FrancophonIA/ELRC3.0 huggingface dataset:
English: A laxative effect was observed in up to 50% of the diacerein-treated patients in clinical studies.
Danish: Laksativ effekt iagttoges hos op til 50 % af patienter behandlet med diacerein i de kliniske undersøgelser.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diacerein containing medicinal products;
Danish: • PRAC tog stilling til den procedure i medfør af artikel 31 i direktiv 2001/83/EF, der var foranlediget af lægemiddelovervågningsdata for lægemidler indeholdende diacerein,
English: The PRAC recommended not to use diacerein-containing medicinal product for patients older than 65 years, but did not consider it as a contraindication.
Danish: PRAC frarådede, at lægemidler indeholdende diacerein anvendtes hos patienter på 65 år og derover, men betragtede det ikke som en kontraindikation.
English: Pain and functional disability of the affected joints are the main manifestations of osteoarthritis.
Danish: Smerter og nedsat funktion af de berørte led er de vigtigste manifestationer af osteoartritis.
English: The correct diagnosis includes both clinical and radiological criteria.
Danish: Diagnosen stilles på grundlag af en kombination af kliniske og radiologiske kriterier.
English: Furthermore, as previously assessed, a paracetamol sparing effect (in eight trials) and a sparing effect on NSAIDs (in one trial) could be detected, but further research would be needed as proof of evidence.
Danish: Desuden kunne der som tidligere vurderet konstateres en paracetamolbesparende virkning (i otte undersøgelser) og en NSAID-besparende virkning (i én undersøgelse), men der behøvedes yderligere undersøgelser for at dette kunne anses for bevist.
English: With regards to posology, as some patients may experience loose stools or diarrhoea after the intake of two capsules per day during the first few weeks of treatment, it is advisable to start treatment with half the recommended daily dose, i.e. one capsule of diacerein 50 mg per day.
Danish: Hvad doseringen angår, kan nogle patienter få tynd afføring eller diarré efter indtagelse af to kapsler dagligt i de første få uger af behandlingen, hvorfor det tilrådes at påbegynde behandlingen med den halve anbefalede dosis, dvs. én kapsel af 50 mg diacerein dagligt.
English: In addition, in a comparative study of the efficacy and tolerability of two therapeutic regimens of diacerein (usual treatment (50 mg twice a day) for 3 months versus progressive treatment (50 mg once a day for one month; then 50 mg twice a day for two months) the proportion of patients developing diarrhoea decreased by approx. 10% in the group treated by 50mg once a day followed by 50mg twice a day compared to the group with no titration.
Danish: I en sammenlignende undersøgelse af virkningen og tolerabiliteten af to behandlingsregimener med diacerein (sædvanlig behandling (50 mg to gange dagligt i tre måneder) over for progressiv behandling (50 mg en gang dagligt i en måned efterfulgt af 50 mg to gange dagligt i to måneder)) faldt andelen af patienter, der udviklede diarré, endvidere med ca. 10 % i den gruppe, der blev behandlet med 50 mg en gang dagligt efterfulgt af 50 mg to gange dagligt, sammenlignet med gruppen uden titrering.
English: The product information should reflect the recommendation to monitor signs of hepatic injury and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury.
Danish: Produktinformationen burde afspejle anbefalingen om at overvåge tegn på leverskade og udvise forsigtighed, når diacerein anvendes sammen med andre lægemidler, der er forbundet med leverskade.
English: It was also concluded that diacerein should no longer be recommended in patients aged 65 years and above as this patient population is more vulnerable to diarrhoea complications.
Danish: Endvidere blev det konkluderet, at diacerein ikke længere burde anbefales til patienter på 65 år og derover, da denne patientpopulation er mere sårbar over for komplikationerne ved diarré.
English: The CMDh therefore considered that any existing information on the recommended dose in this patient population should not be deleted from section 4.2 of the SmPC and section 3 of the PL.
Danish: CMD(h) fandt derfor, at ingen af de nuværende oplysninger om den anbefalede dosis til denne patientpopulation burde slettes fra produktresuméets afsnit 4.2 og indlægssedlens afsnit 3.
English: In general its place in therapy is considered supplementary to the analgesics and anti-inflammatory drugs.
Danish: Sædvanligvis betragtes de som et supplement til analgetiske og antiinflammatoriske lægemidler.
