natgillin/translations-raw huggingface dataset:
Hvis der er tegn på nyopstået eller forværret leverdysfunktion (herunder klinisk signifikant forhøjede leverenzymer og/eller symptomer såsom træthed, anoreksi, kvalme, gulsot, mørk urin, ømhed ved leveren, hepatomegali) hos patienter, der tager Symtuza, skal det omgående overvejes om behandlingen skal afbrydes midlertidigt eller helt seponeres (se pkt. 
If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using Symtuza, interruption or discontinuation of treatment should be considered promptly (see section 5.3).
Emtricitabintriphosphat hæmmer hiv-replikationen ved optagelsen i det virale DNA, der medieres af hiv revers-transkriptase (RT), hvilket resulterer i DNA-kædeafslutning. 
Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination.
Filmovertrækket indeholder polyethylenglycol (macrogol), polyvinylalkohol (delvist hydrolyseret), talcum, titandioxid og jernoxid, gul. 
The film-coating contains polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide and yellow ferric oxide.
Cobicistat metaboliseres via CYP3A- (primært) og CYP2D6- (i mindre grad) medieret oxidation og gennemgår ikke glukuronidering. 
Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
I det kliniske udviklingsprogram for darunavir/ritonavir (N=3.063) blev der rapporteret alvorlige hudreaktioner, som kunne være ledsaget af feber og/eller forhøjede aminotransferaser, hos 0,4 % af patienterne. 
During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Baseret på teoretiske overvejelser forventes Symtuza at øge eksponeringen for lomitapid ved co-administration. 
Based on theoretical considerations, Symtuza is expected to increase the exposure of lomitapide when coadministered.
Det er påvist, at behandling med 800/150 mg darunavir/cobicistat i det andet og tredje trimester fører til lav eksponering for darunavir med en reduktion i værdierne for Cmin på ca. 90 % (se pkt. 
Treatment with darunavir/cobicistat 800/150 mg during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Baseret på teoretiske overvejelser forventes Symtuza at øge koncentrationen af clonazepam (Hæmning af CYP3A). 
Based on theoretical considerations Symtuza is expected to increase concentrations of clonazepam (inhibition of CYP3A)
Dosisjustering af Symtuza er ikke er nødvendig hos patienter med en estimeret glomerulær filtrationshastighed i henhold til Cockcroft-Gault-formlen (eGFRCG) ≥ 30 ml/min. 
No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate according to the Cockcroft-Gault formula (eGFRCG) ≥ 30 mL/min.
Knogletoksicitet blev observeret som nedsat knoglemineraltæthed hos rotter og hunde ved eksponeringer for tenofovir, der var mindst fire gange større, end hvad der forventes efter administration af Symtuza. 
Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Symtuza.
Der foreligger ingen farmakokinetiske data for tenofoviralafenamid hos patienter med eGFRCG <15 ml/min. 
There are no pharmacokinetic data on tenofovir alafenamide in patients with eGFRCG < 15 mL/min.
Koncentrationen af disse lægemidler øges muligvis ved co-administration med Symtuza og kan således muligvis resultere i en øget forekomst af de bivirkninger, som normalt er forbundet med disse lægemidler. 
Concentrations of these medicinal products may be increased when co-administered with Symtuza resulting in the potential for increased adverse events usually associated with these medicinal products.
Co-administration af Symtuza og andre lægemidler, der hæmmer CYP3A, kan nedsætte clearance af darunavir og cobicistat og medføre øgede plasmakoncentrationer af darunavir og cobicistat (f.eks. antimykotiske azoler som clotrimazol). 
Co-administration of Symtuza and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals like clotrimazole).
Darunavir binder primært til α1-glykoproteinsyre i plasma. 
Darunavir binds primarily to plasma α1-acid glycoprotein.
Symtuza og antacida kan anvendes samtidig uden dosisjustering. 
Symtuza and antacids can be used concomitantly without dose adjustment.
