FrancophonIA/ELRC3.0 huggingface dataset:
English: The placebo-corrected increases in walk distance in the whole cohort compared to baseline were 35 metres (p = 0.006; ANCOVA) and 31 metres (p < 0.05; ANCOVA), respectively.
Danish: De placebo-korrigerede forøgelser i gangdistance for hele kohorten sammenlignet med baseline var henholdsvis 35 meter (p=0,006; ANCOVA) og 31 meter (p<0,05; ANCOVA).
English: If you forget to take Thelin
Danish: Hvis De har glemt at tage Thelin
English: Study results suggest that the dose of sildenafil does not need to be adjusted during concomitant administration with sitaxentan sodium.
Danish: Forsøgsresultater antyder, at dosis af sildenafil ikke behøver at blive justeret ved samtidig administration af sitaxentannatrium.
English: Large / abnormally shaped livers, a delay in auditory function development, a delay in preputial separation and a reduction in the number of embryonic implants occurred at higher maternal doses.
Danish: Større/unormalt formede levere, en forsinkelse i præputial separation og en reduktion i antallet af embryonale implantater forekom ved større maternale doser.
English: • If you have raised levels of some liver enzymes (detected by blood tests);
Danish: • Hvis De har forhøjede niveauer af visse leverenzymer (ses ved blodprøver).
English: Women should not breastfeed while using Thelin.
Danish: Kvinder bør ikke amme under brugen af Thelin.
English: Increases in the vitamin K antagonist dose should be done in small increments to reach an appropriate target INR.
Danish: Stigning i dosis af vitamin K-antagonisten skal foretages lidt efter lidt for at nå et passende mål-INR.
English: Potential effects in humans are unknown.
Danish: Den potentielle risiko for mennesker er ukendt.
English: There is an increased risk of bleeding with Thelin, mainly in the form of epistaxis and gingival bleeding.
Danish: Blødning: Der er forøget risiko for blødning med Thelin, fortrinsvis i form af epistaxis og gingival blødning.
English: Administration of Thelin to female rats from late-pregnancy through lactation reduced pup survival, and caused testis tubular aplasia and delayed vaginal opening at the lowest exposure tested (17-45 times the human exposure).
Danish: Indgivelse af Thelin til hunrotter fra sen-graviditet gennem laktation reducerede ungernes overlevelse og forårsagede aplasi af testis tubularis og forsinket åbning af vagina ved den laveste testede eksponering (17-45 gange den menneskelige eksponering).
English: In STRIDE-4, a statistically non-significant placebo-corrected mean improvement of 24.3 metres (p = 0.2078) was observed in the whole cohort.
Danish: I STRIDE4 blev der observeret en statistisk ikke-signifikant placebo-korrigeret gennemsnitlig forøgelse på 24,3 meter (p=0,2078) for hele kohorten.
English: Thelin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Danish: Børn og unge (< 18 år): Thelin bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og effekt.
English: Investigations
Danish: Undersøgelsers
English: A known undesirable effect is dizziness, which could influence the ability to drive or use machines.
Danish: En kendt bivirkning er svimmelhed, som kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The efficacy of Thelin as monotherapy has not been established in patients with NYHA/WHO functional class IV PAH.
Danish: Thelins effekt som monoterapi er ikke blevet fastslået hos patienter med NYHA/WHOfunktionsklasse IV PAH.
English: • yellowing of the skin or eyes ( jaundice) and persistent nausea and/or vomiting may indicate changes in liver function
Danish: • Gulfarvning af hud og det hvide i øjnene (gulsot) og vedvarende kvalme og/eller opkastning kan tyde på ændring i leverfunktionen.
English: •That Thelin is hepatotoxic and they will need to attend for regular blood tests
Danish: • At Thelin er levertoksisk, og at de er nødt til at møde op til regelmæssig blodprøvetagning.
English: Compared with placebo treatment, Thelin resulted in statistically significant improvement in pulmonary vascular resistance (PVR) and cardiac index (CI) after 12 weeks of treatment (see below).
