FrancophonIA/ELRC3.0 huggingface dataset:
English: Please read the information under “Contraceptives” and “Other medicines and STAYVEER”
Danish: Læs venligst oplysningerne under "Prævention" og "Brug af anden medicin sammen med STAYVEER”
English: Patients could receive additional PAH treatment as required in the open-label extension.
Danish: Patienterne kunne om nødvendigt få supplerende PAH-behandling i det åbne forlængelsesstudie.
English: The overall change in WHO functional class during both studies was significantly better among bosentan-treated patients as compared with placebo-treated patients.
Danish: Den totale ændring i WHO funktionsklasser i løbet af begge studier var signifikant bedre blandt patienter, der blev behandlet med bosentan, end blandt patienter, der fik placebo.
English: In vitro, bosentan inhibits the bile salt export pump in hepatocyte cultures.
Danish: In vitro inhiberer bosentan galdesalt-eksportpumpen i hepatocytkulturer.
English: The average exposure to bosentan in these paediatric patients was about half the exposure in adult patients at the 125 mg twice daily maintenance dose but showed a large overlap with the exposures in adults.
Danish: Den gennemsnitlige eksponering for bosentan hos disse pædiatriske patienter var cirka det halve af eksponering hos voksne patienter ved 125 mg to gange dagligt som vedligeholdelsesdosis, men viste en betydelig overlapning med eksponeringerne hos voksne.
English: The mean duration of exposure to bosentan treatment was 3.6 ± 1.8 years (up to 6.1 years), with 73% of patients treated for at least 3 years and 62% for at least 4 years.
Danish: Den gennemsnitlige eksponeringsvarighed for bosentan-behandling var 3,6 ± 1,8 år (op til 6,1 år), og 73% af patienter blev behandlet i mindst 3 år og 62% i mindst 4 år.
English: After 16 weeks, the mean oxygen saturation was increased in the bosentan group by 1.0% (95% CI -0.7%-2.8%) as compared to the placebo group (n = 17), showing that bosentan did not worsen hypoxaemia.
Danish: Efter 16 uger var den gennemsnitlige iltmætning øget i bosentan gruppen med 1,0% (95% CI -0,7; 2,8%) sammenlignet med placebo gruppen (n = 17), hvilke viste, at bosentan ikke forværrer hypoxæmi.
English: Your doctor will advise you on your dosing.
Danish: Deres læge vil vejlede Dem med hensyn til doseringen.
English: However, 1,611 patients (804 bosentan- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo controlled study (study AC-052-301/302 [ENABLE 1 & 2]).
Danish: Imidlertid blev 1.611 patienter (hvoraf 804 fik bosentan og 807 placebo) med alvorlig kronisk hjerteinsufficiens (CHF) behandlet i gennemsnitligt 1½ år i en placebokontrolleret undersøgelse (studiet AC-052-301/302 [ENABLE 1 & 2]).
English: ET-1 concentrations in tissues and plasma are increased in several cardiovascular disorders and connective tissue diseases, including PAH, scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension and atherosclerosis, suggesting a pathogenic role of ET-1 in these diseases.
Danish: ET-1 koncentrationer i væv og plasma er forhøjede ved flere kardiovaskulære sygdomme og bindevævssygdomme, inklusive PAH, sklerodermi, akut og kronisk hjerteinsufficiens, myokardieiskæmi, systemisk hypertension og aterosklerose, hvilket kunne tyde på, at ET-1 spiller en patogen rolle i forbindelse med disse sygdomme.
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Danish: • forårsaget af medfødte hjertefejl med shunt (unormale passager), som giver unormal blodgennemstrømning gennem hjerte og lunger.
English: In a study investigating the effects of bosentan on testicular function in male PAH patients, 8 out of 24 patients showed a decreased sperm concentration from baseline of at least 42% after 3 or 6 months of treatment with bosentan.
Danish: I et studie af bosentans indvirkning på testikelfunktionen hos mandlige PAH-patienter udviste 8 ud af 24 patienter en reduktion i spermatozokoncentrationen på mindst 42% i forhold til baseline efter 3 eller 6 måneders behandling med bosentan.
English: Limited data in patients show that the exposure to bosentan in adult PAH patients is approximately 2-fold greater than in healthy adult subjects.
Danish: Begrænsede data fra patienter viser, at eksponeringen for bosentan hos voksne patienter med PAH er ca. 2 gange højere end hos voksne, raske individer.
