FrancophonIA/ELRC3.0 huggingface dataset:
English: It is given 21 to 49 days after transplantation, but only if the transplant has not already restored the patient's immune system and if the patient has not developed graft-versus-host disease (when transplanted cells attack the body).
Danish: Det gives 21-49 dage efter transplantationen, men kun hvis transplantatet ikke allerede har genoprettet patientens immunforsvar, og kun hvis patienten ikke har udviklet Graft versus Host-sygdom (hvor transplanterede celler angriber kroppen).
English: Although more data are needed to determine the size of the benefit, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zalmoxis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Selvom der er behov for yderligere data for at kunne vurdere omfanget af fordelene, besluttede Agenturets Udvalg for Lægemidler til Mennesker (CHMP), at fordelene ved Zalmoxis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Zalmoxis has been given ‘conditional approval'.
Danish: Zalmoxis har fået en "betinget godkendelse".
English: The safety profile of Zalmoxis is considered acceptable.
Danish: Zalmoxis sikkerhedsprofil anses for at være acceptabel.
English: 77% of the patients receiving Zalmoxis (23 out of 30) had their immune systems restored.
Danish: 77 % af de patienter, der fik Zalmoxis (23 ud af 30), fik genoprettet deres immunforsvar.
English: These T cells are then genetically modified to include a ‘suicide gene'.
Danish: Disse T-celler bliver så genetisk modificerede, så de indeholder et "selvmordsgen".
English: The number of patients who survived after one year was 51% for patients who received Zalmoxis compared with 34 to 40% for patients who did not receive Zalmoxis.
Danish: Andelen af patienter, der var i live efter ét år, var 51 % blandt de patienter, der fik Zalmoxis, sammenlignet med 34-40 % blandt de patienter, der ikke fik Zalmoxis.
English: Zalmoxis is given as an infusion (drip) into a vein lasting 20 to 60 minutes, every month for up to four months until the circulating T cells reach a certain level.
Danish: Zalmoxis gives som infusion (drop) i en vene over 20-60 minutter én gang om måneden i op til fire måneder, indtil de cirkulerende T-celler når et vist niveau.
English: What measures are being taken to ensure the safe and effective use of Zalmoxis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zalmoxis?
English: The full EPAR for Zalmoxis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zalmoxis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Zalmoxis
Danish: Andre oplysninger om Zalmoxis
English: Zalmoxis is prepared for use in a specific patient.
Danish: Zalmoxis fremstilles til brug hos en specifik patient.
English: The most common side effect with Zalmoxis (which may affect more than 1 in 10 people) is acute graft-versus-host disease (where the condition develops within approximately 100 days of the transplant).
Danish: De hyppigste bivirkninger ved Zalmoxis (som optræder hos mere end 1 ud af 10 patienter) er akut Graft versus Host-sygdom (hvor sygdommen udvikler sig inden for ca. 100 dage efter transplantationen).
English: Data from the main study were also combined with data from a second ongoing study, and survival rates for 37 patients treated with Zalmoxis (23 from the main study and 14 from the ongoing study) were compared with rates from a patient database of 140 patients who have undergone haploidentical HSCT in the past.
Danish: Data fra hovedundersøgelsen blev også kombineret med data fra en anden igangværende undersøgelse, og overlevelsesrater for 37 patienter, der blev behandlet med Zalmoxis (23 fra hovedundersøgelsen og 14 fra den igangværende undersøgelse), blev sammenlignet med overlevelsesrater fra en patientdatabase på 140 patienter, der tidligere har fået haploidentisk HSCT.
English: It must also not be used in patients who have already developed graft-versus-host disease that requires treatment.
Danish: Det må heller ikke bruges hos patienter, der allerede har udviklet behandlingskrævende Graft versus Host-sygdom.
English: The company will also collect data from all patients treated with Zalmoxis through a registry and will monitor their progress after treatment to study long-term safety and effectiveness of the medicine.
Danish: Virksomheden vil også indsamle data fra alle patienter, der behandles med Zalmoxis, via et register og følge deres udvikling efter behandling for at undersøge lægemidlets sikkerhed og virkning over tid.
English: The dose of Zalmoxis depends on the bodyweight of the patient.
