FrancophonIA/ELRC3.0 huggingface dataset:
English: From rilpivirine Phase III trials, in the week 48 pooled resistance analysis conducted with previously untreated patients, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
Danish: I fase III-studierne med rilpivirin viser de sammenlagte uge 48-resistensanalyser med tidligere ubehandlede patienter at 62 ud af 72 med virologisk svigt i rilpiviringruppen havde resistensdata ved baseline og på tidspunktet for virologisk svigt.
English: No data are available in patients with severe hepatic impairment (Child-Pugh score C); therefore Juluca is not recommended in these patients (see section 5.2).
Danish: Der er ingen tilgængelige data om patienter med svært nedsat leverfunktion (ChildPugh-klasse C); derfor frarådes anvendelse af Juluca hos disse patienter (se pkt.
English: Animal studies indicate no clinically relevant effects on male or female fertility (see section 5.3).
Danish: Dyreforsøg indikerer ikke nogen klinisk relevant virkning på fertiliteten hos mænd eller kvinder (se pkt.
English: Juluca contains lactose
Danish: Juluca indeholder lactose
English: The pooled primary analysis demonstrated that dolutegravir plus rilpivirine is non-inferior to CAR, with 95% of subjects in both arms achieving the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm (Table 3).
Danish: Den sammenlagte, primære analyse viste, at dolutegravir plus rilpivirin er noninferior i forhold til CAR, idet 95 % af personerne i begge grupper opnåede det primære endepunkt på <50 kopier/ml hiv1-RNA i plasma ved uge 48 baseret på snapshot-algoritmen (tabel 3).
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Danish: Lægemidler, der inducerer eller inhiberer CYP3A, kan derfor påvirke clearance af rilpivirin (se pkt.
English: Co-administration with the following medicinal products: - dofetilide; - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; - rifampicin, rifapentine; - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole; - systemic dexamethasone, except as a single dose treatment; - St John's wort (Hypericum perforatum).
Danish: Administration samtidigt med følgende lægemidler: - dofetilid - carbamazepin, oxcarbazepin, phenobarbital, phenytoin - rifampicin, rifapentin - protonpumpehæmmere som omeprazol, esomeprazol, lansoprazol, pantoprazol og rabeprazol - systemisk dexamethason, undtagen som enkeltdosisbehandling - perikon (Hypericum perforatum).
English: In patients with severe renal impairment or end-stage renal disease, the combination of Juluca with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk.
Danish: Hos patienter med svært nedsat nyrefunktion eller terminal nyresygdom må Juluca kun kombineres med en stærk CYP3A-hæmmer, hvis fordelen opvejer risikoen.
English: - The other ingredients are mannitol (E421), magnesium stearate, microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, lactose monohydrate, croscarmellose sodium, povidone (K30), polysorbate 20, silicified microcrystalline cellulose, polyvinyl alcohol- part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172), iron oxide red (E172).
Danish: - Øvrige indholdsstoffer: mannitol (E421), magnesiumstearat, mikrokrystallinsk cellulose, povidon (K29/32), natriumstivelsesglycolat, natriumstearylfumarat, lactosemonohydrat, croscarmellosenatrium, povidon (K30), polysorbat 20, silicificeret mikrokrystallinsk cellulose, polyvinylalkohol- delvist hydrolyseret, titandioxid (E171), macrogol, talcum, gul jernoxid (E172), rød jernoxid (E172).
English: If you get any symptoms of infection or if you notice any of the symptoms above:
Danish: Hvis du får nogle symptomer på infektion, eller hvis du bemærker nogen af ovennævnte symptomer: Fortæl det omgående til lægen.
English: No recommendations for dose adjustments can be made for Juluca.
Danish: Der kan ikke gives nogen anbefalinger for dosis regulering for Juluca.
English: H2-receptor antagonists should be taken well separated in time from the administration of Juluca (minimum 4 hours after or 12 hours before)
Danish: H2-receptorantagonister skal tages tidsforskudt fra administrationen af Juluca (mindst 4 timer efter eller 12 timer før)
English: Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay.
Danish: Rilpivirin er testet negativt ved fravær og tilstedeværelse af et metabolisk aktiveringssystem i in vitroAmes revers mutationstest og in vitro-clastogenicitetsanalysen af muselymfomer.
