FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the uncertainties around the exact mechanism of action of the immune-mediated liver injury and as the risk of hepatitis B reactivation with daclizumab has not been characterised, the PRAC recommended that patients should be screened for these viruses prior to treatment initiation.
Danish: Da der hersker usikkerhed om den nøjagtige virkningsmekanisme, hvad angår immunmedieret leverskade, og da risikoen for reaktivering af hepatitis B ved brug af daclizumab ikke er beskrevet, anbefaler PRAC, at patienterne bør screenes for disse virusser inden behandlingsstart.
English: The efficacy of daclizumab was demonstrated in two pivotal studies in subjects with relapsing remitting multiple sclerosis (RRMS) that led to the indication in relapsing multiple sclerosis.
Danish: Effekten af daclizumab blev påvist i to hovedundersøgelser af patienter med recidiverende remitterende multipel sklerose (RRMS), og det førte til indikationen recidiverende multipel sklerose.
English: Physicians should consider discontinuing therapy if an adequate response has not been achieved or the patient fails to follow the requirement for scheduled liver test monitoring.
Danish: Lægerne bør overveje at seponere behandlingen, hvis der ikke ses tilstrækkeligt respons, eller hvis patienten ikke kommer til de planlagte leverkontroller.
English: • The PRAC reviewed the totality of the data provided by the marketing authorisation holder on cases of serious liver injury reported since the initial marketing authorisation and safety and efficacy data from clinical trials, in relation to the overall risk of liver injury with daclizumab.
Danish: • PRAC gennemgik alle markedsføringstilladelsesindehaverens indsendte data om tilfælde af alvorlig leverskade, der var indberettet siden den første markedsføringstilladelse, samt sikkerheds- og effektdata fra kliniske undersøgelser, hvad angår den samlede risiko for leverskade ved brug af daclizumab.
English: Furthermore, PRAC recommended that all patients are informed about signs or symptoms suggestive of liver dysfunction and promptly referred to a hepatologist in case of such signs or symptoms.
Danish: PRAC anbefaler derudover, at alle patienter orienteres om, hvilke tegn og symptomer der tyder på nedsat leverfunktion, og omgående henvises til en leverspecialist ved sådanne tegn og symptomer.
English: The PRAC thus considered that further measures to those implemented as part of the provisional measures were justified to minimise this risk and, in view of its unpredictable and potentially fatal nature, to limit the use of the medicinal product.
Danish: Derfor vurderer PRAC, at det er relevant at gennemføre yderligere tiltag som supplement til dem, der allerede er gennemført som led i de foreløbige foranstaltninger, for at minimere risikoen for leverskade, samt at begrænse anvendelsen af lægemidlet, da denne risiko er uforudsigelig og potentielt dødelig.
English: To complement the laboratory follow-up, it was considered key by the SAG and the PRAC, that patients should be informed about the risk of hepatic injury, and warned about signs or symptoms suggestive of hepatic dysfunction.
Danish: Som supplement til laboratorieopfølgningen anser den rådgivende gruppe og PRAC det for meget væsentligt, at patienterne informeres om risikoen for leverskade og orienteres om tegn og symptomer, der tyder på nedsat leverfunktion.
English: The occurrence of a fatal case of fulminant liver failure despite adherence to the risk minimisation measures implemented before this procedure, including monthly liver monitoring, was particularly of concern.
Danish: Det er navnlig bekymrende, at der forekom et dødeligt tilfælde af fulminant leversvigt, selvom man overholdt de risikominimerende foranstaltninger, der var iværksat før denne procedure, herunder månedlig overvågning af leverfunktionen.
English: Overall, considering the data available, the occurrence of daclizumab induced liver injury is considered to be unpredictable.
Danish: Ud fra de samlede data vurderes det at være uforudsigeligt, hvor ofte der forekommer daclizumab-induceret leverskade.
English: Daclizumab treatment also resulted in clinically meaningful slowing of the accumulation of neurological disability as measured by both clinician-assessed and patient-reported outcome measures.
Danish: Behandling med daclizumab gav også klinisk betydningsfulde resultater i form af en langsommere akkumulering af neurologiske funktionsnedsættelser i henhold til både klinikernes vurdering og patienternes egen oplevelse.
