FrancophonIA/ELRC3.0 huggingface dataset:
English: You are advised to stop breast-feeding if Tracleer 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 Tracleer, da det ikke vides, om medicinen går over i mælken.
English: Treatment must be stopped and re-introduction of Tracleer is not to be considered.
Danish: Behandlingen skal afbrydes, og det skal ikke overvejes at reintroducere Tracleer.
English: Tracleer tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Danish: Tracleer tabletter indeholder bosentan, som blokerer virkningen af det naturligt forekommende hormon endothelin-1 (ET-1), som er årsag til forsnævring af blodkarrene.
English: These cases reinforce the importance of strict adherence to the monthly schedule for monitoring of liver function for the duration of treatment with Tracleer (see section 4.4).
Danish: Disse tilfælde understreger betydningen af nøje overholdelse af månedlig monitorering af leverfunktionen under behandling med Tracleer (se pkt.
English: The same recommendations apply to re-introduction of Tracleer after treatment interruption (see section 4.4).
Danish: De samme anbefalinger gør sig gældende ved reintroduktion af Tracleer efter behandlingsafbrydelse (se pkt.
English: Therefore, concomitant use of Tracleer and tacrolimus or sirolimus is not advisable.
Danish: Derfor er samtidig anvendelse af Tracleer og tacrolimus eller sirolimus ikke tilrådelig.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
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 placebobehandlede patienter.
English: When treatment with Tracleer is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer 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 Tracleer initieres hos patienter, som kræver ritonavir-boostede proteaseinhibitorer, bør patientens tolerabilitet over for Tracleer nøje monitoreres i begyndelsen af initieringsfasen med særlig opmærksomhed på risikoen for hypotension og med leverfunktionstest.
English: The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant Tracleer treatment.
Danish: Det kan være nødvendigt at justere dosis af disse produkter efter påbegyndelse af behandlingen, ved dosisændring, eller ved seponering af samtidig Tracleer behandling.
English: Consequently, should signs of pulmonary oedema occur when Tracleer is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered.
Danish: Skulle der forekomme tegn på pulmonært ødem, når Tracleer administreres til patienter med PAH, bør muligheden for associeret veno-okklusiv sygdom derfor tages i betragtning.
English: These elevations in aminotransferases may reverse spontaneously while continuing treatment with the maintenance dose of Tracleer 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 Tracleer eller efter dosisreduktion, men afbrydelse eller ophør kan være nødvendig (se pkt.
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-1koncentrationer og sygdommens sværhedsgrad og prognoser.
English: Re-introduction of treatment with Tracleer should only be considered if the potential benefits of treatment with Tracleer outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Danish: Reintroduktion af behandling med Tracleer bør kun overvejes, hvis de potentielle fordele ved behandling med Tracleer opvejer de potentielle risici, og hvis leveraminotransferaseniveauerne er inden for de samme værdier som før behandlingens start.
English: Each Tracleer dispersible tablet can be dissolved in water to make a liquid medicine.
Danish: Hver Tracleer dispergibel tablet kan opløses i vand for at få en flydende medicin.
English: Tracleer contains aspartame and sodium
Danish: Tracleer indeholder aspartam og natrium
English: You should have a pregnancy test before initiation of Tracleer 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 Tracleer og månedligt under behandlingen, selv om De ikke tror, at De er gravid.
English: Patients and prescribers must be aware that due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see section 4.5).
Danish: Patienten og den ordinerende læge skal være opmærksom på, at Tracleer, på grund af de mulige farmakokinetiske interaktioner, kan gøre de hormonale præventionsmetoder ineffektive (se pkt.
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: Tutti frutti flavour
Danish: Tutti frutti aroma
English: • a pregnancy test if you are a woman of childbearing potential Some patients taking Tracleer have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Danish: • en graviditetstest, hvis De er en kvinde i den fødedygtige alder Hos nogle patienter, som tager Tracleer, har man fundet unormale leverfunktionsprøver og blodmangel (lavt hæmoglobin).
English: Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking Tracleer.
Danish: Deres læge eller gynækolog vil fortælle Dem om pålidelige svangerskabsforbyggende metoder, der skal bruges, mens De tager Tracleer.
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 Tracleer.
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 Tracleer.
English: Separate the individual blister cavity at the perforations.
