FrancophonIA/ELRC3.0 huggingface dataset:
English: The following may be signs of lactic acidosis: deep, rapid breathing tiredness or drowsiness feeling sick (nausea), being sick (vomiting) stomach pain
Danish: Følgende kan være tegn på laktatacidose: dyb, hurtig vejrtrækning træthed eller døsighed kvalme, opkastning mavesmerter
English: In studies GS-US-236-0102 and GS-US-236-0103, decreases in estimated creatinine clearance occurred early in treatment with Stribild, after which they stabilised.
Danish: I studierne GS-US-236-0102 og GS-US-236-0103 forekom reduktionerne i estimeret kreatininclearance tidligt i behandlingsforløbet med Stribild, hvorefter de stabiliseredes.
English: That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil fumarate-containing products such as Stribild.
Danish: At der er en øget risiko for nyresygdom hos hiv-inficerede patienter forbundet med tenofovirdisoproxilfumarat-indeholdende præparater, såsom Stribild.
English: The median terminal plasma half-life of cobicistat following administration of Stribild is approximately 3.5 hours and the associated cobicistat exposures provide elvitegravir Ctrough approximately 10-fold above the protein-binding adjusted IC95 for wild-type HIV-1 virus.
Danish: Den mediane terminale halveringstid i plasma for cobicistat efter administration af Stribild er ca. 3,5 timer, og de forbundne cobicistat-eksponeringer giver en Ctrough for elvitegravir, der er ca. 10 gange over IC95 justeret for proteinbinding for vildtype hiv 1-virus.
English: Co-administration of Stribild and rifabutin is not recommended.
Danish: Samtidig administration af Stribild og rifabutin anbefales ikke.
English: Elvitegravir is 98-99% bound to human plasma proteins and binding is independent of drug concentration over the range of 1 ng/mL to 1,600 ng/mL.
Danish: Elvitegravir er 98-99 % bundet til humane plasmaproteiner, og bindingen er uafhængig af lægemiddelkoncentrationer i intervallet fra 1 ng/ml til 1.600 ng/ml.
English: Indigo carmine aluminium lake (E132) Macrogol 3350 (E1521) Polyvinyl alcohol (partially hydrolysed) (E1203) Talc (E553B)
Danish: Indigocarmin aluminiumpigment (E132) Macrogol 3350 (E1521) Polyvinylalkohol (delvist hydrolyseret) (E1203) Talkum (E553B)
English: Cobicistat has no detectable anti-HIV activity and does not antagonise or enhance the antiviral effects of elvitegravir, emtricitabine, or tenofovir.
Danish: Cobicistat har ingen målelig anti-hiv-aktivitet, og antagoniserer og øger ikke de antivirale virkninger af elvitegravir, emtricitabin og tenofovir.
English: See section 4.4 regarding patients with creatinine clearance that falls below 70 mL/min while on treatment with Stribild.
Danish: 4.4 for patienter med kreatininclearance, der falder til under 70 ml/min, mens de behandles med Stribild.
English: Concurrent administration of salmeterol and Stribild is not recommended.
Danish: Samtidig administration af salmeterol og Stribild anbefales ikke.
English: Four (0.6%) of the subjects who received Stribild developed laboratory findings consistent with proximal tubulopathy leading to discontinuation of Stribild during the first 48 weeks.
Danish: 4 (0,6 %) af de personer, der modtog Stribild, udviklede laboratoriefund i overenesstemmelse med proksimal tubulopati, hvilket førte til seponering af Stribild i løbet af de første 48 uger.
English: There are uncertainties associated with the long-term effects of tenofovir disoproxil bone and renal toxicity.
Danish: Der er uvished forbundet med de langsigtede virkninger af tenofovirdisoproxils knogle- og nyretoksicitet.
English: Midazolam and triazolam are primarily metabolised by CYP3A.
Danish: Midazolam og triazolam metaboliseres primært af CYP3A.
English: Stribild should be administered with caution to elderly patients (see section 4.4).
Danish: Stribild bør administreres med forsigtighed til ældre patienter (se pkt.
English: For both studies at 48 weeks, the virologic response rate was evaluated in both treatment arms.
Danish: I begge studier blev den virologiske responsrate evalueret i begge behandlingsarme ved uge 48.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling af hepatitis B eller C henvises der til de relevante produktresuméer.