English: Liver toxicity associated with liver enzyme induction was observed in rodents following rilpivirine administration.
Danish: Der er observeret levertoksicitet forbundet med leverenzyminduktion i gnavere efter administration af rilpivirin.
English: Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1).
Danish: Juluca er indiceret til behandling af infektion med humant immundefektvirus type 1 (hiv-1) hos voksne, som er virologisk supprimerede (hiv-1-RNA <50 kopier/ml) og har fået behandling med et stabilt antiretroviralt regime i mindst seks måneder uden virologisk svigt i anamnesen og uden kendt eller formodet resistens over for nogen non-nukleosid revers transkriptasehæmmer eller integrasehæmmer (se pkt.
English: NNRTI resistance associated substitution K101K/E mixture with no decreased susceptibility to rilpivirine (FC=1.2) was observed in one subject with identified adherence issues that received dolutegravir plus rilpivirine.
Danish: Der blev observeret en K101/E-blanding af substitution relateret til NNRTI-resistens uden nedsat følsomhed over for rilpivirin (FC = 1,2) hos én person med påviste adhærensproblemer, som fik dolutegravir plus rilpivirin.
English: Juluca should not be administered with other antiretroviral medicinal products for the treatment of HIV (see section 4.5).
Danish: Juluca bør ikke administreres sammen med andre antiretrovirale lægemidler til behandling af hiv (se pkt.
English: What Juluca contains - The active substances are dolutegravir and rilpivirine.
Danish: Juluca indeholder: - Aktive stoffer: dolutegravir og rilpivirin.
English: At baseline, in the pooled analysis, characteristics were similar between treatment arms with the median age of subjects of 43 years (28%, 50 years of age or older; 3%, 65 years of age or older), 22% female, 20% nonwhite and 77% were CDC Class A. Median CD+cell count was about 600 cells per mm3 with 11% having CD4+ cell count less than 350 cells per mm3.
Danish: I den sammenlagte analyse var karakteristika de samme i behandlingsgrupperne ved baseline med personernes medianalder på 43 år (28 % med alder 50 år eller ældre, 3 % med alder 65 år eller ældre), 22 % var kvinder, 20 % var ikke-hvide, og 77 % var CDC-klasse A. Median for CD+celletal var omkring 600 celler pr. mm
English: What you need to know before you take Juluca
Danish: Det skal du vide, før du begynder at tage Juluca
English: The safety and efficacy of Juluca in pregnancy have not yet been established.
Danish: Julucas sikkerhed og virkning ved graviditet er endnu ikke klarlagt.
English: Frequency category*
Danish: Hyppighedskategori* Bivirkninger
English: In Phase I studies in healthy subjects, between-subject CVb% for AUC and Cmax ranged from ~20 to 40% and Cτ from 30 to 65% across studies.
Danish: I fase I-studier hos raske forsøgspersoner lå interindivid-variabiliteten (CVb %) for AUC og Cmax i intervallet ~20-40 % og C i intervallet 30-65 % på tværs af studierne.
English: Rifabutin/ Rilpivirine1 300 mg once daily2
Danish: Rifabutin/ rilpivirin 300 mg en gang dagligt
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose-/galactosemalabsorption.
English: Rilpivirine demonstrated limited in vitro activity against HIV-2 with IC50 values ranging from 2,510 to 10,830 nM.
Danish: Der er begrænset in vitro-aktivitet mod hiv-2 med rilpivirin med IC50-værdier fra 2.510 til 10.830 nM.
English: Juluca must be taken orally, once daily with a meal (see section 5.2).
Danish: Juluca skal tages oralt en gang dagligt sammen med et måltid (se pkt.
English: → Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Juluca.
Danish:  Tal med lægen for yderligere råd om, hvordan du skal tage calciumtilskud, jerntilskud eller multivitaminer sammen med Juluca.
English: As dolutegravir and rilpivirine are highly bound to plasma proteins, dialysis is unlikely to result in significant removal of the active substances.
Danish: Da dolutegravir og rilpivirin i høj grad er bundet til plasmaproteiner, er det usandsynligt, at de aktive stoffer kan elimineres væsentligt som følge af dialyse.
