FrancophonIA/ELRC3.0 huggingface dataset:
English: • rapidly worsening, severe disease, who have had 2 or more relapses in one year and whose brain scans show certain brain lesions.
Danish: • svær sygdom, der udvikler sig hurtigt, og som har haft 2 eller flere tilbagefald på ét år, og hvor hjernescanninger viser visse læsioner i hjernen.
English: Side effects reported with Lemtrada are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Lemtrada vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: CD52 is found on lymphocytes, white blood cells that are part of the immune system.
Danish: CD52 findes på lymfocytter, der er en type hvide blodlegemer, der indgår i immunsystemet.
English: The way alemtuzumab acts in multiple sclerosis is not fully understood, but it is believed that its effect on lymphocytes reduces the immune system's damaging activity.
Danish: Det vides ikke nøjagtigt, hvordan alemtuzumab virker ved multipel sklerose, men det menes, at virkningen på lymfocytterne reducerer immunsystemets skadelige aktivitet.
English: Treatment should only be started and supervised by a neurologist experienced in treating MS.
Danish: Behandlingen bør kun påbegyndes og overvåges af en neurolog med erfaring i behandling af multipel sklerose.
English: What are the risks associated with Lemtrada?
Danish: Hvilke risici er der forbundet med Lemtrada?
English: Over half of patients included in the extension study did not have disease progression and did not need additional Lemtrada infusions.
Danish: Over halvdelen af patienterne i forlængelsesstudiet oplevede ikke sygdomsforværring og havde ikke behov for yderligere Lemtrada-infusioner.
English: Lemtrada can only be obtained with a prescription.
Danish: Lemtrada fås kun på recept.
English: For more information about using Lemtrada, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Lemtrada, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: In both studies, Lemtrada was compared with another medicine for multiple sclerosis, interferon beta-1a.
Danish: I begge undersøgelser blev Lemtrada sammenlignet med et andet lægemiddel mod multipel sklerose, interferon beta-1a.
English: The company will ensure that doctors expected to prescribe the medicine receive educational materials containing important safety information, and a checklist covering the necessary screening, medicines to reduce side effects, monitoring before, during and after infusion, and long-term monitoring of patients.
Danish: Virksomheden skal sikre, at læger, der forventes at ordinere lægemidlet, modtager undervisningsmateriale, der indeholder vigtige sikkerhedsoplysninger, og en tjekliste, der omfatter den nødvendige screening, lægemidler, der skal reducere bivirkninger, overvågning før, under og efter infusion og langtidsovervågning af patienter.
English: The first study involved previously untreated patients, while the second study involved patients whose disease had relapsed despite treatment.
Danish: Det første studie omfattede tidligere ubehandlede patienter, og det andet studie omfattede patienter, der havde fået tilbagefald af sygdommen trods behandling.
English: With regards to safety, Lemtrada has rare but serious side effects, including disorders of the heart, blood vessels and immune system and measures have been put in place to minimise this risk.1
Danish: Med hensyn til sikkerheden har Lemtrada sjældne, men alvorlige bivirkninger, herunder forstyrrelser i hjerte, blodkar og immunsystem, og der er truffet foranstaltninger til at minimere denne risiko1.
English: Lemtrada contains the active substance alemtuzumab.
Danish: Lemtrada indeholder det aktive stof alemtuzumab.
English: For those patients who needed one or two additional infusions with Lemtrada, the number of relapses was lower, and disability progression was slower, compared with the previous year.
Danish: Hos de patienter, der havde behov for en eller to ekstra infusioner med Lemtrada, var antallet af tilbagefald lavere og forværringen af invaliditet langsommere sammenholdt med det tidligere år.
English: When alemtuzumab attaches to the lymphocytes, it causes them to die, and they are replaced by new lymphocytes.
Danish: Når alemtuzumab binder sig til lymfocytterne, dør de og bliver erstattet af nye lymfocytter.