Danish: Sammenlignet med placebobehandling resulterede Thelin i en statistisk signifikant forbedring af lungekarmodstand (PVR) og hjerteindeks (CI) efter 12-ugers behandling (se nedenfor).
English: Endothelin receptor antagonists, as a class, have been associated with liver function abnormalities.
Danish: Endothelinreceptor-antagonister er, som klasse, blevet forbundet med leverfunktionsabnormiteter.
English: Most of this decrease of haemoglobin concentration was detected during the first few weeks of treatment and haemoglobin levels stabilized by 4 weeks of Thelin treatment.
Danish: Hovedparten af faldet i hæmoglobinkoncentration blev påvist i løbet af de første få uger af behandlingen, og hæmoglobinniveauet stabiliseredes efter 4 ugers behandling med Thelin.
English: However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
Danish: Der er dog blevet rapporteret om tilfælde af livstruende lungeødem ved anvendelse af vasodilatorer (hovedsagligt prostacyclin) hos denne type patienter.
English: Liver aminotransferases increase, bilirubin increase (associated with liver aminotransferase increase)
Danish: Stigninger i lever-aminotransferase, stigning i bilirubin (forbundet med lever-aminotransferase)
English: The influence of liver impairment on the pharmacokinetics of sitaxentan sodium has not been evaluated.
Danish: Indflydelsen af nedsat leverfunktion på farmakokinetikken af sitaxentannatrium er ikke blevet evalueret.
English: Blood and lymphatic system disorders Haemoglobin decrease (rarely resulting in anaemia), haematocrit decrease
Danish: Blod og lymfesystem Fald i hæmoglobin (resulterer sjældent i anæmi), fald i hæmatokrit
English: Sub-maximal exercise capacity: This was assessed by measuring distance walked in 6 minutes (6-minute walk test) at 12 weeks for STRIDE-1 and 18 weeks for STRIDE-2 and STRIDE-4.
Danish: Nedsat fysisk funktionsevne blev bedømt ved at måle den distance, patienten kunne gå på 6 minutter (6 min gangtest) efter 12 uger for STRIDE-1 og 18 uger for STRIDE-2 og STRIDE-4.
English: Testing for liver problems
Danish: Test for leverproblemer
English: Therefore, at higher doses of nifedipine, an increase in exposure cannot be excluded.
Danish: En forøgelse i eksponering kan derfor ikke udelukkes ved højere nifedipindoser.
English: A decrease in haemoglobin concentration by at least 1 g/dl was observed in 60% of patients treated with Thelin as compared to 32% of placebo-treated patients.
Danish: Et fald i hæmoglobinkoncentration med mindst 1 g/dl blev observeret i 60 % af patienter behandlet med Thelin sammenlignet med i 32 % af patienter behandlet med placebo.
English: Thelin is to be taken orally as a dose of 100 mg once daily.
Danish: Thelin skal tages oralt som en dosis på 100 mg én gang dagligt.
English: Sitaxentan sodium does not affect the p-glycoprotein transporter, but it is postulated to be a substrate of OATP transporter proteins.
Danish: Sitaxentannatrium påvirker ikke p-glycoprotein-transportstoffet, men det er et substrat af OATP-transportproteiner.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: • If you are allergic (hypersensitive) to sitaxentan sodium or any of the other ingredients in these tablets;
Danish: • Hvis De er allergisk (overfølsom) over for sitaxentannatrium eller et af de øvrige indholdsstoffer.
English: However, patients completing STRIDE-2 were eligible to enrol in open-label studies (STRIDE-2X and STRIDE-3).
Danish: Patienter, som fuldførte STRIDE-2, var dog kvalificerede til at blive inkluderet i åbne forsøg (STRIDE-2X og STRIDE-3).
English: Subjects receiving warfarin achieve therapeutic anticoagulation (International Normalised Ratio [INR] target) with lower doses of the anticoagulant in the presence of sitaxentan sodium.
