FrancophonIA/ELRC3.0 huggingface dataset:
English: The interactions described are based on studies conducted with Descovy, or the components of Descovy as individual agents and/or in combination, or are potential drug-drug interactions that may occur with Descovy.
Danish: De beskrevne interaktioner er baseret på studier udført med Descovy eller Descovy-komponenterne som individuelle stoffer og/eller i kombination, eller de er mulige lægemiddelinteraktioner, der kan forekomme med Descovy.
English: There were no clinically significant changes in fasting lipid laboratory tests in patients who switched.
Danish: Der var ingen klinisk signifikante ændringer i fastende laboratorieprøver for lipider hos patienter, som skiftede.
English: 2 When data are available from drug-drug interaction studies.
Danish: 2 Når data er tilgængelige fra lægemiddelinteraktionsstudier.
English: At baseline, median eGFR was 56 mL/min, and 33% of patients had an eGFR from 30 to 49 mL/min.
Danish: Ved baseline var median eGFR 56 ml/min, og 33 % af patienterne havde en eGFR fra 30 til 49 ml/min.
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
Danish: In vitro- og kliniske farmakokinetiske lægemiddelinteraktionsstudier har vist, at risikoen for CYP-medierede interaktioner, der involverer emtricitabin og andre lægemidler, er lav.
English: • If you are allergic to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • Hvis De er allergisk over for emtricitabin, tenofoviralafenamid eller et af de øvrige indholdsstoffer i Descovy (angivet i punkt 6 i denne indlægsseddel).
English: Pooled treatment outcomes at 48 and 144 weeks are shown in Table 4.
Danish: Samlede behandlingsresultater efter 48 og 144 uger vises i tabel 4.
English: Table 1: Dose of Descovy according to third agent in the HIV treatment regimen
Danish: Tabel 1: Dosis af Descovy i henhold til behandlingsregime for hiv med et tredje stof
English: Emtricitabine systemic exposure was unaffected when emtricitabine was administered with food.
Danish: Den systemiske eksponering for emtricitabin var ikke påvirket, når emtricitabin blev administreret sammen med mad.
English: Fluconazole Isavuconazole
Danish: Fluconazol Isavuconazol
English: Tenofovir alafenamide exposure is expected to decrease when tipranavir/ritonavir is used in combination with Descovy.
Danish: Tenofoviralafenamid-eksponeringen forventes at falde, når tipranavir/ritonavir anvendes i kombination med Descovy.
English: Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Danish: Emtricitabin absorberes hurtigt og i omfattende grad efter oral administration med maksimale plasmakoncentrationer 1 til 2 timer efter dosering.
English: Descovy containing regimen (n = 333)
Danish: Regime indeholdende Descovy (n = 333)
English: However, a large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Danish: Data fra et stort antal gravide kvinder (mere end 1.000) indikerer imidlertid ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin.
English: Maraviroc Nevirapine Raltegravir
Danish: Maraviroc Nevirapin Raltegravir
English: Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir
Danish: Dolutegravir, efavirenz, maraviroc, nevirapin, rilpivirin, raltegravir
English: No dose adjustment of sertraline is required.
Danish: Dosisjustering af sertralin er ikke nødvendig.
English: Once you start taking Descovy, look out for:
Danish: Når De begynder med at tage Descovy, skal De holde øje med:
English: Do not stop taking Descovy without talking to your doctor.
Danish: Hold ikke op med at tage Descovy uden at tale med Deres læge.
English: Descovy comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Danish: Descovy leveres i beholdere, der indeholder 30 tabletter (med et silicagel-tørremiddel, der skal opbevares i beholderen for at hjælpe med at beskytte tabletterne).
English: Some patients taking combination antiretroviral medicines such as Descovy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der tager antiretroviral kombinationsmedicin, såsom Descovy, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød, forårsaget af manglende blodforsyning til knoglerne).
English: In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion (aids) og som har haft opportunistiske infektioner tidligere (infektioner, der forekommer hos personer med et svagt immunsystem) kan der forekomme tegn og symptomer på betændelse fra tidligere infektioner kort tid efter den antiretrovirale behandling startes.
