FrancophonIA/ELRC3.0 huggingface dataset:
English: In human clinical studies, a 25 mg oral dose of tenofovir alafenamide resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 300 mg oral dose of tenofovir disoproxil fumarate.
Danish: I kliniske studier af mennesker resulterede en 25 mg oral dosis af tenofoviralafenamid i tenofovirdiphosphatkoncentrationer > 4 gange højere i PBMC'er og > 90 % lavere koncentrationer af tenofovir i plasma sammenlignet med en 300 mg oral dosis af tenofovirdisoproxilfumarat.
English: Patients should be informed that dizziness has been reported during treatment with the components of Biktarvy (see section 4.8).
Danish: Patienter bør informeres om, at svimmelhed er blevet indberettet under behandling med indholdsstofferne i Biktarvy (se pkt.
English: Bictegravir was not carcinogenic in a 6-month rasH2 transgenic mouse study (at doses of up to 100 mg/kg/day in males and 300 mg/kg/day in females, which resulted in exposures of approximately 15 and 23 times, in males and females, respectively, the exposure in humans at the recommended human dose) nor in a 2-year rat study (at doses of up to 300 mg/kg/day, which resulted in exposures of approximately 31 times the exposure in humans).
Danish: Bictegravir var ikke karcinogent i et 6-måneders studie med gensplejsede rasH2-mus (med doser op til 100 mg/kg/dag hos hanner og 300 mg/kg/dag hos hunner, hvilket resulterede i eksponeringer, der var cirka 15 og 23 gange højere hos hhv. hanner og hunner end eksponeringen hos mennesker ved brug af den anbefalede dosis til mennesker) eller i et 2-årigt rottestudie (med doser op til 300 mg/kg/dag, hvilket resulterede i eksponeringer, der var cirka 31 gange højere end eksponeringen hos mennesker).
English: Talk to your doctor before taking Biktarvy:
Danish: Kontakt lægen, før De tager Biktarvy:
English: Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir (see section 5.1).
Danish: Biktarvy er indiceret til behandling af voksne, der er inficeret med human immundefekt virus 1 (hiv 1) uden nuværende eller tidligere evidens for viral resistens over for integrasehæmmerklassen, emtricitabin eller tenofovir (se pkt.
English:  Get advice from your doctor or pharmacist before taking Biktarvy if you are taking any of these medicines.
Danish:  Spørg lægen eller apotekspersonalet til råds, før De tager Biktarvy, hvis De tager et eller flere af disse lægemidler.
English: In vitro drug resistance selection studies with tenofovir alafenamide have shown no development of high-level resistance after extended culture.
Danish: In vitro-selektionsstudier vedrørende lægemiddelresistens med tenofoviralafenamid har ikke vist udvikling af høj grad af resistens efter længerevarende dyrkning.
English: Biktarvy [Outer packaging only]
Danish: Biktarvy [Kun på den ydre emballage]
English: Contents of the pack and other information What Biktarvy contains
Danish: Pakningsstørrelser og yderligere oplysninger Biktarvy indeholder:
English: No dose adjustment is required upon co-administration.
Danish: Dosisjustering er ikke nødvendig ved samtidig administration.
English: vomiting, abdominal pain, dyspepsia, flatulence
Danish: opkastning, abdominalsmerter, dyspepsi, flatulens
English: In addition, 6 patients had the pre-existing INSTI resistance-associated mutation T97A; all had HIV-1 RNA < 50 copies/mL at Week 96 or the last visit.
Danish: Derudover havde 6 patienter præeksisterende INSTI-resistens-associeret mutation T97A; alle havde hiv 1-RNA < 50 kopier/ml ved uge 96 eller patientens sidste besøg.
English: DTG = dolutegravir 3TC = lamivudine a Week 48 window was between Day 295 and 378 (inclusive).
Danish: DTG = dolutegravir 3TC = lamivudin a Uge 48-vinduet var mellem dag 295 og 378 (inklusive).
English: Biktarvy film-coated tablets are purplish-brown, capsule-shaped, film-coated tablets debossed on one side with “GSI” and “9883” on the other side.
Danish: Biktarvy filmovertrukne tabletter er lilla-brunlige, kapselformede, filmovertrukne tabletter, der er præget med "GSI" på den ene side og "9883" på den anden side.
