FrancophonIA/ELRC3.0 huggingface dataset:
English: The terminal elimination half-life (t½) is 10 hours.
Danish: Den afsluttende elimineringshalveringstid (t½) er 10 timer.
English: Your doctor will advise you about suitable contraception.
Danish: Deres læge vil rådgive Dem om egnet prævention.
English: The absolute bioavailability of Thelin is between 70 and 100%.
Danish: Den absolutte biotilgængelighed af Thelin er mellem 70 og 100 %.
English: For your own safety, it is very important that you have regular blood tests.
Danish: Af hensyn til Deres sikkerhed er det yderst vigtigt, at De får taget regelmæssige blodprøver.
English: Therefore an interaction with such a drug cannot be excluded.
Danish: Interaktion med et sådant lægemiddel kan derfor ikke udelukkes.
English: The dose of these medicines may need to be adjusted by your doctor.
Danish: Dosis af denne medicin skal muligvis justeres af Deres læge;
English: Median Difference from Placebo (95% CI)
Danish: Median forskel fra placebo ( 95% CI)
English: To be written in braille at time of manufacture.
Danish: Skal skrives i braille-skrift på fremstillingstidspunktet.
English: Less than 1% of the dose is excreted as unchanged active ingredient.
Danish: Mindre end 1 % af dosen udskilles som uændret aktivt stof.
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre websites om sjældne sygdomme, og hvordan de behandles.
English: These may be signs that your liver is not working properly.
Danish: Disse symptomer kan være tegn på, at Deres lever ikke fungerer korrekt.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Danish: Behandling bør kun indledes og monitoreres af en læge med erfaring i behandling af PAH.
English: OTHER CONDITIONS
Danish: ANDRE BETINGELSER
English: Clearance of ciclosporin A was unchanged.
Danish: Clearance af ciclosporin er uændret.
English: He or she may want you to stop taking Thelin.
Danish: Han eller hun vil muligvis have, at De stopper med at tage Thelin.
English: Patients in need of the combination should be closely monitored.
Danish: De patienter, der har behov for en kombination, bør monitoreres omhyggeligt.
English: • your blood may take longer to clot.
Danish: • Det kan tage længere for blodet at størkne
English: If necessary, pregnancy testing should be undertaken.
Danish: Om nødvendigt skal der foretages en graviditetstest.
English: Reproduction toxicity has been evaluated in rats only.
Danish: Reproduktionstoksicitet er kun blevet evalueret i rotter.
English: Bottle Label (fix-a form)
Danish: Flaskeetiket (fix-a-form etiket)
English: Interaction with sildenafil may be serious if hypotension occurs beyond a safe level.
Danish: Interaktion med sildenafil kan være alvorlig, hvis der forekommer hypotension udover et sikkert niveau.
English: Symptomatic hepatitis
Danish: Symptomatisk hepatitis
English: You may need to take Thelin for a month or two before feeling any effect.
Danish: Det er muligt, at De skal tage Thelin i en eller to måneder for at mærke en virkning.
English: Frequencies are reported as very common ( 1/10), common (> 1/100, < 1/10), uncommon (> 1/1,000,  1/100), rare (> 1/10,000,  1/1,000), and very rare ( 1/10,000).
Danish: Hyppighederne er rapporteret som 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) og meget sjælden (<1/10.000).
English: This may lead to hepatic failure, which can be fatal, and highlights the need for regular monitoring of transaminases and bilirubin.
Danish: Dette kan føre til leversvigt, som kan være fatalt, og understreger behovet for regelmæssig monitorering af transaminaser og bilirubin.
English: Metabolism and Elimination
Danish: Metabolisme og eliminering:
English: If you miss a dose, take the missed dose as soon as you remember but do not take two tablets in one day.
Danish: Hvis De har glemt en dosis, så tag den så snart, De kommer i tanke om det.Tag ikke to tabletter på én dag.
