FrancophonIA/ELRC3.0 huggingface dataset:
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Danish: Alle henvisninger til ovennævnte indikationer skal slettes i de relevante afsnit i indlægssedlerne.
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Danish: • Symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk svækkelse hos ældre (eksklusive Alzheimers sygdom og andre demenssygdomme)
English: • Prophylaxis of migraine headache All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Danish: • Profylaktisk mod migrænehovedpine Alle henvisninger til ovennævnte indikationer skal slettes i de øvrige afsnit i produktresuméerne.
English: • Acute retinopathies of vascular origin
Danish: • Akut retinopati af vaskulær oprindelse
English: • Ancillary treatment of Raynaud's syndrome
Danish: • Supplerende behandling af Raynauds syndrom
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)
Danish: • Supplerende behandling af claudicatio intermittens ved symptomatisk perifer arteriel okklusiv sygdom (PAOD stadie II)
English: A. Summary of Product Characteristics
Danish: A. Produktresuméer
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Danish: • Supplerende behandling af synsnedsættelse og synsfeltforstyrrelser, der formodes at have vaskulær oprindelse
English: 4.1 Therapeutic indications
Danish: B. Indlægssedler
English: B. Package Leaflet
Danish: Anvendelsesområder
English: This was reflected in the product information in order to adequately inform healthcare providers and patients.
Danish: Dette blev afspejlet i produktinformationen, så denne informerer sundhedspersoner og patienter tilstrækkeligt herom.
English: The PRAC therefore revised the indication accordingly.
Danish: PRAC reviderede derfor indikationen i henhold hertil.
English: As a result of the review, the PRAC recommended the suspension of the marketing authorisations of these products.
Danish: Som resultat af gennemgangen anbefalede PRAC suspendering af markedsføringstilladelserne for disse produkter.
English: PRAC recommendation
Danish: PRAC's anbefaling
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: The PRAC considered that the clinical development data on acipimox was very limited and noted that no clinical outcome studies were conducted.
Danish: PRAC fandt oplysningerne om den kliniske udvikling af acipimox meget begrænsede, og bemærkede, at der ikke var udført undersøgelser af de kliniske udfald.
English: The PRAC also agreed that acipimox should not be indicated for increasing HDL-C or for cardiovascular prevention in line with the recent data casting doubts on the association between elevating HDL-C levels and reducing the risk of cardiovascular disease.
Danish: PRAC vedtog desuden, at acipimox ikke burde være indiceret til at øge HDL-C eller til kardiovaskulær profylakse i henhold til de nyere data, der rejser tvivl om sammenhængen mellem forhøjelse af HDL-C-niveauet og nedsættelse af kardiovaskulær sygdomsrisiko.
English: Following the conclusion of these procedures, the PRAC was of the view that the concerns regarding the combination products may also be of relevance for the mono-component products and the Danish Health and Medicines Authority therefore initiated a review under Article 31 of Directive 2001/83/EC to assess the impact of the HPS2-THRIVE data on the benefitrisk balance of these products and to give its recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked and if the supply of the medicinal product should be prohibited.
Danish: Efter gennemførelsen af disse procedurer var PRAC af den opfattelse, at betænkelighederne vedrørende kombinationsprodukterne også kan være relevante for monokomponentprodukterne, hvorfor Sundhedsstyrelsen i Danmark indledte en gennemgang i henhold til artikel 31 i direktiv 2001/83/EF for at vurdere betydningen af dataene fra HPS2-THRIVE for benefit/risk-forholdet for disse produkter og fremsætte en anbefaling om, hvorvidt markedsføringstilladelserne for dem burde opretholdes, ændres, suspenderes eller inddrages, og om udlevering af lægemidlet burde forbydes.
English: The safety data available for acipimox, including data on nicotinic acid obtained from HPS2-THRIVE, showed that the safety profile of acipimox is well characterised.
Danish: De foreliggende sikkerhedsdata for acipimox, herunder data om nicotinsyre fra HPS2-THRIVE, viste, at sikkerhedsprofilen af acipimox er velkarakteriseret.
