FrancophonIA/ELRC3.0 huggingface dataset:
English: Polyamide / aluminium / HDPE / PE with an embedded desiccant agent / HDPE blister sealed with an aluminium foil.
Danish: Polyamid / aluminium / HDPE / PE med indlagt tørremiddel / HDPE-blister forseglet med en aluminiumsfolie.
English: As human EP4 receptors are not activated by selexipag or its active metabolite, this effect is species-specific and, therefore, not relevant to humans.
Danish: Da humane EP4-receptorer ikke aktiveres af selexipag eller dets aktive metabolit er denne virkning artsspecifik og derfor ikke relevant for mennesker.
English: Effect of other medicinal products on selexipag
Danish: Andre lægemidlers virkning på selexipag
English: It lets your body adjust to the new medicine.
Danish: Det giver kroppen mulighed for at vænne sig til den nye medicin.
English: In clinical practice, gastro-intestinal events have been observed to respond to anti-diarrhoeal, anti-emetic, and anti-nauseant medicinal products and/or medicinal products for functional gastro-intestinal disorders.
Danish: I klinisk praksis har gastrointestinale hændelser vist sig at respondere på diarréhæmmende, antiemetiske og kvalmestillende lægemidler og/eller lægemidler mod funktionelle gastrointestinale forstyrrelser.
English: There is limited experience with abrupt discontinuation of Uptravi in patients with PAH.
Danish: Der er begrænset erfaring med brat seponering af Uptravi hos patienter med PAH.
English: The patient titration guide along with the Patient Information Leaflet should be given to the patient after the demonstration.
Danish: Titreringsvejledningen til patienter og indlægssedlen bør gives til patienten efter demonstrationen.
English: At the beginning of treatment and at each up-titration step it is recommended to take the first dose in the evening.
Danish: I starten af behandlingen og ved hvert optitreringstrin anbefales det, at den første dosis tages om aftenen.
English: Concomitant administration of selexipag with CYP3A4 substrates does not require dose adjustment.
Danish: Samtidig administration af selexipag og CYP3A4-substrater nødvendiggør ikke justering af dosis.
English: Talk to your doctor or nurse if you have side effects.
Danish: Tal med lægen eller sundhedspersonalet, hvis du får bivirkninger.
English: Do not stop taking Uptravi unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Uptravi, medmindre lægen anviser det.
English: If you have any side effects, talk to your doctor.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge.
English: The MAH shall ensure that in each Member State where Uptravi is marketed, all healthcare professionals who are expected to prescribe and/or dispense Uptravi are provided with a Prescriber Kit containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedsfaglige personer, der forventes at ordinere og/eller udlevere Uptravi, i alle de medlemslande, hvor Uptravi markedsføres, har fået udleveret et ordinationssæt, der indeholder følgende:
English: The patients will receive an identical titration guide and Patient Leaflet in their titration packs of Uptravi.
Danish: Patienterne vil modtage en identisk titreringsvejledning og indlægsseddel i titreringspakkerne med Uptravi.
English: Selexipag is a weak substrate of the P-gp efflux pump.
Danish: Selexipag er et svagt substrat for Pgp-efflukspumpen.
English: • Cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
Danish: • Cerebrovaskulære hændelser (f.eks. transitorisk iskæmisk attak, slagtilfælde) inden for de sidste
English: • The distribution of kits to all identified prescribers to minimise the risks of medication error in particular;
Danish: • Forsendelse af et sæt til alle identificerede ordinerende læger med henblik på risikominimering, især hvad angår medicineringsfejl.
English: Excretion in healthy subjects was complete 5 days after administration and occurred primarily via faeces (accounting for 93% of the administered dose) compared to 12% in urine.
Danish: Hos raske forsøgsdeltagere var udskillelsen komplet 5 dage efter administration og foregik primært via fæces (udgør 93 % af den administrerede dosis) i forhold til 12 % via urinen.