English: In patients with severe renal impairment or end-stage renal disease, Juluca should be used with caution, as rilpivirine plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Danish: Juluca bør anvendes med forsigtighed til patienter med svært nedsat nyrefunktion eller terminal nyresygdom, da plasmakoncentrationen kan øges som følge af ændring i lægemiddeloptagelse, -fordeling og/eller -metabolisme, der er sekundær til nyredysfunktion.
English: No clinically important pharmacokinetic differences of dolutegravir or rilpivirine due to race have been identified.
Danish: Der blev ikke fundet nogen farmakokinetiske forskelle af klinisk betydning for dolutegravir eller rilpivirin på grund af race.
English: The combination of Juluca and artemether/lumefantrine should be used with caution.
Danish: Kombinationen af Juluca og artemether/lumefantrin skal anvendes med forsigtighed.
English: Juluca 50 mg/25 mg film-coated tablets dolutegravir/rilpivirine
Danish: Juluca 50 mg/25 mg filmovertrukne tabletter dolutegravir/rilpivirin
English: • artemether/lumefantrine used to prevent you catching malaria
Danish: • artemether/lumefantrin til forebyggelse af malaria
English: If you vomit more than 4 hours after taking Juluca you do not need to take another tablet until your next scheduled dose.
Danish: Hvis du kaster op mere end 4 timer efter at have taget Juluca, behøver du ikke tage en anden tablet før din næste planlagte dosis.
English: Other medicines and Juluca
Danish: Brug af anden medicin sammen med Juluca
English: Population pharmacokinetic analyses from studies with the individual components revealed that gender had no clinically relevant effect on the pharmacokinetics of dolutegravir or rilpivirine.
Danish: Farmakokinetiske populationsanalyser fra studier med de individuelle komponenter viste, at køn ikke havde nogen klinisk relevant effekt på dolutegravirs eller rilpivirins farmakokinetik.
English: Rilpivirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1.
Danish: Rilpivirin er en diarylpyrimidin-non-nukleosid revers transkriptasehæmmer (NNRTI) af hiv-1.
English: In a Week 96 pooled analyses of virologic failures with baseline viral load ≤100,000 copies/mL and resistance to rilpivirine (n = 5), subjects had cross-resistance to efavirenz (n = 3), etravirine (n = 4), and nevirapine (n = 1).
Danish: Tidligere ubehandlede hiv-1-inficerede voksne patienter I den sammenlagte uge 96-analyse af virologisk svigt med viral belastning ≤ 100.000 kopier/ml ved baseline og resistens over for rilpivirin (n = 5) havde personerne krydsresistens over for henholdsvis efavirenz (n = 3), etravirin (n = 4) og nevirapin (n = 1).
English: A higher incidence of liver chemistry elevations (Grade 1) were observed in patients treated with dolutegravir and rilpivirine co-infected with hepatitis C compared to those who were not co-infected.
Danish: Der er begrænsede data tilgængelige om patienter med co-infektion med hepatitis C. Der blev observeret en højere forekomst af forhøjede kemiske leverparametre (grad 1) hos patienter med co-infektion med hepatitis C, der blev behandlet med dolutegravir og rilpivirin, sammenlignet med dem, der ikke var co-inficeret.
English: Monitoring of liver function is recommended in patients with hepatitis B and/or C co-infection.
Danish: Det anbefales at monitorere biokemiske leverparametre hos patienter, der er co-inficeret med hepatitis B- og/eller C-virus.
English: Antacids should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Danish: Antacida skal tages tidsforskudt fra administrationen af Juluca (mindst 6 timer før eller 4 timer efter).
English: Juluca is bioequivalent to a dolutegravir 50 mg tablet and a rilpivirine 25 mg tablet administered together with a meal.
Danish: Juluca er bioækvivalent med en 50 mg dolutegravir tablet og en 25 mg rilpivirin tablet, der administreres sammen med et måltid.
English: In limited data from small numbers of women who received dolutegravir 50 mg once daily in combination with a background regimen, the total exposure (AUC) to dolutegravir was 37% lower during the 2nd trimester of pregnancy, and 29% lower during the 3rd trimester of pregnancy, compared with postpartum (612 weeks).
