FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee considered that Sancuso transdermal patch showed a similar benefit to granisetron taken by mouth but that it may have a slower onset of action.
Danish: Udvalget fandt, at Sancuso depotplaster havde samme fordele for patienterne som granisetron indtaget gennem munden, men at virkningen kan indtræde langsommere.
English: What is Sancuso?
Danish: Hvad er Sancuso?
English: While the reference medicine for Sancuso is Kytril taken by mouth, Sancuso is a patch applied to the skin.
Danish: Referencelægemidlet for Sancuso er Kytril, der indtages gennem munden.
English: What is Sancuso used for?
Danish: Hvad anvendes Sancuso til?
English: How has Sancuso been studied?
Danish: Hvordan blev Sancuso undersøgt?
English: The medicine can only be obtained with a prescription.
Danish: Gengivelse af indholdet heri er tilladt med kildeangivelse.
English: How is Sancuso used?
Danish: Hvordan anvendes Sancuso?
English: What benefit has Sancuso shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er forbundet med Sancuso?
English: The benefit of Sancuso in the prevention of nausea and vomiting caused by chemotherapy was investigated in one main study involving a total of 641 patients.
Danish: Der blev udført én hovedundersøgelse med i alt 641 patienter.
English: How does Sancuso work?
Danish: Hvordan virker Sancuso?
English: This was defined as having no vomiting or retching (strong involuntary contractions of the stomach with the urge to vomit), no more than mild nausea and no need to take other anti-emetic medicines for quick relief after receiving chemotherapy.
Danish: Desuden behøvede de ikke anden kvalmestillende medicin til at give hurtig lindring efter at have fået kemoterapi.
English: In addition, the company will ensure that the medicine is only provided from approved centres.
Danish: Virksomheden vil desuden sikre, at lægemidlet kun leveres fra godkendte centre.
English: Patients will also receive a guide and a card that they should carry with them.
Danish: Patienterne vil også modtage en vejledning og et kort, som de bør bære på sig.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
English: However, measures are in place to monitor such events through a registry of patients and a long-term study to assess patients' long-term outcomes.
Danish: Der er imidlertid iværksat foranstaltninger for at overvåge sådanne tilfælde ved hjælp af et patientregister og et langtidsstudie, som skal vurdere langtidseffekterne for patienterne.
English: Zynteglo has been given ‘conditional authorisation'.
Danish: Zynteglo har fået en "betinget godkendelse".
English: It is given as an infusion (drip) into a vein and the dose depends on the bodyweight of the patient.
Danish: Det gives som en infusion (drop) i en vene, og dosis afhænger af patientens legemsvægt.
English: This means that the patients can avoid the excessive build-up of iron that occurs with regular transfusions and which itself requires treatment.
Danish: Det betyder, at patienterne kan undgå den omfattende ophobning af jern, som opstår med regelmæssige transfusioner, og som i sig selv kræver behandling.
English: As a result, these patients have low red blood cell levels and need frequent blood transfusions.
Danish: Som følge heraf har disse patienter lave niveauer af røde blodlegemer og har brug for hyppige blodtransfusioner.
English: As for all medicines, data on the use of Zynteglo are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Zynteglo løbende overvåget.
English: Further information on Zynteglo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynteglo.
Danish: Yderligere information om Zynteglo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zynteglo.
English: Doctors should consider whether patients can be given the required pre-treatments needed before Zynteglo.
Danish: Læger bør overveje, om patienterne kan gives de nødvendige behandlinger, der kræves, inden Zynteglo gives.
English: Regarding safety, because Zynteglo is produced using a virus, there could be a theoretical risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Danish: Når det gælder sikkerheden kan der, da Zynteglo fremstilles ved hjælp af en virus, være en teoretisk risiko for kræft som følge af utilsigtede ændringer i det genetiske materiale, selvom der dog hidtil ikke er observeret sådanne tilfælde.
English: Although information on the safety of the medicine is limited because of the small number of patients treated to date and the lack of long-term data, the European Medicines Agency decided that Zynteglo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Selv om oplysningerne om sikkerheden ved lægemidlet er begrænsede på grund af det lille antal patienter, der hidtil er blevet behandlet, og manglen på langsigtede data, besluttede Det Europæiske Lægemiddelagentur, at fordelene ved Zynteglo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: There is also a potential risk of bleeding since the medicine may cause a drop in platelets.
