FrancophonIA/ELRC3.0 huggingface dataset:
English: The Cmax and AUC(0-τ) of ambrisentan increased (48% and 121%, respectively) in the presence of multiple doses of cyclosporine A. Based on these changes, the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Danish: Cmax og AUC(0-t) for ambrisentan blev forøget (henholdsvis 48 % og 121 %) ved samtidig administration af flere doser ciclosporin A. Baseret på disse ændringer skal doseringen af ambrisentan begrænses til 5 mg én gang dagligt, når det administreres samtidigt med ciclosporin A (se pkt.
English: Each tablet contains approximately 52 mg of lactose and 20 micrograms of Allura red AC Aluminium lake
Danish: Hver tablet indeholder ca. 52 mg lactose og 20 mikrogram Allura Red AC Aluminium lake.
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: If you forget to take Ambrisentan Mylan
Danish: Hvis du har glemt at tage Ambrisentan Mylan
English: Each tablet contains approximately 26 mg of lactose and 10 micrograms of Allura red AC Aluminium lake
Danish: Hver tablet indeholder ca. 26 mg lactose og 10 mikrogram Allura Red AC Aluminium Lake.
English: In combination with tadalafil
Danish: I kombination med tadalafil
English: The primary endpoint defined for the Phase 3 studies was improvement in exercise capacity assessed by change from baseline in 6minute walk distance (6MWD) at 12 weeks.
Danish: For fase 3-studierne var det primære endepunkt defineret som forbedring i funktionskapaciteten, målt som ændring i gangafstand ved 6 minutters gang (6MWD) i forhold til baseline efter 12 ugers behandling.
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 dem.
English: The incidence of anaemia was increased when ambrisentan was dosed in combination with tadalafil (15% adverse event frequency), compared to the incidence of anaemia when ambrisentan and tadalafil were given as monotherapy (7% and 11%, respectively).
Danish: Incidensen af anæmi var øget, når ambrisentan blev givet i kombination med tadalafil (bivirkningshyppighed 15%) sammenlignet med incidensen af anæmi, når ambrisentan og tadalafil blev givet som monoterapi (henholdsvis 7% og 11%).
English: Steady-state administration of ambrisentan in healthy volunteers had no clinically relevant effects on the single-dose pharmacokinetics of digoxin, a substrate for Pgp (see section 5.2).
Danish: Steady state-administration af ambrisentan til raske frivillige havde ingen klinisk relevant virkning på enkeltdosis-farmakokinetikken af digoxin (et substrat for P-gp) (se pkt.
English: This prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation.
Danish: Blokeringen forhindrer endotelin-medieret aktivering af second messenger-systemer, der ellers ville resultere i vasokonstriktion og proliferation af glatte muskelceller.
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 (WHOgruppe 3).
English: There is no experience in PAH patients of ambrisentan at daily doses greater than 10 mg.
Danish: Der er ingen erfaring med ambrisentan i større doser end 10 mg/dag til PAH-patienter.
English: Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT))>3xULN (see sections 4.2 and 4.4).
Danish: Baseline-værdier for leveraminotransferaser (aspartat-aminotransferase (ASAT) og/eller alaninaminotransferase (ALAT)) > 3 x ULN (se pkt.
English: Co-administration of ambrisentan with a phosphodiesterase inhibitor, either sildenafil or tadalafil (both substrates of CYP3A4) in healthy volunteers did not significantly affect the pharmacokinetics of the phosphodiesterase inhibitor or ambrisentan (see section 5.2).
Danish: Samtidig administration af ambrisentan og en fosfodiesterasehæmmer, enten sildenafil eller tadalafil (begge substrater af CYP3A4), til raske frivillige, påvirkede ikke farmakokinetikken af fosfodiesterasehæmmeren eller ambrisentan signifikant (se pkt.
English: Chronic administration of ambrisentan was not associated with a change in plasma testosterone in clinical studies.
Danish: I kliniske studier er kronisk administration af ambrisentan ikke blevet forbundet med en ændring i plasma-testosteron.
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: Incidensen af perifere ødemer var øget, når ambrisentan blev givet i kombination med tadalafil (bivirkningshyppighed 45%) sammenlignet med incidensen af perifere ødemer, når ambrisentan og tadalafil blev givet som monoterapi (henholdsvis 38% og 28%).
