FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 Study conducted with emtricitabine/tenofovir disoproxil + darunavir (800 mg) + ritonavir (100 mg).
Danish: 7 Studiet blev udført med emtricitabin/tenofovir disoproxil + darunavir (800 mg) + ritonavir (100 mg).
English: The most frequently reported adverse reactions to Stribild in clinical studies through 48 weeks in virologically-suppressed adult patients were nausea (3% to 5%) and fatigue (6%).
Danish: De hyppigst indberettede bivirkninger forbundet med Stribild i kliniske studier igennem 48 uger hos virologisk supprimerede voksne patienter var kvalme (3 % til 5 %) og træthed (6 %).
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Danish: Både emtricitabintriphosphat og tenofovirdiphosphat er svage hæmmere af pattedyrs dna-polymeraser, og der var intet tegn på toksicitet over for mitokondrier in vitro eller in vivo.
English: The EC50 values for tenofovir were in the range of 0.04 to 8.5 µM.
Danish: EC50værdierne for tenofovir var i intervallet fra 0,04 til 8,5 µM.
English: The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Danish: Nedbrydning af muskelvæv, kalktab fra knoglerne (med knoglesmerter; kan nogle gange resultere i knoglebrud), muskelsmerter, muskelsvaghed og fald i blodets kalium- eller fosfatindhold kan forekomme som følge af beskadigelse af de tubulære celler i nyrerne.
English: elevated creatine kinase1
Danish: forhøjet kreatinkinase1
English: Following oral administration of Stribild with food in HIV-1 infected subjects, peak plasma concentrations were observed 4 hours post-dose for elvitegravir, 3 hours post-dose for cobicistat, 3 hours post-dose for emtricitabine, and 2 hours for tenofovir following the rapid conversion of tenofovir disoproxil.
Danish: Efter oral administration af Stribild sammen med mad hos hiv 1-inficerede personer blev maksimale plasmakoncentrationer observeret 4 timer efter dosering for elvitegravir, 3 timer efter dosering for cobicistat, 3 timer efter dosering for emtricitabin og 2 timer for tenofovir efter den hurtige konvertering af tenofovirdisoproxil.
English: In vitro studies indicate that emtricitabine is not an inhibitor of human CYP450 enzymes.
Danish: In vitro-studier indikerer, at emtricitabin ikke er en hæmmer af humane CYP450-enzymer.
English: The use of Stribild in children below 12 years of age and who weigh less than 35kg has not been studied.
Danish: Anvendelsen af Stribild til børn under 12 år, som vejer under 35 kg, er ikke undersøgt.
English: What you need to know before you take Stribild Do not take Stribild
Danish: Det skal De vide, før De begynder at tage Stribild Tag ikke Stribild
English: Co-administration with Stribild may lead to increased tenofovir exposure.
Danish: Samtidig administration af Stribild kan medføre øget tenofovir-eksponering.
English: Moreover, the reversibility of renal toxicity cannot be fully ascertained.
Danish: Derudover er der ikke fuldstændig vished om reversibiliteten af nyretoksicitet.
English: • any signs of inflammation or infection • bone problems
Danish: • ethvert tegn på betændelse eller infektion • knogleproblemer
English: Therefore, information regarding drug-drug interactions with other antiretroviral products (including protease inhibitors and non-nucleoside reverse transcriptase inhibitors) is not provided (see section 4.4).
Danish: Derfor gives der ikke information om lægemiddelinteraktioner med andre antiretrovirale præparater (herunder proteasehæmmere og non-nukleosid-revers transkriptase-hæmmere) (se pkt.
English: Stribild film-coated tablets are green, capsule-shaped tablets, debossed on one side with “GSI” and the number “1” surrounded by a square box on the other side of the tablet.
Danish: Stribild filmovertrukne tabletter er grønne, kapselformede tabletter, på den ene side præget med „GSI“ og tallet „1“, omgivet af en kvadratisk æske på den anden side af tabletten.
English: • any other medicines containing: tenofovir disoproxil tenofovir alafenamide lamivudine adefovir dipivoxil
Danish: • alle andre lægemidler, der indeholder: tenofovirdisoproxil tenofoviralafenamid lamivudin adefovirdipivoxil
English: Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with Stribild.
