FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
Danish: Øvrige indholdsstoffer: Lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, magnesiumstearat, polyvinylalkohol, talcum (E553b), titandioxid (E171), macrogol 3350, lecithin (soja) (E322) og Allura Red AC (E129).
English: NT-proBNP (% reduction)
Danish: NT-proBNP (N-terminal pro B-type natriuretisk peptid) (% reduktion)
English: The increase in digoxin exposure observed in the presence of multiple doses of ambrisentan was not considered clinically relevant, and no dose adjustment of digoxin is warranted (see section 4.5).
Danish: Stigningen i digoxin-eksponering set ved multiple doser ambrisentan anses ikke for klinisk relevant, og der kræves ingen dosisjustering af digoxin (se pkt.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means that it is essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. den er i det væsentlige natrium-fri.
English: Therefore hepatic aminotransferases (ALT and AST) should be evaluated prior to initiation of ambrisentan and treatment should not be initiated in patients with baseline values of ALT and/or AST >3xULN (see section 4.3).
Danish: Derfor skal leveraminotransferaserne (ALAT og ASAT) vurderes, før behandling med ambrisentan igangsættes, og behandling må ikke indledes hos patienter med baselineværdier for ALAT og/eller ASAT > 3 x ULN (se pkt.
English: Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in hemoglobin concentrations persisted for up to 4 years of treatment with ambrisentan in the long-term open-label extension of the pivotal Phase 3 clinical studies.
Danish: Middelfaldene i forhold til baseline (rangerende fra 0,9 til 1,2 g/dl) i hæmoglobinkoncentrationerne blev opretholdt i op til 4 år under behandling med ambrisentan i den langvarige, ublindede forlængelse af de pivotale kliniske fase 3 studier.
English: Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan (see section 5.2).
Danish: Steady state-administration af ketoconazol (en potent CYP3A4-hæmmer) resulterede ikke i en klinisk signifikant stigning i eksponeringen af ambrisentan (se pkt.
English: Cases of pulmonary oedema have been reported with vasodilating medicinal products, such as ERAs, when used in patients with pulmonary veno-occlusive disease.
Danish: Tilfælde af lungeødem er rapporteret i forbindelse med administration af vasodilaterende lægemidler, f.eks. ERA, til patienter med pulmonal veno-okklusiv sygdom.
English: Hypersensitivity to the active substance, to soya, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: Co-administration of rifampicin (an inhibitor of Organic Anion Transporting Polypeptide [OATP], a strong inducer of CYP3A and 2C19, and inducer of P-gp and uridine-diphosphoglucuronosyltransferases [UGTs]) was associated with a transient (approximately 2-fold) increase in ambrisentan exposure following initial doses in healthy volunteers.
Danish: Samtidig administration af rifampicin (en hæmmer af organisk anion-transport-polypeptid [OATP], en stærk CYP3A- og 2C19-inducer samt inducer af P-glykoprotein (P-gp) og uridindifosfatglukuronosyltransferaser [UGTs]) er blevet kædet sammen med en forbigående stigning (omtrent en fordobling) i eksponeringen af ambrisentan efter første dosis hos raske frivillige personer.
English: Monotherapy Pooled (N=247)
Danish: Monoterapi puljede (N=247)
English: The primary endpoint defined for the Phase 3 studies was improvement in exercise capacity assessed by change from baseline in 6 minute walk distance (6MWD) at 12 weeks.
Danish: For fase 3-studierne blev det primære endepunkt defineret som forbedring i funktionskapaciteten ved 6 minutters gang (6MWD).
English: In vitro data indicate that ambrisentan at 300 μM resulted in less than 50 % inhibition of UGT1A1, UGT1A6, UGT1A9, UGT2B7 (up to 30%) or of cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 (up to 25%).
Danish: In vitro data indikerer, at amtrisentan ved 300 µM resulterede i mindre end 50 % hæmning af UGT1A1, UGT1A6, UGT1A9, UGT2B7 (op til 30 %) eller af CYP-enzymerne 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4 (op til 25 %).
English: The incidence of peripheral oedema was increased when ambrisentan was dosed in combination with tadalafil (45% adverse event frequency), compared to the incidence of peripheral oedema when ambrisentan and tadalafil were given as monotherapy (38% and 28%, respectively).
Danish: Incidencen af perifere ødemer var øget, når ambrisentan blev givet i kombination med tadalafil (bivirkningshyppighed 45 %) sammenlignet med incidencen af perifere ødemer, når ambrisentan og tadalafil blev givet som monoterapi (henholdsvis 38 % og 28 %).