Danish: Patienter, som får warfarin, opnår terapeutisk antikoagulation (International normaliseret ratio (INR) mål) med lavere doser af antikoagulans ved tilstedeværelsen af sitaxentannatrium.
English: Additionally, PAH also is characterized by reduced nitric oxide activity.
Danish: Endvidere er PAH ligeledes karakteriseret ved reduceret dinitrogenoxidaktivitet.
English: If you are able to get pregnant, you must use effective contraception while taking Thelin.
Danish: Hvis De kan blive gravid, skal De bruge sikker prævention, mens De tager Thelin.
English: Respiratory, thoracic, and mediastinal disorders Nasal congestion, epistaxis
Danish: Luftveje, thorax og mediastinum Nasal kongestion, epistaxis
English: Elevated aminotransferases prior to initiation of treatment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x ULN).
Danish: Forhøjede aminotransferaser inden påbegyndelse af behandling (aspartat-aminotransferase (ASAT) og/eller alanin-aminotransferase (ALAT) > 3 x ULN).
English: Use in patients using other medicines:
Danish: Patienter, som tager anden medicin:
English: The efficacy and safety of Thelin co-administration with other treatments for PAH (eg, epoprostenol, sildenafil, iloprost) has not been studied in controlled clinical trials.
Danish: Effekten og sikkerheden af samtidig indgivelse af Thelin med andre behandlinger for PAH (f.eks. epoprostenol, sildenafil, iloprost) er ikke blevet undersøgt i kontrollerede kliniske forsøg.
English: Treatment Comparison of Change from Baseline in PVR, and CI at Week 12 by Functional Class - STRIDE 1: Sitaxentan 100 mg Versus Placebo
Danish: Sammenligning af ændringer i PVR og CI fra baseline ved uge 12 opdelt efter funktionsklasseSTRIDE-1: sitaxentan 100 mg versus placebo
English: In these studies, the study medicine was added to patients' current therapy, which could have included a combination of digoxin, anticoagulants, diuretics, oxygen, and vasodilators (eg, calcium channel blockers, ACE inhibitors).
Danish: I disse forsøg blev forsøgsmedicinen føjet til patientens aktuelle behandling, som kunne have inkluderet en kombination af digoxin, antikoagulantia, diuretika, ilt og vasodilatorer (f.eks. kalciumkanalblokkere, ACE-hæmmere).
English: Transfer to a therapy that is recommended at the severe stage of the disease (eg, epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Danish: Skift til en behandling, som anbefales i sygdommens meget svære stadie (f.eks. epoprostenol), bør overvejes, hvis den kliniske tilstand forværres (se pkt.
English: Excipients: Also contains 166.3mg of lactose monohydrate.
Danish: Hjælpestof(fer): Indeholder også 166,3 mg lactosemonohydrat.
English: • If you are taking Ciclosporin A (used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver or kidney transplants);
Danish: • Hvis De tager Ciclosporin (anvendes til at behandle psoriasis og reumatoid artrit (gigt) og til at forhindre afstødning af lever eller nyre efter transplantation).
English: System Organ Class / Adverse reaction
Danish: System organklasse / Bivirkninger
English: High-density polyethylene (HDPE) bottles containing 28 tablets.
Danish: Polyethylen (HDPE)-beholder indeholdende 28 tabletter.
English: Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
Danish: Der er påvist effekt i primær pulmonal hypertension og i pulmonal hypertension forbundet med bindevævssygdom.
English: If INR is not properly monitored and increased exposure to vitamin K antagonists remains undetected, severe or life-threatening bleeding episodes may occur.
Danish: Hvis INR ikke monitoreres omhyggeligt, og stigning i dosis af vitamin K-antagonister forbliver uopdaget, kan der opstå alvorlige eller livstruende blødningstilfælde.
English: Therefore, caution is recommended in case of co-administration.
Danish: Det anbefales derfor, at der udvises forsigtighed ved kombinationsbehandling.
English: Functional Class: A reduction in symptoms of PAH were observed with sitaxentan sodium 100 mg treatment.