Danish: Der er også en potentiel risiko for blødning, da lægemidlet kan mindske antallet af blodplader.
English: Beta thalassaemia is rare, and Zynteglo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 January 2013.
Danish: Beta-thalassæmi er sjælden, og Zynteglo blev udpeget som "lægemiddel til sjældne sygdomme" den 24. januar 2013.
English: An overview of Zynteglo and why it is authorised in the EU
Danish: En oversigt over Zynteglo, og hvorfor det er godkendt i EU
English: For more information about using Zynteglo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Zynteglo, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Zynteglo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zynteglo?
English: Other information about Zynteglo
Danish: Andre oplysninger om Zynteglo
English: Side effects reported with Zynteglo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Zynteglo vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Transfusion-dependent beta thalassaemia is a severe condition for which treatment options are limited.
Danish: Transfusionskrævende beta-thalassæmi er en alvorlig tilstand med begrænsede behandlingsmuligheder.
English: The company that markets Zynteglo will provide educational materials for healthcare professionals expected to use the medicine with information on its safety, including the potential risks of cancer and bleeding, and how it should be given.
Danish: Virksomheden, der markedsfører Zynteglo, vil levere informationsmateriale til sundhedspersoner, der forventes at bruge lægemidlet, med oplysninger om dets sikkerhed, herunder eventuelle risici for kræft og blødning, og hvordan det skal gives.
English: When these modified cells are given back to the patient, they are transported in the bloodstream to the bone marrow where they start to make healthy red blood cells that produce beta-globin.
Danish: Når disse modificerede celler gives tilbage til patienten, transporteres de via blodbanen til knoglemarven, hvor de begynder at fremstille sunde, røde blodlegemer, der producerer betaglobin.
English: A small number of patients have been treated with Zynteglo to date, and the most serious side effect observed is thrombocytopenia (low blood levels of platelets, components that help the blood to clot).
Danish: Et lille antal patienter er blevet behandlet med Zynteglo, og den alvorligste bivirkning er trombocytopeni (lavt antal blodplader, komponenter, der medvirker til at blodet størkner).
English: In these studies, out of the 14 patients who did not completely lack beta-globin and were given Zynteglo, 11 of them had sufficiently high levels of red blood cells so that they did not need blood transfusions for at least 1 year after treatment.
Danish: I disse studier havde 11 af de 14 patienter, der ikke helt manglede betaglobin, og som fik Zynteglo, tilstrækkeligt høje niveauer af røde blodlegemer, så de ikke havde brug for blodtransfusioner i mindst 1 år efter behandlingen.
English: The effects of Zynteglo are expected to last for the patient's lifetime.
Danish: Virkningen af Zynteglo forventes at vare resten af patientens liv.
English: Why is Zynteglo authorised in the EU?
Danish: Hvorfor blev Zynteglo godkendt i EU?
English: The company will also provide data from a registry of patients treated with Zynteglo to study its longterm safety and effectiveness, as well as further data on the tests used in the manufacturing of the medicine to ensure its quality.
Danish: Virksomheden vil også fremlægge oplysninger fra et register over patienter, der er behandlet med Zynteglo, for at undersøge lægemidlets sikkerhed og virkning på lang sigt samt yderligere oplysninger om de test, der anvendes ved fremstillingen af lægemidlet for at sikre dets kvalitet.
English: Since Zynteglo has been given conditional authorisation, the company that markets Zynteglo will provide results of ongoing studies to further assess the effectiveness and safety of the medicine.
Danish: Da Zynteglo har fået en betinget godkendelse, skal virksomheden, der markedsfører Zynteglo, indsende resultater af igangværende studier for yderligere at vurdere lægemidlets sikkerhed og virkning.
English: Zynteglo must not be used in pregnant or breastfeeding women, and in patients who have previously had gene therapy treatment (medicine that delivers genes).
Danish: Zynteglo må ikke anvendes til gravide eller ammende kvinder og til patienter, der tidligere har fået genterapi (lægemiddel, der tilfører gener).
