natgillin/translations-raw huggingface dataset:
Det aktive stof i Sancuso, granisetron, er en “5-5HT3-receptorantagonist”. 
The active substance in Sancuso, granisetron, is a ‘5HT3 antagonist'.
Sancuso er et “hybridt generisk lægemiddel”. 
Sancuso is a ‘hybrid generic medicine'.
Plasteret kan blive siddende på huden i op til syv dage afhængigt af kemoterapiens varighed, og man skal vente med at fjerne det til mindst 24 timer efter at kemoterapien er afsluttet. 
The patch can remain on the skin for up to seven days depending on the duration of the chemotherapy, and it is removed a minimum of 24 hours after completing chemotherapy.
Sancuso bør ikke anvendes hos personer, der er overfølsomme (allergiske) over for granisetron, andre 5HT3-receptorantagonister eller andre af indholdsstofferne. 
Sancuso must not be used in people who are hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.
CHMP afgjorde derfor, at fordelene ved Sancuso overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Sancuso. 
Therefore, the CHMP decided that Sancuso's benefits are greater than its risks and recommended that it be given marketing authorisation.
Sancuso er et lægemiddel, der indeholder det aktive stof granisetron. 
Sancuso is a medicine that contains the active substance granisetron.
Patienterne var i kemoterapi, som medførte moderat eller stærk kvalme og opkastning i flere dage. 
These patients were receiving chemotherapy which was a moderate or strong trigger of nausea and vomiting, lasting for several days.
CHMP fandt alligevel, at Sancuso vil være til fordel for patienter, der har vanskeligt ved at synke og derfor ellers må have intravenøse indsprøjtninger hver dag. 
The CHMP considered however that Sancuso would be of benefit for patients with difficulty swallowing, who might otherwise need to be given daily intravenous injections.
Det anvendes til at forebygge kvalme og opkastning forårsaget af forskellige former for kemoterapi (lægemidler mod kræft), der giver moderat eller kraftig kvalme og opkastninger. 
It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Behandlingens virkning blev hovedsagelig bedømt på det antal patienter, der fik bragt deres kvalme eller opkastninger under kontrol. 
The main measure of effectiveness was the number of patients who had their nausea and vomiting under control.
Sancuso blokerer disse receptorer og forhindrer derved kvalme og opkastning, der ofte optræder efter visse typer kemoterapi. 
By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.
Størstedelen af bivirkningerne var lette til moderate. 
The majority of adverse reactions were mild or moderate in severity.
I undersøgelsen sammenlignedes Sancuso depotplaster, der blev båret i syv dage, med granisetron, der blev indtaget gennem munden en gang dagligt i kemoterapibehandlingens varighed. 
The study compared one Sancuso transdermal patch worn over seven days with granisetron taken by mouth once a day for the duration of the chemotherapy.
Hvilken risiko er der forbundet med Sancuso? 
What is the risk associated with Sancuso?
Hvorfor blev Sancuso godkendt? 
Why has Sancuso been approved?
Den fuldstændige liste over indberettede bivirkninger med Sancuso fremgår af indlægssedlen. 
For the full list of all side effects reported with Sancuso, see the package leaflet.
Plasteret sættes på tør, ren, sund hud på ydersiden af overarmen. 
The patch is applied to dry, clean, healthy skin on the outer part of the upper arm or if this is not possible, it may be applied to the abdomen.
Sancuso anvendes kun til voksne, som har vanskeligt ved at synke medicin og får kemoterapi af 3 til 5 dages varighed Lægemidlet udleveres kun efter recept. 
Sancuso is only used in adults who would have difficulty swallowing medicines and when the chemotherapy lasts from three to five days.
Sancuso er et “antiemetikum”, dvs. et lægemiddel mod kvalme og opkastninger. 
Sancuso is an ‘anti-emetic', a medicine that prevents nausea (feeling sick) and vomiting.
Udvalget fandt, at Sancuso depotplaster havde samme fordele for patienterne som granisetron indtaget gennem munden, men at virkningen kan indtræde langsommere. 
