FrancophonIA/ELRC3.0 huggingface dataset:
English: Antiviral synergy was maintained for elvitegravir, emtricitabine, and tenofovir alafenamide when tested in the presence of cobicistat.
Danish: Antiviral synergi blev opretholdt for elvitegravir, emtricitabin og tenofoviralafenamid, når det blev testet, mens cobicistat var til stede.
English: • antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin and telithromycin
Danish: • antibiotika, der anvendes til at behandle bakterieinfektioner, herunder tuberkulose, og indeholder: rifabutin, clarithromycin og telithromycin
English: No in vitro resistance can be demonstrated with cobicistat due to its lack of antiviral activity.
Danish: In vitro-resistens over for cobicistat kan ikke påvises da cobicistat har ingen antivirale aktivitet.
English: The median terminal plasma half-life of cobicistat following administration of E/C/F/TDF is approximately 3.5 hours and the associated cobicistat exposures provide elvitegravir Ctrough approximately 10-fold above the protein-binding adjusted IC95 for wild-type HIV-1 virus.
Danish: Den mediane terminale halveringstid i plasma for cobicistat efter administration af E/C/F/TDF er ca. 3,5 timer, og de forbundne cobicistat-eksponeringer giver en Ctrough for elvitegravir, der er ca. 10 gange over IC95 justeret for proteinbinding for vildtype hiv 1-virus.
English: Cobicistat and tenofovir alafenamide are not inhibitors of human UGT1A1 in vitro.
Danish: Cobicistat og tenofoviralafenamid er ikke hæmmere af humant UGT1A1 in vitro.
English: However, upon co-administration with cobicistat in Genvoya, near maximal inhibition of P-gp by cobicistat is achieved leading to increased availability of tenofovir alafenamide with resulting exposures comparable to tenofovir alafenamide 25 mg administered alone.
Danish: Ved samtidig administration af cobicistat i Genvoya opnås der imidlertid næsten maksimal hæmning af P-gp af cobicistat, hvilket fører til en øget tilgængelighed af tenofoviralafenamid og resulterende eksponeringer, der svarer til tenofoviralafenamid 25 mg administreret alene.
English: HIV-1 with the raltegravir-selected substitutions T66A/K, Q148H/K, and N155H showed cross-resistance to elvitegravir.
Danish: Hiv 1 med de raltegravir-udvalgte substitutioner T66A/K, Q148H/K og N155H viste krydsresistens over for elvitegravir.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Genvoya.
Danish: En minimal infiltration af histiocytter var til stede i øjet på hunde ved eksponeringer over for hhv. tenofoviralafenamid og tenofovir, der var ca. 4 og 17 gange større, end hvad der forventes efter administration af Genvoya.
English: • lamivudine
Danish: • lamivudin
English: Plasma concentrations of drospirenone are expected to be increased following co-administration with Genvoya and clinical monitoring is recommended due to the potential for hyperkalaemia (see section 4.5).
Danish: Plasmakoncentrationerne af drospirenon forventes at øges efter samtidig administration med Genvoya, og klinisk monitorering anbefales på grund af risikoen for hyperkaliæmi (se pkt.
English: 2 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies for elvitegravir when used with other antiretrovirals.
Danish: 2 Denne bivirkning blev ikke observeret i kliniske fase 3-studier for Genvoya, men blev identificeret i kliniske studier for elvitegravir ved anvendelse sammen med andre antiretrovirale midler.
English: In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
Danish: I et separat fase 1-studie af emtricitabin alene var den gennemsnitlige systemiske emtricitabin-eksponering højere hos patienter med svært nedsat nyrefunktion (estimeret CrCl < 30 ml/min) (33,7 µg•t/ml) end hos personer med normal nyrefunktion (11,8 µg•t/ml).
English: 1 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
Danish: 1 Denne bivirkning blev ikke observeret i kliniske fase 3-studier for Genvoya, men blev identificeret i kliniske studier eller fra erfaring efter markedsføring for emtricitabin ved anvendelse sammen med andre antiretrovirale midler.
