FrancophonIA/ELRC3.0 huggingface dataset:
English: Healthcare professionals should follow these recommendations:
Danish: For sundhedspersoner gælder følgende anbefalinger:
English: • have been treated with Tysabri for more than 2 years, and
Danish: • har været i behandling med Tysabri i over 2 år, og
English: • have tested positive for JC virus, and
Danish: • er testet positive for JC-virus, og
English: Patients should be instructed to seek medical advice if they think their disease is getting worse, or if they notice any new or unusual symptoms.
Danish: Patienterne bør instrueres om at søge læge, hvis de mener, at sygdommen er ved at blive værre, eller hvis de bemærker nye eller usædvanlige symptomer.
English: In these patients, treatment with Tysabri should only be continued if benefits outweigh the risks.
Danish: Hos sådanne patienter bør behandlingen med Tysabri kun fortsættes, hvis fordelene er større end risiciene.
English: Index 0.9 to
Danish: Indeks 0,9 til
English: These tests may be done more often if you are considered at higher risk for PML.
Danish: Disse test vil muligvis blive foretaget oftere, hvis du vurderes til at have højere risiko for PML.
English: This protein is found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Danish: Dette protein findes på overfladen af de fleste hvide blodlegemer (leukocytter), som deltager i inflammationsprocessen.
English: If you believe your disease is getting worse or if you notice any new or unusual symptoms while using Tysabri and for up to 6 months after stopping Tysabri, speak to your doctor as soon as possible.
Danish: Hvis du mener, at sygdommen er ved at blive værre, eller hvis du bemærker nye eller usædvanlige symptomer, mens du bruger Tysabri og i indtil 6 måneder efter at være holdt op med Tysabri, skal du snarest tale med lægen.
English: PML is a rare brain infection caused by John Cunningham (JC) virus.
Danish: PML er en sjælden hjerneinfektion, der forårsages af John Cunningham-virus (JC-virus).
English: In light of the new evidence, patients are considered at higher risk of developing PML if they:
Danish: På baggrund af de nye resultater anses patienterne for at have højere risiko for at udvikle PML, hvis de:
English: By attaching to the integrin, natalizumab stops the leucocytes from going from the blood into the brain, thereby reducing the inflammation and nerve damage caused by MS.
Danish: Ved at bindes til integrinet forhindrer natalizumab leukocytterne i at vandre fra blodet ind i hjernen, hvorved det nedsætter den inflammation og nervebeskadigelse, der forårsages af MS.
English: EMA's recommendations are based on an initial review by its Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: EMA's anbefalinger bygger på en indledende gennemgang foretaget af agenturets Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Your doctor will also check for signs and symptoms suggestive of PML.
Danish: Lægen vil desuden kontrollere dig for tegn og symptomer, der tyder på PML.
English: • Anti-JC virus antibody testing should be done every 6 months in antibody-negative patients.
Danish: • Der bør testes for anti-JC-virus-antistoffer hver 6. måned hos antistofnegative patienter.
English: Index 0.9 or less
Danish: Indeks 0,9 eller derunder
English: The CHMP's opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU.
Danish: CHMP's udtalelse blev derefter overgivet til Europa-Kommissionen, som vedtog en retligt bindende beslutning med gyldighed i hele EU.
English: On 25 February 2016, EMA completed its review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab), and confirmed initial recommendations1 aimed at minimising this risk.
Danish: Den 25. februar 2016 afsluttede EMA sin gennemgang af den kendte risiko for progressiv multifokal leukoencefalopati (PML) med lægemidlet mod multipel sklerose Tysabri (natalizumab), og bekræftede sine oprindelige anbefalinger1 for minimering af denne risiko.
English: New recommendations have been issued which may help early detection of PML and improve patients' outcomes.
Danish: Der er udstedt nye anbefalinger, som kan være medvirkende til tidlig opdagelse af PML og bedre udfald for patienternes.
English: No prior use of immunosuppressants
Danish: Ingen tidligere anvendelse af immunosuppressiva
English: More detailed information on the risk stratification, diagnosis and treatment of PML will be included in the updated Physician Information and Management Guidelines for Tysabri.
Danish: Mere detaljerede oplysninger om risikostratificering, diagnose og behandling af PML vil indgå i de ajourførte retningslinjer "Physician Information and Management Guidelines" for Tysabri.
English: months *from Tysabri Physician Information and Management Guidelines
Danish: Indeks over måneder * fra retningslinjerne "Physician Information and Management Guidelines" for Tysabri
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som 25/04/2016 vedtog en endelig retligt bindende beslutning med gyldighed i alle EU-medlemsstater.
English: Considering these factors, your doctor will be able to advise you about your risk of developing PML.
Danish: Ud fra disse faktorer vil din læge kunne fortælle dig om din risiko for at få PML.