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.
Hvad er Sancuso? 
What is Sancuso?
Referencelægemidlet for Sancuso er Kytril, der indtages gennem munden. 
While the reference medicine for Sancuso is Kytril taken by mouth, Sancuso is a patch applied to the skin.
Hvad anvendes Sancuso til? 
What is Sancuso used for?
Hvordan blev Sancuso undersøgt? 
How has Sancuso been studied?
Gengivelse af indholdet heri er tilladt med kildeangivelse. 
The medicine can only be obtained with a prescription.
Hvordan anvendes Sancuso? 
How is Sancuso used?
Hvilken fordel viser undersøgelserne, at der er forbundet med Sancuso? 
What benefit has Sancuso shown during the studies?
Der blev udført én hovedundersøgelse med i alt 641 patienter. 
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.
Hvordan virker Sancuso? 
How does Sancuso work?
Desuden behøvede de ikke anden kvalmestillende medicin til at give hurtig lindring efter at have fået kemoterapi. 
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.
Virksomheden vil desuden sikre, at lægemidlet kun leveres fra godkendte centre. 
In addition, the company will ensure that the medicine is only provided from approved centres.
Patienterne vil også modtage en vejledning og et kort, som de bør bære på sig. 
Patients will also receive a guide and a card that they should carry with them.
Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091. 
Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
Der er imidlertid iværksat foranstaltninger for at overvåge sådanne tilfælde ved hjælp af et patientregister og et langtidsstudie, som skal vurdere langtidseffekterne for patienterne. 
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.
Zynteglo har fået en "betinget godkendelse". 
Zynteglo has been given ‘conditional authorisation'.
Det gives som en infusion (drop) i en vene, og dosis afhænger af patientens legemsvægt. 
It is given as an infusion (drip) into a vein and the dose depends on the bodyweight of the patient.
Det betyder, at patienterne kan undgå den omfattende ophobning af jern, som opstår med regelmæssige transfusioner, og som i sig selv kræver behandling. 
This means that the patients can avoid the excessive build-up of iron that occurs with regular transfusions and which itself requires treatment.
Som følge heraf har disse patienter lave niveauer af røde blodlegemer og har brug for hyppige blodtransfusioner. 
As a result, these patients have low red blood cell levels and need frequent blood transfusions.
Som for alle lægemidler er data vedrørende brug af Zynteglo løbende overvåget. 
As for all medicines, data on the use of Zynteglo are continuously monitored.
Yderligere information om Zynteglo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zynteglo. 
Further information on Zynteglo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynteglo.
Læger bør overveje, om patienterne kan gives de nødvendige behandlinger, der kræves, inden Zynteglo gives. 
Doctors should consider whether patients can be given the required pre-treatments needed before Zynteglo.
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. 
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.
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. 
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.
Der er også en potentiel risiko for blødning, da lægemidlet kan mindske antallet af blodplader. 
There is also a potential risk of bleeding since the medicine may cause a drop in platelets.
Beta-thalassæmi er sjælden, og Zynteglo blev udpeget som "lægemiddel til sjældne sygdomme" den 24. januar 2013. 
Beta thalassaemia is rare, and Zynteglo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 January 2013.
En oversigt over Zynteglo, og hvorfor det er godkendt i EU 
An overview of Zynteglo and why it is authorised in the EU
For mere information om brug af Zynteglo, se indlægssedlen, eller kontakt lægen eller apotekspersonalet. 
For more information about using Zynteglo, see the package leaflet or contact your doctor or pharmacist.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zynteglo? 
What measures are being taken to ensure the safe and effective use of Zynteglo?
Andre oplysninger om Zynteglo 
Other information about Zynteglo
Bivirkninger rapporteret for Zynteglo vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Zynteglo are carefully evaluated and any necessary action taken to protect patients.
Transfusionskrævende beta-thalassæmi er en alvorlig tilstand med begrænsede behandlingsmuligheder. 
Transfusion-dependent beta thalassaemia is a severe condition for which treatment options are limited.
