FrancophonIA/ELRC3.0 huggingface dataset:
English: The improvement in walk distance was apparent after 4 weeks of treatment, was clearly evident after 8 weeks of treatment and was maintained for up to 28 weeks of double-blind treatment in a subset of the patient population.
Danish: Forbedringen i 6-minutters gangdistance var mærkbar efter 4 ugers behandling og helt tydelig efter 8 ugers behandling og blev opretholdt i op til 28 uger ved en dobbeltblind behandling i en undergruppe af patientpopulationen.
English: There have also been rare reports of liver failure.
Danish: Der har ligeledes været sjældne rapporter om leversvigt.
English: Tests your doctor will do during treatment
Danish: Prøver, som Deres læge vil udføre under behandling
English: Consequently, it is recommended that patients be monitored for signs of fluid retention (e.g., weight gain), especially if they concomitantly suffer from severe systolic dysfunction.
Danish: Som følge heraf anbefales det, at patienter undersøges for tegn på væskeretention (f.eks. vægtøgning), især hvis de samtidig lider af alvorlig systolisk dysfunktion.
English: These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking STAYVEER may get anaemia.
Danish: Disse foretages hver måned i de første 4 måneder af behandlingen, derefter hver 3. måned, da patienter, som tager STAYVEER, kan få blodmangel.
English: The relative contributions of previous placebo treatment in the double-blind phase and of other medications started during the open-label extension period are unknown.
Danish: De relative bidrag fra tidligere placebobehandling i den dobbeltblinde fase og fra anden medicinering indledt i den åbne forlængelsesperiode kendes ikke.
English: In the clinical programme, dose-dependent elevations in liver aminotransferases generally occurred within the first 26 weeks of treatment, usually developed gradually, and were mainly asymptomatic.
Danish: I det kliniske program forekom dosisafhængige stigninger i leveraminotransferaser generelt inden for de første 26 uger af behandlingen, i reglen udviklet gradvist og hovedsageligt asymptomatisk.
English: > 5 and ≤ 8 × ULN The result should be confirmed by a second liver test; if confirmed, treatment should be stopped and aminotransferase levels monitored at least every 2 weeks.
Danish: > 5 og ≤ 8 × ULN Resultatet skal bekræftes med en ekstra leverfunktionstest; hvis bekræftet, skal behandling afbrydes og aminotransferaseniveauer monitoreres mindst hver anden uge.
English: If you have the impression that the effect of STAYVEER is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Danish: Hvis De mener, at virkningen af STAYVEER er for kraftig eller for svag, skal De tale med Deres læge om en eventuel justering af dosis.
English: Adverse reactions observed in 20 placebo-controlled studies and post-marketing experience with bosentan are ranked according to frequency using the following convention: very common (≥ 1/10); common (≥1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Bivirkninger fra 20 placebokontrollerede studier og erfaringer med bosentan efter markedsføring er inddelt efter hyppighed i henhold til følgende konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: The influence of CYP2C9 inhibitors on bosentan concentration has not been studied.
Danish: CYP2C9-inhibitorers indflydelse på bosentankoncentrationen er ikke blevet undersøgt.
English: Overall, 78% of patients remained in WHO functional class II.
Danish: Totalt forblev 78% af patienterne i WHO funktionsklasse II.
English: Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above.
Danish: Aminotransferaseniveauerne skal kontrolleres inden for 3 dage efter reintroduktionen og igen efter yderligere 2 uger og derefter i henhold til ovenstående anbefalinger.
English: However, there was no evidence of bosentan affecting thyroid function (thyroxine, TSH) in humans.
Danish: Der fandtes dog intet bevis for at bosentan påvirker thyroideafunktionen (thyroxin, TSH) hos mennesker.
English: If you take more tablets than you have been told to take, contact your doctor immediately.
Danish: Hvis De tager flere tabletter, end De har fået besked på, skal De omgående søge læge.
English: The Kaplan-Meier estimate of overall survival at 2 years was 91.2%.
Danish: Kaplan-Meier-estimatet for samlet overlevelse efter 2 år var 91,2%.
English: Teratogenic effects, including malformations of the head and face and of the major vessels, were dose dependent.
Danish: Teratogene virkninger, herunder misdannelser af hoved og ansigt og de større kar, var dosisafhængige.
English: Your liver and blood values will be monitored during treatment with STAYVEER (see section 2).
Danish: Deres lever- og blodværdier vil blive overvåget under behandlingen med STAYVEER (se pkt.
