FrancophonIA/ELRC3.0 huggingface dataset:
English: If a biosimilar is highly similar to a reference medicine and has comparable safety and efficacy in one therapeutic indication, safety and efficacy data may be extrapolated to other indications approved for the reference medicine.
Danish: Hvis et biolosimilært lægemiddel har høj grad af lighed med et referencelægemiddel og har sammenlignelig sikkerhed og virkning i én terapeutisk indikation, kan data om sikkerhed og virkning ekstrapoleres til andre indikationer, der er godkendt for referencelægemidlet.
English: Biosimilar development is comparative and progresses in a step-wise manner
Danish: Udviklingen af det biosimilære lægemiddel er sammenlignelig og trinvis
English: The aim of biosimilar development is to demonstrate biosimilarity - high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile.
Danish: Formålet med udvikling af biosimilære lægemidler er at påvise biosimilaritet - høj grad af sammenlinelighed med hensyn til struktur, biologisk aktivitet samt virkning, sikkerhed og immunogenicitetsprofil af reference præparatet og det biosimulære lægemiddel.
English: Comparative non-clinical studies
Danish: Sammenlignende non-kliniske studier
English: Immunogenicity data needed for approval of a biosimilar
Danish: Krav til immunogenicitetsdata til godkendelse af et biosimilært lægemiddel
English: Extrapolation is not a new concept but a well-established scientific principle used routinely when biological medicines with several approved indications undergo major changes to their manufacturing process.
Danish: Ekstrapolering er ikke et nyt begreb, men et veletableret videnskabeligt princip, der anvendes rutinemæssigt ved væsentlige ændringer af fremstillingsprocessen for biologiske lægemidler med flere godkendte indikationer.
English: Interchangeability refers to the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect.
Danish: Udskiftelighed betyder muligheden for at udskifte et lægemiddel med et andet lægemiddel, som forventes at have samme kliniske effekt.
English: Abbreviations
Danish: Forkortelser
English: Reference medicine Biosimilar medicine
Danish: Referencelægemiddel Biosimilært
English: Biosimilars in the EU
Danish: Biosimilære lægemidler i EU
English: Switching, which is when the prescriber decides to exchange one medicine for another medicine with the same therapeutic intent.
Danish: Skift, hvor den ordinerende læge beslutter at skifte fra et lægemiddel til et andet lægemiddel med samme terapeutiske formål.
English: By demonstrating high similarity with the reference medicine, the biosimilar can largely rely on the efficacy and safety experience gained with the reference medicine.
Danish: Når der er påvist stærk similaritet med referencelægemidlet, kan det biosimilære lægemiddel i høj grad basere sig på erfaringerne med referencelægemidlets virkning og sikkerhed.
English: Example of variability between a biosimilar and the reference medicine
Danish: Eksempel på variation mellem et biosimilært lægemiddel og
English: Interchangeability Refers to the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect.
Danish: Henviser til muligheden for at udskifte et lægemiddel med et andet lægemiddel, som forventes at have samme kliniske effekt.
English: Post-authorisation safety study
Danish: Sikkerhedsundersøgelse efter tilladelse til markedsføring
English: To complement this, clinical data on immunogenicity are generally required; animal studies are of limited value in predicting immune response in humans.
Danish: Dyreforsøg er af begrænset værdi med hensyn til at forudsige immunrespons hos mennesker.
English: This is because, by demonstrating biosimilarity, the biosimilar relies on the safety and efficacy experience gained with the reference medicine.
Danish: Det skyldes, at det biosimilære lægemiddel, ved at dokumentere biosimilaritet, baseres på den erfaring med sikkerhed og virkning, som er opnået med referencelægemidlet.
English: The RMP of a biosimilar is based on knowledge and experience gained with the reference medicine.
Danish: Risikostyringsplanen for biosimilære lægemidler er baseret på viden om og erfaring med referencelægemidlet.
English: Inherent degree of variability
Danish: Iboende variation
English: A biosimilar medicine (‘biosimilar') is a medicine highly similar to another biological medicine already marketed in the EU (the so-called ‘reference medicine')
Danish: Et biosimilært lægemiddel er et biologisk lægemiddel der er vist at være sammenligneligt (similært) med et andet biologisk lægemiddel, der allerede markedsføres i EU (“referencelægemidlet”)1,2.
