FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 26 patients without data available in the week 48 window, 7 patients discontinued due to adverse event (AE) or death, 16 patients discontinued for other reasons, and 3 patients were missing data but remained on study drug.
Danish: Af de 26 patienter uden tilgængelige data i uge 48-perioden seponerede 7 patienter behandlingen pga. bivirkninger eller død, 16 patienter seponerede af andre årsager, og 3 patienter manglede data, men blev på studielægemidlet.
English: However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp 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-gp, og som er mere følsomme for hæmning af intestinalt P-gp (f.eks. dabigatranetexilat).
English: • Talk to your doctor if you have a history of liver disease, including hepatitis.
Danish: • Tal med lægen, hvis De har haft en leversygdom, herunder leverbetændelse (hepatitis).
English: • Problems with digestion resulting in discomfort after meals, wind (flatulence)
Danish: • Problemer med fordøjelsen, som resulterer i ubehag efter måltider, afgang af tarmluft (flatulens)
English: No clinically relevant differences in pharmacokinetics of rilpivirine have been observed between men and women.
Danish: Der er ikke blevet observeret klinisk relevante forskelle i rilpivirins farmakokinetik mellem mænd og kvinder.
English: The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Danish: En K103Nsubstitution alene resulterede ikke i nedsat følsomhed for rilpivirin, men kombinationen af K103N og L100I resulterede i 7 gange nedsat følsomhed for rilpivirin.
English: Macrolide antibiotics Clarithromycin Erythromycin
Danish: Makrolidantibiotika Clarithromycin Erythromycin
English: The European Medicines Agency has waived the obligation to submit the results of studies with Eviplera in all subsets of the paediatric population in the treatment of HIV-1 (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Eviplera i alle undergrupper af den pædiatriske population ved behandling af hiv 1 (se pkt.
English: In patients with severe renal impairment or ESRD, plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Danish: Hos patienter med alvorligt nyreinsufficiens eller ESRD kan plasmakoncentrationerne være forhøjet på grund af ændring af absorptionen, distributionen og/eller metabolismen af lægemidlet sekundært til nyredysfunktion.
English: • Deep, rapid breathing
Danish: • Dyb, hurtig vejrtrækning
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Danish: En stor mængde data om gravide kvinder (resultater fra mere end 1.000 graviditeter) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin og tenofovirdisoproxil.
English: Concomitant use contraindicated
Danish: Samtidig anvendelse kontraindiceret
English: The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: K101P and Y181V/I.
Danish: De enkelte resistensassocierede mutationer forbundet med et tab af følsomhed for rilpivirin var: K101P og Y181V/I.
English: DXA substudies showed that small but statistically significant decreases from baseline in whole body BMD and BMC were similar for rilpivirine and control at week 48 and week 96.
Danish: DXA-delstudier viste, at små, men statistisk signifikante reduktioner fra baseline af helkropsBMD og -BMC var sammenlignelige for rilpivirin og kontrollen ved uge 48 og uge 96.
English: • Low white blood cell count (a reduced white blood cell count can make you more prone to infection)
Danish: • Lavt antal hvide blodlegemer (et nedsat antal hvide blodlegemer kan gøre Dem mere modtagelig over for infektion)
English: • If you notice after 12 hours or more of the time you usually take Eviplera, then do not take the missed dose.
Danish: • Hvis De kommer i tanker om det efter 12 timer eller længere fra det tidspunkt, De normalt tager Eviplera på, skal De ikke tage den glemte dosis.
English: Switching from an efavirenz-based regimen
Danish: Skift fra et efavirenz-baseret program
English: The adverse reactions considered at least possibly related to treatment with the components of Eviplera from clinical study and post-marketing experience are listed in Table 2, below, by body system organ class and frequency.
Danish: De bivirkninger, som blev anset for i det mindste at have en mulig forbindelse til behandlingen med indholdsstofferne i Eviplera fra kliniske studier og erfaringer efter markedsføring er opført i tabel 2, nedenfor, efter systemorganklasse og hyppighed.
