FrancophonIA/ELRC3.0 huggingface dataset:
English: Supportive comparisons of combination therapy group vs. the individual monotherapy groups were also made.
Danish: Der blev også foretaget supporterende sammenligninger af kombinationsbehandlingsgruppen vs. de individuelle monoterapigrupper.
English: How much Ambrisentan Mylan to take
Danish: Hvor meget Ambrisentan Mylan skal du tage
English: Due to the mechanism of action, an overdose of ambrisentan could potentially result in hypotension (see section 5.3).
Danish: Pga. virkningsmekanismen kan en overdosis af ambrisentan resultere i hypotension (se pkt.
English: Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Danish: Bivirkningshyppighederne baseret på erfaring fra kliniske studier afspejler ikke nødvendigvis hyppigheden, der vil ses ved normal klinisk praksis.
English: In addition, the rat study showed an increased incidence of interventricular septal defects, trunk vessel defects, thyroid and thymus abnormalities, ossification of the basisphenoid bone, and the occurrence of the umbilical artery located on the left side of the urinary bladder instead of the right side.
Danish: Desuden viste rottestudiet en øget forekomst af interventrikulære septumdefekter, defekter i kroppens centrale kar, abnormiteter i thyroidea og thymus, abnorm forbening af basisphenoid-knoglen samt forekomst af umbilikalarterien på venstre side af urinblæren i stedet for på højre side.
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Danish: Luftveje, thorax og mediastinum Epistaxis
English: • That women of reproductive potential must use effective contraception
Danish: • At kvinder i den fertile alder skal anvende sikker prævention
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: If patients develop sustained, unexplained, clinically significant ALT and/or AST elevation, or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice), ambrisentan therapy should be discontinued.
Danish: Hvis en patient udvikler vedvarende, uforklarlig klinisk signifikant ALAT- og/eller ASATforhøjelse, eller hvis ALAT- og/eller ASAT-forhøjelse ledsages af tegn eller symptomer på leverskader (f.eks. gulsot), skal ambrisentan seponeres.
English: Initiation of ambrisentan is not recommended for patients with clinically significant anaemia.
Danish: Påbegyndelse af behandling med ambrisentan frarådes hos patienter med klinisk signifikant anæmi.
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: I alt 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: Each film-coated tablet contains 5 mg or 10 mg.
Danish: Hver filmovertrukket tablet indeholder 5 mg eller 10 mg.
English: This slight increase in sildenafil Cmax is not considered clinically relevant (see section 4.5).
Danish: Den lette stigning i Cmax for sildenafil anses ikke for klinisk relevant (se pkt.
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 målrettet behandling for PAH (f.eks. prostanoider), blev udelukket.
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 normaliseret ratio (INR) hos patienterne.
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 omfattede: dødsfald, lungetransplantation, indlæggelse pga. PAH, atrieseptostomi, tilføjelse af andre lægemidler til behandling af PAH samt kriterierne for udtræden før tid.
English: Ambrisentan is contraindicated in pregnancy (see section 4.3).
Danish: Ambrisentan er kontraindiceret under graviditet (se pkt.
English: Ambrisentan was clastogenic when tested at high concentrations in mammalian cells in vitro.
Danish: Ambrisentan var klastogent ved test med høje koncentrationer i pattedyrsceller in vitro.
English: Ambrisentan Mylan widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Danish: Ambrisentan Mylan udvider blodkarrene til lungerne (lungearterierne) og gør det nemmere for hjertet at pumpe blod igennem dem.
English: The MAH will agree the distribution plan with the National Competent Authorities before the product launch in each territory and will ensure that all patients taking Ambrisentan Mylan have been provided with the relevant educational materials.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal sammen med den relevante, nationale myndighed aftale en distributionsplan inden lancering i det pågældende land og sikre, at alle patienter som anvender Ambrisentan Mylan, har fået udleveret følgende oplysningsmaterialer:
English: In male rats, there were no effects of ambrisentan on sperm motility at all doses tested (up to 300 mg/kg/day).
