FrancophonIA/ELRC3.0 huggingface dataset:
English: Cobicistat inhibits the tubular secretion of creatinine and may cause modest increases in serum creatinine and modest declines in creatinine clearance (see section 4.8).
Danish: Cobicistat hæmmer den tubulære sekretion af kreatinin og kan forårsage moderate forhøjelser af serum-kreatinin og moderate reduktioner i kreatininclearance (se pkt.
English: cisapride (used to relieve certain stomach problems) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it lovastatin, simvastatin (used to lower blood cholesterol) pimozide, lurasidone (used to treat abnormal thoughts or feelings) sildenafil (used to treat pulmonary arterial hypertension - a lung disease that makes breathing difficult) orally administered midazolam, triazolam (used to help you sleep and/or relieve anxiety)
Danish: dihydroergotamin, ergotamin, ergometrin (anvendes til at behandle migræne hovedpine) cisaprid (anvendes til at lindre visse maveproblemer) prikbladet perikum (Hypericum perforatum, et naturlægemiddel, der anvendes mod depression og angst) eller lægemiddel, der indeholder det lovastatin, simvastatin (anvendes til at sænke kolesterol i blodet) pimozid, lurasidon (anvendes til at behandle unormale tanker og følelser) sildenafil (anvendes til at behandle pulmonal arteriel hypertension - en lungesygdom, der gør det vanskeligt at trække vejret) oralt administreret midazolam, triazolam (anvendes til at hjælpe dig med at sove og/eller lindre angst)
English: Magnesium/aluminium-containing antacid suspension (20 mL single dose)/Elvitegravir (50 mg single dose)/Ritonavir (100 mg single dose)
Danish: Magnesium/aluminium-indeholdende antacidum-suspension (20 ml enkeltdosis)/Elvitegravir (50 mg enkeltdosis)/Ritonavir (100 mg enkeltdosis)
English: Following oral administration of [14C]elvitegravir/ritonavir, 94.8% of the dose was recovered in faeces, consistent with the hepatobiliary elimination of elvitegravir; 6.7% of the administered dose was recovered in urine.
Danish: Efter oral administration af [14C]elvitegravir/ritonavir blev 94,8 % af dosis genfundet i fæces i overensstemmelse med den hepatobiliære elimination af elvitegravir.
English: suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness), depression Nervous system disorders: Very common:
Danish: selvmordstanker og selvmordsforsøg (hos patienter med en eksisterende anamnese med depression eller en psykisk sygdom), depression
English: The pharmacokinetics of emtricitabine and tenofovir are altered in subjects with renal impairment.
Danish: Emtricitabins og tenofovirs farmakokinetik ændres hos personer med nedsat nyrefunktion.
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil (see section 4.8).
Danish: Der er rapporteret nyresvigt, nedsat nyrefunktion, forhøjet kreatinin, hypophosphatæmi og proksimal tubulopati (herunder Fanconis syndrom) ved brug af tenofovirdisoproxil (se pkt.
English: In HIV-1 infected adolescents (aged 12 to < 18 years), the BMD Z-scores observed in subjects who received tenofovir disoproxil were lower than those observed in subjects who received placebo.
Danish: Hos hiv 1-inficerede unge (i alderen 12 til < 18 år) blev der set lavere BMD Z-scorer hos de forsøgsdeltagere, der fik tenofovirdisoproxil, end hos de forsøgsdeltagere, der fik placebo.
English: Co-administration with Stribild may result in increased plasma concentrations of sildenafil and tadalafil, which may result in PDE-5 inhibitor-associated adverse reactions.
Danish: Samtidig administration med Stribild kan føre til øgede plasmakoncentrationer af sildenafil og tadalafil, hvilket kan føre til bivirkninger associeret med PDE-5hæmmeren.
English: If serum phosphate is confirmed to be < 0.96 mmol/L (3.0 mg/dL) in any paediatric patient receiving Stribild, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Danish: Hvis serumphosphat bekræftes at være < 0,96 mmol/l (3,0 mg/dl) hos en pædiatrisk patient, der får Stribild, skal vurderingen af nyrefunktionen gentages inden for en uge, herunder måling af glucose- og kaliumkoncentration i blodet samt uringlucose (se pkt.