English: Green, capsule-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and the number “1” surrounded by a square box on the other side.
Danish: Grønne, kapselformede, filmovertrukne tabletter, der måler 20 mm x 10 mm og er præget med „GSI“ på den ene side og tallet „1“ omgivet af en kvadratisk æske på den anden.
English: In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials in paediatric patients than in adults (see section 4.8, Tabulated summary of adverse reactions).
Danish: Udover de bivirkninger, der er indberettet hos voksne, forekom anæmi (9,5 %) og misfarvning af huden (31,8 %) hyppigere i kliniske studier hos pædiatriske patienter end hos voksne (se pkt.
English:  If you are taking an antacid 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 eller et multivitamin-tilskud, skal De tage det mindst 4 timer før eller mindst 4 timer efter Stribild.
English: It is important not to miss a dose of Stribild.
Danish: Det er vigtigt, at De husker at tage hver dosis af Stribild.
English: Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg once daily)6 +
Danish: Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg én gang daglig)6 +
English:  Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection (such as yellowing of your skin or the white part of your eyes, dark “tea-coloured” urine, light-coloured stools, loss of appetite for several days or longer, feeling or being sick, or stomach-area pain).
Danish:  Bemærker De nogle nye eller usædvanlige symptomer efter behandlingens ophør, skal De omgående oplyse Deres læge herom, især hvis det drejer sig om symptomer, som De normalt ville forbinde med hepatitis B-infektion (såsom gulfarvning af huden eller det hvide i øjnene, mørk ”te-farvet” urin, lys afføring, manglende appetit i flere dage eller mere, kvalme eller opkastning eller smerter i maveregionen).
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R substitution.
Danish: Tenofovirdisoproxil bør undgås i tilfælde af K65R-substitution i hiv 1-patienter.
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Danish: BMD Z-scoren faldt med -0,012 for spinalis lumbalis og med -0,338 for hele kroppen hos de 64 forsøgsdeltagere, der blev behandlet med tenofovirdisoproxil i 96 uger.
English: It is recommended that Stribild is discontinued in patients with creatinine clearance that falls to < 70 mL/min while on treatment unless it is considered that the potential benefit of this combination of antiretroviral agents for the individual patient outweighs the possible risks of continuing with therapy.
Danish: Det anbefales, at Stribild seponeres hos patienter med kreatininclearance, der falder til < 70 ml/min under behandling, medmindre den potentielle fordel ved denne kombination af antiretrovirale stoffer for den individuelle patient anses for at opveje den potentielle risiko ved at fortsætte behandlingen.
English: hyperglycaemia1, hypertriglyceridaemia1, decreased appetite
Danish: hyperglykæmi1, hypertriglyceridæmi1, nedsat appetit
English: The pharmacokinetics of elvitegravir or cobicistat in paediatric subjects <12 years of age have not been fully established.
Danish: Elvitegravirs eller cobicistats farmakokinetik hos pædiatriske personer < 12 år er ikke fuldstændig klarlagt.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Danish: Højdensitets-polyethylen (HDPE)- tabletbeholder med børnesikret lukke af polypropylen indeholdende 30 filmovertrukne tabletter sammen med silicagel-tørremiddel.
English: 3 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Danish: 3 Denne bivirkning kan forekomme som resultat af proksimal renal tubulopati.
English: Plasma concentrations of drospirenone are expected to be increased following co-administration with Stribild and clinical monitoring is recommended due to the potential for hyperkalaemia (see section 4.5).
Danish: Plasmakoncentrationerne af drospirenon forventes at øges efter samtidig administration af Stribild, og klinisk monitorering anbefales på grund af risikoen for hyperkaliæmi (se pkt.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in a peripostnatal toxicity study at maternally toxic doses.
Danish: Tenofovirdisoproxil reducerede imidlertid afkommets levedygtighed og vægt i peri-postnatale toksicitetsstudier ved doser, der var toksiske for moderen.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).
Danish: Hyppigheden blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret for emtricitabin i randomiserede, kontrollerede kliniske studier (n = 1.563) eller tenofovirdisoproxil i randomiserede, kontrollerede, kliniske studier og i programmet for expanded access (n = 7.319).
English: The cobicistat component of Stribild has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting renal glomerular function.
Danish: Cobicistat-komponenten af Stribild har vist sig at reducere den estimerede kreatininclearance på grund af hæmning af den tubulære sekretion af kreatinin, uden at den renale glomerulære funktion påvirkes.