English: Vascular disorders Hypotension
Danish: Vaskulære sygdomme Hypotension
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 baseline værdier for ALAT og/eller ASAT >3xULN (se pkt.
English: The mean decreases in systolic and diastolic blood pressures persisted for up to 4 years of treatment with ambrisentan in the long-term open label ARIES E study.
Danish: Middelfaldene i det systoliske og diastoliske blodtryk blev opretholdt i op til 4 år under behandling med ambrisentan i det langvarige, ublindede ARIES-E-studie.
English: NT-proBNP (% reduction)
Danish: NT-proBNP (Nterminal pro Btype natriuretisk peptid) (% reduktion)
English: Peripheral oedema was reported more frequently with 10 mg ambrisentan in short-term clinical studies (see section 4.8).
Danish: Perifere ødemer forekom hyppigere med 10 mg ambrisentan i kliniske studier af kort varighed (se pkt.
English: Pink, capsule shaped, biconvex film-coated tablet with ‘M' debossed on one side and ‘AN1' on the other, approximately 9.9 mm long and 4.8 mm wide.
Danish: Pink, kapselformet, bikonveks, filmovertrukket tablet, der er præget med 'M' på den ene side og med 'AN1' på den anden side, og som er cirka 9,9 mm lang og 4,8 mm bred.
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'er, til patienter med pulmonal veno-okklusiv sygdom.
English: Ambrisentan Mylan contains the active substance ambrisentan.
Danish: Ambrisentan Mylan indeholder det aktive lægemiddelstof ambrisentan.
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and NTCP.
Danish: In vitro har ambrisentan ingen hæmmende effekt på humane transportører ved klinisk relevante koncentrationer, herunder Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 og NTCP.
English: Before you start taking Ambrisentan Mylan, 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 Ambrisentan Mylan, og regelmæssigt mens du er i behandling med Ambrisentan Mylan, vil lægen tage blodprøver for at undersøge:
English: Ambrisentan monotherapy
Danish: Ambrisentan monoterapi
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 testikulær tubulusatrofi hos dyr er blevet forbundet med kronisk indgift af ERA'er, herunder ambrisentan (se pkt.
English: Anaemia (reduced number of red blood cells)
Danish: Blodmangel (nedsat antal røde blodlegemer)
English: Cases of autoimmune hepatitis, including cases of exacerbation of autoimmune hepatitis, and hepatic injury have been reported during ambrisentan therapy.
Danish: Tilfælde af autoimmun hepatitis, inklusive tilfælde af eksacerbation af autoimmun hepatitis, og leverskade er set under behandling med ambrisentan.
English: Ambrisentan Mylan is supplied as 5 mg and 10 mg film-coated tablets in packs of 30 tablets and unit dose blister packs of 30x1 tablets.
Danish: Ambrisentan Mylan 5 mg og 10 mg filmovertrukne tabletter fås i pakninger med 30 tabletter og i enkeltdosisblister med 30x1 tabletter.
English: Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor.
Danish: Ambrisentan er en oralt aktivt ERA af gruppen propionsyre, som er selektiv for endotelin Areceptoren (ETA).
English: Ambrisentan Mylan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
Danish: Behandling med Ambrisentan Mylan må ikke indledes hos kvinder i den fertile alder, medmindre der foreligger negativ graviditetstest, og der anvendes sikker prævention.
English: Therefore breast-feeding is contraindicated in patients taking ambrisentan (see section 4.3).
Danish: Amning er derfor kontraindiceret hos patienter, der tager ambrisentan (se pkt.
English: Ambrisentan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
Danish: Behandling med ambrisentan må ikke indledes hos kvinder i den fertile alder, medmindre der foreligger en negativ graviditetstest, og der anvendes sikker prævention.
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 (>3xULN (Upper Limit of Normal)); se pkt.
English: The active substance is ambrisentan.
Danish: Aktivt stof: ambrisentan.
English: In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4).
Danish: I post-marketing-perioden er der rapporteret tilfælde af transfusionskrævende anæmi (se pkt.
English: Clinical efficacy in combination with tadalafil
Danish: Klinisk virkning ved kombination med tadalafil
English: It is not known whether ambrisentan is excreted in human breast milk.
Danish: Det vides ikke, om ambrisentan udskilles i human mælk.
English: Danmark BGP Products ApS Tlf: + 45 28116932
Danish: BGP Products ApS Tlf: +45 28116932
English: The advice of a hepatologist is recommended.