English: Oxidative metabolism catalysed mainly by CYP2C8 and to a smaller extent by CYP3A4 leads to the formation of hydroxylated and dealkylated products.
Danish: Oxidativ metabolisme katalyseret primært af CYP2C8 og i mindre grad af CYP3A4 fører til dannelsen af hydroxylerede og dealkylerede produkter.
English: Uptravi is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Det frarådes at anvende Uptravi under graviditeten og hos kvinder i den fertile alder, der ikke anvender kontraceptiva.
English: Tell your doctor if you are taking other medications as your doctor may recommend that you take Uptravi only once daily.
Danish: Fortæl det til lægen, hvis du tager andre lægemidler, da din læge kan anbefale, at du kun tager Uptravi én gang dagligt.
English: Selectivity against EP1, EP3, FP, and TP is important because these are well-described contractile receptors in the gastro-intestinal tract and blood vessels.
Danish: Selektivitet for EP1, EP3, FP, og TP er vigtigt, fordi disse er velbeskrevne kontraktile receptorer i mave-tarm-kanalen og blodkarrene.
English: If you cannot tolerate the side effects even after your doctor or nurse has tried to treat them, he or she may recommend you step down to a lower dose.
Danish: Hvis du stadig ikke kan tolerere bivirkningerne, efter at lægen eller sundhedspersonalet har forsøgt at behandle dem, kan de anbefale, at du trapper ned til en lavere dosis.
English: Do this only if instructed to do so by your doctor.
Danish: Gør kun dette, hvis din læge har anvist det.
English: Use the following diary pages if your doctor or nurse prescribes 800 microgram tablets in addition to your 200 microgram tablets.
Danish: Brug følgende dagbogssider, hvis lægen eller sundhedspersonalet ordinerer 800 mikrogram-tabletter i tillæg til dine 200 mikrogram-tabletter.
English: If you have poor vision or experience any type of blindness, get help from another person when taking Uptravi during the titration period.
Danish: Hvis dit syn er nedsat, eller du har en form for blindhed, skal du have hjælp fra en anden person, når du tager Uptravi i titreringsperioden.
English: At baseline, the majority of enrolled patients (80%) were being treated with a stable dose of a specific therapy for PAH, either an ERA (15%) or a PDE-5 inhibitor (32%) or both an ERA and a PDE-5 inhibitor (33%).
Danish: Ved baseline var størstedelen af de inkluderede patienter (80 %) i behandling med en stabil dosis af en specifik PAH-behandling, enten en ERA (15 %) eller en PDE-5-hæmmer (32 %) eller både en ERA og en PDE-5-hæmmer (33 %).
English: Adverse reactions obtained from the pivotal clinical study are tabulated below.
Danish: De bivirkninger, der er indberettet fra det pivotale kliniske studie, er angivet i tabellen nedenfor.
English: Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Danish: Der er rapporteret om tilfælde af lungeødem i forbindelse med brug af vasodilatatorer (hovedsageligt prostacykliner) hos patienter med pulmonal veno-okklusiv sygdom.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC27
Danish: Farmakoterapeutisk klassifikation: antitrombostiske midler, trombocytaggregationshæmmere eksklusive heparin, ATC-kode: B01AC27.
English: Uptravi should only be prescribed by a doctor experienced in the treatment of PAH.
Danish: Uptravi bør kun ordineres af en læge med erfaring i behandling af PAH.
English: However, if the decision to withdraw Uptravi is taken, it should be done gradually while an alternative therapy is introduced.
Danish: Hvis det besluttes at seponere Uptravi, bør det dog gøres gradvist, samtidig med at der iværksættes anden behandling.
English: Selexipag and its active metabolite are substrates of OATP1B1 and OATP1B3.
Danish: Selexipag og dets aktive metabolit er substrater for OATP1B1 og OATP1B3.
English: There is limited experience with Uptravi in patients older than 75 years.
Danish: Der er begrænset erfaring med Uptravi hos patienter over 75 år.
English: What is important is that you reach the dose that is most appropriate to treat you.