English: Up to two additional courses, each of 12 mg daily for 3 days, can be given at 12-month intervals.
Danish: Der kan gives op til to yderligere forløb, hver med 12 mg dagligt i 3 dage, med 12 måneders mellemrum.
English: It should be given in a hospital with access to intensive care, as well as equipment and specialist staff for managing serious reactions and side effects that can occur with Lemtrada.
Danish: Behandlingen bør gives på et hospital med adgang til intensiv behandling og med udstyr og specialpersonale til rådighed til håndtering af alvorlige reaktioner og bivirkninger, der kan forekomme med Lemtrada.
English: Lemtrada must not be used in patients with HIV and in patients with severe infections.
Danish: Lemtrada må ikke anvendes hos patienter med hiv eller svære infektioner.
English: It is initially given in two courses of treatment: a first course of 12 mg daily for 5 days, followed 12 months later by a second course of 12 mg daily for 3 days.
Danish: Det gives indledningsvist som to behandlingsforløb: et første forløb med 12 mg dagligt i 5 dage, efterfulgt af et andet forløb 12 måneder senere med 12 mg dagligt i 3 dage.
English: Patients involved in the two main studies were followed-up for at least four years in an extension study, during which they were given up to two additional doses of Lemtrada, at one-year intervals, if their disease progressed.
Danish: Der blev fulgt op på de deltagende patienter i de to hovedstudier i mindst 4 år i et forlængelsesstudie, hvor de fik op til to yderligere doser Lemtrada med et års mellemrum, hvis sygdommen forværredes.
English: Patients will receive a patient alert card and a guide explaining the risks with the medicine and symptoms of Lemtrada's serious side effects.
Danish: Patienterne modtager et patientinformationskort og en vejledning, der forklarer risiciene ved lægemidlet og symptomerne på alvorlige bivirkninger ved Lemtrada.
English: In the first study, the average number of relapses per year in patients given Lemtrada was less than half the number in patients given interferon beta-1a (0.18 versus 0.39), but there was no meaningful effect in terms of progression of disability.
Danish: I det første studie var det gennemsnitlige antal tilbagefald pr. år hos patienter, der fik Lemtrada, levere end halvdelen af antallet hos de patienter, som fik interferon beta-1a (0,18 mod 0,39), men der blev ikke observeret nogen betydelig virkning med hensyn til forværring af invaliditet.
English: In the second study, the average number of relapses per year in patients given Lemtrada was half the number in patients given interferon beta-1a (0.26 versus 0.52), and around 13% of patients given Lemtrada had a sustained progression of disability compared with around 21% of patients given interferon beta-1a.
Danish: I det anden studie var det gennemsnitlige antal tilbagefald pr. år hos de patienter, der fik Lemtrada, det halve af antallet hos de patienter, der fik interferon beta-1a (0,26 mod 0,52); og hos ca. 13 % af de patienter, der fik Lemtrada, fortsatte forværringen af invaliditet sammenlignet med ca. 21 % af de patienter, der fik interferon beta-1a.
English: How is Lemtrada used?
Danish: Hvordan anvendes Lemtrada?
English: The most common side effects with Lemtrada (which may affect more than 1 in 5 people) are rash, headache, fever and respiratory tract infections (throat and chest infections).
Danish: De hyppigste bivirkninger ved Lemtrada (som kan forekomme hos flere end 1 ud af 5 personer) er udslæt, hovedpine, feber og luftvejsinfektioner (i svælget og brystkassen).
English: It must not be used in patients with uncontrolled hypertension (high blood pressure), patients who have had arterial dissection (tears) of the cervicocephalic arteries (blood vessels in the head and neck), stroke, angina pectoris (pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart) or myocardial infarction (heart attack).
Danish: Det må ikke anvendes hos patienter med ukontrolleret hypertension (højt blodtryk), patienter, der har haft arteriedissektion (rifter) i de cervikale cerebrale arterier (blodkar i hoved og hals), slagtilfælde, angina pectoris (smerter i brystet, kæben og ryggen forårsaget af fysisk anstrengelse og på grund af problemer med blodtilstrømningen til hjertet) eller myokardieinfarkt (hjerteanfald).