English: Tell your doctor at once if you are or plan to become pregnant in the near future.
Danish: Fortæl det straks til Deres læge, hvis De er gravid eller planlægger at blive gravid i nær fremtid.
English: During clinical trials, these changes were usually reversible when monitoring and discontinuation guidelines were followed.
Danish: Disse ændringer var som regel reversible i kliniske forsøg, når retningslinjerne for monitorering og behandlingsafbrydelse blev fulgt.
English: If a marked decrease in haemoglobin concentration occurs, further evaluation should be undertaken to determine the cause and need for specific treatment.
Danish: Hvis der forekommer et markant fald i hæmoglobinkoncentration, skal der foretages yderligere evaluering for at fastslå årsagen og behovet for specifik behandling.
English: • If you are taking a high dose of nifedipine.
Danish: • Hvis De tager høje doser af nifedipin.
English: The reduction in mean pulmonary artery pressure of 3 mmHg (6%) was not statistically significant.
Danish: Reduktionen i gennemsnitlig lungearterietryk på 3 mmHg (6 %) var ikke statistisk signifikant.
English: •The need to tell their doctor about any adverse events
Danish: • Nødvendigheden af at fortælle deres læge om alle uønskede hændelser.
English: In PAH patients, peak plasma concentrations are generally achieved within 1-4 hours.
Danish: Hos PAH patienter blev den maksimale plasmakoncentration sædvanligvist opnået inden for 1-4 timer.
English: Your doctor may recommend monthly pregnancy tests while you are taking Thelin.
Danish: Deres læge vil muligvis anbefale månedlige graviditetstester, mens De tager Thelin.
English: Like all medicines, Thelin can cause side effects, although not everybody gets them.
Danish: Thelin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Elderly patients: No dosage adjustment is needed in patients over the age of 65 years.
Danish: Ældre patienter: Der kræves ingen dosisjustering hos patienter over 65 år.
English: Approximately 50-60% of an oral dose is excreted in the urine with the remainder eliminated in the faeces.
Danish: Omkring 50-60 % af en oral dosis udskilles i urinen, og resten elimineres via fæces.
English: Thelin may affect your liver.
Danish: Thelin kan påvirke Deres lever.
English: Two randomized, double-blind, multi-centre, placebo-controlled trials were conducted to demonstrate efficacy.
Danish: To randomiserede, dobbelt-blinde, multicenter, placebo-kontrollerede forsøg blev foretaget for at påvise effekten.
English: Sitaxentan sodium does not penetrate into erythrocytes and does not appear to cross the blood-brain barrier.
Danish: Sitaxentannatrium penetrerer ikke ind i erythrocytter og lader ikke til at krydse blod-hjerne-barrieren.
English: The mechanism of liver toxicity is not fully documented and it might vary between endothelin receptor antagonists.
Danish: Mekanismen ved levertoksicitet er ikke fuldstændigt dokumenteret og kan variere mellem endothelinreceptor-antagonisterne.
English: Following this, the test will continue to be done every three months to check for anaemia (a reduced amount of red blood cells).
Danish: Prøven tages derefter hver tredje måned for at kontrollere, om De har blodmangel (nedsat antal røde blodlegemer).
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFF(ER)
English: Store below 25°C.
Danish: Opbevares under 25°C.
English: Thelin was not carcinogenic when administered to rats for 97-99 weeks or when administered to p53(+/-) transgenic mice for 6 months.
Danish: Thelin var ikke karcinogent ved administration til rotter i 97-99 uger eller ved administration til p53(+/-) transgeniske mus i 6 måneder.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I henhold til ”CHMP Guideline on Risk Management Systems for Medicinal Products for Human Use” skal den opdaterede RMP indsendes samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
English: A total of 145 patients were treated with sitaxentan sodium 100 mg and their long term survival status was assessed for a minimum of 3 years.
