FrancophonIA/ELRC3.0 huggingface dataset:
English: Both studies compared Vidaza with conventional care (treatment chosen for each patient based on local practice and the patient's condition).
Danish: I begge undersøgelser blev Vidaza sammenlignet med konventionel behandling (behandlingen blev udvalgt for hver enkelt patient på baggrund af lokal praksis og patientens tilstand).
English: The recommended dose of Vidaza is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede startdosis for Vidaza er 75 mg pr. kvadratmeter legemsflade (beregnet ud fra patientens højde og vægt).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vidaza.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Vidaza skal anvendes.
English: For more information about treatment with Vidaza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vidaza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Vidaza was more effective than conventional care in extending survival.
Danish: Vidaza var mere effektiv end den konventionelle behandling, når det gjaldt livsforlængelse.
English: Because the number of patients with these diseases is low, the diseases are considered ‘rare', and Vidaza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February 2002 for myelodysplastic syndromes and on 29 November 2007 for AML.
Danish: Da antallet af patienter med disse sygdomme er lavt, betragtes de som "sjældne", og Vidaza blev udpeget som "lægemiddel til sjældne sygdomme" den 6. februar 2002 mod myelodysplastiske syndromer og den 29. november 2007 mod AML.
English: Vidaza treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines.
Danish: Behandling med Vidaza bør gives og overvåges af en læge med erfaring i at behandle med lægemidler mod kræft.
English: Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA).
Danish: Azacitidin er en cytidinanalog, hvilket betyder, at det optages i cellernes arvemateriale (RNA og DNA).
English: The CHMP decided that Vidaza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Vidaza opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Vidaza.
English: It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment.
Danish: Det gives som en injektion under huden på overarmen, låret eller maven dagligt i en uge efterfulgt af en hvileperiode på tre uger.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Vidaza can be found on the Agency's website: here (myelodysplastic syndromes) and here (AML).
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Vidaza findes på agenturets websted: her (myelodysplastiske syndromer) og her (AML).
English: It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA.
Danish: Det menes at virke ved at ændre den måde, cellerne tænder og slukker generne på, samt ved at påvirke produktionen af ny RNA og DNA.
English: Vidaza is used in patients with an intermediate to high risk of progressing to AML or death;
Danish: Vidaza anvendes hos patienter med intermediær til høj risiko for at udvikle AML eller dø
English: The most common side effects of Vidaza in more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells) are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Danish: De hyppigste bivirkninger ved Vidaza hos mere end 60 % af patienter med myelodysplastiske syndromer, CMML eller AML (20-30 % abnorme celler), er bivirkninger i blodet, herunder trombocytopeni (lavt antal blodplader), neutropeni (lavt niveau af neutrofiler, en art hvide blodlegemer) og leukopeni (lavt antal hvide blodlegemer), bivirkninger i mave- og tarmregionen, herunder kvalme og opkastning, og reaktioner på injektionsstedet.
English: Vidaza must not be used in patients with advanced liver cancer or in women who are breastfeeding.
Danish: Vidaza må ikke anvendes hos patienter med fremskreden levercancer eller hos kvinder, som ammer.
English: Vidaza is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow's ability to produce healthy blood cells):
Danish: Vidaza anvendes til at behandle voksne med følgende sygdomme, hvis de ikke er egnede til hæmatopoietisk stamcelletransplantation (hvor patienten modtager stamceller med henblik på at gendanne knoglemarvens evne til at producere sunde blodceller):
English: Vidaza is a medicine that contains the active substance azacitidine.
Danish: Vidaza er et lægemiddel, der indeholder det aktive stof azacitidin.
English: What is the risk associated with Vidaza?
Danish: Hvilken risiko er der forbundet med Vidaza?
English: In the first study, patients receiving Vidaza survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Danish: I den første undersøgelse overlevede de patienter, der fik Vidaza, i gennemsnit i 24,5 måneder sammenlignet med 15,0 måneder for de patienter, der fik konventionel behandling.
English: The active substance in Vidaza, azacitidine, belongs to the group ‘anti-metabolites'.
Danish: Det aktive stof i Vidaza, azacitidin, er et middel, som tilhører gruppen "antimetabolitter".
English: Vidaza is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Danish: Vidaza anvendes, når knoglemarven består af 10-29 % abnorme celler, og knoglemarven ikke producerer et større antal af hvide blodlegemer
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Danish: • AML, der har udviklet sig fra et myelodysplastisk syndrom, og knoglemarven består af 20-30 % abnorme celler
English: These actions are thought to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Danish: Dette menes at løse de problemer med modning og vækst af unge blodceller i knoglemarven, der medfører myelodysplastiske sygdomme, samt at dræbe cancerceller ved leukæmi.
