FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 February 2014 EMA/108603/2014
Danish: Den 20. februar 2014 EMA/108603/2014
English: This was endorsed by the CMDh.
Danish: Dette blev godkendt af CMDh.
English: In the EU, acipimox-containing medicines are currently marketed in Austria, Belgium, Denmark, Hungary, Italy, Luxembourg, the Netherlands and the United Kingdom.
Danish: I EU markedsføres lægemidler indeholdende acipimox på nuværende tidspunkt i Østrig, Belgien, Danmark, Ungarn, Italien, Luxembourg, Nederlandene og Det Forenede Kongerige.
English: 2 More information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
Danish: 2 Yderligere oplysninger findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Anbefalingerne fra PRAC blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMDh), som vedtog et endeligt standpunkt.
English: These recommendations were originally made by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 5-8 November 2013.
Danish: Disse anbefalinger blev oprindeligt fremsat af Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) på dettes møde 5.-8. november 2013.
English: • Most patients taking acipimox are already using it in this way, but the product information is being updated to clarify the recommended use.
Danish: • De fleste patienter, der får acipimox, anvender det i forvejen på denne måde, men produktinformationen bliver ført ajour for at præcisere den anbefalede brug.
English: Medicines containing nicotinic acid or related substances have been authorised in the EU via national procedures since the mid-1950s.
Danish: Lægemidler indeholdende nicotinsyre eller beslægtede stoffer har været godkendt i EU siden midten af 1950'erne via nationale procedurer.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Disse data blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: In higher doses, it reduces the levels of fat in the blood.
Danish: I højere doser nedsætter det blodets fedtstofindhold.
English: CMDh endorses PRAC recommendation
Danish: CMDh vedtager PRAC's anbefaling
English: In addition, the PRAC consulted an ad-hoc expert group of European experts on the use of acipimox.
Danish: PRAC rådførte sig desuden med en ad hoc-gruppe af europæiske eksperter om anvendelsen af acipimox.
English: • Patients who have any questions should ask their doctor or pharmacist.
Danish: • Patienter, der ønsker yderligere oplysninger, bør kontakte lægen eller apotekspersonalet.
English: 1 The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: 1 CMDh repræsenterer EU's medlemsstater og har ansvaret for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
English: Acipimox-containing medicines should be used when changes in lifestyle, including diet and exercise, and treatment with other medicines are not adequate.
Danish: Lægemidler indeholdende acipimox bør anvendes, når ændringer i livsstil, herunder kost og motion, og behandling med andre lægemidler ikke er tilstrækkelige.
English: The review of nicotinic acid and its related substances acipimox and xantinol nicotinate was initiated on 27 February 2013 at the request of the Danish Health and Medicines Authority, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af nicotinsyre og de beslægtede stoffer acipimox og xantinolnicotinat blev indledt den 27. februar 2013 på anmodning af den danske sundhedsstyrelse i medfør af artikel 31 i direktiv 2001/83/EF.
English: Nicotinic acid is a naturally occurring substance used in low doses as a vitamin (known as niacin or vitamin B3).
Danish: Nicotinsyre er et naturligt forekommende stof, der i lave doser anvendes som et vitamin (kendt som niacin eller vitamin B3).
English: As a result, the European Medicines Agency recommended the suspension of medicines containing the combination of nicotinic acid and laropiprant across the EU2.
Danish: Som følge heraf anbefalede Det Europæiske Lægemiddelagentur suspendering af lægemidler indeholdende kombinationen af nicotinsyre og laropiprant i EU2.
English: Nicotinic acid was also authorised in combination with laropiprant.
Danish: Nicotinsyre blev også godkendt i kombination med laropiprant.
English: • Acipimox is a medicine used to treat disorders related to high levels of fat in the blood.
Danish: • Acipimox er et lægemiddel, der anvendes til behandling af sygdomme vedrørende for højt fedtstofindhold i blodet.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Danish: Da CMDh vedtog sit standpunkt ved en flertalsafgørelse, blev det overgivet til Europa-Kommissionen, som godkendte det og den 20. februar 2014 vedtog en retligt bindende afgørelse for hele EU.
