FrancophonIA/ELRC3.0 huggingface dataset:
English: Boceprevir ↔ (historical controls).
Danish: Boceprevir  (historiske kontroller).
English: Increases in serum creatinine occurred within the first four weeks of treatment with Juluca and remained stable through 48 weeks.
Danish: Niveauet af serumkreatinin steg i løbet af de første fire uger af behandlingen med Juluca, og det forblev stabilt igennem 48 uger.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer bør vurderes og behandling indledes efter behov.
English: Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take Juluca.
Danish: Fortæl det til lægen, hvis du har eller har haft problemer med din lever, herunder hepatitis B og/eller C. Din læge vil vurdere, hvor alvorlig din leversygdom er, inden han eller hun beslutter, om du kan tage Juluca.
English: Symptoms of infection may develop, caused by old, hidden infections flaring up again as the body fights them.
Danish: Der kan komme infektionssymptomer, der skyldes gamle, skjulte infektioner, der blusser op igen, når kroppen bekæmper dem.
English: These changes are related to inhibition of active transport, and are not considered to be clinically relevant as they do not reflect a change in glomerular filtration rate.
Danish: Disse ændringer er relateret til hæmning af aktiv transport og anses ikke for at være klinisk relevante, da de ikke afspejler en ændring i den glomerulære filtreringshastighed.
English: • any medicines to treat HIV infection
Danish: • ethvert lægemiddel til behandling af hiv-infektion
English: No integrase resistance was observed.
Danish: Der blev ikke observeret integraseresistens.
English: Pharmacokinetic data in subjects >65 years old are very limited.
Danish: Farmakokinetiske data om anvendelse til personer> 65 år er meget begrænset.
English: No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.
Danish: Der sås ingen overførsel fra mor til barn hos nogen af de 10 spædbørn født af de mødre, som gennemførte studiet, og for hvem hiv-statussen var tilgængelig.
English: All other drug-drug interactions shown are predicted.
Danish: Alle andre lægemiddelinteraktioner er forventede.
English: * Adjusted for baseline stratification factors and assessed using a non-inferiority margin of - 8%.
Danish: * Justeret for stratificeringsfaktorer ved baseline og evalueret ved hjælp af en noninferioritetsmargen på - 8 %.
English: The R263K mutation was also selected in vitro (see above).
Danish: R263Kmutationen blev også selekteret in vitro (se ovenfor).
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Danish: (Stigning er angivet som "↑", fald som "↓", ingen ændring som "↔", arealet under koncentrations-tidskurven som "AUC", den observerede maksimumskoncentration som "Cmax" og koncentrationen ved slutningen af doseringsinterval som "Cτ").
English: Of the 29 subjects that completed the study, 27 subjects were suppressed at the end of the study.
Danish: Af de 29 personer, der gennemførte studiet, var 27 personer viralt hæmmet i slutningen af studiet.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningernes hyppighed er defineret som: meget almindelig (1/10), almindelig ( 1/100 til < 1/10), ikke almindelig ( 1/1.000 til < 1/100), sjælden ( 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Juluca in one or more subsets of the paediatric population in the treatment of HIV infection.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Juluca i en eller flere undergrupper af den pædiatriske population ved behandling af hivinfektion.
English: You need to know about important signs and symptoms to look out for while you're taking Juluca.
Danish: Det er nødvendigt, at du kender vigtige tegn og symptomer, som du skal holde øje med, mens du tager Juluca.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion overføres ved seksuel kontakt med en person, der har infektionen, eller ved overførsel af inficeret blod (f.eks. ved at dele injektionsnåle med andre).
English: Not known Frequency cannot be estimated from the available data:
Danish: Hypigheden kan ikke estimeres ud fra forhåndenværende data:
English: Patients should be advised that Juluca does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Danish: Patienterne bør informeres om, at Juluca ikke kurerer hiv-infektion, og at de stadig kan udvikle opportunistiske infektioner og andre komplikationer fra hiv-infektion.