Danish: I alt 145 patienter blev behandlet med sitaxentannatrium 100 mg, og deres langtidsoverlevelsesstatus blev vurderet efter minimum 3 år.
English: • blocked nose and nosebleeds
Danish: • Tilstoppet næse og næseblod
English: There are no human data regarding the use of sitaxentan sodium during pregnancy.
Danish: Der er ingen humane data for anvendelse af sitaxentannatrium under graviditet.
English: Cartons contain 14, 28, 56, or 84 tablets.
Danish: Kartonerne indeholder 14, 28, 56, eller 84 tabletter.
English: The effect of Thelin on the outcome of the disease is unknown.
Danish: Virkningen af Thelin på udfaldet af sygdommen kendes ikke.
English: Safety of Thelin has been evaluated in clinical trials of more than 1200 patients with PAH, as well as post-marketing safety data.
Danish: Thelins sikkerhed er vurderet i kliniske forsøg med mere end 1200 patienter med PAH, såvel som i sikkerhedsdata efter markedsføring.
English: The estimates may have been influenced by the initiation of new or additional PAH therapies, which occurred in 24% of patients at one year.
Danish: Skønnene kan være påvirket af initiering af nye eller supplerende PAH-behandlinger, som forekom hos 24 % af patienter efter 1 år
English: Special Populations
Danish: Specielle populationer;
English: Blister Carton
Danish: BLISTER-KARTON
English: In this total population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 85% and 78% respectively.
Danish: I denne samlede population var Kaplan-Meier-skønnet for overlevelse efter 1, 2 og 3 år henholdsvis 96 %, 85 % og 78 %.
English: The degree of binding is independent of concentration in the clinically relevant range.
Danish: Bindingsgraden er uafhængig af koncentration inden for det klinisk relevante værdiområde.
English: There was no change in Cmax or AUC for the active metabolite, n-desmethylsildenafil.
Danish: Der var ingen ændring i Cmax eller AUC for den aktive metabolit n-desmethylsildenafil.
English: Sitaxentan sodium is more than 99% protein bound to plasma proteins, predominantly albumin.
Danish: Sitaxentannatrium er mere end 99 % proteinbundet til plasmaproteiner, hovedsagligt til albumin.
English: There is no specific experience with the management of Thelin overdose.
Danish: Der er ingen specifik erfaring med håndtering af overdosering af Thelin.
English: •That Thelin is teratogenic
Danish: • At Thelin er teratogent.
English: Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom
Danish: Pfizer Limited Sandwich Kent, CT13 9NJ Storbritannien
English: Thelin is a potent (Ki 0.43 nM) and highly selective ETA antagonist (approximately 6,500-fold more selective for ETA as compared to ETB).
Danish: Thelin er en potent (Ki 0,43 nM) og yderst selektiv ETA-antagonist (omkring 6.500 gange mere selektiv for ETA sammenlignet med ETB).
English: The change in AUC was not considered clinically significant.
Danish: Ændringen i AUC blev ikke betragtet som klinisk signifikant.
English: If you miss a period or think you may be pregnant, contact your doctor right away.
Danish: Hvis De ikke får menstruation eller tror, at De måske er gravid, skal De straks kontakte Deres læge.
English: Recommendations in case of treatment-emergent ALT/AST elevations: If ALT/AST measurements rise to the following levels then changes to the monitoring or treatment are given:
Danish: Anbefalinger i tilfælde af ALAT/ASAT forhøjelse, som opstår under behandling: Hvis ALAT-/ASAT-målinger stiger til følgende niveauer, bør der foretages ændringer af monitorering eller behandling:
English: It is recommended that haemoglobin concentrations be checked prior to treatment, after 1 and 3 months, and every 3 months thereafter.
Danish: Det anbefales, at hæmoglobinkoncentrationen kontrolleres inden behandling, igen efter 1 og 3 måneder, og derefter hver tredje måned.
English: Thelin was teratogenic at the lowest tested dose in rats, corresponding to exposures more than 30 times the human exposure.
