FrancophonIA/ELRC3.0 huggingface dataset:
English: Each patient should be up-titrated to the highest individually tolerated dose, which can range from 200 micrograms given twice daily to 1,600 micrograms given twice daily (individualised maintenance dose).
Danish: Den enkelte patient bør optitreres til den højeste individuelt tolererede dosis, som kan variere fra 200 mikrogram givet to gange dagligt til 1.600 mikrogram givet to gange dagligt (individuelt tilpasset vedligeholdelsesdosis).
English: Hypotension (see section 4.4)
Danish: Hypotension (se pkt.
English: 60 or 140 film-coated tablets Titration pack
Danish: 60 eller 140 filmovertrukne tabletter Titreringspakke
English: More subjects reported adverse events after administration in the fasted than in the fed state.
Danish: Der var flere forsøgsdeltagere, der rapporterede om bivirkninger efter administration i fastende tilstand end efter indtagelse af føde.
English: Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors.
Danish: Uptravi anvendes til langvarig behandling af pulmonal arteriel hyptertension (PAH) hos voksne patienter, som ikke kan opnå tilstrækkelig effekt med andre typer af lægemidler mod PAH, der kaldes for endothelinreceptorantagonister og phosphodiesterase type 5-hæmmere.
English: Midazolam At steady state after up-titration to 1,600 μg selexipag twice a day, no clinically relevant change in exposure to midazolam, a sensitive intestinal and hepatic CYP3A4 substrate, or its metabolite, 1-hydroxymidazolam, was observed.
Danish: Ved steady state efter optitrering til 1.600 μg selexipag to gange dagligt blev der ikke observeret nogen klinisk relevant ændring i eksponeringen for midazolam, et følsomt tarm- og lever-CYP3A4-substrat, eller dets metabolit, 1-hydroxymidazolam.
English: The dose was increased at weekly intervals by increments of 200 micrograms given twice daily to determine the individualised maintenance dose (200-1,600 micrograms twice daily).
Danish: Dosis blev øget med ugentlige mellemrum i trin af 200 mikrogram givet to gange dagligt for at fastlægge den individualiserede vedligeholdelsesdosis (200-1.600 mikrogram to gange dagligt).
English: Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.
Danish: Uptravi er indiceret til langvarig behandling af pulmonal arteriel hypertension (PAH) hos voksne patienter i WHO-funktionsklasse (FC) II-III, enten som kombinationsbehandling hos patienter, der ikke opnår tilstrækkelig effekt med en endothelinreceptorantagonist (ERA) og/eller en phosphodiesterase type 5-hæmmer (PDE-5hæmmer), eller som monoterapi hos patienter, der ikke er kandidater til disse behandlinger.
English: Your doctor may decide to restart your treatment on a lower dose, gradually increasing to your previous maintenance dose.
Danish: Lægen kan beslutte, at du skal genstarte behandlingen med en lavere dosis, som øges gradvist til din tidligere vedligeholdelsesdosis.
English: Titration diary
Danish: Titreringsdagbog
English: Talk to your PAH doctor or nurse before taking Uptravi if you - are taking medicines for high blood pressure - have low blood pressure associated with symptoms such as dizziness - have recently experienced significant blood loss or fluid loss such as severe diarrhoea or vomiting - have problems with your thyroid gland - have severe problems with your kidneys or are undergoing dialysis - have or have had severe problems with your liver not working properly
Danish: Kontakt din PAH-læge eller sundhedspersonalet, før du tager Uptravi, hvis du - tager medicin mod højt blodtryk - har lavt blodtryk, der er forbundet med symptomer såsom svimmelhed - for nylig har mistet meget blod eller væske, f.eks. som følge af alvorlig diarré eller opkastning - har problemer med skjoldbruskkirtlen - har alvorlige nyreproblemer eller er i dialyse - har eller har haft alvorlige leverfunktionsproblemer
English: The pharmacokinetics of selexipag and its active metabolite are not affected by warfarin.
Danish: Farmakokinetikken af selexipag og dets aktive metabolit påvirkes ikke af warfarin.
