FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 330 hepatic and biliary disorders were reported post-marketing, of which 49 involved liver failure and 15 had a fatal outcome or resulted in liver transplantation.
Danish: Der blev efter markedsføring indberettet i alt 330 tilfælde af hepatiske og biliære lidelser, hvoraf 49 omfattede leversvigt, og 15 havde fatalt udfald eller medførte levertransplantation.
English: • The PRAC is of the opinion that data from safety provide evidence for an increased risk of hepatotoxicity including cases with fatal outcome or resulted in liver transplantation when duration of treatment is longer than 2 weeks.
Danish: • PRAC finder, at sikkerhedsdataene viser øget hepatotoksisk risiko, herunder tilfælde med fatalt eller levertransplantationskrævende udfald, når behandlingsvarigheden er over 2 uger
English: Based on the current available data as described above, the PRAC concluded that flupirtine is associated with an increased risk of hepatotoxicity.
Danish: På grundlag af de beskrevne foreliggende data konkluderede PRAC, at flupirtin er forbundet med øget risiko for hepatotoksicitet.
English: For the treatment of acute pain, the PRAC recommended that the benefit still outweighs the hepatotoxicity risk when treatment with other analgesics (e.g. non-steroidal anti-inflammatory drugs, weak opioids) is contraindicated.
Danish: Til behandling af akutte smerter anbefalede PRAC, at fordelene stadig overstiger den hepatotoksiske risiko, når andre analgetika (f.eks. nonsteroide antiinflammatoriske lægemidler, svage opioider) er kontraindiceret.
English: • The PRAC reviewed all available data from clinical and non-clinical studies, epidemiological studies, spontaneous reports and published literature on the safety and efficacy of flupirtine containing medicinal products, as well as stakeholders' submissions in particular with regards to the risk of hepatotoxicity.
Danish: • PRAC gennemgik alle foreliggende data fra kliniske og ikke-kliniske undersøgelser, epidemiologiske undersøgelser, spontane indberetninger og den publicerede litteratur vedrørende sikkerheden og virkningen af lægemidler indeholdende flupirtin samt oplysninger fra interesserede parter, navnlig om risikoen for hepatotoksicitet
English: In order to ensure a favourable benefit/risk in this indication, PRAC concluded that treatment should be restricted to a maximum of 2 weeks.
Danish: For at sikre et positivt benefit/risk-forhold ved denne indikation konkluderede PRAC, at behandlingsvarigheden bør indskrænkes til højst 2 uger.
English: It is acknowledged that the majority of cases included concomitant medication known to have potential for hepatic adverse reactions and that the combination of COX-2 inhibitors or NSAIDs with flupirtine may significantly increase the severity of the hepato-biliary reactions.
Danish: Det vedgås, at der i størstedelen af tilfældene samtidig blev anvendt lægemidler med potentiale for hepatiske bivirkninger, og at kombinationen af COX-2-hæmmere eller NSAID med flupirtin i betydelig grad kan øge sværheden af de hepatobiliære reaktioner.
English: The PRAC also recommended that the MAH should submit a full risk management plan (RMP) within a certain timeframe.
Danish: PRAC anbefalede desuden, at indehaveren af markedsføringstilladelsen indsender en komplet risikostyringsplan (RMP) inden for en nærmere bestemt frist.
English: If liver function tests show pathological results your doctor will ask you to discontinue intake/use of <Product Name> immediately.
Danish: Hvis leverfunktionsprøverne viser, at der er noget galt, vil lægen bede dig om straks at holde op med at <tage><bruge> <lægemidlets navn>.
English: The CMDh having considered the PRAC recommendation dated 13 June 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC reached a position on the variation to the terms of the marketing authorisations of flupirtine containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Danish: Efter gennemgang af PRAC's anbefaling af 13. juni 2013 tog CMDh i henhold til artikel 107k, stk. 1 og 2, i direktiv 2000/83/EF stilling til ændringerne af betingelserne for markedsføringsgodkendelserne for lægemidler indeholdende flupirtin, for hvilke de relevante afsnit af produktresuméet og indlægssedlen er gengivet i bilag III, og betingelserne fremgår af bilag IV.
