natgillin/translations-raw huggingface dataset:
I 20 placebo-kontrollerede undersøgelser ved forskellige terapeutiske indikationer blev i alt 2.486 patienter behandlet med bosentan i daglige doser fra 100 mg til 2.000 mg, og 1.838 patienter blev behandlet med placebo.
In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
Forøgelser af leveraminotransferaser, dvs. aspartat- og alaninaminotransferaser (ASAT og/eller ALAT) i forbindelse med bosentan er dosisafhængige.
Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent.
Leveraminotransferaseniveauer skal måles inden behandlingens start og derefter med månedlige intervaller under hele behandlingsforløbet med STAYVEER.
Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with STAYVEER.
Deres læge og/eller gynækolog vil sørge for en passende præventionsmetode til Dem.
Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
Tabletterne kan tages i forbindelse med eller uden for måltider.
The tablets can be taken with or without food.
Efter 16 ugers behandling var der signifikante forbedringer fra udgangsværdier for arbejdskapacitet: Den gennemsnitlige øgning i 6 minutters gangdistance +91,4 m fra 332,6 m i gennemsnit ved udgangsværdier (p<0,001).
After 16 weeks' treatment, there were significant improvements from baseline in exercise capacity: the mean increase in 6-minute walk distance was 91.4 metres from 332.6 metres on average at baseline (p < 0.001).
I et dyreforsøg med lungefibrose nedsatte bosentan collagenaflejringen i lungerne.
In an animal model of pulmonary fibrosis, bosentan reduced collagen deposition in the lungs.
- Øvrige indholdsstoffer, tabletkerne: majsstivelse, prægelatineret stivelse, natriumstivelsesglycolat (type A), povidon, glyceroldibehenat og magnesiumstearat.
- The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycolate (Type A), povidone, glycerol dibehenate and magnesium stearate.
Et åbent, non-komparativt studie (AC-052-362 [BREATHE-4]) blev udført med 16 patienter med WHO funktionsklasse III PAH associeret med hiv-infektion.
An open-label, non-comparative study (AC-052-362 [BREATHE-4]) was performed in 16 patients with WHO functional class III PAH associated with HIV infection.
Der blev ikke set dosisproportionalitet, idet steady-state-plasmakoncentrationerne 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).
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).
Der er ikke udført specifikke undersøgelser hos patienter med pulmonal hypertension og samtidig dysfunktion af venstre ventrikel.
No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction.
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.
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.
I post marketing perioden har der været sjældne rapporter om pulmonært ødem hos patienter i behandling med STAYVEER, og som havde pulmonær veno-okklusiv sygdom som formodet diagnose.
In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with STAYVEER who had a suspected diagnosis of pulmonary veno-occlusive disease.
Patienterne blev delt i tre grupper afhængigt af legemsvægt og fik administreret bosentan i en dosis på cirka 2 mg/kg to gange dagligt i 12 uger.
Patients were divided into three body-weight groups and dosed with bosentan at approximately 2 mg/kg twice daily for 12 weeks.
I denne undersøgelse manifesterede væskeretention sig som tidlig vægtøgning, nedsat hæmoglobinkoncentration og øget forekomst af ødemer i ben.
In this study, fluid retention was manifested by early weight gain, decreased haemoglobin concentration and increased incidence of leg oedema.
• Levercirrhose (skrumpelever), leversvigt (alvorlig forstyrrelse af leverfunktionen)
• Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
Plasmakoncentrationen af ciclosporin (et CYP3A4-substrat) faldt med cirka 50%.
The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%.
• Forhøjede leverfunktionsprøver med hepatitis (leverbetændelse), herunder mulig forværring af underliggende hepatitis, og/eller gulsot (gulfarvning af huden eller det hvide i øjnene)
• Elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes)
Som følge af nevirapins udtalte hepatotoksicitet, som vil kunne forstærkes af bosentans hepatotoksicitet, frarådes denne kombination.
Due to the marked hepatotoxicity of nevirapine, which could add to bosentan liver toxicity, this combination is not recommended.
Kaplan-Meier-estimatet (hændelsesfri) for forværring af PAH (død, lungetransplantation eller hospitalsindlæggelse på grund af PAH-forværring) efter 24 uger var hhv. 96,9% og 96,7% i grupperne med dosering to gange dagligt og tre gange dagligt.
The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 24 weeks was 96.9% and 96.7% in the twice daily and three times daily groups, respectively.
Virkningen af moderat nedsat leverfunktion (Child-Pugh klasse B) på farmakokinetikken af bosentan og dets primære metabolit Ro 48-5033 er blevet undersøgt i et studie, der omfattede 5 patienter med pulmonal hypertension forbundet med portal hypertension og leverinsufficiens i Child-Pugh klasse B og 3 patienter med PAH af andre årsager og med normal leverfunktion.
