FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister
English: Ninety events (27%) of IPF progression (including respiratory hospitalisations) or death were observed in the ambrisentan group compared to 28 events (17%) in the placebo group.
Danish: 90 tilfælde (27 %) af IPF-progression (inklusive respiratorisk betingede hospitalsindlæggelser) eller død blev set i ambrisentan-gruppen sammenlignet med 28 tilfælde (17 %) i placebo-gruppen.
English: The occurrence of peripheral oedema was highest within the first month of treatment initiation.
Danish: Forekomsten af perifere ødemer var højest indenfor den første måned efter behandlingsstart.
English: Ambrisentan is primarily bound to albumin (96.5%) and to a lesser extent to alpha1-acid glycoprotein.
Danish: Ambrisentan bindes primært til albumin (96,5 %) og i mindre grad til alfa1-syre glykoprotein.
English: How much Volibris to take
Danish: Hvor meget Volibris skal du tage
English: Idiopathic or heritable PAH was the most common aetiology in the study population (56%), followed by PAH due to connective tissue disorders (37%), PAH associated with drugs and toxins (3%), corrected simple congenital heart disease (2%), and HIV (2%).
Danish: Idiopatisk eller hereditær PAH var den mest almindelige ætiologi i studiepopulationen (56 %), efterfulgt af PAH som følge af bindevævssygdomme (37 %), PAH associeret med lægemidler og toksiner (3 %), korrigeret simpel kongenital hjertesygdom (2 %) og hiv (2 %).
English: Patients WHO FC at baseline was II (31%) and FC III (69%).
Danish: Patienternes WHO-FC ved baseline var II (31 %) og III (69 %).
English: However no testicular changes were observed in dog studies of up to 39 weeks duration at an exposure 35-fold that seen in humans based on AUC.
Danish: Men der sås ingen testikelændringer i hundestudier med op til 39 ugers varighed ved en eksponering, der var 35 gange det til mennesker ud fra AUC.
English: Don't take Volibris:
Danish: Tag ikke Volibris:
English: In addition to the above, except abnormal blood test results for liver function:
Danish: I tillæg til ovenstående, med undtagelse af blodprøver, der viser unormal leverfunktion:
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: However, the magnitude of effect of bilirubin is modest (compared to the typical patient with a bilirubin of 0.6 mg/dl, a patient with an elevated bilirubin of 4.5 mg/dl would have approximately 30% lower oral clearance of ambrisentan).
Danish: Størrelsesordenen af virkningen af bilirubin er dog beskeden (sammenlignet med den typiske patient med en bilirubin på 0,6 mg/dl ville en patient med en forhøjet bilirubin på 4,5 mg/dl have ca. 30 % lavere oral clearance af ambrisentan).
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations) Harmire Road
Danish: Glaxo Operations UK Ltd (registreret som GlaxoWellcome Operations) Harmire Road
English: Multiple doses of ambrisentan resulted in slight increases in digoxin AUC0-last and trough concentrations, and a 29% increase in digoxin Cmax.
Danish: Adskillige doser ambrisentan resulterede i lette stigninger i digoxin AUC0-last og lavpunktskoncentrationer, samt en 29 % stigning i digoxin Cmax.
English: Co. Durham DL12 8DT United Kingdom or
Danish: Co. Durham DL12 8DT Storbritannien eller
English: In juvenile rats administered ambrisentan orally once daily during postnatal day 7 to 26, 36 or 62, a decrease in brain weight (−3% to -8%) with no morphologic or neurobehavioral changes occurred after breathing sounds, apnoea and hypoxia were observed.
Danish: Hos unge rotter, som fik administreret ambrisentan oralt en gang dagligt på dag 7 til 26, 36 eller 62 postnatalt, forekom et fald i hjernevægt (-3 % til -8 %) uden morfologiske eller neurobehaviorale ændringer, efter at åndedrætslyd, apnø og hypoxi blev observeret.
English: A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.
Danish: 17 patienter (6,5 %) i ambrisentan-gruppen havde et fald i hæmoglobin, som var ≥ 15 % i forhold til baseline, og som faldt til under normalgrænsen.
English: Most of these decreases were detected during the first 4 weeks of treatment and haemoglobin generally stabilised thereafter.
Danish: De fleste tilfælde optrådte løbet af de første 4 behandlingsuger, og generelt stabiliseredes hæmoglobin herefter.