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. 
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.
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. 
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.
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). 
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).
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. 
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.
Virkningen af Zynteglo forventes at vare resten af patientens liv. 
The effects of Zynteglo are expected to last for the patient's lifetime.
Hvorfor blev Zynteglo godkendt i EU? 
Why is Zynteglo authorised in the EU?
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. 
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.
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. 
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.
Zynteglo må ikke anvendes til gravide eller ammende kvinder og til patienter, der tidligere har fået genterapi (lægemiddel, der tilfører gener). 
Zynteglo must not be used in pregnant or breastfeeding women, and in patients who have previously had gene therapy treatment (medicine that delivers genes).
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. 
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.
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. 
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.
Hvad er Zynteglo, og hvad anvendes det til? 
What is Zynteglo and what is it used for?
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. 
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.
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. 
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.
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. 
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.
Zynteglo (autologe CD34+-celler, som koder βA-T87Qglobin-genet) 
Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) EMA/205979/2019
Zynteglo gives til patienter, der ikke helt mangler betaglobin, og som er egnede til stamcelletransplantation, men som ikke har en matchende donor. 
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.
Inden Zynteglo gives, vil patienten modtage konditionerende kemoterapi for at rense deres knoglemarv for celler. 
Before Zynteglo is given, the patient will receive conditioning chemotherapy treatment to clear their bone marrow of cells.
Hvilke oplysninger afventes der stadig for Zynteglo? 
What information is still awaited for Zynteglo?
Hvilke risici er der forbundet med Zynteglo? 
What are the risks associated with Zynteglo?
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. 
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.
For at fremstille Zynteglo ændres stamceller, der tages fra patientens blod, ved hjælp af en virus, der overfører kopier af betaglobin-genet til cellerne. 
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.
Zynteglo indeholder som aktivt stof stamceller fra patienten selv, som er blevet genetisk modificeret, så de indeholder et gen, der producerer betaglobin. 
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.
Hvordan anvendes Zynteglo? 
How is Zynteglo used?
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. 
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.
Hvilke fordele viser studierne, at der er ved Zynteglo? 
What benefits of Zynteglo have been shown in studies?
Hvordan virker Zynteglo? 
How does Zynteglo work?
< 7 dage (inden for en cyklus) 
< 7 days (within a cycle)
Dato for første markedsføringstilladelse: 29. juni 2017 
Date of first authorisation: 29 June 2017
MedDRA systemorganklasse Meget almindelig 
MedDRA System organ class Very common
I det kliniske studie var sensitiviteten på visse lokale test lavere end den centrale laboratorietest. 
In the clinical study, the sensitivity of some local tests was lower than the central laboratory test.
Der skal derfor anvendes validerede test, som har demonstreret høj sensitivitet. 
Therefore only validated tests with demonstrated high sensitivity should be used.
B-1930, Zaventem Belgien 
B-1930, Zaventem Belgium
Hvis du føler dig usædvanligt træt (dette er en meget almindelig bivirkning ved BESPONSA), bør du ikke køre eller betjene maskiner. 
If you feel unusually tired (this is a very common side effect of BESPONSA), you should not drive or use machines.
Den rekonstituerede opløsning skal bruges med det samme. 
The reconstituted solution must be used immediately.
Det tilhører en gruppe lægemidler, som er målrettet kræftceller. 
This belongs to a group of medicines that target cancer cells.
Infusionen skal administreres over 1 time. 
The infusion must be administered over 1 hour.
Infektion omfatter også andre typer infektion (11 %). 
a Infection also includes other types of infection (11%).
hvis du får visse bivirkninger. 
if you have certain side effects.
Bemærk, at patienter kan have haft > 1 type infektion. 
Note: patients may have had > 1 type of infection.
Efterfølgende cyklusser er af 4 ugers varighed. 
Subsequent cycles are 4 weeks in duration.
Der foreligger ingen information om fertiliteten hos patienter. 
There is no information on fertility in patients.
Foretrukne termer er anvendt i henhold til MedDRA (Medical Dictionary for Regulatory Activities) version 19.1. 