Danish: Det anbefales at konsultere en leverspecialist.
English: Most cases of peripheral oedema in clinical studies with ambrisentan were mild to moderate in severity, although it may occur with greater frequency and severity in patients ≥65 years.
Danish: De fleste tilfælde af perifere ødemer, der blev observeret i kliniske studier med ambrisentan, var lette til moderate, men hos patienter ≥ 65 år kan ødemer forekomme med større hyppighed, og være mere alvorlige.
English: What you need to know before you take Ambrisentan Mylan
Danish: Det skal du vide, før du begynder at tage Ambrisentan Mylan
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 af warfarin.
English: Decrease in systolic and diastolic blood pressures has been reported with ambrisentan therapy.
Danish: Der er rapporteret om fald i det systoliske og diastoliske blodtryk i forbindelse med ambrisentanbehandling.
English: Adverse reactions identified from 12-week placebo-controlled clinical trial data are included below by system organ class and frequency.
Danish: Bivirkningerne, som blev identificeret fra 12-ugers placebokontrollerede kliniske forsøgsdata, er listet nedenfor efter systemorganklasse og hyppighed.
English: Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Danish: Overfølsomhedsreaktioner (f.eks. angioødem, udslæt, kløe)
English: It is not known if Ambrisentan Mylan is transferred to breast milk.
Danish: Det vides ikke, hvorvidt Ambrisentan Mylan udskilles i mælken.
English: A multicentre, 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 dobbeltblindet, hændelsesdrevet fase 3 outcomemulticenterstudie med aktiv komparator (AMB112565/AMBITION) hos 500 behandlingsnaive PAHpatienter, der blev randomiseret 2:1:1.
English: Since the main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile, hepatic impairment might be expected to increase exposure (Cmax and AUC) to ambrisentan.
Danish: Da ambrisentans primære metaboliseringsvej er via glukuronidering og oxidation med efterfølgende udskillelse i galden, kan det forventes, at nedsat leverfunktion vil øge eksponeringen (Cmax og AUC) for ambrisentan.
English: Ambrisentan Mylan 10 mg film-coated tablet (tablet) is a pink, capsule shaped tablet engraved with ‘M' on one side of the tablet and ‘AN1' on the other side.
Danish: Ambrisentan Mylan 10 mg filmovertrukket tablet (tablet) er en pink, kapselformet tablet, der er præget med 'M' på den ene side og med 'AN1' på den anden side.
English: However, no specific drug-drug interactions studies have been conducted with these active substances.
Danish: Der er dog ikke foretaget specifikke lægemiddelinteraktionsstudier med disse aktive stoffer, og forsigtighed anbefales derfor ved samtidig administration.
English: Warfarin also had no clinically significant effects on the pharmacokinetics of ambrisentan.
Danish: Warfarin havde heller ingen klinisk signifikant indvirkning på farmakokinetikken af ambrisentan.
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: 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: If you are a man taking Ambrisentan Mylan, it is possible that this medicine may lower your sperm count.
Danish: Hvis du er mand og får Ambrisentan Mylan, er der risiko for, at Ambrisentan Mylan kan nedsætte dit sædtal.
English: • Patient Reminder Card
Danish: • Patientkort
English: Eye disorders Blurred vision, visual impairment
Danish: Øjne Sløret syn, nedsat syn
English: Adverse reactions identified from 12 week placebo controlled clinical trial data are included below by system organ class and frequency.
Danish: Bivirkningerne, som blev identificeret fra 12 ugers placebokontrollerede kliniske forsøgsdata, er listet nedenfor efter systemorganklasse og hyppighed.
English: Contains lactose and Allura red AC Aluminium Lake (E129).
Danish: Indeholder lactose og Allura Red AC Aluminium Lake (E129).
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 derfor, at nedsat leverfunktion kan øge eksponeringen (Cmax og AUC) for ambrisentan.
English: Ambrisentan in combination with tadalafil
Danish: Ambrisentan i kombination med tadalafil
English: Hypotension (low blood pressure)
Danish: Lavt blodtryk
English: The pharmacokinetics of ambrisentan in patients with hepatic impairment (with or without cirrhosis) has not been studied.
Danish: Ambrisentans farmakokinetik er ikke undersøgt hos patienter med nedsat leverfunktion (med eller uden cirrose).
