FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.4 Special warnings and precautions for use Transmission of HIV
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Selected established and theoretical interactions between dolutegravir, rilpivirine and co-administered medicinal products are listed in Table 1.
Danish: Udvalgte påviste og teoretiske interaktioner med dolutegravir, rilpivirin og samtidigt administrerede lægemidler er anført i tabel 1.
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 30 and 1.2 times the 50 mg human clinical exposure based on AUC, respectively.
Danish: Den primære effekt af dolutegravir var gastrointestinal intolerance eller irritation hos rotter og aber ved doser, der medfører systemiske eksponeringer på henholdsvis ca. 30 og 1,2 gange den humane kliniske eksponering ved 50 mg baseret på AUC.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - COMPONENT OF MULTIPACK)
Danish: INTERMEDIÆR KARTON (UDEN BLUE BOX - DEL AF MULTIPAKNING)
English: Subjects were enrolled if they were on their first or second antiretroviral regimen with no history of virological failure, had no suspected or known resistance to any antiretroviral and had been stably suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months prior to screening.
Danish: Personerne indgik i studierne, hvis de var på deres første eller andet antiretrovirale regime uden virologisk svigt i anamnesen, ikke havde formodet eller kendt resistens over for noget antitretroviralt middel og havde været stabilt supprimeret (hiv-1 RNA <50 kopier/ml) i mindst 6 måneder før screening.
English: No dose adjustment of oral contraceptives is required when co-administered with Juluca.
Danish: Det er ikke nødvendigt at justere dosis af orale kontraceptiva, når disse administreres sammen med Juluca.
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Danish: G118R nedsætter følsomheden over for dolutegravir i stedspecifikke mutanter (FC 10), men blev ikke påvist hos patienter, der fik dolutegravir i fase III-programmet.
English: In a panel of 67 HIV-1 recombinant laboratory strains with one amino acid substitution at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity (FC≤BCO) against 64 (96%) of these strains.
Danish: I et panel af 67 hiv-1-rekombinante laboratoriestammer med én aminosyresubstitution på RTpositioner relateret til NNRTI-resistens, herunder de mest almindeligt fundne K103N og Y181C, resulterede rilpivirin i antiviral aktivitet (FC≤BCO) mod 64 (96 %) af disse stammer.
English: Patients with hepatitis B or C
Danish: Patienter med hepatitis B eller C
English: Subjects with hepatitis B co-infection or hepatitis C infection in need of anti-HCV therapy were excluded from studies with the dual combination of dolutegravir and rilpivirine.
Danish: Personer med hepatitis B-co-infektion eller hepatitis C-infektion, som havde brug for anti-HCV-behandling, blev ekskluderet fra studier med kombinationen af de to stoffer dolutegravir og rilpivirin.
English: In 100% human serum, the dolutegravir mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Danish: I 100 % humant serum var den gennemsnitlige ændring i dolutegravirs proteinfoldning en faktor 75, hvilket resulterede i en proteinjusteret IC90-værdi på 0,064 g/ml.
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 kontrolpersoner.
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min) and matched healthy controls.
Danish: Et studie af dolutegravirs farmakokinetik blev udført hos personer med svært nedsat nyrefunktion (CLcr <30 ml/min) og svarede til raske kontrolpersoner.
English: Juluca should be used with caution in patients with moderate hepatic impairment.
Danish: Juluca skal anvendes med forsigtighed til patienter med moderat nedsat leverfunktion.
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09
Danish: Den gennemsnitlige IC50-værdi for 3 hiv-2-isolater var 0,18 nM (interval 0,09-0,61).
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on a 50 kg human), and 11 times the human mg/m2 equivalent dose for a 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/m for en klinisk dosis på 50 mg.
English: If you notice after 12 hours, then skip that dose and take the next doses as usual.
Danish: Hvis du bemærker det efter 12 timer, skal du springe denne dosis over og tage de næste doser på de sædvanlige tidspunkter.
