FrancophonIA/ELRC3.0 huggingface dataset:
English: Vitekta stops this enzyme working and reduces the amount of HIV in your body.
Danish: Vitekta stopper dette enzym og nedsætter mængden af hiv i Deres krop.
English: This enzyme helps the virus to multiply in the cells in your body.
Danish: Dette enzym hjælper virusset med at formere sig i cellerne i Deres krop.
English: In treatment-experienced HIV-1 infected patients
Danish: Hos behandlingserfarne, hiv-1-inficerede patienter
English: Pharmacokinetics of elvitegravir have not been fully evaluated in the elderly (over 65 years of age).
Danish: Elvitegravirs farmakokinetik er ikke blevet helt evalueret hos ældre patienter (over 65 år).
English: The pharmacokinetic parameters of the protease inhibitors presented in Table 2 were assessed in the presence of ritonavir.
Danish: De farmakokinetiske parametre for de proteasehæmmere, der anføres i tabel 2, blev vurderet ved tilstedeværelsen af ritonavir.
English: Do not stop taking Vitekta without talking to your doctor.
Danish: Hold ikke op med at tage Vitekta uden at tale med Deres læge.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Ved tegn på forværring af leversygdom hos sådanne patienter, skal man overveje at seponere eller afbryde behandlingen.
English: • contraceptive pill, used to prevent pregnancy
Danish: • p-piller, der anvendes til at forebygge graviditet
English: If overdose occurs the patient must be monitored for evidence of toxicity.
Danish: Ved overdosering, skal patienten overvåges for tegn på toksicitet.
English: • suicidal thoughts and suicide attempts (in patients who have had depression or mental health
Danish: • selvmordstanker og selvmordsforsøg (hos patienter med tidligere depression eller psykiske
English: Further increases in ritonavir dose do not result in further increases in elvitegravir exposure.
Danish: Yderligere stigninger i ritonavir-dosis resulterer ikke i yderligere stigninger i elvitegravir-eksponering.
English: It is recommended to separate Vitekta and antacid administration by at least 4 hours.
Danish: Det anbefales at separere administrationen af Vitekta og antacida med mindst 4 timer.
English: • bosentan, used to treat pulmonary arterial hypertension
Danish: • bosentan, der anvendes til at behandle pulmonal arteriel hypertension
English: Virologic success at week 48
Danish: Virologisk success ved uge 48
English: This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Danish: Det er for at sikre, at medicinen er fuldt ud effektiv, og for at reducere udviklingen af resistens mod behandlingen.
English: Tell your doctor if you are lactose intolerant or intolerant to other sugars.
Danish: Fortæl Deres læge, hvis De lider af lactoseintolerans eller er intolerant over for andre sukkerformer.
English: Other medicines used in treating HIV infection: You should not take Vitekta with other medicines containing:
Danish: Andre lægemidler, der anvendes til at behandle en hiv-infektion: De bør ikke tage Vitekta med andre lægemidler, som indeholder:
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og Pneumocystis jirovecii pneumoni.
English: Integrase is an HIV-1 encoded enzyme that is required for viral replication.
Danish: Integrase er et hiv-1-kodet enzym, der er nødvendigt for viral replikation.
English: The BR was selected by the investigator based on genotypic/phenotypic resistance testing and prior antiretroviral treatment history.
Danish: BR blev valgt af investigatoren baseret på genotype-/fænotype-resistensundersøgelse og tidligere antiretroviral behandlingsanamnese.
English:  Tell your doctor if any of these apply to you.
Danish:  Fortæl det altid til lægen, hvis noget af dette gælder for Dem.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter De er begyndt at tage medicin til behandling af din hiv-infektion.
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: d Includes subjects who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g., withdrew consent,
Danish: d Omfatter personer, som afbrød behandlingen af andre årsager end en AE, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Vitekta or by other medicines that you are taking at the same time, or by the HIV infection
Danish: Når hiv-infektion behandles, er det ikke altid muligt at afgøre, om nogle af de uønskede virkninger er forårsaget af Vitekta eller af anden medicin, som De tager samtidigt, eller af selve hiv-infektionen.