English: Over time, your doctor or nurse may adjust your maintenance dose as needed.
Danish: Med tiden vil lægen eller sundhedspersonalet eventuelt justere din vedligeholdelsesdosis efter behov.
English: In a thorough QT study in healthy subjects, repeated doses of 800 and 1,600 micrograms of selexipag twice daily did not show an effect on cardiac repolarisation (QTc interval) or conduction (PR and QRS intervals) and had a mild accelerating effect on heart rate (the placebo-corrected, baseline-adjusted increase in heart rate reached 6-7 bpm at 1.5 to 3 h after dosing with 800 micrograms selexipag and 9-10 bpm at the same timepoints after 1,600 micrograms selexipag).
Danish: I et omfattende QT-studie med raske forsøgsdeltagere medførte gentagne doser af 800 og 1.600 mikrogram selexipag to gange dagligt ingen virkning på kardiel repolarisering (QTc-interval) eller overledning (PR- og QRS-interval) og havde en mildt accelererende virkning på hjertefrekvensen (den placebokorrigerede, baselinejusterede stigning i hjertefrekvensen nåede 6-7 bpm 1,5 til 3 timer efter dosering af 800 mikrogram selexipag og 9-10 bpm på de tilsvarende tidspunkter efter 1.600 mikrogram selexipag).
English: Finding the right dose for you
Danish: Sådan findes der frem til den rette dosis for dig
English: Hospitalisation for PAH was observed in 86 (15.0%) patients on selexipag and 123 (21.1%) patients on placebo.
Danish: Hospitalisering på grund af PAH blev set hos 86 (15,0 %) af patienterne på selexipag og 123 (21,1 %) af patienterne på placebo.
English: If it is nearly time for your next dose (within 6 hours before you would normally take it), you should skip the missed dose and continue to take your medicine at the usual time.
Danish: Hvis det næsten er tid til næste dosis (under 6 timer til det normale tidspunkt), skal du springe den glemte dosis over og fortsætte med at tage medicinen til sædvanlig tid.
English: The pharmacokinetics of selexipag and the active metabolite, both after single- and multiple-dose administration, were dose-proportional up to a single dose of 800 micrograms and multiple doses of up to 1,800 micrograms twice daily.
Danish: Efter administration af en enkelt eller flere doser var farmakokinetikken af selexipag og den aktive metabolit dosisproportional op til en enkeltdosis på 800 mikrogram og flere doser af op til 1.800 mikrogram to gange dagligt.
English: Hospitalisation due to PAH b n (%)
Danish: Hospitalisering pga. PAH b n (%)
English: The starting dose for Uptravi is 200 micrograms once in the morning and once in the evening.
Danish: Startdosen af Uptravi er 200 mikrogram én gang om morgenen og én gang om aftenen.
English: The number of patients who experienced, as a first event, death due to PAH or hospitalisation for PAH up to end of treatment was 102 (17.8%) in the selexipag group and 137 (23.5%) in the placebo group.
Danish: Antallet af patienter, der som en første hændelse oplevede død på grund af PAH eller hospitalisering på grund af PAH frem til behandlingsafslutningen var 102 (17,8 %) i selexipaggruppen og 137 (23,5 %) i placebogruppen.
English: Death up to study closure d n (%)
Danish: Dødsfald frem til studielukning d n (%)
English: Dosage Adjustment with Co-administration of Moderate CYP2C8 Inhibitors
Danish: Dosisjustering ved samtidig administration af moderate CYP2C8-hæmmere
English: The first pack of tablets you receive will contain the light-yellow 200 microgram tablets.
Danish: Den første tabletpakning, du får, indeholder lysegule 200 mikrogram-tabletter.
English: The exposure to selexipag and its active metabolite is increased in subjects with moderate hepatic impairment (Child-Pugh class B; see section 5.2).
Danish: Eksponeringen for selexipag og dets aktive metabolit er forøget hos patienter med moderat nedsat leverfunktion (ChildPugh-klasse B; se pkt.
English: Others may reach a maintenance dose somewhere inbetween.
