natgillin/translations-raw huggingface dataset:
• Fortæl det straks til lægen og hold op med at tage Eviplera, hvis De udvikler hududslæt med følgende symptomer: feber, blærer, røde øjne og hævelse af ansigt, mund eller krop.
• Tell your doctor immediately and stop taking Eviplera if you develop a skin rash with the following symptoms: fever, blisters, redness in your eyes and swelling of your face, mouth or body.
Eviplera er ikke blevet evalueret hos patienter med tidligere virologisk svigt over for anden antiretroviral behandling.
Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
In vitro-eksperimenter indikerer, at rilpivirinhydrochlorid primært gennemgår oxidativ metabolisme medieret af CYP3A-systemet.
In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system.
Ved en dosis på 25 mg rilpivirin kræves ingen dosisjustering.
At a dose of 25 mg of rilpivirine, no dose adjustment is required.
2 Bivirkning identificeret for rilpivirinhydrochlorid.
2 Adverse reaction identified for rilpivirine hydrochloride.
Hold ikke op med at tage Eviplera Hold ikke op med at tage Eviplera uden at tale med Deres læge.
Do not stop taking Eviplera Do not stop taking Eviplera without talking to your doctor.
Faldet i den ubundne frie fraktion ved eksponering for rilpivirin (dvs. aktiv) under graviditet sammenlignet med postpartum var mindre udtalt end for samlet eksponering for rilpivirin.
The decrease in the unbound free fraction of rilpivirine exposure (i.e. active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
• Methadon, medicin til behandling af opiat-afhængighed, da det kan være nødvendigt, at lægen ændrer Deres methadondosis.
• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
• Smerter (især i hofter, knæ og skuldre)
• Joint aches and pains (especially of the hip, knee and shoulder)
I fæces udgjorde uomdannet rilpivirin i gennemsnit 25 % af den administrerede dosis.
In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Mulige bivirkninger: Fortæl det straks til lægen
Possible side effects: tell a doctor immediately
En populationsfarmakokinetisk analyse indikerede, at samtidig infektion med hepatitis B og/eller hepatitis C-virus ikke havde nogen klinisk relevant virkning på eksponeringen for rilpivirin.
Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine.
• H2-antagonister (famotidin, cimetidin, nizatidin eller ranitidin) Disse former for medicin kan nedsætte mængden af rilpivirin (en komponent i Eviplera) i Deres blod.
• H2-antagonists (famotidine, cimetidine, nizatidine or ranitidine) These medicines can decrease the amount of rilpivirine (a component of Eviplera) in your blood.
Efter oral administration af tenofovirdisoproxil til hiv-inficerede patienter, absorberes tenofovirdisoproxil hurtigt og omdannes til tenofovir.
Following oral administration of tenofovir disoproxil to HIV infected patients, tenofovir disoproxil is rapidly absorbed and converted to tenofovir.
Da rilpivirin i høj grad er proteinbundet, er det usandsynligt, at dialyse resulterer i en betydelig fjernelse af det aktive stof.
Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
1 Bivirkning identificeret for emtricitabin.
1 Adverse reaction identified for emtricitabine.
Den absolutte biotilgængelighed af rilpivirin er ikke kendt.
The absolute bioavailability of rilpivirine is unknown.
Der foreligger utilstrækkelig dokumentation vedrørende sikkerhed for børn under 18 år.
Insufficient safety data are available for children under the age of 18 years.
Både emtricitabin og tenofovir har aktivitet, som er specifik mod hiv 1, hiv 2 og HBV.
Both emtricitabine and tenofovir have activity that is specific to HIV-1, HIV-2 and, HBV.
Så snart der observeres alvorlige hud- og/eller slimhindereaktioner, skal Eviplera seponeres og passende behandling iværksættes.
As soon as serious skin and/or mucosal reactions are observed, Eviplera must be discontinued and appropriate therapy should be initiated.
Endvidere hæmmede emtricitabin ikke uridin-5'diphosphoglucuronyl-transferase, det enzym, som er ansvarlig for glukuronidering.