English: Its uses and safety have been reviewed because of a study showing that a related medicine, nicotinic acid, increased the side effects and gave no additional benefit when it was taken together with other treatments for these disorders.
Danish: Dets anvendelser og sikkerhed er blevet gennemgået, fordi en undersøgelse viste, at det beslægtede lægemiddel nicotinsyre medførte øgede bivirkninger og ikke gav nogen yderligere fordele, når det blev anvendt sammen med andre lægemidler mod disse sygdomme.
English: The CMDh endorsed the PRAC recommendations by majority at its meeting of 16-18 December 2013 and its position was sent to the European Commission which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Danish: CMDh vedtog PRAC's anbefalinger ved en flertalsafgørelse på sit møde den 16.-18. december 2013, og dets udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 20. februar 2014 vedtog en retligt bindende afgørelse for hele EU.
English: Because acipimox was related to nicotinic acid and was marketed for lipid disorders in the EU, its benefit-risk balance was also then reviewed.
Danish: Da acipimox var beslægtet med nicotinsyre og blev markedsført mod lipidforstyrrelser i EU, blev også dettes benefit/risk-forhold gennemgået.
English: The study showed that adding this combination to treatment with statins (another class of medicines used to treat lipid disorders) did not lead to additional benefits in reducing the risk of major vascular events such as heart attack and stroke, but did result in a higher frequency of non-fatal but serious side effects.
Danish: Undersøgelsen viste, at tilføjelse af denne kombination til behandling med statiner (en anden klasse lægemidler, der anvendes til behandling af lipidforstyrrelser) ikke gav ekstra fordele hvad angår mindsket hjerte-kar-risiko i form af større hændelser såsom hjerteanfald og slagtilfælde, men derimod højere hyppighed af ikke-dødelige, men alvorlige bivirkninger.
English: Laropiprant has no effect on cholesterol but it reduces flushing, which is a known side effect of nicotinic acid.
Danish: Laropiprant har ingen virkning på kolesterol, men nedsætter den rødme, der er en kendt bivirkning af nicotinsyre.
English: The review of acipimox was based on the limited available efficacy and safety data on acipimox as well as data from the scientific literature relating to the structurally related compound nicotinic acid.
Danish: Gennemgangen af acipimox var baseret på de begrænsede foreliggende data om virkningen og sikkerheden af acipimox samt data fra den videnskabelige litteratur vedrørende den strukturelt beslægtede nicotinsyre.
English: • Based on the available data, the indications for acipimox should be restricted to alternative or adjunct treatment in patients who have not responded adequately to other treatments such as statin or fibrate treatment.
Danish: • På grundlag af de foreliggende data bør indikationen for acipimox begrænses til anvendelse som alternativ eller supplerende behandling hos patienter, der ikke har responderet adækvat på andre behandlinger såsom statin eller fibrat.
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 lægemidler indeholdende acipimox fortsat er positivt ved normale anvendelsesbetingelser under forudsætning af, at de vedtagne ændringer indføres i produktinformationen.
English: • Having reviewed the available safety data, including data on nicotinic acid obtained from HPS2THRIVE, the PRAC considered the safety profile of acipimox to be well characterised.
Danish: • Efter gennemgang af de foreliggende sikkerhedsdata, herunder data om nicotinsyre fra HPS2THRIVE, fandt PRAC, at sikkerhedsprofilen for acipimox er velkarakteriseret.
English: The original reason for the review of acipimox was HPS2-THRIVE, a large study which looked at the long-term effect of the combination of nicotinic acid (a substance related to acipimox) and another medicine, laropiprant, in treating lipid disorders.
Danish: Den oprindelige anledning til gennemgangen af acipimox var HPS2-THRIVE, en stor undersøgelse af den langsigtede virkning af en kombination af nicotinsyre (som er beslægtet med acipimox) og et andet lægemiddel, laropiprant, til behandling af lipidforstyrrelser.
English: In July 2013 it was established that nicotinic acid and the related substance xantinol nicotinate were not currently marketed in the EU to treat lipid disorders (xantinol nicotinate is authorised in some EU countries for oral use as a vasodilator, a medicine that widens the blood vessels used to treat blood circulation problems) and the review was therefore restricted to acipimox only.