English: No dose adjustment of elvitegravir or cobicistat is necessary for patients with mild to moderate hepatic impairment.
Danish: Ingen dosisjustering af elvitegravir eller cobicistat er nødvendig for patienter med let til moderat nedsat leverfunktion.
English: Plasma concentrations of drospirenone may be increased when co-administered with cobicistat-containing products.
Danish: Plasmakoncentrationer af drospirenon kan øges ved samtidig administration af produkter indeholdende cobicistat.
English: Rifabutin: AUC: ↔
Danish: Digoxin: AUC: ↔
English: Patients receiving Stribild concomitantly with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir should be monitored for adverse reactions related to tenofovir disoproxil.
Danish: Patienter, der får Stribild samtidig med ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir, bør monitoreres for bivirkninger relateret til tenofovirdisoproxil.
English: Stribild is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild (see sections 4.2, 4.4 and 5.1).
Danish: Stribild er indiceret til behandling af infektion med humant immundefekt virus 1 (hiv 1) hos voksne i alderen 18 år og derover, som er antiretroviral-behandlingsnaive eller inficerede med hiv 1 uden kendte mutationer forbundet med resistens over for nogle af de tre antiretrovirale stoffer i Stribild (se pkt.
English: ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/Cobicistat (150 mg once daily)
Danish: ORALE ANTIKONCEPTIVA Drospirenon/Ethinylestradiol (3 mg/0,02 mg enkeltdosis)/Cobicistat (150 mg én gang daglig)
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to < 12 years in a clinical study of tenofovir disoproxil (GS-US-104-0352) (see sections 4.8 and 5.1).
Danish: Der er rapporteret om bivirkninger på nyrerne, der er overensstemmende med proksimal nyre tubulopati, hos hiv 1-inficerede pædiatriske patienter i alderen 2 til < 12 år i et klinisk studie af tenofovirdisoproxil (GS-US-104-0352) (se pkt.
English: The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes.
Danish: Den antivirale aktivitet af tenofovir mod isolater af hiv 1 fra laboratoriet og klinikken blev vurderet i lymfoblastoide cellelinjer, primære monocyt-/makrofage celler og perifere lymfocytter i blodet.
English: ANTIDEPRESSANTS Escitalopram Trazodone
Danish: ANTIDEPRESSIVA Escitalopram Trazodon
English: In patients who received treatment with tenofovir disoproxil, or stavudine or zidovudine, mean lumbar spine BMD Z-score was -1.034 and -0.498, and mean total body BMD Z-score was -0.471 and -0.386, respectively, at baseline.
Danish: Hos patienter, der fik behandling med tenofovirdisoproxil eller med stavudin eller zidovudin, var BMD Z-scoren for columna lumbalis hhv. -1,034 og -0,498, og den gennemsnitlige BMD Z-score for hele kroppen var hhv. -0,471 og -0,386 ved baseline.
English: As in adults, adolescents who experience a confirmed increase in serum creatinine of greater than 26.5 µmol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety (see above).
Danish: Som hos voksne, skal unge, som oplever et bekræftet forhøjet indhold af serumkreatinin på over 26,5 µmol/l (0,3 mg/dl) fra baseline, overvåges nøje for nyresikkerhed (se ovenfor).
English: Co-administration of Stribild and some medicinal products that induce CYP3A such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance (see section 4.3).
Danish: Samtidig administration af Stribild og nogle lægemidler, som inducerer CYP3A såsom prikbladet perikum (Hypericum perforatum), rifampicin, carbamazepin, phenobarbital og phenytoin kan føre til signifikant reducerede plasmakoncentrationer af cobicistat og elvitegravir, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens (se pkt.