English: The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy subjects and in adult antiretroviral treatment-naïve HIV-1 infected patients.
Danish: Rilpivirins farmakokinetiske egenskaber er blevet evalueret hos raske voksne forsøgspersoner og hos antiretroviralnaive hiv-1-inficerede patienter.
English: In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the CYP3A system.
Danish: In vitro-studier tyder på, at rilpivirin primært gennemgår oxidativ metabolisme medieret af CYP3Asystemet.
English: Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (clades A, B, C, D, F, G, H) primary isolates with IC50 values ranging from 0.07 to 1.01 nM and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM.
Danish: Rilpivirin har også vist antiviral aktivitet mod et bredt panel af hiv-1 gruppe M (clade A, B, C, D, F, G, H) primære isolater med IC50-værdier fra 0,07 til 1,01 nM og gruppe O primære isolater med EC50værdier fra 2,88 til 8,45 nM.
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 transportører (se pkt.
English: In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1).
Danish: In vitro hæmmede dolutegravir den renale organiske kation transportør 2 (OCT2) og multidrug og toksin ekstruderingstransportør 1 (MATE1).
English: *** The results of the pooled analysis are in line with those of the individual studies, for which differences in proportions meeting the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 (based on the Snapshot algorithm) for DTG+RPV versus CAR were -0.6 (95% CI: -4.3; 3.0) for SWORD-1 and 0.2 (95% CI: -3.9; 4.2) for SWORD-2 with a preset noninferiority margin of -10%.
Danish: *** Resultaterne fra den samlede analyse stemmer overens med resultaterne fra de enkelte studier, hvor differencerne i andele, der opfyldte det primære endepunkt på <50 kopier/ml plasma hiv-1 RNA ved uge 48 (baseret på snapshot-algoritmen) for DTG+RPV versus CAR, var -0,6 (95 % CI: -4,3; 3,0) for SWORD-1 og 0,2 (95 % CI: -3,9; 4,2) for SWORD-2 med en på forhånd fastlagt inferioritetsmargen på -10 %.
English: Two subjects across the pooled SWORD-1 (201636) and SWORD-2 (201637) studies from each treatment arm experienced confirmed virologic failure leading to withdrawal at any time through Week 48.
Danish: To personer fra hver behandlingsgruppe i den samlede population i studierne SWORD-1 (201636) og SWORD-2 (201637) fik konstateret virologisk svigt, der førte til seponering i forsøgsperioden frem til uge 48.
English: There are no data on the effects of dolutegravir or rilpivirine on human male or female fertility.
Danish: Der foreligger ingen data om dolutegravirs eller rilpivirins virkning på fertiliteten hos mænd eller kvinder.
English: Liver problems including hepatitis B and/or C
Danish: Leverproblemer, herunder hepatitis B og/eller C
English: Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Danish: På baggrund af in vivo- og/eller in vitro-data forventes dolutegravir ikke at påvirke farmakokinetikken af lægemidler, der er substrater for vigtige enzymer eller transportører, som f.eks. CYP3A4, CYP2C9 og P-gp (se pkt.
English: In the pooled analysis, 54%, 26%, and 20% of subjects were receiving an NNRTI, PI, or INI (respectively) as their baseline third treatment agent class prior to randomisation.
Danish: I den sammenlagte analyse fik 54 %, 26 % og 20 % af personerne henholdsvis et NNRTI, PI eller INI, der var valgt i klassen af tredjebehandlingsmidler ved baseline inden randomiseringen.
English: A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh score B) and to 8 matched healthy adult controls.
Danish: En enkelt dosis på 50 mg dolutegravir blev administreret til 8 personer med moderat nedsat leverfunktion (Child-Pugh-klasse B) og til 8 tilsvarende raske voksne kontrolpersoner.
English: • increase in pancreatic amylase (a digestive enzyme).
Danish: • stigning i pancreas-amylase (et fordøjelsesenzym).