English: The high dropout rate due to diarrhoea in clinical trials showed that the acceptability of the treatment was worse in the diacerein group than in the placebo group.
Danish: Den høje frafaldsandel på grund af diarré i de kliniske undersøgelser viste, at acceptabiliteten af behandlingen var ringere i gruppen på diacerein end i placebogruppen.
English: Diacerein was mainly indicated as an oral treatment for osteoarthritis (OA), a chronic joint degenerative disease with a high prevalence in the ageing population.
Danish: Diacerein var hovedsagelig indiceret til oral behandling af osteoartritis (OA), en kronisk degenerativ ledsygdom med høj prævalens i den aldrende population.
English: In 2012, the French national competent authority (Agence nationale de sécurité du médicament et des produits de santé, ANSM) initiated a review of the benefit-risk of diacerein containing medicinal products that underlined the occurrence of very frequent digestive disorders, cases of hepatitis and serious skin reactions in patients treated with diacerein.
Danish: I 2012 indledte de franske kompetente myndigheder (Agence nationale de sécurité du médicament et des produits de santé, ANSM) en gennemgang af benefit/risk-forholdet for lægemidler indeholdende diacerein, som fremhævede forekomsten af meget hyppige fordøjelseslidelser, tilfælde af hepatitis og alvorlige hudreaktioner hos patienter behandlet med diacerein.
English: Diacerein, as other anthraquinone derivatives, has a hepatotoxic effect for which the mechanism of action is unknown.
Danish: Diacerein har ligesom andre anthraquinonderivater hepatotoksisk virkning, hvis mekanisme er ukendt.
English: Furthermore, the PRAC considered that periodic updated safety reports (PSURs) should be submitted on a yearly basis.
Danish: Derudover fandt PRAC, at der burde indsendes periodiske sikkerhedsopdateringsrapporter (PSUR) én gang om året.
English: It was noted that favourable results for the primary criterion, analogue visual scale (VAS) assessment of pain on movement, were shown in patients treated with 50mg/day.
Danish: Det bemærkedes, at der var gunstige resultater for det primære kriterium, smerte ved bevægelse vurderet på en analog visuel skala hos patienter behandlet med 50 mg dagligt.
English: To conclude, the review found that the most frequently reported reactions with diacerein were, as expected, gastrointestinal disorders, especially diarrhoeas, which were frequently severe and leading to complications such as dehydration and disturbances of fluid and electrolyte balance.
Danish: Som konklusion viste gennemgangen, at de oftest indberettede reaktioner med diacerein som forventet var gastrointestinale forstyrrelser, navnlig diarré, ofte svær, og medfødte komplikationer såsom dehydrering og væske- og elektrolytforstyrrelser.
English: Therefore, diacerein is still a relevant option for some patients for symptomatic treatment of OA of the hip and knee, but caution is advised and patients must stop treatment should diarrhoea develop.
Danish: Diacerein er derfor fortsat en relevant mulighed for nogle patienter til symptomatisk behandling af osteoartritis i hofte og knæ, men der tilrådes forsigtighed, og patienterne skal ophøre med behandlingen, hvis der opstår diarré.
English: In the second clinical trial, diacerein was included in one of the control groups in a trial intending to demonstrate the effect of hyaluronic acid intra-articular injections in OA progression which was not demonstrated.
Danish: I den anden kliniske undersøgelse indgik diacerein i en af kontrolgrupperne i et forsøg til påvisning af virkningen af intraartikulær injektion af hyaluronsyre på progressionen af osteoartritis, hvilket ikke kunne påvises.
English: Diacerein is a symptomatic slow acting drug in osteoarthritis (SYSADOA).
Danish: Diacerein er et langsomtvirkende lægemiddel til symptomatisk behandling af osteoartritis (SYSADOA).
English: The CMDh, having considered the revised final PRAC recommendation dated 10 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diacerein containing medicinal products for which the amendments to the product information are set out in annex III and subject to the condition set out in Annex IV.
Danish: Efter at have gennemgået PRAC's endelige reviderede anbefaling af 10. juli 2014 i medfør af artikel 107k, stk. 1 og 2, i direktiv 2001/83/EF tilsluttede CMD(h) sig ændring af markedsføringstilladelserne for lægemidler indeholdende diacerein, for hvilke ændringerne af produktinformationen fremgår af bilag III, under den betingelse, der fremgår af bilag IV.