English: Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Danish: Behandlingen skal afbrydes, og det skal ikke overvejes at reintroducere STAYVEER.
English: The Patient Alert Card, provided as part of the product packaging, aims to:
Danish: Patientadvarselskortet, som medfølger i pakningen, er beregnet til:
English: These will be done every month for the duration of treatment with STAYVEER.
Danish: Disse vil blive foretaget hver måned i behandlingsperioden med STAYVEER.
English: This difference in infection frequency may in part be due to the longer median treatment exposure in the paediatric set (median 71.8 weeks) compared with the adult set (median 17.4 weeks).
Danish: Denne forskel i infektionshyppighed kan til dels skyldes den længere gennemsnitlige behandlingseksponering i den pædiatriske gruppe (median 71,8 uger) i forhold til den voksne gruppe (median 17,4 uger).
English: Background treatments for systemic sclerosis and digital ulcers were permitted if they remained constant for at least 1 month prior to the start of treatment and during the double-blind study period.
Danish: Igangværende medicinsk behandling for systemisk sklerose og fingersår blev tilladt, hvis disse var konstante i mindst 1 måned før påbegyndelse af behandlingen og under det dobbeltblinde studie.
English: It is recommended that haemoglobin concentrations be checked prior to initiation of treatment, every month during the first 4 months, and quarterly thereafter.
Danish: Det anbefales, at hæmoglobinkoncentrationer undersøges, inden behandlingen initieres, hver måned i løbet af de 4 første måneder og derefter hvert kvartal.
English: The treatment effect was driven by improvement in the component symptomatic progression.
Danish: Målet for behandlingseffekten var forbedring i kombinationen af symptomatisk progression.
English: There is no specific clinical experience in patients undergoing dialysis.
Danish: Der foreligger ingen specifik klinisk erfaring med patienter, der er i dialyse.
English: There was one hospitalisation related to PAH worsening in the bosentan group and three hospitalisations in the placebo group.
Danish: Der var én hospitalsindlæggelse som følge af forværring af PAH i bosentangruppen og tre hospitalsindlæggelser i placebogruppen.
English: An increased long-term risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products.
Danish: En øget langtidsrisiko for hepatotoksicitet og hæmatologiske bivirkninger kan ikke udelukkes, når bosentan anvendes i kombination med antiretrovirale lægemidler.
English: In vitro data also suggest an induction of CYP2C19.
Danish: In vitro-data tyder endvidere på en induktion af CYP2C19.
English: However, full induction by bosentan might not have been reached and a further decrease of protease inhibitors cannot be excluded.
Danish: Det er imidlertid ikke sikkert, at den fulde effekt af bosentans inducerende virkning er opnået, og en yderligere reduktion af proteaseinhibitorer kan ikke udelukkes.
English: The possibility of altered efficacy of medicinal products metabolised by these isoenzymes should be considered.
Danish: Muligheden for en ændret virkning af lægemiddelprodukter, som omsættes af disse isoenzymer, bør overvejes.
English: Hypromellose Glycerol triacetate Talc
Danish: Hypromellose Glyceroltriacetat Talcum
English: Enrolled patients were PAH-treatment-naïve (n = 156) or on a stable dose of sildenafil (n = 29).
Danish: Inkluderede patienter var PAH-behandlingsnaive (n = 156) eller på en stabil dosis sildenafil (n = 29).
English: Survival estimates were lower in the subgroup of patients with PAH secondary to systemic sclerosis.
Danish: Overlevelsesestimaterne var lavere i subgruppen af patienter med PAH sekundært til systemisk sklerose.
English: Long-term data were generated from all 173 patients who were treated with bosentan in the controlled phase and/or were switched from placebo to bosentan in the open-label extension phase of the EARLY study.
Danish: Langtidsdata blev genereret fra alle 173 patienter, som blev behandlet med bosentan i den kontrollerede fase, og/eller som skiftede fra placebo til bosentan i den åbne udvidede fase af EARLY-studiet.
English: The accumulation of bosentan in hepatocytes leading to cytolysis with potentially severe damage of the liver, or an immunological mechanism, are not excluded.
Danish: Akkumuleringen af bosentan i hepatocytter, som kan føre til cytolyse med potentiel alvorlig leverskade eller en immunologisk mekanisme, kan ikke udelukkes.
English: In this study there was an increasedincidence of hospitalisation due to CHF during the first 4-8 weeks of treatment with bosentan, which could have been the result of fluid retention.