English: • tenofovir disoproxil, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Danish: • tenofovirdisoproxil, et antiretroviralt lægemiddel, der kaldes en nukleotid-revers transkriptase hæmmer (NtRTI)
English: • pain in the abdomen (tummy) caused by inflammation of the pancreas (pancreatitis)
Danish: • mavesmerter på grund af betændelse i bugspytkirtlen (pankreatitis)
English: • and you notice 18 hours or more after the time you usually take Stribild, then do not take the missed dose.
Danish: • og De kommer i tanker om det 18 timer eller længere efter det tidspunkt, De normalt tager
English: The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Danish: De bivirkninger, der blev set hos de pædiatriske patienter, som fik behandling med tenofovirdisoproxil, var overensstemmende med de bivirkninger, der blev set i kliniske studier med tenofovirdisoproxil hos voksne (se pkt.
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z-score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Danish: Hos de patienter, der fik behandling med tenofovirdisoproxil eller placebo, var den gennemsnitlige BMD Z-score for columna lumbalis hhv. -1,004 og -0,809, og den gennemsnitlige BMD Z-score for hele kroppen var hhv. -0,866 og -0,584 ved baseline.
English: In Study GS-US-236-0103 HIV-1 infected antiretroviral treatment-naïve adult patients received once daily treatment of Stribild or ritonavir-boosted atazanavir (ATV/r) plus fixed-dose combination of emtricitabine (FTC)/tenofovir disoproxil.
Danish: I studie GS-US-236-0103 fik hiv 1-inficerede antiretroviral-naive voksne patienter behandling med Stribild én gang daglig eller ritonavir-boosted atazanavir (ATV/r) plus fastdosiskombination af emtricitabin(FTC)/tenofovirdisoproxil.
English: Cmin: NC
Danish: Cmin: N/A
English: Virologic success HIV-1 RNA < 50 copies/mL Treatment difference
Danish: Hiv 1-rna < 50 kopier/ml
English: No dose adjustment of Stribild is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment (see sections 4.2 and
Danish: En dosisjustering af Stribild er ikke nødvendig hos patienter med let (Child-Pugh klasse A) eller moderat (Child-Pugh klasse B) nedsat leverfunktion (se pkt.
English: The safety of Stribild in 50 HIV-1-infected, treatment-naïve paediatric patients aged 12 to < 18 years was evaluated through 48 weeks in an open-label clinical study (GS-US-236-0112, see section 5.1).
Danish: Sikkerheden af Stribild blev evalueret hos 50 hiv 1-inficerede, behandlingsnaive pædiatriske patienter i alderen 12 til < 18 år igennem 48 uger i et klinisk studie med åben behandling (GS-US-236-0112, se pkt.
English: Elvitegravir/Cobicistat (150 mg/150 mg once daily)8
Danish: Elvitegravir/Cobicistat (150 mg/150 mg én gang daglig)8
English: Concentrations of clarithromycin and/or cobicistat may be altered with co-administration of Stribild.
Danish: Koncentrationer af clarithromycin og/eller cobicistat kan ændres ved samtidig administration af Stribild.
English: No dose adjustment of Stribild is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Danish: Dosisjustering af Stribild er ikke nødvendigt hos patienter med let nedsat (Child-Pugh klasse A) eller moderat nedsat (Child-Pugh klasse B) leverfunktion.
English: The efficacy and safety of Stribild in HIV-1-infected, treatment-naïve paediatric patients aged 12 to less than 18 years is based on the analyses of 48-week data from the single-group, open-label study GS-US-236-0112 (N=50).
Danish: Virkningen og sikkerheden af Stribild hos hiv 1-inficerede behandlingsnaive pædiatriske patienter i alderen 12 til under 18 år er baseret på analyserne af data fra uge 48 enkeltgruppestudiet GS-US236-0112 (n = 50) med åben behandling.
English: The importance of regular monitoring of creatinine clearance, serum phosphate, urine glucose and urine protein during Stribild therapy.
Danish: Vigtigheden af regelmæssig monitorering af kreatininclearance, serumphosphat, glucose og protein i urinen bør monitoreres hver fjerde uge i løbet af behandlingen med Stribild.
English: There is insufficient information on the effects of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil in newborns/infants.