English: Other medicines and Genvoya Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Genvoya Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Interaction not studied with any of the components of Genvoya.
Danish: Interaktion er ikke undersøgt med nogen af Genvoyas komponenter.
English: Elvitegravir may have the potential to induce CYP2C9 and/or inducible uridine diphosphate glucuronosyltransferase (UGT) enzymes; as such it may decrease the plasma concentration of substrates of these enzymes.
Danish: Elvitegravir indebærer en risiko for at inducere CYP2C9 og/eller inducerbare uridindiphosphatglucuronosyltransferase (UGT)-enzymer, og derved reducere plasmakoncentrationen af substrater for disse enzymer.
English: If the patient vomits within 1 hour of taking Genvoya another tablet should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Genvoya, skal der tages en ny tablet.
English: Genvoya should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Genvoya has not been established in these populations.
Danish: Genvoya frarådes hos patienter med en estimeret CrCl ≥ 15 ml/min og < 30 ml/min eller < 15 ml/min, som ikke er i kronisk hæmodialyse, da Genvoyas sikkerhed hos disse populationer ikke er blevet klarlagt.
English: Relative to fasting conditions, the administration of Genvoya with a light meal (~400 kcal, 20% fat) or high-fat meal (~800 kcal, 50% fat) did not affect overall exposures of tenofovir alafenamide to a clinically meaningful extent (approximately 15% and 18% higher AUC with a light or high-fat meal, respectively, versus fasted).
Danish: I forhold til fastende tilstand påvirkede administrationen af Genvoya sammen med et let måltid (~400 kcal, 20 % fedtindhold) eller et måltid med højt fedtindhold (~800 kcal, 50 % fedt) ikke den samlede eksponering for tenofoviralafenamid i en klinisk signifikant grad (ca. 15 % og 18 % højere AUC med hhv. et let måltid eller et måltid med højt fedtindhold kontra fastende).
English: Based on data from an in vitro study, co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g., febuxostat) is not expected to increase systemic exposure to tenofovir in vivo.
Danish: Baseret på data fra et in vitro-studie forventes samtidig administration af tenofoviralafenamid og xanthinoxidasehæmmere (f.eks. febuxostat) ikke at øge den systemiske eksponering over for tenofovir in vivo.
English: Of the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to anti-HBe at Week 48.
Danish: Ud af de patienter, som var HBeAg-positive ved baseline, opnåede 1/30 (3,3 %) serokonvertering til anti-HBe ved uge 48.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Genvoya findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Patients with CrCl between 30 mL/min and 60 mL/min:
Danish: Patienter med CrCl fra 30 ml/min til 60 ml/min:
English: Therefore, information regarding drug-drug interactions with other antiretroviral products (including protease inhibitors [PIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) is not provided (see section 4.4).
Danish: Derfor gives der ikke information om lægemiddelinteraktioner med andre antiretrovirale præparater (herunder PI'er og nonnukleosid-revers transkriptase-hæmmere [NNRTI'er, non nucleoside reverse transcriptase inhibitors]) (se pkt.
English: On the basis of the scientific conclusions for cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for cobicistat/elvitegravir/emtricitabin/tenofoviralafenamid er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder cobicistat/elvitegravir/emtricitabin/tenofoviralafenamid, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Lactose (as monohydrate) Microcrystalline cellulose Croscarmellose sodium Hydroxypropyl cellulose Silicon dioxide Sodium lauryl sulfate Magnesium stearate
Danish: Lactose (som monohydrat) Mikrokrystallinsk cellulose Croscarmellosenatrium Hydroxypropylcellulose Siliciumdioxid Natriumlaurilsulfat Magnesiumstearat
English: Switching from a tenofovir disoproxil-based regimen to Genvoya was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen (Table 4).
Danish: Et skift fra et tenofovirdisoproxil-baseret regime til Genvoya var bedre til at bevare hiv 1-rna < 50 kopier/ml, sammenlignet med at blive på regimet ved baseline (tabel 4).
