FrancophonIA/ELRC3.0 huggingface dataset:
English: The beneficial effect of selexipag was primarily attributable to a reduction in hospitalisation for PAH and a reduction in other disease-progression events (Table 1).
Danish: Den gavnlige virkning af selexipag blev primært tilskrevet en reduktion i hospitalisering pga. PAH og en reduktion i andre sygdomsprogressionshændelser (Tabel 1).
English: Please see section Maintenance dose below for more information.
Danish: Se venligst afsnittet 'Vedligeholdelsesdosis' nedenfor for yderligere oplysninger.
English: The Controlled Access System is aimed to facilitate the identification of prescribers, to approach them with the appropriate information on the safe and effective use of Uptravi, and to provide them with risk minimisation tools, especially regarding the potential risk of medication error.
Danish: Formålet med det kontrollerede adgangssystem er at lette identifikationen af ordinerende læger, at henvende sig til dem med relevante oplysninger vedrørende sikker og effektiv brug af Uptravi, og at give dem værktøjer til risikominimering, særligt hvad angår den potentielle risiko for medicineringsfejl.
English: These effects are usually transient or manageable with symptomatic treatment.
Danish: Disse virkninger er som regel forbigående eller tålelige med symptomatisk behandling.
English: In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them.
Danish: Hos personer, der har PAH, bliver disse arterier smallere, så hjertet skal arbejde hårdere for at pumpe blod igennem dem.
English: - if you are allergic to selexipag or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for selexipag eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
Danish: PAH er højt blodtryk i de blodkar, der fører blod fra hjertet til lungerne (lungearterierne).
English: There were no mean changes in triiodothyronine or thyroxine in either group.
Danish: Der var ingen forandringer i de gennemsnitlige niveauer af trijodthyronin eller thyroxin i nogen af grupperne.
English: * See section Description of selected adverse reactions.
Danish: * Se afsnittet Beskrivelse af udvalgte bivirkninger.
English: • Encouragement and guidance for healthcare professionals to communicate clearly with the patient during their first visit, as well as to take responsibility to contact the patient during the titration phase, facilitating communication between healthcare professional and the patient (need for contact and to schedule telephone calls).
Danish: • Tilskyndelse til og vejledning i at kommunikere tydeligt med patienten ved det første besøg og til at tage ansvaret for at kontakte patienten i titreringsfasen og dermed lette kommunikationen mellem lægen/sundhedspersonalet og patienten (behov for kontakt og planlægning af telefonopkald).
English: The numerical increase in deaths up to end of treatment + 7 days but not up to study closure was further investigated by mathematical modelling, showing that the imbalance in deaths is consistent with the assumption of a neutral effect on PAH mortality and reduction of non-fatal events.
Danish: Den numeriske stigning i dødsfald frem til afslutning af behandlingen + 7 dage, men ikke frem til studielukning, blev yderligere undersøgt ved hjælp af matematisk modellering, der viste, at ubalancen i dødsfald er i overensstemmelse med formodningen om en neutral virkning på PAH-mortalitet og reduktion i ikke-fatale hændelser.
English: This makes it easier for the heart to pump blood through the pulmonary arteries.
Danish: Dermed bliver det nemmere for hjertet at pumpe blod igennem lungearterierne.
English: Symptomatic endpoints
Danish: Symptomatiske endepunkter
English: The film-coated tablets are to be taken orally in the morning and in the evening.
Danish: De filmovertrukne tabletter skal tages oralt om morgenen og aftenen.
English: 7.5% of patients on selexipag discontinued treatment due to these adverse reactions.
Danish: 7,5 % af de patienter, der fik selexipag, fik seponeret behandlingen på grund af disse bivirkninger.
English: This is called the maintenance dose.
Danish: Det kaldes for vedligeholdelsesdosis.
English: Take Uptravi once in the morning and once in the evening, about 12 hours apart.
Danish: Tag Uptravi én gang om morgenen og én gang om aftenen med cirka 12 timers mellemrum.
English: Transporter inhibitors (lopinavir/ritonavir)
Danish: Transporthæmmere (lopinavir/ritonavir)
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event
Danish: Kaplan-Meier-estimater af første morbiditets-mortalitetshændelse
English: Starting Treatment With Uptravi
Danish: Opstart af behandling med Uptravi
English: Patients were randomised to either placebo (N = 582) or selexipag (N = 574) twice daily.
Danish: Patienterne blev randomiseret til enten placebo (N = 582) eller selexipag (N = 574) to gange dagligt.