English: Please read the information under ‘Pregnancy'
Danish: Læs informationen under "Graviditet"
English: The MAH shall ensure that in each Member State where Volibris is marketed, all patients who are expected to use Volibris are provided with the following educational material:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle patienter, der forventes at anvende Volibris, i hvert medlemsland, hvor Volibris markedsføres, får udleveret følgende uddannelsesmateriale:
English: If you are allergic to soya, do not use this medicine (see section 2 ‘Don't take Volibris').
Danish: Hvis du er allergisk over for soja, må du ikke tage Volibris (se punkt 2 ”Tag ikke Volibris”).
English: Co. Durham DL12 8DT United Kingdom
Danish: Co. Durham DL12 8DT Storbritannien
English: You may notice a rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing
Danish: Du kan få udslæt, kløe eller hævelser (sædvanligvis af ansigtet, læberne, tungen eller halsen), som kan medføre åndedræts- eller synkebesvær.
English: After oral administration, maximum plasma concentrations (Cmax) of ambrisentan typically occur around 1.5 hours post-dose under both fasted and fed conditions.
Danish: Efter oral administration ses maksimal plasmakoncentration (Cmax) af ambrisentan typisk ca. 1,5 timer efter indgift ved både faste og sammen med mad.
English: A food-effect study involving administration of ambrisentan to healthy volunteers under fasting conditions and with a high-fat meal indicated that the Cmax was decreased 12% while the AUC remained unchanged.
Danish: Et studie af fødens påvirkning med raske frivillige, som fik ambrisentan under henholdsvis faste og sammen med mad med højt fedtindhold, viste, at Cmax faldt 12 %, mens AUC var uændret.
English: • The selectivity of ambrisentan for the ETA over the ETB receptor is expected to retain ETB receptor mediated production of the vasodilators nitric oxide and prostacyclin.
Danish: • Ambrisentans selektivitet over for ETA-receptoren forventes at medføre bevaret ETB-receptormedieret produktion af vasodilatatorernes nitrogenoxid og prostacyklin.
English: (ARIES-C and post marketing)
Danish: Ambrisentan (ARIES-C og postmarketing)
English: 2 The frequency of headache appeared higher with 10 mg ambrisentan.
Danish: 2 Hyppigheden af hovedpine var højere med 10 mg ambrisentan.
English: The majority of patients had WHO functional Class II (38.4%) or Class III (55.0%) symptoms.
Danish: Hovedparten af patienterne havde symptomer i WHO's funktionsklasse II (38,4 %) eller III (55,0 %).
English: This may be due to the inhibition by cyclosporine A of transporters and metabolic enzymes involved in the pharmacokinetics of ambrisentan.
Danish: Dette kan skyldes ciclosporins hæmning af transportører og metaboliske enzymer, som er involveret i ambrisentans farmakokinetik.
English: The distribution of ambrisentan into red blood cells is low, with a mean blood:plasma ratio of 0.57 and 0.61 in males and females, respectively.
Danish: Fordelingen af ambrisentan i de røde blodlegemer er lav med et middel forhold mellem blod og plasma på henholdsvis 0,57 og 0,61 hos mænd og kvinder.
English: Pregnancy Volibris may harm unborn babies conceived before, during or soon after treatment.
Danish: Volibris kan skade fostre, der er undfanget før, under eller lige efter behandlingen.
English: PVC/PVDC/aluminium foil blisters.
Danish: PVC/PVDC/aluminium-folie blisterpakninger.
English: Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).
Danish: Volibris er indiceret til behandling af pulmonal arteriel hypertension (PAH) hos voksne patienter med WHO-funktionsklasse (FC) II til III, herunder til kombinationsbehandling (se pkt.
English: • if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).
Danish: • hvis du har arvæv i lungerne af ukendt årsag (idiopatisk lungefibrose).
English: These changes in exposure to ethinyl estradiol or norethindrone were small and are unlikely to be clinically significant (see section 4.5).
Danish: Disse ændringer i eksponering af ethinylestradiol eller norethindron var små og vil sansynligvis ikke være klinisk signifikant (se pkt.
English: The usual dose of Volibris is one 5 mg tablet, once a day.
Danish: Den sædvanlige dosis af Volibris er en 5 mg tablet én gang daglig.
English: Ambrisentan is a non-sulphonamide (propanoic acid) ERA.
Danish: Ambrisentan er et non-sulfonamid (propionsyre) ERA.