Danish: Funktionsklasse: en reduktion i PAH-symptomer blev set efter behandling med sitaxentannatrium 100 mg.
English: For more details on liver problems, see ‘Testing for liver problems' in section 2.
Danish: Se ”Test for leverproblemer” i afsnit 2 for flere detaljer om leverproblemer.
English: • If you are taking a statin (e.g. pravastatin or simvastatin).
Danish: • Hvis De tager et statin (f.eks. pravastatin eller simvastatin);
English: Take special care with Thelin:
Danish: Vær ekstra forsigtig med at tage Thelin:
English: No evidence for acute rebound has been observed.
Danish: Der er ikke observeret tegn på akut forværring.
English: Haemodynamic parameters: These were assessed in STRIDE-1 for both functional class II and III patients.
Danish: Hæmodynamiske parametre blev bedømt i STRIDE-1 for både funktionsklasse II og III-patienter.
English: • That treatment with Thelin often causes a decrease in haemoglobin and related red cell parameters o Need for full blood count prior to use and monitoring at clinically appropriate intervals
Danish: • At behandling med Thelin ofte forårsager et fald i hæmoglobin og tilknyttede røde blodlegemers parametre o Nødvendigheden af undersøgelse af det samlede blodbillede før brug og kontrol med
English: The Sitaxentan population also included patients (N = 53) who had discontinued another endothelin receptor antagonist due to liver function abnormalities.
Danish: Sitaxentanpopulationen omfattede også patienter (N=53), hvor behandling med en anden endothelinreceptor-antagonist var seponeret pga. leverfunktionsabnormiteter.
English: The significance of these findings for humans is unknown.
Danish: Betydningen af disse fund for mennesker kendes ikke.
English: As this could result in raised plasma levels of sitaxentan sodium, patients in need of the combination should be closely monitored for adverse events related to sitaxentan sodium (see section 4.5).
Danish: Da det kan resultere i forhøjede plasmaniveauer af sitaxentannatrium, skal patienter, som behøver kombinationen, monitoreres omhyggeligt for bivirkninger forbundet med sitaxentannatrium (se pkt.
English: o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN):
Danish: o Nødvenligheden af tæt overvågning, hvis leverenzymerne er > 3 x den øvre normalgrænse (ULN).
English: • bleeding from the gums
Danish: • Blødning fra gummerne
English: Patients with pre-existent hepatic disease and patients using nonconventional PAH treatments (eg, iloprost) were excluded.
Danish: Patienter med præeksisterende leversygdom og patienter, som fik ikke-konventionelle PAH-behandlinger (f.eks. iloprost), var ekskluderede.
English: The following two blood tests will be carried out before you first take Thelin and at intervals during treatment
Danish: Der vil blive taget to blodprøver, inden De tager Thelin første gang, og derefter med mellemrum under behandlingen.
English: Effects of other medicinal products on Thelin
Danish: Virkninger af andre lægemidler på Thelin
English: In patients already taking a vitamin K antagonist, it is recommended that the dose of the vitamin K antagonist be reduced when starting sitaxentan sodium.
Danish: Hos patienter, som allerede tager en vitamin K-antagonist, anbefales det, at dosis af vitamin K-antagonisten reduceres ved indledning af sitaxentannatrium-behandling.
English: If liver transferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, anorexia, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in total bilirubin > 2x ULN, treatment should be stopped and re-introduction of Thelin is not to be considered.
Danish: Hvis forhøjelse af transferase i leveren er ledsaget af kliniske symptomer på leverskader (såsom kvalme, opkastning, anoreksi, feber, mavesmerter, gulsot, eller usædvanlig apati eller træthed) eller af forhøjelse af total-bilirubin > 2 x ULN, skal behandlingen afbrydes, og behandling med Thelin bør ikke genoptages.
English: Oral contraceptives (substrate of CYP3A4/5): Concomitant administration of Thelin and OrthoNovum 1/35 (1 mg norethindrone/ 0.035 mg ethinyl estradiol) resulted in increases in exposure to ethinyl estradiol (substrate of CYP3A4/5) and norethindrone (CYP3A4/5) of 59 % and 47%, respectively.