English: Lemtrada has been studied in two main studies involving 1,421 patients with relapsing-remitting multiple sclerosis.
Danish: Der er gennemført to hovedstudier af Lemtrada hos 1.421 patienter med recidiverende-remitterende multipel sklerose.
English: Lemtrada must not be used in patients with coagulopathy (problems with blood clotting) or in patients who are taking anti-platelet or anti coagulant therapy.
Danish: Lemtrada må ikke anvendes hos patienter med koagulopati (problemer med blodstørkning) eller hos patienter, der får trombocythæmmende eller antikoagulerende behandling.
English: What benefits of Lemtrada have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Lemtrada?
English: In both studies, the main measure of effectiveness was based on the number of relapses the patients had each year and the progression of disability after two years of treatment.
Danish: Det primære mål for virkningen var i begge undersøgelser antallet af tilbagefald pr. år og forværringen af patienternes invaliditet efter 2 års behandling.
English: For the full list of side effects of Lemtrada, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Lemtrada fremgår af indlægssedlen.
English: The most important side effects with Lemtrada are autoimmune conditions (where the body's defence system attacks normal tissue), including thyroid gland disorders, immune thrombocytopenic purpura (a bleeding disorder caused by low blood platelet counts) and kidney damage, as well as low blood cell counts, reactions to the infusion and infections.
Danish: De vigtigste bivirkninger ved Lemtrada er autoimmune lidelser (hvor kroppens naturlige forsvar angriber normalt væv), herunder lidelser i skjoldbruskkirtlen, immunbetinget trombocytopenisk purpura (en blødningsforstyrrelse, der skyldes et lavt antal blodplader) og beskadigelse af nyrerne samt lavt antal røde og hvide blodlegemer, reaktioner på infusionen og infektioner.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Danish: Ved multipel sklerose opstår der fejl i immunsystemet (kroppens naturlige forsvar), som angriber dele af centralnervesystemet (hjernen, rygmarven og synsnerven [nerve, der sender signaler fra øjnene til hjernen]), og det medfører betændelse, der beskadiger nerverne og det beskyttende lag omkring dem.
English: How does Lemtrada work?
Danish: Hvordan virker Lemtrada?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lemtrada have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lemtrada.
English: Lemtrada is a medicine that is used to treat adults with relapsing-remitting multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves as well as the nerves themselves.
Danish: Lemtrada er et lægemiddel, der anvendes til behandling af voksne med recidiverende-remitterende multipel sklerose (MS), en sygdom, hvor betændelse beskadiger nerverne og det beskyttende lag omkring dem. Recidiverende-remitterende betyder, at patienten har tilbagefald (recidiver) mellem perioder med få eller ingen symptomer (remissioner).
English: It is available as tablets (100 mg).
Danish: Det fås som tabletter (100 mg).
English: The full EPAR for Lamivudine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lamivudine Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lamivudine Teva on 23 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lamivudine Teva den 23. oktober 2009.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lamivudine Teva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Lamivudine Teva skal anvendes.
English: Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Danish: Lamivudin forhindrer virusset i at danne dna og forebygger, at det formerer sig og spredes.
English: This is a summary of the European public assessment report (EPAR) for Lamivudine Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lamivudine Teva.
English: For more information about treatment with Lamivudine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lamivudine Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: If the hepatitis B virus can still be found in the blood after six months of treatment, the doctor should consider changing treatment to reduce the risk of resistance.
Danish: Hvis der stadig findes hepatitis B-virus i blodet efter seks måneders behandling, skal lægen overveje at ændre behandlingen for at mindske risikoen for resistens.
English: Other information about Lamivudine Teva
Danish: Andre oplysninger om Lamivudin Teva
English: It is used in patients with compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘alanine aminotransferase' [ALT] and signs of damage when liver tissue is examined under a microscope).
