FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with a certain human leukocyte antigen genotype (which is more frequent in Japanese and Korean patients, but is also found in Caucasians) are more prone to development of insulin autoimmune syndrome (disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels) when treated with thioctic acid.
Danish: Ved behandling med alfaliponsyre har patienter med en bestemt leukocytantigen-genotype (som er hyppigere hos japanske og koreanske patienter, men som også findes hos den hvide race) øget tilbøjelighed til at udvikle insulin autoimmun syndrom (en sygdom, der berører de hormoner, der reguleret blodsukkeret, med udtalt sænkning af blodsukkeret).
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility [...] may also occur with an unknown frequency.
Danish: Andre bivirkninger såsom nyresvigt, nedsat indhold af urinsyre i blodet, pulmonal hypertension, mandlig infertilitet [...] kan også forekomme.
English: Section 4.8 Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
Danish: Punkt 4.8 Meget sjælden: Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater).
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension has have been reported during treatment with leflunomide (see section 4.8).
Danish: Interstitiel lungesygdom samt sjældne tilfælde af pulmonal hypertension er rapporteret under behandling med leflunomid (se pkt.
English: Section 4.8 - Undesirable effects: Respiratory, thoracic and mediastinal disorders
Danish: Punkt 4.8 - Bivirkninger: Luftveje, thorax og mediastinum
English: IAS should be considered in the differential diagnosis of spontaneous hypoglycaemia in patients using thioctic acid (see section 4.8).
Danish: IAS bør overvejes som differentialdiagnose ved spontan hypoglykæmi hos patienter, der tager alfaliponsyre (se pkt.
English: Thioctic acid - Insulin autoimmune syndrome (EPITT no
Danish: Alfaliponsyre - Insulin autoimmun syndrom (EPITT nr.
English: HLA-DRB1*04:03 allele (susceptibility to IAS odds ratio: 1.6) is especially found in Caucasians, with a higher prevalence in southern than in northern Europe and HLA-DRB1*04:06 allele (susceptibility to IAS odds ratio: 56.6) is especially found in Japanese and Korean patients.
Danish: HLA-DRB1*04:06-allelet (risikoratio for tilbøjelighed til IAS: 56,6) findes især hos japanske og koreanske patienter.
English: Frequency unknown: insulin autoimmune syndrome (see section 4.4)
Danish: Hyppighed "ikke kendt": insulin autoimmun syndrom (se pkt.
English: The risk of its their occurrence is can be increased in patients with a history of interstitial lung disease.
Danish: Risikoen for interstitiel lungesygdom og pulmonal hypertension kan være øget hos patienter med interstitiel lungesygdom i anamnesen.
English: Frequency ‘uncommon': Cases of suspected capillary leak syndrome have been reported with trabectedin.
Danish: Punkt 4.8 - Bivirkninger »Ikke almindelig«: Der er indberettet tilfælde af formodet kapillærlækage-syndrom for trabectedin.
English: Cases of Insulin Autoimmune Syndrome (IAS) have been reported during treatment with thioctic acid.
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen: Der er rapporteret tilfælde af insulin autoimmun syndrom (IAS) under behandling med alfaliponsyre.
English: The treatment is divided into 2 phases: induction and consolidation.
Danish: Behandlingen er opdelt i to faser: induktion og konsolidering.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 10 August 2010.
Danish: Efter at virksomheden havde fremlagt de udbedte yderligere oplysninger, blev de "særlige omstændigheder" ophævet den 10. august
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trisenox on 5 March 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trisenox den 5. marts 2002.
English: Forty-five of the patients in the studies were adults.
Danish: 45 af patienterne i undersøgelserne var voksne.
English: The infusion should last one to two hours, but it may last longer if the patient has certain side effects.
Danish: Infusionen bør vare en til to timer, men kan vare længere, hvis patienten får visse bivirkninger.
English: If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.
Danish: Hvis behandlingen ikke har virket på dag 50 (for tidligere behandlede patienter) eller på dag 60 (for nydiagnosticerede patienter), bør behandlingen afbrydes.
English: The full EPAR for Trisenox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Trisenox findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Trisenox.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trisenox.
English: It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.
Danish: Det menes at forebygge den dna-produktion, som er nødvendig for leukæmicellers vækst.
English: During the consolidation phase, Trisenox is given once a day for five days, followed by a two-day break, repeated for four or five weeks.
Danish: I konsolideringsfasen gives Trisenox en gang dagligt i fem dage efterfulgt af to dages pause, hvilket gentages i fire til fem uger.
English: The CHMP decided that Trisenox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Trisenox opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Looking at the results of these two studies together, 87% of the patients had complete remission (45 out of 52).