English: Vitekta must always be taken with certain other HIV medicines.
Danish: Vitekta skal altid tages sammen med visse former for anden hiv-medicin.
English: The median terminal plasma half-life of ritonavir-boosted elvitegravir is approximately 8.7 to 13.7 hours.
Danish: Den mediane terminale halveringstid i plasma for ritonavir-boosted elvitegravir er ca. 8,7 til 13,7 timer.
English: Do not breast-feed during treatment with Vitekta: It is not known if the active substance in this medicine can pass into human breast milk.
Danish: De må ikke amme, mens De er i behandling med Vitekta: Det er ukendt, om det aktive stof i denne medicin udskilles i mælken hos mennesker.
English: Interactions between elvitegravir and potential co-administered medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Interaktioner mellem elvitegravir og mulige samtidigt administrerede lægemidler ses i tabel 2 nedenfor (stigning er angivet som "↑", fald som "↓", ingen ændring som "↔").
English: Co-administration of Vitekta and rifabutin is not recommended.
Danish: Samtidig administration af Vitekta og rifabutin anbefales ikke.
English: In these subjects, diarrhoea was mild to moderate in severity and did not result in discontinuation of study drug.
Danish: Hos disse personer var diarréen let til moderat i sværhedsgrad og resulterede ikke i seponering af studiemedicinen.
English: If you are also taking didanosine, take it at least 1 hour before or at least 2 hours after Vitekta.
Danish: Hvis De også tager didanosin, skal De tage det mindst 1 time før eller mindst 2 timer efter Vitekta.
English: It is unknown whether elvitegravir/metabolites are excreted in human milk.
Danish: Det vides ikke om elvitegravir/metabolitter udskilles i human mælk.
English: These interactions are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of therapeutic effect.
Danish: Disse interaktioner er baseret på studier af lægemiddelinteraktioner eller forudsete interaktioner pga. det forventede omfang af interaktion og muligheden for alvorlige bivirkninger eller svigtende terapeutisk virkning.
English: Table 1: Recommended dosing regimens Dose of Vitekta
Danish: Tabel 1: Anbefalede doseringsregimer Vitekta dosis
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apotekspersonalet til råds, før De tager nogen form for medicin.
English: Vitekta should be taken orally, once daily with food (see section 5.2).
Danish: Vitekta skal tages oralt, én gang dagligt, sammen med mad (se pkt.
English: As didanosine is administered on an empty stomach, didanosine should be administered at least one hour before or two hours after Vitekta (which is administered with food).
Danish: Da didanosin administreres på tom mave, bør didanosin administreres mindst én time før eller to timer efter Vitekta (som administreres med mad).
English: The safety and efficacy of elvitegravir in children aged 0 to less than 18 years have not yet been established (see section 5.1).
Danish: Elvitegravirs sikkerhed og virkning hos børn i alderen 0 til under 18 år er endnu ikke klarlagt (se pkt.
English: Frequencies are defined as common (≥ 1/100 to < 1/10) or
Danish: Frekvens er defineret som almindelig (≥ 1/100 til < 1/10) eller ikke almindelig (≥ 1/1.000 til < 1/100).
English: If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Vitekta is started.
Danish: Hvis De har fremskreden hiv-infektion (aids) og har en infektion, kan De udvikle symptomer på infektion og betændelse eller forværring af symptomerne på en eksisterende infektion, når behandlingen med Vitekta påbegyndes.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Tilfælde af osteonekrose er rapporteret, specielt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig eksponering for CART.
English: • rifampicin, used to prevent and treat tuberculosis and other infections
Danish: • rifampicin, anvendes til at forebygge og behandle tuberkulose og andre infektioner
English: While taking Vitekta you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Vitekta, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Vitekta.
Danish: Det anbefales at overvåge den internationale normaliserede ratio (INR) ved samtidig administration af Vitekta.
English: HIV-1 isolates with reduced susceptibility to elvitegravir have been selected in cell culture.
Danish: Hiv-1-isolater med nedsat følsomhed for elvitegravir kan selekteres i cellekultur.