Danish: Der sås ingen effekt på sædmotiliteten hos hanrotter ved nogen af de testede ambrisentandoser (op til 300 mg/kg/dag).
English: However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure.
Danish: På dag 8 har steady state-administration af rifampicin dog ingen klinisk relevant effekt på eksponeringen for ambrisentan.
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: This is a blood disorder which can cause tiredness, weakness, shortness of breath, and generally feeling unwell.
Danish: Blodmangel kan medføre træthed, svaghed, åndenød og en generel følelse af utilpashed.
English: The symptoms of your condition can also make you less fit to drive or use machines.
Danish: Symptomerne fra din sygdom kan også påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: • inflammation of the liver caused by the body's own defences (autoimmune hepatitis) In combination with tadalafil
Danish: • leverbetændelse forårsaget af kroppens eget immunforsvar (autoimmun hepatitis).
English: In vitro studies in rat hepatocytes also showed that ambrisentan did not induce Pgp, BSEP or MRP2 protein expression.
Danish: In vitro-studier i rotte-hepatocytter har desuden vist, at ambrisentan ikke inducerede ekspression af Pgp, BSEP eller MRP2.
English: → Don't breast-feed while you're taking Ambrisentan Mylan.
Danish: → Du må ikke amme, mens du tager Ambrisentan Mylan.
English: Ear and labyrinth disorders Tinnitus
Danish: Øre og labyrint Tinnitus
English: Nasal congestion
Danish: Nasal kongestion
English: If you take cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Mylan once a day.
Danish: Hvis du tager medicin, som indeholder ciclosporin A, må du ikke tage mere end én Ambrisentan Mylan 5 mg tablet dagligt.
English: The other ingredients are lactose, see section 2, ‘Ambrisentan Mylan contains lactose', microcrystalline cellulose (E460i), sodium croscarmellose, magnesium stearate (E570), polyvinyl alcohol part hydrolysed, titanium dioxide (E171), macrogol/PEG, talc (E553b), Allura red (E129), see section 2 ‘Ambrisentan Mylan contains Allura red (E129)', Indigo carmine (E132)
Danish: Øvrige indholdsstoffer: lactose, se punkt 2, ‘Ambrisentan Mylan indeholder lactose', mikrokrystallinsk cellulose (E460i), croscarmellosenatrium, magnesiumstearat (E570), polyvinylalkohol (delvist hydrolyseret), titandioxid (E171), macrogol/PEG, talcum (E553b), Allura red AC (E129), se punkt 2 ‘Ambrisentan Mylan indeholder Allura red AC (E129)', Indigocarmin (E132)
English: Poly(vinyl alcohol) (partly hydrolysed) Titanium dioxide (E171) Macrogol
Danish: Poly(vinylalkohol) (delvist hydrolyseret) Titandioxid (E171)
English: The binding affinity of 4-hydroxymethyl ambrisentan for the human endothelin receptor is 65-fold less than ambrisentan.
Danish: Bindingsaffiniteten til den menneskelige endotelin-receptor er 65 gange mindre for 4-hydroxyetyl-ambrisentan end for ambrisentan.
English: Fifty percent of patients had increased from 5 mg to 10 mg ambrisentan during this time.
Danish: I løbet af den tid var 50 % af patienterne skiftet fra 5 mg til 10 mg ambrisentan.
English: The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan.
Danish: Forekomsten af lavt hæmoglobin (anæmi) var højere med 10 mg ambrisentan.
English: If you take more Ambrisentan Mylan than you should If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness:
Danish: Hvis du tager for mange tabletter, er der større risiko for, at du får bivirkninger, såsom hovedpine, ansigtsrødme, svimmelhed, kvalme eller lavt blodtryk, som kan forårsage svimmelhed:
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 af en populationsfarmakokinetisk analyse med raske frivillige og patienter med PAH var farmakokinetikken for ambrisentan ikke signifikant påvirket af køn og alder (se pkt.
English: ARIES-2 included 192 patients and compared ambrisentan 2.5 mg and 5 mg with placebo.