English: The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Danish: Nedbrydning af muskelvæv, kalktab fra knoglerne (med knoglesmerter; kan nogle gange resultere i knoglebrud), muskelsmerter, muskelsvaghed og fald i blodets kalium- eller phosphatniveau kan indtræde som følge af beskadigelse af de tubulære celler i nyrerne.
English: Following oral administration of Eviplera with food emtricitabine is rapidly and extensively absorbed with maximum plasma concentrations occurring within 2.5 hours post-dose.
Danish: Efter oral indgivelse af Eviplera sammen med mad absorberes emtricitabin hurtigt og i udstrakt grad, og maksimale plasmakoncentrationer forekommer inden for 2,5 timer efter dosering.
English: An increased risk of adverse reactions associated with Eviplera and its individual components may be seen in the event of an overdose.
Danish: Der kan forekomme en øget risiko for bivirkninger forbundet med Eviplera og dets komponenter i tilfælde af overdosering.
English: Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Danish: Anvendelse af Eviplera skal undgås ved samtidig eller nylig anvendelse af et nefrotoksisk lægemiddel.
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Danish: Rilpivirin-aktivitet er medieret ved non-kompetitiv hæmning af hiv 1 revers transkriptase (RT).
English: What you need to know before you take Eviplera Do not take Eviplera
Danish: Det skal De vide, før De begynder at tage Eviplera Tag ikke Eviplera
English: The resistance outcome for patients with protocol defined virological failure and phenotypic resistance at week 96 are shown in Table 6:
Danish: Resistensdata for patienter med protokoldefineret virologisk svigt og fænotype-resistens ved uge 96 vises i Tabel 6:
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Silicageltørremidlet er i et separat brev eller en separat beholder og må ikke sluges.
English: Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (also called aldesleukin).
Danish: Eksempler herpå omfatter, men er ikke begrænsede til, aminoglykosider, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir eller interleukin-2 (som også kaldes aldesleukin).
English: No dose adjustment is required following the switch from an efavirenz-containing regimen.
Danish: Der kræves ingen dosisjustering efter skift fra et program indeholdende efavirenz.
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Danish: Rilpivirin er en diarylpyrimidin NNRTI for hiv 1.
English: A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp.
Danish: En risiko for øget dabigatranplasmakoncentration kan ikke udelukkes (hæmning af intestinalt P-gp).
English: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Eviplera with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Danish: Da emtricitabin og tenofovir primært udskilles gennem nyrerne, kan administration af Eviplera sammen med lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær sekretion (f.eks. cidofovir), øge serumkoncentrationerne af emtricitabin, tenofovir og/eller de samtidigt administrerede lægemidler.
English: Eviplera comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Danish: Eviplera leveres i tabletbeholdere, der indeholder 30 tabletter, og i pakninger, der består af 3 tabletbeholdere, der hver indeholder 30 tabletter.
English: Table 2: Tabulated summary of adverse reactions to Eviplera based on clinical study and post-marketing experience with Eviplera and its individual components
Danish: Tabel 2: Resumé af bivirkninger ved Eviplera baseret på erfaringer fra kliniske studier og efter markedsføring med Eviplera og dets individuelle komponenter
English: Eviplera must be administered with food to ensure optimal absorption (see section 4.2).
Danish: Eviplera skal indgives sammen med mad for at sikre optimal absorption (se pkt.
English: The safety and efficacy of Eviplera in children under the age of 18 years have not been established.
Danish: Evipleras sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: As Eviplera contains emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil, any interactions that have been identified with these active substances individually may occur with Eviplera.
Danish: Da Eviplera indeholder emtricitabin, rilpivirinhydrochlorid og tenofovirdisoproxil, kan interaktioner, som er identificeret med disse aktive stoffer individuelt, forekomme med Eviplera.
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 udvalgt i cellekultur, der starter fra vildtype hiv 1 fra forskellige oprindelser og undertyper, samt NNRTI-resistent hiv 1.
English: Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Danish: Efter oral indgivelse er emtricitabins eliminationshalveringstid ca. 10 timer.
