FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reaction should be added under the SOC Skin and subcutaneous tissue disorders with a frequency “not known” (cannot be estimated from available data): “Palmar-plantar erythrodysesthesia syndrome*” *As reported in the post marketing surveillance of paclitaxel.
Danish: Følgende bivirkning bør tilføjes under systemorganklassen Hud og subkutane væv med frekvensen ”ikke kendt (kan ikke estimeres ud fra forhåndenværende data)”: ”Palmar-plantar erytrodysæstesisyndrom*” *Som rapporteret i overvågningen af paclitaxel efter markedsføring Derudover skal den indledende sætning til tabellen over bivirkninger ændres, så den afspejler, at den omfatter bivirkninger fra erfaringer efter markedsføring, som relevant:
English: The following phrase should be included as a footnote of the ADR ‘neuropathy' in the table listing adverse reactions: *Can persist beyond 6 months of paclitaxel discontinuation The following sentence should be included in the text describing nervous system disorders under the section 4.8:
Danish: Følgende sætning bør inkluderes som en fodnote til bivirkningen "neuropati" i tabellen over bivirkninger: *Kan vare ved udover 6 måneder efter seponering af paclitaxel.
English: Therefore, the SmPC of paclitaxel should be updated with the inclusion of palmar-plantar erythrodysesthesia syndrome as an ADR in section 4.8 under SOC Skin and subcutaneous tissue disorders.
Danish: Produktresuméet for paclitaxel bør derfor opdateres med inklusion af palmar-plantar erytrodysæstesi-syndrom som en bivirkning i pkt.
English: In addition, the introductory sentence to the table listing adverse reactions is to be amended to reflect that it includes adverse reactions from post marketing experience, as appropriate: Table X lists adverse reactions (…) observed in (a) clinical study(ies) and adverse reactions from post-marketing experience.
Danish: Tabel X angiver bivirkninger (...) observeret i (et) klinisk(e) studie(r) og bivirkninger fra erfaring efter markedsføring.
English: MA (EU) Number
Danish: EMA´s procedure nr. (Særnavn) Navn
English: Doses could also be decreased depending on tolerability.
Danish: Dosis kunne også nedsættes afhængigt af tolerabilitet.
English: It is best to take your tablet at the same time each day.
Danish: Det er bedst at tage tabletten på samme tidspunkt hver dag.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Danish: En opdateret RMP skal fremsendes: • på anmodning fra Det Europæiske Lægemiddelagentur
English: → Tell your doctor immediately.
Danish: → Fortæl det straks til lægen.
English: • The need for monthly pregnancy tests
Danish: • Behovet for månedlige graviditetstests
English: NR - not reported
Danish: IR - ikke rapporteret
English: • whether your liver is working properly.
Danish: • om din lever fungerer, som den skal.
English: Talk to your doctor about this.
Danish: Tal med lægen om dette.
English: 6MWD (metres, median change)
Danish: 6MWD (meter, median ændring)
English: Cyclosporine A
Danish: Ciclosporin A
English: No specific antidote is available.
Danish: Der findes ingen specifik antidot.
English: Unsatisfactory long-term clinical response
Danish: Utilfredsstillende langvarigt klinisk respons
English: No additional safety concerns were identified in these patients.
Danish: Der var ingen yderligere problemer med sikkerhed hos disse patienter.
English: Difference and Confidence Interval p-value
Danish: Difference og konfidensinterval p-værdi
English: Secondary Endpoints (change from baseline to week 24)
Danish: Sekundære endepunkter (ændring fra baseline til uge 24)
English: • high temperature (fever)
Danish: • høj temperatur (feber)
English: → Don't drive or use machines if you're feeling unwell.
Danish: → Du må ikke føre motorkøretøj eller betjene maskiner, hvis du føler dig utilpas.
English: Talk to your doctor if you have any questions or concerns about this.
Danish: Tal med lægen, hvis du har spørgsmål eller bekymringer om dette.
English: Sometimes this requires a blood transfusion.
Danish: I nogle tilfælde kan blodtransfusion være nødvendigt.
English: Treatment must be initiated by a physician experienced in the treatment of PAH.
Danish: Behandlingen skal indledes af en læge med erfaring i behandling af PAH.
