FrancophonIA/ELRC3.0 huggingface dataset:
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: → Tell your doctor straight away if you get these effects or if they happen suddenly after taking Ambrisentan Mylan.
Danish: → Fortæl det straks til lægen, hvis du får nogen af de nævnte bivirkninger, eller hvis de opstår pludseligt, efter du har taget Ambrisentan Mylan.
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: The safety findings observed with long-term ambrisentan exposure in this study were generally consistent with those observed in the 12 week placebo-controlled studies.
Danish: De sikkerhedsmæssige fund, der blev observeret ved langvarig eksponering for ambrisentan i dette studie, var generelt i overensstemmelse med de resultater, der blev set i de 12-ugers placebokontrollerede studier.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Ambrisentan Mylan and regularly while you are taking this medicine.
Danish: Hvis du er kvinde og kan blive gravid, vil lægen bede dig tage en graviditetstest, inden du starter behandlingen med Ambrisentan Mylan og regelmæssigt, mens du er i behandling med denne medicin.
English: In a population pharmacokinetic analysis, the oral clearance was shown to be decreased as a function of increasing bilirubin levels.
Danish: En populationsfarmakokinetisk analyse viste, at den orale clearance falder som funktion af stigende bilirubin-niveauer.
English: • lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease).
Danish: • en lungesygdom, hvor blodårerne i lungerne er blokeret (pulmonal veno-okklusiv sygdom).
English: Two randomised, double-blind, multi-centre, placebo controlled, Phase 3 pivotal studies were conducted (ARIES-1 and 2).
Danish: Der er gennemført to randomiserede, dobbeltblinde, placebokontrollerede, pivotale fase 3multicenterstudier (ARIES-1 og -2).
English: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Danish: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, Storbritannien
English: • dark-coloured urine
Danish: • mørkfarvet urin
English: Film-coated tablet (tablet)
Danish: Filmovertrukket tablet (tablet).
English: (see section 4.2).
Danish: (angivet i punkt 6).
English: Cmax and area under the plasma concentration-time curve (AUC) increase dose proportionally over the therapeutic dose range.
Danish: Cmax og arealet under plasmakoncentations-tidskurven (AUC) stiger dosisproportionalt over hele det terapeutiske interval.
English: For dose-related adverse reactions the frequency category reflects the higher dose of ambrisentan.
Danish: For dosisrelaterede bivirkninger afspejler hyppighedskategorien den høje dosis af ambrisentan.
English: Concomitant use with other medicinal products
Danish: Samtidig administration med andre lægemidler
English: Ambrisentan has minor or moderate influence on the ability to drive and use machines.
Danish: Ambrisentan påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
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 time efter indgift ved både faste og sammen med mad.
English: If you're taking other medicines used to treat PAH (e.g. iloprost, epoprostenol, sildenafil) your doctor may need to monitor you.
Danish: Hvis du tager anden medicin, der bruges til behandling af PAH (f.eks. medicin indeholdende iloprost, epoprostenol eller sildenafil) kan det være nødvendigt, at lægen følger dig tæt.
English: Post-marketing reports of fluid retention occurring within weeks after starting ambrisentan have been received and, in some cases, have required intervention with a diuretic or hospitalisation for fluid management or decompensated heart failure.
Danish: Der er modtaget postmarketing-rapporter om væskeretention, der opstod inden for nogle uger efter påbegyndt behandling med ambrisentan, og som i nogle tilfælde har krævet intervention med diuretikum eller hospitalsindlæggelse for genopretning af væskebalancen eller behandling af dekompenseret hjerteinsufficiens.
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: In both studies, ambrisentan was added to patients' supportive/background medication, which could have included a combination of digoxin, anticoagulants, diuretics, oxygen and vasodilators (calcium channel blockers, ACE inhibitors).
Danish: I begge studier blev ambrisentan tilføjet til patienternes støttende/bagvedliggende behandling, som kunne omfatte en kombination af digoxin, antikoagulantia, diuretika, oxygen og vasodilatatorer (kalciumkanalblokkere, ACE-hæmmere).
English: → It is important that you have these regular blood tests for as long as you are taking Ambrisentan Mylan.
Danish: → Det er vigtigt, at du får taget disse blodprøver regelmæssigt, så længe du er i behandling med Ambrisentan Mylan.
English: Monthly pregnancy tests during treatment with ambrisentan are recommended.
Danish: Det anbefales, at der tages en graviditetstest hver måned under behandling med ambrisentan.