English: • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam and zolpidem
Danish: • sedativa og hypnotika, anvendes til at behandle angst: buspiron, clorazepat, diazepam, estazolam, flurazepam og zolpidem
English: The most frequently reported adverse reactions considered possibly or probably related to Stribild in clinical studies through 144 weeks in treatment-naïve adult patients were nausea (16%) and diarrhoea
Danish: De hyppigst indberettede bivirkninger, som blev anset for at have en mulig eller sandsynlig forbindelse til Stribild i kliniske studier igennem 144 uger hos behandlingsnaive voksne patienter, var kvalme (16 %) og diarré (12 %).
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Stribild.
Danish: Da ældre patienter har ofterere nedsat nyrefunktion, skal der udvises forsigtighed ved behandling af ældre patienter med Stribild.
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with hepatitis B virus (HBV).
Danish: Aktuelle hiv-behandlingsretningslinjer for optimal håndtering af hiv-infektion hos patienter med samtidig infektion med hepatitis B-virus (HBV) bør konsulteres.
English: Stribild met the non-inferiority criteria in achieving HIV-1 RNA < 50 copies/mL when compared to efavirenz/emtricitabine/tenofovir disoproxil and when compared to atazanavir/ritonavir + emtricitabine/tenofovir disoproxil.
Danish: Stribild opfyldte kriterierne for non-inferioritet ved at opnå hiv 1-rna < 50 kopier/ml, sammenlignet med efavirenz/emtricitabin/tenofovirdisoproxil, og sammenlignet med atazanavir/ritonavir + emtricitabin/tenofovirdisoproxil.
English: Stribild should be discontinued in patients with confirmed creatinine clearance that falls to < 50 mL/min (since the required dose interval adjustments are not possible using this fixed dose combination tablet) or with decreases in serum phosphate to < 0.32 mmol/L (1.0 mg/dL) (see sections 4.2 and 5.2).
Danish: Stribild bør seponeres hos patienter med bekræftet kreatininclearance, der falder til < 50 ml/min (da de påkrævede justeringer af dosisintervallet ikke er mulige med denne fastdosis-kombinationstablet) eller med fald i serumphosphat til < 0,32 mmol/l (1,0 mg/dl) (se pkt.
English: The Cmax and AUC of tenofovir increased 20% and 25% respectively with a light meal, while the Cmax was unaffected and AUC increased 25% with a high fat meal.
Danish: Cmax og AUC for tenofovir øgedes med hhv. 20 % og 25 % sammen med et let måltid, mens Cmax ikke var påvirket og AUC øgedes med 25 % sammen med et måltid med højt fedtindhold.
English: Table 5: Changes in pharmacokinetic parameters from the IMPAACT P1026s study for elvitegravir and cobicistat in women receiving cobicistat and elvitegravir-containing regimens during the second and third trimesters of pregnancy compared to paired postpartum data
Danish: Tabel 5: Ændringer i farmakokinetiske elvitegravir- og cobicistat-parametre fra studiet IMPAACT P1026s hos kvinder, der fik regimer indeholdende cobicistat og elvitegravir i andet og tredje trimester af graviditeten, sammenlignet med parrede postpartumdata
English: Effects on drug levels Mean percent change in AUC, Cmax,
Danish: Virkning på lægemiddelkoncentrationer Gennemsnitlig ændring (%) i AUC, Cmax, Cmin1
English: Table 4: Virologic outcome of randomised treatment of studies GS-US-236-0102 and GS-US-236-0103 at Week 48 (snapshot analysis)a and Week 144b
Danish: Tabel 4: Virologisk resultat af randomiseret behandling i studie GS-US-236-0102 og GS-US-236-0103 ved uge 48 (snapshot-analyse)a og uge 144b
English: Methadone/Tenofovir disoproxil
Danish: Methadon/ Tenofovirdisoproxil
English: In patients, HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil.
Danish: Hos patienter udviste hiv 1, der udtrykte 3 eller flere thymidin-analog-forbundne mutationer (TAMs), som omfattede enten M41L- eller L210W-revers transkriptasemutation, reduceret følsomhed over for tenofovirdisoproxil.
English: • liver and pancreas problems
Danish: • problemer med lever og bugspytkirtlen
English: The mean rate of BMD gain was less in the tenofovir disoproxil group compared to the placebo group.