English: Effect of ambrisentan on xenobiotic transporters
Danish: Ambrisentans virkning på xenobiotiske transportører
English: The effect was significant for both FC II and FC III patients.
Danish: Virkningen var signifikant for både FC II- og FC III-patienter.
English: Ambrisentan is absorbed rapidly in humans.
Danish: Ambrisentan absorberes hurtigt hos mennesker.
English: Steady-state is generally achieved following 4 days of repeat dosing.
Danish: Steady state nås generelt efter 4 dage med gentagen dosering.
English: The clinical relevance of this finding to the paediatric population is not fully understood.
Danish: Den kliniske relevans af dette fund for den pædiatriske population er ikke fuldt ud forstået.
English: → Don't take Ambrisentan Mylan if you are pregnant or planning to become pregnant.
Danish: → Tag ikke Ambrisentan Mylan, hvis du er gravid eller planlægger at blive gravid.
English: Long term data
Danish: Langtidsdata
English: The median double-blind treatment duration for combination therapy was greater than 1.5 years.
Danish: Den mediane dobbeltblindede behandlingsvarighed for kombinationsbehandling var længere end 1,5 år.
English: A pre-specified combined analysis of the Phase 3 studies (ARIES-C) was conducted.
Danish: Der blev gennemført en præ-specificeret kombinationsanalyse af fase 3-studierne (ARIES-C).
English: This lowers the blood pressure and relieves the symptoms.
Danish: Dette sænker blodtrykket og lindrer symptomerne.
English: It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure).
Danish: Det tilhører en gruppe lægemidler, der kaldes ”andre antihypertensiva” (der bruges til behandling af forhøjet blodtryk).
English: See section ‘Description of selected adverse reactions'.
Danish: Se afsnittet ”Beskrivelse af udvalgte bivirkninger”.
English: If you have been told by your doctor that you have an intolerance to some sugars:
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter:
English: Patients with ALT and AST values >2xULN at baseline were also excluded.
Danish: Patienter med ALAT- og ASAT-værdier > 2xULN ved baseline blev også ekskluderet.
English: % subjects achieving a satisfactory clinical response at week 24
Danish: % forsøgspersoner, som opnåede tilfredsstillende klinisk respons ved uge 24
English: Other targeted PAH treatments
Danish: Andre målrettede PAH-behandlinger
English: Your doctor will decide whether Ambrisentan Mylan is suitable for you.
Danish: Lægen vil afgøre, om Ambrisentan Mylan er egnet til dig.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Hyppigheden defineres som: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: At baseline, 96% of patients were naive to any previous PAH-specific treatment, and the median time from diagnosis to entry into the study was 22 days.
Danish: Ved baseline var 96% af patienterne naive over for enhver tidligere PAH-specifik behandling, og mediantiden fra diagnose til inklusion i studiet var 22 dage.
English: Make sure that you have also read the information in section 2 under ‘You will need regular blood tests' and ‘Signs that your liver may not be working properly'.
Danish: Sørg for også at læse informationen i punkt 2 ”Det er nødvendigt, at du får taget regelmæssige blodprøver” og ”Følgende symptomer kan tyde på, at din lever muligvis ikke fungerer, som den skal”.
English: There is no experience in humans.
Danish: Der er ingen erfaring med behandling af mennesker.
English: Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.
Danish: Patienterne skal monitoreres for tegn på leverskade, og månedlig monitorering af ALAT og ASAT anbefales.
English: Your doctor may decide to increase your dose to 10 mg, once a day.
Danish: Lægen kan beslutte at øge din dosis til 10 mg én gang dagligt.
English: Conditions you and your doctor need to look out for:
Danish: Symptomer, som du og lægen skal være opmærksomme på:
English: In the case of pronounced hypotension, active cardiovascular support may be required.
Danish: I tilfælde af udtalt hypotension kan det være nødvendigt med aktiv kardiovaskulær støtte.
English: Talk to your doctor, who will decide whether this medicine is suitable for you - if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).
Danish: Tal med lægen, som vil afgøre, om dette lægemiddel er egnet til dig - hvis du har arvæv i lungerne af ukendt årsag (idiopatisk lungefibrose).