English: Zynteglo is made individually for each patient out of stem cells collected from their blood, and must only be given to the patient for whom it is made.
Danish: Zynteglo fremstilles individuelt til hver patient af stamceller, der indsamles fra deres blod, og må kun gives til den patient, som det er fremstillet til.
English: People with this genetic condition cannot make enough beta-globin, a component of haemoglobin, the protein in red blood cells that carries oxygen around the body.
Danish: Personer med denne genetisk betingede sygdom kan ikke producere nok betaglobin, en bestanddel i hæmoglobin, som er det protein i de røde blodlegemer, der transporterer ilt rundt i kroppen.
English: What is Zynteglo and what is it used for?
Danish: Hvad er Zynteglo, og hvad anvendes det til?
English: Zynteglo has been shown to be effective at reducing the need for blood transfusion in 2 main studies in patients with beta thalassaemia who required regular blood transfusions.
Danish: Zynteglo har vist sig at være effektivt til at reducere behovet for blodtransfusion i 2 hovedstudier hos patienter med beta-thalassæmi, der krævede regelmæssige blodtransfusioner.
English: Studies show that with a one-time treatment with Zynteglo most patients no longer need blood transfusions to increase their levels of working red blood cells.
Danish: Studier viser, at efter en engangsbehandling med Zynteglo har de fleste patienter ikke længere brug for blodtransfusioner for at øge deres indhold af røde blodlegemer.
English: Zynteglo can only be obtained with a prescription and must be given in an approved centre by a doctor experienced in stem cell transplantation and in the treatment of beta thalassaemia.
Danish: Zynteglo udleveres kun efter recept og skal gives i et godkendt center af en læge med erfaring i stamcelletransplantation og i behandling af beta-thalassæmi.
English: Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) EMA/205979/2019
Danish: Zynteglo (autologe CD34+-celler, som koder βA-T87Qglobin-genet)
English: Zynteglo is used in patients who do not completely lack beta-globin and who are eligible for stem cell transplantation but do not have a matching related donor.
Danish: Zynteglo gives til patienter, der ikke helt mangler betaglobin, og som er egnede til stamcelletransplantation, men som ikke har en matchende donor.
English: Before Zynteglo is given, the patient will receive conditioning chemotherapy treatment to clear their bone marrow of cells.
Danish: Inden Zynteglo gives, vil patienten modtage konditionerende kemoterapi for at rense deres knoglemarv for celler.
English: What information is still awaited for Zynteglo?
Danish: Hvilke oplysninger afventes der stadig for Zynteglo?
English: What are the risks associated with Zynteglo?
Danish: Hvilke risici er der forbundet med Zynteglo?
English: Zynteglo is a medicine used to treat a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions.
Danish: Zynteglo er et lægemiddel til behandling af en blodsygdom, som kaldes beta-thalassæmi hos patienter, der er 12 år og derover, og som har brug for regelmæssige blodtransfusioner.
English: To make Zynteglo, the stem cells taken from the patient's blood are modified by a virus that carries working copies of the beta-globin gene into the cells.
Danish: For at fremstille Zynteglo ændres stamceller, der tages fra patientens blod, ved hjælp af en virus, der overfører kopier af betaglobin-genet til cellerne.
English: Zynteglo contains as its active substance stem cells taken from the patients that have been genetically modified to contain a working gene for beta-globin.
Danish: Zynteglo indeholder som aktivt stof stamceller fra patienten selv, som er blevet genetisk modificeret, så de indeholder et gen, der producerer betaglobin.
English: How is Zynteglo used?
Danish: Hvordan anvendes Zynteglo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynteglo have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Zynteglo.
English: What benefits of Zynteglo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zynteglo?
English: How does Zynteglo work?
Danish: Hvordan virker Zynteglo?
English: < 7 days (within a cycle)
Danish: < 7 dage (inden for en cyklus)
English: Date of first authorisation: 29 June 2017
Danish: Dato for første markedsføringstilladelse: 29. juni 2017
English: MedDRA System organ class Very common
Danish: MedDRA systemorganklasse Meget almindelig
English: In the clinical study, the sensitivity of some local tests was lower than the central laboratory test.