English: To ensure adequate screening of the patients at start of treatment, the PRAC also recommended that diacerein is only initiated by specialists experienced in the treatment of osteoarthritis.
Danish: For at sikre tilstrækkelig screening af patienterne ved påbegyndelse af behandlingen anbefalede PRAC desuden, at behandling med diacerein udelukkende indledes af specialister med erfaring i behandling af osteoartritis.
English: Also, diacerein is no longer recommended for patients aged 65 years and above.
Danish: Desuden frarådes diacerein til patienter på 65 år og derover.
English: Finally, with regards to the risk of cutaneous disorders, safety concerns were raised with diacerein following a publication of a fatal case of a toxic epidermal necrolysis, with diacerein being the most suspected drug for the events.
Danish: Hvad endelig angår risikoen for hudlidelser, blev der rejst sikkerhedsbetænkeligheder ved diacerein efter offentliggørelse af ét fatalt tilfælde af toksisk epidermal nekrolyse, hvor diacerein var stærkest mistænkt som årsag.
English: As part of this referral procedure, the PRAC reviewed all available data on the efficacy of diacerein containing medicinal products.
Danish: Som led i denne indbringelsesprocedure gennemgik PRAC alle foreliggende data om virkningen af lægemidler indeholdende diacerein.
English: It was reiterated that structure-modifying effects of cartilage by diacerein in OA and long-term efficacy had not been demonstrated by the presented studies; however, a carry-over effect was confirmed by three studies.
Danish: Det blev på ny fremført, at diacereins strukturmodificerende virkning på brusk ved osteoartritis og langsigtede virkning ikke var påvist i de forelagte undersøgelser; tre af undersøgelserne bekræftede imidlertid en carry-over-virkning.
English: The PRAC was of the view that diacerein should be contraindicated in patients with current and/or history of liver disease and that patient should be screened for major causes of active hepatic disease before start of treatment.
Danish: PRAC fandt, at diacerein burde være kontraindiceret hos patienter med nuværende og/eller tidligere leversygdom, og at patienten burde screenes for de vigtigste årsager til aktiv hepatitissygdom før påbegyndelse af behandlingen.
English: The PRAC also noted that spontaneous notifications reported serious cases of diarrhoea with dehydration and electrolyte disorders.
Danish: PRAC bemærkede desuden, at der i spontane indberetninger blev beskrevet alvorlige tilfælde af diarré med dehydrering og elektrolytforstyrrelser.
English: These included reducing the posology recommendation at the start of the treatment, and new measures such as a contraindication in patients with liver disease, a strong recommendation for patients to stop treatment as soon as diarrhoea occurs and a restriction of use in patients aged 65 years and above.
Danish: Disse bestod i nedsættelse af den anbefalede dosis ved påbegyndelse af behandlingen samt nye foranstaltninger såsom kontraindikation hos patienter med leversygdom, en streng anbefaling til patienterne om at ophøre med behandlingen ved første tegn på diarré, og begrænsninger af anvendelsen hos patienter på 65 år og derover.
English: The PRAC considered that it is of importance that patients stop their treatment with diacerein as soon as diarrhoea occurs, in order to prevent diarrhoea complications such as dehydration and hypokalaemia.
Danish: PRAC fandt det vigtigt, at patienterne ophører med behandlingen med diacerein ved første tegn på diarré for at undgå komplikationer af diarré, såsom dehydrering og hypokaliæmi.
English: In addition treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected.
Danish: Desuden burde behandlingen med diacerein seponeres ved forhøjede leverenzymer eller formodede tegn eller symptomer på leverskade.
English: • The PRAC considered that the available data supporting the use of diacerein have shown a modest but statistically significant effect in the treatment of osteoarthritis of the knee and hip, with a delayed effect.
Danish: • PRAC fandt, at de foreliggende data til støtte for anvendelsen af diacerein har vist en beskeden, men statistisk signifikant virkning til behandling af osteoartritis i knæ og hofte, med forsinket indsættende effekt.
English: Based on the totality of the data available on the safety and the efficacy of diacerein, and considering all the risk minimisation measures proposed during assessment and the re-examination procedure, the PRAC concluded that the benefit-risk balance of diacerein-containing medicinal products remained favourable in the symptomatic treatment osteoarthritis, subject to changes to the product information and conditions.
