FrancophonIA/ELRC3.0 huggingface dataset:
English: Daclizumab beta blocks CD25 (alfa subunit of high affinity IL-2 receptor), decreasing the number and function of CD4+CD25+FoxP3+Treg and produces an activation and expansion of CD56 NK cells.
Danish: Daclizumab beta blokerer CD25 (alfa-underenheden af højaffinitets-IL-2-receptor), hvilket reducerer mængden og funktionen af CD4+CD25+FoxP3+Treg og medfører aktivering og ekspandering af CD56NK-celler.
English: In view of the seriousness of the reactions reported and the biological plausibility, the risk of immunemediated encephalitis and its impact on the benefit-risk balance of the medicinal product should be investigated, as well as the adequacy of the risk minimization measures with regard to immunemediated CNS involvement (encephalitis) need to be assessed.
Danish: I lyset af den alvorlige sværhedsgrad af de indberettede reaktioner og den mulige biologiske årsagssammenhæng bør risikoen for immunmedieret encefalitis og betydningen heraf for lægemidlets benefit/risk-forhold undersøges, og samtidig bør tilstrækkeligheden af de risikominimerende foranstaltninger i forhold til immunmedieret påvirkning af centralnervesystemet (encefalitis) vurderes.
English: Daclizumab beta is hypothesized to exert its activity in MS through immunomodulatory mechanisms.
Danish: Daclizumab beta menes at virke ved multipel sklerose gennem immunmodulerende mekanismer.
English: Due to the conclusion of the previous referral and based on the clinical characteristics of the patients, the MAH has already decided in January 2018 to stop this trial by 30 March 2018;
Danish: Undersøgelsen finder sted i 9 lande, og flere end 400 patienter deltager i den. Som følge af afslutningen af den forrige indbringelsesprocedure og på grundlag af patienternes kliniske karakteristika har indehaveren af markedsføringstilladelse allerede i januar 2018 besluttet at stoppe denne undersøgelse pr. 30. marts 2018.
English: Daclizumab beta is a humanised IgG1 monoclonal antibody that modulates IL-2 signalling by blocking CD25-dependent, high affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Danish: Daclizumab beta er et humaniseret IgG1 monoklonalt antistof, der modulerer IL-2-signalering ved at blokere CD25-afhængig, højaffinitets IL-2-receptorsignalering, hvilket resulterer i højere niveauer af IL-2, som er tilgængelig for signalering via IL-2-receptoren med intermediær affinitet.
English: It was noted that there are ongoing clinical studies for which the MAH informed PRAC that the treatment with daclizumab beta is to be stopped.
Danish: Det blev bemærket, at der er igangværende undersøgelser, og indehaveren af markedsføringstilladelse oplyste PRAC om, at behandlingen med daclizumab beta ville blive stoppet.
English: Further to that on 22 February, PEI informed about 2 new cases of immunemediated disease with CNS involvement.
Danish: I forlængelse af dette informerede Paul Ehrlich-instituttet den 22. februar 2018 om 2 nye tilfælde af immunmedieret sygdom med påvirkning af centralnervesystemet.
English: The PRAC discussed the possibility of the causal relationship of these adverse reactions, as well as the possible mechanism through which they could have been triggered.
Danish: PRAC har drøftet muligheden for en årsagssammenhæng for disse bivirkninger og den mekanisme, der kan have udløst dem. Der var enighed om, at daclizumab betas virkningsmekanisme er kompleks.
English: Patients do not experience many side effects.
Danish: Patienterne får ikke mange bivirkninger.
English: Further information on Ilumetri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Ilumetri findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Ilumetri
Danish: Andre oplysninger om Ilumetri
English: As for all medicines, data on the use of Ilumetri are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Ilumetri løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Ilumetri?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ilumetri?
English: The recommended dose is one 100 mg injection, followed by a further dose after 4 weeks and then an injection every 12 weeks.
Danish: Den anbefalede dosis er en injektion med 100 mg, der gentages efter 4 uger, hvorefter der gives en injektion hver 12. uge.
English: Ilumetri must not be used in patients who have a serious ongoing infection such as tuberculosis.
Danish: Ilumetri må ikke anvendes hos patienter med aktuel alvorlig infektion, f.eks. tuberkulose.