English: The CHMP discussed the recommended wording of the indication, in particular that restricting daclizumab treatment to patients for whom another disease modifying therapy is contraindicated or otherwise unsuitable, and considered that for clarity it should be stated that this relates to any other disease modifying therapy.
Danish: CHMP har drøftet den anbefalede formulering af indikationen, navnlig hvad angår begrænsningen af daclizumab-behandling til patienter, hos hvem behandling med andre sygdomsmodificerende midler er kontraindiceret eller på anden måde uhensigtsmæssigt, og vurderer, at det af hensyn til klarheden bør anføres, at dette henviser til alle andre sygdomsmodificerende midler.
English: The PRAC considered all the data provided by the MAH on cases of liver injury that occurred since the marketing authorisation, including a recent fatal case of fulminant liver failure, as well as safety and efficacy data from clinical trials with daclizumab, in relation to the overall risk of liver injury with daclizumab.
Danish: PRAC gennemgik alle de data om tilfælde af leversvigt opstået efter markedsføringstilladelsen, som indehaveren af markedsføringstilladelsen havde indsendt, herunder et nyligt tilfælde af fulminant leverskade, samt sikkerheds- og effektdata fra kliniske undersøgelser af daclizumab, hvad angår den samlede risiko for leverskade ved brug af daclizumab.
English: Administration of daclizumab with other medicinal products of known hepatotoxic potential should be done with caution.
Danish: Der bør udvises forsigtighed ved samtidig administration af daclizumab og andre lægemidler med kendt levertoksisk potentiale.
English: Taking into account the conclusions from the SAG that the use of the medicinal product should be restricted to patients who are unsuitable for treatment with other disease modifying therapies (DMTs), the PRAC considered that the identification of sub-groups within the target population (i.e. with highly active disease and with rapidly evolving severe disease) was not warranted and that the restriction of the use would apply to all patients with RMS who are unsuitable for treatment with other DMT.
Danish: På baggrund af den rådgivende gruppes konklusioner om, at anvendelsen af lægemidlet bør begrænses til patienter, der ikke er egnede til behandling med andre sygdomsmodificerende midler, vurderer PRAC, at det ikke er relevant at identificere delgrupper i målpopulationen (dvs. patienter med højaktiv sygdom og patienter med svær sygdom, der udvikler sig hurtigt), og at den begrænsede anvendelse bør gælde alle patienter med recidiverende multipel sklerose, der ikke er egnede til behandling med andre sygdomsmodificerende midler.
English: Discontinuation should also be considered if an adequate response has not been achieved or if the liver function monitoring is not adhered to.
Danish: Seponering bør også overvejes, hvis der ikke opnås tilstrækkeligt respons, eller hvis patienten ikke kommer til de planlagte leverkontroller.
English: However, in view of the seriousness of the reactions reported, leading in one case to a fatal outcome despite adherence to the RMMs, the EC considered that the impact of the risk of liver injury on the benefit-risk balance of the medicinal product and the adequacy of the related RMMs should be reviewed.
Danish: I betragtning af de alvorlige bivirkninger, der blev indberettet, og som i et tilfælde havde dødelig udgang til trods for, at de risikominimerende foranstaltninger blev overholdt, vurderede Kommissionen, at der bør foretages en gennemgang af, hvilken indvirkning risikoen for leverskade har på lægemidlets benefit/risk-forhold, og af, om de tilknyttede risikominimerende foranstaltninger er tilstrækkelige.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Danish: CHMP anbefaler derfor, at betingelserne for markedsføringstilladelserne for Zinbryta (daclizumab) ændres.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Danish: Udvalget anbefaler derfor, at betingelserne for markedsføringstilladelserne for Zinbryta (daclizumab) ændres.
English: Considering that immune-mediated conditions and autoimmune conditions have been reported in clinical trials, that the effect of daclizumab on other autoimmune disorders and the role of such disorder on daclizumab-induced liver injury is unknown, as also highlighted by the SAG, the PRAC considered that daclizumab treatment should not be recommended in patients with history of concurrent autoimmune conditions other than multiple sclerosis.