Danish: I begrænsede data fra et mindre antal kvinder, der fik dolutegravir 50 mg en gang dagligt i kombination med et baggrundsregime, var den samlede eksponering (AUC) for dolutegravir 37% lavere i 2. trimester af graviditeten og 29% lavere i 3. trimester af graviditeten sammenlignet med postpartum (6-12 uger).
English: • signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome).
Danish: • tegn eller symptomer på betændelsestilstand eller infektion, for eksempel feber, kulderystelser,
English: Taking Juluca in fasted condition or with only a protein-rich nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of Juluca.
Danish: Hvis Juluca tages ved faste eller kun sammen med en proteinrig ernæringsdrik, kan dette resultere i nedsat plasmakoncentration af rilpivirin, hvilket muligvis kan reducere Julucas terapeutiske effekt.
English: At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 5.1).
Danish: Ved supraterapeutiske doser (75 og 300 mg en gang dagligt) er rilpivirin blevet forbundet med forlængelse af QTc-intervallet på elektrokardiogrammet (EKG) (se pkt.
English: The pharmacokinetics of rilpivirine in 36 antiretroviral treatment-naïve HIV-1 infected adolescent subjects (12 to <18 years of age) receiving rilpivirine 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving rilpivirine 25 mg once daily.
Danish: Farmakokinetikken af rilpirivin hos 36 ART-naive hiv-1-inficerede unge (fra 12 år til < 18 år), der fik rilpivirin 25 mg én gang dagligt, var sammenlignelig med farmakokinetikken hos de behandlingsnaive hiv-1-inficerede voksne, der fik rilpivirin 25 mg én gang dagligt.
English: (induction of CYP3A enzymes).
Danish: (induktion af CYP3Aenzymer).
English: If a patient vomits more than 4 hours after taking Juluca, the patient does not need to take another dose of Juluca until the next regularly scheduled dose.
Danish: Hvis en patient kaster op mere end 4 timer efter at have taget Juluca, behøver patienten ikke tage en anden dosis Juluca før næste planlagte, regelmæssige dosis.
English: Site-directed NNRTI mutant virus
Danish: Virus med stedspecifikke NNRTI-mutanter
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.56 times the 50 mg human clinical exposure based on AUC).
Danish: Hos kaniner blev der observeret maternel toksicitet (nedsat fødeindtagelse, sparsom/ingen fæces/urin, hæmmet vægtøgning) ved 1.000 mg/kg (0,56 gange den humane kliniske eksponering ved 50 mg baseret på AUC).
English: These medicinal products are recommended to be administered 12 hours before or 4 hours after Juluca (see section 4.5).
Danish: Det anbefales, at disse lægemidler administreres 12 timer før eller 4 timer efter Juluca (se pkt.
English: Considering all of the available in vitro and in vivo data, the following amino acid substitutions, when present at baseline, are likely to affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I or M230L.
Danish: Når alle tilgængelige in vitro- og in vivo-data tages i betragtning, vil tilstedeværelse af følgende aminosyresubstitutioner ved baseline sandsynligvis påvirke rilpivirins aktivitet: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I eller M230L.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Juluca with metformin, to maintain glycaemic control.
Danish: Justering af metformindosis bør overvejes ved opstart eller ophør af samtidig administration af Juluca og metfomin for at opretholde glykæmisk kontrol.
English: Drug Interactions Medicinal products by therapeutic areas
Danish: Lægemidler efter terapeutiske områder
English: No pharmacokinetic data are available for the combination of dolutegravir and rilpivirine in pregnancy.
Danish: Der foreligger ingen farmakokinetiske data for kombinationen af dolutegravir og rilpivirin under graviditet.
English: These medicinal products are recommended to be administered 6 hours before or 4 hours after Juluca (see section 4.5).
Danish: Det anbefales, at disse lægemidler administreres 6 timer før eller 4 timer efter Juluca (se pkt.
English: The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Danish: De mest almindeligt observerede aminosyresubstitutioner, der fremkom, inkluderede L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C og M230I.
English: Don't stop taking Juluca without advice from your doctor Take Juluca for as long as your doctor recommends.