English: • palpitations (fast or irregular heart-beats)
Danish: • hjertebanken (hurtige eller uregelmæssige hjerteslag)
English: If there is any doubt on what contraceptive advice should be given to the individual patient, consultation with a gynaecologist should be considered.
Danish: Hvis der er tvivl om, hvilken prævention den enkelte patient skal bruge, bør henvisning til en gynækolog overvejes.
English: More than 90% of patients achieved this.
Danish: Flere end 90% af patienterne kom op på dette dosisniveau.
English: The primary endpoint was the time to first occurrence of a clinical failure event, defined as: - death, or - hospitalisation for worsening PAH, - disease progression; - unsatisfactory long-term clinical response.
Danish: Det primære endepunkt var tiden til første hændelse af klinisk behandlingssvigt, defineret som: - død, eller - hospitalsindlæggelse for forværring af PAH, - sygdomsprogression; - utilfredsstillende langvarigt klinisk respons.
English: It is used to treat pulmonary arterial hypertension (PAH) in adults.
Danish: Det bruges til at behandle pulmonal arteriel hypertension (PAH) hos voksne.
English: Pharmacotherapeutic group: Anti-hypertensives, other anti-hypertensives, ATC code: C02KX02
Danish: Farmakoterapeutisk klassifikation: Antihypertensiva, andre antihypertensiva, ATC-kode: C02KX02
English: • The need for regular monitoring of liver function because Ambrisentan Mylan may cause liver injury.
Danish: • Nødvendigheden af regelmæssig kontrol af leverfunktionen, eftersom Ambrisentan Mylan kan forårsage leverskade
English: Ambrisentan (ARIES-C and post marketing)
Danish: Ambrisentan (ARIES-C og post marketing)
English: • That pregnant women must not take Ambrisentan Mylan
Danish: • At gravide kvinder ikke må tage Ambrisentan Mylan
English: Sinusitis, rhinitis
Danish: Sinuitis, rhinitis
English: PVC/PVdC blisters
Danish: PVC/PVdC-blisterpakninger
English: Secondary endpoints were tested:
Danish: Sekundære endepunkter testet:
English: • sudden hearing loss.
Danish: • pludseligt høretab.
English: Patients should be aware of how they might be affected by ambrisentan before driving or using machines.
Danish: Patienter skal være klar over, hvordan de kan blive påvirket af ambrisentan, før de kører bil og betjener maskiner.
English: These effects occurred at exposures approximately 1.8 to 7 times human paediatric exposures at 10 mg (age 9 to 15 years), based on AUC.
Danish: Dette forekom ved eksponeringer på ca. 1,8 til 7 gange den humane pædiatriske eksponering ved 10 mg (alder 9 til 15 år), baseret på AUC.
English: The treatment effect was driven by a 63% reduction in hospitalisations on combination therapy, was established early and was sustained.
Danish: Behandlingseffekten blev drevet af en reduktion på 63% i hospitalsindlæggelser ved kombinationsbehandling, der blev opnået tidligt, og som blev fastholdt.
English: In combination with tadalafil (another PAH medicine) in addition to the above:
Danish: I kombination med tadalafil (et andet lægemiddel til behandling af PAH) i tillæg til ovenstående:
English: Ambrisentan Mylan may also be used in combination with other medicines used to treat PAH.
Danish: Ambrisentan Mylan kan også anvendes i kombination med andre lægemidler, som anvendes til behandling af PAH.
English: Haemodynamic parameters were not assessed in these studies.
Danish: Hæmodynamiske parametre blev ikke vurderet i disse studier.
English: With longer observation in uncontrolled studies (mean observation of 79 weeks), the safety profile was similar to that observed in the short- term studies.
Danish: Ved længere tids observation i ukontrollerede studier (middelobservation på 79 uger) svarede sikkerhedsprofilen til den, der blev set i korttidsstudierne.
English: Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Danish: Hyppighedskategorierne tager ikke højde for andre faktorer, såsom varierende studielængde, forud eksisterende tilstande og patientkarakteristika ved baseline.
English: Routine pharmacovigilance data are also presented.
Danish: Data fra rutinemæssig lægemiddelovervågning er også medtaget.