English: • Baseline values of liver aminotransferases, i.e., aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 × the upper limit of normal (ULN; see section 4.4)
Danish: • Baseline-værdier for leveraminotransferaser, dvs. aspartataminotransferase (ASAT) og/eller alaninaminotransferase (ALAT), der er over 3 x den normale øvre grænse (ULN; se pkt.
English: Consequently, should signs of pulmonary oedema occur when STAYVEER is administered in patients with PAH, the possibility of associated venoocclusive disease should be considered.
Danish: Skulle der forekomme tegn på pulmonært ødem, når STAYVEER administreres til patienter med PAH, bør muligheden for associeret veno-okklusiv sygdom derfor tages i betragtning.
English: However, no effects on general development, growth, sensory, cognitive function and reproductive performance were detected at 7 (males) and 19 (females) times the human therapeutic exposure at Day 21 post partum.
Danish: Der blev imidlertid ikke set nogen indvirkning på generel udvikling, vækst, sensorisk og kognitiv funktion og reproduktionsevne ved eksponeringer, der var 7 (hanner) og 19 (hunner) gange højere end den terapeutiske eksponering hos mennesker (dag 21 post partum).
English: Kaplan-Meier estimates of survival were 90% and 85% at 3 and 4 years after the start of treatment, respectively.
Danish: Kaplan-Meier-estimater for overlevelse var henholdsvis 90% og 85% 3 og 4 år efter behandlingsstart.
English: Treatment with bosentan was associated with a significant reduction in the rate of clinical worsening compared with placebo at 28 weeks (10.7% vs 37.1%, respectively; p = 0.0015).
Danish: Behandling med bosentan var forbundet med en signifikant reduktion i forekomsten af klinisk forværring i sammenligning med placebo ved 28 uger (henholdsvis 10,7% imod 37,1%; p = 0,0015).
English: If you stop taking STAYVEER
Danish: Hvis De holder op med at tage STAYVEER
English: The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect.
Danish: Ligheden mellem det mønster for misdannelser, der er iagttaget i forbindelse med andre ET-receptorantagonister og hos ET-knockoutmus, indikerer, at der er tale om en klasseeffekt.
English: The plasma concentrations of bosentan were not affected by concomitant simvastatin.
Danish: Plasmakoncentrationen af bosentan påvirkedes ikke ved samtidig indgift af simvastatin.
English: Data on other CYP3A4 inducers, e.g., carbamazepine, phenobarbital, phenytoin and St. John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan.
Danish: Data fra andre CYP3A4-inducere f.eks. carbamazepin, phenobarbital, phenytoin og perikon mangler, men samtidig administration forventes at medføre reduceret systemisk eksponering for bosentan.
English: The most frequent adverse events were upper respiratory tract infections (25%), pulmonary (arterial) hypertension (20%), nasopharyngitis (17%), pyrexia (15%), vomiting (13%), bronchitis (10%), abdominal pain (10%), and diarrhoea (10%).
Danish: De hyppigste bivirkninger var infektioner i øvre luftveje (25%), pulmonal (arteriel) hypertension (20%), nasopharyngitis (17%), pyreksi (15%), opkastning (13%), bronchitis (10%), abdominalsmerter (10%) og diarré (10%).
English: Recommendations in the event of ALT/AST elevations ALT/AST levels
Danish: Anbefalinger i tilfælde af forøgelse af ALAT/ASAT
English: • jaundice (yellowing of your skin or the whites of your eyes)
Danish: • gulsot (gulfarvning af Deres hud eller af det hvide i øjnene)
English: • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with STAYVEER.
Danish: • sirolimus eller tacrolimus (lægemidler, der anvendes efter transplantationer), da det ikke anbefales at bruge disse sammen med STAYVEER.
English: > 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
Danish: > 3 og ≤ 5 × ULN Resultatet skal bekræftes med en ekstra leverfunktionstest; hvis bekræftet, skal der tages en beslutning på individuel basis om at fortsætte med STAYVEER, eventuelt med reduceret dosis, eller seponere STAYVEER (se pkt.
English: The mechanism of this interaction is most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.
Danish: Mekanismen for denne interaktion er højst sandsynlig ciclosporins hæmning af transportprotein-medieret optagelse af bosentan i hepatocytter.
English: Safety and tolerability of bosentan was investigated in an exploratory, uncontrolled 12-week study in 11 patients with pulmonary hypertension secondary to severe COPD (stage III of GOLD classification).