English: HR (99% CI) p-value
Danish: HR (99 % CI) p-værdi
English: However, if a patient reaches a dose that cannot be tolerated, the dose should be reduced to the previous dose level.
Danish: Hvis en patient når en dosis, som vedkommende ikke kan tolerere, bør dosen dog reduceres til det foregående dosisniveau.
English: Animal studies indicated an increased risk of intussusception, but the clinical relevance of these findings is unknown (see section 5.3).
Danish: Dyrestudier viste en øget risiko for intussusception, men den kliniske relevans af disse fund kendes ikke (se pkt.
English: Uptravi 200 microgram
Danish: Uptravi 200 mikrogram
English: It could take several weeks to find the dose that is right for you.
Danish: Det kan tage flere uger at finde den rette dosis til dig.
English: Endpoints & statistics
Danish: Endepunkter og statistik
English: If confirmed, treatment with Uptravi should be discontinued.
Danish: Hvis dette bekræftes, skal behandlingen med Uptravi seponeres.
English: Pharmacological effects associated with titration and maintenance treatment
Danish: Farmakologiske virkninger i forbindelse med titrering og vedligeholdelsesbehandling
English: In the first several weeks, you will work with your doctor to find the dose of Uptravi that is right for you.
Danish: I de første mange uger skal du i samarbejde med lægen finde frem til den dosis af Uptravi, der er den rigtige for dig.
English: Your maintenance dose is the dose you should continue to take on a regular basis.
Danish: Din vedligeholdelsesdosis er den dosis, som du skal fortsætte med at tage regelmæssigt.
English: Doctor's office telephone and e-mail:
Danish: Lægens telefonnummer og e-mail:
English: Selexipag This medicine is subject to additional monitoring.
Danish: Selexipag Dette lægemiddel er underlagt supplerende overvågning.
English: Administration of selexipag in the paediatric population is not recommended.
Danish: Det frarådes at administrere selexipag i den pædiatriske population.
English: TITRATION GUIDE - TITRATION PACK Page 1
Danish: TITRERINGSVEJLEDNING - TITRERINGSPAKKE Side 1
English: Take the tablets with meals as you might tolerate your medicine better.
Danish: Tag tabletterne i forbindelse med måltider, da det kan medvirke til, at du bedre kan tåle medicinen.
English: The diagram below shows stepping down to a lower dose.
Danish: Diagrammet nedenfor viser nedtrapning til en lavere dosis.
English: The active metabolite is a weak substrate of the breast cancer resistance protein (BCRP).
Danish: Den aktive metabolit er et svagt substrat for det brystcancerresistente protein (BCRP).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Quality of life was assessed in a subset of patients in the GRIPHON study using the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaire.
Danish: Livskvaliteten blev vurderet i en undergruppe af patienter i GRIPHON-studiet på baggrund af spørgeskemaet CAMPHOR (Cambridge Pulmonary Hypertension Outcome Review).
English: There are treatments available that can help relieve them.
Danish: Der findes behandlinger, der kan hjælpe med at lindre dem.
English: This is called titration.
Danish: Dette kaldes for titrering.
English: In adult and juvenile dogs, intestine and bone / bone marrow were identified as the main target organs after treatment with selexipag.
Danish: Hos voksne og unge hunde blev tarmen og knoglerne/knoglemarven identificeret som de primære targetorganer efter behandling med selexipag.
English: This stepping-down process will help you find the dose that is right for you, also called your maintenance dose.
Danish: Dette nedtrapningsforløb vil hjælpe dig med at finde den rette dosis til dig, også kaldet din vedligeholdelsesdosis.
English: The patient titration guide to be used by the healthcare professionals during discussions with the patient should contain the following key elements:
Danish: Titreringsvejledningen til patienten, som lægen og sundhedspersonalet skal bruge i forbindelse med samtaler med patienten, bør indeholde følgende nøgleelementer:
English: In the 2-year carcinogenicity studies, selexipag caused an increased incidence of thyroid adenomas in mice and Leydig cell adenomas in rats.
Danish: I de 2-årige karcinogenicitetsstudier forårsagede selexipag en øget incidens af thyroideadenomer hos mus og Leydig-celleadenomer hos rotter.
English: Selectivity against EP2, EP4, and DP1 is important because these receptors mediate immune depressive effects.
Danish: Selektivitet for EP2, EP4, og DP1 er vigtigt, fordi disse receptorer medierer immunhæmmende virkninger.
