FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of patients were diagnosed as primary pulmonary hypertension (72%) and were in WHO functional class III (84%).
Danish: Størstedelen af patienterne blev diagnosticeret som primær pulmonal hypertension (72%) og var i WHO funktionsklasse III (84%).
English: The differences between the two groups, 125 mg twice daily and 250 mg twice daily, were not statistically significant but there was a trend towards improved exercise capacity in the group treated with 250 mg twice daily.
Danish: Forskellene mellem de to grupper på 125 mg to gange dagligt og 250 mg to gange dagligt var ikke statistisk signifikante, men der var en tendens til forbedret arbejdskapacitet i den gruppe, der blev behandlet med 250 mg to gange dagligt.
English: In the FUTURE 1 study, the median exposure to study treatment was 13.1 weeks (range: 8.4 to 21.1).
Danish: I FUTURE 1-studiet var den gennemsnitlige eksponering for studiebehandlingen 13,1 uger (interval 8,4 til 21,1).
English: Other antiretroviral agents: No specific recommendation can be made with regard to other available antiretroviral agents due to the lack of data.
Danish: Andre antiretrovirale stoffer: På grund af manglende data kan der ikke gives specifikke rekommandationer for andre antiretrovirale stoffer.
English: Gender and concomitant use of intravenous epoprostenol had no significant effect on the pharmacokinetics of bosentan.
Danish: Køn og samtidig anvendelse af intravenøs epoprostenol havde ingen signifikant virkning på bosentans farmakokinetik.
English: STAYVEER with food and drink
Danish: Brug af STAYVEER sammen med mad og drikke
English: The terminal elimination halflife (t1/2) is 5.4 hours.
Danish: Den terminale eliminationshalveringstid (t½) er 5,4 timer.
English: • Hormonal contraceptives cannot be the sole method of contraception during treatment with STAYVEER
Danish: • Hormonelle antikonceptiva må ikke være den eneste præventionsmetode under behandlingen med STAYVEER
English: In patients with mildly impaired liver function (Child-Pugh class A) no relevant changes in the pharmacokinetics have been observed.
Danish: Hos patienter med let nedsat leverfunktion (Child-Pugh klasse A) er der ikke blevet observeret nogen relevante farmakokinetiske ændringer.
English: The co-primary endpoints were percentage change from baseline in pulmonary vascular resistance (PVR) and change from baseline in 6-minute walk distance to Month 6 versus placebo.
Danish: Det primære slutpunkt var den procentvise ændring fra baseline i pulmonal vaskulær modstand (PVR) og ændring fra baseline ved tilbagelagt afstand i 6 minutters gangdistance i forhold til 6. måned versus placebo.
English: Remember to have your liver blood test every month.
Danish: Husk at få foretaget blodprøver for at undersøge leverfunktionen hver måned.
English: Caution is recommended in the case of co-administration.
Danish: Forsigtighed tilrådes ved samtidig administration.
English: Animal studies showed testicular effects (see section 5.3).
Danish: Dyrestudier har vist testikulære virkninger (se pkt.
English: When treatment with STAYVEER is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER should be closely monitored with special attention, at the beginning of the initiation phase, to the risk of hypotension and to liver function tests.
Danish: Når behandling med STAYVEER initieres hos patienter, som kræver ritonavir-boostede proteaseinhibitorer, bør patientens tolerabilitet over for STAYVEER nøje monitoreres i begyndelsen af initieringsfasen med særlig opmærksomhed på risikoen for hypotension og med leverfunktionstest.
English: No formal conclusion can be drawn regarding the effects of bosentan on antiretroviral drug efficacy (see also section 4.4).
Danish: Der kan ikke drages nogen formel konklusion med hensyn til virkningen af bosentan på virkningen af antiretrovirale lægemidler (se også pkt.
English: Tablets are to be taken orally morning and evening, with or without food.
Danish: Tabletterne skal indtages oralt morgen og aften sammen med eller uden føde.
English: • Digital ulcers: (sores on the fingers and toes) in adult patients with a condition called scleroderma.
Danish: • Fingersår: (sår på fingre og tæer) hos voksne patienter med en tilstand kaldet sklerodermi.
English: These elevations in aminotransferases may reverse spontaneously while continuing treatment with the maintenance dose of STAYVEER or after dose reduction, but interruption or cessation may be necessary (see section 4.4).