Danish: I juli 2013 blev det fastslået, at nicotinsyre og det beslægtede stof xantinolnicotinat ikke på dette tidspunkt blev markedsført i EU til behandling af lipidforstyrrelser (i nogle EU-lande er xantinolnicotinat godkendt til oral anvendelse til udvidelse af blodkarrene (som vasodilator) ved kredsløbsforstyrrelser).
English: • The review has shown that acipimox can be useful as an additional or alternative treatment to lower high levels of triglycerides (a particular type of fat) in the blood of patients with high levels of these fats (with or without high cholesterol), who cannot be treated by means such as diet, exercise, or other medicines.
Danish: • Gennemgangen har vist, at acipimox kan være nyttigt som supplerende eller alternativ behandling til at sænke et højt indhold af triglycerider (en særlig form for fedtstof) i blodet på patienter, der har højt indhold af disse fedtstoffer (med eller uden højt kolesterol), og som ikke kan behandles ved foranstaltninger såsom diæt, motion eller andre lægemidler.
English: • The main role of acipimox is to prevent the non-cardiovascular complications of hypertriglyceridaemia and acipimox should not be used for the prevention of cardiovascular disease in the absence of convincing LDL-C or outcome data.
Danish: • Acipimox' hovedrolle er forebyggelse af de ikke-kardiovaskulære komplikationer ved hypertriglyceridæmi; det bør ikke anvendes til forebyggelse af kardiovaskulær sygdom i fravær af overbevisende data vedrørende LDL-kolesterol eller udfald.
English: Patients receiving acipimox should have their treatment reviewed at their next regular appointment.
Danish: Patienter i behandling med acipimox bør få revurderet behandlingen ved næste planlagte konsultation.
English: • 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: • Acipimox blev anset for at være effektivt til at sænke triglyceridniveauet hos patienter med hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IV) og signifikant overlegent i forhold til placebo hos patienter med hyperkolesterolæmi og hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IIb).
English: • Acipimox is indicated for the treatment of hypertriglyceridaemia with or without hypercholesterolaemia (Fredrickson type IIb or type IV hyperlipoproteinaemia).
Danish: • Acipimox er indiceret til behandling af hypertriglyceridæmi med eller uden hyperkolesterolæmi (hyperlipoproteinæmi Fredrickson type IIb eller type IV).
English: On 18 December 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 confirmed by majority that medicines containing acipimox should have their marketing authorisations amended to ensure that they are used across the European Union only as an additional or alternative treatment in type IIb and type IV hyperlipoproteinaemia.
Danish: Den 18. december 2013 bekræftede koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMDh)1 ved en flertalsafgørelse, at markedsføringstilladelserne for lægemidler indeholdende acipimox bør ændres, så de i hele EU kun anvendes som supplement eller behandlingsalternativ ved hyperlipoproteinæmi type IIb og IV. Ved disse tilstande er blodets indhold af fedtstoffer af typen triglycerider forhøjet (hypertriglyceridæmi) med eller uden kolesterolforhøjelse.
English: 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 associated with the concomitant use of acipimox with statins, which was addressed by adding a warning to the product information.
Danish: PRAC fandt, at de foreliggende data ikke viste nye sikkerhedsoplysninger af betydning for benefit/risk-forholdet for acipimox bortset fra en potentiel risiko for muskeltoksicitet ved samtidig brug af statiner, hvilket er blevet taget i betragtning ved tilføjelse af en advarsel i produktinformationen.
English: • Based on the available data, the PRAC noted a number of clinical differences between acipimox and nicotinic acid, with acipimox having a longer duration of action and non-clinical studies showing that acipimox is consistently less potent than nicotinic acid as an agonist of the HCA2 receptor.
Danish: • På grundlag af de foreliggende data konstaterede PRAC en række kliniske forskelle mellem acipimox og nicotinsyre, idet acipimox har længere virkningsvarighed, og de ikke-kliniske undersøgelser samstemmende viser, at acipimox er mindre potent end nicotinsyre som agonist til HCA2-receptoren.
English: • Patients taking acipimox should have their treatment re-evaluated at their next regular appointment.
