FrancophonIA/ELRC3.0 huggingface dataset:
English: • You will be given a diary to help you keep track of the number of tablets you need to take during the titration phase.
Danish: • Du får en dagbog til at hjælpe dig med at holde styr på det antal tabletter, som du skal tage i titreringsfasen.
English: • Before prescribing Uptravi, healthcare professionals must register with the company's controlled access system.
Danish: • Før sundhedspersoner kan ordinere Uptravi, skal de registreres i virksomhedens adgangskontrolsystem.
English: • Uptravi is available as tablets in different strengths (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Danish: • Uptravi fås som tabletter i forskellige styrker (200, 400, 600, 800, 1 000, 1 200, 1 400 og 1 600 mikrogram).
English: • If during titration it is difficult to tolerate certain side effects, your doctor may reduce the dose by reducing the number of tablets that you take.
Danish: • Hvis du under titreringen oplever bivirkninger, som du har svært ved at tåle, kan lægen sætte dosen ned ved at reducere det antal tabletter, som du skal tage.
English: The diary contains for each strength two boxes for each day of treatment, one for the morning dose and one for the evening dose.
Danish: Dagbogen indeholder for hver styrke to felter for hver dag i behandlingen (én for morgendosen og én for aftendosen).
English: Once a maintenance dose has been established, a different strength may be prescribed so that the patient takes only a single tablet twice daily.
Danish: Når en vedligeholdelsesdosis er fastlagt, kan der udskrives en ny styrke, så patienten kan nøjes med at tage én tablet to gange dagligt.
English: • Once a suitable dose for you has been established (known as the maintenance dose), the doctor may prescribe a different strength of Uptravi tablet so you only need to take one tablet in the morning and one in the evening to get the right amount of the medicine.
Danish: • Når den dosis, der passer til dig, er blevet fastlagt ("vedligeholdelsesdosen"), kan din læge udskrive en anden styrke af Uptravi-tabletter, så du kan nøjes med at tage én tablet om morgenen og én om aftenen for at få den rette mængde medicin.
English: The diary contains for each day and each strength two boxes for the patient to mark the number of tablets they take in the morning and evening.
Danish: Dagbogen indeholder for hver dag og hver styrke to felter, hvor patienten kan notere det antal tabletter, som han/hun tager morgen og aften.
English: If side effects are manageable after stepping down the dose, your doctor may decide that you should stay on that dose.
Danish: Hvis du bedre kan klare bivirkningerne efter nedsættelsen af dosen, kan lægen vurdere, at du skal blive på denne dosis.
English: Use these boxes to write down the number of tablets you take.
Danish: Brug disse felter til at notere det antal tabletter, som du tager.
English: If the patient does not tolerate the dose, the doctor may decrease the dose.
Danish: Hvis patienten ikke tåler dosen, kan lægen nedsætte den.
English: During the titration phase only the 200 and 800 microgram strengths are used.
Danish: I titreringsfasen anvendes kun styrkerne 200 mikrogram og 800 mikrogram.
English: Once a maintenance dose is established, the other strengths can be used to allow patients to take only one tablet in the morning and one in the evening, instead of multiple tablets each time.
Danish: Når vedligeholdelsesdosen er fastlagt, giver de andre styrker patienten mulighed for at nøjes med én tablet morgen og aften i stedet for at skulle tage flere tabletter hver gang.
English: Use the diary boxes corresponding to the strength of tablets you take.
Danish: Brug de felter i dagbogen, der svarer til den tabletstyrke, som du skal tage.
English: If patients do not tolerate the dose, the dose may be decreased to the previous step.
Danish: Hvis patienten ikke tåler dosen, kan den sættes ned til det forrige niveau.
English: • If you have any questions regarding your treatment, please contact your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: • When prescribing Uptravi, healthcare professionals should follow the instructions provided in the summary of product characteristics and the educational material for Uptravi (brochure).
Danish: • De ordinerende læger skal følge vejledningen i produktresuméet og informationsbrochuren for Uptravi.
English: Treatment should be started at a dose of 200 micrograms twice a day, in the morning and in the evening.
Danish: Behandlingen bør startes med en dosis på 200 mikrogram to gange dagligt (morgen og aften).