Danish: I betragtning af, at der er rapporteret om immunmedierede tilstande og autoimmune tilstande i kliniske undersøgelser, og af, at man ikke kender daclizumabs indvirkning på andre autoimmune forstyrrelser, herunder disse forstyrrelsers betydning for daclizumab-induceret leverskade, jf. den rådgivende gruppes betænkeligheder, vurderer PRAC, at daclizumab-behandling ikke bør anbefales hos patienter med samtidige autoimmune tilstande i anamnesen, ud over multipel sklerose.
English: In addition, considering the lack of clinical data in patients with pre-existent significant hepatic diseases as these were excluded from clinical trials, the seriousness of the hepatic adverse reaction, and the increased susceptibility of patients with basal hepatic disease to experience worsening of the hepatic impairment, the PRAC considered that daclizumab should be contraindicated in all patients with pre-existing hepatic disease or hepatic impairment.
Danish: Da der mangler kliniske data fra patienter med eksisterende signifikant leversygdom, fordi disse patienter har været udelukket fra kliniske undersøgelser, og i betragtning af de alvorlige hepatiske bivirkninger og det faktum, at den nedsatte leverfunktion hos patienter med primær leversygdom forværres yderligere, vurderer PRAC desuden, at daclizumab bør være kontraindiceret hos alle patienter med eksisterende leversygdom eller nedsat leverfunktion.
English: Based on the limited data available, any synergistic hepatotoxic effects in patients taking concomitant hepatotoxic medications on the liver injury caused by daclizumab could not be fully elucidated.
Danish: Med de begrænsede tilgængelige data er det ikke fuldt belyst, i hvilket omfang samtidige levertoksiske lægemidler har synergistisk levertoksisk indvirkning hos patienter med daclizumabinduceret leverskade.
English: The PRAC concluded that the benefit-risk balance remained positive, provided that Zinbryta is only used in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable and that changes are implemented in the product information to minimise the risk of serious liver injury.
Danish: PRAC konkluderer, at benefit/risk-forholdet stadig er positivt, forudsat at Zinbryta kun anvendes til behandling af voksne patienter med recidiverende multipel sklerose, der har udvist utilstrækkeligt respons på mindst to sygdomsmodificerende midler, og hos hvem behandling med et andet sygdomsmodificerende middel er kontraindiceret eller på anden måde uhensigtsmæssigt, og forudsat at der foretages ændringer i produktinformationen med henblik på minimering af risikoen for alvorlig leverskade.
English: Risk or predictive factors that may play a role on the occurrence of liver damage such as comorbidities, relation with dose, timing, genetic or biochemical markers could not be identified by the PRAC or the SAG.
Danish: herunder komorbiditeter, dosis, timing og genetiske eller biokemiske markører.
English: In view of the above, the Committee considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the agreed amendments to the product information and the additional risk minimisation measures.
Danish: På grundlag af ovenstående konkluderer PRAC, at benefit/risk-forholdet for Zinbryta (daclizumab) fortsat er positivt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen, og at de yderligere risikominimerende foranstaltninger gennemføres.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the amendments to the product information described above.
Danish: På baggrund af ovenstående vurderer CHMP, at benefit/risk-forholdet for Zinbryta (daclizumab) fortsat er positivt under forudsætning af, at de nævnte ændringer indføres i produktinformationen.
English: • As a consequence, the PRAC recommended restriction of the indication of daclizumab to the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable.
Danish: • På den baggrund anbefaler PRAC at begrænse indikationen for daclizumab til behandling af voksne patienter med recidiverende multipel sklerose (RMS), der har udvist utilstrækkeligt respons på mindst to sygdomsmodificerende midler, og hos hvem behandling med andre sygdomsmodificerende midler er kontraindiceret eller på anden måde uhensigtsmæssigt.
English: Therefore PRAC recommended that the indication of daclizumab should be restricted to the treatment of adult patients with RMS who have had an inadequate response to at least two DMTs and for whom treatment with another DMT is contraindicated or otherwise unsuitable.