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. dofetilide, metformin) (see Table 1 and sections 4.3 and 4.4).
Danish: In vivo kan dolutegravir øge plasmakoncentrationerne af lægemidler, for hvilke udskillelsen afhænger af OCT2 eller MATE-1 (f.eks. dofetilid, metformin) (se tabel 1 og pkt.
English: Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT)1A1.
Danish: Dolutegravir elimineres overvejende gennem metabolisering via uridindifosfatglukuronosyltransferase (UGT)1A1.
English: Investigations common creatine phosphokinase (CPK) elevations * Frequencies are assigned based on the maximum frequencies observed in the pooled SWORD studies or studies with the individual components ** This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other ARVs.
Danish: * Hyppighederne er tildelt ud fra de maksimale observerede hyppigheder i de sammenlagte SWORD-studier eller i studier med de enkelte komponenter ** Denne bivirkning blev identificeret under overvågningen efter markedsføringen for dolutegravir i kombination med andre antiretrovirale lægemidler.
English: Juluca should not be taken with any other medicinal product containing dolutegravir or rilpivirine, except in case of co-administration with rifabutin (see section 4.5).
Danish: Juluca må ikke tages sammen med nogen andre lægemidler, der indeholder dolutegravir eller rilpivirin, undtagen i tilfælde af samtidig administration af rifabutin (se pkt.
English: Rilpivirine is primarily metabolised by CYP3A.
Danish: Rilpivirin metaboliseres primært af CYP3A.
English: The absolute bioavailability of dolutegravir or rilpivirine has not been established.
Danish: Den absolutte biotilgængelighed af dolutegravir eller rilpivirin er ikke klarlagt.
English: The single amino acid substitutions associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Danish: Aminosyresubstitutionerne, der optrådte enkeltvis og var forbundet med tab af følsomhed over for rilpivirin, var: K101P, Y181I og Y181V.
English: If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid:  Det anbefales ikke at anvende Juluca.
English: The primary endpoint and other outcomes (including outcomes by key baseline covariates) for the pooled SWORD-1 and SWORD-2 studies are shown in Table 3.
Danish: Resultaterne for det primære endepunkt er vist i tabel 3 sammen med andre resultater (blandt andet resultater fordelt efter væsentlige kovariater ved baseline) for de sammenlagte studier SWORD-1 og SWORD-2.
English: • methadone, used in the treatment of opioid dependence
Danish: • methadon, til behandling af opioidafhængighed
English: The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Danish: Rilpivirins farmakokinetik er ikke blevet undersøgt hos patienter med nyreinsufficiens.
English: In a rilpivirine study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Danish: I et studie af rilpivirin, hvor 8 patienter med let nedsat leverfunktion (Child-Pugh-score A) blev sammenlignet med 8 matchede kontrolpersoner, og 8 patienter med moderat nedsat leverfunktion (Child-Pugh-score B) blev sammenlignet med 8 matchede kontrolpersoner, var eksponeringen ved flere doser af rilpivirin 47 % højere hos patienter med let nedsat leverfunktion og 5 % højere hos patienter med moderat nedsat leverfunktion.
English: Juluca should not be co-administered at the same time as antacids.
Danish: Juluca bør ikke administreres samtidig med antacida.
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Danish: I analysen fra uge 48 sammenholdt med uge 96 forekom der yderligere 24 (3,5 %) og 14 (2,1 %) tilfælde af virologisk svigt i henholdsvis rilpivirin- og efavirenzgruppen.
English: Hepatobiliary disorders very common increased transaminases (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations)
Danish: Lever og galdeveje Meget almindelig Stigning i transaminaser (forhøjet niveau af alaninaminotransferase (ALAT) og/eller aspartataminotransferase (ASAT))
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, uridine diphosphate glucuronosyl transferase (UGT)1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 or MRP4.
