FrancophonIA/ELRC3.0 huggingface dataset:
English: In this review, the CHMP assessed all of the available information on the safety and efficacy of veralipride.
Danish: I denne gennemgang vurderede CHMP alle de foreliggende oplysninger om sikkerheden og virkningen af veraliprid.
English: Following reports of serious side effects affecting the nervous system, the Spanish National Competent Authority concluded that its benefits did not outweigh its potential risks.
Danish: Efter indberetninger om alvorlige bivirkninger fra nervesystemet konkluderede de kompetente spanske myndigheder, at produktets fordele ikke opvejer dets potentielle risici.
English: Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/risk assessment of veralipride.
Danish: Europa-Kommissionen indledte derfor en indbringelsesprocedure den 7. september 2006 og anmodede CHMP om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for produkter indeholdende veraliprid burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU efter vurdering af disse sikkerhedsrisici og deres betydning for benefit/risk-vurderingen for veraliprid.
English: Most of them occurred beyond 3 months of treatment.
Danish: De fleste satte ind efter mere end tre måneders behandling.
English: This included mainly 11 studies involving around 600 women, in which veralipride was compared with placebo, and two studies in around 100 women where it was compared with conjugated oestrogens.
Danish: Oplysningerne bestod hovedsagelig i 11 undersøgelser med tilsammen ca. 600 kvindelige patienter, hvor veraliprid blev sammenlignet med placebo, og to andre undersøgelser med tilsammen ca. 100 kvindelige patienter, hvor det blev sammenlignet med konjugerede østrogener.
English: The absence of cases of suggestive QT-prolongation in the database is not sufficient to conclude that this effect does not occur with veralipride.
Danish: At der i databasen ikke findes tilfælde, der tyder på QT-forlængelse, er ikke tilstrækkeligt til at konkludere, at denne effekt ikke optræder i forbindelse med veraliprid.
English: In addition, some of these side effects can occur not only during treatment, but also after it is stopped and it is also impossible to predict which women may be at risk.
Danish: Desuden indtræder visse af disse bivirkninger ikke kun under behandlingen, men også efter behandlingsophør, og det ikke muligt at forudsige, hvilke kvinder der er udsat.
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, INDEHAVER AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: However, cases of tardive dyskinesia have also been reported within the first 3 months of treatment.
Danish: Der er imidlertid også beskrevet tilfælde af tardiv dyskinesi inden for de første 3 måneders behandling.
English: In addition, hyperprolactinemia and the risk of QT prolongation are also concerns;
Danish: Også hyperprolaktinæmi og risikoen for QT-forlængelse giver anledning til betænkelighed
English: No studies were performed to evaluate whether veralipride has an effect on QT.
Danish: Der blev ikke udført undersøgelser til vurdering af, om veraliprid har indvirkning på QT-intervallet.
English: The CHMP therefore concluded on 19 July 2007 that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Danish: CHMP konkluderede derfor den 19. juli 2007, at benefit/risk-forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser.
English: The proposal of close monitoring including neurological examination after each 20 day treatment cycle might reduce these risks, but is a measure of considerable burden to both patient and doctor.
Danish: Den foreslåede tætte overvågning, herunder neurologisk undersøgelse for hver 20 dages behandling, vil muligvis mindske denne risiko, men vil være en betydelig byrde for både patient og læge.
English: Therefore, the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing veralipride throughout Europe.
Danish: CHMP anbefalede derfor tilbagekaldelse af alle markedsføringstilladelser for lægemidler indeholdende veraliprid i hele EU.
English: It has to be noted that tardive dyskinesias are not predictable and can develop even after the treatment has been discontinued.
Danish: Det må bemærkes, at tardive dyskinesier ikke er forudsigelige og kan sætte ind selv efter behandlingsophør.
English: Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c, B-1831 Diegem
Danish: Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c
English: The CHMP also looked at other small studies.
Danish: En række andre små undersøgelser blev desuden taget i betragtning af CHMP.
English: But the effect of hyperprolactinemia in women with history of breast cancer is not elucidated.
Danish: Effekten af hyperprolaktinæmi hos kvinder med brystkræft i anamnesen er imidlertid ikke udredt.
English: -Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
Danish: -Indskrænkning af behandlingsvarigheden til 3 måneder kombineret med undersøgelse en gang om måneden med henblik på at begrænse psykiske og neurologiske bivirkninger.