English: Interactions between Biktarvy or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”; all No
Danish: Interaktioner mellem Biktarvy eller dets individuelle indholdsstof(fer) og samtidigt administrerede lægemidler er anført i tabel 1 nedenfor (stigning vises med “↑”, fald med “↓” og ingen ændring med “↔”; alle grænseområder uden effekt er 70 %-143 %).
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 vira med M184V/I-substitution var krydsresistente over for lamivudin, men havde bevaret følsomhed for didanosin, stavudin, tenofovir og zidovudin.
English: Bictegravir is an integrase strand transfer inhibitor (INSTI) that binds to the integrase active site and blocks the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Danish: Bictegravir er en integrasestrengtransferhæmmer (INSTI, integrase strand transfer inhibitor), der bindes til det integraseaktive site og blokerer trinnet med strengtransfer i forbindelse med den retrovirale integration af deoxyribonukleinsyre (dna), som er nødvendigt for hivreplikationscyklussen.
English: The mean baseline CD4+ cell count was 460 cells/mm3 (range 0-1,636) and 11% had CD4+ cell counts less than 200 cells/mm3.
Danish: Gennemsnitligt CD4+ celletal ved baseline var 460 celler/mm3 (interval 0-1.636), og 11 % havde CD4+ celletal under 200 celler/mm3.
English: Co-administration with rifampicin and St. John's wort (Hypericum perforatum) (see section 4.5).
Danish: Samtidig administration af rifampicin og perikon (Hypericum perforatum) (se pkt.
English: Four patients had missing HBV DNA data at Week 96 (one lost to follow-up from Week 48, 1 lost to follow-up after Week 72, 1 with missing HBV data but HIV-1 RNA < 50 copies/mL, and 1 with missing data in Week 96 window).
Danish: Der manglede HBV-dnadata for fire patienter ved uge 96 (én tabt for opfølgning fra uge 48, 1 tabt for opfølgning efter uge 72, 1 med manglende HBV-data, men hiv 1-rna < 50 kopier/ml, og 1 med manglende data i uge 96vinduet).
English: In vitro binding of bictegravir to human plasma proteins was > 99% (free fraction ~0.25%).
Danish: In vitro var bictegravirs binding til humane plasmaproteiner > 99 % (fri fraktion ~0,25 %).
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 fumarate in loading tenofovir into 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 tenofovirdisoproxilfumarat til at overføre tenofovir til perifere mononukleære blodceller (PBMC'er, peripheral blood mononuclear cells) (herunder lymfocytter og andre hiv-målceller) og makrofager.
English: Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir) (see also table below).
Danish: Det anbefales derfor at udvise forsigtighed, når bictegravir kombineres med lægemidler, der hæmmer P-gp og/eller BCRP (f.eks. makrolider, ciclosporin, verapamil, dronedaron og glecaprevir/pibrentasvir) (se også tabellen nedenfor).
English: Treatment outcomes between treatment groups were similar across subgroups by age, sex, race, baseline viral load, baseline CD4+ cell count, and region.
Danish: Behandlingsresultaterne mellem behandlingsgrupperne var ensartede på tværs af undergrupper ud fra alder, køn, race, virusmængde ved baseline, CD4+ celletal ved baseline og region.
English: In Studies GS-US-380-1489 and GS-US-380-1490, the mean age was 35 years (range 18-77), 89% were male, 58% were White, 33% were Black, and 3% were Asian.
Danish: I studie GS-US-380-1489 og GS-US-380-1490 var gennemsnitsalderen 35 år (interval 18-77), 89 % var mænd, 58 % var hvide, 33 % var sorte og 3 % var asiater.
English: b Includes patients who had ≥ 50 copies/mL in the Week 48 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Danish: b Omfattede patienter, som havde ≥ 50 kopier/ml i uge 48-vinduet, patienter, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning, patienter, som afbrød behandlingen af andre årsager end manglende eller svigtende virkning, og som på tidspunktet for seponering havde en virusmængde på ≥ 50 kopier/ml.
