FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects of Lenalidomide Celgene Europe were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Lenalidomide Celgene Europe blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for LENALIDOMIDE CELGENE EUROPE
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for LENALIDOMIDE CELGENE EUROPE
English: The study looked at the effects of treatment with a daily dose of 10 mg Lenalidomide Celgene Europe either given continuously or as a repeated cycle of three weeks on treatment followed by one week off.
Danish: Undersøgelsen så på virkningerne af behandling med en daglig dosis på 10 mg Lenalidomide Celgene Europe enten givet løbende eller som en cyklus på tre uger med behandling efterfulgt af en uge uden behandling.
English: The evaluation had finished and the CHMP had given a negative opinion, which had been confirmed following a re-examination procedure.
Danish: Vurderingen var afsluttet, og CHMP havde afgivet en negativ udtalelse, som var blevet bekræftet efter at den negative udtalelse var blevet taget op til fornyet overvejelse.
English: There are no consequences of this withdrawal on the use of Revlimid, which also contains lenalidomide, in its authorised indication.
Danish: Tilbagetrækningen for ingen konsekvenser for anvendelsen af Revlimid, som også indeholder lenalidomid i sin godkendte indikation.
English: Lenalidomide has been authorised in the European Union since June 2007 under the name Revlimid, for the treatment of multiple myeloma.
Danish: Lenalidomid har været godkendt i Den Europæiske Union siden 2007 under navnet Revlimid til behandling af multiple myelomer.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Lenalidomide Celgene Europe had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Lenalidomide Celgene Europe ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: Multiple myeloma is a cancer of the plasma cells in the bone marrow.
Danish: Multiple myelomer er kræft i plasmacellerne i knoglemarven.
English: What is happening with Revlimid used for the treatment of multiple myeloma?
Danish: Hvad sker der med Revlimid, som anvendes til behandling af andre sygdomme?
English: In particular, because the study did not compare the medicine to any other treatment, it was difficult to determine if treatment with Lenalidomide Celgene Europe increased the risk of progression to acute myeloid leukaemia.
Danish: Først og fremmest fordi undersøgelsen ikke sammenlignede lægemidlet med nogen anden behandling var det svært at fastslå, om behandling med Lenalidomide Celgene Europe øgede risikoen for udvikling af akut myeloid leukæmi.
English: The CHMP had concerns over the way the main study was carried out, which meant that the safety of Lenalidomide Celgene Europe was difficult to assess.
Danish: Udvalget var bekymret over den måde undersøgelsen var blevet gennemført på, hvilket betød, at det var svært at vurdere sikkerheden af Lenalidomide Celgene Europe.
English: Lenalidomide Celgene Europe was designated as an orphan medicinal product on 8 March 2004.
Danish: Lenalidomide Celgene Europe blev udpeget som lægemiddel til sjældne sygdomme den 8. marts 2004.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Lenalidomide Celgene Europe for the for the treatment of anaemia due to myelodysplastic syndromes.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Lenalidomide Celgene Europe til behandling af anæmi forårsaget af myelodysplastisk syndrom.
English: On 30 May 2008, Celgene Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lenalidomide Celgene Europe, for the treatment of anaemia due to myelodysplastic syndromes.
Danish: Den 30. maj 2008 meddelte Celgene Europe Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Lenalidomide Celgene Europe til behandling af anæmi forårsaget af myelodysplastisk syndrom.
English: The company informed the CHMP that it will continue to make lenalidomide available for patients included in clinical trials or compassionate use programmes.
Danish: Virksomheden har informeret CHMP om, at den vil sørge for at lenalidomid fortsat er til rådighed for patienter, som deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse.
English: The main measure of effectiveness was the proportion of patients who became ‘transfusion independent', meaning that their anaemia was controlled without the need for a blood transfusion over an eight-week period.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, der blev ‘transfusionsuafhængige', hvilket betyder, at deres anæmi var under kontrol, og at de ikke havde behov for en blodtransfusion i løbet af en otte ugers periode.
English: In some cases, myelodysplastic syndromes can lead to the development of acute myeloid leukaemia (a type of cancer affecting the white blood cells).
Danish: I visse tilfælde kan myelodysplastisk syndrom medføre udvikling af akut myeloid leukæmi (en kræftform, der påvirker de hvide blodlegemer).
English: The active substance in Lenalidomide Celgene Europe, lenalidomide, is an immunomodulating agent.
Danish: Det aktive stof i Lenalidomide Celgene Europe, lenalidomid, er et immunmodulerende middel.
English: The exact way that lenalidomide works in myelodysplastic syndromes is not known, but it is thought that it blocks the growth of tumour cells in the bone marrow, while allowing the growth of normal bone marrow cells, including the cells that produce red blood cells.