Danish: In vitro har dolutegravir ikke direkte, eller kun svagt, vist hæmning (IC50>50 µM) af enzymerne cytokrom P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, uridindifosfatglukuronosyltransferase (UGT)1A1 eller UGT2B7, eller transportørerne Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 eller MRP4.
English: Pink, oval, biconvex tablets, approximately 14 x 7 mm, debossed with ‘SV J3T' on one side.
Danish: Lyserøde, ovale, bikonvekse tabletter på ca. 14 x 7 mm præget med 'SV J3T' på den ene side.
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Danish: Rilpivirins aktivitet medieres ved ikke-kompetitiv hæmning af hiv-1 revers transkriptase (RT).
English: The single INI-resistance substitutions T66K, I151L, and S153Y conferred a greater than 2-fold decrease in dolutegravir susceptibility (range: 2.3fold to 3.6-fold from reference).
Danish: T66K, I151L og S153Y med en enkelt INI-resistent substitution medførte et fald, der var større end 2 gange, i dolutegravirs følsomhed (interval: 2,3 gange til 3,6 gange i forhold til referencen).
English: • metformin, to treat diabetes
Danish: • metformin, til behandling af diabetes (sukkersyge)
English: It is not known whether the ingredients of Juluca can pass into your breast milk.
Danish: Det vides ikke, om indholdsstofferne i Juluca udskilles i mælken.
English: • increase in the level of enzymes produced in the muscles (creatine phosphokinase).
Danish: • øget niveau af enzymer, der dannes i musklerne (kreatinkinase)
English: • loss of appetite
Danish: • nedsat appetit
English: The effect of severe hepatic impairment (Child-Pugh score C) on the pharmacokinetics of dolutegravir or rilpivirine has not been studied, therefore Juluca is not recommended in these patients.
Danish: Virkningen af svært nedsat leverfunktion (Child-Pugh-klasse C) på dolutegravirs eller rilpivirins farmkokinetik er ikke blevet undersøgt, derfor frarådes anvendelse af Juluca hos disse patienter.
English: The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Danish: Effekten af rilpivirin ved den anbefalede dosis på 25 mg en gang dagligt på QTcF-intervallet blev vurderet i et randomiseret, placebokontrolleret og aktivt kontrolleret (moxifloxacin 400 mg en gang dagligt) overkrydsningsstudie med 60 raske voksne, hvor der blev udført 13 målinger i løbet af 24 timer ved steady state.
English: Available toxicological data in animals has shown excretion of dolutegravir and rilpivirine in milk.
Danish: De tilgængelige toksikologiske data fra dyreforsøg viser, at dolutegravir og rilpivirin udskilles i mælk.
English: The use of Juluca during pregnancy is not recommended.
Danish: Det anbefales ikke at anvende Juluca under graviditet.
English: After single dose oral administration of 14C-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Danish: C-rilpivirin kunne gennemsnitligt 85 % og 6,1 % af radioaktiviteten genfindes i henholdsvis fæces og urin.
English: Serial passage is used to study resistance evolution in vitro.
Danish: Udvikling af resistens in vitro undersøges ved hjælp af seriel passage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
Danish: YDRE KARTON (KUN MULTIPAKNINGER - MED BLUE BOX)
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median IC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Danish: Rilpivirin udviste aktivitet mod laboratoriestammer af vildtype-hiv-1 i en akut inficeret T-cellelinje med en median IC50-værdi for hiv-1/IIIB på 0,73 nM (0,27 ng/ml).
English: Metabolic inducers may significantly decrease dolutegravir/rilpivirine plasma concentrations, resulting in loss of therapeutic effect.
Danish: Metaboliske inducere kan nedsætte plasmakoncentrationen af dolutegravir/rilpivirin signifikant, hvilket medfører tab af terapeutisk effekt.
English: In reproductive toxicity studies in animals, dolutegravir was shown to cross the placenta.
Danish: Dyreforsøg vedrørende reproduktionstoksicitet viste, at dolutegravir passerer placenta.