English: The preliminary results of the HPS2-THRIVE study showed that the study did not meet its primary endpoint (reduction of the risk of major vascular events such as heart attack and stroke) as well as a statistically significant increase in the incidence of non-fatal but serious adverse events in the nicotinic acid/laropiprant group compared to the placebo group.
Danish: De indledende resultater af HPS2-THRIVE-undersøgelsen viste, at undersøgelsen ikke nåede sit primære endepunkt (reduktion af risiko for større vaskulære hændelser såsom hjerteanfald og slagtilfælde), og at der var en statistisk signifikant stigning i forekomsten af ikke-fatale, men alvorlige bivirkninger i gruppen på nicotinsyre/laropiprant i forhold til placebogruppen.
English: The PRAC also noted that according to the experts, the current data available did not have any major impact on the safety profile of acipimox.
Danish: PRAC bemærkede endvidere, at de foreliggende data ifølge eksperterne ikke havde større betydning for sikkerhedsprofilen af acipimox.
English: On 19 December 2012, the European Medicines Agency was made aware of preliminary results from a large randomised clinical study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE) designed to assess the incremental benefit of extended release nicotinic acid (ERN)/laropiprant (LRPT) versus placebo in over 25,673 high-risk patients.
Danish: Den 19. december 2012 blev Det Europæiske Lægemiddelagentur gjort opmærksom på de indledende resultater af en stor randomiseret klinisk undersøgelse (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE), der var beregnet til at fastlægge den supplerende fordel af en depotformulering af nicotinsyre (ERN)/laropiprant (LRPT) i forhold til placebo hos mere end 25 673 højrisikopatienter.
English: Nevertheless, the PRAC considered that the efficacy of acipimox in lowering blood lipids in patients with some forms of hyperlipoproteinaemia is demonstrated.
Danish: Alligevel fandt PRAC, at virkningen af acipimox var godtgjort til at sænke blodlipiderne hos patienter med visse former for hyperlipoproteinæmi.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for nicotinic-acid and related substances initiated by Denmark and decided to restrict the scope of the procedure to products containing acipimox, the only high-dose nicotinic acid-related substance indicated in lipid disorders authorised in the EU;
Danish: • PRAC vurderede den procedure i henhold til artikel 31 i direktiv 2001/83/EF, der var foranlediget af lægemiddelovervågningsdata for nicotinsyre og beslægtede stoffer og var indledt af Danmark, og besluttede at indskrænke proceduren til produkter indeholdende acipimox, der er det eneste højdosismiddel beslægtet med nicotinsyre, som er godkendt til lipidforstyrrelser i EU,
English: A review of all available data was undertaken by the Pharmacovigilance Risk Assessment Committee (PRAC) to assess the above safety concerns and their impact on the benefit-risk balance of the centrally authorised combination products Tredaptive, Trevaclyn and Pelzont.
Danish: Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) gennemgik alle foreliggende data for at vurdere de nævnte sikkerhedsmæssige problemer og betydningen heraf for benefit/risk-forholdet for de centralt godkendte kombinationsprodukter Tredaptive, Trevaclyn og Pelzont.
English: Having reviewed the list of EU products containing nicotinic acid or related substances, the PRAC noted that acipimox is the only high-dose substance indicated in lipid disorders still authorised in the EU and the scope of the procedure was therefore restricted to acipimox-containing products.
Danish: Efter gennemgang af listen over EU-produkter indeholdende nicotinsyre eller stoffer beslægtet hermed bemærkede PRAC, at acipimox er det eneste højdosismiddel, der stadig er godkendt i EU til lipidforstyrrelser, hvorfor proceduren blev indskrænket til produkter indeholdende acipimox.
English: Most identified adverse events are already reflected in the acipimox product information and the PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity, which was addressed by adding a warning to the product information.
Danish: Størstedelen af de fundne bivirkninger afspejler sig i forvejen i produktinformationen for acipimox, og PRAC fandt, at de foreliggende data ikke viste nye sikkerhedsoplysninger af betydning for benefit/risk-forholdet for acipimox bortset en potentiel risiko for muskeltoksicitet, der blev taget i betragtning med tilføjelse af en advarsel i produktinformationen.