Danish: Cobicistat hæmmer MATE1 reversibelt, og koncentrationer af metformin kan øges ved samtidig administration af Stribild.
English: If Stribild is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule.
Danish: Hvis Stribild bruges samtidig med nefrotoksiske lægemidler, skal nyrefunktionen monitoreres tæt i henhold til det anbefalede skema.
English: • immunosuppressants, used to control your body's immune response after a transplant, such as: ciclosporin, sirolimus and tacrolimus
Danish: • immunundertrykkende midler, anvendes til at kontrollere kroppens immunrespons efter en transplantation, såsom: ciclosporin, sirolimus og tacrolimus
English: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir have not been evaluated in the elderly (over 65 years).
Danish: Elvitegravirs, cobicistats, emtricitabins og tenofovirs farmakokinetik er ikke blevet evalueret hos ældre patienter (over 65 år).
English: Reduced susceptibility to elvitegravir was most commonly associated with the integrase substitutions T66I, E92Q and Q148R.
Danish: Nedsat følsomhed for elvitegravir var hyppigst forbundet med integrasesubstitutionerne T66I, E92Q og Q148R.
English: Interaction not studied with Stribild.
Danish: Interaktion er ikke undersøgt med Stribild.
English: The EC50 values for emtricitabine were in the range of 0.0013 to 0.64 µM.
Danish: EC50værdierne for emtricitabin var i intervallet fra 0,0013 til 0,64 µM.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Stribild findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Of these discontinuations, 7 in the Stribild group and 1 in the ATV/r+FTC/tenofovir disoproxil group occurred during the first 48 weeks.
Danish: Af disse seponeringer forekom 7 i Stribild-gruppen og 1 i gruppen med ATV/r+FTC/tenofovirdisoproxil i løbet af de første 48 uger.
English: Antiviral synergy was maintained for elvitegravir, emtricitabine, and tenofovir when tested in the presence of cobicistat.
Danish: Antiviral synergi blev opretholdt for elvitegravir, emtricitabin og tenofovir, når det blev testet mens cobicistat var til stede.
English: Stribild is also used to treat HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that have caused side effects.
Danish: Stribild anvendes også til behandling af unge i alderen 12 til under 18 år med hiv 1-infektion, som vejer mindst 35 kg, og som allerede er blevet behandlet med anden hiv-medicin, der har forårsaget bivirkninger.
English: The results reported from a prospective study (IMPAACT P1026s) showed that treatment with cobicistat and elvitegravir-containing regimens during pregnancy results in lower elvitegravir and cobicistat exposures (Table 5).
Danish: De indberettede resultater fra et prospektivt studie (IMPAACT P1026s) viste, at behandling med regimer indeholdende cobicistat og elvitegravir under graviditet medfører lavere eksponering for elvitegravir og cobicistat (Tabel 5).
English: Women of childbearing potential / contraception in males and females The use of Stribild must be accompanied by the use of effective contraception (see section 4.5).
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Anvendelsen af Stribild skal ledsages af anvendelse af effektiv kontraception (se pkt.
English: • breakdown of muscle, muscle pain or weakness
Danish: • nedbrydning af muskelvæv, muskelsmerter og -svaghed
English: Stribild renal educational brochure for prescribers of adolescent patients.
Danish: Den renale uddannelsesbrochure for Stribild til læger, der ordinerer til unge patienter.
English: When administering with Stribild, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Danish: Ved samtidig administration af Stribild bør den maksimale daglige dosis af ketoconazol ikke overskride 200 mg daglig.
English: The types of renal adverse reactions seen with Stribild were consistent with previous experience with tenofovir disoproxil.
Danish: De observerede typer af nyrebivirkning med Stribild var i overensstemmelse med tidligere erfaring for tenofovirdisoproxil.
English: The laboratory findings in these 4 subjects with evidence of proximal tubulopathy improved without clinical consequence upon discontinuation of Stribild, but did not completely resolve in all subjects.
Danish: Laboratorieparametrene hos disse 4 personer med bevis for proksimal tubulopati forbedredes uden kliniske konsekvenser ved seponering af Stribild, men normaliseredes ikke helt hos alle personer.