English: During titration, the 200 and 800 micrograms strengths are used.
Danish: I titreringsfasen anvendes styrkerne 200 mikrogram og 800 mikrogram.
English: If you do not tolerate the dose, the doctor may decrease the dose to the previous step.
Danish: Hvis du ikke tåler dosen, kan lægen sætte den ned til det forrige niveau.
English: • You will start treatment with one 200 microgram tablet twice a day, in the morning and in the evening (approximately 12 hours apart).
Danish: • Til at starte med får du én tablet på 200 mikrogram to gange dagligt (morgen og aften med ca. 12 timers mellemrum).
English: In this case you should refer to the following diary page to help you keep track of the number of tablets you need to take:
Danish: Du skal nu anvende den følgende side i dagbogen for at holde styr på det antal tabletter, som du skal tage.
English: • If you tolerate this dose, your doctor will then increase your dose usually every week by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily as detailed in the following diagram:
Danish: • Hvis du tåler denne dosis, vil lægen øge den én gang om ugen med 200 mikrogram morgen og aften, op til en maksimal dosis på 1 600 mikrogram to gange dagligt som vist i følgende diagram:
English: • If the patient tolerates the dose, the dose can be increased weekly by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily.
Danish: • Hvis patienten tåler dosen, kan dosen øges én gang om ugen med 200 mikrogram morgen og aften, op til en maksimal dosis på 1 600 mikrogram to gange dagligt.
English: If the patient tolerates the dose, the doctor may increase the dose every week by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily.
Danish: Hvis patienten tåler dosen, kan lægen øge den ugentligt med 200 mikrogram morgen og aften, op til en maksimal dosis på 1 600 mikrogram to gange dagligt.
English: Treatment may be interrupted or stopped altogether in case of certain side effects.
Danish: Behandlingen kan afbrydes eller helt standses i tilfælde af visse bivirkninger.
English: This was switched to a full marketing authorisation on 18 June 2018.
Danish: Dette blev ændret til en fuldgyldig markedsføringstilladelse den 18. juni 2018.
English: Blincyto received a conditional marketing authorisation valid throughout the EU on 23 November 2015.
Danish: Blincyto fik en betinget markedsføringstilladelse med gyldighed i hele EU den 23. november 2015.
English: Patients will also be provided with a patient alert card.
Danish: Patienterne vil også få udleveret et patientkort.
English: As for all medicines, data on the use of Blincyto are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Blincyto løbende overvåget.
English: Blincyto was given ‘conditional approval' but the company has provided more evidence about the medicine and the Agency has recommended that the Blincyto's marketing authorisation should no longer be conditional.
Danish: Blincyto fik en "betinget godkendelse", men virksomheden har fremlagt mere dokumentation om lægemidlet, og agenturet har anbefalet, at markedsføringstilladelsen for Blincyto ikke længere bør være betinget.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/en/medicines/human/orphan-designations.
English: What measures are being taken to ensure the safe and effective use of Blincyto?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Blincyto?
English: The study found that ALL improved in 43% (81 out of 189) of patients given Blincyto.
Danish: Studiet viste, at ALL bedredes hos 43 % (81 ud af 189) af de Blincyto-behandlede patienter.
English: Blincyto has also been studied in a main study in 116 patients with minimal residual disease.
Danish: Blincyto er også blevet undersøgt i et hovedstudie med 116 patienter med minimal residual sygdom.
English: Patients lived for an average of around 6 months before the cancer came back, which could enable suitable patients to have a blood stem cell transplant.
Danish: Patienterne levede i gennemsnit ca. 6 måneder, før kræften vendte tilbage, hvilket kunne gøre det muligt for egnede patienter at få en blodstamcelletransplantation.
English: ALL is rare, and Blincyto was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Danish: ALL er sjælden, og Blincyto blev udpeget som "lægemiddel til sjældne sygdomme" den 24. juli 2009.
English: Other information about Blincyto
Danish: Andre oplysninger om Blincyto
English: It also attaches to a protein (CD3) on T cells (another type of white blood cell).
Danish: Det binder også til et protein (CD3) på T-celler (en anden type hvide blodlegemer).