Danish: Den gennemsnitlige BMD-forøgelsesrate var mindre i tenofovirdisoproxilgruppen end i placebogruppen.
English: A study of pharmacokinetics of cobicistat-boosted elvitegravir was performed in non-HIV-1 infected subjects with severe renal impairment (creatinine clearance below 30 mL/min).
Danish: Et farmakokinetikstudie af cobicistat-boosted elvitegravir blev udført hos non-hiv 1-inficerede personer med svært nedsat nyrefunktion (kreatininclearance under 30 ml/min).
English: The mean change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -14.0 ± 16.6 mL/min for Stribild, -1.9 ± 17.9 mL/min for EFV/FTC/tenofovir disoproxil, and -9.8 ± 19.4 mL/min for ATV/r+FTC/tenofovir disoproxil.
Danish: Den gennemsnitlige ændring i estimeret glomerulær filtrationshastighed (eGFR, estimated glomerular filtration rate) via Cockcroft-Gault-metoden efter 144 ugers behandling var -14,0 ± 16,6 ml/min for Stribild, -1,9 ± 17,9 ml/min for EFV/FTC/tenofovirdisoproxil og -9,8 ± 19,4 ml/min for ATV/r+FTC/tenofovirdisoproxil.
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Danish: Der er rapporteret om tilfælde af akut nyresvigt efter opstart af høje doser eller flere typer af nonsteroide antiinflammatoriske lægemidler (NSAID'er) hos patienter, der var i behandling med tenofovirdisoproxil, og som havde risikofaktorer for nyredysfunktion.
English: Croscarmellose sodium Hydroxypropyl cellulose Lactose (as monohydrate) Magnesium stearate Microcrystalline cellulose Silicon dioxide Sodium lauryl sulfate
Danish: Croscarmellosenatrium Hydroxypropylcellulose Lactose (som monohydrat) Magnesiumstearat Mikrokrystallinsk cellulose Siliciumdioxid Natriumlaurilsulfat
English: 1 This adverse reaction was not observed in the Phase 3 clinical studies for Stribild but identified from clinical studies or post-marketing experience for emtricitabine or tenofovir disoproxil when used with other antiretrovirals.
Danish: 1 Denne bivirkning blev ikke observeret i fase 3-kliniske studier for Stribild, men blev identificeret i kliniske studier eller fra erfaring efter markedsføring for emtricitabin eller tenofovirdisoproxil ved anvendelse sammen med andre antiretrovirale midler.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: tenofovirdisoproxil eller et af de øvrige indholdsstoffer i Stribild (angivet i punkt 6 i denne indlægsseddel).
English: Plasma concentrations of these medicinal products may be increased when co-administered with Stribild, resulting in reduced serum cortisol concentrations.
Danish: Plasmakoncentrationen af disse lægemidler kan øges ved samtidig administration af Stribild, hvilket medfører nedsat serumkortisol.
English: The same recommendations apply as in adults (see Co-administration of other medicinal products below).
Danish: Samtidig administration og risiko for nyre toksicitet Der gælder de samme anbefalinger som hos voksne (se Samtidig administration af andre lægemidler nedenfor).
English: Co-administration with Stribild may result in increased plasma concentrations of this drug.
Danish: Samtidig administration af Stribild kan føre til øgede plasmakoncentrationer af dette lægemiddel.
English: hypokalaemia1,3
Danish: hypokaliæmi1,3
English: Caution should be exercised, including consideration of dose reduction, when co-administering Stribild with tadalafil for the treatment of pulmonary arterial hypertension.
Danish: Der bør udvises forsigtighed, og en dosisreduktion bør overvejes ved samtidig administration af Stribild og tadalafil til behandling af pulmonal arteriel hypertension.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Danish: Cobicistat er en selektiv, mekanismebaseret hæmmer af cytokromer P450 fra CYP3A-undergruppen.
English: In animal studies it has been shown that elvitegravir, cobicistat and tenofovir are excreted in milk.
Danish: Det er blevet vist i dyrestudier, at elvitegravir, cobicistat og tenofovir udskilles i mælk.
English: Stribild may interact with other medicines.
Danish: Stribild kan påvirke anden medicin.
English: Other substitutions in integrase that occurred in addition to a primary INSTI resistance substitution each in single cases were H51Y, L68V, G140C, S153A, E157Q, and G163R.