Danish: Det samlede resultat af de to undersøgelser var, at 87 % af patienterne havde opnået fuld remission (45 af 52).
English: The recommended dose of Trisenox depends on the body weight of the patient.
Danish: Den anbefalede dosis af Trisenox afhænger af patientens legemsvægt.
English: This is when there are no more leukaemia cells in the bone marrow and the levels of platelets and white blood cells in the blood have recovered.
Danish: Dette er tilfældet, når der ingen leukæmiceller er tilbage i knoglemarven, og antallet af blodplader og hvide blodlegemer i blodet er normaliseret.
English: The number of times these cycles are repeated depends on whether patients have received previous treatment or not.
Danish: Antallet af gange, som cyklussen gentages, afhænger af, om patienten tidligere er blevet behandlet.
English: Trisenox is used in:
Danish: Trisenox anvendes hos:
English: The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes).
Danish: De hyppigste bivirkninger ved Trisenox (som optræder hos 1 ud af 10 patienter) er hyperglykæmi (højt blodsukkerniveau), hypomagnesæmi (lavt indhold af magnesium i blodet), hypokalæmi (lavt indhold af kalium i blodet), paræstesi (snurren eller følelsesløshed og prikken), svimmelhed, hovedpine, takykardi (hjertebanken), dyspnø (stakåndethed), differentieringssyndrom (en potentiel dødelig komplikation ved kemoterapi hos patienter med akut promyelocyt leukæmi), diarré, opkastning, kvalme, pruritus (kløe), udslæt, myalgi (muskelsmerter), pyreksi (feber), smerter, træthed, ødem (hævelser), forlænget QTinterval på et elektrokardiogram (en ændring af den elektriske aktivitet i hjertet) samt forhøjede niveauer af alanin-aminotransferase og aspartat-aminotransferase (leverenzymer).
English: Trisenox was not compared with any other medicine in either study.
Danish: Trisenox blev ikke sammenlignet med andre lægemidler i undersøgelserne.
English: Trisenox was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Danish: Trisenox blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet kun forelå sparsomme oplysninger som følge af sygdommens sjældenhed.
English: • Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Danish: • Patienter med akut promyelocyt leukæmi, der ikke har reageret på tidligere behandling med et retinoid eller lægemidler mod kræft, eller når deres sygdom er vendt tilbage efter en sådan behandling.
English: What measures are being taken to ensure the safe and effective use of Trisenox?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trisenox?
English: The way it works in this disease is not completely understood.
Danish: Det vides ikke nøjagtigt, hvordan stoffet virker ved denne sygdom.
English: Other information about Trisenox
Danish: Andre oplysninger om Trisenox
English: The main measure of effectiveness was the number of patients who had complete remission.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, som opnåede fuld remission.
English: The active substance in Trisenox, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia.
Danish: Det aktive stof i Trisenox, arsentrioxid, er et kemisk stof, som har været anvendt i lægemidler i mange år, bl.a. til behandling af leukæmi.
English: During the induction phase, Trisenox is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Danish: I induktionsfasen gives Trisenox dagligt, indtil der er tegn på, at behandlingen virker (når knoglemarven er fri for leukæmiceller).
English: The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Danish: Translokationen påvirker den måde, hvorpå de hvide blodlegemer vokser, og de er derfor ikke i stand til at bruge retinsyre (A-vitamin).
English: On average, it took 57 days for the patients to reach complete remission.
Danish: Patienterne opnåede gennemsnitligt fuld remission på 57 dage.
English: Trisenox contains the active substance arsenic trioxide.
Danish: Trisenox indeholder det aktive stof arsentrioxid.
English: What is Trisenox and what is it used for?
Danish: Hvad er Trisenox, og hvad anvendes det til?
English: Trisenox can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Danish: Trisenox udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i behandling af patienter med akut leukæmi.
English: 97% (72 out of 74) of patients treated with Trisenox did not have any event, compared with 86% (65 out of 76) of those treated with anthracyclines.
Danish: Andelen af Trisenoxbehandlede patienter, som ikke oplevede nogen hændelser, var 97 % (72 ud af 74) sammenlignet med 86 % (65 ud af 76) af de anthracyclin-behandlede patienter.
English: Trisenox is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Danish: Trisenox anvendes til behandling af voksne (over 18 år) med akut promyelocyt leukæmi (APL), en sjælden form for leukæmi (kræft i de hvide blodlegemer), som skyldes en genetisk "translokation" (når to kromosomer bytter gener).
English: It is not intended to provide practical advice on how to use Trisenox.