Danish: Andre vil nå frem til en vedligeholdelsesdosis, der ligger imellem disse doser.
English: If your doctor or nurse tells you to step down to a lower dose, you should take one less 200 microgram tablet in the morning and one less in the evening.
Danish: Hvis lægen eller sundhedspersonalet fortæller dig, at du skal trappe ned til en lavere dosis, skal du tage én 200 mikrogram-tablet mindre om morgenen og én mindre om aftenen.
English: The recommended starting dose is 200 micrograms given twice daily, approximately 12 hours apart.
Danish: Den anbefalede startdosis er 200 mikrogram givet to gange dagligt med cirka 12 timers mellemrum.
English: • Headache • Diarrhoea • Nausea • Vomiting • Jaw pain • Muscle pain • Leg pain • Joint pain • Facial redness
Danish: • Hovedpine • Diarré • Kvalme • Opkastning • Smerter i kæben • Muskelsmerter • Smerter i benene • Ledsmerter • Ansigtsrødme
English: A Phase 2 double-blind, placebo-controlled clinical study assessed haemodynamic variables after 17 weeks of treatment in patients with PAH WHO FC II-III and concomitantly receiving ERAs and/or PDE-5 inhibitors.
Danish: I et dobbeltblindet, placebokontrolleret, klinisk fase 2-studie blev de hæmodynamiske variabler vurderet efter 17 ugers behandling af patienter med PAH i WHO-funktionsklasse II-III, som samtidig fik ERA'er og/eller PDE-5-hæmmere.
English: In the Phase 3 placebo-controlled study in patients with PAH, a transient increase in mean heart rate of 3-4 bpm at 2-4 hours post-dose was observed.
Danish: I det placebokontrollerede fase 3-studie med patienter med PAH blev der set en forbigående stigning i den gennemsnitlige hjertefrekvens på 3-4 bpm 2-4 timer efter indgivelse af dosis.
English: The doctor may then prescribe you a lower single-tablet strength.
Danish: Lægen vil eventuelt ordinere en lavere tabletstyrke.
English: Patients titrating selexipag to an individually tolerated dose (200 micrograms twice daily increments up to 800 micrograms twice daily; N = 33) achieved a statistically significant mean reduction in pulmonary vascular resistance of 30.3% (95% confidence interval [CI]: −44.7%, −12.2%; p = 0.0045) and an increase in cardiac index (mean treatment effect) of 0.48 L/min/m2 (95% CI: 0.13, 0.83) compared to placebo (N = 10).
Danish: De patienter, der fik titreret selexipag til en individuelt tolereret dosis (trin af 200 mikrogram to gange dagligt op til 800 mikrogram to gange dagligt; N = 33), opnåede en statistisk signifikant gennemsnitlig reduktion i den pulmonale vaskulære modstand på 30,3 % (95 % konfidensinterval [CI]: -44,7 %, -12,2 %; p = 0,0045) og en stigning i indekseret minutvolumen (gennemsnitlig behandlingsvirkning) på 0,48 l/min/m2 (95 % CI: 0,13; 0,83) sammenlignet med placebo (N = 10).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - TITRATION PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - TITRERINGSPAKKE
English: By mimicking the action of prostacyclin, Uptravi widens the pulmonary arteries and reduces their hardening.
Danish: Uptravi efterligner virkningen af prostacyklin og udvider lungearterierne og gør dem mindre hårde.
English: For example, if your highest tolerated dose during titration was 1,200 micrograms once in the morning and once in the evening:
Danish: Eksempel: hvis den højeste dosis, du kunne tolerere i forbindelse med titrering, var 1.200 mikrogram én gang om morgenen og én gang om aftenen:
English: Treatment with selexipag 200-1,600 micrograms twice daily resulted in a 40% reduction (hazard ratio [HR] 0.60; 99% CI: 0.46, 0.78; one-sided log-rank p value < 0.0001) of the occurrence of morbidity or mortality events up to 7 days after last dose compared to placebo (Figure 1).
