FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 These are medicinal products within class where similar interactions could be predicted.
Danish: 2 Disse er lægemidler i samme klasse, hvor lignende interaktioner kunne forudsiges.
English: ATC code: J05AR08.
Danish: ATC-kode: J05AR08.
English: This may become severe or potentially life-threatening.
Danish: Dette kan blive alvorligt eller muligvis livstruende.
English: The virus may then become harder to treat.
Danish: Virus kan så blive sværere at behandle.
English: *based on historic controls
Danish: *baseret på tidligere kontroller
English: • Talk to your doctor if you are over 65 years of age.
Danish: • Tal med lægen, hvis De er over 65 år.
English: a Week 24 window is between day 127 and 210 (inclusive).
Danish: a Uge 24-perioden er mellem dag 127 og 210 (inklusive).
English: Pregnant women should not take Eviplera unless you and your doctor decide it is clearly needed.
Danish: Gravide kvinder må ikke tage Eviplera, medmindre De og Deres læge bestemmer, at det er klart nødvendigt.
English: This is important to get the right levels of active substance in your body.
Danish: Dette er vigtigt for at opnå det rigtige niveau af de aktive stoffer i kroppen.
English: b Snapshot analysis.
Danish: b Snapshot-analyse.
English: Interaction studies with these active substances have only been performed in adults.
Danish: Interaktionsstudier med disse aktive stoffer er kun udført hos voksne.
English: • Tell your doctor immediately if you become pregnant or if you plan to become pregnant.
Danish: • Fortæl det straks til lægen, hvis De bliver gravid eller planlægger at blive gravid.
English: The studies are identical in design with the exception of the background regimen (BR).
Danish: Studierne er identiske i design med undtagelse af baggrundsprogrammet (BR).
English: Demographic Characteristics Median age (range), years
Danish: Demografiske karakteristika Median alder (interval), år
English: In dogs cholestasis-like effects were noted.
Danish: Hos hunde blev der bemærket kolestase-lignende virkninger.
English: R(-) methadone:
Danish: R(-)-methadon:
English: Your doctor will discuss the potential benefits and risks of taking Eviplera to you and your child.
Danish: Deres læge vil drøfte de potentielle fordele og risici ved at tage Eviplera med Dem og Deres barn.
English: allergic reaction1
Danish: allergisk reaktion1
English: Other effects that may be seen during HIV treatment
Danish: Andre bivirkninger, der kan forekomme under hiv-behandling
English: Your doctor will discuss a different medicine if required.
Danish: Deres læge vil diskutere en anden medicin med Dem, hvis det er nødvendigt.
English: Treatment outcomes through 24 weeks are presented in Table 7.
Danish: Behandlingsresultater til og med 24 uger ses i tabel 7.
English: Discontinued due to adverse event (AE)
Danish: Seponering pga. uønsket hændelse (AE)
English: It is recommended that Eviplera be swallowed whole with water.
Danish: Det anbefales, at Eviplera sluges hele sammen med vand.
English: Cimetidine2 Nizatidine2 Ranitidine2
Danish: Cimetidin2 Nizatidin2 Ranitidin2
English: Eviplera reduces the amount of HIV in your body.
Danish: Eviplera nedsætter mængden af hiv i Deres krop.
English: There are no adequate and well-controlled studies of Eviplera or its components in pregnant women.
Danish: Der foreligger ingen fyldestgørende og velkontrollerede studier af Eviplera eller dets komponenter til gravide kvinder.
English: If you are over 65 years of age and are prescribed Eviplera, your doctor will monitor you carefully.
Danish: Hvis De er over 65 år og får ordineret Eviplera, vil Deres læge overvåge Dem nøje.
English: Tenofovir concentrations not measured, no effect is expected.
Danish: Tenofovir-koncentrationer ikke målt, der forventes ingen virkning
English: • Women must not get pregnant while taking Eviplera.
Danish: • Kvinder må ikke blive gravide, mens de tager Eviplera.
English: Resistance to tenofovir (K65R)
Danish: Resistens over for tenofovir (K65R)
English: You may need blood tests to check how your liver is working for 4 months after stopping treatment.
Danish: Det kan være nødvendigt at få taget blodprøver for at kontrollere, hvordan Deres lever virker i 4 måneder efter ophør med behandlingen.
English: There was no teratogenicity with rilpivirine in rats and rabbits.