Baseret på stratumjusteret MH-test, hvor stratificeringsfaktorerne er hiv-1 RNA-niveau (≤100.000 eller > 100.000 kopier/ml) og CD4+-celletal (< 200 eller ≥200 celler/µl). 
Based on stratum adjusted MH test where stratification factors are HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and CD4+ cell count (< 200 or ≥ 200 cells/µL).
De i alt 725 patienter havde en gennemsnitsalder på 34 år (interval 18-71), 88,3 % var mænd, 83,2 % hvide, 11,1 % sorte, 1,5 % asiater. 
The 725 patients in total had a median age of 34 years (range 18-71), 88.3% were male, 83.2% White, 11.1% Black, 1.5% Asian.
Lægemidler, der inducerer P-gp-aktivitet (f.eks. rifampicin, rifabutin, carbamazepin, phenobarbital) forventes at nedsætte absorptionen af tenofoviralafenamid, hvilket fører til en nedsat plasmakoncentration af tenofoviralafenamid, hvilket kan føre til tab af terapeutisk effekt af tenofoviralafenamid og udvikling af resistens. 
Medicinal products that induce P-gp activity (e.g., rifampicin, 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 tenofovir alafenamide and development of resistance.
Tenofoviralafenamid er et substrat for OATP1B1 og OATP1B3 in vitro. 
Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Fase 3-studiet TMC114IFD3013 (EMERALD) evaluerede virkningen af Symtuza hos virologisk supprimerede (hiv-1 RNA under 50 kopier/ml) hiv-1-inficerede patienter. 
Phase 3 trial TMC114IFD3013 (EMERALD) evaluated the efficacy of Symtuza in virologicallysuppressed (HIV-1 RNA less than 50 copies/mL) HIV-1 infected patients.
Se produktresuméet for darunavir for yderligere oplysninger. 
Consult the Summary of Product Characteristics for darunavir for further details.
Ud over de opportunistiske infektioner kan autoimmune lidelser (når immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion på grund af en forbedring af kroppens immunforsvar. 
In addition to the opportunistic infections, autoimmune disorders (when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection, due to an improvement in the body's immune response.
(CYP3A-hæmning) Koncentrationen af clarithromycin kan øges efter co-administration med DRV/COBI. 
(CYP3A inhibition) Concentrations of clarithromycin may be increased upon co-administration with DRV/COBI.
Der findes ingen farmakokinetiske data for emtricitabin og tenofoviralafenamid under graviditet. 
No pharmacokinetic data are available for emtricitabine and tenofovir alafenamide during pregnancy.
Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv-1-inficerede personer med moderat nedsat leverfunktion (Child-Pugh klasse B). 
A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Det anbefalede dosisregime til voksne og unge i alderen 12 år og derover, der vejer mindst 40 kg, er én tablet, der tages én gang dagligt sammen med mad. 
The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food.
For tenofoviralafenamid var Cmax 1,82 gange højere i fastende tilstand, mens AUC var 20 % lavere til sammenligning i fastende og ikke-fastende tilstand. 
For tenofovir alafenamide, the Cmax was 1.82-fold higher in fasted condition, while the AUC was 20% lower to comparable in a fasted compared to fed condition.
Klinisk monitorering anbefales ved co-administration af Symtuza med perphenazin, risperidon eller thioridazin. 
Clinical monitoring is recommended when co-administering Symtuza with perphenazine, risperidone or thioridazine.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after “EXP”.
• cobicistat, der booster (forstærker) virkningen af darunavir 
• cobicistat, a booster (enhancer) of darunavir
Co-administration sammen med den moderate CYP3A-inducer efavirenz påvirkede ikke eksponeringen af tenofoviralafenamid signifikant. 
Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Revers transkriptase 
Reverse transcriptase
Den samlede sikkerhedsprofil for Symtuza er baseret på data fra et randomiseret, dobbeltblindet, sammenlignende fase 2-studie, GS-US-299-0102 (N = 103 på darunavir/cobicistat/emtricitabin/tenofoviralafenamid [D/C/F/TAF]), data fra to fase 3-studie TMC114FD2HTX3001 (AMBER, N = 362 på D/C/F/TAF) og TMC114IFD3013 (EMERALD, N = 763 på D/C/F/TAF), og på alle tilgængelige data fra kliniske studier og efter markedsføringen af de enkelte komponenter. 
The overall safety profile of Symtuza is based on data from a randomised, double-blinded, comparative Phase 2 trial, GS-US-299-0102 (N = 103 on darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), data from 2 Phase 3 trials TMC114FD2HTX3001 (AMBER, N = 362 on D/C/F/TAF) and TMC114IFD3013 (EMERALD, N = 763 on D/C/F/TAF), and on all available clinical trial and post-marketing data of its components.
Sildenafil til behandling af hjerte- og lungesygdommen der kaldes pulmonal arteriel hypertension. 
Sildenafil to treat a heart and lung disorder called pulmonary arterial hypertension.
ALFA-RECEPTORANTAGONISTER Alfusozin 
ALPHA ADRENORECEPTOR ANTAGONISTS Alfusozin
I fase 3-studiet TMC114FD2HTX3001med behandlingsnaive patienter, var Symtuza associeret med ingen eller mindre reduktion i knoglemineraldensitet (BMD) sammenlignet med kontrolgruppen (DRV/COBI+F/TDF) målt med DXA-analyse af hofte (least square means-procentændring: 0,17 % vs -2,69 %, p < 0,001) og lændehvirvelsøjlen (least square means procentændring: -0,68 % vs -2,38 %, p =0,004) efter 48 ugers behandling. 
In the Phase 3 study TMC114FD2HTX3001in treatment-naïve patients, Symtuza was associated with no or smaller reductions in bone mineral density (BMD) compared DRV/COBI+F/TDF as measured by DXA analysis of hip (LS means percent change: 0.17% vs -2.69%, p < 0.001) and lumbar spine (LS means percent change: -0.68% vs -2.38%, p =0.004) after 48 weeks of treatment.
Medianen for CD4+-celletallet ved baseline var 628 x 10 
The median baseline CD4+ cell count was 628 x 10
Selvom darunavir ikke er blevet undersøgt hos patienter med nedsat nyrefunktion, viste en populationsfarmakokinetisk analyse, at darunavirs farmakokinetik ikke var signifikant påvirket hos hiv-inficerede patienter med moderat nedsat nyrefunktion (eGFRCG mellem 30 og 60 ml/min, N=20) (se pkt. 
Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (eGFRCG between 30-60 mL/min, N = 20) (see sections 4.2 and 4.4).
De virologiske resultater fra uge 48 og 96 i EMERALD-studiet er vist i tabel 6. 
Week 48 and 96 virologic outcomes in the EMERALD trial are provided in Table 6.
Over 96 ugers behandling i fase 3-studierne TMC114FD2HTX3001 (AMBER) hos behandlingsnaive patienter og TMC114IFD3013 (EMERALD) hos virologisk supprimerede, behandlingserfarne patienter blev der udført resistenstestning på prøver fra patienter, som oplevede protokoldefineret virologisk svigt (PDVF), og som havde hiv-1 RNA ≥ 400 kopier/ml ved svigtet eller på senere tidspunkter. 
Over 96 weeks of treatment in the Phase 3 studies TMC114FD2HTX3001 (AMBER) in treatmentnaïve patients and TMC114IFD3013 (EMERALD) in virologically suppressed treatment-experienced patients, resistance testing was performed on samples from patients experiencing protocol-defined virologic failure (PDVF) and who had HIV-1 RNA ≥400 copies/mL at failure or at later time points.
Symtuza er derfor kontraindiceret til patienter med svært nedsat leverfunktion. 
Symtuza is, therefore, contraindicated in patients with severe hepatic impairment.
Hos hivinficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af CART kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer. 
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Symtuza kan forhøje blodsukkerniveauet. 
Symtuza might increase sugar levels in the blood.