Danish: Det vigtigste er, at du når frem til den dosis, der er mest velegnet til behandling af dig.
English: Dialysis is unlikely to be effective because selexipag and its active metabolite are highly protein bound.
Danish: Dialyse er sandsynligvis ikke nyttig, idet selexipag og dets aktive metabolit har en høj proteinbinding.
English: Pharmacist's telephone:
Danish: Apotekets telefonnummer:
English: Mechanistically, the effect is considered to be induced by life-long vasodilation and subsequent changes in ocular haemodynamics.
Danish: Mekanistisk set vurderes denne virkning at være forårsaget af livslang vasodilatation og deraf følgende forandringer i okulær hæmodynamik.
English: The approximate rate of adverse reactions that were serious was 2.3% in the selexipag group and 0.5% in the placebo group.
Danish: Den tilnærmelsesvise procentdel af bivirkninger, der var alvorlige, var 2,3 % i selexipaggruppen og 0,5 % i placebogruppen.
English: Some patients may have 200 micrograms in the morning and in the evening as their maintenance dose, while some will reach the highest dose of 1,600 micrograms in the morning and in the evening.
Danish: Nogle patienter får 200 mikrogram om morgenen og om aftenen som vedligeholdelsesdosis, mens andre vil nå frem til den højeste dosis på 1.600 mikrogram om morgenen og om aftenen.
English: Intra-subject variability in exposure was 24% and 19% for selexipag and the active metabolite, respectively.
Danish: Den intraindividuelle variation i eksponeringen var hhv. 24 % og 19 % for selexipag og den aktive metabolit.
English: The highest dose that you can tolerate during titration will become your maintenance dose.
Danish: Den højeste dosis, som du kan tolerere i titreringsfasen, vil blive din vedligeholdelsesdosis.
English: The cover letter to the healthcare professional should explain that the purpose of the educational materials is to reduce the risk of medication error due to the availability of multiple tablets and dose strengths, and it should provide a list of the contents of the Prescriber Kit.
Danish: Følgebrevet til læger og sundhedspersonale skal tydeliggøre, at formålet med oplysningsmaterialerne er at reducere risikoen for medicineringsfejl som følge af de forskellige markedsførte tabletter og dosisstyrker, og det skal indeholde en liste over indholdet i ordinationssættet.
English: In the presence of food, the exposure to selexipag after a single dose of 400 micrograms was increased by 10% in Caucasian subjects and decreased by 15% in Japanese subjects, whereas exposure to the active metabolite was decreased by 27% (Caucasian subjects) and 12% (Japanese subjects).
Danish: I nærvær af føde steg eksponeringen for selexipag efter en enkelt dosis på 400 mikrogram med 10 % hos kaukasiske forsøgsdeltagere og faldt med 15 % hos japanske forsøgsdeltagere, hvorimod eksponeringen for den aktive metabolit faldt med 27 % (kaukasiske forsøgsdeltager) og 12 % (japanske forsøgsdeltagere).
English: If, at any time, after taking the same dose for a long time, you experience side effects that you cannot tolerate or side effects that have an impact on your normal daily activities, contact your doctor as your dose may need to be reduced.
Danish: Hvis du på et tidspunkt efter at have taget den samme dosis i lang tid får bivirkninger, som du ikke kan tolerere, eller bivirkninger, der påvirker dine dagligdagsaktiviteter, skal du kontakte lægen, da det kan være, at din dosis skal nedsættes.
English: Contents of the package and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: Disease progression b n (%)
Danish: Sygdomsprogression b n (%)
English: Decreased appetite Weight decrease
Danish: Nedsat appetit Vægttab
English: There is no clinical experience with selexipag in patients with severe liver impairment (Child-Pugh class C), therefore Uptravi should not be administered in these patients.
Danish: Der er ikke nogen klinisk erfaring med selexipag hos patienter med svært nedsat leverfunktion (ChildPugh-klasse C), og derfor bør Uptravi ikke administreres til sådanne patienter.