Danish: Bosentans sikkerhed og tolerabilitet blev undersøgt i et eksplorativt, ukontrolleret 12-ugers studie hos 11 patienter med pulmonal hypertension sekundært til alvorlig KOL (GOLD klassifikation grad III).
English: If you forget to take STAYVEER, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Danish: Hvis De har glemt at tage STAYVEER, skal De gøre det, så snart De kommer i tanke om det og derefter på de normale tidspunkter.
English: Anaemia or haemoglobin decreases requiring red blood cell transfusion1
Danish: Anæmi eller nedsat hæmoglobin, der kræver transfusion af røde blodlegemer1
English: Patients in need of the combination should be closely monitored for adverse events related to STAYVEER and for tacrolimus and sirolimus blood concentrations.
Danish: Patienter, der har behov for kombinationen, skal overvåges nøje med hensyn til bivirkninger, der er relateret til STAYVEER samt plasmakoncentrationer af tacrolimus og sirolimus.
English: • Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
Danish: • Pulmonal arteriel hypertension sekundært til sklerodermi uden signifikant interstitiel pulmonal sygdom
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking STAYVEER.
Danish: Hvis De kan blive gravid, skal De anvende en pålidelig svangerskabsforebyggende metode (prævention), mens De tager STAYVEER.
English: There is limited experience with abrupt discontinuation of STAYVEER in patients with PAH.
Danish: Der er begrænset erfaring med pludselig seponering af STAYVEER hos patienter med PAH.
English: Pregelatinised starch Sodium starch glycolate (Type A) Povidone
Danish: Prægelatineret stivelse Natriumstivelsesglycolat (type A) Povidon
English: In addition, liver aminotransferase levels must be measured 2 weeks after any dose increase.
Danish: Desuden skal leveraminotransferaseniveauerne måles 2 uger efter enhver dosisforhøjelse.
English: He had symptoms of nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Danish: Han havde symptomer som kvalme, opkastning, svimmelhed, svedtendens og sløret syn.
English: For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with STAYVEER is not recommended.
Danish: Af samme årsag kan samtidig administration af både en stærk CYP3A4-inhibitor (som f.eks. ketoconazol, itraconazol eller ritonavir) og en CYP2C9-inhibitor (som f.eks. voriconazol) sammen med STAYVEER ikke anbefales.
English: • if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis) If any of these apply to you, tell your doctor.
Danish: • hvis De bliver behandlet med ciclosporin (et lægemiddel, som anvendes efter en transplantation eller til behandling af psoriasis) Fortæl det til Deres læge, hvis noget af dette gælder for Dem.
English: Moreover, if you are suffering from pulmonary hypertension disease, the occurrence of a pregnancy can severely deteriorate the symptoms of your disease.
Danish: Hvis De har pulmonal arteriel hypertension kan en graviditet endvidere forårsage en alvorlig forværring i symptomerne på Deres sygdom.
English: Because of possible hormonal contraception failure during STAYVEER treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with STAYVEER are recommended to allow early detection of pregnancy.
Danish: Da hormonel prævention muligvis ikke er effektiv under behandling med STAYVEER, og også på grund af risikoen for at pulmonal hypertension forværres alvorligt under graviditet, anbefales det, at der udføres månedlige graviditetsprøver under STAYVEER-behandlingen for at opdage en graviditet tidligst muligt.
English: In this total population, Kaplan-Meier estimates of survival were 93% and 84% 1 and 2 years after the start of treatment with bosentan, respectively.
Danish: I denne samlede population var Kaplan-Meier estimater vedrørende overlevelse henholdsvis 93% og 84% henholdsvis 1 og 2 år efter behandlingsstart med bosentan.
English: The effect of bosentan on mitochondrial function is unknown.
Danish: Virkningen af bosentan på mitokondriefunktionen er ikke kendt.
English: The benefit/risk balance of bosentan has not been established in patients with WHO class I functional status of PAH.
Danish: Balancen mellem fordele/risici for bosentan er ikke undersøgt hos patienter med WHO klasse I funktionsstatus ved PAH.
English: However, STAYVEER can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Danish: STAYVEER kan imidlertid medføre hypotension (for lavt blodtryk), som kan gøre Dem svimmel, påvirke Deres syn og påvirke Deres evne til at fore motorkøretøj og betjene maskiner.
English: An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan, with the maximum level during the first 4 days of treatment (see section 4.5).