Hiv-1-behandlingserfarne patienter 
HIV-1 Treatment experienced Patients
Emtricitabins antivirale aktivitet mod laboratorie- og kliniske isolater af hiv-1 blev vurderet i lymfoblastoide cellelinjer, MAGI CCR5-cellelinjen og PBMC'er. 
The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI CCR5 cell line, and PBMCs.
Sikkerheden af komponenterne i Symtuza blev imidlertid evalueret i det kliniske studie TMC114-C230 (N=12) for darunavir med ritonavir og GS-US-292-0106 (N=50) for en fastdosiskombination indeholdende elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid. 
However,the safety of components of Symtuza was evaluated through the clinical study TMC114-C230 (N = 12) for darunavir with ritonavir and GS-US-292-0106 (N = 50) for a fixed dose combination containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Almene symptomer og reaktioner på administrationsstedet almindelig asteni, træthed 
General disorders and administration site conditions common asthenia, fatigue
Der har været rapporter om hyppigere spontane blødninger hos patienter med hæmofili, der fik antiretrovirale proteasehæmmere (se pkt. 
There have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Darunavir udviser aktivitet mod laboratoriestammer og kliniske isolater af hiv-1 og laboratoriestammer af hiv-2 i akut inficerede T-cellelinjer, humane PBMC'er og humane monocytter/makrofager med mediane EC50-værdier i intervallet fra 1,2 til 8,5 nM (0,7 til 5,0 ng/ml). 
Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human PBMCs and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/mL).
Når du er ved at løbe tør for Symtuza, skal du bede om mere fra lægen eller på apoteket. 
When your supply of Symtuza starts to run low, get more from your doctor or pharmacist.
Udover disse opportunistiske infektioner kan autoimmune lidelser (en tilstand, der opstår, når immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion. 
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.
Derfor skal mærkningen af hvert lægemiddel, som administreres sammen med Symtuza, gennemgås for information releteret til metabolismevejen, interaktions mekanismerne, potentielle riscici og konkrete forholdsregler, som skal tages i forbindelse med co-administration. 
The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with Symtuza should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
I studie GS-US-292-0106 blev virkningen, sikkerheden og farmakokinetikken af emtricitabin og tenofoviralafenamid evalueret i et åbent studie, i hvilket 50 hiv-1-inficerede behandlingsnaive unge fik emtricitabin og tenofoviralafenamid (10 mg) med elvitegravir og cobicistat som en fastdosiskombinationstablet. 
In the study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Hos nogle patienter med fremskreden hiv-infektion, som havde usædvanlige infektioner på grund af et svækket immunforsvar (opportunistiske infektioner), kan tegn og symptomer på betændelse fra tidligere infektioner vise sig kort efter, at du har påbegyndt hiv-behandling. 
In some patients with advanced HIV infection and who had unusual infections due to a weakened immune system (opportunistic infection), signs and symptoms of inflammation from previous infections may occur soon after you start HIV treatment.
Fluticason 
Fluticasone
Der findes imidlertid farmakokinetiske data for de forskellige komponenter i Symtuza, der indikerer, at doser på 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabin og 10 mg tenofoviralafenamid resulterer i tilsvarende eksponeringer hos voksne og unge fra alderen 12 år og op, som vejer mindst 40 kg. 
However, there are pharmacokinetic data for the different components of Symtuza, indicating that doses of 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide result in similar exposures in adults and adolescents aged 12 years and older, weighing at least 40 kg.
Hiv-1-behandlingsnaive patienter 
HIV-1 Treatment naïve Patients
Det er påvist in vitro og in vivo, at nukleosid- og nukleotidanaloger i forskellig grad forårsager skader på mitokondrierne. 
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Samtidig brug af en HMG-CoAreduktasehæmmer og Symtuza kan øge plasmakoncentrationen af det lipidsænkende stof, hvilket kan medføre bivirkninger såsom myopati. 