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML, who were unlikely to go on to have a stem cell transplant.
Danish: Den første undersøgelse omfattede 358 voksne med intermediære til højrisikobetingede myelodysplastiske syndromer, CMML eller AML, som sandsynligvis ikke ville få foretaget en knoglemarvstransplantation.
English: In the second study in AML patients with more than 30% abnormal cells, patients receiving Vidaza survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Danish: I den anden undersøgelse der omfattede AML-patienter med mere end 30 % abnorme celler, overlevede de patienter, der fik Vidaza, i gennemsnit i 10,4 måneder, sammenlignet med 6,5 måneder for de patienter, der fik konventionel behandling.
English: At the time of orphan medicine designation, CMML was classified as a type of myelodysplastic syndrome.
Danish: På tidspunktet for godkendelsen som lægemiddel til sjældne sygdomme var CMML klassificeret som en type myelodysplastisk syndrom.
English: The second study involved 488 patients with AML who were 65 years or older and could not have haematopoietic stem cell transplantation.
Danish: Den anden undersøgelse omfattede 488 AML-patienter, som var mindst 65 år, og som ikke kunne gennemgå en hæmatopoietisk stamcelletransplantation.
English: • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Danish: • myelodysplastiske syndromer (MDS), en gruppe af tilstande, hvor knoglemarven producerer for få blodlegemer.
English: Why has Vidaza been approved?
Danish: Hvorfor blev Vidaza godkendt?
English: In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells).
Danish: I visse tilfælde kan myelodysplastiske syndromer føre til udviklingen af akut myeloid leukæmi (AML, en cancertype, som påvirker de hvide blodlegemer, der kaldes myeloidceller).
English: For the full list of all side effects reported with Vidaza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Vidaza fremgår af indlægssedlen.
English: It is available as a powder to be made up into a suspension for injection.
Danish: Det fås som et pulver med injektionsvæske og gives ved indsprøjtning.
English: • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes).
Danish: • - kronisk myelomonocytleukæmi (CMML, en cancertype, som påvirker de hvide blodlegemer, der kaldes monocytter).
English: See the summary of product characteristics (also part of the EPAR) for full details.
Danish: Fuldstændige oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: Patients should receive medicines to prevent nausea (feeling sick) and vomiting before giving Vidaza.
Danish: Patienter bør medicineres mod kvalme og opkastning, før behandling med Vidaza påbegyndes.
English: What is Vidaza?
Danish: Hvad er Vidaza?
English: Side effects were similar in AML patients with more than 30% abnormal cells.
Danish: Lignende bivirkninger forekom hos AML-patienter med mere end 30 % abnorme celler.
English: • AML, when the bone marrow has more than 30% abnormal cells.
Danish: • AML, når knoglemarven består af mere end 30 % abnorme celler.
English: The patients' bone marrow contained up to 30% abnormal cells.
Danish: Patienternes knoglemarv indeholdt op til 30 % abnorme celler.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vidaza have 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 Vidaza.
English: Their bone marrow contained more than 30% abnormal cells.
Danish: Deres knoglemarv indeholdt mere end 30 % abnorme celler.
English: What benefit has Vidaza shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Vidaza?
English: How has Vidaza been studied?
Danish: Hvordan blev Vidaza undersøgt?
English: What is Vidaza used for?
Danish: Hvad anvendes Vidaza til?
English: How is Vidaza used?
Danish: Hvordan anvendes Vidaza?
English: How does Vidaza work?
Danish: Hvordan virker Vidaza?
English: It must also not be used in patients infected with hepatitis B, C and/or HIV virus.
Danish: Det må heller ikke anvendes hos patienter, der er smittet med hepatitis B, C og/eller hiv-virus.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom patientens brusk.
English: However, knowledge on the long-term effects of the medicine is still awaited.
Danish: Langtidsvirkningerne af lægemidlet er dog stadig ukendte.
English: The full EPAR for Spherox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Spherox findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The safety profile was considered acceptable; most side effects expected can be due to the surgery.
Danish: Sikkerhedsprofilen blev anset for at være acceptabel, og de fleste forventede bivirkninger kan skyldes det operative indgreb.
English: It is used where the affected area is no larger than 10 cm².
Danish: Det anvendes, hvis det berørte område ikke er større end 10 cm2.
English: This is a summary of the European public assessment report (EPAR) for Spherox.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Spherox.
English: The medicine is prepared specifically for each individual patient and must be given by a qualified doctor in a medical facility.