Danish: Det vides endnu ikke med nøjagtighed, hvordan lenalidomid virker ved myelodysplastisk syndrom, men det menes at blokere væksten af tumorceller i knoglemarven, mens normale knoglemarvsceller for lov at vokse, herunder de celler, der producerer røde blodceller.
English: The study involved 148 patients with transfusion-dependent anaemia, low or intermediate (level 1) risk myelodysplastic syndromes and a deletion of part of chromosome 5 (‘5q deletion').
Danish: Undersøgelsen omfattede 148 patienter med transfusionsafhængig anæmi, lav eller mellemstor (niveau 1) risiko for myelodysplastisk syndrom og mangel på en del af kromosom nr. 5 (‘5q- mangel').
English: Lenalidomide Celgene Europe is a medicine containing the active substance lenalidomide.
Danish: Lenalidomide Celgene er et lægemiddel, der indeholder det aktive stof lenalidomid.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lenalidomide Celgene Europe?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Lenalidomide Celgene Europeeller i programmer for anvendelse med særlig udleveringstilladelse?
English: Lenalidomide Celgene Europe was to be used in patients who were dependent on receiving blood transfusions to treat their anaemia and whose myelodysplastic syndromes were associated with a specific genetic mutation (deletion of part of chromosome number 5), and with a low to intermediate risk of progressing to leukaemia or death.
Danish: Lenalidomide Celgene Europe skulle anvendes til patienter, der var afhængige af blodtransfusioner til behandling af deres anæmi og hos hvem myelodysplastisk syndrom var forbundet med en bestemt genetisk mutation (mangel på en del af kromosom nummer 5) og en lav til mellemstor risiko for, at det udviklede sig til leukæmi eller fik en dødelig udgang.
English: What is Lenalidomide Celgene Europe?
Danish: Hvad er Lenalidomide Celgene Europe?
English: Lenalidomide Celgene Europe was expected to be used to treat anaemia (low red blood cell counts) caused by myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Danish: Lenalidomide Celgene Europe forventedes anvendt til behandling af anæmi (lavt antal røde blodlegemer) forårsaget af myelodysplastisk syndrom (en tilstand, hvor knoglemarven ikke kan producere nok blodceller).
English: What was Lenalidomide Celgene Europe expected to be used for?
Danish: Hvad forventedes Lenalidomide Celgene Europe anvendt til?
English: How is Lenalidomide Celgene Europe expected to work?
Danish: Hvordan forventes Lenalidomide Celgene Europe at virke?
English: --1 Live attenuated Muscovy duck parvovirus ≥ 2.6 log10 CCID50 * * Cell culture infectious dose 50%
Danish: --1 Levende attenueret parvovirus fra moskusand ≥ 2.6 log10 CCID50 *
English: Packaging Content Package size
Danish: Indhold Paknings størrelse
English: 10 bags + 10 trocars
Danish: 10 poser + 10 trokarer
English: 1 bag + 1 trocar
Danish: 1 pose + 1 trokarer
English: Strength Pharmaceutical form
Danish: EU (MA) Nummer Særnavn Styrke Lægemiddelform Dyrearter som lægemidlet er beregnet til
English: This summary was last updated in 12-2016.
Danish: Dette sammendrag blev sidst ajourført 12-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Relistor on 2 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Relistor den 2. juli 2008.
English: These side effects are generally mild or moderate.
Danish: Disse bivirkninger er sædvanligvis lette eller moderate.
English: The percentages of successful injections for the two groups were around 30% and 9%, respectively.
Danish: Procentdelen af vellykkede injektioner i de to grupper var henholdsvis ca. 30 % og 9 %.
English: The dose depends on the patient's body weight.
Danish: Dosen afhænger af patientens kropsvægt.
English: The full EPAR for Relistor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Relistor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Relistor.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Relistor.
English: Other information about Relistor
Danish: Andre oplysninger om Relistor
English: This means that it blocks a specific type of opioid receptor called the ‘mu-opioid receptor'.
Danish: Det betyder, at det blokerer en særlig type opioidreceptor kaldet "mu-opioid-receptoren".
English: The Agency's Committee for Medicinal Products for Human Use decided that Relistor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Relistor opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: What measures are being taken to ensure the safe and effective use of Relistor?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Relistor?
English: The dose of Relistor should be reduced in patients who have severe kidney problems.
Danish: Dosen af Relistor bør nedsættes for patienter med svære nyreproblemer.
English: Relistor methylnaltrexone bromide
Danish: Relistor methylnaltrexonbromid
English: What is Relistor and what is it used for?
Danish: Hvad er Relistor, og hvad anvendes det til?
