FrancophonIA/ELRC3.0 huggingface dataset:
English: † Based on CMH-stratified analysis adjusting for the following baseline stratification factors: Plasma HIV-1 RNA (≤100,000 c/mL vs. >100,000 c/mL) and CD4+ cell count (≤200 cells/mm3 vs. >200 cells/mm3).
Danish: † Baseret på CMH-stratificeret analyse med justering for følgende stratificeringsfaktorer ved baseline: Plasma hiv-1-RNA (≤100.000 c/ml vs. >100.000 c/ml) og CD4+-celletal (≤200 celler/mm3 vs. >200 celler/mm3).
English: Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Danish: Meget sjældne bivirkninger, der muligvis kan ses i blodprøver, er: • manglende dannelse af nye røde blodceller i knoglemarven (ren erytrocytaplasi).
English: - If Dovato is taken in a fasted state, such supplements should be taken a minimum 2 hours after or 6 hours before the intake of Dovato.
Danish: Hvis Dovato indtages i fastende tilstand, skal sådanne tilskud tages mindst 2 timer efter eller 6 timer før indtagelse af Dovato.
English: At week 48, dolutegravir plus lamivudine was non-inferior to dolutegravir plus tenofovir disoproxil/emtricitabine FDC in GEMINI-1 and GEMINI-2 studies.
Danish: I uge 48 var dolutegravir plus lamivudin non-inferior til dolutegravir plus tenofovirdisoproxil/emtricitabin FDC i studierne GEMINI-1 og GEMINI-2.
English: The absorption of dolutegravir is reduced by certain metal cation-containing anti-acid substances and supplements (see Table 1).
Danish: Absorptionen af dolutegravir reduceres af visse metalkationholdige syreneutraliserende stoffer og tilskud (se tabel 1).
English: Lamivudine, via its active metabolite 5'-triphosphates (TP) (an analogue for cytidine), inhibits reverse transcriptase of HIV-1 and HIV-2 through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Danish: Med sine aktive metabolitter 5'-triphosphater (TP) (en analog for cytidin) hæmmer lamivudin revers transkriptase af hiv-1 og hiv-2 ved at inkorporere monophosphatformen i den virale dna-kæde, hvilket resulterer i kædetermination.
English: Swallow the tablet with some liquid.
Danish: Synk tabletten med væske.
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion (Child-Pugh-klasse A eller B).
English: The efficacy of Dovato, or the dual combination of dolutegravir plus lamivudine (as single entities) has not been studied in children or adolescents.
Danish: Virkningen af Dovato eller kombinationen af dolutegravir plus lamivudin (som enkeltstoffer) er ikke undersøgt hos børn og unge.
English: In the Phase III studies for the dolutegravir single agent, patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Danish: I fase III-studierne for dolutegravir som enkeltstof var det tilladt for patienter med co-infektion med hepatitis B og/eller C at deltage, såfremt baseline leverparametertests ikke overskred 5 gange den øvre grænse for normal (ULN).
English: No clinically significant drug interactions are expected between dolutegravir and lamivudine.
Danish: Der forventes ingen klinisk signifikante lægemiddelinteraktioner mellem dolutegravir og lamivudin.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, som behandles med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt fatale leverbivirkninger.
English: Symptoms of infection and inflammation
Danish: Symptomer på infektion og betændelse
English: Dolutegravir is present in the female and male genital tract.
Danish: Dolutegravir er til stede i genitalorganerne hos kvinder og mænd.
English: No relevant effects were seen with dolutegravir on the QTc interval, with doses exceeding the clinical dose by approximately three fold.
Danish: Der sås ingen relevante effekter af dolutegravir på QTc-intervallet ved behandling med cirka 3 gange højere dosis end den kliniske dosis.
English: In vitro, dolutegravir was not a substrate of human OATP 1B1, OATP 1B3 or OCT 1.
Danish: In vitro var dolutegravir ikke et substrat for humant OATP 1B1, OATP 1B3 eller OCT 1.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Autoimmune lidelser (såsom Graves' sygdom og autoimmun hepatitis) er også rapporteret, men den rapporterede tid til udbrud er mere variabel, og disse hændelser kan ske mange måneder efter initiering af behandling (se pkt.
English: Oval, biconvex, white, film coated tablet, approximately 18.5 x 9.5 mm, debossed with “SV 137” on one face.
Danish: Oval, bikonveks, hvid filmovertrukket tablet på ca. 18,5 x 9,5 mm præget med "SV 137" på den ene side.