English: It was noted that acipimox was of particular use in patients who either do not tolerate a statin or do not achieve triglyceride goals with statin therapy alone and could therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Danish: Det bemærkedes, at acipimox var særlig nyttigt hos patienter, der enten ikke tåler et statin eller ikke opnår målværdierne for triglycerider med statinbehandling alene, og at det derfor kunne anvendes som et alternativ eller supplement for at sænke triglyceridniveauet hos sådanne patienter.
English: The PRAC also took into account the views of the European experts consulted in an Ad-Hoc expert meeting, according to which acipimox has a role as lipid-lowering therapy in well-defined settings and indications, such as the treatment of severe hypertriglyceridaemia but only as a second or third line agent.
Danish: PRAC tog desuden hensyn til synspunkterne hos de europæiske eksperter, der blev rådspurgt på et ad hoc-ekspertmøde, ifølge hvilke acipimox har en rolle som lipidsænkende behandling under forudsætning af veldefinerede rammer og indikationer såsom behandling af svær hypertriglyceridæmi, men kun som andet- eller tredjevalg.
English: Having considered the matter, the PRAC therefore recommended the variation of the marketing authorisations for acipimox-containing medicinal products.
Danish: Efter gennemgang af sagen anbefalede PRAC derfor ændring af markedsføringstilladelsen for produkter indeholdende acipimox.
English: The PRAC concluded that the benefit-risk balance of acipimox-containing products remains favourable under normal conditions of use, subject to the agreed changes to the product information.
Danish: PRAC konkluderede, at benefit/risk-forholdet for produkter indeholdende acipimox fortsat er positivt ved normale anvendelsesbetingelser under forudsætning af de vedtagne ændringer af produktinformationen.
English: The CMDh, having considered the PRAC recommendation pursuant to article 107k of Directive 2001/83/EC dated 7 November 2013, reached a position on the variation to the terms of the marketing authorisations of acipimox for which the relevant sections of the summary of product characteristics and package leaflets are set out in Annex III.
Danish: Efter gennemgang af PRAC's anbefaling af 7. november 2013 tog CMDh i henhold til artikel 107k i direktiv 2000/83/EF stilling til ændringen af betingelserne for markedsføringstilladelserne for acipimox, for hvilke de relevante afsnit af produktresuméet og indlægssedlerne fremgår af bilag III.
English: • The PRAC reviewed the totality of the available data, including studies and publications on acipimox, the MAH responses as well as relevant data on nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies;
Danish: • PRAC gennemgik alle foreliggende data, herunder undersøgelser og publikationer om acipimox, besvarelserne fra markedsføringstilladelsesindehaveren samt relevante data om nicotinsyre, herunder AIM-HIGH- og HPS2-THRIVE-undersøgelserne,
English: Having reviewed all the available data, including studies and publications on acipimox as well as data on the related substance nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies, the PRAC considered the efficacy of acipimox in the treatment of certain well-defined lipid disorders to be demonstrated and that acipimox therefore remains a treatment alternative in the management of lipid disorders characterised by elevated plasma levels of triglycerides (Fredrickson type IV hyperlipoproteinaemia), or both triglycerides and cholesterol
Danish: Efter gennemgang af alle foreliggende data, herunder undersøgelser og publikationer om acipimox og data om det beslægtede stof nicotinsyre, herunder AIM-HIGH- og HPS2-THRIVE-undersøgelserne, fandt PRAC, at virkningen af acipimox til behandling af visse veldefinerede lipidforstyrrelser var godtgjort, og at acipimox derfor fortsat er et behandlingsalternativ ved lipidforstyrrelser karakteriseret af forhøjet plasmaniveau af triglycerider (hyperlipoproteinæmi Fredrickson type IV) eller af både triglycerider og kolesterol (hyperlipoproteinæmi Fredrickson type Iib).