English: The K65R and K70E mutations result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Danish: K65R- og K70E-mutationer resulterer i nedsat følsomhed for abacavir, didanosin, lamivudin, emtricitabin og tenofovir, men de bevarer følsomhed for zidovudin.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 14 and 43 times greater, respectively, than those expected after administration of B/F/TAF.
Danish: En minimal infiltration af histiocytter var til stede i øjet på hunde ved eksponeringer over for hhv. tenofoviralafenamid og tenofovir, der var ca. 14 og 43 gange større, end hvad der forventes efter administration af B/F/TAF.
English: Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Danish: Biktarvy 50 mg/200 mg/25 mg filmovertrukne tabletter
English: Based on drug interaction studies conducted with Biktarvy or the components of Biktarvy, no clinically significant drug interactions are expected with: amlodipine, atorvastatin, buprenorphine, drospirenone, famciclovir, famotidine, fluticasone, methadone, naloxone, norbuprenorphine, omeprazole or rosuvastatin.
Danish: På baggrund af lægemiddelinteraktionsstudier udført med Biktarvys eller indholdsstofferne i Biktarvy forventes der ingen klinisk signifikante interaktioner, når Biktarvy kombineres med følgende lægemidler: amlodipin, atorvastatin, buprenorphin, drospirenon, famciclovir, famotidin, fluticason, methadon, naloxon, norbuprenorphin, omeprazol eller rosuvastatin.
English: Patients had a mean age of 46 years (range 20-79), 83% were male, 66% were White, and 26% were Black.
Danish: Patienterne havde en gennemsnitsalder på 46 år (interval 20-79), 83 % var mænd, 66 % var hvide og 26 % var sorte.
English: If you do miss a dose:
Danish: Hvis De har glemt at tage en dosis:
English: The other ingredients are
Danish: Øvrige indholdsstoffer
English: Multinucleoside resistant HIV-1 with a T69S double insertion mutation or with a Q151M mutation complex including K65R showed reduced susceptibility to tenofovir alafenamide.
Danish: Multinukleosid-resistent hiv 1 med en T69S dobbelt indsætningsmutation eller med et Q151M-mutationskompleks, der omfattede K65R, viste en nedsat følsomhed over for tenofoviralafenamid.
English: Patients had a mean age of 45 years (range 20-71), 89% were male, 73% were White, and 22% were Black.
Danish: Patienterne havde en gennemsnitsalder på 45 år (interval 20-71), 89 % var mænd, 73 % var hvide og 22 % var sorte.
English: Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least 43 times greater than those expected after administration of B/F/TAF.
Danish: Knogletoksicitet blev observeret som nedsat knoglemineraltæthed hos rotter og hunde ved eksponeringer for tenofovir, der var mindst 43 gange større, end hvad der forventes efter administration af B/F/TAF.
English: Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger af emtricitabin, hvad angår fertilitetsparametre, graviditet, føtal udvikling, fødsel og postnatal udvikling.
English: Medicinal products that induce P-gp activity (e.g. rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of Biktarvy and development of resistance.
Danish: Lægemidler, der inducerer P-gp-aktivitet (f.eks. rifabutin, carbamazepin, phenobarbital) forventes at nedsætte absorptionen af tenofoviralafenamid, hvilket fører til en nedsat plasmakoncentration af tenofoviralafenamid, hvilket kan forårsage en svigtende terapeutisk virkning af Biktarvy samt udvikling af resistens.
English: Biktarvy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatment of HBV infection.
Danish: Biktarvy bør ikke indgives samtidigt med lægemidler, som indeholder tenofoviralafenamid, tenofovirdisoproxil, lamivudin eller adefovirdipivoxil, og som anvendes til behandling af HBV-infektion.
English: No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Danish: Dosisjustering af Biktarvy er ikke nødvendig hos patienter med let nedsat (Child-Pugh klasse A) eller moderat nedsat (Child-Pugh klasse B) leverfunktion.
English: No dose adjustment of Biktarvy is required in patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Danish: Dosisjustering af Biktarvy er ikke nødvendig hos patienter med estimeret kreatininclearance (CrCl) ≥ 30 ml/min.
English: Interaction not studied with bictegravir.
Danish: Interaktion ikke undersøgt med bictegravir.
English: There are no pharmacokinetic data on bictegravir or tenofovir alafenamide in patients with creatinine clearance less than 15 mL/min.