English: Safety of biosimilars
Danish: Biosimilære lægemidlers sikkerhed
English: Natural variability is inherent to all biological medicines and strict controls are always in place during manufacturing to ensure that it does not affect the way the medicine works or its safety.
Danish: Alle biologiske lægemidler har en iboende naturlig variation, og under fremstillingsprocessen kontrolleres det altid strengt, at denne variation ikke påvirker lægemidlets virkemåde eller sikkerhed.
English: By demonstrating biosimilarity, a biosimilar can rely on the safety and efficacy experience gained with the reference medicine.
Danish: Når biosimilaritet vises, kan et biosimilært lægemiddel nyde godt af den erfaring med sikkerhed og virkning, som er høstet for referencelægemidlet.
English: In the EU, the SmPC of a biosimilar is aligned with that of the reference medicine.
Danish: I EU er produktresuméet for et biosimilært lægemiddel bragt i overensstemmelse med produktresuméet for referencelægemidlet.
English: Telephone +31 (0)88 781 6000 Send a question www.ema.europa.eu/contact www.ema.europa.eu
Danish: Send et spørgsmål www.ema.europa.eu/contact www.ema.europa.eu
English: They should represent the largest difference in efficacy that would not matter in clinical practice; treatment differences within this range would thus be acceptable because they have no clinical relevance.
Danish: Behandlingsforskelle inden for dette interval er således acceptable, fordi de ikke har klinisk relevans.
English: Proteins Monoclonal antibodies
Danish: Monoklonale antistoffer
English: Biosimilar development relies heavily on ‘comparability studies' to establish biosimilarity to the reference medicine.
Danish: Ved udvikling af biosimilære lægemidler benyttes studier af sammenlignelighed i høj grad for at konstatere biosimilaritet i forhold til referencelægemidlet.
English: Over the past 10 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable experience of their use and safety.
Danish: I løbet af de seneste 10 år har EU godkendt det højeste antal biosimilære lægemidler i verden.
English: An overview of biosimilar development compared with the development of reference medicines is provided in table 4.
Danish: Tabel 4 viser en oversigt over udviklingen af et biosimilært lægemiddel sammenlignet med udviklingen af referencelægemidlet.
English: Comparability is conceived as a step-wise process that is tailor-made for each product (figure 5); knowledge from the initial quality comparability studies
Danish: Sammenlignelighed opfattes som en trinvis proces, der er skræddersyet til det enkelte produkt (figur 5).
English: Safety monitoring of biosimilars follows the same requirements that apply to all biological medicines There is no specific requirement just for biosimilars.
Danish: Overvågningen af biosimilære lægemidlers sikkerhed er underlagt de samme krav som alle biologiske lægemidler10.
English: Overview of biosimilar development compared with a reference medicine Biological medicine with new active substance (e.g. reference medicine)
Danish: Biologisk lægemiddel med et nyt virksomt stof (f.eks. referencelægemidlet)
English: Generic medicine
Danish: Generiske lægemidler
English: Immunogenicity is always studied for biological medicines
Danish: Immunogenicitet undersøges altid for biologiske lægemidler6,7.
English: Switching
Danish: Skift
English: 9, for example whenever a biological medicine with several approved indications undergoes major changes to its manufacturing process (e.g. new manufacturing site or development of new formulations).
Danish: Ekstrapolering er et veletableret videnskabeligt princip, som har været anvendt i mange år9, f.eks. når fremstillingsprocessen ændres væsentligt for et biologisk lægemiddel med adskillige godkendte indikationer (f.eks. et nyt produktionssted eller udvikling af nye formuleringer).
English: Since then, the EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
Danish: Siden da har EU godkendt det højeste antal biosimilære lægemidler i verden.
English: eu/docs/en_GB/document_library/Scientific_ guideline/2014/10/WC500176768.pdf.
Danish: ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2014/10/WC500176768.pdf.
