FrancophonIA/ELRC3.0 huggingface dataset:
English: A mean change from baseline of 8.22 µmol/L (range -26.5 to 51.2 µmol/L) was observed after 48 weeks treatment.
Danish: Der blev observeret en gennemsnitlig ændring i forhold til baseline på 8,22 mol/l (interval -26,5 til 51,2 mol/l) efter 48 ugers behandling.
English: Systemic exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Danish: Systemisk eksponering for rilpivirin var generelt lavere hos hiv-1-inficerede patienter end hos raske personer.
English: Dexamethasone/ Rilpivirine (systemic, except for single dose use)
Danish: Dexamethasone/ rilpivirin (systemisk, undtagen til anvendelse som enkeltdosis)
English: Juluca contains dolutegravir.
Danish: Juluca indeholder dolutegravir.
English: • palpitations (rapid or irregular heartbeat) or tremor
Danish: • hjertebanken (hurtige eller uregelmæssige hjerteslag) eller skælven
English: Dolutegravir activity was determined against a panel of 60 INI-resistant site-directed mutant HIV-1 viruses (28 with single substitutions and 32 with 2 or more substitutions).
Danish: Dolutegravirs aktivitet blev bestemt mod et panel af 60 INI-resistente stedspecifikke hiv 1-mutantvirus (28 med en enkelt substitution og 32 med 2 eller flere substitutioner).
English: Lower exposures of dolutegravir or rilpivirine were observed when taken once daily, in combination with a background regimen, during pregnancy.
Danish: Lavere eksponeringer for dolutegravir eller rilpivirin blev observeret, når det blev taget en gang dagligt, i kombination med et baggrundsregime, under graviditet.
English: The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis.
Danish: Det tilsyneladende fordelingsvolumen er 17 l til 20 l hos hiv-inficerede patienter baseret på en farmakokinetisk populationsanalyse.
English: • clarithromycin and erythromycin, to treat bacterial infections
Danish: • clarithromycin og erythromycin til behandling af bakterieinfektioner
English: Juluca should not be co-administered at the same time as H2-receptor antagonists.
Danish: Juluca bør ikke administreres samtidig med H2-receptorantagonister.
English: Separate preparations of dolutegravir or rilpivirine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated (see section 4.5).
Danish: Separate præparater med dolutegravir eller rilpivirin er tilgængelige i de tilfælde, hvor seponering eller dosisjustering af et af de aktive stoffer er indiceret (se pkt.
English: • dabigatran etexilate, used to treat or prevent blood clots.
Danish: • dabigatranetexilat, der anvendes til at behandle eller forebygge blodpropper.
English: Seven hundred and five raltegravir resistant isolates from raltegravir experienced patients were analysed for susceptibility to dolutegravir.
Danish: I alt 705 raltegravir-resistente isolater fra raltegravir-erfarne patienter blev analyseret for følsomhed over for dolutegravir.
English: Rilpivirine AUC(0-∞) was increased by 57% and 72% and Cmax by 89% and 117%, with moderate and high fat meals respectively, compared to fasted conditions.
Danish: Rilpivirins AUC(0-) blev øget med 57 % og 72 % og Cmax med 89 % og 117 % med måltider med henholdsvis moderat og højt fedtindhold sammenlignet med faste.
English: If the next dose is due within 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis den næste dosis skal tages inden for 12 timer, skal patienten ikke tage den glemte dosis, men blot genoptage den sædvanlige doseringsplan.
English: Juluca must not be taken with some other medicines (see ‘Do not take Juluca' earlier in section 2).
Danish: Juluca må ikke tages sammen med visse andre lægemidler (se under 'Tag ikke Juluca' tidligere under punkt 2).
English: However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate.
Danish: Men det kan ikke helt udelukkes, at rilpivirin kan øge eksponeringen for andre lægemidler, der transporteres af P-gp og er mere sensitive over for intestinal hæmning af P-gp, f.eks. dabigatranetexilat.
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=876, follow-up of 48-96 weeks).
Danish: Hos tidligere ubehandlede patienter, som fik dolutegravir + 2 NRTI'er i fase IIb og fase III, blev der ikke set udvikling af resistens over for integrasehæmmere eller over for NRTI-klassen (n = 876 opfølgning på 48-96 uger).