Danish: Det anvendes til patienter med kompenseret leversygdom (hvor leveren er beskadiget, men fungerer normalt) og hvor der endvidere er tegn på, at virusset stadig formerer sig, og hvor der er tegn på leverbeskadigelse (forhøjede mængder af leverenzymet ‘alanin-amino-transferase' [ALT] og tegn på beskadigelse ved mikroskopisk undersøgelse af levervævet).
English: This means that Lamivudine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zeffix.
Danish: Det betyder, at Lamivudin Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Zeffix.
English: What are the benefits and risks of Lamivudine Teva?
Danish: Hvilke fordele og risici er der forbundet med Lamivudin Teva?
English: Lamivudine Teva is a ‘generic medicine'.
Danish: Lamivudin Teva er et ‘generisk lægemiddel'.
English: Treatment with Lamivudine Teva should be initiated by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Lamivudine Teva is 100 mg once a day.
Danish: Behandling med Lamivudin Teva bør iværksættes af en læge, som har erfaring i behandling af kronisk hepatitis B. Den anbefalede dosis Lamivudine Teva er 100 mg en gang dagligt.
English: The CHMP concluded that, in accordance with EU requirements, Lamivudine Teva has been shown to have comparable quality and to be bioequivalent to Zeffix.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Lamivudine Teva er af sammenlignelig kvalitet og er bioækvivalent med Zeffix.
English: Lamivudine Teva is used to treat adult patients who have chronic (long term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus).
Danish: Lamivudin Teva anvendes til behandling af voksne patienter med kronisk (langvarig) hepatitis B (en leversygdom, der skyldes infektion med hepatitis B-virus.
English: EPAR summary for the public lamivudine
Danish: EPAR sammendrag for offentligheden lamivudin
English: Lamivudine interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Danish: Lamivudin påvirker virkningsmekanismen for et viralt enzym, dna-polymerase, som er involveret i dannelsen af viralt dna.
English: Because the hepatitis B virus can become resistant to Lamivudine Teva, the doctor should only consider prescribing Lamivudine Teva if other treatments that are less likely to lead to resistance cannot be used.
Danish: Fordi hepatitis B-virusset kan udvikle resistens over for Lamivudine Teva, bør lægen kun overveje ordinering af Lamivudine Teva, hvis det ikke er muligt at benytte andre behandlingsformer, som medfører en lavere risiko for resistens.
English: Lamivudine Teva is a medicine that contains the active substance lamivudine.
Danish: Lamivudin Teva er et lægemiddel, der indeholder det aktive stof lamivudin.
English: Patients infected with a virus that has the ‘YMDD mutation' (a change in the virus's DNA that is often found after treatment with lamivudine) should take Lamivudine Teva in combination with another medicine against hepatitis B. For more information, please see the Summary of Product Characteristics (also part of the EPAR).
Danish: Patienter, som er smittet med virus med den såkaldte ‘YMDD-mutation' (en ændring i virussets dna, der ofte ses efter behandling med lamivudin), skal tage Lamivudine Teva i kombination med et andet lægemiddel mod hepatitis B. De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: Therefore, the CHMP's view was that, as for Zeffix, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Zeffix.
English: Because Lamivudine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Danish: Da Lamivudin Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Lamivudine Teva, lamivudine, is an antiviral agent belonging to the class of the nucleoside analogues.
Danish: Det aktive stof i Lamivudin Teva, lamivudin, er et antiviralt stof, der tilhører gruppen af nukleosidanaloger.
English: The Committee recommended that Lamivudine Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Lamivudin Teva.
English: Because Lamivudine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Zeffix.
Danish: Da Lamivudin Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Zeffix.
English: Why has Lamivudine Teva been approved?
Danish: Hvorfor blev Lamivudin Teva godkendt?
English: The dose needs to be lowered for patients who have problems with their kidneys.
