FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
Danish: Som følge af studiets begrænsninger blev der ikke påvist nogen fordel ved tenofovirdisoproxil i forhold til placebo på baggrund af hiv 1 rna-niveauer i plasma ved uge 24.
English: Your doctor may do blood tests to see if your kidneys are working properly
Danish: Deres læge kan tage blodprøver for at se, om Deres nyrer fungerer ordentligt
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Stribild.
Danish: Det anbefales at overvåge den internationale normaliserede ratio (INR) ved samtidig administration af Stribild.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000
Danish: Hyppighed er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) eller sjælden (≥ 1/10.000 til < 1/1.000).
English: For information on other acid reducing agents (e.g. H2-receptor antagonists and proton pump inhibitors), see Studies conducted with other medicinal products.
Danish: For information om andre syrereducerende stoffer (f.eks. H2-receptorantagonister og protonpumpehæmmere), se Studier, der blev udført med andre lægemidler.
English: 5 The predominant circulating metabolite of sofosbuvir.
Danish: 5 Den primære cirkulerende sofosbuvirmetabolit.
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: Therefore, Stribild should not be co-administered with medicinal products that include, but are not limited to, the following (see section 4.5):
Danish: Derfor bør Stribild ikke administreres samtidig med lægemidler, der omfatter, men ikke er begrænset til, følgende (se pkt.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Stribild in adolescent patients are provided with a physician educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere/bruge Stribild til unge patienter, forsynes med en uddannelsespakke til læger, der indeholder følgende:
English: Twenty patients from these studies who switched to Stribild had the NNRTI-associated K103N substitution in their historical genotype prior to starting initial antiretroviral therapy.
Danish: I disse studier havde tyve patienter, der skiftede til Stribild, den NNRTI-associerede K103N-substitution i deres historiske genotype, før de startede den initiale antiretrovirale behandling.
English: The median terminal plasma half-life of elvitegravir following administration of Stribild is approximately 12.9 hours.
Danish: Den mediane terminale halveringstid i plasma for elvitegravir efter administration af Stribild er ca. 12,9 timer.
English: Tell your doctor or pharmacist if you are taking any other medicines or have recently taken any.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Thirteen percent of the dose was recovered in the urine as three putative metabolites.
Danish: 13 procent af dosis blev genfundet i urinen som tre putative metabolitter.
English: • passing a lot of urine and feeling thirsty (nephrogenic diabetes insipidus)
Danish: • udskillelse af store mængder urin og en fornemmelse af at være tørstig (nefrogen diabetes insipidus)
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)1,3,5, myopathy1,3
Danish: osteomalaci (manifesterer sig som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer)1,3,5, myopati1,3
English:  If any of these applies to you, you should not take Stribild and you should tell your doctor immediately.
Danish:  Hvis noget af dette gælder for Dem, må De ikke tage Stribild og De skal omgående fortælle Deres læge det.
English: Stribild comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Danish: Stribild leveres i tabletbeholdere, der indeholder 30 tabletter (med et silicagel-tørremiddel, der skal opbevares i beholderen for at hjælpe med at beskytte tabletterne).
English: If you vomit less than 1 hour after taking Stribild, take another tablet with food.
Danish: Hvis De kaster op mindre end 1 time efter, De har taget Stribild, skal De tage en ny tablet sammen med mad.
English: No development of resistance to cobicistat can be demonstrated in HIV-1 in vitro due to its lack of antiviral activity.
Danish: Resistens over for cobicistat kan ikke påvises i hiv 1 in vitro som følge af den manglende antivirale aktivitet.
English: Among them, 3 patients experienced a clinically meaningful decline in estimated GFR during therapy which improved after discontinuation of tenofovir disoproxil.
Danish: Blandt disse oplevede tre patienter en klinisk betydelig reduktion i estimeret GFR under behandlingen, som blev bedre efter seponering af tenofovirdisoproxil.
English: Orally administered midazolam Triazolam
Danish: Oralt administret midazolam Triazolam
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Silicagel-tørremidlet er i et separat brev eller en separat beholder, og må ikke sluges.