English: Extrapolation across different clinical settings
Danish: Ekstrapolering mellem kliniske miljøer
English: For identifying and tracing biological medicines in the EU, medicines have to be distinguished by the tradename and batch number and this is particularly important in cases where more than one medicine with the same INN exists on the market.
Danish: Til identifikation og sporing af biologiske lægemidler i EU skal lægemidler have deres eget handelsnavn og batchnummer.
English: ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2016/08/WC500211728.pdf.
Danish: http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2016/08/WC500211728.pdf.
English: Many biological medicines are intended for longterm management of chronic conditions, and therefore, over time the patient may receive biological medicines with slight differences.
Danish: Mange biologiske lægemidler er bestemt til langsigtet håndtering af kroniske sygdomme.
English: 2016. http://ec.europa.eu/growth/toolsdatabases/newsroom/cf/itemdetail.cfm?item_ id=9066.
Danish: 2016. http://ec.europa.eu/growth/content/ commission-publishes-qa-biosimilar-medicinespatients-0_en.
English: eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500003935.pdf.
Danish: europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003935.pdf.
English: Biosimilar approved in the EU (as at October 2019)
Danish: © Det Europæiske Lægemiddelagentur, 2019.
English: europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500002805.pdf.
Danish: ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500002805.pdf.
English: http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2012/06/WC500128688.
Danish: europa.eu/docs/en_GB/document_library/Scientific_ guideline/2012/06/WC500128688.pdf.
English: Classes of biological medicines
Danish: Biosimilært lægemiddel
English: Biosimilar medicine
Danish: Biosimilære lægemidler:
English: Comparability
Danish: Indbyrdes udskiftelighed
English: Biosimilar medicines: definition and features
Danish: Definition og karakteristika
English: Death (all-cause)
Danish: Død (alle årsager)
English: Patient reminder card should include the following key elements:
Danish: Patientkortet skal indeholde følgende nøgleelementer:
English: P-value, Log-rank test
Danish: P-værdi, Log-rank test
English: Difference and Confidence Interval p value
Danish: Difference og konfidensinterval p-værdi
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 hjertekarstøtte.
English: Vistor hf.
Danish: Vistor ehf.
English: → Your doctor will decide whether Volibris is suitable for you.
Danish: → Lægen vil afgøre, om Volibris er egnet til dig.
English: Secondary endpoints Secondary endpoints were tested:
Danish: Sekundære endepunkter Sekundære endepunkter testet:
English: • if you are allergic to ambrisentan, soya, or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for ambrisentan, soja eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6)
English: • ringing in the ears (tinnitus) only when taking the combination treatment.
Danish: • ringen for ørerne (tinnitus) kun ved anvendelse af kombinationsbehandlingen.
English: A pre-specified combined analysis of the Phase 3 studies (ARIES-C) was conducted.
Danish: Der blev gennemført en pre-specificeret kombinationsanalyse af fase 3-studierne (ARIES-C).
English: Talk to your doctor, who will decide whether this medicine is suitable for you
Danish: Tal med lægen, som vil afgøre, om dette lægemiddel er egnet til dig
English: % subjects achieving a satisfactory clinical response at week 24
Danish: % forsøgspersoner, som opnåede tilfredsstillende klinisk respons ved uge
English: → Don't take Volibris if you are pregnant or planning to become pregnant.
Danish: → Tag ikke Volibris, hvis du er gravid eller planlægger at blive gravid.
English: → Don't stop taking Volibris unless you have agreed this with your doctor.
Danish: → Stop ikke med at tage Volibris, medmindre du har aftalt det med lægen.
English: Taking out a tablet
Danish: Sådan tages en tablet ud
English: Volibris may also be used in combination with other medicines used to treat PAH.
Danish: Volibris kan også anvendes i kombination med andre lægemidler, som anvendes til behandling af PAH.
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 overfor enhver tidligere PAH-specifik behandling og mediantiden fra diagnose til inklusion i studiet var 22 dage.
English: → Don't take two doses at the same time to make up for a forgotten dose.
Danish: → Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Information from longer term non-placebo controlled studies (ARIES-E and AMBITION (combination with tadalafil)) is also included below.