English: The most common symptoms of PML are progressive weakness, speech and communication difficulties, vision changes, and sometimes changes in mood or behaviour.
Danish: De hyppigste symptomer på PML er tiltagende svaghed, tale- og kommunikationsbesvær, synsændringer og undertiden ændringer i humør eller adfærd.
English: Prior use of immunosuppressants
Danish: Tidligere anvendelse af immunosuppressiva
English: It is used when the disease has failed to respond to treatment with a beta-interferon or glatiramer acetate (other types of medicines used in MS), or is severe and getting worse rapidly.
Danish: Det anvendes, når behandling med visse andre lægemidler, der anvendes mod MS (beta-interferon eller glatirameracetat) ikke har virket, eller sygdommen er svær og hurtigt forværres.
English: • More information about the risk of PML with Tysabri is included in the Patient Alert Card you have been given by your doctor.
Danish: • Flere oplysninger om risikoen for PML med Tysabri findes på det patientkort, du har fået udleveret af din læge.
English: • PML should be considered in the differential diagnosis of any patient presenting with neurological symptoms and/or new brain lesions on MRI.
Danish: • PML bør overvejes ved differentialdiagnose af alle patienter med neurologiske symptomer og/eller nye hjerneforandringer på MRI.
English: In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients.
Danish: Hos patienter, der er testet negative for JC-virusantistoffer, er den beregnede risiko for PML uændret 0,1 pr. 1 000 patienter.
English: 2 PML risk estimates were derived using the life table method based on the pooled cohort of 21,696 patients who participated in the STRATIFY-2, TOP, TYGRIS, and STRATA clinical studies.
Danish: Beregningen af risikoen for PML blev foretaget med livstabelmetoden på grundlag af den poolede kohorte på 21 696 patienter, som deltog i de kliniske undersøgelser STRATIFY-2, TOP, TYGRIS, og STRATA.
English: FLAIR, T2-weighted and DW imaging) should be considered, as earlier detection of PML in asymptomatic patients is associated with improved PML outcomes.
Danish: FLAIR, T2-vægtet og DW-billeddannelse), da tidligere opdagelse af PML hos asymptomatiske patienter er forbundet med bedre udfald af PML.
English: • During treatment with Tysabri, patients should be monitored at regular intervals for signs and symptoms of new neurological dysfunction, and a full brain MRI should be performed at least once a year for the duration of treatment.
Danish: • Under behandlingen med Tysabri bør patienterne overvåges regelmæssigt for tegn og symptomer på ny neurologisk dysfunktion, og der bør foretages en fuldstændig hjerne-MRI mindst én gang årligt i hele behandlingens varighed.
English: Tysabri is a medicine used to treat adults with highly active multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Danish: Tysabri er et lægemiddel til behandling af voksne med højaktiv multipel sklerose (MS), som er en nervesygdom, hvor den beskyttende skede omkring nervecellerne ødelægges ved inflammation.
English: Patients who have low index values and no history of prior immunosuppressant use should also be retested every 6 months once they reach the 2-year treatment point.
Danish: Patienter med lavt indeks og uden tidligere behandling med immunosuppressiva bør desuden på ny testes hver 6. måned, når de har været behandlet i 2 år.
English: All patients taking Tysabri should undergo full MRI scans at least once a year, but on the basis of the new data EMA recommended that for patients at higher risk of PML more frequent MRI scans (e.g. every 3 to 6 months) performed using simplified protocols should be considered.
Danish: Alle patienter, der får Tysabri, bør have foretaget fuldstændig MRI-skanning mindst én gang årligt, men på grundlag af de nye data anbefalede EMA, at det bør overvejes at MRI-skanne patienter med større risiko for PML hyppigere (f.eks. hver 3. til 6. måned) efter de forenklede protokoller.
English: • Before starting treatment with Tysabri, patients and carers should be advised about the risk of PML.
Danish: • Før påbegyndelse af behandling med Tysabri bør patienter og omsorgsgivere adviseres om risikoen for PML.
English: • Patients and carers should be advised to continue to be vigilant about the risk of PML for up to 6 months following discontinuation of Tysabri.
Danish: • Patienter og omsorgsgivere bør adviseres om fortsat at være opmærksomme på risikoen for PML i op til 6 måneder efter seponering af Tysabri.
English: • Before starting treatment with Tysabri, and then regularly during treatment, your doctor will do blood tests to measure the level of antibodies for JC virus and MRI scans to monitor your condition.
Danish: • Før påbegyndelse af behandlingen med Tysabri, og derefter regelmæssigt under behandlingen, vil din læge tage blodprøver til bestemmelse af indholdet af antistoffer mod JC-virus og lade foretage MRI-skanning for at overvåge din tilstand.