Danish: ARIES-2 omfattede 192 patienter og sammenlignede 2,5 mg og 5 mg ambrisentan med placebo.
English: In a population pharmacokinetic analysis, creatinine clearance was found to be a statistically significant covariate affecting the oral clearance of ambrisentan.
Danish: En populationsfarmakokinetisk analyse viste, at kreatininclearance er en statistisk signifikant kovariant, der påvirker den perorale clearance af ambrisentan.
English: Autoimmune hepatitis (see section 4.4)
Danish: Autoimmun hepatitis (se pkt.
English: Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in haemoglobin 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: Abnormalities of the lower jaw, tongue, and/or palate were seen at all doses tested.
Danish: Abnormiteter i underkæbe, tunge og/eller gane sås ved alle testede doser.
English: Information from longer term non-placebo-controlled studies (ARIES-E and AMBITION
Danish: Information fra længerevarende, ikke-placebokontrollerede studier (ARIES-E og AMBITION (kombination med tadalafil)) er også inkluderet nedenfor.
English: Allura red AC Aluminium Lake (E129) Indigo Carmine Aluminium Lake (E132).
Danish: Allura red AC Aluminium Lake (E129) Indigocarmin Aluminium Lake (E132).
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 på 10 mg/dag.
English: • a runny or blocked nose, congestion or pain in the sinuses
Danish: • løbende eller stoppet næse, tilstoppede bihuler eller smerter i bihulerne
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-eksponeringen set ved multiple doser ambrisentan anses ikke for klinisk relevant, og der kræves ingen dosisjustering af digoxin (se pkt.
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 middelhjerteindeks, et fald i middel lungearterietryk og et fald i middel pulmonal vaskulær modstand.
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: When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil.
Danish: Ved kombination med tadalafil fik patienterne initialt 5 mg ambrisentan og 20 mg tadalafil.
English: Upper respiratory (e.g. nasal, sinus) congestion, sinusitis, nasopharyngitis, rhinitis
Danish: Kongestion i øvre luftveje (f.eks næse, sinus), sinuitis og nasopharyngitis, rhinitis
English: In dogs, slight inflammatory responses were observed following chronic high dose administration of ambrisentan at exposures greater than 20-fold that observed in patients.
Danish: Hos hunde sås lette inflammatoriske reaktioner efter kroniske, høje doser ambrisentan ved eksponeringer på mere end 20 gange mere end hos patienter.
English: • loss of appetite
Danish: • appetitmangel
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 for at vurdere forekomsten af øgede serumaminotransferase-koncentrationer hos patienter, som tidligere var ophørt med anden ERA-behandling pga. abnormiteter i aminotransferase.
English: Although no clear evidence of a detrimental effect of ambrisentan long-term exposure on sperm count was found in ARIES-E study, chronic administration of ambrisentan was associated with changes in markers of spermatogenesis.
Danish: I studiet ARIES-E blev der ikke fundet klart bevis for en skadelig virkning af længerevarende eksposition for ambrisentan på sædtallet, men kronisk administration af ambrisentan blev sat i forbindelse med ændringer i markører for spermatogenese.
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 ekstrahepatisk metabolisme.
English: Blisters
Danish: BLISTER
English: Furthermore, ambrisentan did not induce MRP2, Pgp or BSEP protein expression in rat hepatocytes.
Danish: Endvidere inducerede ambrisentan ikke ekspression af MRP2, P-gp eller BSEP i rotte-hepatocytter.
English: PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs.
Danish: Ved PAH er blodtrykket forhøjet i de blodkar, der fører blodet fra hjertet til lungerne (lungearterierne).
English: • anaemia (a reduced number of red blood cells)
Danish: • blodmangel (nedsat antal røde blodlegemer)
English: Ambrisentan Mylan 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 én gang dagligt, som kan øges til 10 mg dagligt afhængigt af klinisk respons og tolerabilitet.
English: Heart failure
Danish: Hjerte Hjerteinsufficiens
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 henholdsvis 93%, 85% og 79%.