Danish: I denne undersøgelse var der en øget forekomst af hospitalsindlæggelser på grund af CHF i løbet af de første 4-8 uger af behandling med bosentan, som kan have været resultat af væskeretention.
English: STAYVEER may harm unborn babies conceived before starting or during treatment.
Danish: STAYVEER kan skade ufødte børn, som er undfanget før eller under behandlingen.
English: You are advised to stop breast-feeding if STAYVEER is prescribed for you, because it is not known whether this medicine passes into breast milk.
Danish: De bør holde op med at amme, hvis De får ordineret STAYVEER, da det ikke vides, om medicinen går over i mælken.
English: Re-introduction must follow the guidelines detailed in section 4.2.
Danish: Reintroduktion skal følge de retningslinjer, som er anført i pkt.
English: If the decision to withdraw STAYVEER is taken, it should be done gradually while an alternative therapy is introduced.
Danish: Hvis det besluttes at seponere STAYVEER, skal dette gøres gradvist, mens en alternativ behandling indledes.
English: In patients with severe renal impairment (creatinine clearance 15-30 mL/min), plasma concentrations of bosentan decreased by approximately 10%.
Danish: Hos patienter med alvorligt nedsat nyrefunktion (kreatininclearance 15-30 ml/min) faldt plasmakoncentrationer af bosentan med omkring 10%.
English: At steady state, the systemic exposures in paediatric patients weighing 10-20 kg, 20-40 kg and > 40 kg were 43%, 67% and 75%, respectively, of the adult systemic exposure.
Danish: Ved steady-state er den systemiske eksponering hos pædiatriske patienter med en legemsvægt på 10-20 kg, 20-40 kg og > 40 kg henholdsvis 43%, 67% og 75% af den systemiske eksponering hos voksne.
English: Suddenly stopping your treatment with STAYVEER may lead to your symptoms getting worse.
Danish: Hvis De pludselig stopper behandlingen med STAYVEER, kan det medføre, at Deres symptomer forværres.
English: Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Danish: Tågesyn har også været indberettet med ukendt hyppighed (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: As a result, a significantly reduced effect of bosentan is expected when it is co-administered with rifampicin.
Danish: Som resultat deraf kan signifikant nedsat virkning af bosentan forventes ved samtidig administration af rifampicin.
English: There are no studies to demonstrate beneficial effects of STAYVEER treatment on survival.
Danish: Der foreligger ingen studier med formålet at vise fordelagtige virkninger af behandling med STAYVEER på overlevelse.
English: • Abnormal liver function which may affect more than 1 in 10 people
Danish: • Abnorm leverfunktion, som kan påvirke flere end 1 ud af 10 personer
English: Based on physicochemical properties and the high degree of protein binding, bosentan is not expected to be removed from the circulation by dialysis to any significant extent (see section 4.2).
Danish: Baseret på fysisk-kemiske egenskaber og den høje proteinbindingsgrad forventes det ikke, at bosentan kan fjernes fra cirkulationen i betydeligt omfang ved dialyse (se pkt.
English: If there is any doubt about what contraceptive advice should be given to the individual patient, consultation with a gynaecologist is recommended.
Danish: Hvis der hos den individuelle patient er nogen som helst tvivl om, hvilken form for præventionsrådgivning der skal gives, bør rådgivning finde sted hos en gynækolog.
English: Pharmacokinetics were studied in paediatric patients in 4 clinical studies (BREATHE-3, FUTURE 1, FUTURE-3 and FUTURE-4; see section 5.1).
Danish: Farmakokinetikken er blevet undersøgt hos pædiatriske patienter i 4 kliniske studier (BREATHE-3, FUTURE 1, FUTURE-3 OG FUTURE-4; se pkt.
English: • Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes,
Danish: • Anafylaksi (generelle allergiske reaktioner), angioødem (hævelser, hyppigst omkring øjne,
English: STAYVEER can be taken with or without food.
Danish: STAYVEER kan tages sammen med mad eller uden mad.
English: In addition, an increased incidence of elevated aminotransferases was observed in patients receiving concomitant therapy.
Danish: Der blev desuden observeret en forøget forekomst af forhøjede aminotransferaser hos patienter, som modtog ledsagende terapi.
English: After a single intravenous dose of 250 mg, the clearance was 8.2 L/h.
Danish: Efter en enkelt intravenøs dosis på 250 mg var clearance 8,2 l/t.
English: The clinical benefit of the combination has not been demonstrated.