English: Herrmann WM: Final report: Investigation of the long-term tolerability of the analgesic flupirtine in patients who require analgesics regularly over long periods of time.
Danish: Herrmann WM: Final report: Investigation of the long-term tolerability of the analgesic flupirtin in patients who require analgesics regularly over long periods of time.
English: The PRAC also noted that according to the current scientific knowledge including the Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain (CPMP/EWP/612/00) clinical data of at least 3 months for the treatment of mild to moderately severe chronic back pain is required.
Danish: PRAC bemærkede desuden, at der i henhold til den gældende vejledning om klinisk undersøgelse af lægemidler til behandling af nociceptive smerter (CPMP/EWP/612/00) kræves kliniske data af mindst tre måneders varighed ved behandling af lette til moderate kroniske rygsmerter.
English: The PRAC reviewed the data submitted by the marketing authorisation holders and other stakeholders from clinical and non-clinical studies, epidemiological studies, spontaneous reports and published literature.
Danish: PRAC gennemgik alle de oplysninger, der var forelagt af indehaveren af markedsføringstilladelsen og andre involverede parter, herunder ikke-kliniske undersøgelser, epidemiologiske undersøgelser, spontane indberetninger og den publicerede litteratur.
English: The 100 mg immediate release capsules are available in all MSs.
Danish: 100 mg kapsler med hurtig udløsning markedsføres i alle disse medlemsstater.
English: Furthermore the PRAC agreed on additional pharmacovigilance activities and risk minimisation measures.
Danish: Endelig vedtog PRAC supplerende lægemiddelovervågning og risikominimeringsforanstaltninger.
English: The PRAC noted that based on clinical and histological features, the hepatotoxicity of flupirtine may be immune-mediated and that hepatotoxicity associated with flupirtine treatment may be type B or idiosyncratic adverse drug reaction.
Danish: PRAC bemærkede, at flupirtins hepatotoksicitet ud fra de kliniske og histologiske egenskaber kan være immunmedierede, og at den hepatotoksicitet, der forbundet med behandling med flupirtin, kan være en type B-bivirkning eller idiosynkratisk.
English: The PRAC endorsed a Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review to the healthcare professionals, in particular, the restricted indication and maximum duration of use and to highlight the risk of hepatotoxicity and the necessary measures needed to minimise this risk.
Danish: PRAC godkendte en direkte meddelelse til fagfolk i sundhedssektoren (DHPC) om resultatet af denne gennemgang, navnlig vedrørende den indskrænkede indikation og den maksimale behandlingsvarighed og med fremhævelse af risikoen for hepatotoksicitet og de foranstaltninger, der er nødvendige for at minimere denne risiko.
English: Your doctor will test liver function every week during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
Danish: Lægen vil undersøge leverfunktionen hver uge under behandlingen med <lægemidlets navn>, da der er indberettet stigninger i leverenzymer, hepatitis og leversvigt ved behandling med flupirtin.
English: In view of the risks of hepatotoxicity the PRAC considered there was a need to recommend further risk minimisation measures to ensure the safety and effective use in acute pain.
Danish: På baggrund af risikoen for hepatotoksicitet fandt PRAC det nødvendigt med yderligere risikominimeringsforanstaltninger for at garantere sikker og effektiv anvendelse ved akutte smerter.
English: The exact wording recommended by the PRAC to relevant sections of the Summary of Product Characteristics (SmPC) and Package Leaflet (PIL) are found in Annex III of this recommendation.
Danish: Den nøjagtige ordlyd, der anbefales af PRAC for de pågældende punkter i produktresuméet og indlægssedlen, fremgår af bilag III til denne anbefaling.
English: Furthermore the PRAC requested that the protocol of a Post Authorisation Safety Study (PASS) should be submitted within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Danish: Endvidere anmodede PRAC om, at der i forbindelse med indsendelse af risikostyringsplanen forelægges en protokol til en sikkerhedsundersøgelse efter markedsføring (PASS) for at vurdere effektiviteten af tiltagene til risikominimering.