English: Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL Baseline CD4+ cell count < 200 cells/mm3 ≥ 200 cells/mm3
Danish: Viral load ved baseline ≤ 100.000 kopier/ml > 100.000 kopier/ml CD4+ celletal ved baseline < 200 celler/mm3 ≥ 200 celler/mm3
English: Overall, 22% had baseline plasma HIV-1 RNA > 100,000 copies/mL.
Danish: I alt havde 22 % hiv 1-rna i plasma ved baseline på > 100.000 kopier/ml.
English: Following oral administration of [14C]-cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Danish: Efter oral administration af [14C]-cobicistat var 99 % af den cirkulerende radioaktivitet i plasma fra uændret cobicistat.
English: Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil in concentrating tenofovir in peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
Danish: Tenofoviralafenamid er permeabelt i cellerne, og som følge af en øget plasmastabilitet og intracellulær aktivering via hydrolyse af cathepsin A er tenofoviralafenamid mere effektivt end tenofovirdisoproxil til at koncentrere tenofovir i perifere mononukleære blodceller (PBMC'er, peripheral blood mononuclear cells) (herunder lymfocytter og andre hiv-målceller) og makrofager.
English: Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs at Week 48.
Danish: Ud af de patienter, som var HBsAg-positive ved baseline, opnåede 3/70 (4,3 %) serokonvertering til anti-HBs ved uge 48.
English: If you are taking an antacid such as aluminium/magnesium hydroxide or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Genvoya.
Danish: Hvis De tager et syreneutraliserende middel, såsom aluminium-/magnesiumhydroxid, eller et multivitamin-tilskud, skal De tage det mindst 4 timer før eller mindst 4 timer efter Genvoya.
English: Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Danish: Tenofoviralafenamid elimineres primært efter metabolisme til tenofovir.
English: Animal studies do not indicate direct or indirect harmful effects of elvitegravir, cobicistat, or emtricitabine, administered separately, with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger af elvitegravir, cobicistat eller emtricitabin, administreret separat, hvad angår fertilitetsparametre, graviditet, føtal udvikling, fødsel og postnatal udvikling.
English: Caution should be exercised, including consideration of dose reduction, when co-administering Genvoya with tadalafil for the treatment of pulmonary arterial hypertension.
Danish: Der bør udvises forsigtighed, og en dosisreduktion bør overvejes ved samtidig administration af Genvoya og tadalafil til behandling af pulmonal arteriel hypertension.
English: Improvements in BMD were noted at 96 weeks after switching to Genvoya from a tenofovir disoproxil-containing regimen compared to maintaining the tenofovir disoproxil-containing regimen.
Danish: Forbedringer i BMD blev bemærket 96 uger efter skift til Genvoya fra et tenofovirdisoproxil-baseret regime, sammenlignet med regimet, der bibeholder tenofovirdisoproxil.
English: c P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (EFV/FTC/tenofovir disoproxil, FTC/tenofovir disoproxil plus boosted atazanavir, or
Danish: c P-værdi for superioritetstest, der sammenligner procenterne af virologisk succes, var fra CMH-testen stratificeret ved det tidligere behandlingsregime (EFV/FTC/tenofovirdisoproxil, FTC/tenofovirdisoproxil plus boosted atazanavir eller E/C/F/TDF).
English: In animal studies it has been shown that elvitegravir, cobicistat, and tenofovir are excreted in milk.
Danish: Det er blevet vist i dyrestudier, at elvitegravir, cobicistat og tenofovir udskilles i mælk.
English: Based on this, section 4.8 of the SmPC of medicinal products containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide FDC has been updated to add suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness) as new adverse drug reactions.
Danish: På dette grundlag er punkt 4.8 i produktresuméet til lægemidler indeholdende elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid i fastdosiskombination blevet opdateret med tilføjelsen af selvmordstanker og selvmordsforsøg (hos patienter med depression eller psykisk sygdom i anamnesen) som nye bivirkninger.