Danish: Skil den enkelte blisterdel ad ved perforationen.
English: In this study there was an increased incidence 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: Please read the information under “Contraceptives” and “Other medicines and
Danish: Læs venligst oplysningerne under "Prævention" og "Brug af anden medicin sammen med Tracleer"
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 PAHmedicin (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 PAHbehandling under studiet.
English: Each dispersible tablet can be dissolved in water to make a liquid medicine, by adding the tablet to a little water on a spoon, using enough water to cover the whole tablet.
Danish: Hver dispergibel tablet kan opløses i vand for at fremstille en flydende medicin ved at tilsætte tabletten en smule vand på en ske under anvendelse af nok vand til at dække hele tabletten.
English: When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be monitored.
Danish: Ved samtidig administration af lopinavir+ritonavir eller andre ritonavir-boostede proteaseinhibitorer skal patientens tolerabilitet over for Tracleer monitoreres.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Tracleer 32 mg dispersible tablets contain a source of phenylalanine (Aspartame - E951).
Danish: Tracleer 32 mg dispergible tabletter indeholder en fenylalaninkilde (aspartam - E951).
English: There is limited clinical study experience with the use of Tracleer 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 Tracleer hos patienter med PAH associeret med hiv-infektion behandlet med antiretrovirale lægemidler (se pkt.
English: The remaining parts of a divided dispersible tablet can be stored at room temperature and should be used within 7 days.
Danish: Resterende dele af en delt dispergibel tablet kan opbevares ved stuetemperatur og bør anvendes inden for 7 dage.
English: Monthly pregnancy tests are recommended while you are taking Tracleer and are of childbearing age.
Danish: Det anbefales, at der udføres månedlige graviditetsprøver, så længe De tager Tracleer og er i den fødedygtige alder.
English: Patients in need of the combination should be closely monitored for adverse events related to Tracleer and for tacrolimus and sirolimus blood concentrations.
Danish: Patienter, der har behov for kombinationen, skal overvåges nøje med hensyn til bivirkninger, der er relateret til Tracleer samt plasmakoncentrationer af tacrolimus og sirolimus.
English: These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking Tracleer may get anaemia.
Danish: Disse foretages hver måned i de første 4 måneder af behandlingen, derefter hver 3. måned, da patienter, som tager Tracleer, kan få blodmangel.
English: • Tracleer treatment must not be initiated in women of childbearing potential unless they practise reliable contraception and the result of the pre-treatment pregnancy test is negative
Danish: • Tracleer-behandling må ikke påbegyndes hos kvinder i den fertile alder, medmindre de bruger pålidelig prævention, og en graviditetsprøve inden behandlingens start er negativ
English: Please note that Tracleer is also available as a dispersible 32 mg tablet formulation, which may make correct dosing easier for children and patients with low body weight or difficulties to swallow filmcoated tablets.
Danish: Bemærk, at Tracleer også fås som en dispergibel tablet på 32 mg, som gør det nemmere at give den korrekte dosering til børn og patienter med lav kropsvægt.
English: 43 (67.2%) were ≥ 2 years to 11 years old, 15 (23.4%) were between 1 and 2 years old, and 6 (9.4%) were between 3 months and 1 year old.
Danish: 43 (67,2%) var ≥ 2 år til 11 år, 15 (23,4%) var mellem 1 og 2 år, og 6 (9,4%) var mellem 3 måneder og 1 år.
English: Тел.
Danish: Teл.
English: For children aged 1 year and older, treatment with Tracleer is usually started with 2 mg per kg bodyweight twice daily (morning and evening).
Danish: Hos børn i alderen 1 år og derover starter behandlingen med Tracleer sædvanligvis med 2 mg pr. kg legemsvægt to gange dagligt (morgen og aften).
English: A bioavailability comparison between dispersible tablets and film-coated tablets performed in adult subjects indicated lower exposure to bosentan with the dispersible tablet (see section 5.2).
Danish: En sammenligning af biotilgængeligheden mellem dispergible tabletter og filmovertrukne tabletter udført hos voksne personer viste, at eksponeringen for bosentan var lavere med de dispergible tabletter (se pkt.
English: Tracleer is contraindicated in pregnancy (see section 4.3).
Danish: Tracleer er kontraindiceret under graviditet (se pkt.