The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function.
• en blodprøve for at kontrollere for blodmangel (lavt hæmoglobin)
• a blood test to check for anaemia (low haemoglobin)
Synkope1,4
Syncope1, 4
Det overordnede mål med patientadvarselskortet er at oplyse patienterne om at være opmærksomme på vigtig sikkerhedsinformation før og under behandlingen med STAYVEER.
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 STAYVEER.
Studier med børn med pulmonal arteriel hypertension
Studies performed in children with pulmonary arterial hypertension
33 af disse patienter fik fortsat behandling med bosentan dispergible tabletter i en dosis på 4 mg/kg to gange dagligt i den ikke-kontrollerede forlængelsesfase FUTURE 2 med en gennemsnitlig samlet behandlingsvarighed på 2,3 år (interval 0,2 til 5,0 år).
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).
I en retrospektiv respondensanalyse baseret på ændringen i 6-minutters gangdistance, WHO funktionsklasse og dyspnø hos de 95 patienter, som var randomiseret til bosentan 125 mg to gange daglig i de placebokontrollerede studier, blev det observeret, at i uge 8 havde 66 patienter forbedrede resultater, 22 var stabiliseret, og 7 havde forringede resultater.
In a retrospective responder analysis based on change in walking distance, WHO functional class and dyspnoea of the 95 patients randomised to bosentan 125 mg twice daily in the placebo-controlled studies, it was found that at week 8, 66 patients had improved, 22 were stable and 7 had deteriorated.
I begge studier var det mindre sandsynligt at patienter, som blev behandlet med bosentan, udviklede flere nye fingersår i løbet af studiet, og det tog længere tid at udvikle hvert af disse nye fingersår hos disse end hos patienter behandlet med placebo.
In both studies, patients on bosentan were less likely to develop multiple new digital ulcers during the study and took longer to develop each successive new digital ulcer than did those on placebo.
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.
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.
Fluconazol og andre hæmmere af både CYP2C9 og CYP3A4: Samtidig administration af fluconazol, som hovedsagligt hæmmer CYP2C9, men også i en vis udstrækning CYP3A4, kan medføre store forøgelser af plasmakoncentrationerne af bosentan.
Fluconazole and other inhibitors of both CYP2C9 and CYP3A4: Co-administration with fluconazole, which inhibits mainly CYP2C9, but to some extent also CYP3A4, could lead to large increases in plasma concentrations of bosentan.
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.
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.
((Bagside))
((Back cover))
Der er ikke udført specifikke studier af STAYVEERS direkte virkning på evnen til at føre motorkøretøj og betjene maskiner.
No specific studies have been conducted to assess the direct effect of STAYVEER on the ability to drive and use machines.
Farmakokinetiske data fra yngre børn med denne sygdom er ikke tilgængelige for STAYVEER.
Pharmacokinetic data are not available for STAYVEER in young children with this disease.
Derfor vil plasmakoncentrationer af stoffer, som omsættes af disse isoenzymer, nedsættes ved samtidig indgift af STAYVEER.
Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when STAYVEER is co-administered.
Patienterne havde primær pulmonal hypertension (10 patienter) eller PAH relateret til kongenit hjertesygdom (9 patienter) og var i WHO-funktionsklasse II (n=15, 79%) eller III (n=4, 21%) ved baseline.
Patients had primary pulmonary hypertension (10 patients) or PAH related to congenital heart diseases (9 patients) and were in WHO functional class II (n = 15, 79%) or class III (n = 4, 21%) at baseline.
Behandling med diuretika bør overvejes hos patienter med konstateret væskeretention før initiering af behandling med STAYVEER.
Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with STAYVEER.
Farmakokinetikken af bosentan er hovedsagelig vist hos raske individer.
The pharmacokinetics of bosentan have mainly been documented in healthy subjects.
For PVC/PE/PVDC/aluminium-blisterpakninger:
For PVC/PE/PVDC/aluminium-blisters:
Filmovertræk: hypromellose, glyceroltriacetat, talcum, titandioxid (E171), gult jernoxid (E172), rødt jernoxid (E172) samt ethylcellulose.
The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
For hvide polyethylenflasker af høj densitet:
For white high-density polyethylene bottles:
Der blev set en let øget forekomst af testikulær tubulær atrofi hos rotter, der fik oralt administreret bosentan i doser på helt ned til 125 mg/kg/dag (cirka 4 gange højere end den maksimalt anbefalede dosis til mennesker [MRHD] og de laveste afprøvede doser) i to år, men ikke ved doser på helt op til 1.500 mg/kg/dag (cirka 50 gange højere end MRHD) i 6 måneder.