Danish: Der var ingen teratogenicitet med rilpivirin i rotter og kaniner.
English: If you are taking rifabutin.
Danish: Hvis De tager rifabutin.
English: Talk to your doctor about an alternative regimen.
Danish: Tal med lægen om et alternativt program.
English: Non-response Virologic failure (all patients)
Danish: Non-respons Virologisk svigt (alle patienter)
English: Missing data during window but on study drug
Danish: Mangler data i løbet af perioden, men på studielægemidlet
English: Rilpivirine was well tolerated during pregnancy and postpartum.
Danish: Rilpivirin var veltolereret under graviditet og postpartum.
English: No virologic data in week 24 window
Danish: Ingen virologiske data i uge 24-perioden
English: The usual dose is one tablet taken each day by mouth.
Danish: Den sædvanlige dosis er en tablet, der tages hver dag gennem munden.
English: • This is because the active substances in this medicine pass into human breast milk.
Danish: • Dette skyldes, at de aktive stoffer i denne medicin udskilles i mælken hos mennesker.
English: • Use effective contraception while taking Eviplera.
Danish: • Anvend effektiv prævention mens De tager Eviplera.
English: This, will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Danish: Dette vil forbedre Deres immunsystem og nedsætte risikoen for at udvikle sygdomme forbundet med hiv-infektionen.
English: • If you have taken Eviplera during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: • Hvis De har taget Eviplera under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Table 1: Interactions between Eviplera or its individual component(s) and other medicinal products
Danish: Tabel 1: Interaktion mellem Eviplera eller dets individuelle komponent(er) og andre lægemidler
English: Alternatively, switching to another antiretroviral regimen could be considered.
Danish: Alternativt kan det overvejes at skifte til et andet antiretroviralt program.
English: There were no new cross-resistance patterns at week 96 compared to week 48.
Danish: Der var ikke noget nyt krydsresistensmønster ved uge 96 sammenlignet med uge 48.
English: The combination of Eviplera and dabigatran etexilate should be used with caution.
Danish: Kombinationen af Eviplera og dabigatranetexilat bør anvendes med forsigtighed.
English: This should be considered when assessing a patient's ability to drive or operate machinery.
Danish: Dette bør overvejes, når patientens evne til at føre motorkøretøj eller betjene maskiner vurderes.
English: The absolute bioavailability of emtricitabine from 200 mg hard capsules was estimated to be 93%.
Danish: Den absolutte biotilgængelighed af emtricitabin fra 200 mg hårde kapsler blev estimeret til 93 %.
English: Do not give this medicine to children and adolescents under 18 years of age.
Danish: Denne medicin må ikke gives til børn og teenagere under 18 år.
English: No mother to child transmission occurred in all 10 infants born to the mothers who completed the study and for whom the HIV status was available.
Danish: Der forekom ingen overførsel fra mor til barn hos nogen af de 10 spædbørn født af mødre, der gennemførte studiet, og for hvem hiv-status var tilgængelig.
English: Your doctor may need to give you an additional dose of rilpivirine.
Danish: Det kan være nødvendigt, at Deres læge giver Dem en yderligere dosis rilpivirin.
English: • Medicines that may damage your kidneys, examples include:
Danish: • Medicin, der kan beskadige Deres nyrer, eksempler herpå omfatter:
English: • interleukin-2, also called aldesleukin (to treat cancer)
Danish: • interleukin-2 også kaldet aldesleukin (til behandling af kræft)
English: • Any other medicines containing:
Danish: • Al anden medicin, der indeholder:
English: Wait and take the next dose, with food, at your usual time.
Danish: Vent og tag den næste dosis sammen med mad til sædvanlig tid.
English: Effects on electrocardiogram
Danish: Virkninger på elektrokardiogram
English: It is not known whether placental transfer of rilpivirine occurs in pregnant women.
Danish: Det vides ikke, om der sker placental overførsel af rilpivirin hos gravide kvinder.
English: In vitro binding of rilpivirine to human plasma proteins is approximately 99.7%, primarily to albumin.
Danish: Rilpivirins binding in vitro til humane plasmaproteiner er ca. 99,7 %, primært til albumin.
English: While taking Eviplera you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Eviplera, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: It is important not to stop taking Eviplera without talking to your doctor: see section 3, Do not stop taking Eviplera.
Danish: Det er vigtigt ikke at holde op med at tage Eviplera uden at tale med lægen: se punkt 3, Hold ikke op med at tage Eviplera.