Danish: Dosen af Zalmoxis afhænger af patientens legemsvægt.
English: Because the number of patients undergoing haploidentical HSCT is low, Zalmoxis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2003.
Danish: Da antallet af patienter, der gennemgår haploidentisk HSCT, er lavt, blev Zalmoxis den 20. oktober 2003 udpeget som "lægemiddel til sjældne sygdomme".
English: Before receiving an HSCT, the patient will have received treatment to remove existing cells from the bone marrow, including cancer cells and immune cells.
Danish: Før patienter får en HSCT, vil de have modtaget behandling for at fjerne eksisterende celler fra knoglemarven, herunder kræftceller og immunceller.
English: It is not intended to provide practical advice on how to use Zalmoxis.
Danish: Det er ikke en praktisk vejledning i, hvordan Zalmoxis bør anvendes.
English: Graftversus-host disease occurred in 10 patients who were then given ganciclovir or valganciclovir, either alone or in combination with other medicines.
Danish: Graft versus Host-sygdom forekom hos 10 patienter, som derpå fik ganciclovir eller valganciclovir, enten alene eller i kombination med andre lægemidler.
English: Zalmoxis is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Danish: Zalmoxis er et lægemiddel til avanceret terapi, som kaldes et "somatisk celleterapiprodukt".
English: The company that markets Zalmoxis will provide educational material for healthcare professionals with detailed information on the risks, including graft-versus-host disease, and how to use the medicine correctly.
Danish: Virksomheden, der markedsfører Zalmoxis, vil fremlægge informationsmateriale til sundhedspersoner med detaljerede oplysninger om risiciene, herunder Graft versus Host-sygdom, og om, hvordan lægemidlet anvendes korrekt.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Zalmoxis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Zalmoxis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Zalmoxis approved?
Danish: Hvorfor blev Zalmoxis godkendt?
English: All 10 patients recovered from graft-versus-host disease.
Danish: Alle 10 patienter blev raske igen efter Graft versus Host-sygdommen.
English: What is Zalmoxis and what is it used for?
Danish: Hvad er Zalmoxis, og hvad anvendes det til?
English: Zalmoxis must not be used in patients whose immune system has been restored.
Danish: Zalmoxis må ikke anvendes hos patienter, hvis immunforsvar er genoprettet.
English: To make Zalmoxis, T cells from the HSCT donor are separated from the rest of the cells in the transplant.
Danish: For at fremstille Zalmoxis udskiller man T-celler fra HSCTdonoren fra resten af cellerne i transplantatet.
English: Since Zalmoxis has been granted a conditional approval, the company that markets Zalmoxis will provide the results of an ongoing study in high-risk acute leukaemia patients.
Danish: Da Zalmoxis har fået en betinget godkendelse, skal den virksomhed, der markedsfører produktet, fremlægge resultaterne af en igangværende undersøgelse blandt højrisikopatienter med akut leukæmi.
English: For more information about treatment with Zalmoxis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zalmoxis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Zalmoxis is a medicine used as an add-on treatment in adults who have received a haematopoietic stem cell transplant (HSCT, a transplant of cells that can develop into different types of blood cells) from a partially matched donor (a so-called haploidentical transplant).
Danish: Zalmoxis er et lægemiddel, der anvendes som tillægsbehandling hos voksne, der har fået en hæmatopoietisk stamcelletransplantation (HSCT, en transplantation af celler, der kan udvikle sig til forskellige typer blodlegemer) fra en partielt matchende donor (en såkaldt haploidentisk transplantation).
English: The main measure of effectiveness was restoration of the immune system as measured by blood levels of T cells.
Danish: Virkningen blev hovedsageligt målt på genoprettelsen af immunforsvaret bedømt ved koncentrationen af T-celler i blodet.
English: What information is still awaited for Zalmoxis?
Danish: Hvilke oplysninger afventes der stadig for Zalmoxis?
English: For the full list of restrictions and side effects reported with Zalmoxis, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Zalmoxis fremgår af indlægssedlen.
English: When using Zalmoxis, this can be treated with ganciclovir or valganciclovir.
Danish: Når Zalmoxis anvendes, kan denne bivirkning behandles med ganciclovir eller valganciclovir.