Danish: Thelin var teratogent ved den lavest testede dosis i rotter, svarende til eksponering på mere end 30 gange den menneskelige eksponering.
English: If you stop taking Thelin Talk to your doctor before stopping treatment.
Danish: Hvis De holder op med at tage Thelin Tal med Deres læge, inden De stopper behandlingen.
English: The most common metabolic products are at least 10 times less potent as ETA antagonists than sitaxentan sodium in a standard in vitro test of activity.
Danish: De mest almindelige metaboliske produkter er mindst 10 gange mindre potente som ETA-antagonister end sitaxentannatrium i en standard in vitro-aktivitetstest.
English: Pharmacotherapeutic group: Other antihypertensives, ATC code: C02KX03
Danish: Farmakoterapeutisk klassifikation: Andre antihypertensiver, ATC-kode: C02KX03
English: • swelling in the arms and legs
Danish: • Hævelse i arme og ben
English: Do not take Thelin if you are taking Ciclosporin A.
Danish: De må ikke tage Thelin, hvis De tager ciclosporin.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • Inden for 60 dage efter at en vigtig milepæl er nået i forbindelse med pharmacovigilance eller risikominimering
English: In vitro and in vivo tests on genetic toxicology did not provide any evidence for a clinically relevant genotoxic potential.
Danish: In vitro- og in vivo-test af genetisk toksikologi gav ingen beviser på et klinisk relevant genotoksisk potentiale.
English: Your doctor will take blood tests to check that your liver is working properly, before and during treatment with Sitaxentan sodium.
Danish: Deres læge vil tage blodprøver for at kontrollere, at Deres lever fungerer korrekt inden og under behandling med sitaxentannatrium.
English: Long-term survival:There are no randomised studies to demonstrate beneficial effects on survival of treatment with sitaxentan sodium.
Danish: Langtidsoverlevelse: Der er ingen randomiserede forsøg til at påvise gunstig virkning på overlevelse ved behandling med sitaxentannatrium.
English: PVR (dyne*sec/cm
Danish: PVR (dyn*sek/cm
English: Dose-dependent malformations of the head, mouth, face and large blood vessels occurred.
Danish: Dosisafhængige misdannelser af hovedet, munden, ansigtet og store blodkar forekom.
English: In the case of clinical deterioration despite Thelin treatment for at least 12 weeks, alternative therapies should be considered.
Danish: Ved klinisk forværring på trods af Thelinbehandling i mindst 12 uger bør andre behandlingsmuligheder overvejes.
English: Effects of Thelin on other medicinal products
Danish: Virkninger af Thelin på andre andre lægemidler
English: Thelin lowers the blood pressure by widening these vessels, so your heart can pump blood more effectively.
Danish: Thelin sænker blodtrykket ved at udvide disse kar, så Deres hjerte kan pumpe blod mere effektivt.
English: Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity.
Danish: Behandling af patienter med pulmonal arteriel hypertension (PAH) klassificeret som WHOfunktionsklasse III for at forbedre fysisk funktionsevne.
English: In the event of overdose, symptomatic and supportive measures should be employed.
Danish: I tilfælde af overdosering skal der tages understøttende foranstaltninger.
English: Insomnia, dizziness
Danish: Insomni, svimmelhed
English: EXP: {MM/YYYY}
Danish: EXP: {MM/ÅÅÅÅ}:
English: Very common side effects (likely to affect more than 1 in 10 patients): • headache
Danish: Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 patienter): • Hovedpine
English: Do not use Thelin after the expiry date which is stated on the blister pack, bottle or carton after EXP.
Danish: Brug ikke Thelin efter den udløbsdato, der står på blisterkortet, beholderen eller kartonen.
English: • If you develop liver problems or symptoms that might relate to the liver (see ‘Testing for liver problems', below);
Danish: • Hvis De får leverproblemer eller symptomer, som kan være relateret til leveren (se ‘Test for leverproblemer' nedenfor);
English: In both STRIDE-1 and STRIDE-2 trials, treatment with Thelin resulted in a significant increase in exercise capacity.