Danish: Den kliniske fordel ved kombinationsbehandling er ikke vist.
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Danish: • forårsaget af sklerodermi (også kaldet systemisk sklerose, en sygdom, hvor der er abnorm vækst i det bindevæv, som støtter huden og andre organer);
English: In the post-marketing period, cases of anaemia requiring red blood cell transfusion have been reported (see section 4.8).
Danish: I perioden efter markedsføring har der været rapporteret tilfælde af anæmi, som krævede transfusion af røde blodlegemer (se pkt.4.8).
English: In the post-marketing period there was one reported overdose of 10,000 mg of bosentan taken by an adolescent male patient.
Danish: I perioden efter markedsføring blev der rapporteret ét tilfælde med en overdosis på 10.000 mg bosentan, som blev taget af en ung mandlig patient.
English: Hypersensitivity reactions (including dermatitis, pruritus and rash)2
Danish: Overfølsomhedsreaktioner (herunder dermatitis, pruritus og udslæt)2
English: Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.
Danish: Behandling af pulmonal arteriel hypertension (PAH) for at forbedre arbejdskapacitet og symptomer hos patienter med WHO funktionsklasse III.
English: In the event of clinical deterioration (e.g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite STAYVEER treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered.
Danish: I tilfælde af klinisk forværring (f.eks. mindst 10% reduktion i 6-minutters gangdistance i sammenligning med målinger inden behandlingens start) på trods af STAYVEER behandling i mindst 8 uger (måldosis i mindst 4 uger), bør alternativ behandling overvejes.
English: After oral administration, the systemic exposure is proportional to dose up to 500 mg. At higher oral doses, Cmax and AUC increase less than proportionally to the dose.
Danish: Efter peroral indgift er den systemiske eksponering proportional med doser op til 500 mg. Ved højere perorale doser forøges Cmax og AUC mindre end proportionalt med dosis.
English: 40.6% (26/64) remained on bosentan monotherapy during the 24 weeks of study treatment without experiencing PAH worsening.
Danish: 40,6% (26/64) fortsatte med bosentan som monoterapi i de 24 uger med studiebehandling uden at opleve PAH-forværring.
English: Although not demonstrated through in vivo studies, similar increases in bosentan plasma concentrations are expected with the other potent CYP3A4 inhibitors (such as itraconazole or ritonavir).
Danish: Skønt det ikke er blevet påvist ved in vivo undersøgelser, forventes lignende forhøjede plasmakoncentrationer af bosentan med de andre potente CYP3A4-inhibitorer (som f.eks. itraconazol eller ritonavir).
English: Bosentan does not penetrate into erythrocytes.
Danish: Bosentan penetrerer ikke erytrocytter.
English: There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years; however, this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age.
Danish: Der var ingen relevant forskel i bivirkningshyppigheden hos patienter over og under 2 år, men dette er imidlertid baseret på bare 21 børn under 2 år, herunder 6 patienter i alderen 3 måneder til 1 år.
English: Transfer to a therapy that is recommended at the severe stage of the disease (e.g., epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Danish: Skift til en behandling, som anbefales på det svære stadie af sygdommen (f.eks. epoprostenol) bør overvejes, hvis den kliniske tilstand forværres (se pkt.
English: These increases may be partly due to competitive inhibition of the elimination of bile salts from hepatocytes but other mechanisms, which have not been clearly established, are probably also involved in the occurrence of liver dysfunction.
Danish: Disse forøgelser kan delvist skyldes kompetitiv hæmning af galdesaltelimineringen fra hepatocytter, men andre mekanismer, som ikke er blevet helt fastlagt, er sandsynligvis ligeledes involveret i forekomsten af leverdysfunktion.
English: The neurohormone endothelin-1 (ET-1) is one of the most potent vasoconstrictors known and can also promote fibrosis, cell proliferation, cardiac hypertrophy and remodelling, and is pro-inflammatory.
Danish: Neurohormonet endothelin-1 (ET-1) er en af de mest potente vasokonstriktorer, der kendes, og kan også fremme fibrose, celleproliferation, hjertehypertrofi og remodellering og er pro-inflammatorisk.
English: Anaphylaxis and/or angioedema1
Danish: Anafylaksi og/eller angioødem1
English: Changes in exercise test parameters at week 12 from baseline were highly variable and none were significant.
Danish: Ændringer i parametre ved motionstest efter 12 uger sammenlignet med udgangsværdierne var meget variable og ingen var signifikante.