Danish: Information fra længerevarende, ikke-placebokontrollerede studier (ARIES-E og AMBITION (kombination med tadalafil)) er også inkluderet nedenfor.
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 daglig.
English: Volibris is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.
Danish: Volibris bør ikke anvendes til børn og unge under 18 år, da sikkerheden og virkningen ikke er undersøgt i denne aldersgruppe.
English: More than 90% of patients achieved this.
Danish: Flere end 90 % af patienterne kom op på dette dosisniveau.
English: Prior to use of Volibris in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Forud for anvendelse af Volibris i hvert medlemsland skal indehaveren af markedsføringstilladelsen (MAH) blive enig med den relevante kompetente myndighed omkring indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmodaliteter og andre aspekter af programmet.
English: If you forget a dose of Volibris, just take the tablet as soon as you remember, then carry on as before.
Danish: Hvis du glemmer at tage en dosis af Volibris, skal du tage tabletten, så snart du kommer i tanke om det. Fortsæt derefter som før.
English: 1 See section ‘Description of selected adverse reactions'.
Danish: 1 Se afsnittet nedenfor ”Beskrivelse af udvalgte bivirkninger”.
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 tilfælde af klinisk behandlingssvigt, defineret som: - død, eller - hospitalsindlæggelse for forværring af PAH, - sygdomsprogression; - utilfredsstillende langvarigt klinisk respons.
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: 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: Patients with ALT and AST values >2xULN at baseline were also excluded.
Danish: Patienter med ALAT- og ASAT-værdier > 2 x ULN ved baseline blev også ekskluderet.
English: You can take Volibris with or without food.
Danish: Volibris kan tages med eller uden mad.
English: • worsening shortness of breath shortly after starting Volibris
Danish: • forværret vejrtrækningsbesvær kort efter behandlingsstart med Volibris
English: Your doctor may need to adjust your dose of Volibris if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis).
Danish: Lægen vil muligvis justere din dosis af Volibris, hvis du begynder at tage medicin, som indeholder ciclosporin (medicin, som bruges efter en transplantation eller til behandling af psoriasis).
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: Patients should be aware of how they might be affected by ambrisentan before driving or using machines.
Danish: Patienten skal være klar over, hvordan de kan blive påvirket af ambrisentan, før de kører bil og betjener maskiner.
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: Plasma elimination half-life in humans ranges from 13.6 to 16.5 hours.
Danish: Plasmaeliminationens halveringstid hos mennesker varierer fra 13,6 til 16,5 timer.
English: If you're taking rifampicin (an antibiotic used to treat serious infections) your doctor will monitor you when you first start taking Volibris.
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 Volibris.
English: Push out the tablet: gently push one end of the tablet through the foil layer.
Danish: Tryk tabletten ud: Tryk forsigtigt den ene ende af tabletten ud gennem folien.
English: →Tell your doctor straight away if you get these effects or if they happen suddenly after taking Volibris.
Danish: → Fortæl det straks til lægen, hvis du får nogen af de nævnte bivirkninger, eller hvis de opstår pludseligt, efter du har taget Volibris.
English: Date of latest renewal: 14 January 2013
Danish: Dato for første markedsføringstilladelse: 21. april 2008 Dato for seneste fornyelse: 14. januar 2013
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 eksponering på ca. 1,8 til 7 gange den humane pædiatriske eksponering ved 10 mg (alder 9 til 15 år), baseret på AUC.
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: • 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: • 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: 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 > 3 x ULN, som krævede permanent ophør med behandlingen.
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: • palpitations (fast or irregular heart beats)
Danish: • hjertebanken (hurtige eller uregelmæssige hjerteslag)
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Volibris 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 i behandlingen med Volibris og regelmæssigt, mens du er i behandling med denne medicin.
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: 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: The testicular changes were not fully recoverable during the off-dose periods evaluated.
Danish: Testikelændringer var ikke helt normaliseret i de vurderede perioder uden indgift.
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: 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, multicenter, placebokontrollerede, fase 3 pivotale studier (ARIES-1 og -2).
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 (5,7 %) og 17 (47 %).