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. metformin) (see Table 1 and section 4.3).
Danish: In vivo kan dolutegravir øge plasmakoncentrationerne af lægemidler, for hvilke udskillelsen afhænger af OCT2 eller MATE-1 (f.eks. metformin) (se tabel 1 og pkt.
English: Dolutegravir increased metformin concentrations.
Danish: Dolutegravir øgede koncentrationen af metformin.
English: Opaque, white HDPE (high density polyethylene) bottles closed with child resistant polypropylene closures, with a polyethylene faced induction heat seal liner.
Danish: Uigennemsigtige, hvide HDPE (højdensitetspolyethylen)-flasker lukket med børnesikret lukke af polypropylen med en polyethylenbelagt induktionsforsegling.
English: Available toxicological data in animals has shown excretion of dolutegravir in milk.
Danish: De tilgængelige toksikologiske data fra dyreforsøg viser, at dolutegravir udskilles i mælk.
English: Co-administration of Dovato and other medicinal products that inhibit UGT1A1, UGT1A3, UGT1A9, CYP3A4, and/or P-gp may, therefore, increase dolutegravir plasma concentration.
Danish: Samtidig administration af Dovato og andre lægemidler, der hæmmer UGT1A1, UGT1A3, UGT1A9, CYP3A4 og/eller P-gp, kan derfor øge plasmakoncentrationen af dolutegravir.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - COMPONENT OF MULTIPACK)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INTERMEDIÆR KARTON (UDEN BLUE BOX - DEL AF MULTIPAKNING)
English: vomiting, flatulence, abdominal pain/ discomfort
Danish: opkastning, flatulens, abdominalsmerter/-ubehag
English: Administration of a single Dovato tablet with a high fat meal increased dolutegravir AUC(0-∞) and Cmax by 33% and 21%, respectively, and decreased the lamivudine Cmax by 30% compared to fasted conditions.
Danish: Administration af en enkelt Dovato-tablet sammen med et måltid med højt fedtindhold øgede dolutegravirs AUC(0-∞) og Cmax med henholdsvis 33 % og 21 % og reducerede lamivudins Cmax med 30 % sammenlignet med fastetilstand.
English: Common side effects that may show up in blood tests are:
Danish: Almindelige bivirkninger, der muligvis kan ses i blodprøver, er:
English: While the total dolutegravir concentration in plasma was similar, a 1.5 to 2 fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Danish: Mens den totale koncentration af dolutegravir i plasma var ens for de to grupper, blev en 1,5- til 2-gange øgning i ubundet eksponering for dolutegravir observeret hos patienter med moderat nedsat leverfunktion sammenlignet med raske kontroller.
English: Dovato is indicated in the absence of documented or suspected resistance to the integrase inhibitor class and to lamivudine (see section 4.1).
Danish: Dovato er indiceret i fravær af dokumenteret eller mistænkt resistens over for integrasehæmmerklassen og over for lamivudin (se pkt.
English: * The results of the pooled analysis are in line with those of the individual studies, for which the primary endpoint (difference in proportion <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm for dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil /emtricitabine FDC) was met.
Danish: * Resultaterne af den sammenlagte analyse er i overensstemmelse med de individuelle studier, hvori det primære endepunkt (proportionsforskel <50 kopier/ml plasma hiv-1-RNA i uge 48 baseret på snapshot-algoritmen for dolutegravir plus lamivudin versus dolutegravir plus tenofovirdisoproxil/emtricitabin FDC) blev opfyldt.
English: The unbound fraction of dolutegravir in plasma is increased at low levels of serum albumin (<35 g/L) as seen in subjects with moderate hepatic impairment.
Danish: Den ubundne fraktion af dolutegravir i plasma øges ved lave niveauer af serumalbumin (<35 g/l), som der er set hos personer med moderat nedsat leverfunktion.
English: Dovato and other suspect medicinal products should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema).
Danish: Dovato og andre mistænkte lægemidler skal omgående seponeres, hvis der udvikles tegn eller symptomer på overfølsomhedsreaktioner (herunder, men ikke begrænset til, svært udslæt eller udslæt ledsaget af et øget niveau af leverenzymer, feber, generel utilpashed, træthed, muskel- eller ledsmerter, blærer, orale læsioner, konjunktivitis, ansigtsødem, eosinofili, angioødem).
English: Cimetidine
Danish: Cimetidin
English: No specific symptoms or signs have been identified following acute overdose with dolutegravir or lamivudine, apart from those listed as adverse reactions.