English: Combination with tadalafil (AMBITION)
Danish: Kombination med tadalafil (AMBITION)
English: Patient reminder card should include the following messages
Danish: Patientpåmindelseskort skal indeholde information om:
English: During a mean of 53 weeks of treatment with ambrisentan, none of the patients enrolled had a confirmed serum ALT >3xULN that required permanent discontinuation of treatment.
Danish: Efter en middelbehandlingstid på 53 uger med ambrisentan havde ingen af de inkluderede patienter et bekræftet serum-ALAT > 3xULN, som krævede permanent ophør med behandlingen.
English: The magnitude of the decrease in oral clearance is modest (20-40%) in patients with moderate renal impairment and therefore is unlikely to be of any clinical relevance.
Danish: Men størrelsesordenen i faldet i oral clearance er beskeden (20-40%) hos patienter med moderat nedsat nyrefunktion, og det er derfor usandsynligt, at det har nogen klinisk relevans.
English: The safety and efficacy of ambrisentan in children and adolescents aged below 18 years has not been established.
Danish: Ambrisentans sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt.
English: Oral contraceptives
Danish: Orale antikonceptiva
English: Therapy that is recommended at the severe stage of the disease (e.g. epoprostenol) should be considered if the clinical condition deteriorates.
Danish: Behandling, som anbefales i sygdommens svære stadier (f.eks. epoprostenol), bør overvejes, hvis den kliniske tilstand forringes.
English: The effect on male human fertility is not known but a deterioration of spermatogenesis cannot be excluded.
Danish: Virkningen på fertiliteten hos mænd kendes ikke, men en ugunstig påvirkning af spermatogenesen kan ikke udelukkes.
English: Your doctor may need to adjust your dose of Ambrisentan Mylan if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis).
Danish: Lægen vil muligvis justere din dosis af Ambrisentan Mylan, hvis du begynder at tage medicin, som indeholder ciclosporin A (medicin, som bruges efter en transplantation eller til behandling af psoriasis).
English: - if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception).
Danish: - hvis du er gravid, hvis du planlægger at blive gravid, eller hvis du kunne blive gravid, fordi du ikke bruger sikker prævention.
English: You can take Ambrisentan Mylan with or without food.
Danish: Ambrisentan Mylan kan tages med eller uden mad.
English: Plasma elimination half-life in humans ranges from 13.6 to 16.5 hours.
Danish: Plasmaeliminationshalveringstiden hos mennesker varierer fra 13,6 til 16,5 timer.
English: No 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: Hospitalisation for worsening PAH
Danish: Hospitalsindlæggelse for forværret PAH
English: The in-vitro plasma protein binding of ambrisentan was, on average, 98.8% and independent of concentration over the range of 0.2 - 20 microgram/ml.
Danish: In vitro-plasmaproteinbindingen for ambrisentan var gennemsnitligt 98,8% og uafhængig af koncentrationen i intervallet 0,2 - 20 mikrogram/ml.
English: If you're taking rifampicin (an antibiotic used to treat serious infections) your doctor will monitor you when you first start taking Ambrisentan Mylan.
Danish: Hvis du tager medicin indeholdende rifampicin (et antibiotikum, der bruges til behandling af alvorlige infektioner), vil lægen følge dig tæt, når du starter med at tage Ambrisentan Mylan.
English: The mean age of all patients was 54 years (SD 15; range 18-75 years of age).
Danish: Gennemsnitsalderen af alle patienter var 54 år (standardafvigelse 15; interval 18-75 år).
English: → Contact your doctor before taking this medicinal product.
Danish: → Kontakt lægen, inden du tager dette lægemiddel.
English: It is recommended that the tablet should not be split, crushed or chewed.
Danish: Det anbefales, at tabletten ikke deles, knuses eller tygges.
English: P-value, Log-rank test
Danish: P-værdi, Log-ranktest
English: Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH.
Danish: Begrænsede data tyder på, at brat ophør med ambrisentan ikke er forbundet med rebound-forværring af PAH.
English: Ambrisentan Mylan is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.
Danish: Ambrisentan Mylan bør ikke anvendes til børn og unge under 18 år, da sikkerheden og virkningen ikke er undersøgt i denne aldersgruppe.