English: Tenofovir alafenamide exposure is not expected to be affected by maraviroc, nevirapine or raltegravir, nor is it expected to affect the metabolic and excretion pathways relevant to maraviroc, nevirapine or raltegravir.
Danish: Det forventes ikke, at eksponering over for tenofoviralafenamid påvirkes af maraviroc, nevirapin eller raltegravir, og det forventes heller ikke at påvirke metaboliske veje og udskillelsesveje relevante for maraviroc, nevirapin eller raltegravir.
English: 6 Emtricitabine/tenofovir alafenamide was taken with food in this study.
Danish: 6 Emtricitabin/ tenofoviralafenamid blev taget sammen med mad i dette studie.
English: Virologic success rates at Week 48 were: Descovy Containing Regimen: 89.7% (227 of 253 subjects); Abacavir/lamivudine Containing Regimen: 92.7%% (230 of 248 subjects).
Danish: De virologiske succesrater ved uge 48 var: Regime indeholdende Descovy: 89,7 % (227 af 253 patienter); Regimen indeholdende abacavir/lamivudin: 92,7 % (230 af 248 patienter).
English: Do not stop taking Descovy
Danish: Hold ikke op med at tage Descovy
English: Table 7: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Danish: Tabel 7: Farmakokinetik for emtricitabin og tenofoviralafenamid hos antiretroviral-naive unge og voksne
English: The safety and efficacy of Descovy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Danish: Descovys sikkerhed og virkning hos børn under 12 år, eller der vejer < 35 kg, er endnu ikke klarlagt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Descovy 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 Descovy i en eller flere undergrupper af den pædiatriske population ved behandlingen af hiv 1-infektion (se pkt.
English: Emtricitabine did not inhibit the glucuronidation reaction of a non-specific UGT substrate in vitro.
Danish: Emtricitabin hæmmede ikke glucuronidationsreaktionen af et non-specifikt UGT substrat in vitro.
English: 2 This adverse reaction was not observed in the clinical studies of F/TAF-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
Danish: 2 Denne bivirkning blev ikke observeret i kliniske studier med F/TAF-indholdende præparater, men blev identificeret i kliniske studier eller fra erfaring efter markedsføring for emtricitabin ved anvendelse sammen med andre antiretrovirale midler.
English: Most HIV-1 isolates from patients in both treatment groups who developed resistance mutations to elvitegravir in integrase also developed resistance mutations to emtricitabine in RT.
Danish: De fleste hiv 1-isolater fra patienter i begge behandlingsgrupper, der udviklede resistensmutationer over for elvitegravir i integrase, udviklede også resistensmutationer over for emtricitabin i RT.
English: Emtricitabine and tenofovir alafenamide demonstrated synergistic antiviral activity in cell culture.
Danish: Emtricitabin og tenofoviralafenamid viste synergistisk antiviral aktivitet i cellekultur.
English: Patients co-infected with HIV and HBV who discontinue Descovy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Danish: Patienter med hiv-infektion, som samtidig er inficerede med HBV, og som ophører med Descovy, bør monitoreres tæt med opfølgning både klinisk og i laboratoriet i mindst adskillige måneder efter, behandlingen med Descovy ophører.
English: Adults and adolescents aged 12 years and older, weighing at least 35 kg Descovy should be administered as shown in Table 1.
Danish: Voksne og unge i alderen 12 år og ældre, der vejer mindst 35 kg Descovy skal administreres som vist i tabel 1.
English: There are no or limited data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af tenofoviralafenamid til gravide kvinder.
English: Dose of Descovy
Danish: Dosis af Descovy
English: 1 When doses are provided, they are the doses used in clinical drug-drug interaction studies.
Danish: 1 Når der er angivet doser, er det de doser, der er anvendt i kliniske lægemiddelinteraktionsstudier.
English: In vitro Reduced susceptibility to emtricitabine is associated with M184V/I mutations in HIV-1 RT.