Danish: Lægemidlet fremstilles specifikt til den enkelte patient og skal gives af en kvalificeret læge på en klinik.
English: The company will also continue the first study to obtain more information about the long-term safety and effectiveness of Spherox.
Danish: Virksomheden vil ligeledes fortsætte den første undersøgelse for at fremskaffe flere oplysninger om sikkerheden og virkningen af Spherox på lang sigt.
English: Cartilage in the knee can be damaged because of an accident, such as a fall or a sport injury.
Danish: Brusken i knæet kan blive beskadiget som følge af en ulykke, f.eks. et fald eller en sportsskade.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Danish: Denne type lægemiddel indeholder celler eller væv, der er manipuleret, så de kan anvendes til at reparere, regenerere eller erstatte væv.
English: All these patients received treatment with Spherox, as microfracture is not recommended to repair large defects.
Danish: Alle disse patienter fik behandling med Spherox, da mikrofraktur ikke anbefales til reparation af store defekter.
English: In this study, patients' outcome scores with Spherox improved by 16 points in the first year and further improvements were seen up to three years after treatment.
Danish: I denne undersøgelse blev patienternes resultatscorer med Spherox forbedret med 16 point i det første år, og der blev set yderligere forbedringer i op til tre år efter behandlingen.
English: The KOOS was self-measured by patients rating the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.
Danish: KOOS blev målt af patienterne selv, som angav sværhedsgraden af deres symptomer såsom smerter, indflydelse på dagligdagen, sport og fritidsaktiviteter samt livskvalitet.
English: In addition, two other studies will be carried out on the manufacture of Spherox, which will look, among other things, at the consistency of the finished product.
Danish: Endvidere vil der blive foretaget to undersøgelser mere om fremstillingen af Spherox, hvor man bl.a. vil se på konsistensen af det færdige lægemiddel.
English: Patients treated with Spherox should follow a specific rehabilitation programme, including physiotherapy.
Danish: Patienter, som er blevet behandlet med Spherox, skal følge et særligt genoptræningsprogram, som bl.a. omfatter fysioterapi.
English: The European Medicines Agency therefore decided that Spherox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Spherox opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Spherox.
English: Preliminary data from this study after one year show that Spherox improved by 22 points the outcome score and was as effective as microfracture.
Danish: Foreløbige data fra denne undersøgelse efter et år viser, at Spherox forbedrede resultatscoren med 22 point og var lige så effektivt som mikrofraktur.
English: What measures are being taken to ensure the safe and effective use of Spherox?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Spherox?
English: Other information about Spherox
Danish: Andre oplysninger om Spherox
English: The cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids.
Danish: Herefter dyrkes bruskcellerne i laboratoriet for at fremstille en suspension af chondrocytsfæroider.
English: Spherox is a type of advanced therapy medicine called a ‘tissue engineered product'.
Danish: Spherox er et lægemiddel til avanceret terapi, som kaldes et "produkt fremstillet ved vævsteknik".
English: The chondrocyte spheroids attach to the cartilage within 20 minutes.
Danish: Chondrocytsfæroiderne binder sig til brusken i løbet af 20 minutter.
English: In the first study involving 102 patients, Spherox was compared with microfracture (a type of surgery used to treat defects in cartilage).
Danish: I den første undersøgelse, som omfattede 102 patienter, blev Spherox sammenlignet med mikrofraktur (en type operation, der anvendes til at behandle bruskdefekter).
English: It is not intended to provide practical advice on how to use Spherox.
Danish: Det er ikke en praktisk vejledning i, hvordan Spherox bør anvendes.
English: The second study looked at 73 patients with large cartilage defects of the knee from 4 to 10 cm².
Danish: Den anden undersøgelse omfattede 73 patienter med store knæbruskdefekter på mellem 4 cm² og 10 cm².
English: The main measure of effectiveness was the KOOS (knee injury and osteoarthritis outcome score), which is graded on a scale of 0 to 100 (where 0 means severest symptoms and 100 means no symptoms).
Danish: Hovedeffektmålet var KOOS (Knee injury and Osteoarthritis Outcome Score), et mål for knæskader og osteoartritis, som vurderes på en skala fra 0 til 100 (hvor 0 er de sværeste symptomer, og 100 betyder ingen symptomer).
English: Spherox is a medicine used to repair defects to the cartilage in the knee in adults who are experiencing symptoms (such as pain and problems moving the knee).
Danish: Spherox er et lægemiddel, der anvendes til at reparere bruskdefekter i knæet hos voksne, som oplever symptomer (såsom smerter og problemer med at bevæge knæet).
English: Why is Spherox approved?
Danish: Hvorfor blev Spherox godkendt?