Danish: Der er ingen farmakokinetiske data for bictegravir eller tenofoviralafenamid hos patienter med kreatininclearance under 15 ml/min.
English: It is not known whether bictegravir or tenofovir alafenamide is excreted in human milk.
Danish: Det er ukendt, om bictegravir eller tenofoviralafenamid udskilles i human mælk.
English: Tablet core Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Danish: Tabletkerne Microkrystallinsk cellulose, croscarmellosenatrium, magnesiumstearat.
English: Caution is recommended due to the potential effect of these agents on the bictegravir component of Biktarvy.
Danish: Det anbefales at udvise forsigtighed på grund af disse stoffers potentielle indvirkning på indholdsstoffet bictegravir i Biktarvy.
English: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data for emtricitabin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Bictegravir was not mutagenic or clastogenic in conventional genotoxicity assays.
Danish: Bictegravir var ikke mutagent eller klastogent i konventionelle genotoksicitets-assays.
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup By baseline viral load ≤ 100,000 copies/ mL > 100,000 copies/ mL By baseline CD4+ cell count < 200 cells/mm3 ≥ 200 cells/mm3
Danish: Manglende data i tidsvinduet, men får studiemedicin Andel (%) patienter med hiv 1-rna < 50 kopier/ml pr. undergruppe Virusmængde ved baseline ≤ 100.000 kopier/m l > 100.000 kopier/m l CD4+ celletal ved baseline < 200 celler/mm3 ≥ 200 celler/mm3
English: Bictegravir is not an inhibitor or inducer of CYP in vivo.
Danish: Bictegravir er ikke en hæmmer eller inducer af CYP in vivo.
English: - adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide, or tenofovir disoproxil
Danish: - adefovir-dipivoxil, atazanavir, bictegravir, emtricitabin, lamivudin, tenofoviralafenamid eller tenofovirdisoproxil
English: Other medicines and Biktarvy 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 Biktarvy Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: HIV-1 isolates with reduced susceptibility to emtricitabine have been selected in cell culture and had M184V/I mutations in HIV-1 RT.
Danish: Hiv 1-isolater med reduceret følsomhed over for emtricitabin er blevet selekteret i cellekultur og havde M184V/I-mutationer i hiv 1-RT.
English: White, high density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Danish: Hvid, højdensitets-polyethylen (HDPE)- tabletbeholder med børnesikret skruelåg af polypropylen foret med induktionsaktiveret aluminiumsfolie indeholdende 30 filmovertrukne tabletter.
English: At the time of study entry, one treatment-naïve patient had pre-existing INSTI resistance-associated mutations Q148H + G140S and had HIV-1 RNA < 50 copies/mL at Week 4 through Week 96.
Danish: På tidspunktet for indtræden i studiet havde én behandlingsnaiv patient præeksisterende INSTI-resistens-associerede mutationer Q148H + G140S og havde hiv 1-RNA < 50 kopier/ml ved uge 4 til og med uge 96.
English: There were no discontinuations due to hepatic adverse events through Week 96 in Biktarvy clinical studies.
Danish: Der var ingen seponeringer på grund af hepatiske bivirkninger til og med uge 96 i de kliniske studier med Biktarvy.
English: In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
Danish: In vitro-studier har vist, at tenofoviralafenamid metaboliseres til tenofovir (primær metabolit) af cathepsin A i PBMC'er (herunder lymfocytter og andre hiv-målceller) og makrofager og af carboxylesterase-1 i hepatocytter.
English: In vitro phenotyping studies showed that bictegravir is primarily metabolised by CYP3A and UGT1A1.
Danish: Fænotypestudier in vitro viste, at bictegravir primært metaboliseres via CYP3A og UGT1A1.
English: In Study GS-US-380-1490, 8 patients with HIV/HBV co-infection at baseline were randomised to receive B/F/TAF.
Danish: I studie GS-US-380-1490 blev 8 patienter med samtidig hiv/HBV-infektion ved baseline randomiseret til at få B/F/TAF.
English: HIV-1 RNA < 20 copies/mL
Danish: Hiv 1-rna < 20 kopier/ml
English: These modest changes are not considered clinically meaningful and B/F/TAF can be administered with or without food.