English: Polyvinyl alcohol- part hydrolysed Titanium dioxide (E171) Macrogol
Danish: Polyvinylalkohol - delvist hydrolyseret Titandioxid (E171)
English: Juluca is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and rilpivirine.
Danish: Juluca er et lægemiddel, der indeholder to aktive stoffer, som anvendes til behandling af hiv (humant immundefektvirus) -infektion: dolutegravir og rilpivirin.
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Danish: Dolutegravir hæmmer hiv-integrase ved at binde til det aktive sted på integrase og blokere strand transfer-trinnet i integrationen af retroviral deoxyribonukleinsyre (DNA), hvilket er essentielt for hiv's replikationscyklus.
English: The apparent oral clearance (CL/F) is approximately 1L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Danish: Den tilsyneladende orale clearance (CL/F) er cirka 1 l/t hos hiv-inficerede patienter baseret på en farmakokinetisk populationsanalyse.
English: Within-subject variability (CVw%) is lower than between-subject variability.
Danish: Intra-individ-variabiliteten (CVw %) er lavere end inter-individvariabiliteten.
English: Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Danish: Rilpivirin i den anbefalede dosis på 25 mg en gang dagligt forbindes ikke med klinisk relevant effekt på QTc.
English: 2 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered drug.
Danish: Dette interaktionsstudie er blevet udført med en højere dosis end den anbefalede dosis af rilpvirin, hvor den maksimale effekt på det samtidigt administrerede lægemiddel blev vurderet.
English: Rifabutin, a medicine to treat some bacterial infections, can lower the amount of Juluca in your body and make it less effective.
Danish: Rifabutin, som er et lægemiddel til behandling af visse bakterieinfektioner, kan nedsætte mængden af Juluca i kroppen og gøre det mindre effektivt.
English: R263K was reported from two individual patients with subtype B and subtype C in the Phase III clinical program for ART experienced, INI naive subjects, but without effects on dolutegravir susceptibility in vitro.
Danish: R263K blev rapporteret fra to individuelle patienter med undertype B og C i det kliniske program i fase III for ART-erfarne, INI-naive (integrasehæmmere) personer, men uden effekt på følsomheden over for dolutegravir in vitro.
English: Phosphodiesterase type 5 (PDE-5) inhibitors Sildenafil /
Danish: Hæmmere af phosphodiesterase type 5 (PDE-5) Sildenafil / dolutegravir
English: AUC: ↔* Cmin: ↔* Cmax: ↔*
Danish: Rilpivirin: AUC: ↔* Cmin: ↔* Cmax: ↔*
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og beholderen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • decreased number of platelets, which are involved in blood clotting
Danish: • nedsat antal blodplader, der bidrager til, at blodet størkner
English: AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
Danish: AUC i cervicovaginalvæske, cervikalt væv og vaginalt væv var 6-10 % af AUC-værdierne i tilsvarende plasma ved steady state.
English: Dolutegravir or rilpivirine did not change ethinyl estradiol and norelgestromin (dolutegravir) or norethindrone (rilpivirine) plasma concentrations to a clinically relevant extent.
Danish: Dolutegravir eller rilpivirin ændrede ikke plasmakoncentrationen af ethinylestradiol og norelgestromin (dolutegravir) eller norethindron (rilpivirin) i et klinisk relevant omfang.
English: Moderate and high fat meals increased the dolutegravir AUC(0-∞) by approximately 87% and Cmax by approximately 75%.
Danish: Måltider med moderat og højt fedtindhold øgede dolutegravirs AUC(0-) med cirka 87 % og Cmax med cirka 75 %.
English: Neither Juluca nor the combination dolutegravir and rilpivirine as single entities have been studied in children.
Danish: Hverken Juluca eller kombinationen af dolutegravir og rilpivirin som enkeltenheder er undersøgt hos børn.
English: The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Danish: K103N- substitutionen alene medførte ikke nedsat følsomhed over for rilpivirin, men kombinationen af K103N og L100I medførte en følsomhedsreduktion over for rilpivirin på 7 gange.