English: The Juluca tablet must be taken with a meal.
Danish: Juluca tabletten skal tages sammen med et måltid.
English: • medicines called H2 receptor antagonists (for example cimetidine, famotidine, nizatidine, ranitidine) to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux).
Danish: • lægemidler kaldet H2-receptorantagonister (for eksempel cimetidin, famotidin, nizatidin eller ranitidin) til behandling af mavesår eller sår på tarmen eller til lindring af halsbrand, der skyldes tilbageløb af syre).
English: White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner.
Danish: Hvide HDPE (højdensitetspolyethylen)-beholdere lukket med børnesikret lukke af polypropylen med en polyethylenbelagt induktionsforsegling.
English: Rilpivirine studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
Danish: Dyrestudier med rilpivirin har ikke vist tegn på relevant embryonal eller føtal toksicitet eller påvirkning af den reproduktive funktion.
English: Animal studies with dolutegravir or rilpivirine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med dolutegravir eller rilpivirin indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
English: The primary efficacy endpoint for the SWORD studies was the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 (Snapshot algorithm for the ITTE population).
Danish: Det primære effektendepunkt for SWORD-studierne var andelen af personer med hiv-1-RNA <50 kopier/ml i plasma ved uge 48 (snapshot-algoritme for ITT-E-populationen).
English: Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and rilpivirine belongs to a group of anti-retroviral medicines called nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Danish: Dolutegravir tilhører en gruppe af antiretrovirale lægemidler, der kaldes integrasehæmmere (INI'er), og rilpvirin tilhører en gruppe af antiretrovirale lægemidler, der kaldes non-nukleosid reverse transcriptasehæmmere (NNRTI'er).
English: In a DEXA substudy mean bone mineral density (BMD) increased from Baseline to Week 48 in subjects who switched to dolutegravir plus rilpivirine (1.34% total hip and 1.46% lumbar spine) compared with those who continued on treatment with a TDF-containing antiretroviral regimen (0.05% total hip and 0.15% lumbar spine.
Danish: I et DEXA-substudie steg den gennemsnitlige knoglemineraltæthed (BMD) fra baseline til uge 48 hos personer, der skiftede til dolutegravir plus rilpvirin (1,34 % i hele hoften og 1,46 % i lænderygsøjlen) sammenlignet med dem, der fortsatte med en behandling med et antiretroviralt regime, hvori TDF indgik (0,05 % i hele hoften og 0,15 % i lænderygsøjlen).
English: 300 mg once daily (+ 25 mg once daily rilpivirine)
Danish: 300 mg en gang dagligt (+ 25 mg rilpivirin en gang dagligt)
English: The most severe adverse reaction, possibly related to the treatment with dolutegravir (from pooled from Phase IIb and Phase III clinical studies), seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Danish: De alvorligste bivirkninger, som muligvis er relaterede til behandlingen med dolutegravir (fra sammenlagte data fra kliniske studier i fase IIb og fase III), der blev set hos en enkelt patient, var en overfølsomhedsreaktion, som omfattede udslæt og svære leverpåvirkninger (se pkt.
English: H2 receptor antagonists (for example cimetidine, famotidine, nizatidine, ranitidine) H2 receptor antagonist medicines can stop Juluca being absorbed into your body and make it less effective.
Danish: H2-receptorantagonister (for eksempel cimetidin, famotidin, nizatidin eller ranitidin) H2-receptorantagonister kan modvirke optagelsen af Juluca i kroppen og gøre det mindre effektivt.
English: In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Danish: Hos 13 behandlingsnaive personer på et stabilt regime med dolutegravir plus abacavir/lamivudin lå koncentrationen af dolutegravir i CSF i gennemsnit på 18 ng/ml (sammenlignelig med plasmakoncentrationen af ubundet dolutegravir, og over IC50-værdien).
English: Juluca must be taken with a meal.
Danish: Juluca skal tages sammen med et måltid.