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Ingen patienter i SBR-armen udgik af studiet pga. TEAE.
No patients discontinued from the study due to a TEAE in the SBR arm.
• Forhøjet niveau af fedtsyrer (triglycerider), bilirubin eller sukker i blodet
• Increased fatty acids (triglycerides), bilirubin or sugar in the blood
De farmakokinetiske data viser, at samlet eksponering (AUC) for rilpivirin som del af et antiretroviralt program var cirka 30 % lavere under graviditet sammenlignet med postpartum (612 uger).
The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Det bør imidlertid ikke udelukkes, at eksponering for den farmakologisk aktive, ubundne rilpivirin er signifikant øget ved moderat nedsat leverfunktion.
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Der er ikke undersøgt tilstrækkeligt mange patienter over 65 år.
Not enough patients over the age of 65
Nogle patienter, der tager antiretroviral kombinationsmedicin, såsom Eviplera, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød, forårsaget af manglende blodforsyning til knoglerne).
Some patients taking combination antiretroviral medicines such as Eviplera may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
• Medicin, som indeholder didanosin (mod hiv-infektion): Hvis De tager Eviplera sammen med anden antiviral medicin, som indeholder didanosin, kan det øge indholdet af didanosin i blodet og reducere CD4+-celletallet.
• Medicines containing didanosine (for HIV infection): Taking Eviplera with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4+ cell counts.
Forekomsten af virologisk svigt var højere i rilpivirin-armen end i efavirenz-armen ved uge 96, men de fleste virologiske svigt forekom imidlertid i løbet af de første 48 behandlingsuger.
The incidence of virologic failure was higher in the rilpivirine arm than in the efavirenz arm at week 96; however, most of the virologic failures occurred within the first 48 weeks of treatment.
• Kalktab fra knoglerne (med knoglesmerter; kan nogle gange resultere i knoglebrud)
• Softening of the bones (with bone pain and sometimes resulting in fractures)
 Fortæl det til lægen, hvis De tager nogle af disse former for medicin.
 Tell your doctor if you are taking any of these medicines.
I tilfælde af samtidig antiviral behandling af hepatitis B eller C henvises der også til de relevante produktresuméer til disse lægemidler.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Deres læge kan tage blodprøver for at se, om Deres nyrer fungerer ordentligt.
Your doctor may do blood tests to see if your kidneys are working properly
K65R, M184V og K65R+M184V-mutanter af hiv 1 forbliver fuldt ud følsomme for rilpivirin.
The K65R, M184V, and K65R+M184V mutants of HIV-1 remain fully susceptible to rilpivirine.
Randomisering blev stratificeret med anvendelse af tenofovirdisoproxil og/eller lopinavir/ritonavir i baseline-programmet.
Randomisation was stratified by use of tenofovir disoproxil and/or lopinavir/ritonavir in the baseline regimen.
Tenofovir udskilles primært af nyrerne både ved filtration og et aktivt tubulært transportsystem (human organisk anion-transporter 1 [hOAT1]), hvor ca. 70-80 % af dosen udskilles uomdannet i urinen efter intravenøs indgivelse.
Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system (human organic anion transporter 1 [hOAT1]) with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
PHOSPHODIESTERASE TYPE 5 (PDE-5)-HÆMMERE Sildenafil/Emtricitabin
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil/Emtricitabine
Behandling med Eviplera resulterede i en tidlig lille forhøjelse af gennemsnitlige serumkreatininniveauer, hvilket var stabilt over tid, og ikke anses for at være klinisk relevant (se pkt.
Treatment with Eviplera resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant (see section 4.8).
Der er ikke identificeret andre veje for resistens over for emtricitabin eller tenofovir.
No other pathways of resistance to emtricitabine or tenofovir have been identified.
Farmakokinetikken af rilpivirin og tenofovirdisoproxil hos børn og teenagere er i gang med at blive undersøgt.
The pharmacokinetics of rilpivirine and tenofovir disoproxil in children and adolescents are under investigation.