English: Interactions with CYP3A inducers
Danish: Interaktioner med CYP3A-inducere
English: Vitekta may interact with other medicines which can affect the amounts of Vitekta or other medicines in your blood.
Danish: Vitekta kan påvirke anden medicin, hvilket kan påvirke mængden af Vitekta eller anden medicin i Deres blod.
English: Vitekta is a treatment for human immunodeficiency virus (HIV) infection in adults aged 18 years
Danish: Vitekta er en behandling for infektion med human immundefekt virus (hiv) hos voksne i alderen
English:  Tell your doctor if you are taking these or any other medicines.
Danish:  Fortæl det altid til lægen, hvis De tager disse eller andre lægemidler.
English: Metabolites produced by aromatic and aliphatic hydroxylation or glucuronidation are present in very low levels and do not contribute to the overall antiviral activity of elvitegravir.
Danish: Metabolitter produceret af aromatisk og alifatisk hydroxylering og glukuronidation er til stede i meget lave niveauer, og bidrager ikke til den samlede antivirale aktivitet af elvitegravir.
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Danish: Hvis kombinationen er nødvendig, er den anbefalede dosis rifabutin 150 mg 3 gange ugentligt på faste dage (for eksempel mandag-onsdagfredag).
English: As the effect of cationic complexation of elvitegravir cannot be excluded when co-administered with multivitamin supplements, it is recommended to separate Vitekta and multivitamin supplements dosing by at least 4 hours.
Danish: Da virkningen af kationisk kompleksation af elvitegravir ikke kan udelukkes ved samtidig administration med multivitamin-tilskud, anbefales det at separere administrationen af Vitekta og multivitamintilskud med mindst 4 timer.
English: Stopping Vitekta can seriously affect your response to future treatment.
Danish: Hvis De holder op med at tage Vitekta, kan det i alvorlig grad påvirke Deres reaktion på fremtidig behandling.
English: Mean steady-state exposure (AUCtau) of unboosted elvitegravir is ~ 20% lower after multiple dosing versus a single dose, indicating modest autoinduction of its metabolism.
Danish: Gennemsnitlig steady-state eksponering (AUCtau) af ikke-boosted elvitegravir er ~ 20% lavere efter flere doseringer versus en enkelt dosis, hvilket indikerer en beskeden autoinduktion af dets metabolisme.
English: Medicines that should never be taken with Vitekta:
Danish: Visse lægemidle bør aldrig indtages sammen med Vitekta:
English: • if you are allergic to elvitegravir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • Hvis De er allergisk over for elvitegravir eller et af de øvrige indholdsstoffer i Vitekta (angivet i punkt 6 i denne indlægsseddel).
English: Elvitegravir does not inhibit human topoisomerases I or II.
Danish: Elvitegravir hæmmer ikke humane topoisomeraser I eller II.
English: Adverse reactions to elvitegravir from clinical study experience are listed in Table 3 below, by body system organ class and frequency.
Danish: Elvitegravirs bivirkninger fra erfaring fra kliniske studier er opført i nedenstående tabel 3, efter systemorganklasse og frekvens.
English: If you accidentally take more than the recommended dose of Vitekta you may be at increased risk of experiencing possible side effects with this medicine (see section 4 of this leaflet).
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Vitekta, kan De have større risiko for at få bivirkninger med denne medicin (se pkt.
English: HIV-1 RNA < 50 copies/mL, n/N (%)
Danish: Hiv-1-rna < 50 kopier/ml, n/N (%)
English: Inhibition of integrase prevents the integration of HIV-1 DNA into host genomic DNA, blocking the formation of the HIV-1 provirus and propagation of the viral infection.
Danish: Hæmning af integrase forhindrer integration af hiv-1-dna i det humane dna, og blokerer dannelsen af hiv-1-provirus og propagation af den virale infektion.
English: Vitekta should be administered once daily as follows: - Either at the same time as a once daily ritonavir-boosted protease inhibitor - Or with the first dose of a twice daily ritonavir-boosted protease inhibitor.