English: • Depression and depressed mood
Danish: • Depression og nedtrykthed
English: • foscarnet, ganciclovir, cidofovir (for viral infections)
Danish: • foscarnet, ganciclovir, cidofovir (mod virusinfektioner)
English: • Lactic acidosis (see Possible side effects: tell a doctor immediately)
Danish: • Laktatacidose (se Bivirkninger: Fortæl det straks til lægen)
English: A subgroup of patients with baseline CrCl between 50 and 60 mL/min, receiving once daily dosing, had a 2- to 4-fold increase in tenofovir exposure and worsening renal function.
Danish: En undergruppe af patienterne med baselineCrCl mellem 50 og 60 ml/min, som fik én daglig dosis, havde en 2 til 4 gange højere eksponering for tenofovir og desuden forværring af nyrefunktionen.
English: 2 Phenotypic resistance to rilpivirine (> 3.7-fold change compared to control).
Danish: 1 Fænotype-resistens over for rilpivirin (> 3,7 gange sammenlignet med kontrol).
English: • Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.
Danish: • Dabigatranetexilat, medicin, der bruges i forbindelse med behandling af hjertesygdomme, da det kan være nødvendigt, at lægen kontrollerer niveauet af denne medicin i Deres blod.
English: • If you are taking an H2-antagonist (also used to treat stomach acid or acid reflux disease), take it at least 12 hours before or at least 4 hours after Eviplera.
Danish: • Hvis De tager en H2-antagonist (som også anvendes som behandling mod mavesyre eller sure opstød), skal De tage den mindst 12 timer før eller mindst 4 timer efter Eviplera.
English: No significant cross-resistance has been demonstrated between rilpivirine-resistant HIV-1 variants and emtricitabine or tenofovir, or between emtricitabine- or tenofovir-resistant variants and rilpivirine.
Danish: Der er ikke påvist signifikant krydsresistens mellem rilpivirin-resistente hiv 1-varianter og emtricitabin eller tenofovir, eller mellem emtricitabin- eller tenofovir-resistente varianter og rilpivirin.
English: Since Eviplera is a combination product and the dosing interval of the individual components cannot be altered, treatment with Eviplera must be interrupted in patients with confirmed CrCl decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Danish: Da Eviplera er et kombinationspræparat, og doseringsintervallet for de enkelte komponenter ikke kan ændres, skal behandlingen med Eviplera afbrydes hos patienter med bekræftet CrCl på under < 50 ml/min eller fald i serumphosphat til < 1,0 mg/dl (0,32 mmol/l).
English: • amphotericin B, pentamidine (for fungal infections)
Danish: • amphotericin B, pentamidin (mod svampeinfektioner)
English: If you forget to take Eviplera
Danish: Hvis De har glemt at tage Eviplera
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 med 67 hiv 1 rekombinante laboratoriestammer med en resistensassocieret mutation ved RTpositioner forbundet med NNRTI-resistens, herunder de hyppigst fundne K103N og Y181C, viste rilpivirin antiviral aktivitet mod 64 (96 %) af disse stammer.
English: The difference in the rate of new virologic failures from the week 48 to week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Danish: Forskellen i hyppigheden af nyt virologisk svigt fra analysen ved uge 48 og ved uge 96 mellem rilpivirin-armen og efavirenz-armen var ikke statistisk signifikant.
English: After week 24, the HIV-1 from 2 additional patients in the Eviplera arm developed resistance by week 48 (total of 4 of 469 patients, 0.9%).
Danish: Efter uge 24 havde yderligere 2 patienter i Evipleraarmen udviklet hiv 1-resistens ved uge 48 (i alt 4 ud af 469 patienter, 0,9 %).
English: If you are taking an antacid such as medicines containing magnesium or potassium.
Danish: Hvis De tager et syreneutraliserende middel som for eksempel lægemidler, der indeholder magnesium eller kalium.