English: The dose may be increased to 200 mg in certain patients, for example patients badly affected by the disease or with bodyweight over 90 kg.
Danish: Dosen kan øges til 200 mg hos visse patienter, f.eks. patienter med meget svær sygdom eller patienter med en legemsvægt på over 90 kg.
English: After training, patients may inject Ilumetri themselves if the doctor considers it appropriate.
Danish: Efter oplæring kan patienten selv foretage indsprøjtningen med Ilumetri, hvis lægen finder det hensigtsmæssigt.
English: The European Medicines Agency decided that Ilumetri's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Ilumetri opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Ilumetri and what is it used for?
Danish: Hvad er Ilumetri, og hvad anvendes det til?
English: Interleukin 23 is a substance that controls the growth and maturation of some types of T cells.
Danish: Interleukin 23 er et stof, der styrer vækst og modning af visse typer T-celler.
English: For more information about using Ilumetri, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ilumetri, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: By blocking the action of interleukin 23, Ilumetri reduces inflammation and symptoms associated with the disease.
Danish: Ved at blokere aktiviteten af interleukin 23 mindsker Ilumetri den betændelse og de symptomer, der er forbundet med sygdommen.
English: An overview of Ilumetri and why it is authorised in the EU
Danish: En oversigt over Ilumetri, og hvorfor det er godkendt i EU
English: Side effects reported with Ilumetri are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ilumetri vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: These T cells, which are part of the immune system (the body's natural defences), are involved in causing inflammation that is linked to the development of plaque psoriasis.
Danish: Disse T-celler, som er en del af immunsystemet (kroppens naturlige forsvar), er med til at forårsage den betændelse, der er forbundet med udvikling af plaquepsoriasis.
English: Why is Ilumetri authorised in the EU?
Danish: Hvorfor blev Ilumetri godkendt i EU?
English: What are the risks associated with Ilumetri?
Danish: Hvilke risici er der forbundet med Ilumetri?
English: The second study involving 1,090 patients compared Ilumetri with placebo and with etanercept (another psoriasis medicine).
Danish: Det andet studie, der omfattede 1.090 patienter, sammenlignede Ilumetri med placebo og med etanercept (et andet psoriasis-middel).
English: The active substance in Ilumetri, tildrakizumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity.
Danish: Det aktive stof i Ilumetri, tildrakizumab, er et protein af typen monoklonalt antistof, der er designet til at binde til interleukin 23 og blokere dettes aktivitet.
English: Ilumetri is effective in treating psoriasis and some patients can experience total clearing of their psoriasis.
Danish: Ilumetri er effektivt til behandling af psoriasis, og nogle patienter kan opleve, at deres psoriasis forsvinder fuldstændigt.
English: The most common side effects with Ilumetri are upper respiratory tract (nose and throat) infections (which may affect more than 1 in 10 people).
Danish: De hyppigste bivirkninger ved Ilumetri er infektioner i de øvre luftveje (kan forekomme hos mere end 1 ud af 10 patienter).
English: Information on the use of Ilumetri in the long term is limited and studies are ongoing.
Danish: Der foreligger kun begrænsede data om langtidsbrug af Ilumetri, men en række studier er i gang.
English: Ilumetri can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Danish: Ilumetri udleveres kun efter recept og bør anvendes under opsyn af en læge med erfaring i at diagnosticere og behandle plaquepsoriasis.
English: The first study involving 771 patients compared Ilumetri with placebo (a dummy treatment).
Danish: Det første studie, der omfattede 771 patienter, sammenlignede Ilumetri med placebo (ikke-aktivt stof).
English: For the full list of side effects and restrictions with Ilumetri, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Ilumetri fremgår af indlægssedlen.
English: Headache, gastroenteritis (diarrhoea and vomiting), nausea (feeling sick), diarrhoea, pain at the site of the injection and back pain may affect up to 1 in 10 people.
Danish: Hovedpine, mave-tarm-katar, kvalme, diarré, ømhed ved injektionsstedet og rygsmerter kan forekomme hos op til 1 ud af 10 patienter.
English: Two main studies involving adults found Ilumetri effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough.
Danish: I to hovedstudier med voksne deltagere blev Ilumetri fundet effektivt til behandling af moderat til svær plaquepsoriasis hos patienter, hvor midler til påføring på huden ikke virkede godt nok.