English: However, tardive dyskinesia may still occur within the first 3 months of treatment.
Danish: Tardiv dyskinesi kan imidlertid sætte ind i løbet af de første 3 måneders behandling.
English: Regulatory actions were also taken in some other EU Member States where the product is authorised and veralipride's product information was restricted with the aim to reduce the risk of patients developing side effects.
Danish: Også i visse andre EU-medlemsstater, hvor produktet er godkendt, greb tilsynsmyndighederne ind og indførte begrænsninger i produktinformationen med henblik på at mindske risikoen for bivirkninger.
English: -Introduction of the contraindications in patients with Parkinson's disease, or in combination with other neuroleptics and dopaminergic agonists.
Danish: -Indførelse af kontraindikationerne Parkinsons sygdom og kombination med andre neuroleptika og dopaminagonister.
English: As for the other adverse events related with the blockage of the dopamine receptor, especially hyperprolactinemia is a concern.
Danish: Af de øvrige bivirkninger, der er knyttet til blokering af dopaminerge receptorer, giver især hyperprolaktinæmi anledning til betænkelighed.
English: Overall, the restriction to limit the use of veralipride to 3 months in combination with monthly medical neurological examinations and breast monitoring is not considered adequate to limit the risk of all adverse effects reported with veralipride and adequately treat the vasomotor symptoms associated with the menopause.
Danish: Overordnet anses begrænsningen af anvendelsen af veraliprid til 3 måneder, kombineret med månedlige neurologiske undersøgelser og overvågning af brysterne, ikke for tilstrækkelig til at begrænse risikoen for alle de bivirkninger, der er indberettet for veraliprid, og samtidig tilfredsstillende behandle de vasomotoriske symptomer forbundet med menopausen.
English: -Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
Danish: -Anbefalinger om lægelig overvågning af brysterne og intermitterende doseringsplan (20 dage efterfulgt af 10 dage uden behandling) for at mindske risikoen for hyperprolaktinæmi med henblik på at øge sikkerheden for brysterne (det vides dog ikke, om denne foranstaltning har nogen virkning på det iagttagne bivirkningsmønster knyttet til hyperprolaktinæmi, således mammahypertrofi, galaktorré og risici for patienter med prolaktinafhængige tumorer som f.eks. hypofyse-prolaktinom og brystcancer).
English: In addition, the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Danish: Desuden var undersøgelserne for kortvarige til at give tilstrækkelig mulighed for at vurdere, om virkningen vedblev.
English: The proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.
Danish: Den foreslåede intermitterende behandling på 20 dage efterfulgt af en 10-dages behandlingsfri periode kan muligvis dæmpe effekten på prolaktinindholdet, men det vides ikke, om den vil få indflydelse på bivirkningsmønsteret.
English: The CHMP took note of the MAH's proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
Danish: CHMP noterede sig de forslag til begrænsning af sådanne risici, der var stillet af indehaveren af markedsføringstilladelsen, og hvoraf nogle allerede var indført i nogle stater, således:
English: Member State Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelse Særnavn
English: • The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
Danish: • udvalget konkluderede på baggrund af de foreliggende data, at risiciene ved anvendelse af veraliprid til behandling af hedeture i forbindelse med menopausen opvejer de begrænsede fordele.
English: In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Danish: På baggrund af de foreliggende kliniske data konkluderede CHMP, at de risici, der er forbundet med anvendelse af veraliprid til behandling af hedeture forbundet med menopausen, især de neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson-syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), opvejer de begrænsede fordele.
English: Sanofi-Synthelabo S.P.A. via Messina, 38
Danish: via Messina, 38
English: Veralipride treatment is contra-indicated in patients with prolactindependent tumours such as pituitary gland prolactinoma and breast cancer.
Danish: Veraliprid er kontraindiceret ved prolaktinafhængige tumorer som f.eks. prolaktinomer i hypofysen samt brystkræft.
English: -Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
Danish: -Indførelse af advarsler om neuroleptikas klassevirkninger (malignt neuroleptikasyndrom, QTforlængelse, tardiv dyskinesi) og abstinenssymptomer som angst og depressivt syndrom.
English: In order to avoid psychiatric AE, extrapyramidal symptoms and tardive dyskinesia, the MAH proposed a maximally allowed duration of 3 months veralipride treatment.
