FrancophonIA/ELRC3.0 huggingface dataset:
English: Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and Tracleer has not been studied in man but co-administration of tacrolimus or sirolimus and Tracleer may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant Tracleer may reduce the plasma concentrations of tacrolimus and sirolimus.
Danish: Tacrolimus, sirolimus: Samtidig administration af tacrolimus eller sirolimus og Tracleer har ikke været undersøgt hos mennesker, men samtidig administration af tacrolimus eller sirolimus og Tracleer kan medføre forhøjede plasmakoncentrationer af bosentan ligesom ved samtidig administration af ciclosporin.
English: Aluminium/Aluminium peel-push blisters containing 14 dispersible tablets.
Danish: Aluminium/aluminium peel-push blistre indeholdende 14 dispergible tabletter.
English: If you stop taking Tracleer
Danish: Hvis De holder op med at tage Tracleer
English: If possible, a glass of water should be taken to ensure that all the medicine has been ingested.
Danish: Om muligt bør der drikkes et glas vand for at sikre at al medicin er indtaget.
English: Dispersible tablet:
Danish: Dispergibel tablet:
English: In a pharmacokinetic crossover study (AC-052-116), 16 healthy adult subjects received 62.5 mg bosentan using the 62.5 mg film-coated tablet formulation or 64 mg bosentan using the 32 mg dispersible tablet formulation.
Danish: I et farmakokinetisk crossover-studie (AC-052-116) fik 16 raske voksne personer 62,5 mg bosentan som 62,5 mg filmovertrukken tablet eller 64 mg bosentan som 32 mg dispergible tabletter.
English: Contents of the pack and other information What Tracleer contains
Danish: Pakningsstørrelser og yderligere oplysninger Tracleer indeholder
English: The dispersible tablet is contained in a child-proof blister.
Danish: Den dispergible tablet er anbragt i et børnesikret blister.
English: Tadalafil: Bosentan (125 mg twice daily) reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration.
Danish: Tadalafil: Bosentan (125 mg to gange dagligt) reducerede tadalafil (40 mg en gang om dagen) systemisk eksponering med 42% og Cmax med 27% efter samtidig administration af flere doser.
English: If possible, you should drink a glass of water to ensure that all the medicine has been taken.
Danish: De skal om muligt drikke et glas vand for at sikre, at al medicin er taget.
English: Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
Danish: Bosentan filmovertrukne tabletter blev evalueret i et åbent ikke-kontrolleret studie med 19 pædiatriske patienter i alderen 3 til 15 år med PAH.
English: In study AC-052-391 (FUTURE 4) conducted in neonates, bosentan concentrations increased slowly and continuously over the first dosing interval, resulting in low exposure (AUC0-12 in whole blood: 164 ng·h/mL, n = 11).
Danish: I studie AC-052-391 (FUTURE 4) udført hos nyfødte steg bosentankoncentrationerne langsomt og kontinuerligt i løbet af det første doseringsinterval, hvilket resulterede i lav eksponering (AUC0-12 i helblod: 164 ng·t/ml, n=11).
English: • cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with Tracleer.
Danish: • ciclosporin (et lægemiddel, der anvendes efter transplantationer samt til behandling af psoriasis), som ikke må tages sammen med Tracleer.
English: The efficacy of Tracleer has not been established in patients with severe PAH.
Danish: Tracleers virkning er ikke undersøgt hos patienter med svær PAH.
English: Tracleer 62.5 mg film-coated tablets EU/1/02/220/001
Danish: Tracleer 62,5 mg filmovertrukne tabletter EU/1/02/220/001
English: Tracleer contains sodium
Danish: Tracleer indeholder natrium
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with Tracleer should be avoided (see section 4.5).
Danish: Samtidig administration af både en CYP3A4- og en CYP2C9-inhibitor og Tracleer bør undgås (se pkt.
English: Peel-push blisters containing 14 dispersible tablets; cartons contain 56 dispersible tablets.
Danish: Peel-push blistre indeholdende 14 dispergible tabletter, æsker indeholder 56 dispergible tabletter.