English: H2-recepter antagonists Famotidine
Danish: H2-receptorantagonister Famotidin
English: The safety and efficacy of Juluca in children and adolescents aged less than 18 years have not yet been established.
Danish: Julucas sikkerhed og virkning hos børn og unge i alderen under 18 år er endnu ikke klarlagt.
English: After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Danish: Efter oral administration nås rilpivirins maksimale plasmakoncentration generelt inden for 4-5 timer.
English: This patient's viral load was 1,059,771 copies/mL at the suspected virologic withdrawal visit and was <50 copies/mL at the withdrawal visit.
Danish: Denne patients virale belastning var 1.059.771 kopier/ml ved det formodede virologiske seponeringsbesøg, og den var <50 kopier/ml ved seponeringsbesøget.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring, including monitoring of vital signs and ECG (QT interval), as necessary.
Danish: Hvis der sker en overdosering, skal patienten have den nødvendige understøttende behandling med relevant monitorering, herunder monitorering af vitale tegn med EKG (QT-interval) efter behov.
English: As a number of different medicines can cause this condition, you should ask your doctor or pharmacist if you are not sure
Danish: Da flere forskellige lægemidler kan være årsag til denne tilstand, skal du spørge lægen eller apotekspersonalet, hvis du er i tvivl
English: Potential increase via inhibition of OCT2 transporter.
Danish: Potentiel stigning via hæmning af OCT2transportør.
English: Take the rilpivirine tablet at the same time you take Juluca.
Danish: Tag rilpivirintabletten samtidigt med, at du tager Juluca.
English: Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Juluca.
Danish: Lægen kan beslutte at foretage undersøgelser for at tjekke din lever, dine nyrer eller dit blod og vil måske bede dig om at stoppe med at tage Juluca.
English: Juluca can make you dizzy, tired or drowsy or and have other side effects that make you less alert.
Danish: Juluca kan gøre dig svimmel, træt eller døsig eller give andre bivirkninger, som gør dig mindre opmærksom.
English: If you take rifabutin, your doctor may need to give you an additional dose of rilpivirine.
Danish: Hvis du tager rifabutin, vil din læge måske skulle give dig yderligere en dosis rilpivirin.
English: • liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine).
Danish: • leversvigt (tegn kan være gulfarvning af huden og det hvide i øjnene eller usædvanlig mørk urin).
English: In these cases the physician should refer to the Summary of Product Characteristics for these medicinal products.
Danish: I disse tilfælde henvises lægen til produktresuméet for disse lægemidler.
English: Carcinogenicity studies with rilpivirine in mice and rats revealed tumorigenic potential specific for these species, but are regarded as of no relevance for humans.
Danish: Karcinogenicitetsstudier med rilpivrin i mus og rotter viste tumorigent potentiale, der var specifikt for disse arter, men dette anses ikke for at have relevans for mennesker.
English: Patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Juluca.
Danish: Patienterne bør informeres om, at der er rapporteret træthed, svimmelhed og døsighed under behandling med komponenterne i Juluca.
English: • increase in triglycerides (a type of fat)
Danish: • stigning i triglycerider (en type fedt)
English: Effects on bone
Danish: Effekt på knogler
English: Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.
Danish: Dolutegravir absorberes hurtigt efter oral administration, med en median-Tmax 2-3 timer efter dosering af tabletformulering.
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Danish: Da gastrointestinal (GI) intolerance anses for at skyldes lokal administration af det aktive stof, er måleenhederne mg/kg eller mg/m hensigtsmæssige i forbindelse med beskrivelse af sikkerhed for denne toksicitet.
English: Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Danish: Der er også rapporteret om forekomst af autoimmune forstyrrelser (f.eks. Graves' sygdom) ved immunrekonstitution, men den rapporterede tid til indtrædelse varierer mere, og disse hændelser kan opstå mange måneder efter indledning af behandlingen.