English: Asymptomatic cases of PML can be detected on MRI scans, and experts in the field of MRI and multiple sclerosis agree that simplified MRI protocols (which allow for shorter procedures, and also limit the burden for patients undergoing the scans) permit the identification of PML lesions.
Danish: Asymptomatiske tilfælde af PML kan påvises ved MRI-skanning, og eksperter inden for MRI og multipel sklerose er enige om, at PML-forandringerne kan identificeres med forenklede MRI-protokoller (som giver mulighed for kortere procedurer og desuden er mindre belastende for de patienter, der skannes).
English: • After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
Danish: • Efter 2 års behandling bør patienterne på ny informeres om risikoen for PML med Tysabri.
English: • Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
Danish: • Den alvorlige hjerneinfektion PML (progressiv multifokal leukoencefalopati) er kendt som en ikke almindelig risiko ved lægemidlet Tysabri, der anvendes mod multipel sklerose.
English: • Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
Danish: • Før påbegyndelse af behandlingen bør der foreligge en baseline-MRI (sædvanligvis inden for 3 måneder) som reference, og der bør foretages en baseline-anti-JCV antistoftest for at underbygge risikostratificeringen for PML.
English: • Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
Danish: • Din risiko for PML afhænger af en række faktorer, såsom om du har haft antistoffer mod JC-virus i blodet (som tegn på, at du har været udsat for det virus, der forårsager PML) og i hvilken koncentration, hvor længe du har fået Tysabri, og om du har fået lægemidler, der undertrykker immunsystemet, før du begyndte behandlingen med Tysabri.
English: • Symptoms of PML may be similar to those of a multiple sclerosis attack, and include progressive weakness, speech and communication difficulties, vision problems, and sometimes changes in mood or behaviour.
Danish: • Symptomerne på PML kan svare til symptomerne på et anfald af multipel sklerose og kan bestå i tiltagende svaghed, tale- og kommunikationsbesvær, synsvanskeligheder og undertiden ændringer i humør og adfærd.
English: Cases of asymptomatic PML based on MRI and positive JC virus DNA in the CSF have been reported.
Danish: Der er beskrevet tilfælde af asymptomatisk PML baseret på MRI og positiv JC-virus-DNA-test i cerebrospinalvæske.
English: More frequent MRI scans should be considered for patients at higher risk
Danish: For patienter med højere risiko bør hyppigere MRI-skanning overvejes
English: • For patients at higher risk of PML, more frequent MRIs (e.g. every 3-6 months) using an abbreviated protocol (e.g.
Danish: • For patienter med højere risiko for PML bør der overvejes hyppigere MRI-skanning (f.eks. hver 3.6. måned) med brug af en forkortet protokol (f.eks.
English: The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Danish: De ajourførte risikoberegninger viser, at ved antistof-indeksværdier på 0,9 eller derunder er risikoen for at udvikle PML lille og lavere end tidligere beregnet, og at risikoen øges væsentligt ved indeks over 1,5 og behandling med Tysabri længere end 2 år.
English: Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
Danish: Kendte risikofaktorer for at udvikle PML ved behandling med Tysabri er tilstedeværelse af antistoffer mod JC-virus, behandling med Tysabri længere end to år, samt forudgående brug af immunosuppressiva.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted its final opinion.
Danish: PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som vedtog udvalgets endelige udtalelse.
English: Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
Danish: Yderligere stratificering af PMLrisikoen efter anti-JC virus-antistofindeks for patienter, der ikke tidligere havde brugt immunosuppressiva, blev foretaget ved kombination af den samlede årlige risiko med fordelingen af antistofindeks.
English: • If you have any questions or concerns, speak to your doctor, nurse or pharmacist.
Danish: • Spørg lægen, sygeplejersken eller apotekspersonalet, hvis der er mere, du vil vide.
English: • either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
Danish: • enten har fået et immundæmpende middel før de begyndte at få Tysabri eller har højt JC-virusantistofindeks uden at have fået immundæmpende midler.
English: If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Danish: Hvis der konstateres forandringer tydende på PML, bør MRI-protokollen udvides til at omfatte "kontrastforstærket T1-vægtet MRI", og det bør overvejes at undersøge spinalvæsken for JC-virus.
English: Recent studies suggest that early detection and treatment of PML when the disease is asymptomatic (is still in the initial stages and shows no symptoms) may improve patients' outcomes.
Danish: Nyere undersøgelser viser, at udfaldet for patienterne kan forbedres ved tidlig opdagelse og behandling af PML, mens sygdommen endnu er i de indledende stadier og er uden symptomer (asymptomatisk).
English: This virus is very common in the general population and is normally harmless; however, it can lead to PML in persons whose immune system is weakened.