English: Component as First Clinical Failure Event (Adjudicated)
Danish: Komponent som første hændelse af klinisk behandlingssvigt (evalueret)
English: The measure included: death, lung transplantation, hospitalisation for PAH, atrial septostomy, addition of other PAH therapeutic agents and early escape criteria.
Danish: Klinisk forværring blev defineret som dødsfald, lungetransplantation, indlæggelse pga. PAH, atrieseptostomi, tilføjelse af endnu et lægemiddel til behandling af PAH samt kriterierne for udtræden før tid.
English: In the ARIES-E open label long term extension study, the 2 year risk of developing serum aminotransferase elevations >3xULN in patients treated with ambrisentan was 3.9%.
Danish: I ARIES-E, et langvarigt, ublindet forlængelsesstudie, var der en risiko på 3,9 % for udvikling af serumaminotranferase-stigninger > 3 x ULN inden for 2 år hos de patienter, der blev behandlet med ambrisentan.
English: Time to First Clinical Failure Event (Adjudicated) Clinical failure, no. (%)
Danish: Varighed til første hændelse af klinisk behandlingssvigt (evalueret) Klinisk behandlingssvigt, antal (%)
English: Uncommon3, 8
Danish: Ikke almindelig3, 8
English: If you take cyclosporine A, do not take more than one 5 mg tablet of Volibris, once a day.
Danish: Hvis du tager medicin, som indeholder ciclosporin, må du ikke tage mere end én 5 mg Volibris-tablet daglig.
English: General disorders and administration site conditions Peripheral oedema, fluid retention Very common
Danish: Almene symptomer og reaktioner på administrationsstedet Perifert ødem, væskeretention Meget almindelig
English: PHARMACEUTICAL FORM AND CONTENTS 10x1 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 10x1 filmovertrukne tabletter.
English: Read the information under ‘Breast-feeding'
Danish: Læs informationen under "Amning"
English: • whether you have anaemia • whether your liver is working properly.
Danish: • om din lever fungerer, som den skal.
English: Before you start taking Volibris, and at regular intervals while you're taking it, your doctor will take blood tests to check:
Danish: Det er nødvendigt, at du får taget regelmæssige blodprøver Inden du starter behandling med Volibris, og regelmæssigt, mens du er i behandling med Volibris, vil lægen tage blodprøver for at undersøge:
English: Volibris tablets contain less than 1 mmol sodium (23 mg), which is essentially ‘sodium-free'.
Danish: Volibris tabletter indeholder mindre end 1 mmol (23 mg) natrium, dvs. lægemidlet er i det væsentlige ”natrium-frit”.
English: 8 Cases of autoimmune hepatitis, including cases of exacerbation of autoimmune hepatitis, and hepatic injury have been reported during ambrisentan therapy.
Danish: 8 Tilfælde af autoimmun hepatitis inklusive tilfælde af eksacerbation af autoimmun hepatitis og leverskade er set under behandling med ambrisentan.
English: Volibris contains lactose, lecithin (soya), Allura red AC Aluminium Lake (E129) and sodium Volibris tablets contain small amounts of a sugar called lactose.
Danish: Volibris indeholder lactose, lecithin (soja), Allura Red AC (E129) og natrium Volibris-tabletter indeholder en lille mængde af en sukkerart, der hedder lactose.
English: If you are a man taking Volibris, it is possible that this medicine may lower your sperm count.
Danish: Hvis du er mand og får Volibris, er der risiko for, at Volibris kan nedsætte dit sædtal.
English: Treatment with ambrisentan led to a statistically significant improvement in Borg Dyspnea Index (BDI) at week 12 (placebo-adjusted BDI of -1.1 (95% CI: -1.8 to -0.4; p=0.019; combined dose group)).
Danish: 12 ugers behandling med ambrisentan medførte en statistisk signifikant forbedring på Borgs dyspnøskala (BDI) (placebojusteret BDI på -1,1 (95 % CI: -1,8 til -0,4; p = 0,019; kombineret dosis-gruppe)).
English: A statistically significant increase (3.41 ± 6.96) was observed for the combined dose group in the physical functioning scale of the SF-36 Health Survey compared with placebo (-0.20 ± 8.14, p=0.005).