English: Controlled clinical study experience in this indication is limited to 6 months (see section 5.1).
Danish: Erfaring med denne indikation i kontrollerede kliniske studier er begrænset til 6 måneder (se pkt.
English: Bosentan specifically antagonises ET receptors and does not bind to other receptors.
Danish: Bosentan er en specifik antagonist til ET-receptorer og bindes ikke til andre receptorer.
English: In vitro data demonstrated that bosentan had no relevant inhibitory effect on the CYP isoenzymes tested (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
Danish: In vitro- data påviste, at bosentan ikke havde nogen relevant inhiberende virkning på de CYP-isoenzymer, som blev testet (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1 og 3A4).
English: Both glibenclamide and bosentan inhibit the bile salt export pump, which could explain the elevated aminotransferases.
Danish: Både glibenclamid og bosentan inhiberer galdesalt-eksportpumpen, hvilket kunne forklare de forhøjede aminotransferaser.
English: • Thrombocytopenia (low number of blood platelets)
Danish: • Trombocytopeni (lavt antal blodplader)
English: Inhibition of these isoenzymes may increase the plasma concentration of bosentan (see ketoconazole).
Danish: Hæmning af disse isoenzymer kan forøge plasmakoncentrationen af bosentan (se ketoconazol).
English: Treatment with bosentan led to a WHO functional class improvement in 42.4% of patients (placebo 30.4%).
Danish: Behandlingen med bosentan forbedrede WHO funktionsklasse hos 42,4% af patienterne (placebo 30,4%).
English: Therefore, concomitant use of STAYVEER and tacrolimus or sirolimus is not advisable.
Danish: Derfor er samtidig anvendelse af STAYVEER og tacrolimus eller sirolimus ikke tilrådelig.
English: The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant STAYVEER treatment.
Danish: Det kan være nødvendigt at justere dosis af disse produkter efter påbegyndelse af behandlingen, ved dosisændring, eller ved seponering af samtidig STAYVEER behandling.
English: The safety profile in this pooled analysis of uncontrolled paediatric studies was similar to that observed in the pivotal trials in adult patients with PAH except for infections, which were more frequently reported than in adults (69.0% vs 41.3%).
Danish: Sikkerhedsprofilen i denne samlede analyse af ikke-kontrollerede pædiatriske studier var sammenlignelig med den sikkerhedsprofil, der blev set i pivotalstudierne hos voksne patienter med PAH, med undtagelse af infektioner, som blev indberettet hyppigere end hos voksne (69,0% kontra 41,3%).
English: Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors.
Danish: Bosentan er en dobbelt endothelinreceptoragonist (ERA) med affinitet til både endothelin A- og B(ETA- og ETB-) receptorer.
English: The median treatment duration was 71.8 weeks (range 0.4-258 weeks).
Danish: Den gennemsnitlige behandlingsvarighed var 71,8 uger (interval 0,4-258 uger).
English: These haemodynamic improvements from baseline were similar with or without co-administration of epoprostenol.
Danish: Disse hæmodynamiske forbedringer fra basalniveau var ens både med og uden samtidig administration af epoprostenol.
English: At the same timepoints, 88% and 79% of patients remained free from PAH worsening (defined as all-cause death, lung transplantation, atrial septostomy or start of intravenous or subcutaneous prostanoid treatment).
Danish: På samme tidspunkter var 88% og 79% stadig fri for forværring af PAH (defineret som død uanset årsag, lungetransplantation, atrieseptostomi eller påbegyndt intravenøs eller subkutan behandling med prostanoider).
English: • Neutropenia/leukopenia (low number of white blood cells)
Danish: • Neutropeni/leukopeni (lavt antal hvide blodlegemer)
English: • warfarin (an anticoagulant agent);
Danish: • warfarin (et antikoagulerende middel)
English: In placebo-controlled studies, bosentan-related decreases in haemoglobin concentration were not progressive, and stabilised after the first 4-12 weeks of treatment.
Danish: I placebo-kontrollerede studier var bosentan-relateret fald i hæmoglobinkoncentrationen ikke progressivt og stabiliseredes efter de første 4-12 ugers behandling.
English: These cases reinforce the importance of strict adherence to the monthly schedule for monitoring of liver function for the duration of treatment with STAYVEER (see section 4.4).
Danish: Disse tilfælde understreger betydningen af nøje overholdelse af månedlig monitorering af leverfunktionen under behandling med STAYVEER (se pkt.