Danish: • Patienter i behandling med acipimox bør få revurderet behandlingen ved næste planlagte konsultation.
English: However, findings from the HPS2-THRIVE study were used to expand the warnings in the acipimox product information concerning a possible increased risk of painful muscle damage when acipimox is used together with a statin.
Danish: Resultaterne af HPS2-THRIVEundersøgelsen blev imidlertid grundlag for i produktinformationen for acipimox at udvide advarslerne om mulig øget risiko for smertefuld muskelskade ved anvendelse af acipimox sammen med et statin.
English: • Although the review of acipimox-containing medicines was originally triggered by concerns arising from the HPS2-THRIVE study, the extended release nicotinic acid/laropiprant combination used in that study cannot be regarded as the same as mono-component acipimox and the concerns can therefore not be extrapolated to acipimox, in particular due to the possible confounding effect of laropiprant.
Danish: • Skønt gennemgangen af lægemidler indeholdende acipimox oprindeligt var foranlediget af betænkelighederne ved HPS2-THRIVE-undersøgelsen, kan den i undersøgelsen anvendte depotformulering af en kombination af nicotinsyre og laropiprant ikke sidestilles med acipimox som monokomponent; betænkelighederne kan derfor ikke ekstrapoleres til acipimox, navnlig på grund af den mulige konfunderende virkning af laropiprant.
English: • However, based on the results from HPS2-THRIVE and the chemical similarity of acipimox and nicotinic acid, prescribers should be aware of the potential increased risk of myopathy when acipimox is used in combination with a statin.
Danish: • På baggrund af resultaterne af HPS2-THRIVE og den kemiske lighed mellem acipimox og nicotinsyre bør ordinerende læger dog være opmærksomme på den potentielt øgede risiko for myopati ved anvendelse af acipimox kombineret med et statin.
English: Acipimox is a substance closely related to nicotinic acid that has been available since 1984 as Olbetam and other trade names for the treatment of lipid disorders.
Danish: Acipimox, der er nært beslægtet med nicotinsyre, har været på markedet siden 1984 bl.a. under handelsnavnet Olbetam til behandling af lipidforstyrrelser.
English: It was noted that acipimox was of particular use in patients who either do not tolerate statin or fibrates or who do not achieve triglyceride goals with statin or fibrate 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 statiner eller fibrater eller ikke opnår målværdierne for triglycerider med statin- eller fibratbehandling alene.
English: nicotinic acid and acipimox were also identified.
Danish: Gennemgangen blev derfor begrænset til acipimox.
English: Flushing, rash and gastrointestinal effects (nausea, dyspepsia, diarrhoea and upper abdominal pain) are the most frequently reported adverse effects for acipimox and are listed in the acipimox product information, together with pruritus, erythema, urticaria and angioedema.
Danish: De hyppigst indberettede bivirkninger ved acipimox er rødme, udslæt og gastrointestinale virkninger (kvalme, dyspepsi, diarré og øvre abdominalsmerter).
English: After looking at the available data on acipimox, including evidence from the literature, spontaneous reports of adverse effects and advice from a group of experts in the treatment of lipid disorders, as well as data from HPS2-THRIVE, the PRAC concluded that acipimox continues to have a role as an additional or alternative treatment to reduce triglycerides in those forms of hyperlipoproteinaemia that involve high triglyceride levels (with or without increased cholesterol), in patients in whom lifestyle changes and use of other medicines such as fibrates and statins are not adequate.
Danish: Udvalget konkluderede heraf, at acipimox fortsat har en rolle som supplerende eller alternativ behandlingsmulighed ved reduktion af triglycerider ved de former af hyperlipoproteinæmi, der indebærer højt triglyceridniveau (med eller uden kolesterolforhøjelse) hos patienter, hos hvem livsstilsændringer og andre lægemidler, såsom fibrater og statiner, ikke er tilstrækkelige.
English: The results from HPS2-THRIVE could not be applied directly to acipimox since the study investigated the effect of the combination with laropiprant, whose effects were not established, and possible differences between
Danish: undersøgelsen vedrørte virkningen af kombinationen med laropiprant, hvis virkninger ikke var fastlagt, og da der blev påvist mulige forskelle mellem nicotinsyre og acipimox.