English: How is Ilumetri used?
Danish: Hvordan anvendes Ilumetri?
English: Ilumetri is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Danish: Ilumetri er et lægemiddel, der virker på immunsystemet og anvendes til behandling af sygdommen plaquepsoriasis, der giver røde, skællende hudområder.
English: The doctor may decide to stop treatment if the condition does not improve after 28 weeks.
Danish: Hvis patientens tilstand ikke er bedret efter 28 uger, kan lægen beslutte at standse behandlingen.
English: Ilumetri is available as a solution in pre-filled syringes for injection under the skin.
Danish: Ilumetri fås som injektionsvæske i en fyldt sprøjte til indgivelse under huden.
English: How does Ilumetri work?
Danish: Hvordan virker Ilumetri?
English: What benefits of Ilumetri have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ilumetri?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ilumetri have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ilumetri.
English: Of those given Ilumetri, 55% (for 100 mg) and 59% (for 200 mg) had almost complete skin clearance compared with 48% given etanercept and 5% given placebo.
Danish: Blandt de patienter, der fik Ilumetri, opnåede hhv. 55 % (ved 100 mg) og 59 % (ved 200 mg) næsten helt ren hud, sammenholdt med 48 % af de patienter, der fik etanercept, og 5 % af de patienter, der fik placebo.
English: After 12 weeks, 61% and 66% of patients given 100 mg and 200 mg Ilumetri respectively had at least 75% improvement in severity compared with 48% of those given etanercept and 6% given placebo.
Danish: Efter 12 uger oplevede 61 % og 66 % af de patienter, der fik hhv. 100 mg og 200 mg Ilumetri, en bedring på mindst 75 % i form af nedsat sværhedsgrad, sammenholdt med 48 % af de patienter, der fik etanercept, og 6 % af de patienter, der fik placebo.
English: Additionally, 58% of those given 100 mg and 59% of those given 200 mg had almost complete skin clearance compared with 7% given placebo.
Danish: Desuden opnåede 58 % af de patienter, der fik 100 mg, og 59 % af de patienter, der fik 200 mg, næsten helt ren hud, sammenholdt med 7 % af de patienter, der fik placebo.
English: After 12 weeks, 64% and 62% of patients given 100 mg and 200 mg Ilumetri respectively had at least a 75% improvement in disease severity compared with 6% of those given placebo.
Danish: Efter 12 uger oplevede 64 % og 62 % af de patienter, der fik hhv. 100 mg og 200 mg Ilumetri, en bedring på mindst 75 % i form af nedsat sværhedsgrad, sammenholdt med 6 % af de patienter, der fik placebo.
English: Treatment centre: ____________________________________ Name of prescribing doctor: ___________________________ Phone number of prescribing doctor: _____________________
Danish: Behandlingscenter: ___________________________________ Ordinerende læges navn: ___________________________ Ordinerende læges telefonnummer: _____________________
English: The potential risk for humans is still unknown.
Danish: Den potentielle risiko for mennesker er stadig ukendt.
English: Talk to your doctor about this.
Danish: Tal med lægen herom.
English: The uncertainties of such modelling should be considered.
Danish: Der skal tages højde for usikkerheden ved sådanne modeller.
English: Date of latest renewal: 23 August 2018
Danish: Dato for seneste fornyelse: 23 August 2018
English: Summary of the safety profile.
Danish: Sammendrag af sikkerhedsprofilen.
English: Opsumit should be taken every day at about the same time.
Danish: Opsumit skal tages hver dag på cirka samme tidspunkt.
English: ATC code: C02KX04.
Danish: ATC-kode: C02KX04.
English: Tubular dilatation was fully reversible.
Danish: Tubulær dilatation var fuldstændigt reversibel.
English: It is best to take the tablet at the same time each day.
Danish: Det er bedst at tage tabletten på samme tidspunkt hver dag.
English: The treatment effect was established early and was sustained.
Danish: Behandlingens effektindsatte tidligt og blev opretholdt.
English: Maximum plasma concentrations of macitentan are achieved about 8 hours after administration.
Danish: De maksimale plasmakoncentrationer af macitentan opnås cirka 8 timer efter administration.