Danish: Disse forøgelser af aminotransferaser kan reverseres spontant, når behandlingen fortsættes med vedligeholdelsesdoser af STAYVEER eller efter dosisreduktion, men afbrydelse eller ophør kan være nødvendig (se pkt.
English: The most common adverse reaction was headache of mild to moderate intensity.
Danish: Den mest almindelige bivirkning var hovedpine i mild til moderat grad.
English: Upon multiple dosing, plasma concentrations of bosentan decrease gradually to 50-65% of those seen after single dose administration.
Danish: Efter gentagne doser falder plasmakoncentrationerne af bosentan gradvist til 50-65% af de koncentrationer, som observeres efter administration af en enkeltdosis.
English: The analysis on the global population included (64 patients) showed that the majority had remained at least stable (i.e., without deterioration) based on non-paediatric-specific WHO functional class assessment (97% twice daily, 100% three times daily) and physician's global clinical impression (94% twice daily, 93% three times daily) during the treatment period.
Danish: Analysen af den totale inkluderede population (64 patienter) viste, at størstedelen som minimum forblev stabile (dvs. uden forværring), baseret på en ikke-pædiatrisk-specifik vurdering af WHO-funktionsklasse (97% to gange dagligt, 100% tre gange dagligt) og lægens samlede kliniske vurdering (94% to gange dagligt, 93% tre gange dagligt) i behandlingsperioden.
English: Bosentan competes with the binding of ET-1 and other ET peptides to both ETA and ETB receptors, with a slightly higher affinity for ETA receptors (Ki = 4.1-43 nanomolar) than for ETB receptors (Ki = 38-730 nanomolar).
Danish: Bosentan konkurrerer med bindingen af ET-1 og andre ET-peptider til både ETA- og ETB-receptorer med en lidt højere affinitet til ETA-receptorer (Ki = 4,1-43 nanomolær) end til ETB-receptorer (Ki = 38-730 nanomolær).
English: • lethargy or fatigue (unusual tiredness or exhaustion)
Danish: • sløvhed eller træthed (usædvanlig træthed eller udmattelse)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Half of the patients in each group were already being treated with intravenous epoprostenol and the dose of epoprostenol remained constant for the duration of the study.
Danish: Halvdelen af patienterne i hver gruppe var allerede i behandling med intravenøs epoprostenol og epoprostenoldosis var uændret i hele studiets forløb.
English: No dose adjustment is needed for warfarin and similar oral anticoagulant agents when bosentan is initiated, but intensified monitoring of INR is recommended, especially during bosentan initiation and the up-titration period.
Danish: Der kræves ingen dosisjustering for warfarin og tilsvarende orale antikoagulantia ved initiering af bosentan, men der anbefales en forstærket monitorering af INR, især i starten og i optitreringsperioden.
English: In this study, the exposure to bosentan decreased with time in a manner consistent with the known auto-induction properties of bosentan.
Danish: I dette studie aftog eksponeringen for bosentan over tid på en måde, der svarede til bosentans kendte autoinduktionsegenskaber.
English: • Primary (idiopathic and heritable) pulmonary arterial hypertension
Danish: • Primær (idiopatisk og hereditær) pulmonal arteriel hypertension
English: The educational programme consists of a Patient Alert Card to be held by the patient.
Danish: Uddannelsesprogrammet består af et patientadvarselskort, som patienten skal have på sig.
English: Haemodynamics were measured in 17 patients.
Danish: Hæmodynamikken blev målt hos 17 patienter.
English: The duration of double-blind therapy was 16 weeks in study AC-052-401, and 24 weeks in study AC-052-331.
Danish: Varigheden af den dobbeltblinde behandling var 16 uger i studie AC-052-401 og 24 uger i studie AC-052-331.
English: Re-introduction of treatment with STAYVEER should only be considered if the potential benefits of treatment with STAYVEER outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Danish: Reintroduktion af behandling med STAYVEER bør kun overvejes, hvis de potentielle fordele ved behandling med STAYVEER opvejer de potentielle risici, og hvis leveraminotransferaseniveauerne er inden for de samme værdier som før behandlingens start.
English: What you need to know before you take STAYVEER Do not take STAYVEER:
Danish: Det skal De vide, før De begynder at tage STAYVEER Tag ikke STAYVEER:
English: Should this occur, starting treatment with diuretics is recommended, or the dose of existing diuretics should be increased.