Danish: For at undgå psykiske bivirkninger, ekstrapyramidale symptomer og tardiv dyskinesi foreslog indehaveren af markedsføringstilladelsen, at den tilladte behandlingsvarighed med veraliprid begrænses til 3 måneder.
English: The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Danish: (Der blev således som regel ikke angivet baseline-værdier, hvorfor fyldestgørende vurdering af den observerede bedring ikke er mulig, og hverken den statistiske signifikans eller kliniske betydning af virkningen kan kvantificeres nøjagtigt, da den statistiske plan var uklar eller helt manglede, og da beskrivelsen af resultaterne var mangelfuld.)
English: In addition, the effect size cannot be accurately quantified due to methodological shortcomings and the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Danish: Desuden kan virkningens størrelse ikke bestemmes nøjagtigt, da undersøgelserne var for kortvarige til at muliggøre en fyldestgørende vurdering af, om virkningen vedblev.
English: Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QTprolongation are considered a concern.
Danish: I forbindelse med anvendelse af veraliprid er beskrevet tilfælde af uforudsigelig og potentielt irreversibel tardiv dyskinesi samt tidlige ekstrapyramidale symptomer, depression, angst og abstinenssyndrom; sammen med risikoen for hyperprolaktinæmi og for QT-forlængelse, der er en klasseeffekt, findes disse risici at give anledning til betænkelighed.
English: Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptoms associated with the menopause.
Danish: Veraliprid er et neuroleptikum i benzamidgruppen, som er indiceret til behandling af vasomotoriske symptomer knyttet til menopausen.
English: The CHMP concluded that the data submitted showed only limited effect of veralipride in the treatment of vasomotor symptoms associated with the menopause.
Danish: CHMP konkluderede, at de forelagte data kun viser begrænset virkning af veraliprid til behandling af vasomotoriske symptomer knyttet til menopausen.
English: • The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
Danish: • udvalget tog i betragtning, at der i forbindelse med anvendelse af veraliprid er beskrevet neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson-syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), herunder potentielt irreversibel tardiv dyskinesi.
English: It should be noted that in the evaluation of the causality assessment of veralipride in the psychiatric events, the role of veralipride is not always clear.
Danish: Det må her bemærkes, at det ikke altid klart fremgår, hvordan årsagssammenhængen med veraliprid er blevet vurderet.
English: Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotor symptoms associated with the menopause.
Danish: De forelagte oplysninger synes at vise, at veraliprid har virkning på vasomotoriske symptomer knyttet til menopausen.
English: • The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause;
Danish: • udvalget fandt, at de forelagte data kun viser begrænset virkning af veraliprid til behandling af hedeture knyttet til menopausen
English: Psychiatric adverse events mainly referred to depressive and anxiety states have also been reported with veralipride.
Danish: Desuden er der i forbindelse med veraliprid beskrevet psykiske bivirkninger, hovedsagelig depression og angst.
English: • The Committee, as a consequence, concluded that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Danish: • CHMP konkluderede derfor, at benefit/risk-forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser anbefalede CHMP tilbagekaldelse af markedsføringstilladelserne for de i bilag I omhandlede lægemidler indeholdende veraliprid.
English: GROUNDS FOR THE WITHDRAWAL OF THE MA
Danish: BEGRUNDELSE FOR TILBAGEKALDELSEN AF MARKEDSFØRINGSTILLADELSEN
English: Neurological adverse events referred to extrapyramidal symptoms and particularly tardive dyskinesias have been reported with veralipride and represent a real concern due to their potential seriousness and irreversibility.
Danish: De neurologiske bivirkninger vedrørte ekstrapyramidale symptomer, specielt er der beskrevet tardiv dyskinesi.
English: • The risk of infections, including opportunistic infections, and the contraindication for use in
Danish: • Risikoen for infektioner, inklusive opportunistiske infektioner samt kontraindikation for anvendelse
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide Teva with a physician educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Leflunomid Teva forsynes med informationsmateriale til lægerne, indeholdende følgende:
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory
Danish: Læger og patienter skal gøres opmærksomme på, at at der findes en ad hocinformationsservice, som rådgiver i forbindelse med laboratorietests af leflunomid i plasma.
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of
Danish: Informationen i folderen bør oplyse om reduktion af dosis, afbrydelse af behandling samt udvaskningsprocedure.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
Danish: • Information om den identificerede risiko for synergistisk hepato- eller hæmatotoksicitet forbundet med kombinationsbehandling med andre DMARDs (Disease-Modifying Antirheumatic Drugs)
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Danish: • At der er risiko for alvorlig leverskade, og det derfor er vigtigt med regelmæssige målinger af ALAT for at overvåge leverfunktionen.