English: For more information about using Blincyto, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Blincyto, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Results showed that around 78% of patients did not have measurable residual cancer cells after treatment with Blincyto.
Danish: Resultaterne viste, at ca. 78 % af patienterne ikke havde målelige tilbageværende kræftceller efter behandling med Blincyto.
English: Side effects reported with Blincyto are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Blincyto vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Further information on Blincyto can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/blincyto.
Danish: Yderligere information om Blincyto findes på agenturets websted under: ema.europa.eu/medicines/Human/EPAR/blincyto.
English: The safety profile of Blincyto was considered acceptable provided that recommendations on its use are observed.
Danish: Blincytos sikkerhedsprofil vurderedes til at være acceptabel, forudsat at anbefalingerne vedrørende lægemidlets anvendelse overholdes.
English: An overview of Blincyto and why it is authorised in the EU
Danish: En oversigt over Blincyto, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Blincyto'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 Blincyto opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The company that markets Blincyto will provide data from two studies looking at the safety and use of Blincyto in clinical practice.
Danish: Virksomheden, der markedsfører Blincyto, skal fremlægge data fra to studier om sikkerheden ved og anvendelsen af Blincyto i klinisk praksis.
English: Patients who have no signs of cancer after 2 cycles may be treated with up to 3 additional cycles of Blincyto if the benefits outweigh the risks for the patient.
Danish: Patienter, der ikke har tegn på kræft efter 2 behandlingscyklusser, kan behandles med op til 3 yderligere cyklusser med Blincyto, hvis fordelene opvejer risiciene for patienten.
English: Blincyto must not be given to breastfeeding women.
Danish: Blincyto må ikke gives til kvinder, der ammer.
English: For treatment of patients with minimal residual disease, the dose depends on the patient's bodyweight.
Danish: Ved behandling af patienter med minimal residual sygdom afhænger dosis af patientens kropsvægt.
English: Patients should also be given chemotherapy medicines injected in the spine area to prevent leukaemia in the nervous system.
Danish: Patienterne skal desuden have kemoterapeutiske lægemidler indsprøjtet i området omkring rygsøjlen for at forhindre leukæmi i nervesystemet.
English: Blincyto can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.
Danish: Blincyto udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af patienter med blodkræft.
English: In most patients whose ALL improved, there was no evidence of cancer cells left.
Danish: Hos størstedelen af de patienter, hos hvem ALL bedredes, var der ingen tegn på, at der var kræftceller tilbage.
English: The most common side effects with Blincyto (which may affect more than 1 in 10 people) are infections, fever, infusion-related reactions (like fever, changes in blood pressure and rash), headache, febrile neutropenia (low levels a type of white blood cell counts called neutrophils with fever), anaemia (low red blood cell counts), oedema (swelling because of fluid retention), neutropenia, leukopenia (low levels of white blood cell), thrombocytopenia (low platelet count), blood tests showing changes in liver function, tremor (shaking), back pain, chills, low blood pressure, low levels of immunoglobulins (antibodies), cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), rapid heartbeat, insomnia (difficulty sleeping), pain in the arms and legs, cough and rash.
Danish: De hyppigste bivirkninger ved Blincyto (som optræder hos mere end 1 ud af 10 patienter) er infektioner, feber, infusionsrelaterede reaktioner (f.eks. feber, ændret blodtryk og udslæt), hovedpine, febril neutropeni (lavt antal af en type hvide blodlegemer kaldet neutrofiler med feber), blodmangel (lavt antal røde blodlegemer), ødem (hævelse på grund af væskeophobning), neutropeni, leukopeni (lavt antal hvide blodlegemer), trombocytopeni (lavt antal blodplader), ændringer i leverfunktionen, som kan ses i blodprøver, skælven, rygsmerter, kulderystelser, lavt blodtryk, lavt niveau af immunglobuliner (antistoffer), cytokinfrigivelsessyndrom (en potentielt livstruende tilstand, der kan forårsage feber, opkastning, åndenød, smerter og lavt blodtryk), hurtig hjerterytme, søvnbesvær, smerter i arme og ben, hoste og udslæt.