English: • decreased phosphate in your blood
Danish: • fald i phosphat i blodet
English: Renal and bone effects in adults
Danish: Virkninger på nyrer og knogler hos voksne
English: HIV-1 with the raltegravir-selected substitutions T66A/K, Q148H/K, and N155H showed cross-resistance to elvitegravir.
Danish: Hiv 1 med raltegravir-udvalgte substitutioner T66A/K, Q148H/K og N155H viste krydsresistens over for elvitegravir.
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
Danish: I et 144-ugers kontrolleret, klinisk studie, som sammenlignede tenofovirdisoproxil med stavudin i kombination med lamivudin og efavirenz hos antiretroviral-naive patienter, sås mindre reduktioner i BMD i hoften og rygraden hos begge behandlingsgrupper.
English: elevated amylase including elevated pancreatic amylase1, elevated serum lipase1, abdominal pain, dyspepsia, constipation, abdominal distension1, flatulence
Danish: forhøjet amylase herunder forhøjet pancreasamylase1, forhøjet serum-lipase1, abdominalsmerter, dyspepsi, forstoppelse, abdominal udspiling1, flatulens
English: Cobicistat is metabolised via CYP3A and/or CYP2D6-mediated oxidation and does not undergo glucuronidation.
Danish: Cobicistat metaboliseres via CYP3A og/eller CYP2D6-medieret oxidation og gennemgår ikke glukuronidation.
English: If the patient vomits within 1 hour of taking Stribild another tablet should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Stribild, skal der tages en ny tablet.
English: Possible serious side effects: tell a doctor immediately
Danish: Alvorlige bivirkninger: Fortæl det straks til lægen
English: If the patient misses a dose of Stribild within 18 hours of the time it is usually taken, the patient should take Stribild with food as soon as possible and resume the normal dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Stribild i mindre end 18 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Stribild sammen med mad så snart som muligt og derefter fortsætte med den normale doseringsplan.
English: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Danish: Ved uge 48 havde seks unge i tenofovirdisoproxilgruppen og én ung i placebogruppen signifikant BMD-tab i columna lumbalis (defineret som > 4 % tab).
English: Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion.
Danish: Emtricitabin og tenofovir elimineres primært gennem nyrerne ved en kombination af glomerulusfiltration og aktiv tubulær sekretion.
English: • Children given emtricitabine very commonly experienced changes in skin colour including darkening of the skin in patches
Danish: • En meget almindelig bivirkning hos børn, der får emtricitabin, er ændringer i hudfarven, herunder - mørke pletter i huden
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (rats and dogs).
Danish: Knogletoksicitet blev diagnosticeret som osteomalaci (aber) og nedsat knoglemineraltæthed (rotter og hunde).
English: rhabdomyolysis1,3, muscular weakness1,3
Danish: rhabdomyolyse1,3, muskelsvækkelse1,3
English: If Stribild is co-administered with an NSAID, renal function should be monitored adequately.
Danish: Hvis Stribild administreres samtidig med et NSAID, bør nyrefunktionen monitoreres på passende vis.
English: Therefore Stribild should not be used during breast-feeding.
Danish: Stribild bør derfor ikke anvendes under amning.
English: It is not known whether elvitegravir or cobicistat are excreted in human milk.
Danish: Det er ukendt, om elvitegravir eller cobicistat udskilles i human mælk.
English: Patients co-infected with HIV and HBV who discontinue Stribild 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 Stribild, bør monitoreres tæt med både klinisk og laboratorisk opfølgning i mindst adskillige måneder efter, behandlingen med
English: No dose adjustment of clarithromycin is required for patients with normal renal function or mild renal impairment (ClCr 60-90 mL/min).
Danish: Der kræves ingen dosisjustering af clarithromycin for patienter med normal og let nedsat nyrefunktion (ClCr 60-90 ml/min).
English: insomnia, abnormal dreams
Danish: søvnløshed, unormale drømme
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Danish: Titandioxid (E171)
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/mL.
Danish: Tenofovirs proteinbinding in vitro til plasma- eller serumproteiner var mindre end henholdsvis 0,7 og 7,2 % i tenofovirkoncentrationsområdet på 0,01-25 µg/ml.