English: Eviplera contains three active substances that are used to treat Human Immunodeficiency Virus (HIV) infection:
Danish: Eviplera indeholder tre aktive stoffer, der anvendes til behandling af infektion med humant immundefektvirus (hiv):
English: In the studies, the presence of the mutations V90I and V189I at baseline did not affect the response.
Danish: Tilstedeværelse af mutationerne V90I og V189I ved baseline i studierne påvirkede ikke responset.
English: Once you start taking Eviplera, look out for:
Danish: Når De begynder med at tage Eviplera, skal De holde øje med:
English: Your doctor may consider giving you the components of Eviplera separately if you are having problems or need your dose adjusted.
Danish: Deres læge kan overveje at give Dem komponenterne i Eviplera separat, hvis De har problemer eller har behov for at Deres dosis bliver justeret.
English: For the resistance analyses, a broader definition of virologic failure was used than in the primary efficacy analysis.
Danish: For resistensanalyser blev der anvendt en bredere definition på virologisk svigt end for den primære effektanalyse.
English: increased bilirubin1, 2
Danish: forhøjet bilirubin1, 2
English: The clinical implications of this finding are currently unknown.
Danish: Den kliniske betydning af dette fund er ikke kendt på nuværende tidspunkt.
English: Your doctor may need to change the dose of the antibiotic or give you a different antibiotic.
Danish: Det kan være nødvendigt for Deres læge at ændre antibiotika-dosis, eller give Dem et andet antibiotikum.
English: • If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
Danish: • Hvis De er en kvinde med hiv, anbefales det, at De ikke ammer for at undgå at overføre virus til barnet via mælken.
English: Virologic failure and development of resistance
Danish: Virologisk svigt og resistensudvikling
English: This medicine is not a cure for HIV infection.
Danish: Denne medicin kan ikke helbrede hivinfektion.
English: Maximum tenofovir concentrations are observed in plasma within 2 hours and maximum plasma concentrations of rilpivirine are generally achieved within 4-5 hours.
Danish: Maksimale tenofovirkoncentrationer observeres i plasma inden for 2 timer og maksimale plasmakoncentrationer af rilpivirin opnås generelt inden for 4-5 timer.
English: Concomitant use where caution is recommended
Danish: Samtidig anvendelse, hvor forsigtighed anbefales
English: e e.g. lost to follow up, non-compliance, withdrew consent.
Danish: e F.eks. tabt for opfølgning, non-compliance, tilbagetrækning af samtykke.
English: The most common mutations were the same in the week 48 and week 96 analyses.
Danish: De hyppigste mutationer var de samme i analyserne ved uge 48 og uge 96.
English: The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Danish: E138K-substitutionen fremkom hyppigst i løbet af rilpivirinbehandling, almindeligvis i kombination med M184I-substitutionen.
English: • Antibiotics used to treat bacterial infections including tuberculosis containing:
Danish: • Antibiotika, der anvendes til at behandle bakterieinfektioner, herunder tuberkulose,
English: Carcinogenicity studies with rilpivirine in mice and rats revealed tumorigenic potential specific for these species, but are regarded as of no relevance for humans.
Danish: Karcinogenicitetsstudier med rilpivirin hos mus og rotter viste tumorigent potentiale specifikt for disse arter, men anses ikke for at være relevante for mennesker.
English: There is no specific antidote for overdose with Eviplera.
Danish: Der er intet specifikt antidot for overdosering med Eviplera.
English: Eviplera has not been studied in patients over the age of 65 years.
Danish: Eviplera er ikke blevet undersøgt hos patienter over 65 år.
English: 52% of patients with virologic failure in the rilpivirine arm developed concomitant NNRTI and NRTI mutations.
Danish: 52 % af patienterne med virologisk svigt i rilpivirin-armen udviklede samtidig NNRTI- og NRTI-mutationer.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Danish: Kliniske Oplysninger 4.1 Terapeutiske indikationer
English: Do not drive or operate machines if you feel tired, sleepy or dizzy after taking your medicine.
Danish: Før ikke motorkøretøj og lad være med at betjene maskiner, hvis De bliver træt, søvnig eller svimmel, efter De har taget Deres medicin.
English: Each of these active substances, also known as antiretroviral medicines, works by interfering with an enzyme (a protein called ‘reverse transcriptase') that is essential for the virus to multiply.
