner.
English: The ADRs are listed by system organ class (SOC) and frequency.
Danish: Bivirkningerne er opført efter systemorganklasse og frekvens.
English: ANTI-INFECTIVES Antiretrovirals HIV NRTIs/N[t]RTIs
Danish: ANTIINFEKTIVA Antiretrovirale midler Hiv-NRTI/N[t]RTI Didanosin*
English: If you forget to take EDURANT
Danish: Hvis du har glemt at tage EDURANT
English: 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).
Danish: 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.
English: Medicinal products that affect rilpivirine exposure
Danish: Lægemidler, som påvirkes af rilpivirin
English: 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).
Danish: 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.
English: Similar efficacy for rilpivirine was seen in each trial demonstrating non-inferiority to efavirenz.
Danish: Sammenlignelig effekt blev påvist for rilpivirin i hvert af studierne, hvilket påviste noninferioritet i forhold til efavirenz.
English: What EDURANT contains - The active substance is rilpivirine in the form of rilpivirine hydrochloride.
Danish: EDURANT indeholder: - Aktivt stof: rilpivirin i form af rilpivirinhydrochlorid.
English: If you belong to this age group, please discuss the use of EDURANT with your doctor.
Danish: Hvis du tilhører denne aldersgruppe, skal du tale med lægen om, hvorvidt du kan tage EDURANT.
English: A risk for increases in dabigatran plasma concentrations cannot be excluded.
Danish: Det kan ikke udelukkes, at der er risiko for øget dabigatran-plasmakoncentration.
English: 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).
Danish: Resultaterne for unge (fra 12 til under 18 år) i TMC278-C213-studiet var generelt på linje med disse data (se pkt.
English: 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.
Danish: 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.
English: Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
Danish: Der blev observeret lavere eksponering for rilpivirin, når rilpivirin 25 mg blev taget én gang daglig under graviditet.
English: EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Danish: EDURANT indeholder rilpivirin, der anvendes til behandling af hiv-infektion (dvs. smitte med humant immundefektvirus).
English: Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
Danish: Andre boostede PI (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
English: QT prolonging medicinal products
Danish: QT-forlængende lægemidler
English: However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment.
Danish: Det kan dog ikke udelukkes, at eksponering for farmakologisk aktivt, ubundet rilpivirin øges signifikant ved moderat nedsat leverfunktion.
English: By baseline viral load (copies/ml)
Danish: Inddelt efter viral load ved baseline (kopier/ml)
English: No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women.
Danish: Der er ikke observeret klinisk relevante forskelle i farmakokinetikken for rilpivirin mellem mænd og kvinder.
English: rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum.
Danish: Under graviditetens 3. trimester var værdierne for Cmax, AUC24h og Cmin henholdsvis 20 %, 31 % og 42 % lavere ved sammenligning med postpartum.
English: This observation was the same in the efavirenz arm.
Danish: Det samme blev observeret i efavirenz-gruppen.
English: - The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
Danish: - Øvrige indholdsstoffer i den filmovertrukne tabletkerne: lactosemonohydrat, croscarmellosenatrium, povidon K30, polysorbat 20, silicificeret mikrokrystallinsk cellulose og magnesiumstearat.
English: Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay.
Danish: Resistens over for rilpivirin blev fastsat som en ændring (i fold) i EC50-værdien over analysens biologiske skæringspunkt.
English: 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).
Danish: 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).
English: No dose adjustments are required when initiating co-administration of methadone with rilpivirine.
Danish: Der kræves ingen dosisjustering ved påbegyndelse af samtidig indgift af methadon og rilpivirin.
English: Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
Danish: Der blev observeret lavere eksponering for rilpivirin under graviditet, og viral load skal derfor overvåges nøje.
English: In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
Danish: I et klinisk studie sås ingen signifikant påvirkning af digoxins farmakokinetik.
English: EDURANT must be taken orally, once daily with a meal (see section 5.2).
Danish: EDURANT skal indtages oralt en gang dagligt i forbindelse med et måltid (se pkt.
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Danish: Lægemidler, der inducerer eller hæmmer CYP3A, kan således påvirke clearance af rilpivirin (se pkt.