English: The dispersible tablets should be added to a little water on a spoon, and the liquid stirred to aid dissolution, before swallowing.
Danish: De dispergible tabletter skal tilsættes en smule vand på en ske og væsken omrøres for at fremme opløsning før indtagelse.
English: In male children, a long-term impact on fertility after treatment with bosentan cannot be excluded.
Danish: Hos drengebørn kan det ikke udelukkes, at der på lang sigt er en indvirkning på fertiliteten efter behandling med bosentan.
English: Hold the tablet between the thumb and the index finger on either side of the score line, with the score line facing upwards.
Danish: Hold tabletten mellem tommel- og pegefinger på hver side af delekærven, med delekærven vendende opad.
English: Because of possible hormonal contraception failure during Tracleer treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Danish: Da hormonel prævention muligvis ikke er effektiv under behandling med Tracleer, og også på grund af risikoen for at pulmonal hypertension forværres alvorligt under graviditet, anbefales det, at der udføres månedlige graviditetsprøver under behandlingen med Tracleer for at opdage en graviditet tidligst muligt.
English: Patients with suboptimal response to inhaled nitric oxide (iNO) despite at least 4 hours of continuous treatment were treated with bosentan dispersible tablets at 2 mg/kg twice daily (N = 13) or placebo (N = 8) via nasogastric tube as add-on therapy on top of iNO until complete weaning of iNO or until treatment failure (defined as need for extra-corporeal membrane oxygenation [ECMO] or initiation of alternative pulmonary vasodilator), and for a maximum of 14 days.
Danish: Patienter med suboptimalt respons på inhaleret nitrogenmonoxid (iNO) til trods for mindst 4 timers kontinuerlig behandling blev behandlet med bosentan dispergible tabletter i en dosis på 2 mg/kg to gange dagligt (n = 13) eller placebo (n = 8) via nasogastrisk sonde som tillægsbehandling til iNO, indtil de var fuldstændigt afvænnet fra iNO, eller indtil behandlingssvigt (defineret som behov for ekstrakorporal membranoxygenering [EMCO] eller opstart af anden pulmonal vasodilatator), og i højst 14 dage.
English: Birth control based on hormones - such as oral contraceptives or birth control pills, hormone injections, implants, or birth control skin patches don't reliably prevent pregnancy in women who are taking Tracleer.
Danish: Prævention, der er baseret på hormonelle metoder som f.eks. p-piller, hormonindsprøjtninger, implantater eller plastre til at sætte på huden, er ikke pålidelige til at forebygge graviditet hos kvinder, der er i behandling med Tracleer.
English: • hormonal contraceptives, which are not effective as the sole method of contraception when you take Tracleer.
Danish: • hormonale præventionsmidler, da disse ikke er effektive som eneste præventionsmetode, hvis De tager Tracleer.
English: However, Tracleer can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Danish: Tracleer kan imidlertid medføre hypotension (for lavt blodtryk), som kan gøre Dem svimmel, påvirke Deres syn og påvirke Deres evne til at føre motorkøretøj og betjene maskiner.
English: At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6.
Danish: Ved steady state var AUCτ i helblod 6.165 ng·t/ml (CV 133%, n = 7), hvilket svarer til den eksponering, der blev set hos voksne PAH-patienter, der fik 125 mg to gange dagligt, under hensyntagen til en blod/plasmafordelingsratio på 0,6.
English: White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets.
Danish: Hvide polyethylenflasker af høj densitet med et tørremiddel af silicagel, der indeholder 56 filmovertrukne tabletter
English: Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of Tracleer above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see section 5.2).
Danish: Pædiatriske farmakokinetiske data har vist, at plasmakoncentrationen af bosentan gennemsnitlig var lavere hos børn med PAH i alderen fra 1 år til 15 år end hos voksne patienter, og at koncentrationen ikke øgedes ved en dosisøgning af Tracleer til over 2 mg/kg legemsvægt eller ved øgning af doseringshyppigheden fra to gange dagligt til tre gange dagligt (se pkt.
English: However, Tracleer may induce hypotension, with symptoms of dizziness, blurred vision or syncope that could affect the ability to drive or use machines.