English: There are treatments available that can help relieve the side effects.
Danish: Der findes behandlinger, der kan bidrage til at lindre bivirkningerne.
English: The efficacy of selexipag on the primary endpoint was consistent across subgroups of age, sex, race, aetiology, geographical region, WHO FC, and as monotherapy or in combination with an ERA or a PDE-5 inhibitor or triple combination with both an ERA and a PDE-5 inhibitor.
Danish: Selexipags virkning på det primære endepunkt var konsistent på tværs af undergrupper ud fra alder, køn, race, ætiologi, geografisk region, WHO-funktionsklasse, og ved monoterapi eller i kombination med en ERA eller en PDE-5-hæmmer eller en trippelkombination med både en ERA og en PDE-5hæmmer.
English: Idiopathic or heritable PAH was the most common aetiology in the study population (58%) followed by PAH due to connective tissue disorders (29%), PAH associated with simple corrected congenital heart disease (10%), and PAH associated with other aetiologies (drugs and toxins [2%] and HIV
Danish: Idiopatisk eller hereditær PAH var den mest almindelige ætiologi i studiepopulationen (58 %), efterfulgt af PAH på grund af bindevævssygdom (29 %), PAH forbundet med simpel, korrigeret kongenit hjertesygdom (10 %) og PAH forbundet med andre ætiologier (lægemidler og toksiner [2 %] og hiv [1 %]).
English: The tablets should not be split, crushed or chewed, and are to be swallowed with water.
Danish: Tabletterne må ikke deles, knuses eller tygges.
English: Stimulation of the IP receptor by selexipag and the active metabolite leads to vasodilatory as well as anti-proliferative and anti-fibrotic effects.
Danish: Selexipags og den aktive metabolits stimulation af IP-receptoren fører til vasodilatoriske og antiproliferative og antifibrotiske virkninger.
English: It lets your body gradually adjust to the medicine.
Danish: Det giver kroppen mulighed for at gradvist at vænne sig til medicinen.
English: The overall median double-blind treatment duration was 63.7 weeks for the placebo group and 70.7 weeks for the selexipag group.
Danish: Den samlede gennemsnitlige dobbeltblindede behandlingsvarighed var 63,7 uger i placebogruppen og 70,7 uger i selexipaggruppen.
English: Given the 37-fold higher potency of the active metabolite, this effect is not clinically relevant.
Danish: Med udgangspunkt i den 37 gange højere potens af den aktive metabolit er denne virkning ikke klinisk relevant.
English: A potential pharmacokinetic interaction with strong inhibitors of UGT1A3 and UGT2B7 cannot be excluded.
Danish: En potentiel farmakokinetisk interaktion med stærke UGT1A3- og UGT2B7-hæmmere kan ikke udelukkes.
English: This may cause people to feel tired, dizzy, short of breath, or experience other symptoms.
Danish: Dette kan forårsage træthed, svimmelhed, stakåndethed eller andre symptomer.
English: Read the package leaflet and titration guide before use.
Danish: Læs indlægssedlen og titreringsvejledningen inden brug.
English: A reduction (up to −0.3 MU/L from a baseline median of 2.5 MU/L) in median thyroid-stimulating hormone was observed at most visits in the selexipag group.
Danish: Der blev set et fald (op til -0,3 mU/l i forhold til en median på 2,5 mU/l ved baseline) i medianniveauet af thyroideastimulerende hormon ved de fleste besøg i selexipaggruppen.
English: No accumulation in plasma, either of parent compound or active metabolite, occurred after multiple-dose administration.
Danish: Der var ingen akkumulation i plasma af hverken moderstoffet eller den aktive metabolit efter administration af flere doser.
English: Your doctor will instruct you to gradually increase your dose.
Danish: Din læge vil anvise, at du gradvist øger dosis.
English: No clinically relevant effects of sex, race, age, or body weight on the pharmacokinetics of selexipag and its active metabolite have been observed in healthy subjects or PAH patients.