Danish: Der foreligger utilstrækkelige data for virkningen af elvitegravir, cobicistat, emtricitabin og tenofovirdisoproxil på det ammede barn.
English: If you are affected while taking Stribild, do not drive and do not use any tools or machines.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle og lad være med at arbejde med værktøj eller maskiner, hvis Deoplever dette, når De tager Stribild.
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at concentrations at least 11-fold higher than the human exposure at the recommended 150 mg daily dose.
Danish: Ex vivo-studier af kaniner og in vivo-studier af hunde tyder på, at cobicistat har en lav risiko for QT-forlængelse, og kan forlænge PR-intervallet let og reducere den venstre ventrikelfunktion ved koncentrationer, der er mindst 11 gange højere end den humane eksponering ved den anbefalede daglige dosis på 150 mg. I et humant klinisk studie af 35 raske personer blev der udført ekkokardiogrammer ved baseline og efter personerne fik 150 mg cobicistat én gang daglig i mindst 15 dage og de indikerede ingen klinisk signifikant ændring i venstre ventrikelfunktion.
English: Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
Danish: Stribild 150 mg/150 mg/200 mg/245 mg filmovertrukne tabletter elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxil
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Danish: Behandlingen bør ikke seponeres hos patienter med fremskreden leversygdom eller levercirrose, da hepatitiseksacerbationer efter behandlingen kan føre til hepatisk dekompensation.
English: • inflammation of the kidney (nephritis)
Danish: • nyrebetændelse (nefritis)
English: No dose adjustment of elvitegravir or cobicistat is necessary for patients with renal impairment.
Danish: Ingen dosisjustering af elvitegravir eller cobicistat er nødvendig for personer med nedsat nyrefunktion.
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adult with renal impairment treated with Stribild (see sections 4.2, 4.4 and 5.2).
Danish: Da tenofovirdisoproxil kan forårsage nyretoksicitet, anbefales tæt monitorering af nyrefunktionen hos alle voksne med nedsat nyrefunktion, som behandles med Stribild (se pkt.
English: Concomitant use with nephrotoxic medicinal products Use of Stribild should be avoided with concurrent or recent use of a nephrotoxic medicinal product, e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin 2 (also called aldesleukin) (see section 4.5).
Danish: Det bør undgås at anvende Stribild ved samtidig eller nylig brug af et nefrotoksisk lægemiddel, f.eks. aminoglykosider, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir eller interleukin 2 (også kaldet aldesleukin) (se pkt.
English: angioedema1
Danish: angioødem1
English: Concentrations of ketoconazole and/or cobicistat may increase with co-administration of Stribild.
Danish: Koncentrationer af ketoconazol og/eller cobicistat kan øges ved samtidig administration af Stribild.
English: Package leaflet: Information for the user Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
Danish: Indlægsseddel: Information til brugeren Stribild 150 mg/150 mg/200 mg/245 mg filmovertrukne tabletter elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxil
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Danish: Brug sammen med visse antivirale midler mod hepatitis C Det er påvist, at samtidig administration af tenofovirdisoproxil og ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir øger plasmakoncentrationen af tenofovir, især ved brug sammen med et hiv-regime, der indeholder tenofovirdisoproxil og en farmakokinetisk booster (ritonavir eller cobicistat).
English: Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4).
Danish: Hepatitis-eksacerbationer efter seponering af behandling Hos hiv-inficerede patienter, som samtidigt er inficeret med HBV, er der set klinisk og paraklinisk evidens for hepatitis efter seponering af behandlingen (se pkt.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil.
Danish: Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle på grund af køn for cobicistat-boosted elvitegravir, emtricitabin og tenofovirdisoproxil.
English: When your supply of Stribild starts to run low, get more from your doctor or pharmacist.
Danish: Når De snart ikke har mere af Stribild, skal De bede om mere fra lægen eller på apoteket.
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/Elvitegravir (150 mg single dose)/Cobicistat (150 mg single dose)
Danish: HMG CO-A-REDUKTASEHÆMMERE Rosuvastatin (10 mg enkeltdosis)/Elvitegravir (150 mg enkeltdosis)/Cobicistat (150 mg enkeltdosis)
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil.