Danish: Dog kan Tracleer medføre hypotension med symptomer som svimmelhed, tågesyn eller synkope, som kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: 33 of these patients were provided with continued treatment with bosentan dispersible tablets at a dose of 4 mg/kg twice daily in the FUTURE 2 uncontrolled extension phase for a median overall treatment duration of 2.3 years (range: 0.2 to 5.0 years).
Danish: 33 af disse patienter fik fortsat behandling med bosentan dispergible tabletter i en dosis på 4 mg/kg to gange dagligt i den ikkekontrollerede forlængelsesfase FUTURE 2 med en gennemsnitlig samlet behandlingsvarighed på 2,3 år (interval: 0,2 til 5,0 år).
English: Tracleer is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease.
Danish: Tracleer anbefales ikke til pædiatriske patienter med systemisk sklerose og aktiv finger/tåsårssygdom.
English: - The other ingredients are cellulose microcrystalline, calcium hydrogen phosphate anhydrous, croscarmellose sodium, silica colloidal anhydrous, tartaric acid, tutti frutti flavour, aspartame (E951, please read further information at the end of section 2), acesulfame potassium, magnesium stearate.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, vandfri calciumhydrogenphosphat, croscarmellosenatrium, vandfri kolloid silica, vinsyre, tutti frutti aroma, aspartam (E951, se yderligere oplysninger i slutningen af pkt.
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: (≥ 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: Some patients taking Tracleer were found to have abnormal liver function tests.
Danish: Nogle patienter, der er i behandling med Tracleer, har unormale leverfunktionsværdier.
English: Glycerol dibehenate Magnesium stearate
Danish: Glyceroldibehenat Magnesiumstearat
English: At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone.
Danish: Ved steady state var plasmakoncentrationen af bosentan 3 til 4 gange højere end ved bosentan alene.
English: During treatment with Tracleer, your doctor will arrange for regular blood tests to check for changes in your liver function and haemoglobin level.
Danish: Under behandling med Tracleer vil Deres læge sørge for regelmæssige blodprøver for at kontrollere forandringer i Deres leverfunktion og hæmoglobinniveau.
English: Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).
Danish: Tracleer er ligeledes indiceret til at reducere antallet af nye fingersår hos patienter med systemisk sklerose og eksisterende fingersår (se pkt.
English: In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3 × ULN were observed in 2% of patients.
Danish: I den samlede analyse af 100 PAH-børn fra de ikke-kontrollerede pædiatriske studier FUTURE 1/2 og FUTURE 3/forlængelse blev der set stigning i leveraminotransferaser til ≥ 3 × ULN hos 2% af patienterne.
English: Concomitant use of rifampicin and Tracleer is not recommended.
Danish: Samtidig brug af Rifampicin og Tracleer frarådes.
English: In the adult placebo-controlled studies, a decrease in haemoglobin concentration to below 10 g/dL from baseline was reported in 8.0% of bosentan-treated patients and 3.9% of placebo-treated patients (see section 4.4).
Danish: I de placebokontrollerede studier med voksne blev der rapporteret et fald i hæmoglobinkoncentrationen til under 10 g/dl fra baseline hos 8,0% af de patienter, som fik bosentan, og hos 3,9% af de patienter, som fik placebo (se pkt 4.4).
English: Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Silica colloidal anhydrous Tartaric acid
Danish: Mikrokrystallinsk cellulose Calciumhydrogenphosphat, vandfri Croscarmellosenatrium Silica, kolloid, vandfri Vinsyre
English: Other medicines and Tracleer
Danish: Brug af anden medicin sammen med Tracleer
English: Before the initiation of Tracleer treatment in women of childbearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.
Danish: Graviditet skal udelukkes, før der indledes behandling med Tracleer hos kvinder i den fertile alder, der skal gives passende rådgivning om pålidelige præventionsmetoder, og pålidelig prævention skal være iværksat.
English: Tracleer is contraindicated in patients with moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 4.3).
Danish: Tracleer er kontraindiceret til patienter med moderat til svær leverinsufficiens, dvs. Child-Pugh klasse B eller C (se pkt.