English: If appropriate, initiation of hepatitis B therapy may be warranted.
Danish: Påbegyndelse af hepatitis B-behandlingen kan være nødvendig.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system (human organic anion transporter [hOAT1]) with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Danish: Tenofovir udskilles primært af nyrerne både ved filtration og et aktivt tubulært transportsystem (human organisk aniontransporter [hOAT1]), hvor ca. 70-80 % af dosen udskilles uomdannet i urinen efter intravenøs administration.
English: Patients were randomised in a 2:1 ratio to either switch to Stribild or stay on their baseline antiretroviral regimen (SBR) for 48 weeks.
Danish: Patienterne blev randomiseret i forholdet 2:1 til enten skift til Stribild eller til at forblive i deres baseline antiretrovirale behandlingsregime (SBR) i 48 uger.
English: • increased levels of creatine kinase in the blood that may result in muscle pain and weakness
Danish: • forhøjet kreatinkinase-niveau i blodet, hvilket kan resultere i muskelsmerter og muskelsvaghed
English: Interrupting treatment with Stribild should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Det bør også overvejes at afbryde behandlingen med Stribild i tilfælde af progressiv forværring af nyrefunktionen, hvis der ikke er identificeret nogen anden årsag.
English: • lactic acidosis (see Possible serious side effects: tell a doctor immediately)
Danish: • laktatacidose (se Alvorlige bivirkninger: Fortæl det straks til lægen)
English: • softening of the bones (with bone pain and sometimes resulting in fractures)
Danish: • kalktab fra knoglerne (med knoglesmerter; kan nogle gange resultere i knoglebrud)
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: I tillæg til opportunistiske infektioner kan der også opstå autoimmunsygdomme (en tilstand der opstår, når immunsystemet angriber sundt kropsvæv), efter De begynder at tage lægemidler til behandling af Deres hiv-infektion.
English: It is recommended that Stribild is not initiated in patients with creatinine clearance < 90 mL/min unless, after review of the available treatment options, it is considered that Stribild is the preferred treatment for the individual patient.
Danish: Det anbefales, at Stribild ikke påbegyndes hos patienter med kreatininclearance < 90 ml/min medmindre, efter en gennemgang af de tilgængelige behandlingsmuligheder, Stribild anses for at være den foretrukne behandling for den individuelle patient.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Danish: Syv patienter havde estimerede glomerulære filtrationshastighedsværdier mellem 70 og 90 ml/min./1,73 m2.
English: The Stribild renal educational brochure for prescribers of adolescent patients shall contain the following key safety messages:
Danish: Den renale uddannelsesbrochure for Stribild til læger, der ordinerer til unge patienter, bør indeholde de følgende nøglebeskeder for sikkerhed:
English: Primary mutations for raltegravir/elvitegravir do not affect the in vitro susceptibility of dolutegravir as single mutations, and the additional presence of secondary mutations (except Q148) also does not result in relevant fold changes in experiments with site directed mutants.
Danish: Primære mutationer for raltegravir/elvitegravir påvirker ikke in vitro følsomheden for dolutegravir som enkeltvise mutationer, og hvis sekundære mutationer (undtagen Q148) også er til stede, medfører det heller ikke relevante foldændringer i eksperimenter med stedspecifikke mutanter.
English: Virologic response was defined as achieving an undetectable viral load (< 50 HIV-1 RNA copies/mL, snapshot analysis).
Danish: Virologisk respons blev defineret som udetekterbart viral load (< 50 hiv 1-rna kopier/ml, snapshot-analyse).
English: However, a large amount of data in pregnant women (more than1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 graviditetsudfald) indikerer imidlertid ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin og tenofovirdisoproxil.
English: • medicines that may damage your kidneys, examples include:
Danish: • lægemidler, der kan beskadige nyrerne, eksempler herpå:
English: Eight of the 89 patients (9.0%) discontinued study drug due to renal adverse events.