Danish: Ingen specifikke symptomer eller tegn er blevet identificeret efter akut overdosering med dolutegravir eller lamivudin ud over de tegn og symptomer, der er anført som bivirkninger.
English: • a high temperature (fever)
Danish: • høj kropstemperatur (feber)
English: • suicidal attempt (particularly in patients who have had depression or mental health problems before)
Danish: • selvmordsforsøg (særligt hos patienter, som tidligere har haft depression eller psykiske problemer)
English: Some late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Danish: Der er i sjældne tilfælde rapporteret nogle sent forekommende neurologiske forstyrrelser (hypertoni, kramper, abnorm adfærd).
English: There are limited pharmacokinetic data on subjects with hepatitis B co-infection (see section 4.4).
Danish: Der er begrænsede farmakokinetiske data om personer med co-infektion med hepatitis B (se pkt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN ViiV Healthcare BV
English: Blood and lymphatic systems disorders: Uncommon:
Danish: Blod og lymfesystem: Ikke almindelig:
English: Limited data are available in adolescents receiving a daily dose of 300 mg of lamivudine.
Danish: Der er begrænsede data hos unge, der fik en daglig dosis på 300 mg lamivudin.
English: Lamivudine ↔ Ledipasvir ↔ Sofosbuvir ↔
Danish: Lamivudin ↔ Ledipasvir ↔ Sofosbuvir ↔
English: Based on limited available data with the dolutegravir single entity or lamivudine single entity used in combination with other antiretroviral agents to treat adolescents (12 to 17 years), there were no additional types of adverse reactions beyond those observed in the adult population.
Danish: På baggrund af en begrænset mængde data på enkeltkomponenten dolutegravir eller enkeltkomponenten lamivudin anvendt i kombination med andre antiretrovirale lægemidler til behandling af unge (12 til 17 år) sås ingen yderligere typer bivirkninger ud over dem, der blev set hos den voksne population.
English: No drug interaction studies have been conducted using Dovato.
Danish: Der er ikke udført interaktionsstudier med Dovato.
English: None of the six subjects in the dolutegravir plus lamivudine group or the four subjects in the dolutegravir plus tenofovir disoproxil/emtricitabine FDC group that met virological withdrawal criteria through Week 48 across the GEMINI-1 (204861) and GEMINI-2 (205543) studies had treatment emergent integrase inhibitor or NRTI class resistance.
Danish: Ingen af de seks personer i dolutegravir plus lamivudin-gruppen eller de fire personer i dolutegravir plus tenofovirdisoproxil/emtricitabin FDC-gruppen, der opfyldte de virologiske seponeringskriterier til og med uge 48 i studierne GEMINI-1 (204861) og GEMINI-2 (205543), havde behandlingsrelateret resistens over for integrasehæmmer- eller NRTI-klassen.
English: fatigue
Danish: træthed
English: Active renal secretion of lamivudine in the urine is mediated through the organic cation transporter (OCT) 2 and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Danish: Aktiv renal udskillelse af lamivudin via urinen medieres via den organiske kationtransporter (OCT) 2 og multilægemiddel- og toksinekstruderingstransportere (MATE1 og MATE2-K).
English: Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and lamivudine belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Danish: Dolutegravir tilhører en gruppe af antiretrovirale lægemidler, der kaldes integrasehæmmere (INI'er), og lamivudin tilhører en gruppe af antiretrovirale lægemidler, der kaldes nukleosidanalog revers transkriptasehæmmere (NRTI'er).
English: Subjects were enrolled with a screening plasma HIV-1 RNA of 1000 c/mL to ≤500,000 c/mL.
Danish: Personerne indgik med plasma hiv-1 RNA ved screening på 1.000 c/ml til ≤500.000 c/ml.
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min).
Danish: Et studie af dolutegravirs farmakokinetik blev udført hos personer med svært nedsat nyrefunktion (CLcr <30 ml/min).
English: The IC50 values of lamivudine against HIV-1 subtypes (A-G) ranged from 0.001 to 0.170 µM, against Group O from 0.030 to 0.160 µM and against HIV-2 isolates from 0.002 to 0.120 µM in peripheral blood mononuclear cells.
Danish: IC50-værdierne af lamivudin mod hiv-1-undertyper (A-G) varierede fra 0,001 til 0,170 µM mod Gruppe O fra 0,030 til 0,160 µM og mod hiv-2-isolater fra 0,002 til 0,120 µM i mononukleære celler fra perifert blod.