English: If you observe any symptoms that may indicate hepatic damage during treatment with <Product Name> (e.g. loss of appetite, nausea, vomiting, abdominal discomfort, fatigue, dark urine, jaundice,
Danish: Hvis <De><du> iagttager symptomer, der kan tyde på leverskade under behandlingen med <lægemidlets navn> (f.eks. nedsat appetit, kvalme, opkastning, mavegener, træthed, mørk urin,
English: Herrmann WM: Investigation of the long-term tolerability of the analgesic flupirtine in patients who require analgesics regularly over a long period of time.
Danish: 5 Herrmann WM: Investigation of the long-term tolerability of the analgesic flupirtin in patients who require analgesics regularly over a long period of time.
English: These have been requested by PRAC for submission within the risk management plan.
Danish: PRAC har anmodet om, at dette materiale indsendes som en del af risikostyringsplanen.
English: The PRAC also agreed on the need of a risk management plan to be submitted together with a protocol for a drug utilisation study aiming to characterise prescribing practices during typical clinical use in representative groups of prescribers.
Danish: PRAC fandt desuden, at der skulle forelægges af en risikostyringsplan sammen med en protokol til en undersøgelse af lægemiddelanvendelse til karakterisering af typisk ordinationspraksis hos repræsentative grupper af ordinerende læger.
English: [Oral pharmaceutical forms and suppositories] Do not <take><use><Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Danish: [Orale lægemiddelformer og suppositorier] <Tag><brug> ikke <lægemidlets navn> hvis <De><du>: - i forvejen har en leversygdom - lider af alkoholisme - samtidig får andre lægemidler, der medfører leverbeskadigelse.
English: A total of 570 serious (421) and non-serious (149) flupirtine hepatic case reports have been reported up to 28 March 2013, accordingly to the market leader MAH's safety database.
Danish: I alt er der indtil den 28. marts 2013 indgået 570 case-rapporter om leverpåvirkning, heraf 421 alvorlige og 149 ikke-alvorlige, i databasen hos den markedsledende indehaver af markedsføringstilladelse.
English: pruritus) you have to discontinue intake/use of <Product Name> and to seek medical advice immediately if any such symptoms occur.
Danish: gulsot, kløe), skal <De><du> stoppe med at <tage><bruge> <lægemidlets navn> og straks søge lægehjælp, hvis sådanne symptomer viser sig.
English: In fact, available efficacy designed studies are for periods no longer than 8 weeks.
Danish: Ingen af de undersøgelser, hvis design tog henblik på terapeutisk virkning, var af længere varighed end 8 uger.
English: The PRAC considered that in the short term use studies, the efficacy of flupirtine in acute pain was at least comparable to the comparators.
Danish: PRAC fandt, at flupirtin i korttidsundersøgelserne ved akutte smerter havde en virkning mindst svarende til sammenligningsstoffernes.
English: • The PRAC considered that flupirtine containing medicinal products only show very limited efficacy in the management of chronic pain.
Danish: • PRAC vurderede, at lægemidler indeholdende flupirtin kun udviser meget begrænset virkning ved behandling af kroniske smerter.
English: Also aiming minimisation of the hepatotoxicity risk associated with flupirtine, close monitoring of the liver function during treatment should be performed and its use contraindicated in patients with preexisting liver disease.
Danish: Ligeledes for at minimere den hepatotoksiske risiko forudsætter behandling med flupirtin tæt overvågning af leverfunktionen og er kontraindiceret ved præeksisterende leversygdom.
English: Data from the literature as well as data from randomised clinical trials,,, showed an increment of markers for hepato-biliary impairment associated with the treatment of flupirtine.
Danish: Data både fra litteraturen og fra randomiserede kliniske undersøgelser1,2,3,4 viste stigning i markører for nedsat hepatobiliær funktion i forbindelse med behandling med flupirtin.
English: With regards to the management of chronic pain PRAC concluded that the benefit-risk in this indication is no longer favourable.
Danish: Vedrørende behandling af kroniske smerter konkluderede PRAC, at benefit/risk-forholdet ved denne indikation ikke længere er gunstigt.