Danish: Vitekta bør administreres én gang dagligt som følger: - Enten på samme tidspunkt som en ritonavir-boosted proteasehæmmer indgivet én gang dagligt - Eller samtidigt med den første dosis af en ritonavir-boosted proteasehæmmer indgivet to gange dagligt.
English: Elvitegravir did not show inhibition of replication of HBV or HCV in vitro.
Danish: Elvitegravir gav ingen hæmning af replikation af HBV eller HCV in vitro.
English: Elvitegravir is 98-99% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1.0 ng/mL to 1.6 µg/mL.
Danish: Elvitegravir er 98-99 % bundet til humane plasmaproteiner, og bindingen er uafhængig af lægemiddelkoncentrationer i intervallet fra 1,0 ng/ml til 1,6 µg/ml.
English: Interactions requiring dose adjustment of Vitekta
Danish: Interaktioner, som kræver dosisjustering af Vitekta
English: Elimination Following oral administration of ritonavir-boosted [
Danish: Efter oral administration af ritonavir-boosted [
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der er i antiretroviral kombinationsbehandling kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød, forårsaget af manglende blodforsyning til knoglerne).
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with hepatitis B virus (HBV).
Danish: Lægerne bør konsultere aktuelle hiv-behandlingsretningslinjer for optimal håndtering af hiv-infektion hos patienter med samtidig infektion med hepatitis B-virus (HBV).
English: Randomisation was stratified by screening HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) and the class of the second agent (NRTI or other classes).
Danish: Randomisering blev stratificeret efter hiv-1-rna-niveau ved screening (≤ 100.000 kopier/ml eller > 100.000 kopier/ml) og klassen for det andet stof (NRTI eller andre klasser).
English: Polyvinyl alcohol (partially hydrolysed) (E1203) Talc (E553B)
Danish: Polyvinylalkohol (delvist hydrolyseret) (E1203) Talcum (E553B)
English: C]elvitegravir, elvitegravir was the predominant species in plasma, representing approximately 94% and 61% of the circulating radioactivity at 32 and 48 hours, respectively.
Danish: C]elvitegravir var elvitegravir det dominerende stof i plasma og udgjorde ca. 94 % og 61 % af den cirkulerende radioaktivitet ved hhv. 32 og 48 timer.
English: Similar rates of raltegravir resistance development occurred in the HIV-1 from subjects treated with raltegravir (26/351 raltegravir-treated subjects, 7.4%).
Danish: Lignende rater for udvikling af resistens over for raltegravir forekom i hiv-1 fra personer, der blev behandlet med raltegravir (26/351 raltegravir-behandlede personer, 7,4 %).
English: If Vitekta is stopped for any reason, speak to your doctor before you restart taking Vitekta tablets.
Danish: Hvis Vitekta stoppes uanset årsagen, skal De tale med Deres læge, før De igen begynder at tage Vitekta tabletter.
English: Elvitegravir plasma exposures are non-linear and less than dose-proportional, likely due to solubility
Danish: Elvitegravir-eksponering i plasma er non-linær og mindre end dosisproportionel, sandsynligvis pga.
English: Medicinal products that are strong (causing a > 5-fold increase in substrate clearance) or moderate (causing a 2-5 fold increase in substrate clearance) inducers of CYP3A are expected to decrease plasma concentrations of elvitegravir.
Danish: Lægemidler, der er stærke (forårsager en > 5 gange stigning i substratclearance) eller moderate (forårsager en 2-5 gange stigning i substratclearance) inducere af CYP3A, forventes at nedsætte plasmakoncentrationerne af elvitegravir.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Varigheden af indtagelsen af antiretroviral kombinationsbehandling, indtagelse af binyrebarkhormoner, alkoholforbrug, et meget svækket immunsystem og overvægt kan, blandt andet, være nogle af de mange risikofaktorer for at udvikle denne sygdom.
English:  If any of these applies to you, do not take Vitekta and tell your doctor immediately.
Danish:  Hvis noget af dette gælder for Dem, må De ikke tage Vitekta og De skal omgående fortælle Deres læge det.