Danish: Det er ikke en praktisk vejledning i, hvordan Trisenox bør anvendes.
English: For more information about treatment with Trisenox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Trisenox, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Trisenox approved?
Danish: Hvorfor er Trisenox blevet godkendt?
English: For the full list of all side effects and restrictions with Trisenox, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Trisenox fremgår af indlægssedlen.
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA).
Danish: • Patienter med nydiagnosticeret lav eller mellemhøj risiko for akut promyelocyt leukæmi, hvor Trisenox anvendes sammen med lægemidlet hel-trans-retinsyre (ATRA).
English: Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Danish: Patienter med akut promyelocyt leukæmi behandles sædvanligvis med retinoider (stoffer fra A-vitamin).
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Danish: Det leveres som et koncentrat, der blandes til en infusionsvæske,
English: What are the risks associated with Trisenox?
Danish: Hvilke risici er der forbundet med Trisenox?
English: Trisenox has also been investigated in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline and a retinoid.
Danish: Trisenox blev undersøgt i to undersøgelser med 52 patienter med akut promyelocyt leukæmi, som tidligere var blevet behandlet med anthracyclin og et retinoid.
English: Trisenox arsenic trioxide
Danish: Trisenox arsentrioxid
English: For practical information about using Trisenox, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Trisenox, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trisenox 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 Trisenox.
English: How is Trisenox used?
Danish: Hvordan anvendes Trisenox?
English: What benefits of Trisenox have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Trisenox?
English: How does Trisenox work?
Danish: Hvordan virker Trisenox?
English: Trisenox has been investigated in 159 newly diagnosed patients who had not yet received any treatment for APL. Trisenox was compared with an anthracycline (a type of cancer medicine), both taken in combination with ATRA, and the measure of effectiveness was the number of patients who did not experience any event (such as worsening of their disease or death) 2 years after diagnosis.
Danish: Målet for virkningen var antallet af patienter, som ikke oplevede nogen hændelser (såsom sygdomsforværring eller dødsfald) to år efter diagnosen.
English: However these imbalances involved small numbers of events.
Danish: Denne skævhed omfattede dog kun et lille antal hændelser.
English: At the request of the CHMP, an ad-hoc expert advisory group meeting was convened in February 2013.
Danish: På anmodning af CHMP blev der indkaldt en ad hoc-ekspertgruppe i februar 2013.
English: The CASTLE study included patients who were treated up to 3 years.
Danish: CASTLE-undersøgelsen omfattede patienter, der blev behandlet i op til tre år.
English: Overall summary of the scientific evaluation of cilostazol containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder cilostazol (se bilag I)
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC on cilostazolcontaining medicinal products;
Danish: • udvalget fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende cilostazol,
English: The protocol of the studies was agreed by the CHMP.
Danish: Protokollen for undersøgelserne blev godkendt af CHMP.
English: The study was terminated prematurely as a result of a lower than expected event rate and higher than expected drop-out rate.
Danish: Undersøgelsen blev afsluttet før tid som følge af lavere hændelsesrate end forventet og højere frafaldsrate end forventet.
English: Results for secondary efficacy endpoints were consistent with the results for ACD.
Danish: For de sekundære endepunkter for virkning var resultaterne konsistente med resultaterne for ACD.
English: Grounds for the variation to the terms of the marketing authorisation
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen
English: This Article 31 referral was initiated by Spain following review of safety reports received in association with cilostazol during the first 18 months of marketing in Spain (cilostazol was licenced in Spain in 2008).
Danish: Denne artikel 31-indbringelse blev indledt af Spanien efter gennemgang af sikkerhedsindberetninger vedrørende cilostazol fra de første 18 måneders markedsføring i Spanien (cilostazol blev godkendt i Spanien i 2008).
English: No signal for increased mortality was observed in clinical trials, including the CASTLE study.
Danish: Der blev ikke fundet signaler om øget dødelighed i de kliniske undersøgelser, herunder CASTLE-undersøgelsen.
English: Palpitations and tachycardia were well-documented in clinical trials.
Danish: Palpitationer og takykardi var veldokumenteret i de kliniske undersøgelser.
English: In total 3,122 patients were randomised and received at least one dose of investigational product in the 9 efficacy trials.
Danish: I alt blev der randomiseret 3 122 patienter, som fik mindst én dosis forsøgsmedicin i de ni kliniske undersøgelser af virkningen.
English: The primary objective of the CASTLE trial was to assess the long-term effect of cilostazol on all-cause mortality.
Danish: Hovedformålet med CASTLE-undersøgelsen var at vurdere den langsigtede virkning af cilostazol på dødeligheden af alle årsager.