English: Most studies presented are in management of pain in short term use only and management of chronic pain is intended for long term use in most cases.
Danish: De fleste forelagte undersøgelser vedrører kortvarig behandling, skønt kroniske smerter som regel påtænkes behandlet i lang tid.
English: Since no cases of hepatotoxicity including cases with fatal outcome or which resulted in liver transplantation have been identified so far in the first two weeks of treatment, PRAC concluded that flupirtine use should be restricted to a maximum of two weeks.
Danish: Da der hidtil ikke er påvist tilfælde af hepatotoksicitet under de første to ugers behandling, herunder tilfælde med fatalt eller transplantationskrævende udfald, konkluderede PRAC, at anvendelsen af flupirtin bør begrænses til højst to uger.
English: In addition, patients should have their liver function monitored after each full week of treatment and treatment should be stopped if there are signs of liver problems.
Danish: Derudover bør patienternes leverfunktion overvåges efter hver hel uges behandling, og behandlingen bør seponeres ved tegn på leverproblemer
English: • The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit/risk in the management of acute pain, flupirtine containing medicinal products should have treatment duration restricted to 2 weeks, contraindicated in patients with pre-existing liver disease.
Danish: • på baggrund af de foreliggende sikkerhedsdata og med henblik på at opretholde et positivt benefit/risk-forhold for ovennævnte indikationer konkluderede PRAC desuden, at behandling med lægemidler indeholdende flupirtin bør begrænses til to uger og bør være kontraindiceret hos patienter med præeksisterende leversygdom.
English: Moreover, liver function should be kept under closely monitoring i.e. weekly during the treatment with flupirtine which should be discontinued upon symptoms and signals of liver disorders.
Danish: Under behandlingen med flupirtin bør leverfunktionen desuden overvåges tæt, dvs. en gang ugentligt, og behandlingen bør seponeres ved symptomer eller signaler på leverlidelser.
English: Therefore, the PRAC considered that flupirtine containing medicinal products only show very limited efficacy in the management of chronic pain.
Danish: PRAC vurderede derfor, at lægemidler indeholdende flupirtin kun udviser meget begrænset virkning ved behandling af kroniske smerter.
English: The PRAC concluded that the benefit-risk balance for flupirtine containing medicinal products remains favourable in the treatment of acute pain subject to the agreed restrictions, contraindications, warnings, other changes to the product information and additional risk minimisation measures.
Danish: PRAC konkluderede, at benefit/risk-forholdet fortsat er gunstigt for lægemidler indeholdende flupirtin til behandling af akutte smerter under forudsætning af de vedtagne begrænsninger, kontraindikationer, advarsler, andre ændringer i produktinformationen og supplerende risikominimeringsforanstaltninger.
English: Overall, the duration of treatment is recommended to be established individually by the prescriber.
Danish: Den maksimale døgndosis er 600 mg. Overordnet anbefales, at den ordinerende læge fastsætter behandlingsvarigheden individuelt.
English: Pathology of flupirtine-induced liver injury: a histological and clinical study of six cases.
Danish: 4 Puls F, Agne C, Klein F et al. Pathology of flupirtin-induced liver injury: a histological and clinical study of six cases.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations subject to conditions and detailed explanation for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelser for ændring af markedsføringstilladelserne på visse betingelser samt detaljeret redegørelse for afvigelserne fra anbefalingen fra Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC)
English: Data on efficacy of flupirtine in the use of chronic pain is very limited.
Danish: Der findes kun meget begrænsede data om flupirtins virkning ved kroniske smerter.
English: The CMDh considered the below PRAC recommendation dated 13 June 2013 with regards to the flupirtine containing medicinal products.
Danish: CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human)) har gennemgået PRAC's anbefaling af 13. juni 2013 for lægemidler indeholdende flupirtin.
English: The PRAC concluded that the risk-benefit balance of flupirtine containing medicinal product(s) in the treatment of acute pain remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Danish: PRAC konkluderede, at benefit/risk-forholdet fortsat er gunstigt for lægemidler indeholdende flupirtin til behandling af akutte smerter under forudsætning af de vedtagne begrænsninger, advarsler, andre ændringer i produktinformationen, supplerende lægemiddelovervågning og supplerende risikominimeringsforanstaltninger.