Concomitant use of a HMG CoA reductase inhibitor and Symtuza may increase plasma concentrations of the lipid lowering agent, which may lead to adverse reactions such as myopathy.
I fase 2/3-studierne af behandlingsnaive patienter oplevede 12,7 % (59/465) af de patienter, der fik Symtuza, udslæt (af hvilke de fleste var af grad 1), 1,5 % (7/465) af patienterne afbrød behandlingen på grund af udslæt, af hvilke én både havde udslæt og overfølsomhed. 
In the Phase 2/3 trials in treatment-naïve patients, 12.7% (59/465) of patients receiving Symtuza experienced rash (most of which were grade 1), 1.5% (7/465) of patients discontinued treatment due to rash, of whom one for rash and hypersensitivity.
Aktive stoffer: darunavir, cobicistat, emtricitabin og tenofoviralafenamid. 
The active substances are darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
Samtidig brug af everolimus og Symtuza frarådes. 
Concomitant use of everolimus and Symtuza is not recommended.
Et forøsg med farmakokinetikken af cobicistat blev udført hos ikke-hiv-1-inficerede personer med svært nedsat nyrefunktion (eGFRCG under 30 ml/min). 
A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (eGFRCG below 30 mL/min).
Tenofovirdiphosphat hæmmer hiv-replikationen ved optagelsen i det virale DNA, der medieres af hiv-RT, hvilket resulterer i DNA-kædeafslutning. 
Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
Co-administration of tadalafil til behandling af pulmonal arteriel hypertension med Symtuza frarådes. 
Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with Symtuza is not recommended.
Co-administration af tenofoviralafenamid med andre lægemidler, som hæmmer P-gp (f.eks. cobicistat, ritonavir, ciclosporin), forventes at øge absorptionen og plasmakoncentrationen af tenofoviralafenamid. 
Co-administration of tenofovir alafenamide with other medicinal products that inhibit P-gp (e.g., cobicistat, ritonavir, ciclosporin) are expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Kontakt altid lægen, når du får udslæt. 
Please contact your doctor whenever you develop a rash.
Symtuza bør ikke anvendes til pædiatriske patienter under 3 år på grund af problemstillinger vedrørende sikkerhed (se pkt. 
Symtuza should not be used in paediatric patients below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Patienter med kronisk hepatitis B eller C, som er i antiretroviral behandling, har en øget risiko for alvorlige og potentielt dødelige leverbivirkninger. 
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
De selekterede vira kunne ikke vokse ved tilstedeværelse af darunavir-koncentrationer over 400 nM. Vira, der blev selekteret under disse betingelser, og som viste nedsat følsomhed over for darunavir (interval: 23-50 fold), indeholdt 2 til 4 aminosyresubstitutioner i proteasegenet. 
Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Co-administration af Symtuza og disse antikoagulantia frarådes. 
Co-administration of Symtuza and these anticoagulants is not recommended.
Vægtøgning og forhøjede lipider og glucose i blodet kan forekomme under antiretroviral behandling. 
An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Patienter med eksisterende leverdysfunktion, herunder kronisk hepatitis B eller C, har en øget risiko for leverfunktionsanomalier, herunder alvorlige og potentielt dødelige leverbivirkninger. 
Patients with pre-existing liver dysfunction, including chronic hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
Krydsresistens hos hiv-1-inficerede, behandlingsnaive og virologisk supprimerede patienter 
Cross-resistance in HIV-1 infected, treatment-naïve and virologically suppressed patients
Hos hiv-inficerede patienter med svær immundefekt på tidspunktet for initiering af CART kan der opstå en inflammatorisk reaktion på asymptomatiske eller resterende opportunistiske infektioner. 
In HIV infected patients with severe immune deficiency at the time of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for tenofoviralafenamid eller tenofovir hos raske personer og hos patienter med svært nedsat nyrefunktion (eGFRCG > 15 men < 30 ml/min) i studier af tenofoviralafenamid. 
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (eGFRCG > 15 but < 30 mL/min) in studies of tenofovir alafenamide.