Preferred terms were retrieved by applying the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Den rekonstituerede opløsning skal være klar til let uklar, farveløs og i det væsentlige fri for synlige fremmedlegemer. 
The reconstituted solution must be clear to slightly cloudy, colourless, and essentially free of visible foreign matter.
• Lægen vil fastsætte den korrekte dosis. 
• Your doctor will decide on the correct dose.
• Et lavere antal af forskellige typer blodlegemer 
• Reduction in the number of various types of blood cells
De fleste påvirkninger var reversible eller delvist reversible, undtagen påvirkningerne i leveren og nervesystemet. 
Most effects were reversible to partially reversible except for effects in the liver and nervous system.
• Filtration af den fortyndede opløsning er ikke nødvendigt. 
• Filtration of the diluted solution is not required.
Alle hændelser havde en sværhedsgrad på ≤ 2. 
All events were Grade ≤ 2 in severity.
Du må ikke få BESPONSA under graviditet, medmindre din læge mener, at det er det bedste lægemiddel for dig. 
You should not use BESPONSA during pregnancy, unless your doctor thinks that it is the best medicine for you.
Kontakt straks lægen, hvis du eller din partner bliver gravid under behandlingen med dette lægemiddel. 
Contact your doctor immediately if you or your partner becomes pregnant during the period of treatment with this medicine.
BESPONSA har moderat indflydelse på evnen til at føre motorkøretøj og betjene maskiner. 
BESPONSA has moderate influence on the ability to drive and use machines.
Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer): 
Very common (may affect more than 1 in 10 people):
En stamcelletransplantation er et indgreb, hvor man transplanterer en anden persons stamceller (celler, som udvikler sig til nye blodlegemer) ind i din blodbane. 
A stem cell transplant is a procedure to transplant another person's stem cells (cells which develop into new blood cells) into your bloodstream.
Myelosuppression/cytopeni 
Myelosuppression/cytopenias
Potentiel hepatobiliær sygdom skal vurderes og behandles i henhold til almindelig medicinsk praksis. 
Potential hepatobiliary disease should be evaluated and treated according to standard medical practice.
7 dages mellemrum uden behandling med start på dag 21. 
e 7-day treatment-free interval starting on Day 21.
Disse lægemidler kaldes antineoplastiske midler. 
These medicines are called antineoplastic agents.
VOD/SOS blev også indberettet hos 18 patienter efter en efterfølgende HSCT. 
VOD/SOS was also reported in 18 patients after a subsequent HSCT.
Lymfoblastære leukæmiceller har dette protein. 
Lymphoblastic leukaemia cells have this protein.
BESPONSA skal rekonstitueres og fortyndes inden administration. 
BESPONSA must be reconstituted and diluted before administration.
• Lægen vil muligvis ændre din dosis, afbryde eller helt stoppe behandlingen med BESPONSA, 
• Your doctor may change your dose, interrupt, or completely stop treatment with BESPONSA
Udelad næste dosis i cyklussen. 
Omit the next dose within the cycle.
BESPONSAs sikkerhed og virkning blev evalueret i et enkeltarmet, åbent, multicenter fase 1/2-studie (Studie 2). 
The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2).
Fortæl det straks til lægen, hvis du bemærker symptomer på en eller flere af følgende alvorlige bivirkninger: 
Tell your doctor immediately if you have signs and symptoms of any of the following serious side effects:
Der foreligger ingen data om udskillelse af inotuzumab ozogamicin eller dets metabolitter i human mælk, virkningerne på det ammede barn eller virkningerne på mælkeproduktionen. 
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.
Med henblik på forbedring af sporbarheden af biologiske lægemidler bør navn og batchnummer på det administrerede produkt angives tydeligt i patientjournalen. 
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.
BESPONSA må ikke bruges til børn og unge under 18 år, da der ikke foreligger nogen oplysninger om anvendelse til børn og unge. 
BESPONSA should not to be used in children and adolescents under 18 years of age because no data are available in this population.