English: Write down your doctor or nurse's instructions:
Danish: Skriv lægens eller sundhedspersonalets anvisninger ned:
English: No evidence for acute rebound has been observed.
Danish: Der er ikke set nogen evidens for akut rebound.
English: Therefore, safety margins for potential IP receptor-mediated effects on reproduction are accordingly lower than for non-IP-related effects (see section 5.3).
Danish: Derfor er sikkerhedsmarginerne for potentielle IP-receptor-medierede virkninger på reproduktionen lavere end for ikke-IP-relaterede virkninger (se pkt.
English: Coagulation factors
Danish: Koagulationsfaktorer
English: In Phase 1 and 2 studies a slight decrease in plasma levels of von Willebrand factor (vWF) was observed with selexipag; the vWF values remained above the lower limit of the normal range.
Danish: I fase 1- og 2-studier blev der set et let fald i plasmaniveauerne af von Willebrand-faktor (vWF) med selexipag; vWF-værdierne forblev over den nedre grænse for normalområdet.
English: Selexipag and its active metabolite are highly bound to plasma proteins (approximately 99% in total and to the same extent to albumin and alpha1-acid glycoprotein).
Danish: Selexipag og dets aktive metabolit bindes i høj grad til plasmaproteiner (cirka 99 % i alt og i samme omfang til albumin og alfa1-syre-glykoprotein).
English: A delay in the closure of the femoral and/or tibial epiphyseal growth plate was observed in juvenile dogs.
Danish: Der blev set en forsinkelse i lukningen af epifyseskiven i femora og/eller tibia hos unge hunde.
English: After multiple-dose administration, steady state conditions of selexipag and the active metabolite were reached within 3 days.
Danish: Efter administration af flere doser blev steady state for selexipag og den aktive metabolit nået i løbet af 3 dage.
English: The titration pack also contains a titration guide providing information on the titration process and allowing you to record the number of tablets you take every day.
Danish: Titreringspakken indeholder også en titreringsvejledning med oplysninger om titreringsforløbet, og hvori du kan notere hvor mange tabletter, du tager hver dag.
English: Additional histopathological findings of selexipag were observed only at exposures sufficiently in excess of the maximum human exposure, indicating little relevance to humans.
Danish: Der blev kun set yderligere histopatologiske fund med selexipag efter eksponeringer, der var tilstrækkeligt højere end den maksimale humane eksponering, hvilket tyder på ringe relevans hos mennesker.
English: • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Danish: • Kongenitte eller erhvervede klapdefekter med klinisk relevante forstyrrelser i myokardiefunktionen, som ikke er relateret til pulmonal hypertension.
English: The goal of titration is to reach the most appropriate dose.
Danish: Formålet med titrering er at nå den mest velegnede dosis.
English: Uptravi has vasodilatory properties that may result in lowering of blood pressure.
Danish: Uptravi har vasodilatoriske egenskaber, som kan resultere i blodtryksfald.
English: If you have been prescribed both 200 and 800 microgram tablets, use pages 30 to 37 (steps 5-8).
Danish: Hvis du både har fået ordineret 200 og 800 mikrogram-tabletter, skal du bruge side 30 til 37 (trin 5-8).
English: This is most probably due to a first-pass effect of selexipag, as plasma concentrations of the active metabolite are similar after the same oral and intravenous dose administration.
Danish: Dette skyldes sandsynligvis en first pass-effekt af selexipag, idet plasmakoncentrationerne af den aktive metabolit er ensartede efter oral og intravenøs administration af samme dosis.
English: It is unknown whether selexipag or its metabolites are excreted in human milk.
Danish: Det er ukendt, om selexipag/metabolitter udskilles i human mælk.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Danish: Behandlingen bør kun indledes og monitoreres af en læge med erfaring i behandling af PAH.
English: Uptravi can cause side effects such as headaches and low blood pressure (see section 4), which may affect your ability to drive; the symptoms of your condition can also make you less fit to drive.
Danish: Uptravi kan forårsage bivirkninger, såsom hovedpine og lavt blodtryk (se afsnit 4), der kan påvirke din evne til at føre motorkøretøj; symptomerne ved din sygdom kan også nedsætte din evne til at føre motorkøretøj.
English: The clinical status of the patient and the adverse reaction profile of selexipag (such as headache or hypotension) should be kept in mind when considering the patient's ability to drive and use machines.
Danish: Patientens kliniske status og selexipags bivirkningsprofil (såsom hovedpine og hypotension) bør tages i betragtning, når patientens evne til at føre motorkøretøj og betjene maskiner skal vurderes.