English: If you are breast-feeding, or thinking about breast-feeding: → Talk to your doctor immediately.
Danish: Hvis du ammer eller planlægger at amme: → Tal straks med lægen.
English: INFORMATION IN BRAILLE dovato
Danish: INFORMATION I BRAILLESKRIFT dovato
English: Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
Danish: Samlet set var sikkerhedsprofilen for patienter med co-infektion med hepatitis B og/eller C magen til den, der blev observeret hos patienter uden co-infektion med hepatitis B eller C, selvom frekvensen af unormal ASAT- og ALAT-værdier var højere i undergruppen med coinfektion med hepatitis B og/eller C for alle behandlingsgrupper.
English: Reproductive toxicology studies
Danish: Reproduktionstoksikologistudier
English: • oxcarbazepine and carbamazepine, to treat epilepsy or bipolar disorder
Danish: • oxcarbazepin og carbamazepin til behandling af epilepsi eller bipolar lidelse
English: Fifty-three percent of total oral dose is excreted unchanged in the faeces.
Danish: 53 % af den samlede orale dosis udskilles uomdannet i fæces.
English: Animal studies showed lamivudine may inhibit cellular DNA replication (see section 5.3).
Danish: Dyrestudier viste, at lamivudin kan hæmme cellulær dna-replikation (se pkt.
English: There are no data available on the effects of the combination of dolutegravir and lamivudine in animals.
Danish: Der foreligger ingen data om indvirkningen af kombinationen af dolutegravir og lamivudin hos dyr.
English: neutropenia, anaemia, thrombocytopenia
Danish: neutropeni, anæmi, trombocytopeni
English: Multivitamins (containing calcium, iron and magnesium) /Dolutegravir (fasted intake)
Danish: Multivitaminer (indeholdende calcium, jern og magnesium)/dolutegravir (fastetilstand)
English: Subjects were randomised to a two-drug regimen of dolutegravir 50 mg plus lamivudine 300 mg once daily or dolutegravir 50 mg plus tenofovir disoproxil/emtricitabine 245/200 mg once daily.
Danish: Personerne blev randomiseret til et regimen med to lægemidler bestående af dolutegravir 50 mg plus lamivudin 300 mg én gang dagligt eller dolutegravir 50 mg plus tenofovirdisoproxil/emtricitabin 245/200 mg én gang dagligt.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays low plasma protein binding (less than 36%).
Danish: Lamivudin udviser lineær farmakokinetik over det terapeutiske dosisinterval og udviser lav plasmaproteinbinding (under 36 %).
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 16%- 36% to serum albumin).
Danish: Lamivudin udviser lineær farmakokinetik over det terapeutiske dosisinterval og udviser begrænset plasmaproteinbinding in vitro (<16 %-36 % til serumalbumin).
English: Dovato should not be taken with any other medicinal product containing dolutegravir or lamivudine, except where a dose adjustment of dolutegravir is indicated due to drug-drug interactions (see section 4.5).
Danish: Dovato må ikke tages sammen med noget andet lægemiddel, der indeholder dolutegravir eller lamivudin, undtagen når dosisjustering af dolutegravir er indiceret på grund af lægemiddelinteraktioner (se pkt.
English: Following multipledose oral administration of lamivudine 300 mg once daily for seven days, the mean (CV) steady-state Cmax is 2.04 µg/mL (26%) and the mean (CV) AUC(0-24) is 8.87 µg.h/mL (21%).
Danish: Efter oral administration af flere doser lamivudin 300 mg én gang dagligt i syv dage er det gennemsnitlige (CV) steady state Cmax 2,04 µg/ml (26 %) og det gennemsnitlige (CV) AUC(0-24) er 8,87 µg.t/ml (21 %).
English: In HIV-1-infected adult subjects following dolutegravir 50 mg once daily, the steady-state pharmacokinetic parameters (geometric mean [%CV]) based on population pharmacokinetic analyses were AUC(0-24) = 53.6 (27) µg.h/mL, Cmax = 3.67 (20) µg/mL, and Cmin = 1.11 (46) µg/mL.
Danish: Hos hiv-1-inficerede voksne personer efter dolutegravir 50 mg én gang dagligt var steady-state farmakokinetiske parametre (geometrisk middel [%CV]) baseret på farmakokinetiske populationsanalyser AUC(0-24) = 53,6 (27) µg.t/ml, Cmax = 3,67 (20) µg/ml og Cmin = 1,11 (46) µg/ml.