Danish: Disse moderate ændringer vurderes ikke at være af klinisk betydning, og B/F/TAF kan administreres sammen med eller uden mad.
English: The mean baseline CD4+ cell count was 663 cells/mm3 (range 62-2,582).
Danish: Det gennemsnitlige CD4+ celletal ved baseline var 663 celler/mm3 (interval 62-2582).
English: The frequencies were derived from Phase 3 Biktarvy clinical studies in treatment-naïve patients through 96 weeks (GS-US-380-1489 and GS-US-380-1490).
Danish: Hyppighederne blev udledt af kliniske fase 3-studier med Biktarvy hos behandlingsnaive patienter igennem 96 uger (GS-US-380-1489 og GS-US-380-1490)
English: The use of Biktarvy in children and adolescents under 18 years of age has not yet been studied.
Danish: Der er endnu ikke lavet undersøgelser med brug af Biktarvy hos børn og unge under 18 år.
English: If you forget to take Biktarvy
Danish: Hvis De har glemt at tage Biktarvy
English: Discontinuation of Biktarvy therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Danish: Seponering af behandlingen med Biktarvy hos patienter med samtidig infektion med hiv og HBV, kan være forbundet med svær akut eksacerbation af hepatitis.
English: Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Danish: Intracellulært tenofovir fosforyleres dernæst til den farmakologisk aktive metabolit tenofovirdiphosphat.
English: Bictegravir/Emtricitabine/ Tenofovir alafenamide
Danish: Bictegravir/emtricitabin/tenofoviralafenamid
English: Patients were randomised in a 1:1 ratio to either switch to B/F/TAF at baseline (n = 282), or stay on their baseline antiretroviral regimen (n = 281).
Danish: Patienterne blev randomiseret i forholdet 1:1 til enten at skifte til B/F/TAF ved baseline (n = 282) eller til at forblive på deres antiretrovirale regime ved baseline (n = 281).
English: Co-administration not recommended.
Danish: Samtidig administration frarådes.
English: ANTACIDS, SUPPLEMENTS AND BUFFERED MEDICINES Magnesium/aluminium-containing antacid suspension (20 mL single dose5), Bictegravir
Danish: ANTACIDA, TILSKUD OG BUFFERHOLDIGE LÆGEMIDLER Magnesium/aluminiumindeholdende antacidumsuspension (20 ml enkeltdosis5), bictegravir
English: (Inhibition of P-gp/BCRP)
Danish: (Hæmning af P-gp/BCRP)
English: This modest change is not considered clinically meaningful and B/F/TAF can be administered with or without food.
Danish: Denne moderate ændring vurderes ikke at være af klinisk betydning, og B/F/TAF kan administreres sammen med eller uden mad.
English: h Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g. withdrew consent, loss to follow-up, etc.
Danish: h Omfatter patienter, som afbrød behandlingen af andre årsager end en AE, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Danish: Renal udskillelse af intakt tenofoviralafenamid er en mindre eliminationsvej, idet < 1 % af dosen elimineres i urinen.
English: Relative to fasting conditions, the administration of B/F/TAF with either a moderate fat (~600 kcal, 27% fat) or high fat meal (~800 kcal, 50% fat) resulted in an increase in bictegravir AUC (24%).
Danish: I forhold til fastende forhold resulterede administration af B/F/TAF sammen med et måltid med enten et moderat fedtindhold (~600 kcal, 27 % fedt) eller et højt fedtindhold (~800 kcal, 50 % fedt) i en stigning i bictegravirs AUC (24 %).
English: Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet.
Danish: Lilla-brunlige, kapselformede, filmovertrukne tabletter præget med "GSI" på den ene side og "9883" på den anden side.
English: Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Danish: Tenofoviralafenamid er ikke en hæmmer eller inducer af CYP3A in vivo.
English: c Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g. withdrew consent, loss to follow-up, etc.
Danish: c Omfatter patienter, som afbrød behandlingen af andre årsager end en AE, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
English: Emtricitabine is primarily excreted by the kidneys by both glomerular filtration and active tubular secretion.
Danish: Emtricitabin udskilles primært via nyrerne, både via glomerulusfiltration og aktiv tubulær sekretion.