English: • suicidal thoughts and behaviours (particularly in patients who have had depression or mental health problems before)
Danish: • selvmordstanker eller selvmordsadfærd (særligt hos patienter, som tidligere har haft depression eller psykiske problemer)
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Danish: - Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: • rifabutin, to treat tuberculosis (TB) and other bacterial infections.
Danish: • rifabutin, til behandling af tuberkulose (TB) og andre bakterieinfektioner.
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
Danish: Der foreligger begrænset information om potentialet for en farmakodynamisk interaktion mellem rilpivirin og lægemidler, der forlænger QTc-intervallet på EKG.
English: Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Danish: Kun spor af uforandret rilpivirin (<1 % af dosis) blev påvist i urin.
English: No mother to child transmission was identified.
Danish: Der sås ingen overførsel fra mor til barn.
English: Baseline CD4+ (cells/ mm3)
Danish: Baseline-CD4+ (celler/ mm
English: (Not studied)
Danish: (Ikke undersøgt).
English: Very common side effects that may show up in blood tests are:
Danish: Meget almindelige bivirkninger, der muligvis kan ses i blodprøver, er:
English: Dosing recommendations for paediatric patients cannot be made due to insufficient data (see section 4.2).
Danish: Anbefalinger om dosering til pædiatriske patienter kan ikke gives på grund af utilstrækkelige data (se pkt.
English: In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Danish: I fæces udgjorde uforandret rilpivirin gennemsnitligt 25 % af den administrerede dosis.
English: Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Danish: Rilpivirin kombineret med et baggrundsregime blev evalueret i et klinisk forsøg med 19 gravide kvinder i løbet af andet og tredje trimester og postpartum.
English: No treatment emergent resistanceassociated substitutions were observed for the other three subjects who experienced confirmed virologic failure.
Danish: Der blev ikke observeret substitutioner forbundet med behandlingsrelateret resistens hos de andre tre personer, der fik konstateret virologisk svigt.
English: Some medicines can affect how Juluca works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Juluca eller gøre det mere sandsynligt, at du får bivirkninger.
English: Juluca can also affect how some other medicines work.
Danish: Juluca kan også påvirke virkningen af andre lægemidler.
English: These mutations have been selected in patients with pre-existing raltegravir resistance and who were then treated with dolutegravir (listed as secondary mutations for dolutegravir).
Danish: Disse mutationer er blevet selekteret hos patienter med præeksisterende raltegravir-resistens, og som så blev behandlet med dolutegravir (anført som sekundære mutationer for dolutegravir).
English: Delay in stopping treatment with Juluca after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Danish: Forsinket afbrydelse af behandlingen med Juluca efter indtrædelsen af overfølsomhed kan resultere i en livstruende allergisk reaktion.
English: Resistance to rilpivirine was considered present when FC in EC50 value was above the biological cut-off (BCO) of the assay.
Danish: Resistens over for rilpivirin blev betragtet som værende tilstede, når FC i EC50-værdi var over analysens biologiske skæringspunkt (BCO).
English: Juluca has not been studied in patients on dialysis.
Danish: Juluca er ikke undersøgt hos patienter i dialyse.
English: In the case of the Q148-mutation viruses, increasing dolutegravir FC is seen as the number of secondary mutations increase.
Danish: I tilfældet med virus med Q148-mutationen, betragtes stigende dolutegravir FC som stigningen i antallet af sekundære mutationer.
English: Your doctor may decide that you need extra check ups.
Danish: Lægen vil beslutte, om du har brug for flere kontroller.
English: Warnings and precautions Talk to your doctor or, pharmacist before taking Juluca.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Juluca.
English: Juluca is intended for use as a complete regimen for the treatment of HIV-1 infection and should not be administered with other antiretroviral medicinal products for the treatment of HIV.
Danish: Juluca er beregnet til anvendelse som komplet regime til behandling af hiv-1-infektion og bør ikke administreres sammen med andre antiretrovirale lægemidler til behandling af hiv.