Danish: In vitro Nedsat følsomhed for emtricitabin er forbundet med M184V/I-mutationer i hiv 1 RT.
English: Descovy blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply.
Danish: Descovy hæmmer virkningen af revers transkriptase-enzymet, som er afgørende for, at virusmængden kan øges.
English: The mean steady state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
Danish: Den gennemsnitlige steady-state minimale plasmakoncentration 24 timer efter dosering var lig med eller større end den gennemsnitlige in vitro IC90-værdi for anti-hiv 1-aktivitet.
English: Polyvinyl alcohol Titanium dioxide Macrogol 3350
Danish: Polyvinylalkohol Titandioxid Macrogol 3350
English: Atazanavir with ritonavir or cobicistat Darunavir with ritonavir or cobicistat1 Lopinavir with ritonavir
Danish: Atazanavir sammen med ritonavir eller cobicistat Darunavir sammen med ritonavir eller cobicistat1 Lopinavir sammen med ritonavir
English: There are limited clinical data on the use of E/C/F/TAF in HIV/HBV co-infected patients who are treatment-naïve.
Danish: Der er begrænsede kliniske data vedrørende brugen af E/C/F/TAF hos patienter med samtidig infektion med hiv/HBV, som er behandlingsnaive.
English: E/C/F/TAF demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
Danish: E/C/F/TAF udviste statistisk superioritet ved at opnå hiv 1-rna < 50 kopier/ml, sammenlignet med E/C/F/TDF ved uge 144.
English: Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Danish: Tenofovir elimineres af nyrerne, både ved glomerulusfiltration og aktiv tubulær sekretion.
English: What you need to know before you take Descovy Do not take Descovy:
Danish: Det skal De vide, før De begynder at tage Descovy Tag ikke Descovy:
English: ANTICONVULSANTS Oxcarbazepine Phenobarbital Phenytoin
Danish: ANTIKONVULSIVA Oxcarbazepin Phenobarbital Phenytoin
English: In these 2 patients, no amino acid substitutions associated with resistance to any of the components of E/C/F/TAF were identified in HIV-1 or HBV.
Danish: Hos disse 2 patienter blev ingen aminosyresubstitutioner forbundet med resistens over for nogen af komponenterne i E/C/F/TAF identificeret i hiv-1 eller HBV.
English: Contents of the pack and other information What Descovy contains
Danish: Pakningsstørrelser og yderligere oplysninger Descovy indeholder:
English: Male Female
Danish: Køn Mand Kvinde
English: Medicinal product by therapeutic areas1
Danish: Lægemiddel i henhold til terapeutiske områder1
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thioldelen, så der dannes 3'-sulfoxid-diastereomere (~ 9 % af dosen) og konjugering med glucuronsyre til at danne 2'-O-glucuronid (~ 4 % af dosen).
English: If you vomit less than 1 hour after taking Descovy, take another tablet.
Danish: Hvis De kaster op mindre end 1 time efter, De har taget Descovy, skal De tage en ny tablet.
English: Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL
Danish: Viral load ved baseline ≤ 100.000 kopier/ml > 100.000 kopier/ml
English: Third agent in HIV treatment regimen (see section 4.5)
Danish: Tredje stof i behandlingsregime for hiv (se pkt.
English: 7 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposurers expected in HCV-infected patients.
Danish: 7 Studie udført med yderligere 100 mg voxilaprevir for at opnå de voxilaprevir-eksponeringer, der forventes hos HCV
English: Tipranavir/ritonavir results in P-gp induction.
Danish: Tipranavir/ritonavir fører til P-gpinduktion.
English: Sofosbuvir metabolite GS-331007:
Danish: Sofosbuvir-metabolit GS-331007:
English: Patients receiving Descovy or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and, therefore, should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: Patienter, som får Descovy eller anden antiretroviral behandling, har fortsat risiko for opportunistiske infektioner eller andre hiv-relaterede komplikationer, og bør derfor følges nøje af læger med erfaring i behandlingen af patienter med hiv-associerede sygdomme.