English: neutropenia1
Danish: neutropeni1
English: That use of Stribild should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Danish: Brug af Stribild bør undgås ved samtidig eller nylig brug af nefrotoksiske lægemidler.
English: • yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver (hepatitis)
Danish: • gul hud eller gule øjne, kløe eller mavesmerter på grund af betændelse i leveren (hepatitis)
English: Patients had to be stably suppressed for at least six months prior to study entry, have no current or past history of resistance to the antiretroviral components of Stribild, and have HIV-1 RNA < 50 copies/mL at screening.
Danish: Patienterne skulle være stabilt supprimerede i mindst seks måneder, før de indgik i studiet, de måtte ikke have nogen aktuel eller tidligere resistens over for de antiretrovirale indholdsstoffer Stribild, og de skulle have hiv 1-rna < 50 kopier/ml ved screening.
English: In infants and children older than 4 months, the majority of patients taking emtricitabine achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/ml and 77% achieved ≤ 50 copies/ml).
Danish: Hos spædbørn og børn over 4 måneder opnåede eller opretholdt størstedelen af de patienter, der fik emtricitabin, fuldstændig suppression af hiv 1 rna igennem 48 uger (89 % opnåede ≤ 400 kopier/ml, og 77 % opnåede ≤ 50 kopier/ml).
English: Renal function (creatinine clearance and urine glucose and urine protein) should be evaluated prior to treatment initiation, and creatinine clearance, serum phosphate, urine glucose and urine protein should be monitored during treatment as in HIV-1 infected adults (see above).
Danish: Nyrefunktionen (kreatininclearance og uringlucose og urinprotein) bør evalueres inden opstart af behandlingen, og kreatininclearance, serumphosphat, uringlucose og urinprotein bør monitoreres under behandlingen på samme måde som hos hiv 1-inficerede voksne (se ovenfor).
English: Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Danish: Emtricitabin-resistente virus med M184V/I-substitution var krydsresistente over for lamivudin, men havde bevaret følsomhed for didanosin, stavudin, tenofovir og zidovudin.
English: Exposures of elvitegravir and tenofovir in paediatric patients aged 12 to <18 years who received Stribild in GS-US-236-0112 were increased by 30% and 37% respectively, when compared with historical adult controls.
Danish: Eksponeringen for elvitegravir og tenofovir hos pædiatriske patienter i alderen 12 til < 18 år, som fik Stribild i GS-US-236-0112, steg med hhv. 30 % og 37 % i forhold til historiske kontrolværdier hos voksne.
English: renal failure4, proximal renal tubulopathy including Fanconi syndrome acquired4, proteinuria
Danish: nyresvigt4, proksimal renal tubulopati, herunder erhvervet Fanconis syndrome4, proteinuri
English: Elvitegravir is a modest inducer and may have the potential to induce CYP2C9 and/or inducible UGT enzymes; as such it may decrease the plasma concentration of substrates of these enzymes.
Danish: Elvitegravir er en moderat inducer og indebærer en risiko for at inducere CYP2C9 og/eller inducerbare UGT-enzymer, og i derved reducere plasmakoncentrationen af substrater for disse enzymer.
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 Stribild.
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 Stribild.
English: If concomitant use of Stribild and nephrotoxic agents is unavoidable, renal function must be monitored weekly.
Danish: Hvis samtidig brug af Stribild og nefrotoksiske midler ikke kan undgås, skal nyrefunktionen monitoreres ugentligt.
English: All 48 patients who received at least one dose of Stribild remained suppressed (HIV-1 RNA < 50 copies/mL) through Week 48.
Danish: Alle 48 patienter, som fik mindst én dosis Stribild, var fortsat supprimerede (hiv 1-rna < 50 kopier/ml) til og med uge 48.
English: increased blood creatinine4
Danish: forhøjet kreatinin i blodet4
English: Buprenorphine/Naloxone/ Elvitegravir/Cobicistat
Danish: Buprenorphin/Naloxon/ Elvitegravir/Cobicistat
English: Creatinine clearance, serum phosphate, urine glucose and urine protein should be monitored every four weeks during the first year and then every three months during Stribild therapy.
Danish: Kreatininclearance, serumphosphat, glucose og protein i urinen bør monitoreres hver fjerde uge i løbet af det første år og derefter hver tredje måned i løbet af behandlingen med Stribild.