Danish: I det kliniske studie var sensitiviteten på visse lokale test lavere end den centrale laboratorietest.
English: Therefore only validated tests with demonstrated high sensitivity should be used.
Danish: Der skal derfor anvendes validerede test, som har demonstreret høj sensitivitet.
English: B-1930, Zaventem Belgium
Danish: B-1930, Zaventem Belgien
English: If you feel unusually tired (this is a very common side effect of BESPONSA), you should not drive or use machines.
Danish: Hvis du føler dig usædvanligt træt (dette er en meget almindelig bivirkning ved BESPONSA), bør du ikke køre eller betjene maskiner.
English: The reconstituted solution must be used immediately.
Danish: Den rekonstituerede opløsning skal bruges med det samme.
English: This belongs to a group of medicines that target cancer cells.
Danish: Det tilhører en gruppe lægemidler, som er målrettet kræftceller.
English: The infusion must be administered over 1 hour.
Danish: Infusionen skal administreres over 1 time.
English: a Infection also includes other types of infection (11%).
Danish: Infektion omfatter også andre typer infektion (11 %).
English: if you have certain side effects.
Danish: hvis du får visse bivirkninger.
English: Note: patients may have had > 1 type of infection.
Danish: Bemærk, at patienter kan have haft > 1 type infektion.
English: Subsequent cycles are 4 weeks in duration.
Danish: Efterfølgende cyklusser er af 4 ugers varighed.
English: There is no information on fertility in patients.
Danish: Der foreligger ingen information om fertiliteten hos patienter.
English: Preferred terms were retrieved by applying the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Danish: Foretrukne termer er anvendt i henhold til MedDRA (Medical Dictionary for Regulatory Activities) version 19.1.
English: The reconstituted solution must be clear to slightly cloudy, colourless, and essentially free of visible foreign matter.
Danish: Den rekonstituerede opløsning skal være klar til let uklar, farveløs og i det væsentlige fri for synlige fremmedlegemer.
English: • Your doctor will decide on the correct dose.
Danish: • Lægen vil fastsætte den korrekte dosis.
English: • Reduction in the number of various types of blood cells
Danish: • Et lavere antal af forskellige typer blodlegemer
English: Most effects were reversible to partially reversible except for effects in the liver and nervous system.
Danish: De fleste påvirkninger var reversible eller delvist reversible, undtagen påvirkningerne i leveren og nervesystemet.
English: • Filtration of the diluted solution is not required.
Danish: • Filtration af den fortyndede opløsning er ikke nødvendigt.
English: All events were Grade ≤ 2 in severity.
Danish: Alle hændelser havde en sværhedsgrad på ≤ 2.
English: You should not use BESPONSA during pregnancy, unless your doctor thinks that it is the best medicine for you.
Danish: Du må ikke få BESPONSA under graviditet, medmindre din læge mener, at det er det bedste lægemiddel for dig.
English: Contact your doctor immediately if you or your partner becomes pregnant during the period of treatment with this medicine.
Danish: Kontakt straks lægen, hvis du eller din partner bliver gravid under behandlingen med dette lægemiddel.
English: BESPONSA has moderate influence on the ability to drive and use machines.
Danish: BESPONSA har moderat indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer):
English: A stem cell transplant is a procedure to transplant another person's stem cells (cells which develop into new blood cells) into your bloodstream.
Danish: En stamcelletransplantation er et indgreb, hvor man transplanterer en anden persons stamceller (celler, som udvikler sig til nye blodlegemer) ind i din blodbane.
English: Myelosuppression/cytopenias
Danish: Myelosuppression/cytopeni
English: Potential hepatobiliary disease should be evaluated and treated according to standard medical practice.
Danish: Potentiel hepatobiliær sygdom skal vurderes og behandles i henhold til almindelig medicinsk praksis.
English: e 7-day treatment-free interval starting on Day 21.
Danish: 7 dages mellemrum uden behandling med start på dag 21.
English: These medicines are called antineoplastic agents.
Danish: Disse lægemidler kaldes antineoplastiske midler.
English: VOD/SOS was also reported in 18 patients after a subsequent HSCT.
Danish: VOD/SOS blev også indberettet hos 18 patienter efter en efterfølgende HSCT.