Danish: Derfor anbefaler PRAC, at indikationen for daclizumab bør begrænses til behandling af voksne patienter med recidiverende multipel sklerose, der udviser utilstrækkelig respons på mindst to sygdomsmodificerende midler, og hos hvem behandling med et andet sygdomsmodificerende middel er kontraindiceret eller på anden måde uhensigtsmæssigt.
English: The Company submitted a total of seven studies, involving over 1,000 patients.
Danish: Firmaet har fremlagt i alt syv undersøgelser med tilsammen over 1 000 patienter.
English: International Non-proprietary Name (INN): besilesomab
Danish: Internationalt fællesnavn (INN): besilesomab
English: London, 1 June 2006 Doc.Ref.
Danish: London, den 1.juni 2006 Ref.dok.
English: The Company will continue to supply this product in the countries where the product is authorised nationally (Czech Republic, Hungary and Sweden).
Danish: Firmaet vil fortsat levere produktet i de lande, hvor det er godkendt nationalt (Tjekkiet, Ungarn og Sverige).
English: The application was at Day 120 when the Company withdrew it.
Danish: Denne ansøgning var på dag 120, da firmaet trak den tilbage.
English: In the European Union, this product has already been authorised in the Czech Republic, Hungary and Sweden, in 1993 and 1994, through national procedures, for similar indications.
Danish: I EU er produktet i forvejen godkendt nationalt i Tjekkiet, Ungarn og Sverige i 1993 og 1994 til tilsvarende indikationer.
English: The design of the main studies essentially focused on the safety and how well the medicine was tolerated by the patient.
Danish: Ved tilrettelæggelsen af hovedundersøgelserne var der hovedsagelig tænkt på sikkerheden og på, hvor godt lægemidlet tåles af patienterne.
English: SCINTIMUN contains the active substance besilesomab.
Danish: SCINTIMUN indeholder det aktive stof besilesomab.
English: What is SCINTIMUN?
Danish: Hvad er SCINTIMUN?
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF THE MARKETING APPLICATION for SCINTIMUN
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for SCINTIMUN
English: What were the main concerns of the CHMP?
Danish: Hvori bestod CHMPs vigtigste betænkeligheder?
English: Following CHMP opinion, it usually takes around 2 months for the European Commission to give a licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at udstede tilladelsen.
English: The CHMP had formulated a list of questions to be answered by the Company, and the Company had not responded to them.
Danish: CHMP havde opstillet en række spørgsmål, som firmaet skulle besvare, hvilket endnu ikke var sket.
English: If you are being treated, in a clinical trial or in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig denne behandling.
English: The effects of SCINTIMUN were first tested in experimental models before being studied in humans.
Danish: Virkningerne af SCINTIMUN er først testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
English: The Company has informed the CHMP that the ongoing clinical studies of SCINTIMUN will continue until completion.
Danish: Firmaet har oplyst til CHMP, at de igangværende kliniske undersøgelser med SCINTIMUN vil fortsætte, til de er gennemført.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
Danish: På grundlag af gennemgangen af den indledende dokumentation opstiller CHMP en række spørgsmål (på dag 120), der forelægges firmaet.
English: What were the reasons given by the Company to withdraw the application?
Danish: Hvilke grunde angav firmaet for tilbagetrækningen af ansøgningen?
English: Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining question(s) (at day 180).
Danish: Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (på dag 180).
English: This medicine was to be restricted for administration by healthcare professionals experienced on handling radioactive medicines only.
Danish: Lægemidlet måtte kun udleveres af specialuddannet sundhedspersonale med erfaring i brug af radioaktive lægemidler.
English: What was SCINTIMUN expected to be used for?
Danish: Hvad forventedes SCINTIMUN anvendt til?
English: What documentation has been presented by the Company to support the application to the CHMP?
Danish: Hvilken dokumentation har firmaet fremlagt i forbindelse med ansøgningen til CHMP?
English: The letter from the Company notifying the EMEA of the withdrawal of the application is available here.
Danish: Firmaets brev til EMEA med meddelelsen om tilbagetrækningen kan ses her.
English: SCINTIMUN is a white powder to be mixed with a radioactive substance (sodium pertechnetate (99mTc)), to make up a solution for intravenous injection.