Danish: Otte af de 89 patienter (9,0 %) fik seponeret studiemedicinen på grund af nyrebivirkninger.
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Stribild.
Danish: Til behandling af erektionsproblemer anbefales det, at en enkeltdosis af sildenafil på ikke over 25 mg hver 48. time, vardenafil på ikke over 2,5 mg hver 72. time eller tadalafil på ikke over 10 mg hver 72. time administreres sammen med Stribild.
English: Cobicistat exposures were unaffected by a light meal and although there was a modest decrease of 24% and 18% in Cmax and AUC respectively with a high-fat meal, no difference was observed in its pharmacoenhancing effect on elvitegravir.
Danish: Cobicistat-eksponeringer var ikke påvirket af et let måltid, og selvom der var en moderat reduktion på hhv. 24 % og 18 % i Cmax og AUC sammen med et måltid med højt fedtindhold, blev der ikke observeret nogen forskel i den farmakoforstærkende virkning på elvitegravir.
English: Following intravenous administration the volume of distribution of emtricitabine and tenofovir was approximately 1,400 mL/kg and 800 mL/kg, respectively.
Danish: Efter intravenøs administration blev emtricitabins og tenofovirs fordelingsvolumen vurderet til at være hhv. 1.400 ml/kg og 800 ml/kg.
English: • suicidal ideation and suicide attempt (in patients who have had depression or mental health problems before), depression
Danish: • selvmordstanker og selvmordsforsøg (hos patienter med tidligere depression eller psykiske problemer), depression
English: Relative to fasting conditions, the administration of Stribild with a light meal (~373 kcal, 20% fat) or high-fat meal (~800 kcal, 50% fat) resulted in increased exposures of elvitegravir and tenofovir.
Danish: I forhold til fastende tilstand, resulterede administ-rationen af Stribild sammen med et let måltid (~ 373 kcal, 20 % fedtindhold) eller et måltid med højt fedtindhold (~ 800 kcal, 50 % fedtindhold) i øgede eksponeringer af elvitegravir og tenofovir.
English: The substitutions that emerged were M184V/I (n = 17) and K65R (n = 5) in reverse transcriptase and E92Q (n = 9), N155H (n = 5), Q148R (n = 3), T66I (n = 2), and T97A (n = 1) in integrase.
Danish: De substitutioner, der opstod, var M184V/I (n = 17) og K65R (n = 5) i revers transkriptase og E92Q (n = 9), N155H (n = 5), Q148R (n = 3), T66I (n = 2) og T97A (n = 1) i integrase.
English: Renal and bone effects in the paediatric population
Danish: Virkninger på nyrer og knogler hos den pædiatriske population
English: Some patients taking combination antiretroviral medicines such as Stribild 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 Stribild, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød, forårsaget af manglende blodforsyning til knoglerne).
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: If you forget to take Stribild
Danish: Hvis De har glemt at tage Stribild
English: Stribild may affect your kidneys.
Danish: Stribild kan have indvirkning på Deres nyrer.
English: The difference in the proportion of patients who maintained < 400 copies/mL at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
Danish: Forskellen i andelen af patienter, der havde < 400 kopier/ml ved uge 48, skyldtes primært, at der var et højere antal af seponeringer i tenofovirdisoproxilgruppen.
English:  If any of these applies to you, talk to your doctor before taking Stribild.
Danish:  Hvis noget af dette gælder for Dem, skal De tale med lægen før De tager Stribild.
English: Based on drug interaction studies conducted with the components of Stribild, no clinically significant drug interactions have been either observed or are expected between the components of Stribild and the following medicinal products: entecavir, famciclovir, famotidine, omeprazole, ribavirin and sertraline.
Danish: Baseret på lægemiddelinteraktionsstudier udført med Stribild-komponenterne, er der ikke blevet observeret og der forventes heller ikke nogen klinisk signifikante lægemiddelinteraktioner mellem Stribild-komponenterne og de følgende lægemidler: entecavir, famciclovir, famotidin, omeprazol, ribavirin og sertralin.