English: However the T cells in Zalmoxis can sometimes attack the patient's body, causing graft-versus-host disease.
Danish: Nogle gange kan det dog forekomme, at T-cellerne i Zalmoxis angriber patientens krop og forårsager Graft versus Host-sygdom.
English: What are the risks associated with Zalmoxis?
Danish: Hvilke risici er der forbundet med Zalmoxis?
English: The T cells in Zalmoxis have a suicide gene, which makes them susceptible to the medicines ganciclovir and valganciclovir.
Danish: T-cellerne i Zalmoxis har et selvmordsgen, der gør dem følsomme over for lægemidlerne ganciclovir og valganciclovir.
English: Zalmoxis can only be obtained with a prescription and treatment is given under the supervision of a doctor who has experience in the treatment of blood cancers using HSCT.
Danish: Zalmoxis udleveres kun efter recept, og behandlingen gives under opsyn af en læge med erfaring i behandling af blodkræft ved hjælp af HSCT.
English: Zalmoxis is given to help restore the patient's immune system after the transplant.
Danish: Zalmoxis gives for at hjælpe patientens immunsystem med at restituere sig efter transplantationen.
English: If the patient develops graftversus-host disease, ganciclovir or valganciclovir is given, which kills the T cells that have the suicide gene thereby treating the disease and preventing its further development.
Danish: Hvis patienten udvikler Graft versus Host-sygdom, gives der ganciclovir eller valganciclovir, som dræber de T-celler, der har selvmordsgenet, hvorved sygdommen behandles, og dens videre udvikling forebygges.
English: The main risk is graft-versus-host disease, however this can be successfully treated with ganciclovir or valganciclovir, which kill the T cells in Zalmoxis.
Danish: Den primære risiko er Graft versus Host-sygdom, men denne kan behandles effektivt med ganciclovir eller valganciclovir, der dræber T-cellerne i Zalmoxis.
English: When given after transplantation, Zalmoxis helps the patient to build up their immune system and so helps to protect them from infections.
Danish: Når Zalmoxis gives efter en transplantation, hjælper det patientens krop med at opbygge immunforsvaret og beskytter således patienten mod infektioner.
English: Zalmoxis has been shown to help restore the immune systems of patients who had haploidentical HSCT for serious blood cancers; these patients have limited treatment options and a poor prognosis.
Danish: Det er påvist, at Zalmoxis hjælper med at genoprette immunforsvaret hos patienter, der har fået haploidentisk HSCT mod alvorlig blodkræft; disse patienter har begrænsede behandlingsmuligheder og en dårlig prognose.
English: The study will compare haploidentical HSCT followed by treatment with Zalmoxis with haploidentical HSCT containing T cells followed by treatment with cyclophosphamide (a medicine to prevent graft-versus-host disease) and with haploidentical HSCT without T cells.
Danish: I undersøgelsen sammenlignes haploidentisk HSCT efterfulgt af behandling med Zalmoxis med haploidentisk HSCT indeholdende T-celler efterfulgt af behandling med cyclophosphamid (et lægemiddel, der bruges til at forhindre Graft versus Host-sygdom) og med haploidentisk HSCT uden Tceller.
English: Zalmoxis has been investigated in a main study involving 30 patients who had haploidentical HSCT for serious blood cancers.
Danish: Zalmoxis er undersøgt i en hovedundersøgelse med 30 patienter, der havde fået haploidentisk HSCT på grund af alvorlig blodkræft.
English: Zalmoxis is used in patients who have received a haploidentical HSCT because they have serious blood cancers, such as certain leukaemias and lymphomas.
Danish: Zalmoxis anvendes hos patienter, der har fået en haploidentisk HSCT, fordi de har alvorlig blodkræft, f.eks. visse typer leukæmi eller lymfomer.
English: Zalmoxis contains T cells (a type of white blood cell) that have been genetically modified1.
Danish: Zalmoxis indeholder T-celler (en type hvide blodlegemer),
English: For practical information about using Zalmoxis, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zalmoxis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How does Zalmoxis work?
Danish: Hvordan virker Zalmoxis?
English: How is Zalmoxis used?
Danish: Hvordan anvendes Zalmoxis?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zalmoxis 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 Zalmoxis.
English: What benefits of Zalmoxis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zalmoxis?