English: As with all medicines, you may experience side effects with Uptravi as you step up to higher doses.
Danish: Som det gælder for al medicin, kan du få bivirkninger med Uptravi, når du trapper op til højere doser.
English: Selexipag and its main metabolite showed 20- to 80-times lower prostacyclin (IP) receptor potency in vitro for animal species used in reproductive toxicity testing compared to humans.
Danish: Selexipag og dets hovedmetabolit udviste 20 til 80 gange lavere prostacyklin (IP)-receptorpotens in vitro hos de anvendte dyrearter i reproduktionstoksicitetstest sammenlignet med mennesker.
English: Use pages 20 to 27 to track the first weeks of treatment, when you are using 200 microgram tablets only (steps 1-4).
Danish: Brug side 20 til 27 til at holde styr på de første uger af behandlingen, hvor du kun bruger 200 mikrogram-tabletter (trin 1-4).
English: The percentages of patients with an event at Month 36 were 28.9% and 41.3% in the selexipag and placebo groups, respectively, with an absolute risk reduction of 12.4%.
Danish: Procentdelen af patienter med en hændelse ved måned 36 var henholdsvis 28,9 % og 41,3 % i selexipag- og placebogruppen, med en absolut risikoreduktion på 12,4 %.
English: Selexipag and the active metabolite are high-affinity IP receptor agonists with a high selectivity for the IP receptor versus other prostanoid receptors (EP1-EP4, DP, FP, and TP).
Danish: Selexipag og den aktive metabolit er højaffinitets-IPreceptoragonister med høj selektivitet for IP-receptoren i forhold til andre prostanoidreceptorer (EP1EP4, DP, FP og TP).
English: • Diary to facilitate Uptravi use and serve as a reminder for the patients (e.g., to contact her/his doctor), and a place to record intake of tablets;
Danish: • Dagbog, der letter brugen af Uptravi og fungerer som en påmindelse for patienterne (f.eks. om at kontakte lægen), og hvor der er plads til registrering af tabletindtag.
English: In the rat pre-/post-natal development study, selexipag induced no effects on maternal and pup reproductive function.
Danish: I studiet af præ-/postnatal udvikling hos rotter forårsagede selexipag ikke nogen virkninger på reproduktionsfunktionen hos moderdyret og ungerne.
English: - The active substance is selexipag.
Danish: - Aktivt stof: selexipag.
English: Uptravi is a medicine that contains the active substance selexipag.
Danish: Uptravi er et lægemiddel, der indeholder det aktive stof selexipag.
English: Selexipag prevents cardiac and pulmonary remodelling in a rat model of PAH and causes proportional decreases in pulmonary and peripheral pressures, indicating that peripheral vasodilation reflects pulmonary pharmacodynamic efficacy.
Danish: Selexipag forebygger kardiel og pulmonal remodellering i en rottemodel af PAH og forårsager proportionelle fald i pulmonale og perifere tryk, hvilket tyder på, at perifer vasodilatation afspejler pulmonal farmakodynamisk virkning.
English: You will start at the 200 microgram dose in the morning and in the evening and after discussing with your doctor or nurse step up to the next dose.
Danish: Du starter med en dosis på 200 mikrogram om morgenen og om aftenen, og når du har drøftet det med lægen eller sundhedspersonalet, trapper du op til den næste dosis.
English: Effect of selexipag on other medicinal products
Danish: Selexipags virkning på andre lægemidler
English: Safety margins for potential IP receptor-related effects on reproduction were 20 for fertility and 5 and 1 (based on free exposure) for embryo-foetal development in rats and rabbits, respectively, when adapted for differences in receptor potency.
Danish: Sikkerhedsmarginerne for potentielle IP-receptor-relaterede virkninger på reproduktionen var 20 for fertilitet og 5 og 1 (baseret på fri eksponering) for embryoføtal udvikling hos rotter og kaniner efter justering for forskelle i receptorpotens.
English: Always take Uptravi exactly as your doctor has told you.
Danish: Tag altid Uptravi nøjagtigt efter lægens anvisning.
English: Patients who have poor vision or are blind must be instructed to get assistance from another person when taking Uptravi during the titration period.
Danish: Patienter med nedsat syn eller blindhed skal instrueres i at få hjælp af en anden person i forbindelse med indtagelse af Uptravi i titreringsperioden.
English: If these side effects are difficult for you to tolerate, talk to your doctor about how to manage or treat them.