English: The frequencies were derived from Phase 3 E/C/F/TAF clinical studies in 866 treatment-naïve adult patients through 144 weeks of treatment (GS-US-292-0104 and GS-US-292-0111).
Danish: Hyppighederne blev afledt fra fase 3 E/C/F/TAF kliniske studier hos 866 behandlingsnaive voksne patienter til og med 144 ugers behandling (GS-US-292-0104 og GS-US-292-0111).
English: PI = protease inhibitor a Week 48 window was between Day 294 and 377 (inclusive).
Danish: PI = proteasehæmmer a Uge 48-vinduet var fra dag 294 til 377 (inklusive).
English: You can also report side effects directly via the national reporting system listed in Appendix V.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V.
English: Descovy in combination with other medicines is for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Danish: Descovy i kombination med andre lægemidler er til behandling af infektion med humant immundefekt virus 1 (hiv 1) hos voksne og unge i alderen 12 år og ældre, som vejer mindst 35 kg.
English: ANTI-INFECTIVES Antifungals Ketoconazole Itraconazole
Danish: ANTIINFEKTIVA Antimykotika Ketoconazol Itraconazol
English: No data are available to make dose recommendations in children less than 18 years with end stage renal disease.
Danish: Der er ingen data tilgængelige til at lave dosisanbefalinger hos børn under 18 år med nyresygdom i slutstadiet.
English: Relative to fasting conditions, the administration of tenofovir alafenamide with a high fat meal (~800 kcal, 50% fat) resulted in a decrease in tenofovir alafenamide Cmax (15-37%) and an increase in AUClast (17-77%).
Danish: I forhold til fastende tilstand førte administrationen af tenofoviralafenamid sammen med et måltid med højt fedtindhold (~800 kcal, 50 % fat) til en reduktion i tenofoviralafenamid Cmax (15-37 %) og en forhøjelse i AUClast (17-77 %).
English: No dose adjustment of ledipasvir or sofosbuvir is required.
Danish: Dosisjustering af ledipasvir eller sofosbuvir er ikke nødvendig.
English: The safety of emtricitabine and tenofovir alafenamide has not been established in these patients.
Danish: Sikkerheden af emtricitabin og tenofoviralafenamid er ikke klarlagt hos disse patienter.
English: emtricitabine and tipranavir
Danish: emtricitabin og tipranavir
English: Antimycobacterials Rifabutin
Danish: Antimykobakterielle lægemidler Rifabutin
English: At Week 48, the median percentage change in urine retinol binding protein to creatinine ratio was 4% in the Descovy group and 16% in those remaining on an abacavir/lamivudine containing regimen; and in urine beta-2 microglobulin to creatinine ratio it was 4% vs. 5%.
Danish: I uge 48 var den gennemsnitlige procentvise ændring i urinretinolbindende protein til kreatininforhold 4 % i Descovygruppen og 16 % hos dem, som blev på et abacavir/lamivudin-baseret regimen; og i urin var forholdet af beta 2-mikroglobulin til kreatinin 4 % vs. 5 %.
English: Treatment outcomes of Study GS-US-311-1089 through 48 and 96 weeks are presented in Table 6.
Danish: Behandlingsresultaterne for studie GS-US-311-1089 til og med uge 48 og 96 vises i tabel 6.
English: If a patient misses a dose of Descovy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Descovy i mere end 18 timer, skal patienten ikke tage den manglende dosis, men blot fortsætte med den normale doseringsplan.
English: The safety profile in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Danish: Sikkerhedsprofilen hos patienter med let til moderat nedsat nyrefunktion lignede den for patienter med normal nyrefunktion (se pkt.