Danish: Hvert af disse aktive stoffer, der også kaldes antiretroviral medicin, virker ved at påvirke et enzym (et protein, der kaldes ‘revers transkriptase'), der er essentielt for, at virus kan mangfoldiggøres.
English: Patients had a mean age of 42 years (range 19-73), 88% were male, 77% were White, 17% were Black, and 17% were Hispanic/Latino.
Danish: Patienterne havde en gennemsnitsalder på 42 år (interval 19-73), 88 % var mænd, 77 % var hvide, 17 % var sorte, og 17 % var latinamerikanere.
English: Gilead Sciences Ελλάς Μ.ΕΠΕ.
Danish: Κύπρος Gilead Sciences Ελλάς Μ.ΕΠΕ.
English: If you are taking an H2-antagonist such as famotidine, cimetidine, nizatidine or ranitidine.
Danish: Hvis De tager en H2-antagonist, såsom famotidin, cimetidin, nizatidin eller ranitidin.
English: If you do miss a dose:
Danish: Hvis De ikke tager en dosis:
English: Do not chew, crush or split the tablet - if you do it may affect the way the medicine is released into your body.
Danish: Tabletten må ikke tygges, knuses eller deles - hvis De gør det, kan det påvirke den måde, hvorpå medicinen frigives i kroppen.
English: In patients with phenotypic data (n = 66)
Danish: Hos patienter med fænotype-data (n = 66)
English: Tell your doctor if you are taking any of the following:
Danish: Fortæl det til lægen, hvis De tager nogle af de følgende:
English: Before and during treatment, your doctor may order blood tests to measure kidney function.
Danish: Før og under behandlingen kan Deres læge bestille blodprøver for at måle nyrefunktionen.
English: In some cases, your doctor may need to adjust your dose or check your blood levels.
Danish: I nogle tilfælde kan det være nødvendigt, at lægen justerer Deres dosis eller kontrollerer Deres blodniveau.
English: If you have HIV infection and hepatitis B, it is especially important not to stop your Eviplera treatment without talking to your doctor first.
Danish: Hvis De har hiv-infektion og hepatitis B, er det særlig vigtigt ikke at ophøre med Eviplerabehandlingen uden først at konsultere Deres læge.
English: Eviplera has no or negligible influence on the ability to drive and use machines.
Danish: Eviplera påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: There is not sufficient data to justify the use in patients with prior NNRTI failure.
Danish: Der er utilstrækkelige data til at retfærdiggøre anvendelse hos patienter med tidligere NNRTI-svigt.
English: Eviplera should be initiated by a physician experienced in the management of HIV infection.
Danish: Eviplera skal initieres af en læge med erfaring i behandlingen af hiv-infektion.
English: Lactic acidosis occurs more often in women - particularly if they are overweight, and in people with liver disease.
Danish: Laktatacidose forekommer hyppigere hos kvinder - især hvis de er overvægtige, og hos personer med leversygdom.
English: These symptoms resolved after Eviplera was discontinued.
Danish: Disse symptomer forsvandt, efter Eviplera blev seponeret.
English: The recommended dose of Eviplera is one tablet, taken orally, once daily.
Danish: Den anbefalede dosis af Eviplera er én tablet, taget oralt, én gang dagligt.
English: Take the rilpivirine tablet at the same time you take Eviplera.
Danish: Tag rilpivirin-tabletten samtidigt med Eviplera.
English: The film-coated tablet should not be chewed, crushed or split as it may impact the absorption of Eviplera.
Danish: Den filmovertrukne tablet må ikke tygges, knuses eller deles, da det kan påvirke absorptionen af Eviplera.
English: The tablet must be taken with food.
Danish: Tabletten skal tages sammen med mad.
English: Interrupting treatment with Eviplera should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Det bør også overvejes at afbryde behandlingen med Eviplera i tilfælde af progressiv forværring af nyrefunktionen, når der ikke er identificeret andre årsager.
English: Stopping Eviplera can seriously affect your response to future treatment.
Danish: Eviplera, kan det i alvorlig grad påvirke Deres reaktion på fremtidig behandling.
English: You must remain under the care of your doctor while taking Eviplera.
Danish: De skal fortsætte med at være under lægens opsyn, mens De tager Eviplera.
English: Signs of osteonecrosis are:
Danish: Tegn på osteonekrose er:
English: Women of childbearing potential / contraception in males and females The use of Eviplera must be accompanied by the use of effective contraception.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Anvendelsen af Eviplera skal ledsages af anvendelse af effektiv kontraception.