English: Based on the above safety concerns and further to consideration of the current evidence of efficacy of flupirtine in the treatment of chronic and acute pain, the BfArM considered the benefit-risk not to be favourable in the treatment of chronic pain and potential favourable in acute pain subject to effective implementation of risk minimisation measures (e.g. limited duration of treatment, closely liver monitoring) and therefore on 28 February 2013 initiated an urgent union procedure under Article 107i of Directive 2001/83/EC.
Danish: På grund af ovennævnte sikkerhedsmæssige betænkeligheder og i fortsættelse af vurderingen af den foreliggende evidens for virkningen af flupirtin ved behandling af kroniske og akutte smerter fandt BfArM, at benefit/risk-forholdet ikke er positivt til behandling af kroniske smerter og er potentielt positivt til akutte smerter under forudsætning af effektivt gennemførte risikominimeringsforanstaltninger (f.eks. begrænset behandlingsvarighed og tæt overvågning af leveren).
English: Do not use <Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Danish: Brug ikke <lægemidlets navn> hvis <De><du>: - i forvejen har en leversygdom - lider af alkoholisme - samtidig får andre lægemidler, der medfører leverbeskadigelse.
English: In addition, treatment with flupirtine is contraindicated in patients with pre-existing liver disease or taken concomitantly other medication known to cause drug liver injury.
Danish: Desuden er flupirtin kontraindiceret hos patienter med præeksisterende leversygdom og ved samtidig brug af andre lægemidler, der vides at medføre leverbeskadigelse.
English: In addition, treatment with flupirtine is not recommended in patients with pre-existing liver disease or taken concomitantly other medication known to cause drug liver injury.
Danish: Desuden frarådes behandling med flupirtin af patienter med præeksisterende leversygdom eller ved samtidig behandling med andre lægemidler, der vides at medføre leverbeskadigelse.
English: The protocol of drug utilisation study in order to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription should be also be submitted as part of the RMP.
Danish: Som en del af risikostyringsplanen forelægges endvidere protokol til en undersøgelse af lægemiddelanvendelse med henblik på at karakterisere typisk ordinationspraksis for lægemidlerne hos repræsentative grupper af ordinerende læger og at fastlægge hovedgrundene til ordination.
English: In view of the hepatotoxicity and very limited efficacy PRAC concluded that the benefit/risk for flupirtine containing medicinal products in the management of chronic pain is no longer favourable.
Danish: På baggrund af hepatotoksiciteten og den meget begrænsede virkning konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende flupirtin ikke længere er positivt til behandling af kroniske smerter
English: In view of this and of the very limited efficacy of flupirtine in the management of chronic pain, PRAC concluded that the benefit-risk balance of flupirtine containing medicinal products in the management of chronic pain was no longer favourable.
Danish: På baggrund heraf og af den meget begrænsede virkning af flupirtin til behandling af kroniske smerter konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende flupirtin til behandling af kroniske smerter ikke længere er gunstigt.
English: Overall conclusion and conditions to the Marketing Authorisations Having considered the overall submitted data provided by the MAHs in writing and in the oral explanation, the PRAC concluded that: a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study; b. the marketing authorisation holders should implement risk minimisation measures;
Danish: Samlet konklusion og betingelser for markedsføringstilladelserne Efter gennemgang af alle de oplysninger, der er fremlagt skriftligt og ved den mundtlige forklaring af indehaveren af markedsføringstilladelsen, konkluderede PRAC, at:
English: The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommended by a majority that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study, as well as a drug utilisation study (see Annex IV - Conditions of marketing Authorisations); b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations of flupirtine containing medicinal products (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III).
Danish: b. indehaverne af markedsføringstilladelse gennemfører risikominimeringsforanstaltninger c. markedsføringsgodkendelserne for lægemidler indeholdende flupirtin (se bilag I) ændres (i overensstemmelse med de ændringer i produktinformationen, som fremgår af bilag III).