Danish: Tag Juluca så længe, som lægen anbefaler.
English: Fluconazole Itraconazole Isavuconazole Posaconazole Voriconazole/ Rilpivirine
Danish: Itraconazol Isavuconazol Posaconazol Voriconazol/ rilpivirin
English: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to <18 years of age and weighing ≥40 kg) showed that dolutegravir 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg orally once daily.
Danish: Farmakokinetikken af dolutegravir hos 10 ART-erfarne hiv-1-inficerede unge (fra 12 år til < 18 år med en vægt ≥40 kg) viste, at en dosering på 50 mg dolutegravir oralt én gang dagligt resulterede i en eksponering for dolutegravir, der var sammenlignelig med den eksponering, der blev observeret hos voksne, som fik 50 mg dolutegravir oralt én gang dagligt.
English: • increase in bilirubin (a test of liver function) in your blood.
Danish: • stigning i lipase (et enzym, der bidrager til at nedbryde fedtstoffer) • stigning i bilirubin (en test af leverfunktionen) i blodet.
English: In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT)1 and OAT3.
Danish: In vitro hæmmede dolutegravir de renale optagelsestransportører og de organiske anion-transportører (OAT)1 og OAT3.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) tablets
Danish: Multipakning: 90 (3 pakninger med 30) tabletter
English: Blood and lymphatic systems disorders:
Danish: Blod og lymfesystem Almindelig
English: Population pharmacokinetic analysis using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir or rilpivirine exposures.
Danish: En farmakokinetisk populationsanalyse, hvor der blev brugt data fra hiv-1-inficerede voksne, viste, at der ikke var nogen klinisk relevant betydning af alder på dolutegravirs eller rilpivirins eksponering.
English: In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
Danish: I denne analyse var de resistensrelaterede mutationer (RAM) forbundet med NNRTI-resistens, der blev udviklet i mindst 2 af tilfældene med virologisk svigt af rilpivirin: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y og F227C.
English: Combinations of multiple substitutions T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R or K, Q148R/N155H, T97A/G140S/Q148, and substitutions at
Danish: Kombinationer af multiple substitutioner T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R eller K, Q148R/N155H, T97A/G140S/Q148 og substitutioner på E138/G140/Q148 udviste et større end 2 gange fald i dolutegravirfølsomhed (interval: 2,5 - 21 gange i forhold til referencen).
English: Macrolide antibiotics Clarithromycin Erythromycin /Dolutegravir
Danish: Makrolidantibiotika Clarithromycin Erythromycin /dolutegravir
English: Juluca should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes.
Danish: Juluca skal anvendes med forsigtighed, når det anvendes sammen med et lægemiddel med en kendt risiko for torsades de pointes.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption due to gastric pH increase).
Danish: Der forventes signifikant fald i plasmakoncentrationen af rilpivirin (reduceret absorption pga. stigning i gastrisk pH).
English: Co-administration of Juluca and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 1).
Danish: Samtidig administration af Juluca og andre lægemidler, der hæmmer disse enzymer, kan øge plasmakoncentrationen af dolutegravir (se tabel 1).
English: No dose adjustments are required when initiating co-administration of methadone with Juluca.
Danish: Det er ikke nødvendigt at justere dosis, når samtidig administration af methadon og Juluca indledes.
English: Clarithromycin Erythromycin /Rilpivirine
Danish: Clarithromycin Erythromycin /rilpivirin
English: If calcium supplements, iron supplements or multivitamins cannot be taken at the same time as Juluca, these supplements should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Danish: Hvis calciumtilskud, jerntilskud eller multivitaminer ikke kan tages samtidig med Juluca, skal disse tilskud tages tidsforskudt fra administrationen af Juluca (minimum 6 timer før eller 4 timer efter).
English: The combination of Juluca and H2-receptor antagonists should be used with particular caution.
Danish: Kombinationen af Juluca og H2-receptorantagonister skal anvendes med særlig forsigtighed.
English: Each film-coated tablet contains 52 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 52 mg lactose (som monohydrat).
English: AUC ↔ Cmin ↓ 15% Cmax ↑ 35%
Danish: Atorvastatin AUC ↔ Cmin ↓ 15 % Cmax ↑ 35 %