English: The oral bioavailability of tenofovir from tenofovir disoproxil tablets in fasted patients was approximately 25%.
Danish: Den orale biotilgængelighed af tenofovir fra tenofovirdisoproxil-tabletter hos fastende patienter var ca. 25 %.
English: The remaining 3 Eviplera-treated patients did not have emergent resistance.
Danish: De resterende 3 Eviplerabehandlede patienter udviklede ikke resistens under behandlingen.
English: No clinically relevant drug-drug interaction is expected.
Danish: Ingen klinisk relevant lægemiddel-lægemiddelinteraktion forventes.
English: No human data on the effect of Eviplera on fertility are available.
Danish: Der foreligger ingen humane data vedrørende virkningen af Eviplera på fertilitet.
English: Eviplera contains an NNRTI (rilpivirine) and so Eviplera is not to be combined with other medicines of this type.
Danish: Eviplera indeholder en NNRTI (rilpivirin) og derfor må Eviplera ikke kombineres med anden medicin af denne type.
English: Resistance to emtricitabine/lamivudine (M184I/V)
Danish: Resistens over for emtricitabin/lamivudin (M184I/V)
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the electrocardiogram.
Danish: Der er begrænset tilgængelig information om risikoen for en farmakodynamisk interaktion mellem rilpivirin og lægemidler, der forlænger QTc-intervallet på elektrokardiogrammet.
English: However, in some patients, declines in CrCl did not completely resolve despite tenofovir disoproxil discontinuation.
Danish: Hos nogle patienter gik reduktionen i CrCl imidlertid ikke helt væk trods seponering af tenofovirdisoproxil.
English: If Eviplera for any reason is stopped, speak to your doctor before you restart taking Eviplera tablets.
Danish: Hvis Eviplera uanset årsagen stoppes, skal De tale med Deres læge, før De igen begynder at tage Eviplera tabletter.
English: • Tell your doctor if you had kidney disease, or if tests have shown kidney problems.
Danish: • Fortæl Deres læge, hvis De har haft en nyresygdom, eller hvis undersøgelser har vist nyreproblemer.
English: If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Danish: Hvis De tager en af disse former for medicin, vil Deres læge enten give Dem en anden form for medicin mod mavesår, halsbrand eller sure opstød (reflukssygdom), eller anbefale hvordan og hvornår De skal tage den medicin.
English: • Rifabutin, a medicine to treat some bacterial infections.
Danish: • Rifabutin, medicin til behandling af visse bakterieinfektioner.
English: The safety and efficacy of Eviplera have not been established for the treatment of chronic HBV infection.
Danish: Sikkerheden og virkningen af Eviplera er ikke godtgjort for behandlingen af kronisk HBV-infektion.
English: Your doctor will carefully consider whether to treat you with other medicines used for treating HIV infection (see Other medicines used for HIV infection).
Danish: Deres læge vil nøje tage stilling til om, det er nødvendigt at behandle Dem med anden medicin, der anvendes til behandling af hiv-infektion (se Anden medicin anvendt til hiv-infektion).
English: However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Danish: Klinisk overvågning anbefales imidlertid, da det kan være nødvendigt at justere vedligeholdelsesbehandlinge n med methadon hos nogle patienter.
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Danish: Op til 30 % af emtricitabindosen og cirka 10 % af tenofovirdosen kan fjernes ved hæmodialyse.
English: As a result, the amounts of Eviplera or other medicines in your blood may be affected.
Danish: Som et resultat heraf kan mængden af Eviplera eller anden medicin i Deres blod påvirkes.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge i, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge i, at en vigtig milepæl
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjælden arvelig galactoseintolerans, total lactoseintolerans eller glucose/galactosemalabsorption, bør ikke anvende dette lægemiddel.
English: • Changes to your urine
Danish: • Ændringer i urinen
English: Dosing recommendations for paediatric patients cannot be made due to insufficient data (see section 4.2).
Danish: Der kan ikke gives doseringsanbefalinger for pædiatriske patienter pga. utilstrækkelige data (se pkt.
English: In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) is similar to those seen in adults.
Danish: Generelt er emtricitabins farmakokinetik hos spædbørn, børn og teenagere (fra 4 måneder til 18 år) som hos voksne.
English: P-glycoprotein substrates
Danish: P-glykoproteinsubstrater