English: Peel off the top layer.
Danish: Fjern det øverste lag.
English: To remove the dispersible tablet:
Danish: Udpakning af den dispergible tablet:
English: Inside your pack of Tracleer tablets you will find a Patient Alert Card. You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods.
Danish: De skal udfylde dette kort og medbringe det ved Deres næste konsultation, således at lægen eller gynækologen kan vurdere, om De har brug for en supplerende eller anden form for pålidelig prævention.
English: Do not store above 30 °C
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: Separate into halves by breaking the tablet along the break-marks (see figure below).
Danish: Del tabletten i to halvdele ved at knække tabletten langs med delekærven (se nedenstående figur).
English: The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3-15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Danish: Sikkerhedsprofilen i det første pædiatriske, ikke-kontrollerede studie udført med den filmovertrukne tablet (BREATHE-3; n=19, gennemsnitsalder 10 år [interval 3-15 år], åben behandling med bosentan 2 mg/kg legemsvægt to gange dagligt; 12-ugers behandlingsvarighed) var sammenlignelig med den, der blev observeret i de pivotale studier med voksne patienter med PAH.
English: For white high-density polyethylene bottles, use within 30 days after the first opening.
Danish: For hvide polyethylenflasker af høj densitet skal indholdet anvendes inden for 30 dage efter anbrud.
English: In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with PAH WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
Danish: I et prospektivt multicenter, randomiseret, dobbelblindt, placebokontrolleret studie (AC-052-405 [BREATHE-5]) fik patienter med PAH WHO funktionsklasse III og Eisenmenger fysiologi associeret med kongenit hjertesygdom bosentan 62,5 mg to gange dagligt i 4 uger, herefter 125 mg to gange dagligt i yderligere 12 uger (n = 37, af hvilke 31 havde en overvejende højre mod venstre tovejsshunt).
English: A Patient Alert Card providing important safety information that patients need to be aware of before and during treatment with Tracleer is included in the pack.
Danish: Pakningen indeholder et patientadvarselskort med vigtig sikkerhedsinformation, som patienten skal være opmærksom på før og under behandlingen med Tracleer.
English: Tel: +33 (0)1 55 00 26 66
Danish: Tél: +33 (0)1 55 00 26 66
English: The median exposure to study treatment was 4.5 (range: 0.5-10.0) days in the bosentan group and 4.0 (range: 2.5-6.5) days in the placebo group.
Danish: Den gennemsnitlige eksponering for studiebehandlingen var 4,5 (interval: 0,5-10,0) dage i bosentangruppen og 4,0 (interval: 2,5-6,5) dage i placebogruppen.
English: Based on the findings in studies BREATHE-3, FUTURE 1, and FUTURE-3, it appears that the exposure to bosentan reaches a plateau at lower doses in paediatric patients than in adults, and that doses higher than 2 mg/kg twice daily (4 mg/kg twice daily or 2 mg/kg three times daily) will not result in greater exposure to bosentan in paediatric patients.
Danish: Baseret på resultaterne fra BREATHE-3-, FUTURE 1- og FUTURE-3-studierne er det vist, at eksponering for bosentan når sit højeste niveau ved lavere doser hos pædiatriske patienter end hos voksne, og at højere doser end 2 mg/kg to gange dagligt (4 mg/kg to gange dagligt eller 2 mg/kg tre gange dagligt) ikke vil medføre en større eksponering for bosentan hos pædiatriske patienter.
English: Elevations to ≥ 8 × ULN were seen in 3.6% of the bosentan-treated patients and 0.4% of the placebo-treated patients.
Danish: Der blev set stigninger til >8 x ULN hos 3,6% af de bosentanbehandlede patienter og hos 0,4% af de placebobehandlede patienter.
English: • Headache • Oedema (swelling of the legs and ankles or other signs of fluid retention)
Danish: • Hovedpine • Ødem (hævelse af fødder eller ankler eller andre tegn på væskeophobning)
English: Tracleer has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Danish: Der er ikke påvist en fordelagtig virkning af Tracleer på opheling af eksisterende fingersår.