Danish: Behandling med selexipag 200-1.600 mikrogram to gange dagligt resulterede i en reduktion på 40 % (risikoforhold [HR] 0,60; 99 % CI: 0,46; 0,78; p-værdi ved enkeltsidet log-rank-test < 0,0001) i forekomsten af morbiditets- eller mortalitetshændelser op til 7 dage efter sidste dosis sammenlignet med placebo (Figur 1).
English: Exposure to the active metabolite remained almost unchanged in subjects with mild hepatic impairment and was doubled in subjects with moderate hepatic impairment.
Danish: Eksponeringen for den aktive metabolit var næsten uforandret hos forsøgsdeltagere med mild leverinsufficiens og fordoblet hos forsøgsdeltagere med moderat leverinsufficiens.
English: • The Summary of Product Characteristics for Uptravi;
Danish: • Produktresuméet for Uptravi.
English: Mannitol (E421), maize starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate.
Danish: Mannitol (E421), majsstivelse, lavsubstitueret hydroxypropylcellulose, hydroxypropylcellulose, magnesiumstearat.
English: This will be the highest dose you can tolerate, which may reach the maximum dose of 1,600 micrograms in the morning and in the evening.
Danish: Det vil være den højeste dosis, som du kan tolerere, dog højst 1.600 mikrogram om morgenen og om aftenen.
English: No adjustment to the dose regimen is needed in patients with mild hepatic impairment (Child-Pugh class A).
Danish: Det er ikke nødvendigt at justere dosisregimet hos patienter med mildt nedsat leverfunktion (Child-Pugh-klasse A).
English: The risk of an event for this endpoint was reduced by 30% in patients receiving selexipag compared to placebo (HR 0.70, 99% CI: 0.50, 0.98; one-sided log-rank p = 0.0031).
Danish: Risikoen for en hændelse under dette endepunkt blev reduceret med 30 % hos de patienter, der fik selexipag, i forhold til placebo (HR 0,70; 99 % CI: 0,50; 0,98; enkeltsidet log-rank-p = 0,0031).
English: Uptravi film-coated tablets selexipag
Danish: Uptravi filmovertrukne tabletter selexipag
English: If it is within 6 hours of when you would normally take your next dose, you should skip the missed dose and continue to take your medicine at the usual time.
Danish: Hvis der er mindre end 6 timer til, at du normalt tager din næste dosis, skal du springe den glemte dosis over og fortsætte med at tage medicinen på det sædvanlige tidspunkt.
English: Your doctor or nurse may have you resume treatment at a lower dose, gradually increasing to your previous maintenance dose.
Danish: Lægen eller sundhedspersonalet kan beslutte, at du skal genstarte behandlingen med en lavere dosis, som øges gradvist til din tidligere vedligeholdelsesdosis.
English: If treatment is missed for 3 days or more, Uptravi should be restarted at a lower dose and then up-titrated.
Danish: Hvis patienten glemmer tabletterne i 3 dage eller mere, skal behandlingen med Uptravi genstartes med en lavere dosis, der efterfølgende optitreres.
English: A 1.4- to 1.7-fold increase in exposure (maximum plasma concentration and area under the plasma concentration-time curve) to selexipag and its active metabolite was observed in subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Danish: Eksponeringen (maksimal plasmakoncentration og arealet under plasmakoncentrations-/tidskurven) for selexipag og dets aktive metabolit steg 1,4 til 1,7 gange hos forsøgsdeltagere med svært nedsat nyrefunktion (eGFR < 30 ml/min./1,73 m2).
English: Use them to write down the number of tablets you take in the morning and the evening.
Danish: Skriv ned på disse sider hvor mange tabletter, du tager om morgenen og om aftenen.
English: When co-administered with moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide), reduce the dosing of Uptravi to once daily.
Danish: Ved samtidig administration af moderate CYP2C8-hæmmere (f.eks. clopidogrel, deferasirox og teriflunomid) skal dosis af Uptravi reduceres til én gang dagligt.