Efter intravenøs indgivelse blev de enkelte komponenter emtricitabins og tenofovirs fordelingsvolumen vurderet til at være henholdsvis 1.400 ml/kg og 800 ml/kg.
Following intravenous administration the volume of distribution of the single components emtricitabine and tenofovir was approximately 1,400 mL/kg and 800 mL/kg, respectively.
Rilpivirin hæmmer P-glykoprotein (P-gp) in vitro (IC50 er 9,2 μM).
Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (IC50 is 9.2 µM).
Fund fra toksicitetsstudier efter gentagne doser hos rotter, hunde og aber vedeksponeringsniveauer højere end eller lig med kliniske eksponeringsniveauer og med mulig relevans for den kliniske anvendelse omfatter nyre- og knogleændringer og et fald i serum-phosphatkoncentrationen.
Findings in repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use included kidney and bone changes and a decrease in serum phosphate concentration.
Efter oral indgivelse er tenofovirs eliminationshalveringstid ca. 12-18 timer.
Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Der var ingen forskel i ændringen fra baseline af helkrops-BMD eller -BMC for rilpivirin sammenlignet med kontrollen, for den samlede population, eller hos de patienter, der behandles med et baggrundsprogram, der omfatter tenofovirdisoproxil.
There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil.
EC50-værdierne for tenofovir var i intervallet fra 0,04 til 8,5 µM.
The EC50 values for tenofovir were in the range of 0.04 to 8.5 µM.
Rilpivirin hæmmer ikke humane cellulære dna-polymeraser α, β og mitokondriel dna-polymerase γ.
Rilpivirine does not inhibit the human cellular DNA polymerases α, β and mitochondrial DNA polymerase γ.
Administrationen af Eviplera til raske, voksne forsøgspersoner, enten sammen med et let måltid (390 kcal) eller et standardmåltid (540 kcal) førte til øgede eksponeringer for rilpivirin og tenofovir i forhold til fastende tilstand.
The administration of Eviplera to healthy adult subjects with either a light meal (390 kcal) or a standard meal (540 kcal) resulted in increased exposures of rilpivirine and tenofovir relative to fasting conditions.
• non-steroide antiinflammatoriske midler (NSAID'er, til at lindre knogle- eller muskelsmerter)
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Hyppighed er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) eller sjælden (≥ 1/10.000 til < 1/1.000).
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Emtricitabins og tenofovirdisoproxils sikkerhedsprofiler i disse studier svarede til de tidligere erfaringer med disse stoffer, når disse var blevet administreret sammen med andre antiretrovirale stoffer.
The safety profile of emtricitabine and tenofovir disoproxil in these studies was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Der er observeret lavere eksponeringer for rilpivirin, når rilpivirin 25 mg blev taget én gang dagligt under graviditet.
Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
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.
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.
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).
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).
• Tal med lægen, hvis De har haft en leversygdom, herunder leverbetændelse (hepatitis).
• Talk to your doctor if you have a history of liver disease, including hepatitis.
• Problemer med fordøjelsen, som resulterer i ubehag efter måltider, afgang af tarmluft (flatulens)
• Problems with digestion resulting in discomfort after meals, wind (flatulence)
Der er ikke blevet observeret klinisk relevante forskelle i rilpivirins farmakokinetik mellem mænd og kvinder.
No clinically relevant differences in pharmacokinetics of rilpivirine have been observed between men and women.
En K103Nsubstitution alene resulterede ikke i nedsat følsomhed for rilpivirin, men kombinationen af K103N og L100I resulterede i 7 gange nedsat følsomhed for rilpivirin.
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.
Makrolidantibiotika Clarithromycin Erythromycin
Macrolide antibiotics Clarithromycin Erythromycin
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.
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).
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.
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.
• Dyb, hurtig vejrtrækning
• Deep, rapid breathing
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.
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.
Samtidig anvendelse kontraindiceret
Concomitant use contraindicated
De enkelte resistensassocierede mutationer forbundet med et tab af følsomhed for rilpivirin var: K101P og Y181V/I.
The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: K101P and Y181V/I.
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.
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.