English: Do not stop taking Opsumit unless you have agreed this with your doctor.
Danish: Du må ikke stoppe med at tage Opsumit, medmindre du har aftalt det med lægen.
English: Opsumit can affect other medicines.
Danish: Opsumit kan påvirke andre lægemidler.
English: Carry this card with you at all times and show it to any doctor involved in your medical care.
Danish: Hav altid dette kort på dig, og vis det til enhver læge, der er involveret i din medicinske behandling.
English: These changes are not considered clinically relevant.
Danish: Disse ændringer anses ikke for at være af klinisk relevans.
English: The relevance of this finding to humans is unknown, but a deterioration of spermatogenesis cannot be excluded.
Danish: Det er uvist, hvilken relevans dette har hos mennesker, men en forringelse af spermatogenesen kan ikke udelukkes.
English: Macitentan has four primary metabolic pathways.
Danish: Macitentan har fire primære metaboliseringsveje.
English: Due to the species-specific sensitivity and the safety margin, this finding is considered not relevant for humans.
Danish: På grund af den artsspecifikke følsomhed og sikkerhedsmargin anses dette fund ikke for at være af relevans hos mennesker.
English: Macitentan 10 mg improved quality of life assessed by the SF-36 questionnaire.
Danish: Macitentan 10 mg forbedrede livskvaliteten, der blev vurderet på SF-36-spørgeskemaet.
English: These changes were largely reversible and considered non-adverse adaptations of the liver to increased metabolic demand.
Danish: Disse forandringer var stort set reversible og anses for at være ikke-negative tilpasninger af leveren til øget metabolisk behov.
English: The advice of a hepatologist is recommended.
Danish: Det anbefales at søge rådgivning hos en hepatolog.
English: The major excretion route is via urine, accounting for about 50% of the dose.
Danish: Den primære udskillelsesvej er via urinen, hvor ca. 50 % af dosis genfindes.
English: There are no data from the use of macitentan in pregnant women.
Danish: Der er ingen data fra anvendelse af macitentan til gravide kvinder.
English: or subcutaneous (s.c.) prostanoids, or other worsening of PAH.
Danish: eller subkutane (s.c.) prostanoider eller anden forværring af PAH.
English: Opsumit may harm unborn babies conceived before, during or soon after treatment.
Danish: Opsumit kan skade ufødte børn, der undfanges før, under eller kort efter behandlingen.
English: Signs that your liver may not be working properly include:
Danish: Tegn på, at din lever ikke fungerer korrekt, omfatter:
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); not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: EOS was declared when the predefined number of primary endpoint events was reached.
Danish: Studiet blev afsluttet, da det prædefinerede antal af primære endepunkter var nået.
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event in SERAPHIN
Danish: Figur 1 Kaplan-Meier-estimater af første morbiditets-mortalitetshændelse i SERAPHIN
English: • Do not take Opsumit if you are pregnant or planning to become pregnant.
Danish: • Tag ikke Opsumit, hvis du er gravid eller planlægger at blive gravid.
English: Therefore, monitoring of blood pressure and haemoglobin should be considered.
Danish: Det bør derfor overvejes at monitorere blodtryk og hæmoglobin.
English: 1Data derived from pooled placebo-controlled studies.
Danish: 1 Data udledt fra samlede placebokontrollerede studier.
English: Opsumit is a treatment that you will need to keep on taking to control your PAH.
Danish: Opsumit er en behandling, som du skal blive ved med at tage for at holde din PAH under kontrol.
English: Caution is recommended in this population.
Danish: Det anbefales at udvise forsigtighed i denne population.
English: The increase in 6MWD achieved with macitentan was maintained for the duration of the study.
Danish: Den øgning i 6MWD, der blev opnået med macitentan, blev fastholdt igennem hele studiets varighed.
English: • That Opsumit is teratogenic in animals;
Danish: • Opsumit er teratogent hos dyr;
English: • Hypotension (low blood pressure)
Danish: • Hypotension (lavt blodtryk)
English: • That pregnant women must not take Opsumit;
Danish: • Gravide kvinder må ikke tage Opsumit;
English: The patient should be told not to take two doses at the same time if a dose has been missed.
Danish: Patienten skal ikke gives besked om at tage to doser på samme tid, hvis en dosis er glemt.