Danish: Skulle dette forekomme, anbefales initiering af diuretisk behandling eller en øgning af dosis af en allerede eksisterende diuretisk behandling.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 AND 112 TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 56 OG 112 TABLETTER
English: As STAYVEER may render hormonal contraceptives ineffective, and taking into account the risk that pulmonary hypertension deteriorates with pregnancy as well as the teratogenic effects observed in animals:
Danish: Idet STAYVEER kan gøre hormonelle antikonceptiva ineffektive og under hensyntagen til risikoen for, at pulmonal hypertension forværres i forbindelse med graviditet, samt de teratogene effekter, der er observeret hos dyr:
English: Baseline (BL); mean (SD)
Danish: Baseline (BL); gennemsnit (SD)
English: In PAH and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases.
Danish: Ved PAH og hjerteinsufficiens er der ved fravær af endothelin receptorantagonisme en stærk sammenhæng mellem forhøjede ET-1-koncentrationer og sygdommens sværhedsgrad og prognoser.
English: STAYVEER is contraindicated in pregnancy (see section 4.3).
Danish: STAYVEER er kontraindiceret under graviditet (se pkt.
English: Consequently, bosentan is not expected to increase the plasma concentrations of medicinal products metabolised by these isoenzymes.
Danish: Bosentan forventes derfor ikke at forøge plasmakoncentrationerne af lægemidler, som metaboliseres af disse isoenzymer.
English: In patients with evidence of the presence of cholestasis, the exposure to the active metabolite may be increased.
Danish: Hos patienter med konstateret cholestase kan eksponeringen for den aktive metabolit være forhøjet.
English: In addition, the frequency of changes in warfarin dose during the studies due to changes in INR or due to adverse events was similar among bosentan- and placebo-treated patients.
Danish: Den hyppighed, med hvilken warfarindoser blev ændret i løbet af studierne på grund af ændringer i INR eller på grund af bivirkninger, var desuden omtrent den samme blandt bosentan- og placebo-behandlede patienter.
English: The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively.
Danish: NOAEL var hhv. 21 gange (på dag 21 post partum) og 2,3 gange (dag 69 post partum) højere end den terapeutiske eksponering hos mennesker.
English: Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B).
Danish: Selvom antallet af inkluderede patienter var begrænset og med høj variabilitet, indikerer disse data en udtalt stigning i eksponeringen for bosentan og dets primære metabolit Ro 48-5033 hos patienter med moderat leverinsufficiens (Child-Pugh klasse B).
English: • glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (a medicine against fungal infections), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as these medicines are not recommended to be used together with STAYVEER.
Danish: • glibenclamid (mod sukkersyge), rifampicin (til behandling af tuberkulose), fluconazol (et lægemiddel til behandling af svampeinfektioner), ketoconazol (et lægemiddel til behandling af Cushings syndrom) eller nevirapin (til behandling af hiv-infektion), da det ikke anbefales at bruge disse lægemidler sammen med STAYVEER.
English: The steady-state AUC of bosentan was 9% higher and the AUC of the active metabolite, Ro 48-5033, was 33% higher in patients with mild hepatic impairment than in healthy volunteers.
Danish: Steady-state-AUC for bosentan var 9% højere, og AUC for den aktive metabolit, Ro 48-5033, var 33% højere hos patienter med let nedsat leverfunktion end hos raske voluntører.
English: Monthly pregnancy tests are recommended while you are taking STAYVEER and are of childbearing age.
Danish: Det anbefales, at der udføres månedlige graviditetsprøver, så længe De tager STAYVEER og er i den fødedygtige alder.
English: • other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
Danish: • andre lægemidler til behandling af pulmonal hypertension: sildenafil og tadalafil
English: Therefore, if you feel dizzy or that your vision is blurred while taking STAYVEER, do not drive or operate any tools or machines.
Danish: Hvis De bliver svimmel eller får tågesyn, når De tager STAYVEER, må De hverken køre bil eller betjene værktøj eller maskiner.
English: At enrolment, six patients were between 3 months and 1 year old, 15 children were between 1 and less than 2 years old, and 79 were between 2 and 12 years old.
Danish: Ved inklusion var seks patienter mellem 3 måneder og 1 år, 15 børn var mellem 1 år og under 2 år, og 79 børn var mellem 2 og 12 år.
English: In a juvenile rat toxicity study, where rats were treated from Day 4 post partum up to adulthood, decreased absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning.
Danish: I et toksicitetsstudie med unge rotter, hvor rotterne blev behandlet fra dag 4 post partum og frem til voksenalderen, blev der observeret nedsat totalvægt af testiklerne og epididymis og nedsat spermatozotal i epididymis efter afvænning.