English: In patients at risk for renal impairment a more frequent monitoring of renal function is required.
Danish: Hos patienter med risiko for nedsat nyrefunktion, er hyppigere monitorering af nyrefunktionen nødvendig.
English: Substantial cross-resistance was observed between most elvitegravir-resistant HIV-1 isolates and raltegravir, and between emtricitabine-resistant isolates and lamivudine.
Danish: Betydelig krydsresistens blev observeret mellem de fleste elvitegravir-resistente hiv 1-isolater og raltegravir, samt mellem emtricitabinresistente isolater og lamivudin.
English: The dual-drug combinations and the triple combination of elvitegravir, emtricitabine and tenofovir demonstrated synergistic activity in cell culture.
Danish: Kombinationerne med to aktive stoffer og trippelkombinationen af elvitegravir, emtricitabin og tenofovir viste synergistisk aktivitet i cellekultur.
English: • If you have kidney problems, or have had kidney problems, or if tests have shown problems with your kidneys.
Danish: • Hvis De har eller har haft nyreproblemer, eller hvis undersøgelser har vist, at De har nyreproblemer.
English: However, in case of initiation of Stribild in patients previously taking didanosine or discontinuation of Stribild and change to a regimen including didanosine there could be a short period when measurable plasma levels of didanosine and tenofovir occur.
Danish: I tilfælde af påbegyndelse af Stribild hos patienter, som modtager didanosin eller som seponerer Stribild og skifter til et behandlingsregime, som inkluderer didanosin, kan der imidlertid være en kort periode, hvor der kan forekomme målelige plasmaniveauer af didanosin og tenofovir.
English: c Includes subjects who had ≥ 50 copies/mL in the Week 48 or Week 144 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Danish: c Omfatter personer, som havde ≥ 50 kopier/ml i uge 48- eller uge 144-vinduet, personer, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning, personer, som afbrød behandlingen af andre årsager end en adverse event, død eller svigtende virkning, og som på tidspunktet for seponering havde en viral load på ≥ 50 kopier/ml.
English: Long term oral carcinogenicity studies with elvitegravir and cobicistat did not show any carcinogenic potential in mice and rats.
Danish: Langvarige orale karcinogenicitetsstudier med elvitegravir og cobicistat viste ikke karcinogenicitet hos mus og rotter.
English: Co-administration of Stribild and sildenafil for the treatment of pulmonary arterial hypertension is contraindicated.
Danish: Samtidig administration af Stribild og sildenafil til behandling af pulmonal arteriel hypertension er kontraindiceret.
English: When administering with Stribild, the maximum daily dose of itraconazole should not exceed 200 mg per day.
Danish: Ved samtidig administration af Stribild bør den maksimale daglige dosis af itraconazol ikke overskride 200 mg daglig.
English: 2 Studies performed with ritonavir boosted elvitegravir.
Danish: 2 Studierne blev udført med ritonavir-boosted elvitegravir.
English: Clinical monitoring is recommended due to the potential for hyperkalemia.
Danish: Klinisk monitorering anbefales på grund af risikoen for hyperkaliæmi.
English: In phenotypic analyses of isolates from patients in the resistance analysis population, 13 patients (31%) had HIV-1 isolates with reduced susceptibility to elvitegravir, 17 patients (40%) had reduced susceptibility to emtricitabine, and 2 patients (5%) had reduced susceptibility to tenofovir.
Danish: I fænotypeanalyser af isolater fra patienter i resistensanalysepopulationen havde 13 patienter (31 %) hiv 1-isolater med reduceret følsomhed for elvitegravir, 17 patienter (40 %) havde reduceret følsomhed for emtricitabin, og 2 patienter (5 %) havde reduceret følsomhed for tenofovir.
English: Study GS-US-236-0103
Danish: Studie GS-US-236-0103
English: If a patient misses a dose of Stribild by more than 18 hours and it is almost time for the next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Stribild i mere end 18 timer, og det næsten er tid til næste dosis, skal patienten ikke tage den manglende dosis, men blot fortsætte med den normale doseringsplan.