Danish: Et interaktionsstudie med bosentan og lopinavir+ritonavir hos raske individer viste øgede plasmakoncentrationer af bosentan med maksimalt niveau i løbet af de første 4 dages behandling (se pkt.
English: • a pregnancy test if you are a woman of childbearing potential Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Danish: • en graviditetstest, hvis De er en kvinde i den fødedygtige alder Hos nogle patienter, som tager STAYVEER, har man fundet unormale leverfunktionsprøver og blodmangel (lavt hæmoglobin).
English: 1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data.
Danish: Hyppigheder er baseret på statistisk modellering af data fra placebokontrollerede kliniske forsøg.
English: Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
Danish: Bosentan nedsætter både den pulmonale og systemiske vaskulære modstand, hvilket forøger hjertets minutvolumen, uden at hjertefrekvensen øges.
English: At study start, less than half of the patients included (45.3% [29/64]) had bosentan treatment alone not combined with other PAH medication.
Danish: Ved studiestarten fik under halvdelen af de inkluderede patienter (45,3% [29/64]) behandling med bosentan alene uden anden PAH-medicin.
English: The combination should be used with caution.
Danish: Der skal udvises forsigtighed ved brug af denne kombination.
English: • Monthly pregnancy tests are recommended during treatment to allow early detection of pregnancy
Danish: • Det anbefales at udføre månedlige graviditetsprøver med henblik på tidlig konstatering af graviditet.
English: The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH related to congenital heart disease associated with systemic-topulmonary shunts, including Eisenmenger syndrome (13%).
Danish: PAH-ætiologien i henhold til Dana-pointklassifikation omfattede idiopatisk PAH (46%), arvelig PAH (3%), PAH relateret til korrigerende hjertekirurgi (38%) og PAH relateret til kongenit hjertesygdom forbundet med systemiske-til-pulmonale shunts, herunder Eisenmengers syndrom (13%).
English: In the post-marketing period rare cases of liver cirrhosis and liver failure have been reported.
Danish: I post-marketingperioden blev der rapporteret om sjældne tilfælde af levercirrose og leversvigt.
English: Plasma concentrations of bosentan metabolites increased about 2-fold in these patients as compared with subjects with normal renal function.
Danish: Plasmakoncentrationer af bosentanmetaboliter steg til omkring det dobbelte hos disse patienter i sammenligning med personer med normal nyrefunktion.
English: The same recommendations apply to reintroduction of STAYVEER after treatment interruption (see section 4.4).
Danish: De samme anbefalinger gør sig gældende ved reintroduktion af STAYVEER efter behandlingsafbrydelse (se pkt.
English: Pulmonary arterial hypertension associated with HIV infection
Danish: Pulmonal arteriel hypertension associeret med hiv-infektion
English: • a blood test to check your liver function
Danish: • en blodprøve for at kontrollere Deres leverfunktion
English: Treatment with bosentan was associated with a reduction in the rate of clinical worsening, defined as a composite of symptomatic progression, hospitalisation for PAH and death, compared with placebo (proportional risk reduction 77%, 95% confidence interval [CI] 20-94%, p = 0.0114).
Danish: Behandling med bosentan var associeret med en reduktion i hastigheden af klinisk forværring defineret som en kombination af symptomatisk progression, hospitalsindlæggelse for PAH og død sammenlignet med placebo (proportional reduktion i risiko på 77%, 95% konfidensinterval [CI] 2094%, p = 0,0114).
English: An increase in minute ventilation and a decrease in oxygen saturation were observed, and the most frequent adverse event was dyspnoea, which resolved with discontinuation of bosentan.
Danish: Der blev observeret en øget minutventilation og et fald i iltmætning; den hyppigste bivirkning var dyspnø, som forsvandt efter seponering af bosentan.
English: The most frequent adverse events in the bosentan- and placebo-treated patients were, respectively, anaemia or haemoglobin decrease (7 and 2 patients), generalised oedema (3 and 0 patients), and vomiting (2 and 0 patients).
Danish: De hyppigste bivirkninger hos de bosentan- og placebobehandlede patienter var henholdsvis anæmi eller hæmoglobinreduktion (7 og 2 patienter), generaliseret ødem (3 og 0 patienter) og opkastning (2 og 0 patienter).
English: This was a double-blind, placebo-controlled, randomised study in pre-term or term neonates (gestational age 36-42 weeks) with PPHN.
Danish: Dette var et dobbeltblindet, placebokontrolleret, randomiseret studie udført hos præmature og fuldbårne nyfødte (gestationsalder 36-42 uger) med PPHN.