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 serumaminotransferase-stigninger > 3xULN inden for 2 år hos de patienter, der blev behandlet med ambrisentan.
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 (ERA'er), herunder ambrisentan.
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 for ambrisentan (se pkt.
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: In placebo controlled clinical trials of 12 weeks duration mean reduction in systolic and diastolic blood pressures from base line to end of treatment were 3 mm Hg and 4.2 mm Hg respectively.
Danish: I placebokontrollerede kliniske studier af 12 ugers varighed var det gennemsnitlige systoliske og diastoliske blodtryksfald fra baseline til afslutning af behandlingen på hhv. 3 mmHg og 4,2 mmHg.
English: Gastrointestinal disorders Nausea, vomiting, diarrhoea
Danish: Mave-tarm-kanalen Kvalme, opkastning, diarré
English: Ireland or
Danish: Irland eller
English: There was a small increase in mammary fibroadenomas, a benign tumor, in male rats at the highest dose only.
Danish: Der sås en lille stigning i fibroadenomer i brystet, en benign tumor, men kun hos hanrotter, som havde fået den højeste dosis.
English: Swelling (oedema), especially of the ankles and feet
Danish: Hævelser (væskeansamlinger), særligt i ankler og fødder.
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).
English: ARIES-1 included 201 patients and compared ambrisentan 5 mg and 10 mg with placebo.
Danish: ARIES-1 omfattede 201 patienter og sammenlignede 5 mg og 10 mg ambrisentan med placebo.
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-transporterende polypeptid [OATP], en stærk CYP3A- og 2C19-inducer samt inducer af P-glykoprotein (P-gp) og uridindifosfatglukuronosyltransferaser [UGT'er]), er blevet kædet sammen med en forbigående stigning (omtrent en fordobling) i eksponeringen for ambrisentan efter første dosis hos raske frivillige personer.
English: Ambrisentan is highly plasma protein bound.
Danish: Ambrisentan er stærkt bundet til plasmaprotein.
English: Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.
Danish: Ambrisentan blokerer ETA-receptor-undertypen, som hovedsagelig findes på karrenes glatte muskelceller og på hjertemyocytter.
English: Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section 5.1).
Danish: Idiopatisk pulmonal fibrose (IPF) med og uden sekundær pulmonal hypertension (se pkt.
English: The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and soluble guanylate cyclase stimulators) has not been specifically studied in controlled clinical trials in PAH patients (see section 5.1).
Danish: Ambrisentans virkning og sikkerhed ved administration sammen med anden PAH-behandling (f.eks. prostanoider og opløselige guanylatcyklase-stimulatorer) er ikke specifikt undersøgt i kontrollerede kliniske studier med PAH-patienter (se pkt.
English: Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebo controlled clinical trial data.
Danish: Data kommer fra rutinemæssig lægemiddelovervågning, hyppighederne er baseret på statistisk modellering af data fra placebokontrollerede kliniske studier.
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 vivognaverstudier.
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: 30 film-coated tablets 30x1 film-coated tablets.
Danish: 30 filmovertrukne tabletter 30x1 filmovertrukne tabletter.
English: • blurry or other changes to vision
Danish: • sløret syn eller andre synsforstyrrelser
English: Ambrisentan is therefore contraindicated for patients with IPF with or without secondary pulmonary hypertension (see section 4.3).
Danish: Ambrisentan er derfor kontraindiceret hos patienter med IPF med eller uden sekundær pulmonal hypertension (se pkt.
English: Component as First Clinical Failure Event (Adjudicated) Death (all-cause) 9 (4%)
Danish: Død (alle årsager) 9 (4%)
English: Other medicines and Ambrisentan Mylan
Danish: Brug af anden medicin sammen med Ambrisentan Mylan
English: In patients without clinical symptoms of hepatic injury or of jaundice, re-initiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities.
Danish: Hos patienter, der ikke har kliniske symptomer på leverskade eller gulsot, kan genoptagelse af behandlingen med ambrisentan overvejes, når abnormiteterne i leverenzymerne er forsvundet.