Danish: Der er ikke set nogen klinisk relevante indvirkninger af køn, race, alder eller legemsvægt på farmakokinetikken af selexipag og dets aktive metabolit hos raske forsøgsdeltagere eller PAHpatienter.
English: The pharmacokinetics of selexipag and the active metabolite in PAH patients were not influenced by the severity of the disease and did not change with time.
Danish: Farmakokinetikken af selexipag og den aktive metabolit hos PAHpatienter blev ikke påvirket af sygdommens sværhedsgrad og ændrede sig ikke over tid.
English: If your titration steps last longer than 1 week there are additional diary pages to track this.
Danish: Hvis dit titreringstrin varer mere end 1 uge er der flere dagbogssider, hvor du kan notere dette.
English: You should only step down after speaking with your PAH doctor or nurse.
Danish: Du bør kun nedtrappe efter at have talt med din PAHlæge eller sundhedspersonalet.
English: The effect of strong inhibitors of UGT1A3 and UGT2B7 (valproic acid, probenecid, and fluconazole) on the exposure to selexipag and its active metabolite has not been studied.
Danish: Virkningen af stærke UGT1A3- og UGT2B7-hæmmere (valproinsyre, probenecid og fluconazol) på eksponeringen for selexipag og dets aktive metabolit er ikke blevet undersøgt.
English: Since a strong inhibitor of CYP3A4 did not affect the pharmacokinetics of the active metabolite, indicating that the CYP3A4 pathway is not important in the elimination of the active metabolite, no effect of inducers of CYP3A4 on the pharmacokinetics of the active metabolite is expected.
Danish: I og med at en stærk CYP3A4-hæmmer ikke påvirkede farmakokinetikken af den aktive metabolit, hvilket tyder på, at CYP3A4-metaboliseringen ikke er vigtig for eliminationen af den aktive metabolit, forventes CYP3A4-induktorer ikke at påvirke farmakokinetikken af den aktive metabolit.
English: Elimination of selexipag is predominantly via metabolism with a mean terminal half-life of 0.8-2.5 h. The active metabolite has a half-life of 6.2-13.5 h. The total body clearance of selexipag is 17.9 L/h.
Danish: Selexipag elimineres primært via metabolisme med en gennemsnitlig halveringstid på 0,8-2,5 t. Den aktive metabolit har en halveringstid på 6,2-13,5 t. Den totale legemsclearance af selexipag er 17,9 l/t.
English: Thyroid function tests are recommended as clinically indicated in the presence of signs or symptoms of hyperthyroidism.
Danish: Det anbefales at udføre thyroideafunktionstest efter klinisk behov hos patienter med tegn eller symptomer på hyperthyreoidisme.
English: Median 6MWD at baseline was 376 m (range: 90-482 m) and 369 m (range: 50-515 m) in selexipag patients and placebo patients, respectively.
Danish: Gennemsnitlig 6MWD ved baseline var 376 m (interval: 90-482 m) og 369 m (interval: 50-515 m) hos hhv. selexipagbehandlede og placebobehandlede patienter.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Uptravi in one or more subsets of the paediatric population for treatment of pulmonary hypertension, (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Uptravi i én eller flere undergrupper af den pædiatriske population ved pulmonal hypertension (se pkt.
English: System organ class
Danish: Systemorganklasse Meget almindelig
English: Individualised maintenance dose
Danish: Individuelt tilpasset vedligeholdelsesdosis
English: Treatment comparison: selexipag vs placebo
Danish: Behandlingssammenligning: selexipag kontra placebo
English: This is one 200 microgram tablet in the morning and another 200 microgram tablet in the evening.
Danish: Det er én 200 mikrogram-tablet om morgenen og endnu én 200 mikrogram-tablet om aftenen.
English: This lets you take just one tablet in the morning and one in the evening, instead of multiple tablets for each dose.
Danish: På denne måde skal du bare tage én tablet om morgenen og én om aftenen, i stedet for flere tabletter til hver dosis.