Danish: I både STRIDE-1 og STRIDE-4 resulterede behandling med Thelin i betydelig forøgelse af fysisk funktionsevne.
English: This blood test will be done before treatment, then one month and three months after you start taking Thelin tablets.
Danish: Denne blodprøve tages inden behandling og igen én måned og tre måneder efter, at De begynder at tage Thelintabletter.
English: Vitamin K antagonists
Danish: Vitamin K-antagonister:
English: The usual dose is a 100 mg tablet once a day.
Danish: Den sædvanlige dosis er en 100 mg tablet én gang om dagen.
English: Liver function abnormalities have been associated with PAH.
Danish: Abnormiteter i leverfunktion er blevet forbundet med PAH.
English: This was tested for low-dose nifedipine only.
Danish: Dette blev kun undersøgt for en lav dosis af nifedipin.
English: However, a number of patients who showed no response by week 12 of treatment with Thelin responded favourably by week 24, so an additional 12 weeks of treatment may be considered.
Danish: En række patienter, som ikke udviste nogen reaktion ved uge 12 af behandling med Thelin, reagerede dog favorabelt ved uge 24.
English: Pulmonary arterial hypertension is the term used when the heart struggles to pump blood to the lungs.
Danish: Pulmonal arteriel hypertension er betegnelsen, der bruges, når hjertet har svært ved at pumpe blod til lungerne.
English: Given a theoretical higher risk for thromboembolism, traditional concomitant use of vitamin K antagonists should be considered.
Danish: Med den teoretisk højere risiko for tromboembolisme taget i betragtning, bør traditionel samtidig brug af vitamin K-antagonister overvejes.
English: Testicular tubular atrophy was observed in rats, but not in mice or dogs.
Danish: Testikulær tubulær atrofi blev observeret i rotter, men ikke i mus eller hunde.
English: Always take Thelin exactly as your doctor has told you.
Danish: Tag altid Thelin nøjagtigt efter lægens anvisning.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det pharmacovigilancesystem, der er beskrevet i version 2.0 og er præsenteret i Modul 1.8.2 af markedsføringstilladelsen, er på plads og fungerer før, og mens produktet er på markedet.
English: Sitaxentan sodium is rapidly absorbed following oral administration.
Danish: Sitaxentannatrium absorberes hurtigt efter oral indgivelse.
English: Systemic vascular resistance (-276 dynes*sec/cm
Danish: Systemisk vaskulær modstand (-276 dyn*sek/cm
English: If necessary, pregnancy testing should be undertaken (see Section
Danish: Om nødvendigt skal der foretages en graviditetstest (se pkt.
English: These medicines may interfere with the effect of Thelin.
Danish: Denne medicin kan påvirke virkningen af Thelin.
English: Pulmonary veno-occlusive disease (PVOD)
Danish: Pulmonal veneokklusiv sygdom (PVOD):
English: This includes medicines you bought without a prescription, herbal remedies and vitamins.
Danish: Dette gælder også medicin, som ikke er købt på recept, naturlægemidler og vitaminer.
English: PVC/ACLAR/paper-backed aluminium blisters containing 14 tablets.
Danish: PVC/ACLAR/papirbagbeklædte aluminium-blisterkort indeholdende 14 tabletter.
English: Re-introduction of treatment with Thelin should only be considered if the potential benefits of treatment with Thelin outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Danish: Genoptagelse af behandling med Thelin bør kun overvejes, hvis de potentielle fordele ved behandling med Thelin opvejer de potentielle risici derved, og når aminotransferaseniveauer i leveren er inden for værdierne inden behandling.