English: In contrast, starting passage with mutants with mutation Q148H (FC 1), a variety of raltegravir associated secondary mutations accumulated with a consequent increase of FC to values >10.
Danish: Blev passagen derimod startet med mutanter med mutation Q148H (FC 1), blev der akkumuleret en række sekundære mutationer, der var relateret til raltegravir, med en resulterende øgning af FC til værdier> 10.
English: Juluca 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: Juluca 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: It is unknown whether dolutegravir or rilpivirine are excreted in human milk.
Danish: Det er ukendt, om dolutegravir eller rilpivirin udskilles i human mælk.
English: Effect of dolutegravir and rilpivirine on the pharmacokinetics of other medicinal products
Danish: Dolutegravirs og rilpivirins virkning på farmakokinetikken af andre lægemidler
English: Virologic Outcomes of Randomized Treatment at Week 48 (Snapshot algorithm)
Danish: Tabel 3: Virologiske resultater af randomiserede behandlinger ved uge 48 (snapshotalgoritme)
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, cytochrome P450 (CYP)3A4, Pglycoprotein (P-gp), and breast cancer resistance protein (BCRP); therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 1).
Danish: Dolutegravir er også substrat for UGT1A3, UGT1A9, cytokrom P450 (CYP)3A4, Pglycoprotein (P-gp) og brystcancerresistensprotein (BCRP), derfor kan lægemidler, der inducerer disse enzymer, reducere plasmakoncentrationen af dolutegravir og reducere den terapeutiske effekt af dolutegravir (se tabel 1).
English: Rilpivirine-resistant strains were selected in cell culture starting from wild type HIV-1 of different origins and clades as well as NNRTI-resistant HIV-1.
Danish: Rilpivirin-resistente stammer blev selekteret i cellekultur startende fra vildtype-hiv-1 af forskellig oprindelse og clader samt NNRTI-resistent hiv-1.
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase inhibitor experienced or infected with integrase inhibitor resistant virus by transmission.
Danish: Af disse 4 patienter havde 2 en unik R263K-integrasesubstitution, med en FC på maksimalt 1,93, en person havde en polymorf V151V/I-integrasesubstitution, med en FC på maksimalt 0,92, og 1 person havde eksisterende integrasemutationer og anses for at have været integrasehæmmererfaren eller inficeret med integrasehæmmerresistent virus ved overførsel.
English: Iron oxide yellow (E172) Iron oxide red (E172)
Danish: Gult jernoxid (E172) Rødt jernoxid (E172)
English: Thirty-two percent of the total oral dose is excreted in the urine, mainly represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Danish: 32 % af den samlede orale dosis udskilles i urinen og består primært af enten et glukuronid af dolutegravir (18,9 % af den samlede dosis), en metabolit, der er dannet ved N-dealkylering (3,6 % af den samlede dosis), eller en metabolit, der er dannet ved oxidation ved det benzyliske carbon (3,0 % af den samlede dosis).
English: • low white blood cell count
Danish: • lavt antal hvide blodceller
English: * compared to 25 mg once daily rilpivirine alone
Danish: * Sammenlignet med 25 mg rilpivirin alene en gang dagligt
English: Juluca should be prescribed by physicians experienced in the management of HIV infection.
Danish: Juluca skal ordineres af læger med erfaring i behandling af hiv-infektion.
English: Rilpivirine inhibits P-gp in vitro (IC50 is 9.2 μM).
Danish: Rilpivirin hæmmer P-gp in vitro (IC50 er 9,2 μM).
English: Silicified microcrystalline cellulose
Danish: Silicificeret mikrokrystallinsk cellulose
English: Rilpivirine 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
Danish: 25 mg rilpivirin en gang dagligt har sandsynligvis ikke nogen klinisk effekt på eksponeringen for lægemidler, der metaboliseres af CYP-enzymer.
English: In lactating rats that received a single oral dose of dolutegravir 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
Danish: Hos lakterende rotter, som fik en enkelt oral dosis dolutegravir på 50 mg/kg 10 dage post partum, blev der påvist dolutegravir i mælken i koncentrationer, som typisk var højere end i blodet.