English: Lymphoblastic leukaemia cells have this protein.
Danish: Lymfoblastære leukæmiceller har dette protein.
English: BESPONSA must be reconstituted and diluted before administration.
Danish: BESPONSA skal rekonstitueres og fortyndes inden administration.
English: • Your doctor may change your dose, interrupt, or completely stop treatment with BESPONSA
Danish: • Lægen vil muligvis ændre din dosis, afbryde eller helt stoppe behandlingen med BESPONSA,
English: Omit the next dose within the cycle.
Danish: Udelad næste dosis i cyklussen.
English: The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2).
Danish: BESPONSAs sikkerhed og virkning blev evalueret i et enkeltarmet, åbent, multicenter fase 1/2-studie (Studie 2).
English: Tell your doctor immediately if you have signs and symptoms of any of the following serious side effects:
Danish: Fortæl det straks til lægen, hvis du bemærker symptomer på en eller flere af følgende alvorlige bivirkninger:
English: There are no data on the presence of inotuzumab ozogamicin or its metabolites in human milk, the effects on the breast-fed child, or the effects on milk production.
Danish: Der foreligger ingen data om udskillelse af inotuzumab ozogamicin eller dets metabolitter i human mælk, virkningerne på det ammede barn eller virkningerne på mælkeproduktionen.
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Danish: Med henblik på forbedring af sporbarheden af biologiske lægemidler bør navn og batchnummer på det administrerede produkt angives tydeligt i patientjournalen.
English: BESPONSA should not to be used in children and adolescents under 18 years of age because no data are available in this population.
Danish: BESPONSA må ikke bruges til børn og unge under 18 år, da der ikke foreligger nogen oplysninger om anvendelse til børn og unge.
English: Analysis was based on the ITT population with patients without remission being given a duration of zero and considered an event.
Danish: Analyse var baseret på ITT-populationen med patienter uden remission, der blev givet en varighed på nul og blev anset som en hændelse.
English: Acute lymphoblastic leukaemia is a cancer of blood where you have too many white blood cells.
Danish: Akut lymfoblastær leukæmi er kræft i blodet, hvor der er for mange hvide blodlegemer.
English: The 2 treatment groups were generally balanced with respect to the baseline demographics and disease characteristics.
Danish: De 2 behandlingsgrupper var generelt i overensstemmelse med hensyn til demografi og sygdomskarakteristika ved baseline.
English: What you need to know before you are given BESPONSA 3.
Danish: Det skal du vide, før du får BESPONSA 3.
English: Therefore, caution is recommended when driving or operating machines.
Danish: Derfor anbefales det at være forsigtig, når man fører motorkøretøj eller betjener maskiner.
English: Decreased appetite (12%)
Danish: Nedsat appetit (12 %)
English: BESPONSA should not be administered as an intravenous push or bolus.
Danish: BESPONSA må ikke administreres som intravenøst push eller bolus.
English: If the dose is reduced due to BESPONSA-related toxicity, the dose should not be re-escalated.
Danish: Hvis dosis nedsættes pga. toksicitet, der er relateret til BESPONSA, må dosis ikke sættes op igen.
English: Dosing regimen for Cycle 1 All patients:
Danish: Doseringsregime for cyklus 1 Alle patienter:
English: The median time from HSCT to onset of VOD/SOS was 15 days (range: 3-57 days).
Danish: Den gennemsnitlige tid fra HSCT til indtræden af VOD/SOS var 15 dage (interval: 3-57 dage).
English: This risk was most marked in patients who underwent subsequent HSCT.
Danish: Risikoen var mest markant hos patienter, der efterfølgende fik HSCT.
English: BESPONSA must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus.
Danish: BESPONSA må ikke anvendes under graviditet, medmindre den mulige fordel for moderen opvejer den mulige risiko for fosteret.
English: This procedure may take place if your disease responds completely to treatment.
Danish: Du kan få dette indgreb udført, hvis din sygdom reagerer optimalt på behandlingen.
English: The safety and efficacy of BESPONSA in children aged 0 to <18 years have not been established.
Danish: BESPONSAs sikkerhed og virkning i hos børn 0-18 år er ikke klarlagt.