Danish: På grundlag af samtlige foreliggende data om sikkerheden og virkningen af diacerein og i betragtning af de risikominimeringsforanstaltninger, der blev foreslået under vurderingen og den fornyede overvejelsesprocedure, konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende diacerein fortsat var gunstigt til symptomatisk behandling af osteoartritis under forudsætning af ændringer af produktinformationen og betingelserne.
English: In view of the above, the ANSM requested the PRAC to give a recommendation on the balance of benefits and risks of diacerein containing medicinal products in the authorised indications and whether their marketing authorisations should be maintained, varied, suspended or withdrawn.
Danish: Følgelig anmodede ANSM PRAC om at fremsætte en anbefaling om benefit/risk-forholdet for lægemidler indeholdende diacerein til de godkendte indikationer og udtale sig om, hvorvidt markedsføringstilladelserne burde opretholdes, ændres, suspenderes eller inddrages.
English: In addition, warnings were considered necessary for patients receiving concomitantly diuretics, cardiac glycosides or laxatives.
Danish: Desuden fandtes det nødvendigt med advarsler for patienter i samtidig behandling med diuretika, hjerteglykosider eller laksantia.
English: The present review showed that rash, pruritus and eczema were the most common cutaneous reactions reported in clinical trials but available post-marketing data revealed cases of erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Danish: Nærværende gennemgang viste, at udslæt, pruritus og eksem var de oftest beskrevne hudreaktioner i de kliniske undersøgelser, men at de foreliggende data efter markedsføring omfattede tilfælde af erythema multiforme, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (TEN).
English: However, although double blind was an intended methodological feature of the clinical trials performed with diacerein, it was considered doubtful that blinding was achieved in practice, considering the very apparent effects (urine coloration, diarrhoea) produced by diacerein.
Danish: Skønt de udførte kliniske undersøgelser med diacerein var påtænkt som dobbeltblindede, anses det for tvivlsomt, at dette blev opnået i praksis i betragtning af de meget iøjnefaldende virkninger af diacerein (farvet urin, diarré).
English: In addition, meta-analyses confirmed a small but consistent beneficial effect of diacerein on OA symptoms.
Danish: Desuden bekræftede metaanalyserne en lille, men konsekvent gavnlig virkning af diacerein på symptomerne af osteoartritis.
English: • The PRAC considered the grounds for re-examination provided by the MAHs in writing and in the oral explanations;
Danish: • PRAC gennemgik markedsføringstilladelsesindehavernes begrundelse for fornyet overvejelse, der blev fremsat skriftligt og ved de mundtlige fremlæggelser,
English: Only the Dougados study showed efficacy on variables related to a beneficial impact of diacerein on structural progression or disease modifying properties in OA.
Danish: Kun Dougados-undersøgelsen viste virkning på variable vedrørende gavnlig virkning af diacerein på strukturel progression eller sygdomsmodificerende egenskaber ved osteoartritis.
English: With regards to the safety profile of diacerein, it was noted that the most frequently reported events with diacerein when used as per label (100mg/day) in the clinical trials, were loose stools and diarrhoea, including severe diarrhoea.
Danish: Vedrørende sikkerhedsprofilen af diacerein bemærkedes det, at de hyppigst indberettede bivirkninger med diacerein anvendt som anbefalet (100 mg dagligt) var tynd afføring og diarré, herunder svær diarré.
English: Although it was noted that the data from clinical studies showed no significant differences in hepatic disorders between diacerein and the placebo group, when present, hepatic disorders were in most of cases in the diacerein group.
Danish: Skønt data fra kliniske undersøgelser ikke viste signifikante forskelle i leversygdomme mellem diacerein og placebogruppen, optrådte størstedelen af leverlidelserne i gruppen på diacerein.
English: The PRAC acknowledged that although neither the available randomised clinical trials nor the metaanalyses were without flaws, clinical trials show a modest and statistically significant effect for diacerein in the end-points pain relief and function disability.
Danish: PRAC vedgik, at skønt hverken de foreliggende randomiseret kliniske undersøgelser eller metaanalyserne var uden fejl, viser de kliniske undersøgelser en beskeden, statistisk signifikant virkning af diacerein for endepunkterne smertelindring og funktionsnedsættelse.