English: Macitentan is not a substrate for Pgp/MDR-1.
Danish: Macitentan er ikke et substrat for P-gp/MDR-1.
English: The overall median double-blind treatment duration was 115 weeks (up to a maximum of 188 weeks on macitentan).
Danish: Den samlede, gennemsnitlige varighed af blindet behandling var 115 uger (op til højst 188 uger med macitentanbehandling).
English: 6 White blood cells
Danish: 6 Hvide blodlegemer
English: The recommended dose is 10 mg once daily.
Danish: Den anbefalede dosis er 10 mg én gang dagligt.
English: • The risk of anaemia, hepatotoxicity and teratogenicity and the need for reliable contraception;
Danish: • Risikoen for anæmi, hepatotoksicitet og teratogenicitet og behovet for sikker kontraception;
English: Table 1 Summary of outcome events
Danish: TABEL 1 Opsummering af udfaldsrelaterede hændelser
English: Other metabolic pathways yield products without pharmacological activity.
Danish: Øvrige metaboliseringsveje frembringer produkter uden farmakologisk aktivitet.
English: • The importance of telling patients to report immediately any possible pregnancy that occurs during Opsumit use.
Danish: • Vigtigheden af at instruere patienterne i omgående at indberette enhver mulig graviditet, der indtræder under brug af Opsumit.
English: You will need blood tests, as indicated by your doctor:
Danish: Du skal have taget blodprøver i henhold til lægens anvisninger:
English: • if you are allergic to macitentan, soya or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for macitentan, soja eller et af de øvrige indholdsstoffer i dette lægemiddel(angivet i punkt 6).
English: This card contains important safety information you need to be aware of when receiving treatment withOpsumit.
Danish: Dette kort indeholder vigtige sikkerhedsoplysninger, som du skal være opmærksom på, når du er i behandling med Opsumit.
English: The active metabolite circulates in human plasma and may contribute to the pharmacological effect.
Danish: Den aktive metabolit cirkulerer i humant plasma og kan medvirke til den farmakologiske virkning.
English: The requirements for submission of periodic safety updated reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for indsendelse af opdaterede PSUR'er for dette lægemiddel findes på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Relative risk reduction (97.5% CI)
Danish: Relativ risikoreduktion (97,5 % CI)
English: In the event of an overdose, standard supportive measures must be taken, as required.
Danish: I tilfælde af overdosering skal der gives almen understøttende behandling efter behov.
English: Do not take Opsumit:
Danish: Tag ikke Opsumit:
English: The MAH shall agree the details of the Prescriber kit and a controlled distribution system with the National Competent Authority and implement it prior to launch in that Member State.
Danish: Indehaveren af markedsføringstilladelsen skal aftale detaljerne i Ordinationssættet og et kontrolleret distributionssystem med de nationale kompetente myndigheder og implementere det inden lancering i den pågældende medlemsstat.
English: If the patient misses a dose of Opsumit, the patient should be told to take it as soon as possible and then take the next dose at the regularly scheduled time.
Danish: Hvis patienten glemmer en dosis af Opsumit, instrueres patienten i at tage den så hurtigt som muligt og derefter tage den næste dosis på det sædvanlige tidspunkt.
English: In vitro studies
Danish: In vitro-studier
English: Approximately 52%, 46%, and 2% of patients were in WHO FC II, III, and IV, respectively.
Danish: Cirka hhv. 52 %, 46 % og 2 % af patienterne var i WHO-funktionsgruppe II, III og IV
English: Women should not become pregnant for 1 month after discontinuation of Opsumit.
Danish: Kvinder skal undgå graviditet i en måned efter seponering af Opsumit.
English: Thereafter, plasma concentrations of macitentan and its active metabolite decrease slowly, with an apparent elimination half-life of approximately 16 hours and 48 hours, respectively.
Danish: Derefter falder plasmakoncentrationerne af macitentan og dets aktive metabolit langsomt med en terminalhalveringstid på hhv. cirka 16 timer og 48 timer.
English: Macitentan has been administered as a single dose of up to 600 mg to healthy subjects.
Danish: Macitentan er blevet administreret som en enkelt dosis på op til 600 mg hos raske personer.
English: • The need for monthly pregnancy tests;
Danish: • Behovet for månedlige graviditetstest;