English: Contents of the pack and other information What Uptravi contains
Danish: Pakningsstørrelser og yderligere oplysninger Uptravi indeholder:
English: Concomitant administration of Uptravi with clopidogrel (loading dose of 300 mg or maintenance dose of 75 mg once a day), a moderate inhibitor of CYP2C8, had no relevant effect on the exposure to selexipag but increased the exposure to the active metabolite approximately 2.2 and 2.7-fold following loading dose and maintenance dose, respectively.
Danish: Samtidig administration af Uptravi og den moderate CYP2C8-hæmmer clopidogrel (støddosis på 300 mg eller vedligeholdelsesdosis på 75 mg én gang dagligt) havde ikke nogen relevant virkning på eksponeringen for selexipag men øgede eksponeringen for den aktive metabolit omkring 2,2 og 2,7 gange for henholdsvis støddosis og vedligeholdelsesdosis.
English: In the film coat:
Danish: I filmovertrækket:
English: Uptravi should not be administered in patients with severe liver impairment (Child-Pugh class C; see section 4.4).
Danish: Uptravi bør ikke administreres til patienter med svært nedsat leverfunktion (Child-Pugh-klasse C; se pkt.
English: Inhibitors and inducers of CYP3A4
Danish: CYP3A4-hæmmere og -induktorer
English: If, for any reason, you stop taking Uptravi for more than 3 consecutive days (if you missed 6 doses in a row), contact your PAH doctor or nurse immediately as your dose may need to be adjusted to avoid side effects.
Danish: Hvis du af en hvilken som helst årsag stopper med at tage Uptravi i mere end 3 dage i træk (hvis du har glemt 6 doser i træk), skal du straks kontakte lægen eller sundhedspersonalet, da det kan være nødvendigt at justere din dosis for at undgå bivirkninger.
English: Death due to PAH as a component of the endpoint was observed in 16 (2.8%) patients on selexipag and 14 (2.4%) on placebo.
Danish: Død på grund af PAH som en del af endepunktet blev set hos 16 (2,8 %) af patienterne på selexipag og 14 (2,4 %) af patienterne på placebo.
English: Selexipag is hydrolysed to its active metabolite in the liver and in the intestine by carboxylesterases.
Danish: Selexipag hydrolyseres til sin aktive metabolit i leveren og i tarmene via carboxylesteraser.
English: The healthcare professional A4 laminated titration guide is intended to reduce the risk of medication error due to the titration phase at treatment initiation with Uptravi and it should contain the following key elements:
Danish: Formålet med den laminerede titreringsvejledning i A4-format til læger og sundhedspersonale er at reducere risikoen for medicineringsfejl i titreringsfasen ved opstart af behandling med Uptravi.
English: Inducers of CYP2C8
Danish: CYP2C8-induktorer
English: (a) % of patients with an event at 36 months = 100 × (1 - Kaplan-Meier estimate); hazard ratio estimated using Cox's proportional hazard model; unstratified one-sided log-rank p-value (b) % of patients with an event as part of the primary endpoint up to EOT + 7 days; hazard ratio estimated using Aalen Johansen method; 2-sided p-value using Gray's test (c) Includes ‘Need for lung transplantation or atrial septostomy' (1 patient on selexipag and 2 on placebo) (d) % of patients with an event up to EOT + 7 days or up to study closure; hazard ratio estimated using Cox's proportional hazard model; unstratified one-sided log-rank p-value
Danish: (b) % af patienter med en hændelse som en del af det primære endepunkt, frem til EOT + 7 dage; risikoforhold estimeret ved brug af Aalen Johansens metode; 2-sidet p-værdi ved brug af Grays test. (c) Omfatter ‘Behov for lungetransplantation eller atrieseptostomi' (1 patient på selexipag og 2 på placebo) (d) % af patienter med en hændelse frem til EOT + 7 dage eller op til studielukning; risikoforhold estimeret ved brug af Cox' proportionelle risikomodel; ustratificeret enkeltsidet log-rank-test-p-værdi.