English: What is Spherox and what is it used for?
Danish: Hvad er Spherox, og hvad anvendes det til?
English: Spherox spheroids of human autologous matrix-associated chondrocytes
Danish: Sfæroider af humane autologe matrixassocierede chondrocytter
English: Using chondrocyte spheroids that attach to the knee cartilage allows for a less invasive surgery (i.e. arthroscopy).
Danish: Brug af chondrocytsfæroider, som binder sig til knæbrusken, muliggør et mindre invasivt indgreb (dvs. artroskopi).
English: For more information about treatment with Spherox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Spherox, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Spherox is available as a suspension for implantation into the knee joint.
Danish: Spherox fås som suspension til implantation i knæleddet.
English: Spherox has been shown to be effective at treating defects in the knee cartilage between 1 and 10 cm2 in size.
Danish: Det har vist sig, at Spherox er effektivt til at behandle knæbruskdefekter med en størrelse på mellem 1 cm2 og 10 cm2.
English: The materials for other healthcare professionals will include information on how to screen and handle the collected sample and prepare Spherox for implantation, and how to follow patients up and plan the recommended physiotherapy.
Danish: Undervisningsmaterialet til andet sundhedspersonale vil omfatte information om, hvordan man screener og håndterer den udtagne prøve og klargør Spherox til implantation, og hvordan man følger op på patienterne og planlægger den anbefalede fysioterapi.
English: Spherox must not be used in patients with primary generalised osteoarthritis or with advanced osteoarthritis of the knee (conditions causing swelling and pain in the joints) and in patients whose bones in the knee joint are still growing.
Danish: Spherox må ikke anvendes hos patienter med primær (generaliseret) osteoartritis eller med fremskreden osteoartritis i knæet (tilstande, som medfører hævelse og smerter i leddene) eller hos patienter, hvis knogler i knæleddet endnu ikke er udvoksede.
English: To prepare the medicine, a small sample is taken by arthroscopy (a type of keyhole surgery) from the patient's cartilage in the knee.
Danish: For at kunne fremstille lægemidlet tages der en lille prøve ved artroskopi (en type kikkertoperation) fra patientens brusk i knæet.
English: This allows the chondrocyte spheroids to fill in the cartilage defect.
Danish: Dette gør det muligt for chondrocytsfæroiderne at udfylde bruskdefekten.
English: The knee cartilage defects were between 1 and 4 cm2 in size.
Danish: Knæbruskdefekterne havde en størrelse på mellem 1 cm2 og 4 cm2.
English: Spherox contains spheroids made from the patient's own healthy cartilage cells.
Danish: Spherox indeholder sfæroider, som fremstilles af patientens egne raske bruskceller.
English: What are the risks associated with Spherox?
Danish: Hvilke risici er der forbundet med Spherox?
English: The most common side effects with Spherox (seen in more than 1 patient in 10) are arthralgia (joint pain) and joint effusion (accumulation of liquid in the knee), which can cause swelling of the joint.
Danish: De hyppigste bivirkninger ved Spherox (som optræder hos mere end 1 ud af 10 patienter) er artralgi (ledsmerter) og effusion i leddet (væskeansamling i knæet), som kan føre til hævelse i leddet.
English: When the spheroids are implanted into the patient's cartilage, they attach to the area of the defect and produce new tissue, thereby repairing the defects in the knee.
Danish: Når sfæroiderne implanteres i patientens brusk, binder de sig til det defekte område og danner nyt væv.
English: Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage.
Danish: Spherox indeholder sfæroider (sfæriske aggregater) af chondrocytter, som er celler, der findes i sund brusk.
English: For the full list of all side effects reported with Spherox, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Spherox fremgår af indlægssedlen.
English: During arthroscopy, the medicine is placed into the damaged area of the patient's cartilage.
Danish: Ved hjælp af artroskopi placeres lægemidlet i det beskadigede område af
English: The company that markets Spherox will ensure that all surgeons and other healthcare professionals handling or using the medicine receive training materials on how to use and store it.
Danish: Virksomheden, der markedsfører Spherox, vil sikre, at alle kirurger og andet sundhedspersonale, som håndterer eller anvender lægemidlet, modtager undervisningsmateriale om, hvordan de skal anvende og opbevare det. Undervisningsmaterialet til kirurger vil omfatte information om, hvordan man tager bruskprøver fra patienterne, foretager indgrebet og følger op på patienterne.
English: For practical information about using Spherox, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Spherox, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Spherox used?
Danish: Hvordan anvendes Spherox?
English: What benefits of Spherox have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Spherox?
English: How does Spherox work?
Danish: Hvordan virker Spherox?