Slightly increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/day (about 4 times the maximum recommended human dose [MRHD] and the lowest doses tested) for two years but not at doses as high as 1,500 mg/kg/day (about 50 times the MRHD) for 6 months.
Okt _____
Oct _____
STAYVEER 62,5 mg filmovertrukne tabletter EU/1/13/832/001
STAYVEER 62.5 mg film-coated tablets EU/1/13/832/001
Ud af de 7 patienter, som havde dårligere resultater i uge 8, havde 3 forbedrede resultater i uge 12/16, og 4 dårligere resultater sammenlignet med basalniveau.
Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
I studie AC-052-331 skulle patienter have haft mindst et fingersår i nyligt udbrud, og i begge studier havde 85% af patienterne akutte fingersår ved basalniveau.
In study AC-052-331, patients had to have at least one digital ulcer of recent onset, and across the two studies 85% of patients had ongoing digital ulcer disease at baseline.
Tacrolimus, sirolimus: Samtidig administration af tacrolimus eller sirolimus og STAYVEER har ikke været undersøgt hos mennesker, men samtidig administration af tacrolimus eller sirolimus og STAYVEER kan medføre forhøjede plasmakoncentrationer af bosentan ligesom ved samtidig administration af ciclosporin.
Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and STAYVEER has not been studied in man but co-administration of tacrolimus or sirolimus and STAYVEER may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant STAYVEER may reduce the plasma concentrations of tacrolimus and sirolimus.
Hos raske individer udviser bosentan dosis- og tidsafhængig farmakokinetik.
In healthy subjects, bosentan displays dose- and time-dependent pharmacokinetics.
Den gennemsnitlige varighed af bosentan- og placebobehandlingen var henholdsvis 4,5 dage (interval 0,5-10,0 dage) og 4,0 dage (interval 2,5-6,5 dage).
The median bosentan and placebo treatment duration was, respectively, 4.5 days (range 0.5-10.0 days) and 4.0 days (range 2.5-6.5 days).
Palpitationer1,4
Palpitations1, 4
Lignende virkning vil kunne forventes med andre ritonavir-boostede proteaseinhibitorer (se pkt.
Similar effects would be expected with other ritonavir-boosted protease inhibitors (see section 4.4).
Ved samtidig administration var de initiale dalkoncentrationer af bosentan cirka 30 gange højere end dem, der blev målt efter indgift af bosentan alene.
When co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone.
brug af STAYVEER til gravide kvinder.
There are no reliable data on the use of STAYVEER in pregnant women.
Behandlingseffekter
Treatment effects
• hvis De har leverproblemer (spørg Deres læge) • hvis De er gravid, eller kunne blive gravid, fordi De ikke bruger pålidelige præventionsmetoder.
• if you are pregnant, or could get pregnant because you are not using reliable contraceptive methods.
På dag 9 var bosentans plasmakoncentration omtrent 5 gange højere end efter administration af bosentan alene.
On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with bosentan administered alone.
Ved steady-state var plasmakoncentrationen af bosentan 3 til 4 gange højere end ved bosentan alene.
At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone.
Forhøjede aminotransferaser i forbindelse med hepatitis (herunder mulig forværring af underliggende hepatitis) og/eller gulsot1 (se pkt.
Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
Dosisjustering er ikke påkrævet hos patienter med let nedsat leverfunktion (dvs. Child-Pugh klasse A) (se pkt.
No dose adjustment is needed in patients with mild hepatic impairment (i.e., Child-Pugh class A) (see section 5.2).
De skal drøfte disse spørgsmål med Deres læge eller gynækologudfyld bagsiden af dette kort og medbring det ved Deres næste besøg hos læge eller gynækolog.
Be sure to discuss any questions you may have with your doctor or your gynaecologist - complete the details on the back of this card and take it to your doctor or gynaecologist at your next visit.
Digoxin: Samtidig administration i 7 dage af bosentan 500 mg to gange dagligt og digoxin reducerede AUC, Cmax og Cmin for digoxin med henholdsvis 12%, 9% og 23%.
Digoxin: Co-administration for 7 days of bosentan 500 mg twice daily with digoxin decreased the AUC, Cmax and Cmin of digoxin by 12%, 9% and 23%, respectively.
Dette studie var primært designet som et farmakokinetisk studie (se pkt.
This study was primarily designed as a pharmacokinetic study (see section 5.2).
UDVENDIG ÆSKE OG FLASKEETIKET/FLASKER
OUTER CARTON & BOTTLE LABEL/ BOTTLES
• ciclosporin (et lægemiddel, der anvendes efter transplantationer samt til behandling af psoriasis), som ikke må tages sammen med STAYVEER.
• cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with STAYVEER.