English: Ambrisentan Mylan 5 mg film-coated tablet (tablet) is a pink round biconvex tablet engraved with ‘M' on one side and ‘AN' on the other side.
Danish: Ambrisentan Mylan 5 mg filmovertrukket tablet (tablet) er en pink, rund, bikonveks tablet, der er præget med 'M' på den ene side og med 'AN' på den anden side.
English: Ambrisentan Mylan tablets contains lactose and Allura red (E129)
Danish: Ambrisentan Mylan tabletter indeholder lactose og Allura red AC (E129)
English: Ambrisentan has not been studied in individuals with hepatic impairment (with or without cirrhosis).
Danish: Ambrisentan er ikke undersøgt hos personer med nedsat leverfunktion (med eller uden cirrose).
English: CI: -44.8, -20.7
Danish: % difference -33,8; 95% CI:-44,8 - -20,7
English: Ambrisentan did not have any clinically relevant effects on the pharmacokinetics of tadalafil.
Danish: Ambrisentan havde ikke nogen klinisk relevant effekt på farmakokinetikken af tadalafil.
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 dagligt) på farmakokinetikken af en enkelt dosis oral antikonceptionsmiddel indeholdende ethinylestradiol (35 μg) og norethindron (1 mg) blev undersøgt hos raske frivillige kvinder.
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: Pink, round, biconvex film-coated tablet with ‘M' debossed on one side and ‘AN' on the other, approximately 5.7 mm in diameter.
Danish: Pink, rund, bikonveks, filmovertrukket tablet, der er præget med 'M' på den ene side og med 'AN' på den anden side, og har en diameter på cirka 5,7 mm.
English: What Ambrisentan Mylan contains
Danish: Ambrisentan Mylan indeholder:
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 A gav en fordobling af ambrisentaneksponeringen hos raske frivillige.
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 A må ambrisentan dosis højst være 5 mg daglig, og patienten skal monitoreres omhyggeligt (se pkt.
English: • chest pain or discomfort
Danish: • smerter eller ubehag i brystet
English: Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A
Danish: Ambrisentandosis skal derfor begrænses til 5 mg én gang dagligt, når det administreres samtidigt med ciclosporin A (se pkt.
English: The effects of repeat dosing of ambrisentan (10 mg) on the pharmacokinetics of single dose digoxin were studied in 15 healthy volunteers.
Danish: Virkningen af gentagen indgift af ambrisentan (10 mg) på farmakokinetikken af enkeltdoser digoxin blev undersøgt hos 15 raske frivillige.
English: Data derived from routine pharmacovigilance surveillance and frequencies based on placebo controlled clinical trial experience.
Danish: Data fra rutinemæssig lægemiddelovervågning: hyppighederne er baseret på erfaringer fra placebokontrollerede kliniske studier.
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Danish: Der kræves ingen dosisjusteringer hos patienter med nedsat nyrefunktion (se pkt.
English: There was no evidence of carcinogenic potential in 2 year oral studies in rats and mice.
Danish: To års orale studier hos rotter og mus fandt ingen evidens for karcinogent potentiale.
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: 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) were studied in healthy volunteers.
Danish: Virkningen af gentagen indgift af ciclosporin A (100-150 mg to gange dagligt) på steady statefarmakokinetikken af ambrisentan (5 mg en gang dagligt) og virkningen af gentagen indgift af ambrisentan (5 mg en gang dagligt) på steady state-farmakokinetikken af ciclosporin A (100-150 mg to gange dagligt) blev undersøgt hos raske frivillige.
English: General disorders and administration site conditions Peripheral oedema, fluid retention
Danish: Almene symptomer og reaktioner på administrationsstedet Perifert ødem, væskeretention
English: • liver problems
Danish: • problemer med leveren
English: Women of child-bearing potential who are not using reliable contraception (see sections 4.4 and 4.6).
Danish: Kvinder i den fertile alder, som ikke anvender sikker prævention (se pkt.
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: An improvement in haemodynamic parameters was observed in patients with PAH after 12 weeks (n=29) in a Phase 2 study (AMB220).
Danish: I et fase 2-studie (AMB220) blev der efter 12 uger observeret forbedrede hæmodynamiske parametre hos patienter med PAH (n = 29).
English: (N=126)
Danish: Ambrisentanmonoterapi (N=126)