English: The choice of dose of Vitekta depends on the co-administered protease inhibitor (see Table 1 and sections 4.4 and 4.5).
Danish: Dosisvalget af Vitekta afhænger af den samtidigt administrerede proteasehæmmer (se tabel 1 og punkt 4.4 og 4.5).
English: Except where indicated in Table 2, the dose of boosted elvitegravir or co-administered medicinal product was the same when administered alone or in combination.
Danish: Bortset fra hvor det er angivet i tabel 2, var dosis af boosted elvitegravir og hvert samtidigt administrerede lægemiddel uændret, når de blev administreret alene eller i kombination.
English: Elvitegravir-resistant viruses show varying degrees of cross-resistance to the integrase strand transfer inhibitor raltegravir depending on the type and number of substitutions.
Danish: Elvitegravirresistente vira viste forskellige grader af krydsresistens over for integrase strand transferhæmmeren raltegravir, afhængigt af substitutionernes type og antal.
English: Vitekta contains the active substance elvitegravir.
Danish: Vitekta indeholder det aktive stof elvitegravir.
English: As such, elvitegravir may decrease the plasma concentration of substrates of CYP2C9 (such as warfarin) or UGT (such as ethinyl estradiol).
Danish: Elvitegravir kan derfor reducere plasmakoncentrationen af substrater af CYP2C9 (f.eks. warfarin) eller UGT (f.eks. ethinylestradiol).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Viruses expressing the T66I/A substitutions maintain susceptibility to raltegravir, while most other patterns of elvitegravir-associated substitutions are associated with reduced susceptibility to raltegravir.
Danish: Vira, der udtrykker T66I/Asubstitutioner, bevarer følsomhed over for raltegravir, mens de fleste andre mønstre af elvitegravirassocierede substitutioner er forbundet med nedsat følsomhed over for raltegravir.
English: Following oral administration of a single dose of ritonavir-boosted [
Danish: Efter oral administration af en enkelt dosis af ritonavir-boosted [
English: Elvitegravir is a substrate for OATP1B1 and OATP1B3, and an inhibitor of OATP1B3 in vitro.
Danish: Elvitegravir er et substrat for OATP1B1 og OATP1B3, og en hæmmer af OATP1B3 in vitro.
English: • If you have liver problems or a history of liver disease, including hepatitis.
Danish: • Hvis De har leverproblemer eller hvis De tidligere har haft en leversygdom, herunder hepatitis (gulsot).
English: The mean plasma to blood drug concentration ratio is 1.37.
Danish: Forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blodet var 1,37.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with elvitegravir in one or more subsets of the paediatric population in the treatment of 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 elvitegravir i en eller flere undergrupper af den pædiatriske population ved behandlingen af hiv-1-infektion (se pkt.
English: Tell your doctor or pharmacist if you are taking, plan to take, or have recently taken any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De tager anden medicin, planlægger at tage anden medicin eller har gjort det for nylig.
English: Where interactions were studied, the effect on Vitekta was determined by comparing the pharmacokinetics of boosted elvitegravir (using either ritonavir or cobicistat as a pharmacokinetic enhancer) in the absence and presence of the co-administered medicinal product.
Danish: I de tilfælde hvor interaktioner er undersøgt, blev virkningen på Vitekta fastlagt ved at sammenligne farmakokinetikken af boosted elvitegravir (med anvendelse af enten ritonavir eller cobicistat som en farmakokinetisk forstærker) ved fravær og tilstedeværelse af det samtidigt administrerede lægemiddel.
English: Croscarmellose sodium, hydroxypropyl cellulose, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate.
Danish: Croscarmellosenatrium, hydroxypropylcellulose, lactose (som monohydrat), magnesiumstearat, mikrokrystallinsk cellulose, natriumlaurilsulfat.
English: • antacids, used to treat heartburn or acid reflux, such as aluminium/magnesium hydroxide or calcium carbonate (see also section 3 of this leaflet)
Danish: • syreneutraliserende midler, der anvendes til at behandle halsbrand og sure opstød, såsom aluminium/magnesiumhydroxid eller calciumcarbonat (se også punkt 3 i denne indlægsseddel)