Danish: Dette virus er meget udbredt hos den almindelige befolkning og er normalt harmløst.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
Danish: Det aktive stof i Tysabri, natalizumab, er et protein af typen monoklonalt antistof.
English: • If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
Danish: • Ved mistanke om PML bør MRI-protokollen udvides til at omfatte kontrastforstærket T1-vægtet billeddannelse, og det bør overvejes at undersøge cerebrospinalvæsken for JC-virus-DNA ved hjælp af ultrafølsom PCR.
English: If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Danish: Hvis der på noget tidspunkt er mistanke om PML, skal behandlingen med Tysabri standses, indtil PML er udelukket.
English: Pooled data from large clinical studies suggest that, in patients with no prior immunosuppressant use, the level of anti-JC virus antibody response (index) relates to the level of risk for PML.
Danish: Poolede data fra store kliniske undersøgelser tyder på, at der for patienter, der ikke tidligere har fået immunosuppressiva, er sammenhæng mellem niveauet af anti-JC-virus antistofrespons (-indeks) og risikoen for PML.
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
Danish: • Ved mistanke om PML vil lægen standse behandlingen med Tysabri, indtil PML kan udelukkes.
English: • If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Danish: • Hvis der på noget tidspunkt er mistanke om PML, skal behandlingen med Tysabri standses, indtil PML er udelukket.
English: Table 1: PML risk estimates per 1,000 patients in anti-JC virus antibody positive patients* Duration of Tysabri use
Danish: På grundlag af disse data foreligger der ajourførte beregninger af risikoen for PML2 ved behandling af JC-virus-antistof-positive patienter med Tysabri, som vist i tabel 1 nedenfor: Tabel 1: Risiko for PML (pr. 1 000 patienter) for anti-JC-virus-antistofpositive patienter* Varighed af anvendelse af Tysabri
English: New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
Danish: Nye data fra store kliniske undersøgelser tyder desuden på, at der er sammenhæng mellem blodets indhold af JC-virus-antistoffer ("antistofindeks") og risikoen for PML for patienter, der ikke har været i behandling med immundæmpende lægemidler (immunosuppressiva) før påbegyndelse af behandlingen med Tysabri.
English: London, 19 March 2008 Doc.
Danish: London, den 19. marts 2008 Doc.
English: This is expected to help to prevent organ damage.
Danish: Dette forventes at være med til at forhindre beskadigelse af organerne.
English: It was to be available as capsules.
Danish: Det skulle leveres som kapsler.
English: International non-proprietary name (INN): eprodisate sodium
Danish: Internationalt fællesnavn (INN): natriumeprodisat
English: What is Kiacta?
Danish: Hvad er Kiacta?
English: The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Danish: Firmaet havde anmodet om, at den negative udtalelse blev taget op til fornyet overvejelse, men denne var endnu ikke afsluttet, da firmaet trak ansøgningen tilbage.
English: This is a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
Danish: Det er en sjælden, livstruende sygdom, som opstår hos patienter med længerevarende betændelse, som oftest skyldes rheumatoid arthritis (leddegigt).
English: The effects of Kiacta were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Kiacta blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Kiacta was designated an orphan medicinal product on 31 July 2001.
Danish: Kiacta blev udpeget som lægemiddel til sjældne sygdomme den 31. juli 2001.
English: The main measure of effectiveness was the number of patients whose kidney function got significantly worse or who died over two years of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, hos hvem nyrefunktionen blev betydeligt forværret eller som døde i løbet af de to års behandling.
English: What are the consequences of the withdrawal for patients in clinical trials with Kiacta?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Kiacta?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for KIACTA
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for KIACTA
English: Although there was a suggestion that Kiacta may be active, the Committee concluded that another study would be needed to demonstrate the medicine's effectiveness.
Danish: Selvom det blev antydet, at Kiacta muligvis er virksomt, konkluderede udvalget, at det var nødvendigt med en anden undersøgelse for at påvise lægemidlets virkning.
English: Kiacta is a medicine containing the active substance eprodisate disodium.
Danish: Kiacta er et lægemiddel, der indeholder det aktive stof dinatriumeprodisat.
English: On 13 March 2008, Neurochem Luxco II SARL officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kiacta for the treatment of amyloid A amyloidosis.
Danish: Den 13. marts 2008 meddelte Neurochem Luxco II SARL officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Kiacta til behandling af A- amyloidose (AA-amyloidose).
English: The company informed the CHMP that the ongoing clinical trial with Kiacta is being stopped, so that it can carry out a second study to compare Kiacta with placebo.
Danish: Virksomheden underrettede CHMP om, at den igangværende kliniske undersøgelse med Kiacta bliver afbrudt, så der kan udføres en anden undersøgelse for at sammenligne Kiacta med placebo.
English: What was Kiacta expected to be used for?
Danish: Hvad forventedes Kiacta anvendt til?