English: Re-introduction of treatment:
Danish: Genoptagelse af behandling:
English: Pharmacovigilance Plan or risk minimisation activities
Danish: pharmacovigilanceplanen eller risikominimeringsaktiviteter
English: Among patients with PAH associated with CTD in STRIDE-1 and STRIDE-2, a statistically significant difference versus placebo was observed (37.73 metres, p < 0.05).
Danish: Blandt patienter med PAH samt CTD i STRIDE-1 og STRIDE-2, blev der observeret en statistisk signifikant forskel versus placebo (37,73 meter, p<0,05).
English: Mild to severe hepatic impairment (Child-Pugh Class A-C).
Danish: Mildt til alvorligt nedsat leverfunktion (Child-Pugh klasse A-C).
English: Based on results of the population pharmacokinetic analysis and pooled pharmacokinetic data over several studies, it was found that gender, race, and age do not clinically significantly affect the pharmacokinetics of sitaxentan sodium.
Danish: Det blev på grundlag af resultaterne af den farmakokinetiske populationsanalyse samt de farmakokinetiske data kombineret fra flere forsøg fundet, at køn, race og alder ikke påvirker farmakokinetikken af sitaxentannatrium i klinisk betydelig grad
English: Because treatment-associated elevations of AST and/or ALT are a marker for potential serious liver injury, liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals.
Danish: Da behandlingsrelaterede forhøjelse af ASAT og/eller ALAT er en markør for potentielt alvorlige leverskader, skal lever-aminotransferaseniveauer måles, inden behandlingen påbegyndes og derefter månedligt.
English: These changes in sildenafil plasma concentrations were not considered clinically significant.
Danish: Disse ændringer i sildenafils plasmakoncentration blev ikke betragtet som klinisk signifikante.
English: No unexpected accumulation in the plasma was observed after multiple dosing at the recommended dose of 100 mg once daily.
Danish: Ingen uventet ophobning i plasma blev observeret efter flere doseringer ved den anbefalede dosis på 100 mg én gang dagligt.
English: During clinical trials, Thelin was given as a daily oral dose of 1000 mg/day for 7 days to healthy volunteers.
Danish: I de kliniske forsøg blev Thelin givet som en daglig oral dosis på 1.000 mg i 7 dage til raske frivillige.
English: Improvements in functional class were observed across all studies (STRIDE-1, STRIDE-2 & STRIDE-4).
Danish: Forbedring af funktionsklasse blev set i alle studier (STRIDE-1, STRIDE-2 og STRIDE-4).
English: However, at doses of 300 mg or higher, non-linear pharmacokinetics result in disproportionately higher plasma concentrations of sitaxentan sodium.
Danish: Ved doser på 300 mg eller mere resulterer ikke-lineær farmakokinetik dog i uproportionelt højere koncentrationer af sitaxentannatrium i plasma.
English: Thelin is used to help lower blood pressure in the blood vessels when this pressure is raised in pulmonary arterial hypertension (PAH).
Danish: Thelin bruges til at sænke blodtrykket i blodkarrene, når dette tryk er forhøjet ved pulmonal arteriel hypertension (PAH).
English: These survival estimates were similar in the subgroup of patients with PAH associated with CTD for the Thelin treated group (98%, 78% and 67% respectively).
Danish: Disse overlevelsesestimater svarede til estimaterne i undergruppen af patienter med PAH sammen med CTD for gruppen behandlet med Thelin (henholdsvis 98 %, 78 % og 67 %).
English: If you notice any of these signs:
Danish: Hvis De bemærker nogle af disse symptomer:
English: Higher doses did not confer additional benefit sufficient to offset the increased risk of adverse reactions, particularly liver injury (see section 4.4).
Danish: Højere doser gav ikke flere fordele, som var tilstrækkelige til at opveje den øgede risiko for bivirkninger, særligt leverskader (se pkt.
English: The most common adverse effects at this dose were headache, nausea, and vomiting.
Danish: De mest almindelige bivirkninger ved denne dosis var hovedpine, kvalme og opkastning.