English: If you forget to take Juluca
Danish: Hvis du har glemt at tage Juluca
English: → Read the information ‘Other possible side effects' in section 4 of this leaflet.
Danish:  Læs oplysningerne under 'Andre mulige bivirkninger' i punkt 4 i denne indlægsseddel.
English: Subjects were randomised 1:1 to continue their CAR or be switched to a two-drug regimen dolutegravir plus rilpivirine administered once daily.
Danish: Personerne blev randomiseret 1:1 til at fortsætte med deres cART eller skifte til et 2-stof-regime med dolutegravir plus rilpivirin administreret en gang dagligt.
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Danish: In vivo blev et 10-14 % fald i kreatininclearance (sekretionsfraktion afhænger af OCT2 og MATE1-transport) observeret hos patienterne.
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Danish: De farmakokinetiske data påviste, at den samlede eksponering (AUC) for rilpivirin som en del af et antiretroviralt regime var ca. 30 % lavere under graviditet sammenlignet med postpartum (6-12 uger).
English: Dolutegravir was not carcinogenic in long term studies in the mouse and rat.
Danish: Dolutegravir var ikke karcinogent i længerevarende studier i mus og rotter.
English: The effect of Juluca on human pregnancy is unknown.
Danish: Virkningen af Juluca på human graviditet er ikke kendt.
English: Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Danish: Rilpivirin hæmmer ikke de humane cellulære DNA- polymeraser α, β og γ.
English: If you take rifabutin, your doctor may need to give you an additional dose of rilpivirine to treat your HIV infection (see section 3, ‘How to take Juluca')
Danish: Hvis du tager rifabutin, vil din læge måske skulle give dig yderligere en dosis rilpivirin til behandling af din hiv-infektion (se punkt 3, 'Sådan skal du tage Juluca')
English: SWORD-1 and SWORD-2 Pooled Data*** DTG + RPV N=513 n (%)
Danish: Sammenlagte data*** fra SWORD-1 og SWORD-2 DTG + RPV (N = 513) n (%)
English: There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in study C213 (33 to 93 kg), similar to what was observed in adults.
Danish: Legemsvægten havde ingen indvirkning på rilpivirins farmakokinetik hos pædiatriske personer i studie C213 (33 til 93 kg), det samme som var observeret hos voksne.
English: Do not take Juluca if you are taking any of the following medicines as they may affect the way Juluca works: - dofetilide (a medicine to treat heart conditions).
Danish: Tag ikke Juluca, hvis du tager et af følgende lægemidler, da de kan påvirke virkningen af Juluca: - dofetilid (et lægemiddel til behandling af hjertelidelser).
English: Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely.
Danish: Baseret på manglende effekt på in vivo-farmakokinetikken af OAT-substratet tenofovir, er in vivo-hæmning af OAT1 usandsynlig.
English: → Read the information ‘Allergic reactions' in section 4 of this leaflet.
Danish:  Læs oplysningerne under 'Allergiske reaktioner' i punkt 4 i denne indlægsseddel.
English: In phase 3 studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure.
Danish: I fase 3-studier blev lavere eksponering for rilpivirin, svarende til den, der ses under graviditet, forbundet med en øget risiko for virologisk svigt.
English: Dolutegravir had a <10 FC against 94% of the 705 clinical isolates.
Danish: Dolutegravir havde en FC< 10 mod 94 % af de 705 kliniske isolater.
English: When Juluca was taken with a meal, the absorption of both dolutegravir and rilpivirine was increased.
Danish: Når Juluca blev taget sammen med et måltid, blev både dolutegravirs og rilpivirins absorption øget.
English: The clinical status of the patient and the adverse reaction profile of Juluca should be borne in mind when considering the patient's ability to drive or operate machinery.
Danish: Der skal tages hensyn til patientens kliniske status og Julucas bivirkningsprofil ved vurdering af patientens evne til at føre motorkøretøj og betjene maskiner.