Danish: Orale kontraceptiva (CYP3A4/5-substrat): Samtidig administration af Thelin og Ortho-Novum 1/35 (1 mg norethindron/ 0,035 mg ethinylestradiol) resulterede i stigning i eksponering for ethinylestradiol (CYP3A4/5-substrat) og norethindron (CYP3A4/5) på henholdsvist 59 % og 47 %.
English: The clearance of nelfinavir was not clinically significantly changed in one subject that was classified as a CYP2C19 poor metaboliser.
Danish: Nelfinavirs clearance blev ikke klinisk signifikant ændret hos en patient, som var klassificeret som en dårlig omsætter af CYP2C19.
English: ET-1 actions are mediated through endothelin A receptors (ETA), present on smooth muscle cells, and endothelin B receptors (ETB), present on endothelial cells.
Danish: ET-1's virkning medieres gennem endothelin A-receptorer (ETA) på celler i glatte muskelceller og endothelin B-receptorer (ETB) på endotelceller.
English: Re-introduction must follow the guidelines detailed in section 4.2.
Danish: Genoptagelse af behandling skal ske i henhold til de retningslinjer, der er beskrevet i detaljer i pkt.
English: • Anaemia (low blood count)
Danish: • Blodmangel (lavt antal røde blodlegemer)
English: Nausea, constipation, upper abdominal pain, vomiting, dyspepsia and diarrhoea
Danish: Kvalme, obstipation, øvre abdominalsmerter, opkastning, dyspepsi og diarré
English: Sitaxentan sodium caused teratogenicity in rats (see section 5.3).
Danish: Sitaxentannatrium forårsagede teratogenicitet hos rotter (se pkt.
English: Thelin increases oestrogen exposure when given concomitantly with oral contraceptive agents (see Section 4.5).
Danish: Thelin øger eksponering for østrogen, når det gives samtidigt med orale kontraceptiva (se pkt.
English: No clinical interaction study was performed with a substrate of CYP 2C8.
Danish: Der er ikke udført kliniske interaktionsforsøg med et CYP2C8-substrat.
English: Studies in patients with pre-existing liver impairment have not been conducted.
Danish: Der er ikke blevet udført forsøg med patienter med præeksisterende nedsat leverfunktion.
English: Thelin should not be used during pregnancy unless clearly necessary ie, in case no alternative treatment options are available.
Danish: Thelin bør ikke anvendes under graviditet, medmindre det er strengt nødvendigt, og der ikke er andre behandlingsmuligheder.
English: It is expected that a similar increase in anticoagulant effect will be seen with warfarin analogues, including acenocoumarol, fenprocoumon and fluindione.
Danish: Det forventes, at en lignende forøgelse af antikoagulationsvirkningen vil blive set med warfarinanaloger, herunder acenocoumarol, phenprocoumon og fluindion.
English: STRIDE-4 included 98 patients randomised to sitaxentan sodium 50 mg, 100 mg, and placebo once daily for 18 weeks.
Danish: STRIDE-4 omfattede 98 patienter randomiseret til sitaxentannatrium 50 mg, 100 mg og placebo én gang dagligt i 18 uger.
English: In repeated-dose toxicity studies, dose-related liver changes (weight, centrilobular hypertrophy, occasionally necrosis), induction of hepatic drug metabolising enzymes and slightly decreased erythron parameters were seen in mice, rats and dogs.
Danish: I gentagne dosistoksicitetsforsøg sås der dosisrelaterede leverændringer (vægt, centrilobulær hypertrofi, undertiden nekrose), induktion af enzymer til metabolisering af hepatiske lægemidler og en anelse reducerede erytronparametre i mus, rotter og hunde.
English: Patients had moderate to severe (NYHA/WHO functional class II-IV) PAH resulting from idiopathic pulmonary arterial hypertension (IPAH, also known as primary pulmonary hypertension), connective tissue disease (CTD), or congenital heart disease (CHD).