English: Relistor can only be obtained with a prescription.
Danish: Relistor udleveres kun efter recept.
English: For more information about treatment with Relistor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Relistor, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Relistor has also been compared with placebo in a third study involving 496 patients with constipation caused by opioids, but no advanced illness.
Danish: Relistor er blevet sammenlignet med placebo i en tredje undersøgelse omfattende 496 patienter med forstoppelse forårsaget af opioider, men uden fremskreden sygdom.
English: Why is Relistor approved?
Danish: Hvorfor blev Relistor godkendt?
English: It is not intended to provide practical advice on how to use Relistor.
Danish: Det er ikke en praktisk vejledning i, hvordan Relistor bør anvendes.
English: The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal pain (stomach ache), nausea (feeling sick), diarrhoea and flatulence.
Danish: De hyppigste bivirkninger ved Relistor (som optræder hos flere end 1 ud af 10 patienter) er mavesmerter, kvalme, diarré og flatulens.
English: Relistor is usually injected under the skin of the upper legs, belly or upper arms.
Danish: Relistor injiceres normalt under huden på lårene, maven eller overarmene.
English: Relistor is not recommended for patients who have very severe kidney problems that require dialysis (a blood clearance technique).
Danish: Relistor anbefales ikke til patienter med meget svær nyresygdom, som kræver dialyse (en blodrensningsteknik).
English: Relistor is used to treat constipation caused by opioid painkillers (such as morphine) when laxative medicines have not worked well enough.
Danish: Relistor anvendes til behandling af forstoppelse forårsaget af opioide smertestillende midler (såsom morfin), når afføringsmidler ikke er tilstrækkelige.
English: Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Danish: Methylnaltrexonbromid fremstilles af naltrexon, som er et velkendt stof, der anvendes til at blokere virkningen af opioider.
English: By blocking these receptors, Relistor reduces the constipation due to opioids, but does not interfere with their painkilling effects.
Danish: Ved at blokere disse receptorer, reducerer Relistor forstoppelse, som skyldes opioider, uden at hindre midlets smertestillende virkning.
English: Relistor must not be used in patients whose bowel is blocked, who are at risk of recurrent bowel blockage or who have a condition that needs immediate bowel surgery.
Danish: Relistor må heller ikke anvendes hos patienter, hvis tarme er blokerede, som risikerer gentagne blokeringer af tarmene, eller som lider af en sygdom, der kræver øjeblikkelig tarmoperation.
English: What are the risks associated with Relistor?
Danish: Hvilke risici er der forbundet med Relistor?
English: The active substance in Relistor, methylnaltrexone bromide, is a ‘mu-opioid receptor antagonist'.
Danish: Det aktive stof i Relistor, methylnaltrexonbromid, er en "mu-opioid-receptorantagonist".
English: Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Danish: Opioider lindrer smerte ved at binde sig til "opioidreceptorerne" i hjernen og rygmarven.
English: For practical information about using Relistor, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Relistor, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Methylnaltrexone bromide is less able to enter the brain than naltrexone, meaning that it blocks the mu-opioid receptors in the gut but not in the brain.
Danish: Det er sværere for methylnaltrexonbromid at få adgang til hjernen, end det er for naltrexon, hvilket betyder, at det blokerer mu-opioid-receptorerne i mave-tarm-kanalen, men ikke i hjernen.
English: Relistor contains the active substance methylnaltrexone bromide.
Danish: Relistor indeholder det aktive stof methylnaltrexonbromid.
English: In patients not on palliative care, Relistor is given as an injection under the skin at a dose of 12 mg once a day, for at least 4 days per week and up to 7 days per week as needed; treatment with usual laxatives should be stopped when starting Relistor.
Danish: Til patienter, der ikke modtager palliativ behandling, gives Relistor som en injektion under huden i en dosis på 12 mg én gang om dagen i mindst 4 dage pr. uge og højst 7 dage pr. uge efter behov.
English: For the full list of all side effects reported with Relistor, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Relistor fremgår af indlægssedlen.
English: The second study also looked at the number of patients who had a bowel movement at least twice within four hours of the first four doses.
Danish: I den anden undersøgelse så man også på antallet af patienter med udtømning af tarmene mindst to gange inden for fire timer efter de første fire doseringer.
English: Results showed that 34% of patients receiving Relistor (102 out of 298) had a bowel movement within four hours after the first injection, compared with 10% of those receiving placebo (16 out of 162).
Danish: Resultaterne viste, at 34 % af de patienter, der fik Relistor (102 out of 298), opnåede udtømning af tarmene inden for fire timer efter den første injektion sammenlignet med 10 % af de patienter, der modtog placebo (16 ud af 162).