English: Dolutegravir is an OCT2 and MATE1 inhibitor; however, lamivudine concentrations were similar with or without co-administration of dolutegravir based on a cross study analysis, indicating that dolutegravir has no relevant effect on lamivudine exposure in vivo.
Danish: Dolutegravir er en OCT2- og MATE1-hæmmer, men koncentrationen af lamivudin var af samme størrelsesorden med eller uden samtidig administration af dolutegravir i et krydsstudie, hvilket indikerer, at dolutegravir ikke har nogen relevant effekt på eksponeringen for lamivudin in vivo.
English: • supplements or multivitamins containing calcium, iron or magnesium.
Danish: • tilskud eller multivitaminer, der indeholder calcium, jern eller magnesium.
English: Other medicines and Dovato Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Dovato Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on 50 kg human), and 11 times the human mg/m2 equivalent dose for a total daily clinical dose of 50 mg.
Danish: GI-intolerance hos aber forekom ved 30 gange den ækvivalente humane dosis udtrykt i mg/kg (baseret på et menneske på 50 kg) og ved 11 gange den ækvivalente humane dosis udtrykt i mg/m2 for en total daglig klinisk dosis på 50 mg.
English: Tabulated summary of adverse reactions to Dovato based on clinical study and postmarketing experience with Dovato and its individual components Frequency
Danish: Tabel 2: Liste over bivirkninger ved Dovato i tabelform baseret på klinisk studie og erfaringen med Dovato og dets enkelte komponenter efter markedsføringen
English: (organic cation transporter inhibition)
Danish: (hæmning af organiske kationtransportere)
English: Skin and subcutaneous tissue disorders: Common:
Danish: Hud og subkutane væv: Almindelig:
English: Lamivudine is cleared renally.
Danish: Lamivudin udskilles renalt.
English: Dovato contains dolutegravir.
Danish: Dovato indeholder dolutegravir.
English: Supplements or multivitamins containing calcium, iron or magnesium Supplements or multivitamins containing calcium, iron or magnesium can stop Dovato being absorbed into your body and make it less effective.
Danish: Tilskud eller multivitaminer, der indeholder calcium, jern eller magnesium Tilskud eller multivitaminer, der indeholder calcium, jern eller magnesium, kan modvirke optagelsen af Dovato i kroppen og gøre det mindre effektivt.
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Danish: Den gennemsnitlige IC50-værdi for 3 hiv-2-isolater var 0,18 nM (interval 0,09-0,61).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia).
Danish: De hyppigst rapporterede bivirkninger er hæmatologiske forstyrrelser (anæmi, neutropeni) og metaboliske forstyrrelser (hyperlaktatæmi, hyperlipasæmi).
English: Antacids and supplements
Danish: Antacida og tilskud
English: In animal reproductive toxicology studies with dolutegravir, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Danish: I reproduktionstoksikologistudier med dolutegravir hos dyr blev der ikke identificeret nogen skadelige udviklingsudfald, herunder heller ikke neuralrørsdefekt (se pkt.
English: Effect of other medicinal products on the pharmacokinetics of dolutegravir and lamivudine
Danish: Effekt af andre lægemidler på farmakokinetikken af dolutegravir og lamivudin
English: • St. John's wort (Hypericum perforatum), a herbal remedy to treat depression.
Danish: • prikbladet perikon (Hypericum perforatum), et naturlægemiddel til behandling af depression.
English: Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less effective.
Danish: Antacida, der anvendes til behandling af fordøjelsesbesvær og halsbrand, kan modvirke optagelsen af Dovato i kroppen og gøre det mindre effektivt.
English: Based on this data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of major enzymes or transporters (see section 4.5).
Danish: Baseret på disse data forventes det ikke, at dolutegravir påvirker farmakokinetikken af lægemidler, der er substrater for vigtige enzymer eller transportere (se pkt.
English: No clinically important pharmacokinetic differences between subjects with severe renal impairment (CLcr <30 mL/min) and matching healthy subjects were observed.
Danish: Der blev ikke observeret nogen klinisk vigtige farmakokinetiske forskelle mellem personer med svært nedsat nyrefunktion (CLcr <30 ml/min) og tilsvarende raske personer.
English: Binding of dolutegravir to plasma proteins is independent of dolutegravir concentration.
Danish: Bindingen af dolutegravir til plasmaproteiner er uafhængig af dolutegravirs koncentration.