English: The marketing authorisation was renewed on 19 July 2001 and on 19 July 2006.
Danish: Markedsføringstilladelsen blev fornyet den 19. juli 2001 og den 19. juli 2006.
English: The recommended vaccination schedule consists of three doses within the first six months of life, with at least four weeks between each dose.
Danish: Det anbefalede vaccinationsprogram består af tre doser inden for de første seks levemåneder med mindst fire uger mellem hver dosis.
English: The active substances in Tritanrix HepB have been available in the European Union (EU) for a number of years in other vaccines.
Danish: De aktive stoffer i Tritanrix HepB har været på markedet i Den Europæiske Union (EU) i en årrække i andre vacciner.
English: Their breathing should be monitored for up to three
Danish: Deres vejrtrækning bør overvåges i op til tre dage efter vaccinationen.
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Tritanrix HepB on 19 July 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tritanrix HepB til GlaxoSmithKline Biologicals s.a. den 19. juli 1996.
English: This means that the toxoids and the parts of the hepatitis B virus are fixed onto aluminium compounds, to stimulate a better immune response.
Danish: Det vil sige, at toksoiderne og delene af hepatitis B-virus er bundet til aluminiumsforbindelser for at fremkalde et bedre immunrespons.
English: The main measure of effectiveness was the production of protective antibodies in the infants after the first set of vaccinations.
Danish: Det primære mål for virkning var udviklingen af beskyttende antistoffer hos spædbørnene efter den første vaccinationsserie.
English: • killed whole B. pertussis, the bacterium that causes pertussis;
Danish: • dræbte, hele B. pertussis, der er den bakterie, der fremkalder kighoste,
English: The studies showed that the production of protective levels of antibodies against diphtheria, tetanus and hepatitis B occurred in at least 98% of the infants.
Danish: Undersøgelserne viste, at udviklingen af beskyttende niveauer af antistoffer mod difteri, stivkrampe og hepatitis B forekom hos mindst 98 % af spædbørnene.
English: The most common side effects with Tritanrix HepB (seen in more than 1 in 10 doses of the vaccine) are drowsiness, feeding problems, fever, redness, swelling, pain, unusual crying and irritability.
Danish: De hyppigste bivirkninger ved Tritanrix HepB (som ses ved mere end 1 ud af 10 doser vaccine) er døsighed, spiseproblemer, feber, rødme, hævelse, smerte, usædvanlig gråd og irritabilitet.
English: The additional studies showed that starting vaccination at six weeks was adequate, and that a booster dose is needed in the second year of life in order to maintain protection.
Danish: Yderligere undersøgelser viste, at det var hensigtsmæssigt at indlede vaccinationen i seks-ugersalderen, og at det var nødvendigt med en boosterdosis i det andet leveår for at vedligeholde
English: Tritanrix HepB has been studied in six studies involving a total of 872 infants aged between seven and 20 weeks, all of whom received the vaccine.
Danish: Tritanrix HepB er blevet undersøgt i seks undersøgelser, hvor 872 spædbørn i alderen syv til 20 uger deltog.
English: Further studies looked at the effects of the vaccine in younger infants and at the persistence of antibody levels after vaccination.
Danish: I yderligere undersøgelser så forskerne på virkningen af vaccinen hos yngre spædbørn og den fortsatte tilstedeværelse af antistofniveauer efter vaccination.
English: It contains toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough) and parts of the hepatitis B virus as active substances.
Danish: Den indeholder difteri- og stivkrampetoksoider (kemisk svækkede toksiner), inaktiverede (dræbte) Bordetella pertussis (kighostebakterie) og dele af hepatitis B-virus som aktive stoffer.
English: The effects of Tritanrix HepB were first tested in experimental modes before being studied in humans.
Danish: Virkningerne af Tritanrix HepB blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos
English: Tritanrix HepB is a vaccine.
Danish: Tritanrix HepB er en vaccine.
English: At least 92% developed protective levels of
Danish: Mindst 92 % af spædbørnene udviklede beskyttende niveauer af antistoffer mod kighoste.