English: Autoimmune hepatitis (see section
Danish: Autoimmun hepatitis (se pkt.
English: The safety of ambrisentan has been evaluated as monotherapy and/or in combination in clinical trials of more than 1200 patients with PAH (see section 5.1).
Danish: Ambrisentans sikkerhed er undersøgt som monoterapi og/eller i kombination i kliniske studier med flere end 1.200 patienter med PAH (se pkt.
English: • liver injury • inflammation of the liver caused by the body's own defences (autoimmune hepatitis)
Danish: • leverskade • leverbetændelse forårsaget af kroppens eget immunforsvar (autoimmun hepatitis).
English: Treatment with ambrisentan resulted in an increase in mean cardiac index, a decrease in mean pulmonary artery pressure, and a decrease in mean pulmonary vascular resistance.
Danish: Behandling med ambrisentan resulterede i en stigning i middel hjerteindeks, et fald i middel lungearterietryk og et fald i middel pulmonal vaskulær resistens.
English: In an open label study (AMB222), ambrisentan was studied in 36 patients to evaluate the incidence of increased serum aminotransferase concentrations in patients who had previously discontinued other ERA therapy due to aminotransferase abnormalities.
Danish: I et ublindet studie (AMB222) blev ambrisentan undersøgt hos 36 patienter til vurdering af forekomst af øgede serumaminotransferasekoncentrationer hos patienter, som tidligere var ophørt med anden ERA-behandling pga. abnormiteter i aminotransferase.
English: Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor.
Danish: Ambrisentan er et oralt aktivt ERA af gruppen propionsyre, som er selektiv for endotelin A-receptoren (ETA).
English: Don't stop taking Volibris without your doctor's advice Volibris is a treatment that you will need to keep on taking to control your PAH.
Danish: Stop ikke med at tage Volibris, medmindre du har aftalt det med lægen Volibris er en behandling, som du skal blive ved med at tage for at holde din PAH under kontrol.
English: 6 Cases of worsening dyspnoea of unclear aetiology have been reported shortly after starting ambrisentan therapy.
Danish: 6 Tilfælde af forværret dyspnø af ukendt ætiologi er set kort efter behandlingsstart med ambrisentan.
English: In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea and nasal congestion.
Danish: Hos raske frivillige blev der i forbindelse med enkeltdoser på 50 og 100 mg (5 - 10 gange den maksimalt anbefalede dosis) set hovedpine, rødmen, svimmelhed, kvalme og tilstopning af næsen.
English: Approximately 22% of the administered dose is recovered in the urine following oral administration with 3.3% being unchanged ambrisentan.
Danish: Efter peroral indgift genfindes ca. 22 % af den indgivne dosis i urinen, hvoraf 3,3 % er uændret ambrisentan.
English: Exposures of ambrisentan as measured by AUC(0-inf) and Cmax were increased by 35% and 20%, respectively.
Danish: Eksponeringen af ambrisentan blev målt vha. AUC(0-inf) og Cmax og der sås en stigning på henholdsvis 35 % og 20 %.
English: 6MWD (metres, median change)
Danish: 6MWD (meter, median ændring) 49,0
English: Volibris may cause side effects, such as low blood pressure, dizziness, tiredness (see section 4), that may affect your ability to drive or use machines.
Danish: Volibris kan give bivirkninger, såsom lavt blodtryk, svimmelhed og træthed (angivet i punkt 4), der kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogenbased contraceptives.
Danish: På baggrund af dette farmakokinetikstudie forventes ambrisentan ikke at påvirke eksponeringen af antikonceptionsmidler indeholdende østrogen eller progestogen signifikant.
English: Testicular tubular atrophy, which was occasionally associated with aspermia, was observed in oral repeat dose toxicity and fertility studies with male rats and mice without safety margin.
Danish: Testikelatrofi, som lejlighedsvis er forbundet med aspermi, sås efter orale, gentagne dosis-toksicitetsog fertilitetsstudier med hanrotter og -mus uden sikkerhedsmargin.
English: It is important to have regular blood tests, to check for anaemia and that your liver is working properly.
Danish: Det er vigtigt, at du får taget blodprøver regelmæssigt, for at undersøge, om du har blodmangel, og om din lever fungerer, som den skal.
English: If you forget to take Volibris
Danish: Hvis du har glemt at tage Volibris
English: With the exception of a 13% increase in sildenafil Cmax following co-administration with ambrisentan, there were no other changes in the pharmacokinetic parameters of sildenafil, N-desmethyl-sildenafil and ambrisentan.