Danish: Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle på grund af etnicitet for cobicistat-boosted elvitegravir, emtricitabin og tenofovirdisoproxil.
English: This is because some of the active substances in this medicine pass into human breast milk.
Danish: De må ikke amme, mens De er i behandling med Stribild, fordi nogle af de aktive stoffer i denne medicin udskilles i mælken hos mennesker.
English: Tenofovir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 to 2.2 µM) and strain specific activity against HIV-2 (EC50 values ranged from 1.6 to 5.5 µM).
Danish: Tenofovir viste antiviral aktivitet i cellekultur mod hiv 1-kladerne A, B, C, D, E, F, G og O (EC50-værdier var i intervallet fra 0,5 til 2,2 µM) og viste stammespecifik aktivitet mod hiv 2 (EC50-værdier var i intervallet fra 1,6 til 5,5 µM).
English: Ledipasvir:
Danish: Observeret: Ledipasvir:
English: Therefore, no tenofovir disoproxil dose adjustment is required in patients with hepatic impairment.
Danish: Derfor er en dosisjustering af tenofovirdisoproxil ikke nødvendig hos patienter med nedsat leverfunktion.
English: Discontinuation of Stribild therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Danish: Seponering af behandlingen med Stribild hos hiv-inficerede patienter, der samtidig er inficeret med HBV, kan forekomme i forbindelse med svær, akut eksacerbation af hepatitis.
English: Concentrations of telithromycin and/or cobicistat may be altered with co-administration of Stribild.
Danish: Koncentrationer af telithromycin og/eller cobicistat kan ændres ved samtidig administration af Stribild.
English: ATV/r + FTC/ tenofovir disoproxil n = 355
Danish: ATV/r + FTC/tenofovirdisoproxil n = 355
English: Ledipasvir/Sofosbuvir (90 mg/400 mg once daily) + Elvitegravir/Cobicistat (150 mg/150 mg once daily)
Danish: Ledipasvir/Sofosbuvir (90 mg/400 mg én gang daglig) + Elvitegravir/cobicistat (150 mg/150 mg én gang daglig)
English: In HIV-1 infected children (aged 2 to 15 years), the BMD Z-scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Danish: Hos hiv 1-inficerede børn (i alderen 2 til 15 år) blev der set lavere BMD Z-scorer hos de forsøgsdeltagere, der skiftede til tenofovirdisoproxil, end hos de forsøgsdeltagere, der fortsatte med deres stavudin- eller zidovudinholdige regime (se pkt.
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Stribild treatment.
Danish: Ved mistanke om eller påvisning af nyre abnormiteter bør der søges rådgivning hos en nefrolog for at beslutte, om behandlingen med Stribild skal afbrydes.
English: Renal monitoring
Danish: Monitorering af nyrerne
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of treatment.
Danish: Ved mistanke om eller påvisning af nyre abnormiteter bør der søges rådgivning hos en nefrolog for at tage stilling til, om behandlingen bør afbrydes.
English: Stribild should not be initiated in patients with creatinine clearance below 70 mL/min (see sections 4.4 and 5.2).
Danish: Stribild bør ikke påbegyndes hos patienter med en kreatininclearance under 70 ml/min (se pkt.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 23 cells/mm3.
Danish: Ved uge 48 var den gennemsnitlige stigning i CD4+ celletal fra baseline 23 celler/mm3.
English: Each Stribild film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Danish: Hver Stribild filmovertrukken tablet indeholder 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabin og 245 mg tenofovirdisoproxil (svarende til 300 mg tenofovirdisoproxilfumarat eller 136 mg tenofovir).
English: Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Danish: Hver filmovertrukken tablet indeholder 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabin og 245 mg tenofovirdisoproxil (svarende til 300 mg tenofovirdisoproxilfumarat eller 136 mg tenofovir).
English: • rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
Danish: • udslæt (inklusive røde pletter eller skjolder, undertiden med blærer eller hævelse af huden), som kan være allergiske reaktioner, kløe, ændringer i hudfarven, herunder pletvis mørkfarvning af huden