Danish: Patienter med nyreproblemer skal have en lavere dosis.
English: What is Lamivudine Teva?
Danish: Hvad er Lamivudin Teva?
English: How has Lamivudine Teva been studied?
Danish: Hvordan blev Lamivudin Teva undersøgt?
English: Lamivudine Teva is not suitable for patients who require doses below 100 mg.
Danish: Lamivudine Teva egner sig ikke for patienter, som har behov for doser under 100 mg. Behandlingens varighed afhænger af patientens tilstand og respons på behandlingen.
English: How is Lamivudine Teva used?
Danish: Hvordan anvendes Lamivudin Teva?
English: What is Lamivudine Teva used for?
Danish: Hvad anvendes Lamivudin Teva til?
English: How does Lamivudine Teva work?
Danish: Hvordan virker Lamivudin Teva?
English: It should be given twice a week for 12 weeks, and then once a week for 24 weeks.
Danish: Det skal indgives to gange om ugen i 12 uger og derefter en gang om ugen i 24 uger.
English: The patients were followed up for up to 10 years.
Danish: Patienterne blev fulgt i op til 10 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mepact on 6 March 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mepact den 6. marts 2009.
English: The dose of Mepact depends on the patient's height and weight.
Danish: Dosis af Mepact afhænger af patientens højde og vægt.
English: Mepact mifamurtide
Danish: Mepact mifamurtid
English: The main measure of effectiveness was the number of patients who survived without the disease coming back.
Danish: Det primære effektmål var antallet af patienter, som overlevede, uden at sygdommen vendte tilbage.
English: Half of the patients were also given Mepact.
Danish: Halvdelen af patienterne fik også Mepact.
English: This document is a summary of the European public assessment report (EPAR) for Mepact.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mepact.
English: The most common side effects with Mepact (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), loss of appetite, headache, dizziness, tachycardia (rapid heartbeat), hypertension (high blood pressure), hypotension (low blood pressure), dyspnoea (difficulty breathing), tachypnoea (rapid breathing), cough, vomiting, diarrhoea, constipation, abdominal pain (stomach ache), nausea, hyperhidrosis (excessive sweating), myalgia (muscle pain), arthralgia (joint pain), back pain, pain in extremity (the arms and legs), fever, chills, fatigue (tiredness), hypothermia (low body temperature), general pain, malaise (feeling unwell), asthenia (weakness) and chest pain.
Danish: De hyppigste bivirkninger ved Mepact (som optræder hos flere end 1 ud af 10 patienter) er anæmi (lavt antal røde blodceller), appetitløshed, hovedpine, svimmelhed, takykardi (hurtig hjertefrekvens) hypertension (højt blodtryk), hypotension (lavt blodtryk), dyspnø (vejrtrækningsbesvær), takypnø (hurtigt åndedræt), hoste, opkastning, diarré, forstoppelse, mavesmerter, kvalme, hyperhidrose (kraftig svedafsondring), myalgi (muskelsmerter), artralgi (ledsmerter), rygsmerter, smerter i ekstremiteter (arme og ben), feber, kulderystelser, træthed, hypotermi (lav legemstemperatur), generelle smerter, utilpashed, asteni (svækkelse) og brystsmerter.
English: Other information about Mepact:
Danish: Andre oplysninger om Mepact:
English: ‘High grade' means that the cancer is of a severe type, and ‘non-metastatic' means that it is at an early stage and has not spread far within the body.
Danish: "Højt differentieret" betyder, at kræften er af en alvorlig type, og "ikke-metastatisk" betyder, at den er på et tidligt stadium og ikke har bredt sig særligt meget i kroppen.
English: The study compared patients who were given Mepact with those who were not.
Danish: I undersøgelsen sammenlignede man patienter, som fik Mepact, med dem som ikke gjorde.
English: The risk of dying was also reduced by 28% in patients receiving Mepact.
Danish: Risikoen for at dø var desuden reduceret med 28 % hos de patienter, som fik Mepact.