Danish: Med undtagelse af en 13 % stigning i Cmax for sildenafil efter samtidig administration af ambrisentan var der ikke ændringer i de farmakokinetiske parametre for hverken sildenafil, N-desmetyl-sildenafil eller ambrisentan.
English: Following initial doses of rifampicin, a transient increase in ambrisentan AUC(0-τ) (121% and 116% after first and second doses of rifampicin, respectively) was observed, presumably due to a rifampicin-mediated OATP inhibition.
Danish: Efter initiale doser rifampicin er der set en forbigående forøgelse af ambrisentan AUC(0-τ) (121 % og 116 % efter henholdsvis første og anden dosis rifampicin), formodentlig forårsaget af en rifampicin-medieret OATP-hæmning.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen eller blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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 data, er listet nedenfor inddelt efter systemorganklasse og hyppighed.
English: Consequently, if PAH patients develop acute pulmonary oedema when treated with ambrisentan, the possibility of pulmonary veno-occlusive disease should be considered.
Danish: Hvis PAH-patienter udvikler lungeødem under behandling med ambrisentan, skal muligheden for pulmonal veno-okklusiv sygdom derfor overvejes.
English: The higher dose (10 mg) was associated with a higher incidence of these adverse reactions, and peripheral oedema tended to be more severe in patients ≥65 years in short-term clinical studies (see section 4.4).
Danish: Den høje dosis (10 mg) var associeret med en højere bivirkningshyppighed, og perifert ødem havde tendens til at være mere alvorlig hos patienter ≥ 65 år i kliniske studier af kort varighed (se pkt.
English: No clinical data are available (see section 5.3 regarding data available in juvenile animals).
Danish: 5.3 vedrørende data, der er tilgængelige hos unge dyr).
English: 30x1 film-coated tablets.
Danish: 30x1 filmovertrukne tabletter.
English: Ambrisentan in combination with tadalafil When used in combination with tadalafil, Volibris should be titrated to 10 mg once daily.
Danish: Ved anvendelse i kombination med tadalafil bør Volibris titreres til 10 mg en gang daglig.
English: This slight increase in sildenafil Cmax is not considered clinically relevant (see section
Danish: Den lette stigning i Cmax for sildenafil anses ikke for klinisk relevant (se pkt.
English: However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure.
Danish: På dag 8 har steady stateadministration af rifampicin dog ingen klinisk relevant effekt på eksponeringen af ambrisentan.
English: Volibris is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability.
Danish: Den sædvanlige initialdosis er 5 mg en gang daglig, som kan øges til 10 mg dagligt afhængigt af klinisk respons og tolerabilitet.
English: Each film-coated tablet contains 5 or 10 mg.
Danish: Hver filmovertrukket tablet indeholder 5 mg eller 10 mg.
English: → Don't breast-feed while you're taking Volibris.
Danish: → Du må ikke amme, mens du tager Volibris.
English: Patients started on ambrisentan 5 mg and tadalafil 20 mg, and were titrated to 40 mg tadalafil at week 4 and 10 mg ambrisentan at week 8, unless there were tolerability issues.
Danish: Patienterne blev initieret på 5 mg ambrisentan og 20 mg tadalafil og blev titreret op til 40 mg tadalafil ved uge 4 og 10 mg ambrisentan ved uge 8, medmindre der var tolerabilitetsproblemer.
English: Ambrisentan has minor or moderate influence on the ability to drive and use machines.
Danish: Ambrisentan påvirker i mindre til moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section
Danish: Idiopatisk pulmonal fibrose (IPF) med og uden sekundær pulmonal hypertension (se pkt.
English: No evidence for mutagenic or genotoxic effects of ambrisentan were seen in bacteria or in two in vivo rodent studies.
Danish: Der sås ingen tegn på mutagen eller genotoksisk virkning ved ambrisentan i bakterier eller i to in vivo-gnaverstudier.
English: In addition, in patients, ambrisentan had no overall effect on the weekly warfarin-type anticoagulant dose, prothrombin time (PT) and international normalised ratio (INR).
Danish: Ambrisentan havde heller ingen samlet virkning på den ugentlige dosis af warfarinantikoagulant, protrombintid (PT) og international normalized ratio (INR) hos patienterne.
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: Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebocontrolled clinical trial data.