English: No major safety concerns were identified from the clinical trials.
Danish: Der blev ikke fundet væsentlige sikkerhedsmæssige problemer i de kliniske undersøgelser.
English: Spain therefore referred cilostazol to the CHMP/EMA, requesting that it gives its opinion under Article 31 of Directive 2001/83/EC, on whether the marketing authorisations for medicinal products containing cilostazol should be maintained, varied, suspended or withdrawn.
Danish: Spanien indbragte derfor cilostazol for CHMP/EMA og anmodede om, at udvalget fremsatte en udtalelse i henhold til artikel 31 i direktiv 2000/83/EF om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende cilostazol burde opretholdes, ændres, suspenderes eller inddrages.
English: In order to measure the effectiveness of the above measures, the CHMP has agreed on two drug utilisation studies (DUS).
Danish: For at måle effektiviteten af ovennævnte foranstaltninger vedtog CHMP to undersøgelser af lægemiddelanvendelse.
English: • The Committee reviewed all the data provided by the MAHs in writing and in the oral explanation and the outcome of the ad-hoc expert advisory group meeting;
Danish: • udvalget gennemgik alle de oplysninger, der var forelagt af indehaveren af markedsføringstilladelsen, dels skriftligt, dels ved den mundtlige fremlæggelse, og resultatet af mødet i den rådgivende ad hocekspertgruppe,
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
Danish: Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: The experts acknowledged that minor adverse events were commonly seen in some patients but no major side effects were recorded by any of the experts.
Danish: Eksperterne vedgik, at der hos nogle patienter ofte sås mindre betydelige bivirkninger, men ingen af eksperterne konstaterede væsentlige bivirkninger.
English: The range of improvement was between +28% to +100% for cilostazol, and -10% to +42% for placebo in the individual trials.
Danish: Variationsbredden af forbedringen var +28 % til +100 % for cilostazol, og -10 % til +42 % for placebo i de enkelte undersøgelser.
English: • The Committee is of the opinion that some patients may benefit from cilostazol treatment to a clinically relevant degree; however, in view of the existing safety concerns, the Committee considered it appropriate to restrict use to those who have not responded to lifestyle treatment and to recommend that treatment is only continued in those who have shown a meaningful response within the first 3 months;
Danish: • det er udvalgets opfattelse, at nogle patienter kan have klinisk relevant fordel af behandling med cilostazol; i betragtning af de eksisterende sikkerhedsmæssige betænkeligheder fandt udvalget det imidlertid hensigtsmæssigt at begrænse anvendelsen til patienter, der ikke har responderet på livsstilsbehandling, og at anbefale, at behandlingen kun fortsættes hos patienter, der har vist meningsfuld respons inden for de første tre måneder,
English: The need to review the patient's response to treatment at 3 months and to continue treatment only if positive was agreed by all.
Danish: Der var almindelig enighed om nødvendigheden af at gennemgå patientens respons på behandlingen efter tre måneder og kun fortsætte behandlingen, hvis der var positiv respons.
English: The experts agreed that the CASTLE study had some limitations (including early termination and high rate of dropout, study restrictive in certain patient groups, exclusion of high risk patients, and review of the patients by their doctors in a 6-month period) but that some of those were expected with such a long term Phase IV study.
Danish: Eksperterne fandt, at CASTLE-undersøgelsen har visse begrænsninger (herunder afslutning før tid, høj frafaldsrate, undersøgelsens begrænsning til visse patientgrupper, udelukkelse af højrisikopatienter og seks måneder mellem gennemgang af patienterne ved læge), men at nogle af dem var forventelige i en så langvarig fase IV-undersøgelse.
English: A closer monitoring of treatment success after 3 months instead of 6 months, with a view to discontinuing cilostazol where the treatment effect is considered to be inadequate is now recommended.
Danish: Der anbefales nu overvågning af behandlingsresultatet efter kun 3 måneder i stedet for seks måneder med henblik på, at cilostazol skal seponeres ved utilstrækkelig behandlingseffekt.
English: To ensure that health care professionals are informed of the correct indication for use of the product, the MAH has introduced the following measures: proactive communication to physicians on the Otsuka Europe website, re-training of the Medical Information teams and Sales Force teams in the countries where cilostazol is marketed.
Danish: For at sikre, at sundhedspersoner informeres om den korrekte indikation for produktet, har indehaveren af markedsføringstilladelsen truffet følgende foranstaltninger: proaktiv kommunikation til læger gennem Otsuka Europe's websted samt efteruddannelse af virksomhedens medarbejdere inden for medicinsk information og salg i de lande, hvor cilostazol markedsføres.