English: Very common side effects (may affect more than 1 in 10 people) - Headache - Flushing (reddening of the face) - Nausea and vomiting (feeling sick and being sick) - Diarrhoea - Jaw pain, muscle pain, joint pain, leg pain - Nasopharyngitis (stuffy nose)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - Hovedpine - Blussen (ansigtsrødme) - Kvalme og opkastning - Diarré - Smerter i kæben, muskelsmerter, ledsmerter, smerter i benene - Nasofaryngitis (tilstoppet næse)
English: If the therapy over time is less tolerated at a given dose, symptomatic treatment and/or a dose reduction to the next lower dose should be considered.
Danish: Hvis behandlingen med tiden tolereres mindre godt ved en given dosis, bør symptomatisk behandling og/eller dosisreduktion til den dosis, der ligger lige under, overvejes.
English: Your doctor or nurse can prescribe an equivalent single-tablet strength for your maintenance dose.
Danish: Din læge eller sundhedspersonale vil ordinere én tablet med én styrke, der svarer til din vedligeholdelsesdosis.
English: • Lay language version of the healthcare professional A4 laminated titration guide;
Danish: • En lægmandsformuleret version af titreringsvejledningen til læger og sundhedspersonale i A4 format.
English: • Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil; see section 4.5).
Danish: • Samtidig brug af stærke CYP2C8-hæmmere (f.eks. gemfibrozil; se pkt.
English: Selexipag reduced the risk of hospitalisation for PAH as a first outcome event compared to placebo (HR 0.67, 99% CI: 0.46, 0.98; one-sided log-rank p = 0.04).
Danish: Selexipag reducerede risikoen for hospitalisering på grund af PAH som en første udfaldshændelse i forhold til placebo (HR 0,67; 99 % CI: 0,46; 0,98; enkeltsidet log-rank-p = 0,04).
English: Titration Guide
Danish: Titreringsvejledning
English: Headache*
Danish: Kvalme*
English: Common side effects (may affect up to 1 in 10 people) - Anaemia (low red blood cell levels) - Hyperthyroidism (overactive thyroid gland) - Decreased appetite - Weight loss - Hypotension (low blood pressure) - Stomach pain - Pain - Changes in some blood test results including those measuring blood cell counts or your thyroid function - Rashes, including hives, may cause a burning or stinging sensation and skin redness
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - Anæmi (lavt antal røde blodlegemer) - Hyperthyreoidisme (overaktiv skjoldbruskkirtel) - Nedsat appetit - Vægttab - Hypotension (lavt blodtryk) - Mavesmerter - Smerter - Ændringer i visse blodprøveresultater, herunder blodprøver til kontrol af blodtal og skjoldbruskkirtlens funktion.
English: Adverse reactions associated with the mode of action of selexipag have been observed frequently, in particular during the phase of individualised dose titration, and are tabulated below:
Danish: Der er hyppigt set bivirkninger, der er forbundet med selexipags virkningsmåde, især i fasen med individualiseret dosistitrering.
English: Inhibitors of UGT1A3 and UGT2B7
Danish: UGT1A3- og UGT2B7-hæmmere
English: Increase in heart rate
Danish: Øget hjertefrekvens
English: Subjects with severe hepatic impairment (Child-Pugh class C) showed similar predicted exposure at steady state as subjects with moderate hepatic impairment during a once-daily regimen.
Danish: Personer med svær leverinsufficiens (Child-Pugh-klasse C) udviste samme forventede eksponering ved steady state som forsøgsdeltagere med moderat leverinsufficiens under et regime med dosering én gang dagligt.
English: The dose is increased in increments of 200 micrograms given twice daily, usually at weekly intervals.
Danish: Dosis øges i trin af 200 mikrogram givet to gange dagligt, som regel med en uges mellemrum.
English: The number of deaths due to PAH up to study closure was 70 (12.2%) for the selexipag group and 83 (14.3%) for the placebo group.
Danish: Antallet af dødsfald på grund af PAH frem til studielukningen var 70 (12,2 %) i selexipaggruppen og 83 (14,3 %) i placebogruppen.
English: Concomitant administration of Uptravi with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated (see section 4.3).
Danish: Samtidig administration af Uptravi og stærke CYP2C8hæmmere (f.eks. gemfibrozil) er kontraindiceret (se pkt.