English: This is an event rate of 2.3 events per 100 patient years of exposure for ambrisentan.
Danish: Dette svarer til en hyppighed på 2,3 hændelser pr. 100 patientår på ambrisentan.
English: Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Hungary
Danish: Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Ungarn
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: Microcrystalline cellulose (E460i) Croscarmellose sodium Magnesium stearate (E570)
Danish: Mikrokrystallinsk cellulose (E460i) Croscarmellosenatrium Magnesiumstearat (E570)
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: Atrofi af testikulære tubuli, som lejlighedsvis var forbundet med aspermi, sås i studier af toksicitet efter gentagne orale doser og fertilitetstudier med hanrotter og -mus uden sikkerhedsmargin.
English: Patients with WHO FC II and III had a mean baseline 6MWD of 353 metres.
Danish: Patienter med WHO-FC II og III havde en gennemsnitlig 6MWD på 353 meter ved baseline.
English: • worsening shortness of breath shortly after starting Ambrisentan Mylan
Danish: • forværret vejrtrækningsbesvær kort efter behandlingsstart med Ambrisentan Mylan
English: Ambrisentan is a substrate for Pgp-mediated efflux.
Danish: Ambrisentan er et substrat for P-gp-medieret effluks.
English: This is due to the heart not pumping out enough blood, causing shortness of breath, extreme tiredness and swelling in the ankles and legs.
Danish: Dette skyldes, at hjertet ikke pumper tilstrækkeligt meget blod rundt i kroppen, hvilket medfører åndenød, ekstrem træthed samt hævede ankler og ben.
English: In both studies, treatment with ambrisentan resulted in a significant improvement in 6MWD for each dose of ambrisentan.
Danish: I begge studier resulterede behandling med ambrisentan, uanset dosis, i en signifikant forbedring af 6MWD.
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 sandsynligvis ikke være klinisk signifikante (se pkt.
English: The number of patients who received concomitant ambrisentan and sildenafil in ARIES-E and AMB222 was 22 patients (5.7%) and 17 patients (47%), respectively.
Danish: Antallet af patienter, der fik ambrisentan og sildenafil samtidig i ARIES-E og AMB222, var henholdsvis 22 patienter (5,7%) og 17 patienter(47%).
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstilleren (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: Disease progression
Danish: Sygdomsprogression
English: The main primary endpoints of this study were the incidence and severity of adverse events associated with long-term exposure to ambrisentan, including serum LFTs.
Danish: De vigtigste primære endepunkter i dette studie var forekomsten og sværhedsgraden af bivirkninger forbundet med langvarig eksponering for ambrisentan, inklusive serum-LFT'er.
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: It is recommended that haemoglobin and/or haematocrit levels are measured during treatment with ambrisentan, for example at 1 month, 3 months and periodically thereafter in line with clinical practice.
Danish: Det anbefales, at hæmoglobin og/eller hæmatokrit måles undervejs i behandlingen med ambrisentan, f.eks efter 1 måned, 3 måneder og derefter periodisk iht.
English: The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, asthenia, fatigue) should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Danish: Patientens kliniske tilstand og ambrisentans bivirkningsprofil (såsom hypotension, svimmelhed, asteni og træthed) skal tages i betragtning ved vurdering af patientens evne til at udføre opgaver, der kræver dømmekraft, motoriske eller kognitive færdigheder (se pkt.
English: Do not take Ambrisentan Mylan: - if you are allergic to ambrisentan or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Ambrisentan Mylan: - hvis du er allergisk over for ambrisentan eller et af de øvrige indholdsstoffer i dette lægemiddel
English: A slight (<10%) decrease in the percentage of morphologically normal sperms was noted at 300 mg/kg/day but not at 100 mg/kg/day (>9-fold clinical exposure at 10 mg/day).
Danish: Der blev set en lille reduktion (<10%) i procenten af morfologisk normal sperm ved 300 mg/kg/dag, men ikke ved 100 mg/kg/dag (> 9 gange klinisk eksponering ved 10 mg/dag).
English: Ambrisentan Mylan may harm unborn babies conceived before, during or soon after treatment.
Danish: Ambrisentan Mylan kan skade fostre, der er undfanget før, under eller lige efter behandlingen.
English: The safety of ambrisentan has been evaluated as monotherapy and/or in combination in clinical trials of more than 1,200 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: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Danish: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irland
English: The usual dose of Ambrisentan Mylan is one 5 mg tablet, once a day.