Danish: Hvis du har svært ved at tolerere disse bivirkninger, så drøft med lægen, hvordan de kan håndteres eller behandles.
English: Increased bone ossification and related changes in the bone marrow in dog studies are considered to be due to the activation of EP4 receptors in dogs.
Danish: Den øgede knogleossifikation og dermed forbudne forandringer i knoglemarven i hundestudier vurderes at skyldes aktivering af EP4-receptorer hos hunde.
English: Please read the instructions in the package leaflet carefully.
Danish: Læs nøje instrukserne i indlægssedlen.
English: Selexipag and its active metabolite do not inhibit or induce cytochrome P450 enzymes and transport proteins at clinically relevant concentrations.
Danish: Selexipag og dets aktive metabolit hæmmer eller inducerer ikke cytochrom P450-enzymer og transportproteiner ved klinisk relevante koncentrationer.
English: Once your doctor has found the dose that is right for you, this will be the dose you take on a regular basis.
Danish: Når lægen har fundet den rette dosis til dig, vil det være den dosis, du skal tage regelmæssigt.
English: Uncommon side effects (may affect up to 1 in 100 people) - Increased heart rate
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - Hurtigere puls
English: This process is called titration.
Danish: Dette forløb kaldes for titrering.
English: Hyperthyroidism has been observed with Uptravi.
Danish: Der er set hyperthyreoidisme med Uptravi.
English: Interruptions and discontinuations
Danish: Afbrydelser og seponering
English: Death up to EOT + 7 daysd n (%)
Danish: Dødsfald frem til EOT + 7 dage d n (%)
English: Maintenance Selexipag Placebo Selexipag Placebo
Danish: Vedligeholdelse Selexipag Placebo Selexipag Placebo
English: The titration steps usually last about 1 week.
Danish: Titreringstrinene varer som regel omkring 1 uge.
English: CI = confidence interval; EOT = end of treatment; HR = hazard ratio; i.v.
Danish: CI = konfidensinterval; EOT =behandlingsafslutning; HR = risikoforhold; i.v.
English: Safety margins adapted for IP receptor potency for the active metabolite were 2-fold (based on total exposure) in relation to human therapeutic exposure.
Danish: Sikkerhedsmarginer justeret for IP-receptorpotensen for den aktive metabolit var 2 gange højere (baseret på total eksponering) i forhold til den terapeutiske eksponering hos mennesker.
English: Uptravi has minor influence on the ability to drive and use machines.
Danish: Uptravi påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: No adjustment to the dose regimen is needed in patients with mild or moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosisregimet hos patienter med mildt eller moderat nedsat nyrefunktion.
English: Because of the species-specific sensitivity of dogs to develop intussusception, this finding is considered not relevant for adult humans.
Danish: På grund af den artsspecifikke følsomhed for udvikling af intussusception hos hunde anses dette fund ikke for at være af relevans hos voksne mennesker.
English: How should you take Uptravi?
Danish: Hvordan skal jeg tage Uptravi?
English: The highest tolerated dose reached during dose titration should be maintained.
Danish: Den højeste tolererede dosis, nået i forbindelse med dosistitreringen, bør fastholdes.
English: Selexipag did not influence the pharmacodynamic effect of warfarin on the international normalised ratio.
Danish: Selexipag påvirkede ikke warfarins farmakodynamiske virkning på INR (International Normaliseret Ratio).
English: Uptravi is not recommended during pregnancy and breast-feeding.
Danish: Uptravi er ikke anbefalet under graviditet og amning.
English: • The dosing and titration concept;
Danish: • Doserings- og titreringskoncept.
English: Before prescribing Uptravi, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension, hypovolaemia, severe left ventricular outflow obstruction or autonomic dysfunction).
Danish: Inden der ordineres Uptravi, bør lægen nøje overveje, hvorvidt patienter med visse underliggende sygdomme, kan blive negativt påvirket af vasodilatoriske virkninger (f.eks. patienter i antihypertensiv behandling eller med hypotension, hypovolæmi, svær obstruktion i venstre ventrikels udløbsdel eller autonom dysfunktion).
English: Morbiditymortality event a
Danish: /mortalitetshændelse a
English: Selexipag is a selective IP receptor agonist distinct from prostacyclin and its analogues.
Danish: Selexipag er en selektiv IP-receptoragonist, der adskiller sig fra prostacyklin og dets analoger.
English: This dose will be your maintenance dose.
Danish: Den dosis vil være din vedligeholdelsesdosis.