English: Most people will not have come into contact with it and therefore will not have built up protection (‘immunity') against it.
Danish: De fleste mennesker vil ikke have været i kontakt med den før og har derfor ikke udviklet en beskyttelse ("immunitet") mod den.
English: Two doses of the vaccine are recommended and the child should receive the second dose at least 4 weeks after the first.
Danish: To doser af vaccinen anbefales, og barnet bør tidligst få den anden dosis 4 uger efter den første.
English: The dose is one spray (0.1 ml) into each nostril.
Danish: Dosen er ét spray (0,1 ml) i hvert næsebor.
English: It should be given in an officially declared pandemic and according to official guidance.
Danish: Den bør gives efter udbrud af en officielt erklæret pandemi og i henhold til officielle retningslinjer.
English: A flu pandemic can affect people worldwide and cause many deaths.
Danish: En influenzapandemi kan ramme mennesker verden over og forårsage mange dødsfald.
English: This helps to protect against the flu that the virus causes.
Danish: Dette medvirker til at beskytte mod den influenza, som virusset forårsager.
English: It can particularly affect children who have not had seasonal flu or received flu vaccines previously.
Danish: Den kan især ramme børn, der ikke har haft sæsonbetinget influenza eller fået influenzavacciner tidligere.
English: A flu pandemic occurs when a new strain of flu virus appears that can spread easily because people have no immunity (protection) against it.
Danish: En influenzapandemi forekommer, når der opstår en ny stamme af et influenzavirus, der let spredes fra person til person, fordi de ikke har nogen immunitet (beskyttelse) mod den.
English: Thus, the CHMP decided that the benefits of the medicine in children aged 1 to 18 years are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved lægemidlet hos børn og unge i alderen 1-18 år opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for lægemidlet.
English: However, a second vaccine that acts in a different way is able to make antibodies that can be measured easily.
Danish: Derimod kan en anden vaccine, der virker på en anderledes måde, lave antistoffer, som let kan måles.
English: It is not possible to prepare a vaccine for a future pandemic because the strain of the pandemic flu virus is not known in advance.
Danish: Det er ikke muligt at fremstille en vaccine mod en kommende pandemi, fordi stammen i det pandemiske influenzavirus ikke kendes på forhånd.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemic influenza vaccine H5N1 MedImmune on 20 May 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pandemisk influenzavaccine H5N1 MedImmune den 20. maj 2016.
English: However, in a pandemic, it might be appropriate to give it to children with allergies if facilities for medical treatment of severe allergic reactions are immediately available.
Danish: Under en pandemi kan det dog alligevel overvejes at give vaccinen til børn med allergier, hvis udstyr til medicinsk behandling af alvorlige allergiske reaktioner er umiddelbart tilgængeligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that preparing for a potential flu pandemic in children and adolescents meets an important medical need.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at en beredskabsvaccine til børn og unge i tilfælde af en influenzapandemi opfylder et væsentligt medicinsk behov.
English: The results were similar to those from three other studies involving 170 adults given pandemic preparedness vaccines containing similar types of bird flu virus, such as H7N9 and H7N7, instead of H5N1.
Danish: Resultaterne svarer til resultaterne fra tre andre undersøgelser, hvor 170 voksne fik beredskabsvacciner indeholdende lignende typer af fugleinfluenzavirus, f.eks. H7N9 og H7N7, i stedet for H5N1.
English: In addition, there is evidence indicating that the vaccine can protect against different strains of H5N1 virus.
Danish: Desuden er der evidens for, at vaccinen kan beskytte mod forskellige stammer af H5N1-virusset.
English: The full EPAR for Pandemic influenza vaccine H5N1 AstraZeneca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pandemisk influenzavaccine H5N1 AstraZeneca findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A vaccine against a specific disease ‘teaches' the immune system (the body's natural defences) to defend itself against the disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige immunforsvar), hvordan det forsvarer sig mod en specifik sygdom.
English: This vaccine is intended to help with the management of a future pandemic.
Danish: Vaccinen er et led i håndteringen af en kommende pandemi.
English: The vaccine is expected to protect children against pandemic flu, on the basis of data obtained with this vaccine in adults.