Danish: Den sædvanlige dosis af Ambrisentan Mylan er én 5 mg tablet én gang dagligt.
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Danish: Der er påvist effekt ved idiopatisk PAH (IPAH) og ved PAH associeret med bindevævssygdom.
English: When used in combination with tadalafil, Ambrisentan Mylan should be titrated to 10 mg once daily.
Danish: Ved anvendelse i kombination med tadalafil bør Ambrisentan Mylan titreres til 10 mg én gang dagligt.
English: Ketoconazole
Danish: Ketoconazol
English: Please read the information under ‘Pregnancy' - if you are breast feeding.
Danish: Læs informationen under "Graviditet" - hvis du ammer.
English: Other clinical information
Danish: Anden klinisk information
English: Read the information under ‘Breast-feeding' - if you have liver disease.
Danish: Læs informationen under "Amning" - hvis du har en leversygdom.
English: • whether you have anaemia
Danish: • om du har blodmangel
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 ciclosporin A's hæmning af transportører og metaboliske enzymer, som er involveret i ambrisentans farmakokinetik.
English: Ambrisentan Mylan is indicated for the 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: Ambrisentan Mylan 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: The frequency of headache appeared higher with 10 mg ambrisentan.
Danish: Hyppigheden af hovedpine var højere med 10 mg ambrisentan.
English: If you notice any of these signs:
Danish: Hvis du får nogen af disse symptomer:
English: Exposures of ambrisentan as measured by AUC(0-inf) and Cmax were increased by 35% and 20%, respectively.
Danish: Eksponeringen for ambrisentan blev målt vha. AUC(0-inf) og Cmax, og der sås en stigning på henholdsvis 35% og 20%.
English: Ambrisentan is a potent (Ki 0.016 nM) and highly selective ETA antagonist (approximately 4000-fold more selective for ETA as compared to ETB).
Danish: Ambrisentan er en potent (Ki 0,016 nM) og højselektiv ETA-antagonist (ca. 4.000 gange mere selektiv over for ETA end over for ETB).
English: Ambrisentan Mylan 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: Ambrisentan Mylan 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: 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: Blood and lymphatic system disorders Anaemia (decreased haemoglobin, decreased haematocrit)
Danish: Blod og lymfesystem Anæmi (nedsat hæmoglobin, nedsat hæmatokrit)
English: • abnormal blood test results for liver function
Danish: • blodprøver, der viser unormal leverfunktion
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 vasodilatatorerne nitrogenoxid og prostacyklin.
English: The effect of ambrisentan on male human fertility is not known.
Danish: Ambrisentans virkning på fertiliteten hos mænd kendes ikke.
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 for antikonceptionsmidler indeholdende østrogen eller progestogen signifikant.
English: Patients enrolled into ARIES-1 and 2 were eligible to enter a long-term open label extension study ARIES-E (n=383).
Danish: Patienterne, der indgik i ARIES-1 og -2, var egnede til at indgå i et længerevarende, ublindet forlængelsesstudie, ARIES-E (n = 383).
English: Liver function abnormalities have been associated with PAH.
Danish: Abnormiteter i leverfunktionen er blevet forbundet med PAH.
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: Patients enrolled had IPAH or PAH associated with connective tissue disease (PAH-CTD).
Danish: De patienter, der indgik i studiet, havde IPAH eller PAH associeret med bindevævssygdom (PAH-CTD).
English: • swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
Danish: • hævede hænder, ankler eller fødder på grund af væske (perifert ødem)
English: Administration of ambrisentan to female rats from late-pregnancy through lactation caused adverse events on maternal behaviour, reduced pup survival and impairment of the reproductive capability of the offspring (with observation of small testes at necropsy), at exposure 3-fold the AUC at the maximum recommended human dose.
Danish: Indgift af ambrisentan til hunrotter fra sidst i graviditeten til og med amningen forårsagede bivirkninger på moderens adfærd, nedsat overlevelse hos afkommet og nedsættelse af reproduktionsevnen hos afkommet (med observation af små testikler ved obduktion) ved eksponering på 3 gange AUC ved den maksimalt anbefalede dosis til mennesker.
English: • yellowing of your skin or the whites of your eyes (jaundice)
Danish: • din hud eller det hvide i øjnene bliver gult (gulsot)
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 ambrisentans AUC(0-τ) (121% og 116% efter henholdsvis første og anden dosis rifampicin), formodentlig forårsaget af en rifampicin-medieret OATP-hæmning.