English: When opioids attach to the gut receptors, the mobility of the gut is reduced, leading to constipation.
Danish: Når opioider binder sig til mave-tarm-kanalens receptorer, reduceres mave-tarm-kanalens mobilitet, hvilket medfører forstoppelse.
English: The main measures of effectiveness were the number of patients who had a bowel movement within four hours of the first dose, and the percentage of injections that were successful in producing a bowel movement.
Danish: Hovedeffektmålet var antallet af patienter med udtømning af tarmene inden for fire timer efter den første dosis og procentdelen af injektioner, som medførte udtømning af tarmene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relistor have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Relistor.
English: In the second study, 52% of the patients receiving Relistor had a bowel movement at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
Danish: I den anden undersøgelse opnåede 52 % af de patienter, der fik Relistor, udtømning af tarmene mindst to gange inden for de første fire timer efter de første fire doser (32 ud af 62), sammenlignet med 8 % af de patienter, der fik placebo (6 ud af 71).
English: How is Relistor used?
Danish: Hvordan anvendes Relistor?
English: Looking at the results of the two studies taken together, 55% of the patients receiving Relistor had a bowel movement within four hours of the first dose (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
Danish: Af de to undersøgelsers sammenlagte resultater fremgik det, at 55 % af de patienter, der fik Relistor, opnåede udtømning af tarmene inden for fire timer efter den første dosis (91 ud af 165), sammenlignet med 15 % af de patienter, der fik placebo (18 ud af 123).
English: The main measure of effectiveness in both studies was the number of patients who had a bowel movement within four hours of the first dose.
Danish: I begge undersøgelser var hovedeffektmålet antallet af patienter med udtømning af tarmene inden for fire timer efter den første dosis.
English: Patients can inject Relistor themselves once they have been trained appropriately.
Danish: Når patienterne har fået tilstrækkelig undervisning, kan de selv begynde at foretage injektionen.
English: What benefits of Relistor have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Relistor?
English: It is available as a solution for injection in vials or in prefilled syringes.
Danish: Det fås som en injektionsvæske, opløsning, i hætteglas eller i fyldte injektionssprøjter.
English: How does Relistor work?
Danish: Hvordan virker Relistor?
English: These receptors are also found in the gut.
Danish: Disse receptorer findes også i mave-tarm-kanalen.
English: Relistor was shown to be more effective than placebo (a dummy treatment) at stimulating bowel movement in two main studies involving a total of 288 patients with an advanced illness and constipation caused by opioids.
Danish: I to hovedundersøgelser, som omfattede i alt 288 patienter med fremskreden sygdom og forstoppelse forårsaget af opioider, viste Relistor sig at være mere effektivt end placebo (en virkningsløs behandling) til at stimulere tarmmotorikken.
English: In patients who are receiving palliative care (treatment of the symptoms of a serious disease that is not intended to lead to cure), Relistor is given as an injection under the skin, once every two days, in addition to the usual laxative medicines.
Danish: Det gives som en injektion under huden én gang hver anden dag ud over de sædvanlige afføringsmidler.
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal blive enig med de nationale kompetente myndigheder om indholdet af undervisningsprogrammet og skal implementere sådan et program nationalt for at sikre, at alle læger får en informationspakke til sundhedspersonale før receptudskrivelse indeholdende det følgende:
English: • Information on the identified and potential risks.
Danish: • Information om erkendte og potentielle risici
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Danish: • Produktresumé (SPC) og indlægsseddel og mærkning
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse beskrevet nedenfor bliver implementeret:
English: Key elements to be included in the educational material
Danish: Vigtige elementer at have i uddannelsesmaterialet
English: • Information on gel depot formation and possible injections site reactions
Danish: • Information om geldannelse og mulige reaktioner ved injektionsstedet
English: • Educational material
Danish: • Uddannelsesmateriale
English: • Instructions for administration
Danish: • Instruktioner for anvendelse
English: • Posology
Danish: • Dosering
English: The Reference Member States were Germany, Hungary, Norway, Poland, Slovakia, Spain, United Kingdom.
Danish: De berørte medlemsstater var Tyskland, Ungarn, Norge, Polen, Slovakiet, Spanien og Det Forenede Kongerige.
English: The CHMP appointed Dr. J.F.F.
Danish: CHMP udnævnte dr. J.F.F.
English: 1 Article 29(2) of Directive 2001/83/EC, as amended.
Danish: 1 Artikel 29, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
English: A positive opinion was adopted 28 June 2006.
Danish: En positiv udtalelse blev vedtaget den 28. juni 2006.
English: These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Disse medlemsstater har ikke kunnet nå til enighed om en gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.