English: Dolutegravir and rilpivirine have been associated with increases in serum creatinine occuring in the first week of treatment when administered with other antiretroviral medicinal products.
Danish: Dolutegravir og rilpivirin er blevet forbundet med stigninger i serumkreatinin, der opstod i den første behandlingsuge, når lægemidlerne blev administreret sammen med andre antiretrovirale lægemidler.
English: ** Non-inferiority of dolutegravir plus rilpivirine to CAR, in the proportion of subjects classified as virologic non-responders, was demonstrated using a non-inferiority margin of 4%.
Danish: ** Noninferioritet blev påvist for dolutegravir plus rilpivirin i forhold til CAR hos den del af personerne, der var klassificeret som uden virologisk respons, ved anvendelse af en noninferioritetsmargen på 4 %.
English: Juluca contains dolutegravir and rilpivirine, therefore any interactions identified with these active substances are relevant to Juluca.
Danish: Juluca indeholder dolutegravir og rilpivirin, derfor er eventuelle identificerede interaktioner med disse aktive stoffer relevante for Juluca.
English: The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Danish: Fordelingen af rilpivirin i andre kompartmenter end plasma (f.eks. cerebrospinalvæske og genitalsekreter) er ikke vurderet hos mennesker.
English: Juluca is used to treat HIV in adults aged 18 years and over who are taking other antiretroviral medicines and whose HIV-1 infection is under control for at least 6 months.
Danish: Juluca anvendes til behandling af hiv-infektion hos voksne i alderen 18 år og derover, som tager andre antiretrovirale lægemidler, og hvis hiv-1-infektion er under kontrol gennem mindst 6 måneder.
English: • The recommended dose of Juluca is one tablet once a day.
Danish: • Den anbefalede dosis Juluca er en tablet én gang dagligt.
English: Decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected.
Danish: Fald er forventet pga. induktion af UGT1A1 og CYP3A-enzymer, en lignende reduktion i eksponering som observeret for carbamazepin forventes.
English: The film-coated tablets are provided in bottles closed with child-resistant closures.
Danish: De filmovertrukne tabletter fås i beholdere, der er lukket med børnesikret låg.
English: In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Danish: Når immunforsvaret bliver stærkere, kan det i sjældne tilfælde også angribe sundt væv i kroppen (autoimmune sygdomme).
English: • medicines that may cause a life threatening irregular heartbeat (Torsade de Pointes).
Danish: • lægemidler, der kan forårsage livstruende, uregelmæssig hjerterytme (torsades de pointes).
English: The adverse reactions considered at least possibly related to treatment with the components of Juluca from clinical studies and post-marketing experience are listed in Table 2 by body system, organ class and frequency.
Danish: De bivirkninger, der som minimum anses for muligvis at være relateret til behandling med komponenterne i Juluca i de kliniske studier og efter markedsføringen er anført i tabel 2 efter kropssystem, organklasse og hyppighed.
English: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults.
Danish: Der var ingen nye sikkerhedsfund sammenlignet med den kendte sikkerhedsprofil for rilpivirin hos hiv-1-inficerede voksne.
English: The recommended dose of Juluca is one tablet once daily.
Danish: Den anbefalede dosis af Juluca er en tablet én gang dagligt.
English: If you notice within 12 hours of the time you usually take Juluca, you must take the tablet as soon as possible.
Danish: Hvis du bemærker det inden for 12 timer efter det tidspunkt, hvor du plejer at tage Juluca, skal du tage tabletten så hurtigt som muligt.
English: 1 The interaction between dolutegravir and/or rilpivirine and the medicinal product was evaluated in a clinical study.
Danish: Interaktionen mellem dolutegravir og/eller rilpivirin og lægemidlet er blevet evalueret i et klinisk studie.
English: Using strain NL432, integrase mutations E92Q (fold change [FC] 3) and G193E (FC 3) were selected.
Danish: Ved brug af stamme NL432, blev integrasemutationerne E92Q (foldændring [FC] 3) og G193E (FC 3) selekteret.