English: The most serious side effects were infections, neutropenia with or without fever, neurological events (such as confusion, shaking, dizziness, numbness or tingling), cytokine release syndrome, and tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Danish: De alvorligste bivirkninger var infektioner, neutropeni med eller uden feber, neurologiske hændelser (f.eks. forvirring, skælven, svimmelhed, følelsesløshed eller snurren), cytokinfrigivelsessyndrom og tumorlysesyndrom (en komplikation forårsaget af nedbrydningen af kræftceller).
English: The active substance in Blincyto, blinatumomab, is an antibody that has been designed to attach to a protein (CD19) found on B cells, including ALL cells.
Danish: Det aktive stof i Blincyto, blinatumomab, er et antistof, der er designet til at binde til et protein (CD19), som findes på B-celler, herunder ALL-celler.
English: Why is Blincyto authorised in the EU?
Danish: Hvorfor blev Blincyto godkendt i EU?
English: Blincyto is infused continuously during a treatment cycle of 4 weeks.
Danish: Blincyto gives som en kontinuerlig infusion under et 4-ugers behandlingsforløb.
English: Patients were given Blincyto for up to 5 treatment cycles.
Danish: Patienterne fik Blincyto i op til 5 behandlingscyklusser.
English: What is Blincyto and what is it used for?
Danish: Hvad er Blincyto, og hvad anvendes det til?
English: For treatment of relapsed or refractory B-precursor ALL, the dose depends on the patient's bodyweight.
Danish: Til behandling af recidiveret eller refraktær B-prækursor-ALL afhænger dosis af patientens kropsvægt.
English: Before receiving Blincyto, patients should be given medicines to prevent fever and reactions to the infusion.
Danish: Før Blincyto indgives, bør patienterne have lægemidler, der forebygger feber og infusionsreaktioner.
English: What are the risks associated with Blincyto?
Danish: Hvilke risici er der forbundet med Blincyto?
English: Blincyto contains the active substance blinatumomab and is used on its own.
Danish: Blincyto indeholder det aktive stof blinatumomab og anvendes som enkeltstofbehandling.
English: Patients may be treated for up to 3 additional treatment cycles, each one given after a 2-week treatment-free interval.
Danish: Patienter kan behandles i op til 3 ekstra behandlingscyklusser, hvor hver gives efter en pause på 2 uger uden behandling.
English: Each cycle of treatment is separated by a 2-week treatment-free interval.
Danish: Hver behandlingscyklus adskilles af en pause på 2 uger uden behandling.
English: In B-precursor ALL, certain cells that give rise to B cells (a type of white blood cell) multiply too quickly and eventually these abnormal cells replace normal blood cells.
Danish: Ved B-prækursor-ALL ses for hurtig formering af bestemte celler, der danner B-celler (en type hvide blodlegemer), og disse unormale celler erstatter efterhånden de normale blodlegemer.
English: Blincyto is used in patients who are ‘Philadelphia-chromosome-negative' which means that the patients' cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).
Danish: Blincyto anvendes hos såkaldte Philadelphia-kromosom-negative patienter, dvs. patienter, hvis kræftceller ikke har det unormale kromosom Philadelphia-kromosomet, samt hos CD19-positive patienter, dvs. patienter, der har proteinet CD19 på kræftcellerne.
English: Blincyto is also used in adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body).
Danish: Blincyto anvendes også hos voksne, som er blevet behandlet for B-prækursor-ALL, og som har minimal residual sygdom (hvilket betyder, at de stadig har påviselige kræftceller i kroppen).
English: In this study, Blincyto was not compared with any other treatment.
Danish: I dette studie blev Blincyto ikke sammenlignet med nogen anden behandling.
English: The company will also provide patients and healthcare professionals with educational materials on how to give Blincyto and how to manage risks with the medicine.
Danish: Virksomheden skal også sørge for informationsmateriale til patienter og sundhedspersoner med oplysninger om, hvordan Blincyto indgives, og hvordan risiciene ved lægemidlet håndteres.
English: Blincyto therefore acts as a ‘bridge' bringing T cells and B cells together and causing the T cells to release substances that eventually kill the cancerous B cells.