English: 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.
Danish: 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.
English: In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity against 64 (96%) of these strains.
Danish: I et panel af 67 hiv 1-rekombinante laboratoriestammer med en resistensassocieret mutation ved RTpositioner forbundet med NNRTI-resistens, herunder de hyppigst sete K103N og Y181C, viste rilpivirin antiviral aktivitet mod 64 (96 %) af disse stammer.
English: In THRIVE, randomisation was stratified by screening viral load and by N(t)RTI BR.
Danish: I THRIVE blev randomiseringen stratificeret ud fra viral load ved screening og ud fra N(t)RTI-baggrundsregime.
English: Trimester of pregnancy (n=13)
Danish: Graviditetens 3. trimester (n=13)
English: In a study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Danish: I et studie, hvor 8 patienter med let nedsat leverfunktion (Child-Pugh-score A) blev sammenlignet med 8 matchede kontrolpersoner, og 8 patienter med moderat nedsat leverfunktion (Child-Pugh-score B) blev sammenlignet med 8 matchede kontrolpersoner, var eksponeringen ved flere doser af rilpivirin 47 % højere hos patienter med let nedsat leverfunktion og 5 % højere hos patienter med moderat nedsat leverfunktion.
English: It is not recommended to combine EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine.
Danish: EDURANT bør ikke kombineres med andre non-nukleosid reverse transcriptasehæmmere (NNRTI) såsom delavirdin, efavirenz, etravirin og nevirapin.
English: EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
Danish: EDURANT er i kombination med andre antiretrovirale lægemidler indiceret til behandling af humant immundefektvirus type 1- (hiv 1-) infektion hos antiretroviral-naive patienter fra 12 år med en viral load på ≤ 100.000 hiv 1-RNA-kopier/ml.
English: Within each frequency grouping, ADRs are presented in order of decreasing frequency.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter frekvens med de hyppigste først.
English: This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered medicinal product.
Danish: Dette interaktionsstudie blev udført med en højere dosis rilpivirin end den anbefalede dosis til vurdering af den maksimale effekt på det samtidigt indgivne lægemiddel.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om EDURANT findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: As a precautionary measure, it is preferable to avoid the use of EDURANT during pregnancy.
Danish: For en sikkerheds skyld bør EDURANT undgås under graviditeten.
English: EDURANT is not a cure for HIV infection.
Danish: EDURANT kan ikke kurere hiv-infektionen.
English: Didanosine should be administered on an empty stomach at least two hours before or at least four hours after EDURANT (which must be taken with a meal).
Danish: Didanosin skal tages på tom mave mindst to timer før eller mindst fire timer efter EDURANT (som skal tages sammen med et måltid).
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This interaction study has been performed with a dose higher than the recommended dose for rilpivirine.
Danish: Dette interaktionsstudie blev udført med en højere dosis rilpivirin end den anbefalede.
English: The safety and efficacy of rilpivirine in children aged < 12 years have not yet been established.
Danish: Rilpivirins sikkerhed og virkning hos børn i alderen < 12 år er endnu ikke klarlagt.
English: The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
Danish: Eksponeringerne ved embryoføtale niveauer uden observerede negative effekter (NOAEL) hos rotter og kaniner var henholdsvis 15 og 70 gange højere end eksponeringen hos mennesker ved den anbefalede dosis 25 mg x 1
English: (induction of CYP3A due to high rilpivirine dose in the study)
Danish: (induktion af CYP3A pga. høj dosis rilpivirin i studiet)
English: Skin and subcutaneous tissue disorders common rash
Danish: Hud og subkutane væv Almindelige udslæt
English: White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side.
Danish: Hvid til offwhite, rund, bikonveks, filmovertrukket tablet, diameter 6,4 mm, præget med "TMC" på den ene side og "25" på den anden side.