• Lavt antal hvide blodlegemer (et nedsat antal hvide blodlegemer kan gøre Dem mere modtagelig over for infektion)
• Low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• 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.
• If you notice after 12 hours or more of the time you usually take Eviplera, then do not take the missed dose.
Skift fra et efavirenz-baseret program
Switching from an efavirenz-based regimen
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.
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.
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.
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.
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.
Following oral administration of Eviplera with food emtricitabine is rapidly and extensively absorbed with maximum plasma concentrations occurring within 2.5 hours post-dose.
Der kan forekomme en øget risiko for bivirkninger forbundet med Eviplera og dets komponenter i tilfælde af overdosering.
An increased risk of adverse reactions associated with Eviplera and its individual components may be seen in the event of an overdose.
Anvendelse af Eviplera skal undgås ved samtidig eller nylig anvendelse af et nefrotoksisk lægemiddel.
Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Rilpivirin-aktivitet er medieret ved non-kompetitiv hæmning af hiv 1 revers transkriptase (RT).
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Det skal De vide, før De begynder at tage Eviplera Tag ikke Eviplera
What you need to know before you take Eviplera Do not take Eviplera
Resistensdata for patienter med protokoldefineret virologisk svigt og fænotype-resistens ved uge 96 vises i Tabel 6:
The resistance outcome for patients with protocol defined virological failure and phenotypic resistance at week 96 are shown in Table 6:
Silicageltørremidlet er i et separat brev eller en separat beholder og må ikke sluges.
The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Eksempler herpå omfatter, men er ikke begrænsede til, aminoglykosider, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir eller interleukin-2 (som også kaldes aldesleukin).
Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (also called aldesleukin).
Der kræves ingen dosisjustering efter skift fra et program indeholdende efavirenz.
No dose adjustment is required following the switch from an efavirenz-containing regimen.
Rilpivirin er en diarylpyrimidin NNRTI for hiv 1.
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
En risiko for øget dabigatranplasmakoncentration kan ikke udelukkes (hæmning af intestinalt P-gp).
A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp.
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.
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.
Eviplera leveres i tabletbeholdere, der indeholder 30 tabletter, og i pakninger, der består af 3 tabletbeholdere, der hver indeholder 30 tabletter.
Eviplera comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Tabel 2: Resumé af bivirkninger ved Eviplera baseret på erfaringer fra kliniske studier og efter markedsføring med Eviplera og dets individuelle komponenter
Table 2: Tabulated summary of adverse reactions to Eviplera based on clinical study and post-marketing experience with Eviplera and its individual components
Eviplera skal indgives sammen med mad for at sikre optimal absorption (se pkt.
Eviplera must be administered with food to ensure optimal absorption (see section 4.2).
Evipleras sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
The safety and efficacy of Eviplera in children under the age of 18 years have not been established.
Da Eviplera indeholder emtricitabin, rilpivirinhydrochlorid og tenofovirdisoproxil, kan interaktioner, som er identificeret med disse aktive stoffer individuelt, forekomme med Eviplera.
As Eviplera contains emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil, any interactions that have been identified with these active substances individually may occur with Eviplera.
Rilpivirin-resistente stammer blev udvalgt i cellekultur, der starter fra vildtype hiv 1 fra forskellige oprindelser og undertyper, samt NNRTI-resistent hiv 1.
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI-resistant HIV-1.
Efter oral indgivelse er emtricitabins eliminationshalveringstid ca. 10 timer.
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
• Depression og nedtrykthed
• Depression and depressed mood
• foscarnet, ganciclovir, cidofovir (mod virusinfektioner)
• foscarnet, ganciclovir, cidofovir (for viral infections)
• Laktatacidose (se Bivirkninger: Fortæl det straks til lægen)
• Lactic acidosis (see Possible side effects: tell a doctor immediately)
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.
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.
1 Fænotype-resistens over for rilpivirin (> 3,7 gange sammenlignet med kontrol).
2 Phenotypic resistance to rilpivirine (> 3.7-fold change compared to control).
• 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.
• Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.