Danish: I gruppen, der blev behandlet med kombineret dosis, blev der observeret en statistisk signifikant stigning (3,41 +/- 6,96) i den fysiske funktionsskala på helbredsskemaet SF-36 sammenlignet med placebo (-0,20 +/- 8,14; p = 0,005).
English: Volibris tablets contain a colouring called Allura red AC Aluminium Lake (E129) which can cause allergic reactions (see section 4).
Danish: Volibris-tabletter indeholder et farvestof kaldet Allura Red AC (E129), som kan fremkalde allergiske reaktioner (se punkt 4).
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline (Ireland) Limited
English: A study of 492 patients (ambrisentan N=329, placebo N=163) with idiopathic pulmonary fibrosis (IPF), 11% of which had secondary pulmonary hypertension (WHO group 3), has been conducted, but was terminated early when it was determined that the primary efficacy endpoint could not be met (ARTEMIS-IPF study).
Danish: Der har været udført et studie med 492 patienter (ambrisentan n = 329, placebo n = 163) med idiopatisk pulmonal fibrose (IPF), hvoraf 11 % havde sekundær pulmonal hypertension (WHO-gruppe 3).
English: • Patient reminder card
Danish: • Patientkort
English: 3 Data derived from routine pharmacovigilance surveillance and frequencies based on placebocontrolled clinical trial experience.
Danish: 3 Data fra rutinemæssig lægemiddelovervågning: hyppighederne er baseret på erfaringer fra placebokontrollerede kliniske studier.
English: Volibris treatment must not be initiated in women of child-bearing potential unless the result of a pretreatment pregnancy test is negative and reliable contraception is practiced.
Danish: Behandling med Volibris må ikke indledes hos kvinder i den fertile alder, medmindre der foreligger negativ graviditetstest, og der anvendes sikker prævention.
English: INFORMATION IN BRAILLE volibris 10 mg
Danish: INFORMATION I BRAILLESKRIFT volibris 10 mg
English: Therefore ambrisentan must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (>3xULN); see sections 4.3 and 4.4).
Danish: Behandling med ambrisentan må derfor ikke indledes hos patienter med svært nedsat leverfunktion eller med klinisk signifikant forhøjede leveraminotransferaser (større end 3 gange øvre normalgrænse (> 3 x ULN (Upper Limit of Normal)); se pkt.
English: In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them.
Danish: Disse blodkar er forsnævrede hos patienter med PAH, og hjertet skal derfor pumpe kraftigere for at få blod igennem.
English: Tadalafil monotherapy (N=121)
Danish: Tadalafilmonoterapi (N=121)
English: INFORMATION IN BRAILLE volibris 5 mg
Danish: INFORMATION I BRAILLESKRIFT volibris 5 mg
English: The development of testicular tubular atrophy in male animals has been linked to the chronic administration of ERAs, including ambrisentan (see section 5.3).
Danish: Udviklingen af testikeltubulæratrofi hos dyr er blevet forbundet med kronisk indgift af ERA herunder ambrisentan (se pkt.
English: Ambrisentan and its metabolites are eliminated primarily in the bile following hepatic and/or extrahepatic metabolism.
Danish: Ambrisentan og dets metabolitter udskilles primært med galden efter levermetabolisme og/eller anden stofskifte.
English: Steady-state co-administration of ambrisentan and cyclosporine A resulted in a 2-fold increase in ambrisentan exposure in healthy volunteers.
Danish: Samtidig steady state-administration af ambrisentan og ciclosporin gav en fordobling af ambrisentaneksponeringen hos raske frivillige.
English: What you need to know before you take Volibris
Danish: Det skal du vide, før du begynder at tage Volibris
English: A multicenter, double-blind, active comparator, event-driven, Phase 3 outcome study (AMB112565/AMBITION) was conducted to assess the efficacy of initial combination of ambrisentan and tadalafil vs. monotherapy of either ambrisentan or tadalafil alone, in 500 treatment naive PAH patients, randomised 2:1:1, respectively.
Danish: For at vurdere virkningen af initial kombination af ambrisentan og tadalafil vs. monoterapi med enten ambrisentan eller tadalafil alene, blev der udført et randomiseret, dobbeltblindet, hændelsesdrevet fase 3 outcome-studie med aktiv komparator, (AMB112565/AMBITION) hos 500 behandlingsnaive PAHpatienter, der blev randomiseret 2:1:1.
English: Ambrisentan did not have any clinically relevant effects on the pharmacokinetics or pharmacodynamics of warfarin.