English: Adverse events of liver abnormalities and anaemia/haemoglobin decrease occurred in 9% and 5% of patients, respectively.
Danish: Bivirkninger i form af leverabnormiteter og anæmi/hæmoglobinreduktion indtrådte hos henholdsvis 9% og 5% af patienterne.
English: This metabolite is mainly excreted unchanged via the bile.
Danish: Denne metabolit udskilles hovedsagelig uomdannet via galden.
English: Patients were in WHO functional class I (n = 19, 29 %), class II (n = 27, 42%) or class III (n = 18, 28%) at start of study treatment.
Danish: Patienterne var i WHO-funktionsklasse I (n=19, 29%), II (n=27, 42%) eller III (n=18, 28%) ved opstart af studiebehandlingen.
English: The effect of bosentan on reduction of the number of new digital ulcers was more pronounced in patients with multiple digital ulcers.
Danish: Virkningen af bosentan på reduktion af antallet af nye fingersår var mere udtalt hos patienter med mange fingersår.
English: Bosentan has been shown to be teratogenic in rats at plasma levels higher than 1.5 times the plasma concentrations achieved at the therapeutic dose in humans.
Danish: Bosentan har vist sig at være teratogent hos rotter ved plasmakoncentrationer, der er mere end 1,5 gange højere end de plasmakoncentrationer, der blev opnået ved terapeutiske doser hos mennesker.
English: Some patients not responding well to 125 mg twice daily of STAYVEER may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily.
Danish: Nogle patienter, der ikke responderer godt på 125 mg STAYVEER to gange dagligt, kan forbedre deres arbejdskapacitet lidt, hvis dosis øges til 250 mg to gange dagligt.
English: For children aged 1 year and older, treatment with STAYVEER is usually started with 2 mg per kg bodyweight twice daily (morning and evening).
Danish: Hos børn i alderen 1 år og derover starter behandlingen med STAYVEER sædvanligvis med 2 mg pr. kg legemsvægt to gange dagligt (morgen og aften).
English: After 16 weeks, the mean placebo-corrected increase in 6-minute walk distance was 53 metres (p = 0.0079), reflecting improvement in exercise capacity.
Danish: Efter 16 uger var den gennemsnitlige placebokorrigerede øgning i 6 minutters gangdistance, 53 meter (p = 0,0079), hvilket afspejler forbedring i arbejdskapaciteten.
English: There was no evidence of any clinical benefit with 2 mg/kg three times daily as compared to 2 mg/kg twice daily dosing.
Danish: Der var ingen evidens for nogen klinisk fordel ved 2 mg/kg tre gange dagligt i forhold til 2 mg/kg to gange dagligt.
English: If you forget to take STAYVEER
Danish: Hvis De har glemt at tage STAYVEER
English: • STAYVEER treatment must not be initiated in women of childbearing potential unless they practise reliable contraception and the result of the pre-treatment pregnancy test is negative
Danish: • STAYVEER behandling må ikke påbegyndes hos kvinder i den fertile alder, medmindre de bruger pålidelig prævention, og en graviditetsprøve inden behandlingens start er negativ
English: Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Danish: Tilfælde af pulmonært ødem har været rapporteret i forbindelse med vasodilatatorer (især prostacykliner), når de anvendes til patienter med pulmonær veno-okklusiv sygdom.
English: The pharmacokinetics of bosentan have not been studied in patients with Child-Pugh class C hepatic impairment.
Danish: Bosentans farmakokinetik er ikke undersøgt hos patienter med Child-Pugh klasse C nedsat leverfunktion.
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 2 years was 78.9%.
Danish: Kaplan-Meier-estimatet (hændelsesfri) for forværring af PAH (død, lungetransplantation eller hospitalsindlæggelse på grund af PAH-forværring) efter 2 år var 78,9%.
English: STAYVEER reduces the number of new finger and toe ulcers that appear.
Danish: STAYVEER nedsætter antallet af forekomsten af nye finger- og tåsår.
English: Please read this card carefully before starting your treatment with STAYVEER.
Danish: De skal læse det grundigt, inden De starter behandling med STAYVEER.
English: Concomitant use of rifampicin and STAYVEER is not recommended.
Danish: Samtidig brug af Rifampicin og STAYVEER frarådes.
English: This decrease is probably due to auto-induction of metabolising liver enzymes.
Danish: Dette fald skyldes sandsynligvis en autoinduktion af metaboliserende leverenzymer.