English: Treatment with bosentan resulted in fewer new digital ulcers for the duration of therapy, compared with placebo.
Danish: Behandling med bosentan resulterede i færre nye fingersår i behandlingens varighed sammenlignet med placebo.
English: Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking STAYVEER.
Danish: Deres læge eller gynækolog vil fortælle Dem om pålidelige svangerskabsforbyggende metoder, der skal bruges, mens De tager STAYVEER.
English: • Anaemia (low blood value) which may affect up to 1 in 10 people.
Danish: • Anæmi (blodmangel), som kan påvirke op til 1 ud af 10 personer.
English: There is limited clinical study experience with the use of STAYVEER in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
Danish: Der er begrænset erfaring fra kliniske studier med anvendelse af STAYVEER hos patienter med PAH associeret med hiv-infektion behandlet med antiretrovirale lægemidler (se pkt.
English: The combination of bosentan and epoprostenol has been investigated in two studies: AC-052-355 (BREATHE-2) and AC-052-356 (BREATHE-3).
Danish: Kombinationen af bosentan og epoprostenol er undersøgt i to undersøgelser: AC-052-355 (BREATHE-2) og AC-052-356 (BREATHE-3).
English: When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER should be monitored.
Danish: Ved samtidig administration af lopinavir+ritonavir eller andre ritonavir-boostede proteaseinhibitorer skal patientens tolerabilitet over for STAYVEER monitoreres.
English: Note: bosentan is not removed through dialysis.
Danish: OBS: Bosentan kan ikke fjernes ved dialyse.
English: At the end of this study, there was no difference in overall hospitalisations for heart failure nor in mortality between bosentan- and placebo-treated patients.
Danish: Ved undersøgelsens afslutning var der ingen forskel mellem det samlede antal indlæggelser på grund af hjerteinsufficiens eller mortalitet hos bosentan- og placebobehandlede patienter.
English: In adult patients, the exposure to the active metabolite is greater than in healthy subjects.
Danish: Hos voksne patienter er eksponeringen for den aktive metabolit større end hos raske individer.
English: At study entry, patients were treated with PAH medications (most frequently phosphodiesterase type-5 inhibitor [sildenafil] alone [35.9%], bosentan alone [10.9%], and a combination of bosentan, iloprost, and sildenafil [10.9%]) and continued their PAH treatment during the study.
Danish: Ved inklusionen i studiet var patienterne i behandling med PAH-medicin (hyppigst med phosphodiesterase type-5-hæmmer [sildenafil] alene [35,9%], bosentan alene [10,9%] eller en kombination af bosentan, iloprost og sildenafil [10,9%]), og de fortsatte deres PAH-behandling under studiet.
English: Adverse reactions were defined as events occurring in at least 1% of patients on bosentan and at a frequency at least 0.5% more than on placebo.
Danish: Bivirkninger blev defineret som hændelser, der forekom hos mindst 1% af de patienter, som fik bosentan, og med en hyppighed der var mindst 0,5% større end med placebo.
English: The mean pulmonary vascular resistance was significantly reduced in the bosentan group (with a predominant effect observed in the subgroup of patients with bidirectional intracardiac shunt).
Danish: Den gennemsnitlige pulmonale vaskulære modstand var signifikant reduceret i bosentangruppen (med en overvejende virkning observeret i subgruppen af patienter med tovejs intrakardiel shunt).
English: Clinical experience with concomitant administration of bosentan with warfarin in patients with PAH did not result in clinically relevant changes in International Normalized Ratio (INR) or warfarin dose (baseline versus end of the clinical studies).
Danish: Klinisk erfaring med samtidig administration af bosentan og warfarin hos patienter med PAH medførte ingen klinisk relevante ændringer i International Normalized Ratio (INR) eller warfarindosis (initialværdi versus afslutning på de kliniske undersøgelser).
English: Tablets should be taken (morning and evening), swallowed with water.
Danish: Tabletterne skal tages morgen og aften og sluges med vand.
English: Twenty-six patients continued to receive bosentan in the 24-week open-label extension phase (AC-052-409) of the BREATHE-5 study (mean duration of treatment = 24.4 ± 2.0 weeks) and, in general, efficacy was maintained.
Danish: Seksogtyve patienter fortsatte med at få bosentan i den 24-ugers åbne forlængelsesfase (AC-052-409) af BREATHE-5-studiet (middelvarighed af behandlingen = 24,4 ± 2,0 uger), og generelt blev virkningen opretholdt.