Danish: Ambrisentan havde ikke nogen klinisk relevant effekt på farmakokinetikken eller farmakodynamikken for warfarin.
English: Volibris tablets contain lactose.
Danish: Volibris-tabletter indeholder sojalecithin.
English: Contains lactose, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
Danish: Indeholder lactose, lecithin (soja) (E322) og Allura Red AC (E129).
English: The advice of a hepatologist is recommended.
Danish: Det anbefales, at konsultere en leverspecialist.
English: Cases consistent with autoimmune hepatitis, including possible exacerbation of underlying autoimmune hepatitis, hepatic injury and hepatic enzyme elevations potentially related to therapy have been observed with ambrisentan (see sections 4.8 and 5.1).
Danish: Tilfælde forenelige med autoimmun hepatitis inklusive mulig eksacerbation af en underliggende autoimmun hepatitis, leverskade og forhøjede leverenzymer med mulig sammenhæng med behandlingen er set i forbindelse med ambrisentan (se pkt.
English: How to take Volibris
Danish: Sådan skal du tage Volibris
English: Titanium dioxide (E171) Macrogol 3350
Danish: Titandioxid (E171)
English: Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Danish: Ambrisentandosis skal derfor begrænses til 5 mg daglig, når det administreres samtidigt med ciclosporin (se pkt.
English: The main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile and therefore hepatic impairment might be expected to increase exposure (Cmax and AUC) of ambrisentan.
Danish: Ambrisentans primære metaboliseringsvej er via glukuronidering og oxidation med efterfølgende udskillelse i galden, og det forventes, at nedsat leverfunktion kan øge eksponeringen (Cmax og AUC) af ambrisentan.
English: Peripheral oedema has been observed with ERAs including ambrisentan.
Danish: Der er set perifere ødemer ved anvendelse af ERA herunder ambrisentan.
English: Each tablet contains approximately 95 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.11 mg of Allura red AC Aluminium Lake (E129).
Danish: Hver tablet indeholder ca. 95 mg lactose (som monohydrat), ca. 0,25 mg lecithin (soja) (E322) og ca. 0,11 mg Allura Red AC Aluminium Lake (E129).
English: When co-administered with cyclosporine A, the dose of ambrisentan should be limited to 5 mg once daily and the patient should be carefully monitored (see sections 4.5 and 5.2).
Danish: Ved administration sammen med ciclosporin må ambrisentandosis højst være 5 mg daglig, og patienten skal monitoreres omhyggeligt (se pkt.
English: The effects of 12 days dosing with ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of oral contraceptive containing ethinyl estradiol (35 μg) and norethindrone (1 mg) were studied in healthy female volunteers.
Danish: Virkningen af 12 dages behandling med ambrisentan (10 mg en gang daglig) på farmakokinetikken af en enkeltdosis oral antikonceptionsmiddel indeholdende ethinylestradiol (35 μg) og norethindron (1 mg) blev undersøgt hos raske frivillige kvinder.
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including the P-glycoprotein (Pgp), breast cancer resistance protein (BCRP), multidrug resistance related protein 2 (MRP2), bile salt export pump (BSEP), organic anion transporting polypeptides (OATP1B1 and OATP1B3) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Danish: Ambrisentans virkning på xenobiotiske transportører Ved klinisk relevante koncentrationer har ambrisentan in vitro ingen hæmmende effekt på humane transportører, herunder P-glykoprotein (P-gp), brystcancer-resistensprotein (BCRP), multidrugresistensprotein 2 (MRP2), galdesalteksportpumpe (BSEP), organisk anion-transporterende polypeptider (OATP1B1 og OATP1B3) og det natriumafhængige taurocholat co-transporterende polypeptid (NTCP).
English: Each tablet contains approximately 90 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of Allura red AC Aluminium Lake (E129).
Danish: Hver tablet indeholder ca. 90 mg lactose (som monohydrat), ca. 0,25 mg lecithin (soja) (E322) og ca. 0,45 mg Allura Red AC Aluminium Lake (E129).
English: These tablets come in special packaging to prevent children removing them.
Danish: Tabletterne er pakket i en speciel børnesikret pakning.
English: The placeboadjusted mean improvement in 6MWD was 44.6 m (95% CI: 24.3 to 64.9; p<0.001) for the 5 mg dose, and 52.5 m (95% CI: 28.8 to 76.2; p<0.001) for the 10 mg dose.