Danish: Det betyder, at Blincyto fungerer som en "bro", der bringer T-celler og B-celler sammen og får Tcellerne til at frigive stoffer, som efterhånden dræber de kræftramte B-celler.
English: The main measure of effectiveness was based on the percentage of patients whose ALL improved after 2 treatment cycles, measured as resolution of signs of leukaemia and complete or partial return of blood cell counts to normal.
Danish: Virkningen blev hovedsageligt målt på procentdelen af patienter, hvis ALL bedredes efter 2 behandlingscyklusser, vurderet ud fra tegn på, at leukæmien var svundet, og at blodcelletallene var blevet helt eller delvist normale.
English: Blincyto is given by infusion (drip) into a vein using a pump device.
Danish: Blincyto indgives ved infusion (drop) i en vene med en pumpe.
English: The Agency noted that Blincyto is beneficial for high-risk adults and children with Philadelphia-chromosome-negative B-precursor ALL who have few therapeutic options and who generally have a poor prognosis.
Danish: Agenturet bemærkede, at Blincyto er gavnligt for højrisikopatienter (voksne og børn) med Philadelphia-kromosom-negativ B-prækursor-ALL, der har få behandlingsmuligheder og generelt en dårlig prognose.
English: Blincyto is also effective at removing residual cancer cells in adults who have been treated for B-precursor ALL and who are at high risk of the cancer coming back.
Danish: Blincyto er også effektivt til at fjerne tilbageværende kræftceller hos voksne, der er blevet behandlet for B-prækursor-ALL, og som er i høj risiko for, at kræften vender tilbage.
English: In the study, Blincyto was not compared with any other treatment.
Danish: I studiet blev Blincyto ikke sammenlignet med nogen anden behandling.
English: A study in 70 children aged 1 year and above with Philadelphia-chromosome-negative B-precursor ALL found that in 33% of patients treatment with Blincyto led to a resolution of the disease.
Danish: Et studie med 70 børn i alderen 1 år og derover med Philadelphia-kromosom-negativ B-prækursor-ALL viste, at sygdommen forsvandt hos 33 % af de Blincyto-behandlede patienter.
English: How is Blincyto used?
Danish: Hvordan anvendes Blincyto?
English: For the full list of side effects of Blincyto, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Blincyto fremgår af indlægssedlen.
English: Blincyto is a medicine used to treat a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory).
Danish: Blincyto er et lægemiddel til behandling af en type blodkræft, der kaldes B-celle-prækursor akut lymfoblastisk leukæmi (ALL) hos patienter i alderen 1 år og derover, når sygdommen er vendt tilbage (recidiveret) eller ikke er bedret ved tidligere behandling (refraktær).
English: Blincyto has been studied in one main study in 189 Philadelphia-chromosome-negative adults with Bprecursor ALL whose leukaemia had come back or had not improved with treatment.
Danish: Blincyto er blevet undersøgt i ét hovedstudie med 189 patienter med Philadelphia-kromosom-negativ B-prækursor-ALL, hos hvem leukæmien var vendt tilbage eller ikke var bedret ved tidligere behandling.
English: How does Blincyto work?
Danish: Hvordan virker Blincyto?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Blincyto 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 Blincyto.
English: What benefits of Blincyto have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Blincyto?
English: Sweden Medical Valley Invest AB
Danish: Medical Valley Invest AB
English: Active Substance
Danish: Aktivt stof
English: Annex I List of nationally authorised medicinal products and marketing authorisation applications
Danish: Bilag I Liste over nationalt godkendte lægemidler og ansøgninger om markedsføringstilladelse
English: Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation
Danish: BILAG IB: Lægemidler, for hvilke markedsføringstilladelser anbefales til suspendering og ansøgninger om markedsføringstilladelser, som ikke imødekommer kriterierne for godkendelse
English: Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established
Danish: Bilag IA: Lægemidler, der er anbefalet til opretholdelse, og ansøgninger om markedsføringstilladelse for hvilke bioækvivalens med EUreferencelægemidlet er blevet fastlagt
English: Bristol Laboratories Limited
Danish: Storbritannien Bristol Laboratories Limited
English: Brown & Burk UK Limited
Danish: Storbritannien Brown & Burk UK Limited