English: No dose adjustment of Genvoya is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Danish: Dosisjustering af Genvoya er ikke nødvendig hos voksne og unge (i alderen mindst 12 år og med en legemsvægt på mindst 35 kg) med en estimeret kreatininclearance (CrCl) ≥ 30 ml/min.
English: If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, the patient should take Genvoya with food as soon as possible and resume the normal dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Genvoya i mindre end 18 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Genvoya sammen med mad så snart som muligt og derefter fortsætte med den normale doseringsplan.
English: Polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), indigo carmine aluminium lake (E132), iron oxide yellow (E172).
Danish: Polyvinylalkohol (E1203), titandioxid (E171), polyethylenglycol (E1521), talcum (E553b), indigocarmin aluminiumpigment (E132), jernoxid, gul (E172).
English: Genvoya should not be co-administered with colchicine to patients with renal or hepatic impairment.
Danish: Genvoya bør ikke administreres sammen med colchicin til patienter med nedsat nyre- eller leverfunktion.
English: The safety and efficacy of Genvoya in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Danish: Genvoyas sikkerhed og virkning hos patienter, som samtidig er inficerede med hiv 1- og hepatitis C-virus (HCV) er ikke klarlagt.
English: The use of Genvoya with oral contraceptives containing other progestogens should be avoided (see section 4.5).
Danish: Brug af Genvoya med orale antikonceptiva, der indeholder andre progestogener bør undgås (se pkt.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for cobicistat/elvitegravir/emtricitabin/tenofoviralafenamid er CHMP nået frem til følgende konklusioner:
English: Through 144 weeks of treatment, no subject discontinued Genvoya due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p < 0.001).
Danish: Til og med 144 ugers behandling fik ingen forsøgsdeltagere seponeret Genvoya på grund af behandlingsrelaterede renale bivirkninger, sammenlignet med 12 forsøgsdeltagere, der fik seponeret E/C/F/TDF (p < 0,001).
English: The safety profile of Genvoya in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Danish: Sikkerhedsprofilen for Genvoya hos patienter med let til moderat nedsat nyrefunktion lignede den for patienter med normal nyrefunktion (se pkt.
English:  If you notice the side effects described above, tell your doctor immediately.
Danish:  Hvis De bemærker de ovenstående bivirkninger, skal De straks fortælle det til lægen.
English:  If you are taking an antacid or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Genvoya.
Danish:  Hvis De tager et syreneutraliserende middel eller et multivitamin-tilskud, skal De tage det mindst 4 timer før eller mindst 4 timer efter Genvoya.
English: Mean % change of cobicistat pharmacokinetic parametersa
Danish: Gennemsnitlig % ændring af farmakokinetiske parametre for cobicistata
English: Adults and paediatric patients aged 6 years and older, weighing at least 25 kg One tablet to be taken once daily with food.
Danish: Voksne og pædiatriske patienter i alderen 6 år og ældre, der vejer mindst 25 kg. Én tablet tages én gang daglig sammen med mad.
English: d Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Danish: d Omfatter patienter, som afbrød behandlingen som følge af en AE eller død på et tidspunkt fra dag 1 og i løbet af tidsvinduet, hvis dette ikke resulterede i virologiske data om behandlingen i løbet af det specificerede tidsvindue.
English: Table 3: Pooled virologic outcomes of studies GS-US-292-0104 and GS-US-292-0111 at Weeks 48 and 144a,b
Danish: Tabel 3: Samlede virologiske resultater i studie GS-US-292-0104 og GS-US-292-0111 ved uge 48 og 144a,b
English: E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
Danish: E/C/F/TDF = elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat a Uge 48-vindue var fra dag 294 til 377 (inklusive), uge 144-vindue var fra dag 966 til 1049 (inklusive).