English: renal failure (acute and chronic)3, acute tubular necrosis3, nephritis (including acute interstitial nephritis)3, 8, nephrogenic diabetes insipidus3
Danish: nyresvigt (akut og kronisk)3, akut tubulær nekrose3, nefritis (herunder akut interstitiel nefritis)3, 8, nefrogen diabetes insipidus3
English: • aminoglycosides (such as streptomycin, neomycin and gentamicin), vancomycin (for bacterial infections)
Danish: • aminoglykosider (såsom streptomycin, neomycin og gentamicin), vancomycin (mod bakterieinfektioner)
English: Rilpivirine (taken as Eviplera in 16 of 19 patients and another background regimen in 3 of 19 patients) was evaluated in study TMC114HIV3015 in pregnant women during the 2nd and 3rd trimesters, and postpartum.
Danish: Rilpivirin (taget som Eviplera hos 16 ud af 19 patienter og et andet baggrundsprogram hos 3 ud af 19 patienter) blev evalueret I studie TMC114HIV3015 hos gravide kvinder i 2. og 3. trimester og postpartum.
English: 6 This was a rare adverse reaction for tenofovir disoproxil.
Danish: 6 Dette var en sjælden bivirkning for tenofovirdisoproxil.
English: Study GS-US-264-0111
Danish: Studie GS-US-264-0111
English: Eviplera is not usually taken with other medicines that can damage your kidneys (see Other medicines and Eviplera).
Danish: Eviplera tages normalt ikke sammen med anden medicin, som kan skade Deres nyrer (se Brug af anden medicin sammen med Eviplera).
English: The single-tablet regimen (STR), Eviplera, has been studied in virologically suppressed patients who switched from a regimen containing a ritonavir-boosted PI (Phase III study GS-US-264-0106) or from efavirenz/emtricitabine/tenofovir disoproxil (Phase IIb study GS-US-264-0111).
Danish: Behandlingsprogrammet med en enkelt tablet (single tablet regimen - STR) Eviplera er blevet undersøgt hos virologisk supprimerede patienter, som skiftede fra et program indeholdende en ritonavir-boosted PI (fase III-studie GS-US-264-0106) eller fra efavirenz/emtricitabin/ tenofovirdisoproxil (fase IIb-studie GS-US-264-0111).
English: Study GS-US-264-0106
Danish: Studie GS-US-264-0106
English: • Increased levels of cholesterol and/or pancreatic amylase in the blood
Danish: • Forhøjet kolesterol og/eller pancreas-amylase (fra bugspytkirtlen) i blodet
English: If you accidentally take more than the recommended dose of Eviplera you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Eviplera, kan De have større risiko for at få bivirkninger med denne medicin (se pkt.
English: Eviplera may affect your kidneys.
Danish: Eviplera kan have indvirkning på Deres nyrer.
English: Patients co-infected with HIV and HBV who discontinue Eviplera should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Danish: Patienter med hivinfektion, som samtidig er inficerede med HBV, og som ophører med Eviplera, bør monitoreres tæt med både klinisk og laboratorisk opfølgning i mindst flere måneder efter, behandlingen med Eviplera ophører.
English: • Tiredness, feeling sleepy (somnolence)
Danish: • Træthed, følelse af søvnighed (somnolens)
English: *compared to 25 mg once daily rilpivirine alone
Danish: *sammenlignet med 25 mg rilpivirin alene én gang dagligt
English: • Swelling of the face, lips, tongue or throat
Danish: • Hævelse af ansigt, læber, tunge eller svælg
English: One patient with pre-existing K103N at baseline had virologic failure with additional emergent resistance by week 48.
Danish: En patient med præeksisterende K103N ved baseline havde virologisk svigt med yderligere resistensudvikling under behandlingen ved uge 48.
English: Eviplera is a purplish-pink, capsule-shaped, film-coated tablet debossed on one side with “GSI” and plain on the other side.
Danish: Eviplera er en lilla-lyserød, kapselformet filmovertrukket tablet, præget på den ene side med „GSI” og glat på den anden side.
English: Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Danish: Reduktionerne i BMD i rygraden og ændringerne i knoglebiomarkører fra baselinie var i uge 144 signifikant større i gruppen, der blev behandlet med tenofovirdisoproxil.