De hyppigst rapporterede bivirkninger er hovedpine (11,5%), ødem/væskeretention (13,2%), unormal leverfunktionstest (10,9%) og anæmi/fald i hæmoglobin (9,9%).
The most frequent adverse reactions are headache (11.5%), oedema / fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia / haemoglobin decrease (9.9%).
Der blev set stigninger til > 8 x ULN hos 3,6% af de bosentanbehandlede patienter og hos 0,4% af de placebobehandlede patienter.
Elevations to ≥ 8 × ULN were seen in 3.6% of the bosentan-treated patients and 0.4% of the placebo-treated patients.
Baseret på disse farmakokinetiske resultater er den anbefalede start- og vedligeholdelsesdosis ved anvendelse til børn med PAH i alderen 1 år og derover 2 mg/kg morgen og aften.
Based on these pharmacokinetic results, when used in children with PAH aged 1 year and older, the recommended starting and maintenance dose is 2 mg/kg morning and evening.
• hormonale præventionsmidler, da disse ikke er effektive som eneste præventionsmetode, hvis De tager STAYVEER.
• hormonal contraceptives, which are not effective as the sole method of contraception when you take STAYVEER.
I dyremodeller med pulmonal hypertension medførte vedvarende peroral indgift af bosentan en reduktion i pulmonal vaskulær modstand og en reversion af pulmonal vaskulær hypertrofi og højre ventrikel hypertrofi.
In animal models of pulmonary hypertension, chronic oral administration of bosentan reduced pulmonary vascular resistance and reversed pulmonary vascular and right ventricular hypertrophy.
AC-052-355 var et multicenter, randomiseret dobbeltblindt parallelgruppestudie af bosentan sammenlignet med placebo hos 33 patienter med alvorlig PAH, som var i samtidig behandling med epoprostenol.
AC-052-355 was a multi-centre, randomised, double-blind, parallel-group study of bosentan versus placebo in 33 patients with severe PAH who were receiving concomitant epoprostenol therapy.
Efter behandling med bosentan 62,5 mg to gange dagligt i 4 uger var vedligeholdelsesdoserne i disse studier på 125 mg to gange dagligt i AC-052-351 og 125 mg to gange dagligt og 250 mg to gange dagligt i AC-052-352.
After 4 weeks of bosentan 62.5 mg twice daily, the maintenance doses studied in these studies were 125 mg twice daily in AC-052-351, and 125 mg twice daily and 250 mg twice daily in AC-052-352.
• Pulmonal arteriel hypertension associeret med kongenit systemisk til pulmonal shunt og
• Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and
Ved fertilitetsundersøgelser hos han- og hunrotter blev der ikke observeret nogen indflydelse på spermatozotallet, sædens motilitet og levedygtighed, ej heller på parringsevnen eller fertiliteten ved eksponeringer, der var henholdsvis 21 og 43 gange højere end det forventede terapeutiske niveau hos mennesker.
In fertility studies in male and female rats, no effects on sperm count, motility and viability, or on mating performance or fertility were observed at exposures that were 21 and 43 times the expected therapeutic level in humans, respectively; nor was there any adverse effect on the development of the pre-implantation embryo or on implantation.
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.
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.
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.
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.
I den samlede analyse af 100 PAH-børn fra de ikke-kontrollerede pædiatriske studier FUTURE 1/2 og FUTURE 3/forlængelse blev der set et fald i hæmoglobinkoncentrationen fra baseline til under 10 g/dl hos 10,0% af patienterne.
In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, a decrease in haemoglobin concentration from baseline to below 10 g/dL was reported in 10.0% of patients.
Administration af bosentan 2 mg/kg tre gange dagligt øgede ikke eksponeringen; den daglige eksponering var 7.275 ng·t/ml (CV 83%, n=27).
Dosing bosentan 2 mg/kg three times daily did not increase exposure; daily exposure was 7,275 ng·h/mL (CV: 83%, n = 27).
I studie AC-052-331 var de tilsvarende tal i løbet af 24 ugers dobbeltblind behandling henholdsvis 1,9 vs. 2,7 nye fingersår (p= 0,0351).
In study AC-052-331, during 24 weeks of double-blind therapy, the corresponding figures were 1.9 vs 2.7 new digital ulcers, respectively (p = 0.0351).
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.
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).
FUTURE 1 var et åbent, ikke-kontrolleret studie med dispergible bosentantabletter, der blev administreret som en vedligeholdelsesdosis på 4 mg/kg to gange dagligt hos 36 patienter i alderen 2 til 11 år.
FUTURE 1 was an open-label, uncontrolled study that was conducted with the dispersible tablet formulation of bosentan administered at a maintenance dose of 4 mg/kg twice daily to 36 patients from 2 to 11 years of age.