English: Development of testicular tubular atrophy and impaired fertility has been linked with chronic administration of endothelin receptor antagonists in rodents.
Danish: Udvikling af testikulær tubulær atrofi og nedsat fertilitet er blevet forbundet med kronisk administration af endothelinreceptorantagonister hos gnavere.
English: These effects are mediated by endothelin binding to ETA and ETB receptors located in the endothelium and vascular smooth muscle cells.
Danish: Disse effekter formidles af endothelinbindinger til ETA- og ETB-receptorer i endothelium og vaskulære, glatte muskelceller.
English: STAYVEER tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Danish: STAYVEER tabletter indeholder bosentan, som blokerer virkningen af det naturligt forekommende hormon endothelin-1 (ET-1), som er årsag til forsnævring af blodkarrene.
English: Inside your pack of STAYVEER tablets you will find a Patient Alert Card which you should read carefully.
Danish: Inden i pakningen med STAYVEER-tabletter finder De et patientadvarselskort, som De skal læse omhyggeligt.
English: Patients and prescribers must be aware that due to potential pharmacokinetic interactions, STAYVEER may render hormonal contraceptives ineffective (see section 4.5).
Danish: Patienten og den ordinerende læge skal være opmærksom på, at STAYVEER, på grund af de mulige farmakokinetiske interaktioner, kan gøre de hormonale præventionsmetoder ineffektive (se pkt.
English: Do not store above 30 °C
Danish: Må ikke opbevares ved temperaturer over 30 °C
English: Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity; see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet (teratogenicitet, embryotoksicitet; se pkt.
English: The placebo-corrected increases in walk distance compared with baseline were 76 metres (p = 0.02; t-test) and 44 metres (p = 0.0002; Mann-Whitney U test) at the primary endpoint of each study, respectively.
Danish: Den placebokorrigerede forøgelse i 6-minutters gangdistance i sammenligning med initialværdierne var henholdsvis 76 meter (p = 0,02; t-test) og 44 meter (p = 0,0002; Mann-Whitney U test) ved det primære slutpunkt for hvert studie.
English: PATIENT ALERT CARD
Danish: PATIENTADVARSELSKORT
English: STAYVEER is used to treat patients with class III PAH to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Danish: STAYVEER bruges til at behandle patienter med klasse III PAH med henblik på at forbedre evnen til at udføre fysisk aktivitet og bedre symptomerne.
English: In neonates with persistent pulmonary hypertension of the newborn (PPHN), the benefit of bosentan has not been shown in the standard-of-care treatment.
Danish: Hos nyfødte med persisterende pulmonal hypertension hos nyfødte (PPHN) er der ikke påvist gavnlig virkning af bosentan i standardbehandlingen.
English: • Palpitations (fast or irregular heart beats)
Danish: • Hjertebanken (hurtige eller uregelmæssige hjerteslag)
English: Bosentan has been administered as a single dose of up to 2,400 mg to healthy subjects and up to 2,000 mg/day for 2 months in patients with a disease other than pulmonary hypertension.
Danish: Bosentan er blevet indgivet som en enkeltdosis på op til 2.400 mg hos raske frivillige og op til 2.000 mg/dag i 2 måneder hos patienter, der led af en anden sygdom end pulmonal hypertension.
English: • simvastatin (used to treat hypercholesterolaemia).
Danish: • simvastatin (bruges til at behandle hyperkolesterolæmi).
English: Bosentan was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e.g., calcium channel blockers), diuretics, oxygen and digoxin, but not epoprostenol.
Danish: Bosentan blev givet som supplement til patienternes aktuelle behandling, som kunne bestå af en kombination af antikoagulantia, vasodilatatorer (fx. calciumantagonister), diuretika, oxygen og digoxin, men ikke epoprostenol.
English: You should have a pregnancy test before initiation of STAYVEER and every month during the treatment even if you think that you are not pregnant.
Danish: De skal have udført en graviditetsprøve, inden De begynder behandlingen med STAYVEER og månedligt under behandlingen, selv om De ikke tror, at De er gravid.
English: After co-administration of bosentan for 9.5 days, the plasma exposures to lopinavir and ritonavir decreased to a clinically non-significant extent (by approximately 14% and 17%, respectively).
Danish: Efter samtidig administration af bosentan i 9,5 dage faldt plasmaeksponeringen af lopinavir og ritonavir i en klinisk non-signifikant grad (med henholdsvis ca. 14% og 17%).