Danish: Andre substitutioner i integrase, der opstod i tillæg til primær INSTIresistenssubstitution i enkelte tilfælde, var H51Y, L68V, G140C, S153A, E157Q og G163R.
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL at week 48.
Danish: Når manglende data blev ekskluderet havde 91 % af patienterne i den gruppe, der blev behandlet med tenofovirdisoproxil, og 94 % af patienterne i den gruppe, der fik behandling med stavudin eller zidovudin, hiv 1-RNA-koncentrationer < 400 kopier/ml ved uge 48.
English: Contents of the pack and other information What Stribild contains
Danish: Pakningsstørrelser og yderligere oplysninger Stribild indeholder:
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see sections 4.4 and 5.1).
Danish: Der foreligger ingen data, hvorpå der kan laves en dosisanbefaling til patienter over 65 år (se pkt.
English: Stribild should not be initiated in patients with creatinine clearance < 70 mL/min.
Danish: Stribild bør ikke påbegyndes hos patienter med kreatininclearance < 70 ml/min.
English: Of the 18 patients with viral resistance development, 13 occurred through Week 48, 3 occurred between Week 48 to Week 96, and 2 occurred between Week 96 to Week 144 of treatment.
Danish: 13 af de 18 patienter med viral resistensudvikling udviklede resistens i perioden til og med behandlingsuge 48, 3 udviklede resistens mellem behandlingsuge 48 og 96, og 2 mellem behandlingsuge 96 og 144.
English: Stribild should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during Stribild therapy.
Danish: Stribild bør ikke opstartes hos pædiatriske patienter med nedsat nyrefunktion og bør seponeres hos pædiatriske patienter, der får nedsat nyrefunktion under behandlingen med Stribild.
English: • back pain caused by kidney problems, including kidney failure.
Danish: • rygsmerter på grund af nyreproblemer, inklusive nyresvigt.
English: Among the 50 paediatric patients receiving Stribild, mean BMD increased from baseline to Week 48, +0.68% for lumbar spine and +0.77% for total body less head.
Danish: Blandt de 50 pædiatriske patienter, der fik Stribild, steg gennemsnitligt BMD fra baseline til uge 48 med +0,68 % for columna lumbalis og med +0,77 % for hele kroppen minus hovedet.
English: Do not stop taking Stribild
Danish: 3, Hold ikke op med at tage Stribild.
English: At Week 48, 44 of 50 (88%) adolescent patients treated with Stribild achieved HIV-1 RNA <50 copies/mL and 4 achieved HIV-1 RNA ≥50 copies/mL; 1 patient discontinued study drug, and 1 had no virologic data at Week 48.
Danish: Ved uge 48 havde 44 ud af 50 (88 %) pædiatriske patienter behandlet med Stribild opnået hiv 1 rna < 50 kopier/ml, og 4 havde opnået hiv 1 rna ≥ 50 kopier/ml; 1 patient havde fået seponeret studielægemidlet, og 1 patient havde ingen virologiske data ved uge 48.
English: Indigo carmine aluminium lake (E132), macrogol 3350 (E1521), polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553B), titanium dioxide (E171), yellow iron oxide (E172).
Danish: Indigocarmin aluminiumpigment (E132), macrogol 3350 (E1521), polyvinylalkohol (delvist hydrolyseret) (E1203), talcum (E553B), titandioxid (E171), gul jernoxid (E172).
English: At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~ 1.0 and the mean semen to plasma drug concentration ratio was ~ 4.0.
Danish: Ved maksimale plasmakoncentrationer var forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blodet ~ 1,0 og forholdet mellem gennemsnitlig lægemiddelkoncentration i sæd og plasma var ~ 4,0.
English: Three (0.8%) subjects who received ATV/r+FTC/tenofovir disoproxil developed laboratory findings consistent with proximal renal tubular dysfunction leading to discontinuation of ATV/r+FTC/tenofovir disoproxil after Week 96 (see section 4.4).
Danish: 3 (0,8 %) af personerne, der fik ATV/r+FTC/tenofovirdisoproxil, udviklede laboratoriefund i overensstemmelse med dysfunktion af de proksimale renale tubuli, hvilket førte til seponering af ATV/r+FTC/tenofovirdisoproxil efter uge 96 (se pkt.