English: Stribild contains lactose
Danish: Stribild indeholder lactose
English: During treatment with Stribild
Danish: I løbet af behandlingen med Stribild
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Danish: Efter oral administration er tenofovirs eliminationshalveringstid ca. 12-18 timer.
English: As elvitegravir and cobicistat are highly bound to plasma proteins it is unlikely that elvitegravir and cobicistat will be significantly removed by haemodialysis or peritoneal dialysis.
Danish: Da elvitegravir og cobicistat i høj grad er bundet til plasmaproteiner, er det usandsynligt, at elvitegravir og cobicistat i signifikant grad vil fjernes ved hæmodialyse eller peritonealdialyse.
English: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil
Danish: digoxin, disopyramid, flecainid, lidocain, mexiletin, propafenon, metoprolol, timolol, amlodipin, diltiazem, felodipin, nicardipin, nifedipin og verapamil
English: Do not stop taking Stribild without talking to your doctor.
Danish: Hold ikke op med at tage Stribild Hold ikke op med at tage Stribild uden at tale med Deres læge.
English: Findings in repeat-dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use included kidney and bone changes and a decrease in serum phosphate concentration.
Danish: Fund fra toksicitetsstudier efter gentagne doser hos rotter, hunde og aber ved eksponeringsniveauer højere end eller lig med kliniske studier og med mulig relevans ved klinisk brug omfatter nyre- og knogleændringer og et fald i serum-phosphatkoncentrationen.
English: Study GS-US-236-0102
Danish: Studie GS-US-236-0102
English: Due to protocol violation, two patients with historical K103N substitutions discontinued early with HIV-1 RNA < 50 copies/mL.
Danish: På grund af protokolovertrædelser afbrød to patienter med historiske K103N-substitutioner studiet tidligt med hiv 1-rna < 50 kopier/ml.
English: If you accidentally take more than the recommended dose of Stribild you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Stribild, kan De have større risiko for at få bivirkninger med denne medicin (se pkt.
English: In virologically-suppressed patients
Danish: Hos virologisk supprimerede patienter
English: Clinical monitoring is recommended for patients with ClCr < 90 mL/min.
Danish: Der anbefales klinisk overvågning for patienter med ClCr < 90 ml/min.
English: Stribild is not usually taken with other medicines that can damage your kidneys (see Other medicines and Stribild).
Danish: Stribild tages normalt ikke sammen med anden medicin, som kan skade Deres nyrer (se Brug af anden medicin sammen med Stribild).
English: As Stribild contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil, any interactions that have been identified with these active substances individually may occur with Stribild.
Danish: Da Stribild indeholder elvitegravir, cobicistat, emtricitabin og tenofovirdisoproxil, kan interaktioner, som er identificeret med disse aktive stoffer individuelt, forekomme med Stribild.
English: Moreover, at concentrations substantially higher (approximately 300-fold) than those observed in vivo, tenofovir did not inhibit in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1, or CYP1A1/2).
Danish: Ved koncentrationer, der var betragteligt højere (ca. 300 gange) end de koncentrationer, der blev observeret in vivo, hæmmede tenofovir desuden ikke lægemiddelmetabolismen in vitro, der medieres af de større humane CYP450-isoformer involveret i biotransformation af lægemidler (CYP3A4, CYP2D6, CYP2C9, CYP2E1 eller CYP1A1/2).
English: 6 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Danish: 6 Studiet blev udført med yderligere voxilaprevir 100 mg for at opnå de forventede voxilaprevir-eksponeringer hos
English: It's important not to stop taking Stribild without talking to your doctor: see section 3, Do not stop taking Stribild.
Danish: Det er vigtigt ikke at holde op med at tage Stribild uden at tale med lægen: se pkt.
English: The recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment.
Danish: Det anbefalede skema for monitorering af nyrefunktion, med hensyntagen til tilstedeværelsen eller fraværet af yderligere risikofaktorer for nedsat nyrefunktion.