Danish: Vaccinen forventes at beskytte børn og unge mod pandemisk influenza på grundlag af de data, der er opnået ved at give vaccinen til voksne.
English: Pandemic influenza vaccine H5N1 AstraZeneca must not generally be given to children who have had a severe allergic reaction to any of the substances in the vaccine including gelatin and gentamicin or to children who have had a severe allergic reaction to eggs or egg proteins, such as ovalbumin.
Danish: Pandemisk influenzavaccine H5N1 AstraZeneca må generelt ikke gives til børn, der har haft en alvorlig allergisk reaktion på et af stofferne i vaccinen, herunder gelatine og gentamicin, eller til børn, der har haft en alvorlig allergisk reaktion på æg eller æggeproteiner, f.eks. ovalbumin.
English: Because a new pandemic live attenuated vaccine cannot be tested in children, the benefit of this vaccine in children was predicted from studies in adults and from studies of similar live attenuated flu vaccines in children.
Danish: Da en ny pandemisk levende, svækket vaccine ikke kan afprøves hos børn, er virkningen af denne vaccine blevet vurderet ud fra undersøgelser hos voksne og undersøgelser af lignende levende, svækkede vacciner hos børn.
English: Instead, a pandemic preparedness vaccine can be made to contain a bird flu virus strain that could potentially cause a future pandemic.
Danish: I stedet kan man fremstille en beredskabsvaccine, som indeholder en fugleinfluenzavirus-stamme, der potentielt kan forårsage en pandemi.
English: In those who received the second vaccine 3 weeks to 5 years after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca, antibodies increased 4-fold in 73% (8 out of 11) of the individuals compared with 10% of the individuals who had not been previously vaccinated with Pandemic influenza vaccine H5N1 AstraZeneca.
Danish: Hos de personer, der fik den anden vaccine tre uger til fem år efter vaccinationen med Pandemisk influenzavaccine H5N1 AstraZeneca, steg antistofferne med en faktor 4 hos 73 % (8 ud af 11), idet dette kun var tilfældet hos 10 % af de personer, der ikke tidligere var vaccineret med Pandemisk influenzavaccine H5N1 AstraZeneca.
English: Further studies on the effects on the vaccine in children will need to be provided once the the flu strain causing the pandemic is included in the vaccine.
Danish: Det er nødvendigt at gennemføre yderligere undersøgelser af virkningen hos børn, når den influenzastamme, der skaber pandemien, inkluderes i vaccinen.
English: In addition, the company presented extensive supportive data from large studies and from clinical practice on how well other similar pandemic and seasonal live attenuated influenza A vaccines work in children.
Danish: Derudover fremlagde virksomheden en stor mængde understøttende data fra omfattende undersøgelser og fra klinisk praksis, der viste, hvor godt andre lignende pandemiske og sæsonbestemte levende svækkede influenza A-vacciner virkede hos børn.
English: The name of the medicine was changed to Pandemic influenza vaccine H5N1 AstraZeneca on 24 May 2017.
Danish: Lægemidlets navn blev ændret til Pandemisk influenzavaccine H5N1 AstraZeneca den 24. maj 2017.
English: Pandemic influenza vaccine H5N1 AstraZeneca contains live, attenuated (weakened) influenza A virus A/Vietnam/1203/2004 (H5N1) strain.
Danish: Pandemisk influenzavaccine H5N1 AstraZeneca indeholder en levende, svækket stamme af typen influenza A-virus A/Vietnam/1203/2004 (H5N1).
English: The most common side effects with Pandemic influenza vaccine H5N1 AstraZeneca (which may affect more than 1 in 10 people) are decreased appetite, headache, runny or stuffy nose, and feeling unwell.
Danish: De hyppigste bivirkninger ved Pandemisk influenzavaccine H5N1 AstraZeneca (som optræder hos mere end 1 ud af 10 patienter) er nedsat appetit, hovedpine, løbende eller tilstoppet næse og utilpashed.
English: Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine developed to protect children aged between 12 months and 18 years against influenza (flu) during a flu pandemic.
Danish: Pandemisk influenzavaccine H5N1 AstraZeneca er en vaccine, der er udviklet til at beskytte børn og unge i alderen 12 måneder til 18 år mod influenza under en influenzapandemi.