English: Lansoprazole Rabeprazole Pantoprazole Esomeprazole
Danish: Lansoprazol Rabeprazol Pantoprazol Esomeprazol
English: Virologic outcome in adolescent subjects in the TMC278-C213 trial - week 48 and week 240 analysis; ITT-TLOVR* Week 48 N=36
Danish: Virologisk resultat hos unge forsøgspersoner i TMC278-C213-studiet - analyse i uge 48 og uge 240; ITT-TLOVR* Uge 48 N=36
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 22% R(-) methadone Cmax ↓ 14% rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Danish: R(-) methadon AUC ↓ 16 % R(-) methadon Cmin ↓ 22 % R(-) methadon Cmax ↓ 14 % rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * baseret på historiske kontroller
English: Silicified microcrystalline cellulose Magnesium stearate
Danish: Silicificeret mikrokrystallinsk cellulose Magnesiumstearat
English: The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Danish: De enkelte resistensassocierede mutationer forbundet med tab af følsomhed over for rilpivirin var: K101P, Y181I og Y181V.
English: From the week 96 pooled resistance analysis, the resistance outcome for patients with protocol defined virological failure, and paired genotypes (baseline and failure) is shown in table 5.
Danish: Udfaldet af resistens fra den poolede resistensanalyse i uge 96 hos patienter med virologisk svigt som defineret i protokollen og med parrede genotyper (ved baseline og svigt) fremgår af tabel 5.
English: Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics are not different across the age range (18 to 78 years) evaluated, with only 3 subjects aged 65 years or older.
Danish: En farmakokinetisk populationsanalyse af hiv-inficerede patienter har vist, at rilpivirins farmakokinetiske egenskaber ikke varierede i den evaluerede aldersgruppe (18-78 år), hvor kun 3
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for initiering af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
English: The most frequently reported adverse drug reactions (ADRs) (≥ 2%) that were at least of moderate intensity were depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%), and abdominal pain (2.0%).
Danish: De hyppigst rapporterede bivirkninger (≥ 2 %), som var mindst af moderat intensitet, var depression (4,1 %), hovedpine (3,5 %), søvnløshed (3,5 %), udslæt (2,3 %) og abdominalsmerter (2,0 %).
English: During the clinical development program (1,368 patients in the Phase III controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE)), 55.7% of subjects experienced at least one adverse drug reaction (see section 5.1).
Danish: I løbet af det kliniske udviklingsprogram (1.368 patienter i de kontrollerede fase III-studier TMC278-C209 (ECHO) og TMC278-C215 (THRIVE)) oplevede 55,7 % af forsøgspersonerne mindst én bivirkning (se pkt.
English: Immune system disorders uncommon immune reactivation syndrome
Danish: Immunsystemet ikke almindelige immunreaktiveringssyndrom
English: Trimester of pregnancy (n=15)
Danish: Graviditetens 2. trimester (n=15)
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Danish: Rilpivirin er en diarylpyrimidin-NNRTI af hiv 1.
English: In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P450 (CYP) 3A system.
Danish: In vitro-studier tyder på, at rilpivirin primært gennemgår oxidativ metabolisme medieret af cytokrom P450 (CYP) 3A-systemet.
English: The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Danish: Den farmakokinetiske eksponering for rilpivirin hos patienter med co-infektion var sammenlignelig med eksponeringen hos patienter uden co-infektion.
English: No clinically relevant drug-drug interactions are expected.
Danish: Der forventes ingen klinisk relevante lægemiddelinteraktioner.
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/ml).
Danish: Rilpivirin udviste aktivitet mod laboratoriestammer af vildtype hiv 1 i en akut inficeret T-cellelinje med en median EC50-værdi for hiv 1/IIIB på 0,73 nM (0,27 ng/ml).
English: If you take an H2-receptor antagonist (medicines used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux (such as cimetidine, famotidine, nizatidine or ranitidine).
Danish: Hvis du tager en H2-receptorantagonist (medicin, der bruges til behandling af mavesår eller sår på tarmen eller til lindring af halsbrand, der skyldes tilbageløb af syre (f.eks. cimetidin, famotidin, nizatidin eller ranitidin)).
English: No dose adjustment of EDURANT is required in older patients.
Danish: Der kræves ingen dosisjustering af EDURANT til ældre patienter.
English: AZOLE ANTIFUNGAL AGENTS Ketoconazole*
Danish: AZOL-ANTIMYKOTIKA Ketoconazol*