English: Do not take Juluca: - if you are allergic to dolutegravir or rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Juluca: - hvis du er allergisk over for dolutegravir eller rilpivrin eller et af de øvrige indholdsstoffer i Juluca (angivet i punkt 6)
English: The effect of the Q148-based mutations (H/R/K) was also consistent with in vitro passage experiments with site directed mutants.
Danish: Virkningen af mutationer baseret på Q148 (H/R/K) svarede også til eksperimenterne med passage in vitro med stedspecifikke mutanter.
English: The PK variability of dolutegravir is low to moderate.
Danish: PKvariabiliteten af dolutegravir er lav til moderat.
English: In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
Danish: I et klinisk studie påvirkede rilpivirin ikke digoxins farmakokinetik signifikant.
English: Metformin is eliminated renally and therefore it is of importance to monitor renal function when co-treated with Juluca.
Danish: Metformin elimineres renalt, og det er derfor vigtigt at monitorere nyrefunktionen ved administration sammen med Juluca.
English: In serial passage with strain NL432-based site directed mutants at N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
Danish: I seriepassage med stedspecifikke mutanter baseret på stamme NL432 på N155H eller E92Q, blev der ikke set nogen yderligere selektion af resistens (FC uændret omkring 1).
English: The efficacy and safety of switching from an antiretroviral regimen (containing 2 NRTIs plus either an INI, an NNRTI, or a PI) to a dual regimen of dolutegravir 50 mg and rilpivirine 25 mg was evaluated in 2 identical 48-week, randomised, open-label, multicentre, parallel-group, non-inferiority studies SWORD-1 (201636) and SWORD-2 (201637).
Danish: Virkningen og sikkerheden ved skift fra et antiretroviralt regime (med 2 NRTI'er plus enten en INI, en NNRTI eller en PI) til et 2-stof-regime med dolutegravir 50 mg og rilpivirin 25 mg blev vurdereret i 2 identiske 48 ugers, randomiserede, åbne, multicenter-, parallelgruppe-, noninferioritetsstudier, SWORD-1 (201636) og SWORD-2 (201637).
English: HIV-1 RNA <50 copies/mL Treatment Difference* Virologic non response** Reasons Data in window not <50 copies/mL Discontinued for lack of efficacy Discontinued for other reasons while not <50 copies/mL Change in ART No virologic data at Week 48 window Reasons Discontinued study/study drug due to adverse event or death Discontinued study/study drug for other reasons Missing data during window but on study HIV-1 RNA <50 copies/mL by baseline covariates n/N (%)
Danish: Hiv-1-RNA <50 kopier/ml Behandlingsdifference* Manglende virologisk respons** Årsager Data i vinduet ikke <50 kopier/ml Seponeret pga. manglende effekt Seponeret af andre årsager, hvor der ikke var <50 kopier/ml Ændring i ART Ingen virologiske data i uge 48-vinduet Årsager Trukket ud af studiet/lægemiddel seponeret pga. bivirkning eller dødsfald Trukket ud af studiet/lægemiddel seponeret af andre årsager Manglende data i vinduet, men fortsatte i studiet Hiv-1-RNA <50 kopier/ml fordelt efter kovariater ved baseline n/N (%)
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to primary mutations (excluding at Q148) in experiments with site directed mutants, dolutegravir susceptibility remains at or near wildtype level.
Danish: Når mutationer anført som sekundære integrasehæmmer-relaterede mutationer (for raltegravir/elvitegravir) lægges til primære mutationer (med eksklusion af Q148) i eksperimenter med stedspecifikke mutanter, er følsomheden over for dolutegravir fortsat på eller i nærheden af viltypeniveau.
English: There is no specific treatment for an overdose of Juluca.
Danish: Der findes ingen specifik behandling mod overdosering med Juluca.
English: Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Danish: Rilpivirin bevarede sensitivitet (FC ≤ BCO) over for 62 % af 4.786 hiv-1-rekombinante kliniske isolater, der var resistente over for efavirenz og/eller nevirapin.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Danish: Selvom ætiologien anses for at være multifaktoriel (herunder kortikosteroidforbrug, bisphosphonater, alkoholforbrug, svær immunosuppression, højere BMI), er der rapporteret tilfælde af osteonekrose hos patienter med fremskreden hiv-sygdom og/eller langvarig eksponering for antiretroviral kombinationsbehandling (cART).