English: a n = 24 adolescents (GS-US-292-0106); n = 19 adults (GS-US-292-0102) b n = 23 adolescents (GS-US-292-0106, population PK analysis) c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis)
Danish: a n = 24 unge (GS-US-292-0106), n = 19 voksne´ (GS-US-292-0102) b n = 23 unge (GS-US-292-0106, populationsfarmakokinetisk analyse) c n = 539 (TAF) eller 841 (TFV) voksne (GS-US-292-0111 og GS-US-292-0104, populationsfarmakokinetisk analyse)
English: If you forget to take Descovy
Danish: Hvis De har glemt at tage Descovy
English: The safety and efficacy of Descovy in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Danish: Descovys sikkerhed og virkning hos patienter, som samtidig er inficerede med hiv 1- og hepatitis C-virus (HCV) er ikke klarlagt.
English: Darunavir, cobicistat and emtricitabine/tenofovir disoproxil fumarate (n = 50)
Danish: Darunavir, cobicistat og emtricitabin/tenofovir disoproxilfumarat (n = 50)
English: Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 3,112 HIV-1 infected patients received medicinal products containing emtricitabine and tenofovir alafenamide and from post-marketing experience.
Danish: Vurderingen af bivirkninger er baseret på sikkerhedsdata fra alle fase 2- og 3-studier, hvor 3.112 hiv 1-inficerede patienter fik lægemidler, der indeholdt emtricitabin og tenofoviralafenamid samt på erfaringer efter markedsføring.
English: Descovy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil.
Danish: Descovy bør ikke indgives samtidigt med lægemidler, som indeholder tenofoviralafenamid, tenofovirdisoproxil, emtricitabin, lamivudin eller adefovirdipivoxil.
English: The mean age was 58 years (range: 24-82), with 63 patients (26%) who were ≥ 65 years of age.
Danish: Gennemsnitsalderen var 58 år (interval: 24-82) med 63 patienter (26 %), som var ≥ 65 år.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Descovy findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In a study in virologically suppressed adult patients measures of tubular proteinuria were similar in patients switching to a regimen containing Descovy compared to patients who stayed on an abacavir/lamivudine containing regimen at baseline.
Danish: I et studie med virologisk supprimerede voksne patienter var målinger af tubulær proteinuri tilsvarende hos patienter, der skiftede til et regime indeholdende Descovy sammenlignet med patienter, som blev på et abacavir/lamivudin-baseret regime ved baseline.
English: 1 With the exception of angioedema, anaemia and urticaria (see footnotes 2, 3 and 4), all adverse reactions were identified from clinical studies of F/TAF containing products.
Danish: 1 Med undtagelse af angioødem, anæmi og urticaria (se fodnote 2, 3 og 4) blev alle bivirkninger identificeret fra kliniske studier med præparater, der indeholdt F/TAF.
English: Therefore, Descovy should not be used during breast-feeding.
Danish: Descovy må derfor ikke anvendes under amning.
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 Descovy.
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 Descovy.
English: While you are taking Descovy
Danish: Mens De tager Descovy
English: If the patient misses a dose of Descovy within 18 hours of the time it is usually taken, the patient should take Descovy as soon as possible and resume the normal dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Descovy inden for 18 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Descovy så snart som muligt og derefter fortsætte med den normale doseringsplan.
English: • anticonvulsants, used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital and phenytoin
Danish: • antikonvulsiva, der anvendes til at behandle epilepsi, såsom: carbamazepin, oxcarbazepin, phenobarbital og phenytoin
English: Bone toxicity was observed as reduced BMD in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Descovy.
Danish: Knogletoksicitet blev observeret som nedsat BMD hos rotter og hunde ved eksponeringer for tenofovir, der var mindst fire gange større, end hvad der forventes efter administration af Descovy.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which may be life-threatening.
Danish: Hos nogle patienter med fremskreden leversygdom eller cirrose kan det medføre en forværring af hepatitis hvis behandlingen stoppes, hvilket kan være livstruende.
English: It is important not to miss a dose of Descovy.
Danish: Det er vigtigt, at De husker at tage hver dosis af Descovy.
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Danish: Der har været rapporter om en stor hyppighed af virologiske svigt og fremkomst af resistens på et tidligt stadium, når tenofovirdisoproxil blev kombineret med lamivudin og abacavir samt lamivudin og didanosin som et regime med behandling én gang dagligt.