English: However, taking into account the available data as well as the current use of the product and on the basis of expert advice, the PRAC was of the opinion that acipimox should only be used to reduce triglyceride levels in patients who either do not tolerate statin or fibrates or who do not achieve triglyceride goals with statin or fibrate therapy alone and should therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Danish: Ud fra de foreliggende data samt produktets nuværende anvendelse og på grundlag af råd fra eksperterne var PRAC imidlertid den opfattelse, at acipimox kun bør anvendes til nedsættelse af triglyceridniveauet hos patienter, der enten ikke tåler statin eller fibrater, eller som ikke opnår målværdierne for triglycerider med statin eller fibrater alene, hvorfor det bør anvendes som et alternativ eller supplement til at nedsætte triglyceridniveauet hos sådanne patienter.
English: • The PRAC considered that acipimox is efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia) but only, on the basis of available evidence including current medical knowledge on the use of acipimox, as a second or third line agent in patients who have not responded adequately to other treatments such as statin or fibrate treatment;
Danish: • PRAC fandt, at acipimox er effektivt til at nedsætte triglyceridindholdet hos patienter med hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IV) og med hyperkolesterolæmi og hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type Iib), men - på grundlag af den foreliggende evidens, herunder den nuværende kendskab til anvendelsen af acipimox - kun som andet- eller tredjevalg hos patienter, der ikke har responderet tilfredsstillende på andre midler såsom statin eller fibrater,
English: Based on the available data, acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
Danish: På grundlag af de foreliggende data fandtes acipimox at være effektivt til at sænke triglyceridniveauet hos patienter med hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IV) og signifikant superiort over placebo hos patienter med hyperkolesterolæmi og hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IIb).
English: The CMDh considered the below PRAC recommendation dated 7 November 2013 with regard to substances related to nicotinic acid (acipimox) indicated for the treatment of lipid disorders.
Danish: CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human)) har gennemgået PRAC's nedenstående anbefaling af 7. november 2013 for lægemidler indeholdende stoffer beslægtet med nicotinsyre (acipimox), der er indiceret til behandling af lipidforstyrrelser.
English: • The PRAC considered that the available safety data identified a potential risk of muscle toxicity, for which a warning was added to the product information.
Danish: • PRAC fandt, at de foreliggende sikkerhedsdata viste potentiel risiko for muskeltoksicitet, hvorfor der blev tilføjet en advarsel til produktinformationen, konkluderede PRAC, at benefit/risk-forholdet for de i bilag I nævnte lægemidler indeholdende acipimox fortsat er positivt under forudsætning af de vedtagne ændringer af produktinformationen.
English: CMDh position
Danish: CMDh's standpunkt
English: No new significant information was identified regarding this risk.
Danish: Der blev ikke identificeret nogen nye væsentlige oplysninger vedrørende denne risiko.
English: The medicinal products will continue to be listed in the additional monitoring list.
Danish: Lægemidlerne vil fortsat være opført på listen over yderligere overvågning.
English: This guide should be handed over to the patient.
Danish: Vejledningen bør udleveres til patienterne.
English: This resulted in a value which was more than 25,000 times lower than the AUC in a woman treated orally with an equal dose (single oral dose 500 mg).
Danish: Dette medførte en værdi, der var mere end 25.000 gange lavere end AUC hos en kvinde, der blev behandlet oralt med en tilsvarende dosis (oral enkeltdosis på 500 mg).
English: The PRAC adopted a recommendation on 08 February 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Danish: PRAC vedtog den 8. februar 2018 en anbefaling, der efterfølgende er blevet vurderet af CMDh, jf. artikel 107k i direktiv 2001/83/EF.
English: They also provided experience from clinical practice on the management of women who wish to become pregnant or are pregnant.
Danish: De bidrog også med erfaring fra klinisk praksis med behandling af kvinder, der ønsker at blive gravide eller er gravide.
English: Several tests for chromosome damage were positive.
Danish: Adskillige test for kromosomskade var positive.
English: From these consultations it was evident that the specialists are aware of the risks discussed, but the information is not adequately reaching the patients timely and effectively.
Danish: Det fremgik klart af høringerne, at speciallægerne er bevidste om de omtalte risici, men at oplysningerne ikke i tilstrækkelig grad når frem til patienterne rettidigt og effektivt.
English: Having reviewed the PRAC recommendation, the CMDh agrees with the PRAC overall conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's anbefaling tilslutter CMDh sig anbefalingens overordnede konklusioner og begrundelser.