English: No specific symptoms or signs have been identified following acute overdose with dolutegravir or rilpivirine apart from those listed as adverse reactions.
Danish: Ingen specifikke symptomer eller tegn er blevet identificeret efter akut overdosering med dolutegravir eller rilpivirin ud over de tegn og symptomer, der er anført som bivirkninger.
English: Juluca must be taken with a meal to obtain optimal absorption of rilpivirine (see section 4.2).
Danish: Juluca skal tages sammen med et måltid for at opnå optimal absorption af rilpivirin (se pkt.
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 virkninger af dolutegravir på QTc-intervallet ved behandling med cirka 3 gange højere dosis end den kliniske dosis.
English: Limited data are available regarding the use of dolutegravir during pregnancy.
Danish: Der foreligger begrænsede data vedrørende anvendelse af dolutegravir under graviditet.
English: The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
Danish: Eksponeringerne ved embryoføtale niveauer uden observerede negative effekter (NOAEL) i rotter og kaniner var henholdsvis 15 og 70 gange højere end eksponeringen hos mennesker ved den anbefalede dosis på 25 mg en gang dagligt.
English: If the patient misses a dose of Juluca, the patient should take Juluca with a meal as soon as possible, providing the next dose is not due within 12 hours.
Danish: Hvis patienten glemmer en dosis Juluca, skal patienten tage Juluca sammen med et måltid så hurtigt som muligt, forudsat at den næste dosis ikke skal tages inden for 12 timer.
English: Tabulated summary of adverse reactions to Juluca based on clinical study and postmarketing experience with Juluca and its individual components
Danish: Liste over bivirkninger ved Juluca i tabelform baseret på klinisk studie og erfaringen med Juluca og dets enkelte komponenter efter markedsføringen
English: A reduction in the antiviral activity of rilpivirine was observed in the presence of 1 mg/mL alpha-1-acid glycoprotein, 45 mg/mL human serum albumin, and 50% human serum as demonstrated by median IC50 rates of 1.8, 39.2 and 18.5, respectively.
Danish: Der blev observeret en reduktion i rilpivirins antivirale aktivitet ved tilstedeværelse af 1 mg/ml alfa-1-glycoproteinsyre, 45 mg/ml humant serumalbumin og 50 % humant serum som vist via median IC50-værdier på henholdsvis 1,8; 39,2 og 18,5.
English: • muscle or joint aches → See a doctor straight away.
Danish: • muskel- eller ledsmerter  Gå til lægen straks.
English: Effect of other medicinal products on the pharmacokinetics of dolutegravir and rilpivirine
Danish: Effekt af andre lægemidler på farmakokinetikken af dolutegravir og rilpivirin
English: This may result in loss of therapeutic effect of Juluca.
Danish: Dette kan medføre tab af Julucas terapeutiske effekt.
English: Juluca film-coated tablets are pink, oval, biconvex tablets debossed with ‘SV J3T' on one side.
Danish: Juluca filmovertrukne tabletter er lyserøde, ovale, bikonvekse tabletter præget med 'SV J3T' på den ene side.
English: Dolutegravir and rilpivirine are both primarily metabolized and eliminated by the liver.
Danish: Dolutegravir og rilpivirin metaboliseres og elimineres primært af leveren.
English: For dolutegravir, when using the laboratory strain HIV-1 IIIB during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F; these mutations were not selected in patients treated with dolutegravir in the clinical studies.
Danish: For dolutegravir (ved anvendelse af laboratoriestammen hiv 1-IIIB) viste de selekterede mutationer sig langsomt under passage over 112 dage med substitutioner på position S153Y og F. Disse mutationer blev ikke selekteret hos patienter, der blev behandlet med dolutegravir i de kliniske studier.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med alvorlig immundefekt kan der på tidspunktet for påbegyndelse af cART opstå en inflammatorisk reaktion på asymptomatiske eller tilbageværende opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.