English: Creatinine clearance should be calculated and urine glucose and urine protein should be determined in all patients.
Danish: Kreatininclearance bør beregnes og glucose og protein i urinen bør bestemmes hos alle patienter.
English: In Study GS-US-236-0123, patients had to have previously only received RAL in combination with FTC/tenofovir disoproxil as their first antiretroviral regimen for at least six months.
Danish: I studie GS-US-236-0123 måtte patienterne kun tidligere have fået RAL i kombination med FTC/tenofovirdisoproxil som deres første antiretrovirale behandlingsregime i mindst seks måneder.
English: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Stribild with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Danish: Da emtricitabin og tenofovir primært udskilles gennem nyrerne, kan administration af Stribild sammen med lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær sekretion (f.eks. cidofovir), øge serumkoncentrationerne af emtricitabin, tenofovir og/eller de samtidigt administrerede lægemidler.
English: While you are taking Stribild
Danish: Mens De tager Stribild
English: Each tablet contains 10.9 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder 10,9 mg lactose (som monohydrat).
English: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Danish: Der er aktuelt utilstrækkelige data til at bedømme, om samtidig administration af tenofovirdisoproxil og cobicistat er forbundet med en større risiko for nyrebivirkninger, sammenlignet med behandlingsregimer, der inkluderer tenofovirdisoproxil uden cobicistat.
English: For elvitegravir, Cmax and AUC increased 22% and 36% with a light meal, while increasing 56% and 91% with a high-fat meal, respectively.
Danish: For elvitegravir var Cmax og AUC øget med hhv. 22 % og 36 % sammen med et let måltid, mens de øgedes med hhv. 56 % og 91 % sammen med et måltid med højt fedtindhold.
English: That tenofovir disoproxil fumarate may cause a reduction in BMD and the effects of tenofovir disoproxil fumarate associated changes in BMD on long term bone health and future fracture risk are currently unknown in adolescent patients.
Danish: At tenofovirdisoproxilfumarat kan forårsage en reduktion i BMD, og at virkningerne af tenofovirdisoproxilfumarat-forbundne forandringer i BMD på den langsigtede knoglesundhed og risikoen for senere fraktur hos unge patienter ikke er kendt på nuværende tidspunkt.
English: • antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin or telithromycin
Danish: • antibiotika, anvendes til at behandle bakterieinfektioner, herunder tuberkulose, der indeholder: rifabutin, clarithromycin eller telithromycin
English: Resistance to emtricitabine or tenofovir has been seen in vitro and in the HIV-1 from some patients due to the development of the M184V or M184I emtricitabine resistance substitution in reverse transcriptase or the K65R tenofovir resistance substitution in reverse transcriptase.
Danish: Der er observeret resistens over for emtricitabin eller tenofovir in vitro og i hiv 1 fra nogle patienter på grund af udvikling af M184V- eller M184I-substitution, der medfører emtricitabin-resistens i revers transkriptase eller K65R-substitution, der medfører tenofovir-resistens i revers transkriptase.
English: Stribild is not recommended in this population (see section 4.2).
Danish: Stribild bør ikke anvendes til denne population (se pkt.
English: No emergent resistance to Stribild was detected through Week 48.
Danish: Der blev ikke fundet ny resistens over for Stribild til og med uge 48.
English: Stribild is indicated for use as a complete regimen for the treatment of HIV-1 infection and must not be administered with other antiretroviral products.
Danish: Stribild er indiceret som et komplet behandlingsregime til behandling af hiv 1-infektion og må ikke administreres sammen med andre antiretrovirale præparater.
English: As of Week 144, the development of one or more primary elvitegravir, emtricitabine, or tenofovir resistance-associated substitutions was observed in 18 of the 42 patients with evaluable genotypic data from paired baseline and Stribild treatment-failure isolates (2.6%, 18/701 patients).
Danish: Ved uge 144 blev udvikling af en eller flere primære elvitegravir-, emtricitabin- eller tenofovir-resistensassocierede substitutioner observeret hos 18 ud af de 42 patienter med evaluerbare genotypedata fra parrede isolater ved baseline og efter behandlingssvigt med Stribild (2,6 %, 18/701 patienter).