English: Ambrisentan Mylan tablets contain small amounts of a sugar called lactose.
Danish: Ambrisentan Mylan tabletter indeholder en lille mængde af en sukkerart, der hedder lactose.
English: Talk to your doctor, pharmacist or nurse before taking this medicine if you have:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel, hvis du har:
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 akut lungeødem under behandling med ambrisentan, skal muligheden for pulmonal veno-okklusiv sygdom derfor overvejes.
English: If patients have pre-existing fluid overload, this should be managed as clinically appropriate prior to starting ambrisentan.
Danish: Hvis patienterne har eksisterende væskeretention, skal denne korrigeres med passende behandling før opstart af ambrisentan.
English: • That Ambrisentan Mylan is teratogenic in animals
Danish: • At Ambrisentan er teratogent hos dyr
English: Due to the class primary pharmacologic effect, a large single dose of ambrisentan (i.e. an overdose) could lower arterial pressure and have the potential for causing hypotension and symptoms related to vasodilation.
Danish: Pga. ERA-klassens primære farmakologiske virkning kan en enkelt stor dosis af ambrisentan (dvs. en overdosis) sænke blodtrykket og muligvis forårsage hypotension og symptomer relateret til vasodilatation.
English: In the rat, hyperplasia of nasal turbinate bone is a recognised response to nasal inflammation, based on experience with other compounds.
Danish: Hos rotter er hyperplasi af siben en anerkendt reaktion på nasal inflammation ud fra erfaring med andre stoffer.
English: In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerability (see section 5.1).
Danish: I AMBITION-studiet fik patienterne 5 mg ambrisentan dagligt i de første 8 uger, før de blev titreret op til 10 mg, afhængigt af tolerabilitet (se pkt.
English: → Ask your doctor or pharmacist for advice if you take more tablets than prescribed.
Danish: → Spørg lægen eller apotekspersonalet til råds, hvis du tager flere tabletter, end lægen har anvist.
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: Dependent on tolerability the dose of tadalafil was increased to 40 mg after 4 weeks and the dose of ambrisentan was increased to 10 mg after 8 weeks.
Danish: Afhængigt af tolerabiliteten blev tadalafildosis øget til 40 mg efter 4 uger, og ambrisentandosis blev øget til 10 mg efter 8 uger.
English: This change in exposure is unlikely to be of any clinical relevance and therefore ambrisentan may be co-administered with ketoconazole.
Danish: Denne ændring i eksponering forventes ikke at have klinisk relevans, og ambrisentan kan derfor administreres samtidigt med ketoconazol.
English: Ambrisentan is a non-sulphonamide (propanoic acid) ERA.
Danish: Ambrisentan er en non-sulfonamid (propionsyre)-ERA.
English: No dose adjustment is required in patients over the age of 65 (see section 5.2).
Danish: Der kræves ingen dosisjusteringer hos patienter over 65 år (se pkt.
English: No previously unknown adverse reactions were identified with long-term treatment or for ambrisentan in combination with tadalafil.
Danish: Ingen tidligere ukendte bivirkninger blev identificeret ved langtidsbehandling eller ved kombination af ambrisentan med tadalafil.
English: The primary analysis was combination group vs. pooled monotherapy groups.
Danish: Den primære analyse omfattede kombinationsgruppen vs. de puljede monoterapi-grupper.
English: → Tell your doctor or pharmacist if you are taking any of these medicines.
Danish: → Fortæl det til lægen eller apotekspersonalet, hvis du tager nogen af disse typer medicin.
English: If a clinically significant decrease in haemoglobin or haematocrit is observed, and other causes have been excluded, dose reduction or discontinuation of treatment should be considered.
Danish: Hvis der ses et klinisk signifikant fald i hæmoglobin eller hæmatokrit, og andre årsager er udelukket, skal det overvejes at reducere dosis eller afbryde behandlingen.
English: The efficacy of ambrisentan as monotherapy has not been established in patients with WHO functional class IV PAH.
Danish: Effekten af ambrisentan som monoterapi er ikke fastslået hos patienter med PAH WHOfunktionsklasse IV.
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: Cases of worsening dyspnoea of unclear aetiology have been reported shortly after starting ambrisentan therapy.
Danish: Tilfælde af forværret dyspnø af ukendt ætiologi er set kort efter behandlingsstart med ambrisentan.