English: Treatment with Tracleer should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Danish: Behandling bør kun påbegyndes og ledes af en læge, som har erfaring inden for behandling af PAH eller systemisk sklerose.
English: In patients between 3 months and 1 year (n = 2) AUCτ was 5,914 ng·h/mL (CV: 85%), and in patients between 1 and 2 years (n = 7) AUCτ was 3,507 ng·h/mL (CV: 70%).
Danish: Hos patienterne mellem 3 måneder og 1 år (n = 2) var AUCτ 5.914 ng·t/ml(CV 85%), og hos patienter mellem 1 og 2 år (n = 7) var AUCτ 3.507 ng·t/ml (CV 70%).
English: Concomitant use of Tracleer and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Danish: Samtidig anvendelse af Tracleer og ciclosporin A er kontraindiceret (se pkt.
English: Tracleer 32 mg dispersible tablets are pale yellow to off-white, clover-shape dispersible tablets, quadrisected on one side and debossed with “32” on the other side.
Danish: Tracleer 32 mg dispergible tabletter er lysegule til råhvide, kløverformede dispergible tabletter med krydsdelekærv på den ene side og præget med ”32” på den anden side.
English: 14 film-coated tablets 56 film-coated tablets 112 film-coated tablets
Danish: 14 filmovertrukne tabletter 56 filmovertrukne tabletter 112 filmovertrukne tabletter
English: A little more water should be added to the spoon and swallowed by the patient, to make sure all of the medicine has been administered.
Danish: Til skeen sættes en lille smule mere vand, som patienten indtager for at sikre at al medicin er administreret.
English: In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml).
Danish: 360 (212-613) ng∙t/ml, dvs. 4,7 gange højere, og det gennemsnitlige (95% CI) AUC af den aktive metabolit Ro 48-5033 var 106 (58,4-192) ng∙t/ml, dvs. 12,4 gange højere end hos patienterne med normal leverfunktion (bosentan: gennemsnitligt [95% CI] AUC: 76,1 [9,07-638] ng∙t/ml; Ro 48-5033:
English: If necessary, the dispersible tablet can be divided by breaking along the lines cut into the surface.
Danish: Om nødvendigt kan den dispergible tablet deles ved at knække den langs med linjerne, der er skåret ind i overfladen.
English: There are no reliable data on the use of Tracleer in pregnant women.
Danish: brug af Tracleer til gravide kvinder.
English: Hormonal contraceptives: Co-administration of bosentan 125 mg twice daily for 7 days with a single dose of oral contraceptive containing norethisterone 1 mg + ethinyl estradiol 35 mcg decreased the AUC of norethisterone and ethinyl estradiol by 14% and 31%, respectively.
Danish: Hormonelle præventionsmidler: Samtidig administration af bosentan 125 mg to gange dagligt i 7 dage og en enkeltdosis af et oralt kontraceptionsmiddel, der indeholdt norethisteron 1 mg + ethinylestradiol 35 µg, reducerede AUC for norethisteron og ethinylestradiol med henholdsvis 14% og 31%.
English: If necessary the dispersible tablet can be divided by breaking it along the lines cut into the surface (see section 6.6).
Danish: Om nødvendigt kan den dispergible tablet deles ved knække den langs med linjerne, der er skåret ind i overfladen (se pkt.
English: • Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function) 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 56 TABLETTER
English: Cyclosporine A: Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Danish: Ciclosporin: Samtidig administration af Tracleer og ciclosporin (en calcineurinhæmmer) er kontraindiceret (se pkt.
English: For all these tests please refer also to the Patient Alert Card (inside your pack of Tracleer tablets).
Danish: Se patientadvarselskortet (i pakken med Tracleer-tabletter) for mere information om alle disse prøver.
English: If the aminotransferase levels return to pre-treatment values continuing or reintroducing Tracleer according to the conditions described below should be considered.
Danish: Hvis aminotransferaseniveauer retableres til de samme niveauer som inden behandlingen, skal det overvejes at fortsætte eller reintroducere Tracleer i henhold til nedenstående betingelser.