English: What you need to know before you take Genvoya Do not take Genvoya:
Danish: Det skal De vide, før De begynder at tage Genvoya Tag ikke Genvoya:
English: 90 (3 bottles of 30) film-coated tablets 90 (3 bottles of 30) tablets
Danish: 90 (3 tabletbeholdere med 30) filmovertrukne tabletter 90 (3 tabletbeholdere med 30) tabletter
English: Genvoya contains lactose monohydrate.
Danish: Genvoya indeholder lactosemonohydrat.
English: Co-administration is contraindicated with medicinal products that are strong inducers of CYP3A due to the potential for loss of virologic response and possible resistance to Genvoya.
Danish: Samtidig administration med lægemidler, som er stærke inducere af CYP3A, er kontraindiceret på grund af risikoen for svigtende virologisk respons og mulig resistens over for Genvoya.
English: e Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Danish: e Omfatter patienter, som afbrød behandlingen som følge af en AE eller død på et tidspunkt fra dag 1 og i løbet af tidsvinduet, hvis dette ikke resulterede i virologiske data om behandlingen i løbet af det specificerede tidsvindue.
English: [Outer packaging only]
Danish: [kun på den ydre emballage]
English: 4 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate.
Danish: 4 Dette studie blev udført med elvitegravir/cobicistat/emtricitabin/tenofovirdisporoxilfumarat.
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving tenofovir alafenamide with other medicinal products is low.
Danish: In vitro- og kliniske farmakokinetiske lægemiddelinteraktionsstudier har vist, at potentialet for CYP-medierede interaktioner, der involverer tenofoviralafenamid og andre lægemidler, er lav.
English: If you forget to take Genvoya
Danish: Hvis De har glemt at tage Genvoya
English: Fifteen percent of patients identified as Hispanic/Latino.
Danish: Femten procent af patienterne identificerede sig som af spansk/latinsk herkomst.
English: The most frequently reported adverse reactions in clinical studies through 144 weeks were nausea (11%), diarrhoea (7%), and headache (6%) (pooled data from Phase 3 clinical studies GS-US-292-0104 and GS-US-292-0111 in 866 treatment-naïve adult patients receiving Genvoya).
Danish: De hyppigst rapporterede bivirkninger i kliniske studier til og med 144 uger var kvalme (11 %), diarré (7 %) og hovedpine (6 %) (samlede data fra de kliniske fase 3-studier GS-US-292-0104 og GS-US-292-0111 hos 866 behandlingsnaive voksne patienter, der fik Genvoya).
English: Tenofovir alafenamide is active against hepatitis B virus (HBV).
Danish: Tenofoviralafenamid er aktiv mod hepatitis B-virus (HBV).
English: Ninety-two percent (66/72 patients) had HBV DNA < 29 IU/mL using missing = failure analysis at Week 48.
Danish: 92 procent (66/72 patienter) havde HBV DNA < 29 IE/ml ved brug af analyse, hvor manglende data = svigt ved uge 48.
English: Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching to Genvoya.
Danish: Patienterne var virologisk supprimerede (hiv 1-rna < 50 kopier/ml) i mindst 6 måneder, før de skiftede til Genvoya.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
Danish: Emtricitabins binding in vitro til humane plasmaproteiner var < 4 % og uafhængig af koncentrationsområdet på 0,02-200 µg/ml.
English: EFV = efavirenz; FTC = emtricitabine; E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive).
Danish: EFV = efavirenz, FTC = emtricitabin, E/C/F/TDF = elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat a Uge 48-vinduet var fra dag 294 til 377 (inklusive).
English: No dose adjustment of Genvoya is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Danish: Dosisjustering af Genvoya er ikke nødvendig hos patienter med let nedsat (Child-Pugh klasse A) eller moderat nedsat (Child-Pugh klasse B) leverfunktion.
English: Viruses expressing elvitegravir or raltegravir resistance mutations maintain susceptibility to dolutegravir.
Danish: Vira, der udtrykker elvitegravir- eller raltegravir-resistensmutationer, bevarer følsomhed for dolutegravir.