Danish: Data kommer fra rutinemæssig lægemiddelovervågning, hyppighederne er baseret på statistisk modellering af data fra placebokontrollerede kliniske studier.
English: Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Danish: Volibris udvider blodkarrene til lungerne (lungearterierne) og gør det nemmere for hjertet at pumpe blod igennem.
English: Volibris contains the active substance ambrisentan.
Danish: Volibris indeholder det aktive lægemiddelstof ambrisentan.
English: The observed probability of survival for subjects receiving ambrisentan (combined ambrisentan dose group) at 1, 2 and 3 years was 93%, 85% and 79% respectively.
Danish: Hos de personer, der fik ambrisentan (gruppe med kombineret ambrisentan-dosering), var den observerede sandsynlighed for overlevelse efter 1, 2 og 3 år hhv. 93 %, 85 % og 79 %.
English: The Cmax and AUC(0-∞) were slightly decreased for ethinyl estradiol (8% and 4%, respectively), and slightly increased for norethindrone (13% and 14 %, respectively).
Danish: Cmax og AUC(0-∞) var let nedsat for ethinylestradiol (hhv. 8 % og 4 %) og let forøget for norethindron (hhv. 13 % og 14 %).
English: Based on the results of a population pharmacokinetic analysis in healthy volunteers and patients with PAH, the pharmacokinetics of ambrisentan were not significantly influenced by gender or age (see section 4.2).
Danish: Ud fra resultaterne fra en populationsfarmakokinetisk analyse med raske frivillige og patienter med PAH var farmakokinetikken for ambrisentan ikke signifikant påvirket af køn og alder (se pkt.
English: Ambrisentan is glucuronidated via several UGT isoenzymes (UGT1A9S, UGT2B7S and UGT1A3S) to form ambrisentan glucuronide (13%).
Danish: Ambrisentan bliver glukuronideret via adskillige UGT-isoenzymer (UGT1A9S, UGT2B7S og UGT1A3S), og derved dannes ambrisentan-glukuronid (13 %).
English: • Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.
Danish: • Ambrisentan blokkerer ETA-receptor-undertypen, som hovedsagelig findes på karrenes glatte muskelceller og på hjertemyocytter.
English: Systemic exposure to ambrisentan in male rats at this dose (based on steady-state AUC) was 6-fold that achieved at the 10 mg/day clinical dose.
Danish: Systemisk eksponering for denne dosis ambrisentan (baseret på steady state AUC) til hanrotter var 6-dobbelt i forhold til, hvad der blev set efter den kliniske dosis 10 mg/dag.
English: → It is important that you have these regular blood tests for as long as you are taking Volibris.
Danish: → Det er vigtigt, at du får taget disse blodprøver regelmæssigt, så længe du er i behandling med
English: Volibris 10 mg film-coated tablets EU/1/08/451/003
Danish: Volibris 10 mg filmovertrukne tabletter EU/1/08/451/003
English: Patients with pre-existent hepatic disease (cirrhosis or clinically significantly elevated aminotransferases) and patients using other targeted therapy for PAH (e.g. prostanoids) were excluded.
Danish: Patienter med forud eksisterende leversygdom (cirrose eller klinisk signifikant, forhøjede aminotransferaser) og patienter, som var i anden behandling for PAH (f.eks. prostanoider), blev udelukket.
English: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or
Danish: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Tyskland eller
English: Manufacturer Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany
Danish: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Tyskland
English: Reductions in haemoglobin concentrations and haematocrit have been associated with endothelin receptor antagonists (ERAs) including ambrisentan.
Danish: Nedsat hæmoglobinkoncentration og hæmatokrit er blevet forbundet med anvendelse af endotelinreceptorantagonister (ERAer) herunder ambrisentan.
English: Treatment with combination therapy resulted in a 50% risk reduction (hazard ratio [HR] 0.502; 95% CI: 0.348 to 0.724; p=0.0002) of the composite clinical failure endpoint up to final assessment visit when compared to the pooled monotherapy group [Figure 1 and Table 1].
Danish: Kombinationsbehandling resulterede i en 50 % reduktion i risiko (hazard ratio [HR] 0,502; 95 % CI: 0,348 til 0,724; p=0,0002) for det sammensatte endepunkt for klinisk behandlingssvigt inden det afsluttende vurderingsbesøg, ved sammenligning med den puljede monoterapi-gruppe (figur 1 og tabel 1).