Danish: Patienterne havde moderat til svær (NYHA/WHO- funktionsklasse I-IV) PAH som et resultat af idiopatisk PAH (IPAH, også betegnet primær pulmonal hypertension), bindevævssygdom (CTD) eller medfødt hjertesygdom (CHD).
English: >8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Danish: >8xULN: Behandlingen skal afbrydes, og behandling med Thelin bør ikke genoptages.
English: Predominant actions of ET-1 binding to ETA are vasoconstriction and vascular remodelling, while binding to ETB results in ET-1 clearance, and vasodilatory/ antiproliferative effects due in part to nitric oxide and prostacyclin release.
Danish: Den fremherskende virkning af ET-1 binding til ETA er vasokonstriktion og vaskulær remodellering, mens binding til ETB resulterer i ET-1 clearance og vasodilator-/ antispredningsvirkninger.
English: Thelin did not affect fertility in males and females.
Danish: Thelin påvirkede ikke frugtbarheden hverken hos hanner eller hunner.
English: peripheral oedema, and anaemias were the most common adverse events reported in these patients, none of which were considered serious.
Danish: Hovedpine (nogen gange kraftig), perifert ødem og anæmi var de mest almindelige bivirkninger rapporteret hos disse patienter; ingen bivirkninger blev betragtet som alvorlige.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Disse er specificeret i den pharmacovigilanceplan, der er vedtaget i version 5 af Risk Management Planen (RMP), som er præsenteret i Modul 1.8.2 af markedsføringstilladelsen, og enhver følgende opdatering af RMP, som er vedtaget af CHMP.
English: Warfarin (vitamin K antagonist, substrate of CYP2C9): Concomitant treatment with sitaxentan sodium resulted in a 2.4 fold increase in S-warfarin exposure.
Danish: Warfarin (vitamin K-antagonist, CYP2C9-substrat): Samtidig behandling med sitaxentannatrium resulterede i en forøgelse af S-warfarins eksponering på 2,4 gange.
English: There is limited experience with abrupt discontinuation of sitaxentan sodium.
Danish: Der er begrænset erfaring med pludselig afbrydelse af behandling med sitaxentannatrium.
English: Elevations in ALT values > 5 ULN were 4% (36/887) for sitaxentan 100 mg QD and 0.6% in the placebo group (1/155).
Danish: Forhøjelserne i ALAT-værdierne > 5 ULN var 4 % (36/887) for sitaxentan 100 mg én gang dagligt og 0,6 % i placebogruppen (1/155).
English: However, sitaxentan sodium did not affect the anti-ovulatory activity of the oral contraceptive as assessed by the plasma concentrations of follicle stimulating hormone (FSH), luteinising hormone (LH), and progesterone (see section 4.4).
Danish: Thelin påvirkede imidlertid ikke de orale kontraceptivas antiovulationsaktivitet vurderet ved plasmakoncentrationen af det follikelstimulerende hormon (FSH), luteiniserende hormon (LH) og progesteron (se pkt.
English: Digoxin (substrate of p-Glycoprotein): Concomitant administration of Thelin did not alter the pharmacokinetics of digoxin indicating no effect on the p-glycoprotein transporter
Danish: Digoxin (p-glykoprotein-substrat): Samtidig administration af Thelin ændrede ikke digoxins farmakokinetik, hvilket indikerer, at der ingen indvirkning var på p-glykoprotein-transportstof.
English: In placebo-controlled studies, marked decreases in haemoglobin (> 15% decrease from baseline with value < lower limit of normal) were observed in 7% of patients treated with Thelin (N = 149) and 3% of placebo-treated patients (N = 155).
Danish: I placebo-kontrollerede undersøgelser blev markerede fald i hæmoglobin (> 15 % fald fra baseline med værdi < nedre normalgrænse) observeret i 7 % af patienter behandlet med Thelin (N = 149) og 3 % af patienter behandlet med placebo (N = 155).