Danish: SCINTIMUN er et hvidt pulver, der iblandes et radioaktivt stof (natrium pertechnetat (99mTc)) og efter opløsning indsprøjtes i en vene.
English: See here for information on outcome of resubmission.
Danish: Information om resultatet af denne genansøgning findes her.
English: On 17 May 2006, CIS bio international has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for SCINTIMUN, for diagnostic imaging to determine the location of infectious or inflammatory lesions and to detect metastases (when cancer spreads) in bone marrow.
Danish: Den 17. maj 2006 meddelte CIS bio international officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønskede at trække sin ansøgning om markedsføringstilladelse tilbage for SCINTIMUN, der er til brug ved diagnostisk scanning med henblik på lokalisering af betændelse eller betændelseslignende forandringer og til sporing af metastaser (spredning af kræftceller) i knoglemarven.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with SCINTIMUN?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse med SCINTIMUN?
English: They will also continue their compassionate use programme (where doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised) where those are available.
Danish: Firmaet vil desuden fortsætte programmet til anvendelse med særlig udleveringstilladelse (dvs. et program, hvor en læge kan anmode om udlevering af et lægemiddel til en bestemt sygdom, før lægemidlet er endeligt godkendt).
English: How is SCINTIMUN expected to work?
Danish: Hvordan forventes SCINTIMUN at virke?
English: Besilesomab is a monoclonal antibody (a type of protein that has been designed to recognise and bind to a specific structure called an antigen, that may be found on certain cells in the body).
Danish: Besilesomab er et monoklonalt antistof, dvs. en proteintype, hvis form bevirker, at det genkender og binder sig til en bestemt struktur, der kaldes et antigen, og findes på visse celler i organismen.
English: Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that SCINTIMUN could not be approved for diagnostic imaging to determine the location of infectious or inflammatory lesions and to detect metastases in bone marrow.
Danish: Efter gennemgang af de oplysninger, der forelå på tilbagetrækningstidspunktet, var der i CHMP betænkelighed, og udvalgets foreløbige standpunkt var, at SCINTIMUN ikke kunne godkendes til scanning til diagnoseformål med henblik på at lokalisere betændelse eller betændelseslignende forandringer eller spore metastaser i knoglemarv.
English: Those cells accumulate where infection and inflammation occur in the body and also in bone marrow.
Danish: Denne type celler samler sig på steder med infektion og betændelse, samt i knoglemarven.
English: SCINTIMUN was to be used in adults to locate an infection or inflammatory lesion and also to detect whether any metastasis is present in bone marrow.
Danish: SCINTIMUN skulle anvendes hos voksne til at lokalisere infektioner eller betændelseslignende forandringer og desuden til at spore metastaser i knoglemarven.
English: The radioactive accumulation can therefore be detected in areas of infection or inflammation, using a special camera that reveals the areas of radioactivity, as can the lack of radioactivity in bone marrow occupied by metastases.
Danish: Den ansamlede radioaktivitet kan derfor spores i områder med infektion eller betændelse ved hjælp af et særligt kamera.
English: After combination with the radioactive substance and administration, it binds to the antigen present on the surface of a certain type of blood cells, called granulocytes, bringing the radioactivity to them.
Danish: Det binder sig nu til antigenet på overfladen af de hvide blodlegemer og gør derved blodlegemerne radioaktive.
English: Information from scientific publications was presented to support the use of SCINTIMUN in detection of metastases in bone marrow.
Danish: Som dokumentation for brugen af SCINTIMUN til påvisning af metastaser i knoglemarv er anvendt oplysninger fra videnskabelige publikationer.
English: The studies as they were designed could not generate sufficient evidence of the diagnostic value of SCINTIMUN, and the Company is carrying out further work to provide more information on this medicine.
Danish: Undersøgelserne var tilrettelagt på en måde, så de ikke gav tilstrækkelig dokumentation for SCINTIMUNs brugbarhed til diagnoseformål.
English: Keep the bottle tightly closed.
Danish: Hold glasset tæt tillukket.
English: Please contact your veterinarian.
Danish: Kontakt venligst din dyrlæge.