English: If you forget a dose of Ambrisentan Mylan, just take the tablet as soon as you remember, then carry on as before.
Danish: Hvis du glemmer at tage en dosis af Ambrisentan Mylan, skal du tage tabletten, så snart du kommer i tanke om det. Fortsæt derefter som før.
English: A decrease in plasma inhibin-B concentration and an increase in plasma FSH concentration were observed.
Danish: Et fald i plasmakoncentrationen for inhibin-B og en øget plasmakoncentration af FSH blev observeret.
English: Idiopathic Pulmonary Fibrosis
Danish: Idiopatisk pulmonal fibrose
English: Ambrisentan (AMBITION and ARIES-E)
Danish: Ambrisentan (AMBITION og ARIES-E)
English: Any unused medicinal product or waste material should be disposed of in accordance with the local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
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: Efficacy of combination therapy on the primary endpoint was consistent on the comparison to individual monotherapy and across the subgroups of age, ethnic origin, geographical region, aetiology (iPAH/hPAH and PAH-CTD).
Danish: Virkningen af kombinationsbehandling på det primære endepunkt var konsistent ved sammenligning med de individuelle monoterapi-grupper og over subgrupper med alder, etnisk oprindelse, geografisk oprindelse, ætiologi (IPAH/hPAH og PAH-CTD).
English: The occurrence of peripheral oedema was highest within the first month of treatment initiation.
Danish: Forekomsten af perifere ødemer var højest inden for den første måned efter behandlingsstart.
English: Endothelin plays a significant role in the pathophysiology of PAH.
Danish: Endotelin spiller en signifikant rolle i patofysiologien for PAH.
English: The testicular changes were not fully recoverable during the off-dose periods evaluated.
Danish: Testikelændringerne var ikke helt normaliseret i de vurderede perioder uden indgift.
English: This can cause light-headedness.
Danish: Dette kan medføre svimmelhed.
English: Outcome endpoints
Danish: Outcome endepunkter
English: No patients received placebo alone.
Danish: Ingen patienter fik placebo som monoterapi.
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 af op til 39 ugers varighed ved en eksponering, der var 35 gange eksponeringen hos mennesker, ud fra AUC.
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: The combined mean exposure was approximately 145 ± 80 weeks, and the maximum exposure was approximately 295 weeks.
Danish: Den kombinerede middeleksponering var på ca. 145 ± 80 uger, og den maksimale eksponering var på ca. 295 uger.
English: Most of these decreases were detected during the first 4 weeks of treatment and haemoglobin generally stabilised thereafter.
Danish: De fleste tilfælde optrådte i løbet af de første 4 behandlingsuger, og generelt stabiliseredes hæmoglobin herefter.
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 medicines 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: 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-syreglykoprotein.
English: Animal studies have shown that ambrisentan is teratogenic.
Danish: Dyrestudier har vist, at ambrisentan er teratogent.
English: →Don't stop taking Ambrisentan Mylan unless you have agreed this with your doctor.
Danish: Stop ikke med at tage Ambrisentan Mylan, medmindre du har aftalt det med lægen
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 digoxins AUC0-last og lavpunktskoncentrationer, samt en 29% stigning i digoxin-Cmax.
English: This decrease in peak concentration is not clinically significant, and therefore ambrisentan can be taken with or without food.
Danish: Dette fald i peak-koncentration er ikke klinisk signifikant, og ambrisentan kan derfor tages med eller uden mad.
English: Patients with significant anaemia, fluid retention or rare retinal diseases were excluded according to the investigators' criteria.
Danish: Patienter med signifikant anæmi, væskeretention eller sjældne nethindesygdomme blev ekskluderet i henhold til investigators kriterier.
English: Signs that your liver may not be working properly include:
Danish: Følgende symptomer kan tyde på, at din lever muligvis ikke fungerer, som den skal:
English: This causes people to feel tired, dizzy and short of breath.
Danish: Dette medfører, at man føler sig træt, svimmel og har åndenød.
English: Ambrisentan has been shown to be teratogenic in rats and rabbits.
Danish: Det er vist, at ambrisentan er teratogent hos rotter og kaniner.
English: Pulmonary veno-occlusive disease
Danish: Pulmonal veno-okklusiv sygdom