English: If you forget to take Uptravi
Danish: Hvis du har glemt at tage Uptravi
English: The mean treatment duration was 76.4 weeks (median 70.7 weeks) for patients receiving selexipag versus 71.2 weeks (median 63.7 weeks) for patients on placebo.
Danish: Den gennemsnitlige behandlingsvarighed var 76,4 uger (median 70,7 uger) for de patienter, der fik selexipag, og 71,2 uger (median 63,7 uger) for de patienter, der fik placebo.
English: The finding did not occur in mouse or rat toxicity studies.
Danish: Fundet optrådte ikke i toksicitetsstudier hos mus eller rotter.
English: Selexipag does not cause IP receptor desensitisation in vitro nor tachyphylaxis in a rat model.
Danish: Selexipag forårsager ikke IPreceptor-desensibilisering in vitro eller takyfylaksi i en rottemodel.
English: The effect of selexipag on progression of PAH was demonstrated in a multi-centre, long-term (maximum duration of exposure approximately 4.2 years), double-blind, placebo-controlled, parallel-group, event-driven Phase 3 study in 1,156 patients with symptomatic (WHO FC I-IV) PAH.
Danish: Selexipags virkning på progressionen af PAH er påvist i et langvarigt (maksimal eksponeringsvarighed cirka 4,2 år), dobbeltblindet, placebokontrolleret, hændelsesdrevet multicenterforsøg med parallelgrupper i fase 3 med 1.156 patienter med symptomatisk (WHO FC I-IV) PAH.
English: The first intake of Uptravi should be in the evening.
Danish: Den første gang, du tager Uptravi, bør være om aftenen.
English: If a dose is missed, it should be taken as soon as possible.
Danish: Hvis patienten glemmer en dosis, skal vedkommende tage den så hurtigt som muligt.
English: Since selexipag did not affect the exposure to the CYP3A4 substrates midazolam and R-warfarin or to the CYP2C9 substrate S-warfarin, reduced efficacy of hormonal contraceptives is not expected.
Danish: I og med at selexipag ikke påvirker eksponeringen for CYP3A4-substraterne midazolam og R-warfarin eller CYP2C9substratet S-warfarin, forventes der ikke nedsat virkning af hormonelle kontraceptiva.
English: Maximum observed plasma concentrations of selexipag and its active metabolite after oral administration are reached within 1-3 h and 3-4 h, respectively.
Danish: De maksimale plasmakoncentrationer af selexipag og dets aktive metabolit efter oral administration nås i løbet af hhv.1-3 timer og 3-4 timer.
English: To improve tolerability, it is recommended to take Uptravi with food and, at the beginning of each up-titration phase, to take the first increased dose in the evening.
Danish: For at forbedre tolerabiliteten anbefales det, at Uptravi tages sammen med mad, og at den forhøjede dosis tages om aftenen i forbindelse med hver optitreringsfase.
English: The safety of selexipag has been evaluated in a long-term, Phase 3 placebo-controlled study enrolling 1,156 patients with symptomatic PAH.
Danish: Sikkerheden af selexipag er blevet vurderet i et langvarigt placebokontrolleret fase 3-forsøg med 1.156 patienter med symptomatisk PAH.
English: No adjustment to the dose regimen is needed in elderly people (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosisregimet hos ældre personer (se pkt.
English: Selexipag is hydrolysed by carboxylesterases to yield its active metabolite, which is approximately 37-fold more potent than selexipag.
Danish: Selexipag hydrolyseres af carboxylesteraser og omdannes til den aktive metabolit, som er cirka 37 gange mere potent end selexipag.
English: In patients with moderate hepatic impairment, Uptravi should be dosed once daily (see section 4.2).
Danish: Hos patienter med moderat nedsat leverfunktion bør Uptravi doseres én gang dagligt (se pkt.
English: The first intake of the increased dose should be in the evening.
Danish: Den første øgede dosis bør tages om aftenen.
English: • Patient titration guide;
Danish: • Titreringsvejledning til patienter.