English: The dispersible tablet can be divided into four equal parts.
Danish: Den dispergible tablet kan deles i fire lige store dele.
English: Therefore, if you feel dizzy or that your vision is blurred while taking Tracleer, do not drive or operate any tools or machines.
Danish: Hvis De bliver svimmel eller får tågesyn, når De tager Tracleer, må De hverken køre bil eller betjene værktøj eller maskiner.
English: • Hormonal contraceptives cannot be the sole method of contraception during treatment with Tracleer
Danish: • Hormonelle antikonceptiva må ikke være den eneste præventionsmetode under behandlingen med Tracleer
English: For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended.
Danish: Af samme årsag kan samtidig administration af både en stærk CYP3A4-inhibitor (som f.eks. ketoconazol, itraconazol eller ritonavir) og en CYP2C9-inhibitor (som f.eks. voriconazol) sammen med Tracleer ikke anbefales.
English: Following treatment with the dispersible tablet, exposure to bosentan was lower than with the film-coated tablet (ratio of geometric means for AUC0-∞ 0.87 [90% CI: 0.78, 0.97]).
Danish: Efter behandling med den dispergible tablet var eksponeringen for bosentan lavere end med den filmovertrukne tablet (geometrisk middelværdiratio for AUC0-∞ 0,87 [90% CI: 0,78-0,97]).
English: Some patients not responding well to 125 mg twice daily of Tracleer may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily.
Danish: Nogle patienter, der ikke responderer godt på 125 mg Tracleer to gange dagligt, kan forbedre deres arbejdskapacitet lidt, hvis dosis øges til 250 mg to gange dagligt.
English: At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23, 64%) or class III (n = 13, 36%).
Danish: Ved baseline havde patienterne idiopatisk (31 patienter [86%]) eller familiær (5 patienter [14%]) PAH og var i WHOfunktionsklasse II (n=23, 64%) eller III (n=13, 36%).
English: • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with Tracleer.
Danish: • sirolimus eller tacrolimus (lægemidler, der anvendes efter transplantationer), da det ikke anbefales at bruge disse sammen med Tracleer.
English: In the post-marketing period rare cases of liver cirrhosis and liver failure have been reported.
Danish: I postmarketingperioden blev der rapporteret om sjældne tilfælde af levercirrose og leversvigt.
English: > 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue Tracleer, possibly at a reduced dose, or to stop Tracleer administration (see section 4.2).
Danish: > 3 og ≤ 5 × ULN Resultatet skal bekræftes med en ekstra leverfunktionstest; hvis bekræftet, skal der tages en beslutning på individuel basis om at fortsætte med Tracleer, eventuelt med reduceret dosis, eller seponere Tracleer (se pkt.
English: • Monthly pregnancy tests are recommended during treatment to allow early detection of pregnancy
Danish: • Det anbefales at udføre månedlige graviditetsprøver med henblik på tidlig konstatering af graviditet
English: Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when Tracleer is co-administered.
Danish: Derfor vil plasmakoncentrationer af stoffer, som omsættes af disse isoenzymer, nedsættes ved samtidig indgift af Tracleer.
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: 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 CYPisoenzymer, som blev testet (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1 og 3A4).
English: Hold the tablet between the thumb and index finger on either side of one of the lines, with the line facing upwards, and break the tablet along the line (see figure below).
Danish: Hold tabletten mellem tommel- og pegefinger på hver side af en af linjerne med linjerne pegende opad, og knæk tabletten langs med linjen (se figuren nedenfor).
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking Tracleer.
Danish: Hvis De kan blive gravid, skal De anvende en pålidelig svangerskabsforebyggende metode (prævention), mens De tager Tracleer.
English: If you forget to take Tracleer, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Danish: Hvis De har glemt at tage Tracleer, skal De gøre det, så snart De kommer i tanke om det og derefter på de normale tidspunkter.
English: Study performed in neonates with persistent pulmonary hypertension of the newborn (PPHN):
Danish: Studie udført hos nyfødte med persisterende pulmonal hypertension hos nyfødte (PPHN):
English: If you forget to take Tracleer
Danish: Hvis De har glemt at tage Tracleer
English: Women of childbearing age
Danish: Kvinder i fertil alder
English: No specific studies have been conducted to assess the direct effect of Tracleer on the ability to drive and use machines.