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Danish: • Behovet for rådgivning af patienter om vigtige risici i forbindelse med behandling med leflunomid
English: The application was withdrawn before ‘day 120'.
Danish: Ansøgningen blev trukket tilbage inden ”dag 120”.
English: Treatment lasted between six months and a year.
Danish: Behandlingen varede mellem seks måneder og et år.
English: They may also block the multiplication of viruses.
Danish: Muligvis blokerer de også formeringen af virus.
English: The effects of Joulferon were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Joulferon blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: What is Joulferon?
Danish: Hvad er Joulferon?
English: The company informed the CHMP that the withdrawal has no impact on ongoing clinical trials, and that it will continue to make Joulferon available to patients enrolled in these trials.
Danish: Virksomheden meddelte CHMP, at tilbagetrækningen ikke får nogen konsekvenser for igangværende kliniske undersøgelser, og at den fortsat vil gøre Joulferon tilgængelig for patienter, der deltager i sådanne undersøgelser.
English: The company presented the results of two main studies involving a total of 2,255 adults with hepatitis C infection who had not previously been treated.
Danish: Virksomheden fremlagde resultaterne af to hovedundersøgelser af i alt 2 255 voksne smittet med hepatitis C, som ikke tidligere var blevet behandlet.
English: Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Danish: Interferoner er naturlige stoffer, der dannes af kroppen, og som er med til at bekæmpe angreb mod kroppen såsom infektioner forårsaget af vira.
English: On 16 April 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joulferon, for the treatment of hepatitis C infection.
Danish: Den 16. april 2010 meddelte Novartis Europharm Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Joulferon til behandling af hepatitis C-smitte tilbage.
English: The exact way that they work in treating viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).
Danish: Det vides endnu ikke med nøjagtighed, hvordan interferoner virker mod virussygdomme, men det formodes, at de fungerer som immunomodulatorer (stoffer, der ændrer den måde, hvorpå immunsystemet fungerer).
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Danish: Da CHMP var i færd med at vurdere den dokumentation, som virksomheden oprindelig havde fremlagt, var der endnu ikke fremsat nogen anbefalinger.
English: This means that the CHMP was still evaluating the initial documentation provided by the company.
Danish: Det betyder, at CHMP stadig var i færd med at vurdere den dokumentation, som virksomheden oprindelig havde fremlagt.
English: The main measure of effectiveness was based on the level of hepatitis C virus circulating in the blood six months after the end of treatment.
Danish: Behandlingens virkning blev hovedsageligt bedømt på grundlag af den mængde hepatitis C-virus, der cirkulerede i blodet seks måneder efter endt behandling.
English: What was Joulferon expected to be used for?
Danish: Hvad forventedes Joulferon anvendt til?
English: Joulferon is a powder and solvent to be made up into a solution for injection.
Danish: Joulferon er et pulver og en solvens, der blandes til en opløsning til injektion.
English: How is Joulferon expected to work?
Danish: Hvordan forventes Joulferon at virke?
English: Albinterferon alfa-2b is a ‘fusion protein' made up of interferon alfa-2b, which is already available in antiviral medicines in the European Union (EU), attached to a protein called albumin.
Danish: Albinterferon alfa-2b er et ”fusionsprotein”, som består af interferon alfa-2b, der allerede findes i antivirale lægemidler i EU, og som er bundet til et protein kaldet albumin.
English: It was to be used in adults whose liver was damaged and who had not previously been treated with interferon alfa (another medicine for hepatitis C).
Danish: Det skulle have været brugt til voksne, hvis lever var beskadiget, og som ikke tidligere havde været behandlet med interferon alfa (et andet lægemiddel til behandling af hepatitis C).
English: Attaching the interferon to albumin helps to prolong its action against the hepatitis C virus after each injection.
Danish: Når interferon bindes til albumin, forlænges dets virkning mod hepatitis C-virus efter hver injektion.
English: It was to be available as an injection pen and as vials.
Danish: Det skulle have været leveret som injektionspen og hætteglas.
English: It contains the active substance albinterferon alfa-2b.
Danish: Det indeholder det aktive stof albinterferon alfa-2b.