Danish: Den placebojusterede middelforbedring i 6MWD var for 5 mg dosis: 44,6 m (95 % CI: 24,3 til 64,9; p < 0,001) og for 10 mg dosis: 52,5 m (95 % CI: 28,8 til 76,2; p < 0,001).
English: Time to First Hospitalisation for Worsening PAH (Adjudicated) First hospitalisation, no.
Danish: Varighed til første hospitalsindlæggelse for forværret PAH (evalueret)
English: Other medicines and Volibris Tell your doctor or pharmacist if you're taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Inflammation and changes in the nasal cavity epithelium have been seen in rodents after chronic administration at exposures below the therapeutic levels in humans.
Danish: Efter kronisk administration er der set inflammation og ændringer i næsehulens epitel, hos gnavere ved eksponeringer under det terapeutiske niveau hos mennesker.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter hvor alvorlige de er med de mest alvorlige først.
English: Pack sizes with unit dose blisters of 10x1 or 30x1 film-coated tablets.
Danish: Blisterpakninger med afrivelige enkeltdosisblister med 10x1 eller 30x1 filmovertrukne tabletter.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Volibris-tabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10x1 or 30x1 tablets.
Danish: Volibris 5 mg og 10 mg filmovertrukne tabletter fås i blisterpakninger med afrivelige enkeltdosisblister med 10x1 eller 30x1 tabletter.
English: Volibris tablets contain the azo colouring agent Allura red AC Aluminium Lake (E129), which can cause allergic reactions.
Danish: Volibris-tabletter indeholder azo-farvestoffet Allura Red AC (E129), som kan fremkalde allergiske reaktioner.
English: In a clinical study in healthy volunteers, steady-state dosing with ambrisentan 10 mg once daily did not significantly affect the single-dose pharmacokinetics of the ethinyl estradiol and norethindrone components of a combined oral contraceptive (see section 5.2).
Danish: I et klinisk studie med raske personer påvirkede steady state-dosering (10 mg ambrisentan en gang daglig) ikke signifikant enkeltdosis-farmakokinetikken af et oralt kombinations-antikonceptionsmiddel indeholdende ethinylestradiol og norethindron (se pkt.
English: However, no specific drug-drug interactions studies have been conducted with these drugs.
Danish: Der er dog ikke foretaget specifikke lægemiddelinteraktionsstudier med disse lægemidler, og forsigtighed anbefales derfor ved samtidig administration.
English: The effects of repeat dosing of ketoconazole (400 mg once daily) on the pharmacokinetics of a single dose of 10 mg ambrisentan were investigated in 16 healthy volunteers.
Danish: Virkningen af gentagne doser ketoconazol (400 mg en gang daglig) på farmakokinetikken af en enkelt 10 mg dosis ambrisentan blev undersøgt hos 16 raske frivillige.
English: The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily)
Danish: Virkningen af gentagen indgift af ciclosporin (100 - 150 mg to gange daglig) på steady statefarmakokinetikken af ambrisentan (5 mg daglig) og virkningen af gentagen indgift af ambrisentan (5 mg daglig) på steady state-farmakokinetikken af ciclosporin (100 - 150 mg to gange daglig) blev undersøgt hos raske voksne.
English: Always take this medicine exactly as your doctor or pharmacist has told you to.
Danish: Tag altid Volibris nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Therefore ambrisentan should not be initiated in patients with severe hepatic impairment or clinically significant elevated hepatic aminotransferases (>3xULN) (see sections 4.3 and 4.4).
Danish: Ambrisentan må derfor ikke indledes hos patienter med svært nedsat leverfunktion eller med klinisk signifikant forhøjede niveauer af leveraminotransferaser (> 3 x ULN) (se pkt.
English: Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Danish: Gentagne doser ambrisentan har ingen indvirkning på ciclosporins eksponering, og dosisjustering af ciclosporin er ikke påkrævet.
English: Breast-feeding It is not known if Volibris is transferred to breast milk.
Danish: Det vides ikke, hvorvidt Volibris udskilles i mælken.
English: Polyvinyl alcohol (partially hydrolysed) Talc (E553b)
Danish: Polyvinylalkohol (delvist hydrolyseret)
English: However, multiple doses of ambrisentan had no clinically relevant effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Danish: Administration af flere doser ambrisentan har imidlertid ingen klinisk relevant virkning på ciclosporin eksponering og dosisjustering af ciclosporin er ikke påkrævet.