Danish: Der er ikke udført specifikke studier af Tracleers direkte virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Add a little more water to the spoon and swallow all of the liquid to make sure all of the medicine has been taken.
Danish: Tilsæt derefter lidt mere vand på skeen og synk al væsken for at sikre, at al medicin er taget.
English: In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with Tracleer who had a suspected diagnosis of pulmonary veno-occlusive disease.
Danish: I post marketing perioden har der været sjældne rapporter om pulmonært ødem hos patienter i behandling med Tracleer, og som havde pulmonær veno-okklusiv sygdom som formodet diagnose.
English: Please read this card carefully before starting your treatment with Tracleer.
Danish: De skal læse det grundigt, inden De starter behandling med Tracleer.
English: No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
Danish: Der blev ikke set dosisproportionalitet, idet steady-stateplasmakoncentrationerne af bosentan og AUC'erne var ens ved orale doser på 2 og 4 mg/kg (AUCτ: 3,577 ng·t/ml og 3,371 ng·t/ml for hhv. 2 mg/kg to gange dagligt og 4 mg/kg to gange dagligt).
English: In this total population, Kaplan-Meier estimates of survival were 93% and 84% 1 and 2 years after the start of treatment with bosentan, respectively.
Danish: I denne samlede population var KaplanMeier estimater vedrørende overlevelse henholdsvis 93% og 84% henholdsvis 1 og 2 år efter behandlingsstart med bosentan.
English: Concomitant use of Tracleer with glibenclamide, fluconazole and rifampicin is not recommended.
Danish: Samtidig anvendelse af Tracleer og glibenclamid, fluconazol og rifampicin anbefales ikke.
English: There is limited experience with abrupt discontinuation of Tracleer in patients with PAH.
Danish: Der er begrænset erfaring med pludselig seponering af Tracleer hos patienter med PAH.
English: Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with Tracleer.
Danish: Leveraminotransferaseniveauer skal måles inden behandlingens start og derefter med månedlige intervaller under hele behandlingsforløbet med Tracleer.
English: As Tracleer 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 Tracleer 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: Tracleer reduces the number of new finger and toe ulcers that appear.
Danish: Tracleer nedsætter antallet af forekomsten af nye finger- og tåsår.
English: In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN during treatment, but one case of hepatitis occurred 3 days after the end of bosentan treatment.
Danish: I FUTURE-4-studiet, der omfattede 13 nyfødte med PPHN, der blev behandlet med bosentan 2 mg/kg to gange dagligt i under 10 dage (interval 0,5-10,0 dage), var der ingen tilfælde af leveraminotransferaser ≥ 3 × ULN under behandlingen, men der indtrådte ét tilfælde af hepatitis 3 dage efter, bosentanbehandlingen var afsluttet.
English: Pharmacokinetic data are not available for Tracleer in young children with this disease.
Danish: Farmakokinetiske data fra yngre børn med denne sygdom er ikke tilgængelige for Tracleer.
English: The overall goal of the Patient Alert Card is to educate patients on important safety information that they need to be aware of before and during treatment with Tracleer.
Danish: Det overordnede mål med patientadvarselskortet er at oplyse patienterne om at være opmærksomme på vigtig sikkerhedsinformation før og under behandlingen med Tracleer.
English: Tracleer is used to treat patients with class III PAH to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Danish: Tracleer bruges til at behandle patienter med klasse III PAH med henblik på at forbedre evnen til at udføre fysisk aktivitet og bedre symptomerne.
English: Because Tracleer may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Danish: Da Tracleer kan gøre hormonelle præventionsmidler (f. eks. tabletter, indsprøjtninger, implantater eller hudplastre) uvirksomme, er denne metode alene ikke pålidelig.
English: Tracleer has no or negligible influence on the ability to drive and use machines.
Danish: Tracleer påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with Tracleer.
Danish: Behandling med diuretika bør overvejes hos patienter med konstateret væskeretention før initiering af behandling med Tracleer.
English: To make a liquid medicine, add the tablet to a little water on a spoon.
Danish: For at få en flydende medicin tilsættes tabletten en smule vand på en ske.
English: Tracleer 125 mg film-coated tablets EU/1/02/220/004
Danish: Tracleer 125 mg filmovertrukne tabletter EU/1/02/220/004