English: In addition all products should have in place a risk management plan.
Danish: Desuden bør der for alle lægemidler være iværksat en risikostyringsplan.
English: In addition to the boxed text this may include a symbol/pictogram, with the details to be adapted at national level.
Danish: Ud over den indrammede tekst kan dette omfatte et symbol/piktogram; de nærmere detaljer kan aftales på nationalt plan.
English: However, tests for gene mutations were negative.
Danish: Test for genmutationer var imidlertid negative.
English: This included the responses submitted by the marketing authorisation holders in writing as well as the outcomes of the scientific advisory groups in neurology and psychiatry.
Danish: Det omfattede blandt andet de skriftlige svar, som indehaverne af markedsføringstilladelse havde indsendt, samt udfaldet af møderne i de videnskabelige, rådgivende udvalg for neurologi og psykiatri.
English: Therefore, this type of transmission is not likely to occur for valproate.
Danish: Denne form for overførsel synes derfor ikke sandsynlig for valproat.
English: An early communication of complete information about the risks of valproate is considered essential.
Danish: Tidlig kommunikation af alle oplysninger vedrørende risiciene ved valproat er meget vigtigt.
English: There is no clear evidence that mitochondrial dysfunction caused by valproate is associated with the development of autism.
Danish: Der findes ikke klar evidens for, at mitokondriel dysfunktion forårsaget af valproat er forbundet med udvikling af autisme.
English: In the previous European review (2014)3, several educational measures for patients and healthcare professionals (HCPs) were recommended.
Danish: Den tidligere europæiske gennemgang (2014)3 indeholdt en række anbefalinger vedrørende informationstiltag rettet mod patienter og sundhedspersoner.
English: The PRAC re-iterate that a single version of educational materials is disseminated in each member state, where appropriate.
Danish: PRAC understreger, at der uddeles en enkelt version af informationsmaterialerne i hver medlemsstat, hvor det måtte være relevant.
English: Severe chromosome damage is expected to lead to death of sperm cells / reduced fertility and not to transmission of mutations to the offspring.
Danish: Svære kromosomskader forventes at medføre sædcelledød/reduceret fertilitet, men ikke overførsel af mutationer til afkommet.
English: It can be concluded that it is extremely unlikely that valproate, when used by a male patient, could cause adverse effects to the embryo/foetus by this route.
Danish: Det kan konkluderes, at det er højst usandsynligt, at en mandlig patients brug af valproat kan medføre bivirkninger for embryoet/fosteret ad denne vej.
English: The PRAC requested the conduct of a retrospective observational study to further characterise this theoretical risk.
Danish: PRAC anmodede om, at der blev gennemført et retrospektivt observationsstudie med henblik på karakterisering af denne teoretiske risiko.
English: The PRAC is of the opinion that the currently available data do not warrant further investigation regarding the potential association between mitochondrial dysfunction and autism.
Danish: PRAC er af den opfattelse, at de aktuelt tilgængelige oplysninger ikke giver anledning til yderligere undersøgelser af den mulige sammenhæng mellem mitokondriel dysfunktion og autisme.
English: On 08 March 2017 France triggered a procedure under Article 31 of Directive 2001/83/EC, and requested the PRAC to assess the impact on the concerns regarding the effectiveness of the risk minimisation measures on the benefit-risk balance of medicinal products containing substances related to valproate and issue a recommendation on whether the marketing authorisation(s) of these products should be maintained, varied, suspended or revoked.
Danish: Den 8. marts 2017 indledte Frankrig en procedure i henhold til artikel 31 i direktiv 2001/83/EF og anmodede PRAC om at vurdere betydningen af betænkeligheder vedrørende virkningen af de risikominimerende foranstaltninger på benefit/risk-forholdet for lægemidler indeholdende stoffer, der er relateret til valproat, og fremsætte en anbefaling om, hvorvidt markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller tilbagekaldes.
English: With regards to the patient card, the CMDh clarifies that the information is intended to act as a reminder for long-term use of valproate.
Danish: Med hensyn til patientkortet præciserer CMDh, at oplysningerne er ment som en påmindelse ved langvarig brug af valproat.