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
Danish: I et 144-ugers kontrolleret, klinisk studie, som sammenlignede tenofovirdisoproxil med stavudin i kombination med lamivudin og efavirenz hos antiretroviral-naive patienter, sås små reduktioner i BMD i hoften og rygraden hos begge behandlingsgrupper.
English: Switching to Eviplera was non-inferior in maintaining HIV-1 RNA < 50 copies/mL when compared to patients who stayed on a ritonavir-boosted PI in combination with two NRTIs [treatment difference (95% CI): + 3.8% (-1.6% to 9.1%)].
Danish: Skift til Eviplera var non-inferiørt med hensyn til vedligeholdelse af hiv 1-rna < 50 kopier/ml sammenlignet med patienter, som forblev på en ritonavir-boosted PI i kombination med to NRTI'er [behandlingsforskel (95 % CI): +3,8 % (−1,6 % til 9,1 %)].
English: This may result in loss of therapeutic effect of Eviplera (see section 4.3).
Danish: Dette kan resultere i manglende terapeutisk virkning af Eviplera (se pkt.
English: However, patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Eviplera (see section 4.8).
Danish: Patienter bør dog underrettes om, at træthed, svimmelhed og døsighed er blevet indberettet som en bivirkning med komponenterne af Eviplera (se pkt.
English: Rilpivirine hydrochloride
Danish: Rilpivirinhydrochlorid
English: Expected: Sofosbuvir:
Danish: Forventet: Sofosbuvir:
English: • the systemic glucocorticoid dexamethasone, except as a single dose treatment
Danish: • det systemiske glukokortikoid dexamethason, undtagen som enkeltdosisbehandling
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Patients were switched from efavirenz/emtricitabine/tenofovir disoproxil to Eviplera without a washout period.
Danish: Patienterne blev skiftet fra efavirenz/emtricitabin/ tenofovirdisoproxil til Eviplera uden en udvaskningsperiode.
English: Among 49 patients who received at least one dose of Eviplera, 100% of patients remained suppressed (HIV-1 RNA < 50 copies/mL) at week 12 and week 24.
Danish: Blandt 49 patienter, som fik mindst én dosis Eviplera, var 100 % af patienterne supprimerede (hiv 1-rna < 50 kopier/ml) ved uge 12 og uge 24.
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Danish: H2-receptorantagonister, der kan doseres én gang dagligt, bør anvendes.
English: Cytochrome P450 enzyme inhibitors
Danish: Cytokrom P450 enzymhæmmere
English: • If you are allergic to emtricitabine, rilpivirine, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • Hvis De er overfølsom over for emtricitabin, rilpivirin, tenofovirdisoproxil, eller et af de øvrige indholdsstoffer i Eviplera (angivet i punkt 6 i denne indlægsseddel).
English: • If you are taking an antacid (such as medicines containing magnesium or potassium), take it at least 2 hours before or at least 4 hours after Eviplera (see section 3, How to take Eviplera).
Danish: • Hvis De tager syreneutraliserende medicin (som for eksempel lægemidler, der indeholder magnesium eller kalium), skal De tage den mindst 2 timer før eller mindst 4 timer efter Eviplera (se punkt 3, Sådan skal De tage Eviplera).
English: Resistance to emtricitabine/lamivudine Resistance to rilpivirine Resistance to efavirenz
Danish: Resistens over for emtricitabin/lamivudin Resistens over for rilpivirin Resistens over for efavirenz
English: A small clinical study was conducted to evaluate the safety, antiviral activity and pharmacokinetics of tenofovir disoproxil in combination with emtricitabine in HIV infected patients with renal impairment.
Danish: Et lille klinisk studie blev udført for at vurdere sikkerhed, antiviral aktivitet og farmakokinetik for tenofovirdisoproxil i kombination med emtricitabin hos hiv-inficerede patienter med nedsat nyrefunktion.
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 RT, resulting in DNA chain termination.
Danish: Emtricitabintriphosphat og tenofovirdiphosphat hæmmer kompetitivt hiv 1-RT, hvilket resulterer i dna-kædeblokering.