English: The CMDh also agreed with the PRAC that the PSURs should be submitted on a yearly basis.
Danish: CMD(h) var også enigt med PRAC i, at de periodiske sikkerhedsopdateringsrapporter burde indsendes årligt.
English: The available data were therefore not sufficient to conclude on the structure modifying effects of diacerein in osteoarthritis and no data were available regarding a potential effect of diacerein for delaying surgery.
Danish: De foreliggende data var derfor ikke tilstrækkelige til at drage konklusioner om de strukturmodificerende virkninger af diacerein ved osteoartritis, og der forelå ingen data vedrørende en eventuel virkning af diacerein i form af udskydelse af operation.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing diacerein identified in Annex I remains favourable, subject to the changes to the product information and conditions as provided for in Annex IV.
Danish: konkluderede PRAC, at benefit/risk-forholdet for de i bilag I nævnte lægemidler indeholdende diacerein fortsat er positivt under forudsætning af de i bilag IV angivne ændringer af produktinformationen og betingelserne.
English: • The PRAC considered that available data from pre-clinical studies, clinical trials, post-marketing spontaneous case reports, and published literature have shown that the use of diacereincontaining products is associated with safety concerns such as frequent cases of severe diarrhoea and cases of potentially serious hepatotoxicity; a risk of cutaneous reactions could not be excluded.
Danish: • PRAC fandt, at de foreliggende data fra prækliniske undersøgelser, kliniske undersøgelser, spontane indberetninger af case-rapporter efter markedsføring og den publicerede litteratur havde vist, at anvendelse af lægemidler indeholdende diacerein er forbundet med sikkerhedsproblemer, såsom hyppige tilfælde af svær diarré og tilfælde af potentielt alvorlig hepatotoksicitet; risiko for hudreaktioner kunne ikke udelukkes,
English: Having considered the overall submitted data provided by the MAHs in writing and at the oral explanation, the PRAC concluded that the benefit-risk balance of diacerein containing products is not favourable in the currently approved indications.
Danish: Efter gennemgang af alle data, der er forelagt skriftligt og ved den mundtlige fremlæggelse ved markedsføringstilladelsesindehaveren, konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende diacerein ikke er positivt til de aktuelt godkendte indikationer.
English: The evidence obtained from different meta-analysis of the clinical trials performed with diacerein showed a small beneficial effect of diacerein in the treatment of OA of the knee and hip with different criteria for the inclusion of the clinical trials in the meta-analyses.
Danish: Den evidens, der opnåedes ved forskellige metaanalyser af de kliniske undersøgelser med diacerein, viste en lille gavnlig virkning af diacerein til behandling af osteoartritis i knæ og hofter med forskellige kriterier for inklusion af de kliniske undersøgelser i metaanalyserne.
English: These included a recommendation to start treatment at half the normal daily dose, a contraindication in patients with a history and/or current liver disease and a clear recommendation for patients to stop treatment as soon as diarrhoea occurs.
Danish: Hertil hører en anbefaling om at begynde behandlingen med det halve af den normale dagsdosis, en kontraindikation hos patienter med tidligere eller nuværende leversygdom og en klar anbefaling til patienterne om at ophøre med behandlingen ved første optræden af diarré.
English: In general, treatment includes non-pharmacological therapies such as weight control, physical therapy, exercise, patient education as well as pharmacological intervention.
Danish: Sædvanligvis omfatter behandlingen foruden medikamentel terapi vægtkontrol, motion og patientoplysning.
English: With regards to the potential risk of hepatic reactions, several hepatic events have been reported, including serious hepatic reactions and one fatal case of hepatitis was reported.
Danish: Hvad angår den potentielle risiko for leverreaktioner er der indberettet flere leverhændelser, herunder alvorlige leverreaktioner og ét fatalt tilfælde af hepatitis.
English: Diacerein has a delayed initial onset of action and should not be recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Danish: Diacerein har forsinket indsættende initial virkning og bør frarådes til patienter med hurtigt progredierende osteoartritis i hoften, da de kan udvise svagere respons over for diacerein.
English: Hepatic reactions were reported, including symptomatic acute liver injury and one fatal case of fulminant hepatitis.
Danish: Der blev indberettet leverreaktioner, herunder symptomgivende akut leverskade og ét tilfælde af fulminant hepatitis.