FrancophonIA/ELRC3.0 huggingface dataset:
English: The company wanted the changes to be recognised in Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ønskede ændringerne anerkendt i Tjekkiet, Tyskland, Frankrig, Italien, Nederlandene, Polen, Spanien og Det Forenede Kongerige ("de berørte medlemsstater").
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Cardioxane on 19/07/2017.
Danish: Europa-Kommissionen udstedte en retligt bindende beslutning med gyldighed i hele EU om at gennemføre CHMP's anbefaling om Cardioxane 19/07/2017.
English: On 18 May 2017, the European Medicines Agency completed an arbitration procedure for Cardioxane (dexrazoxane powder for solution for injection).
Danish: Den 18. maj 2017 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure for Cardioxane (dexrazoxan, pulver til injektionsvæske, opløsning).
English: In 2015, Clinigen submitted an application to the French medicines regulator ANSM for changes to the terms of the marketing authorisation, including removal of the contraindication in children and adolescents.
Danish: I 2015 indgav Clinigen en ansøgning til den franske lægemiddelstyrelse ANSM om at ændre betingelserne for markedsføringstilladelsen, herunder at slette kontraindikationen for børn og unge.
English: However, as there are a small number of patients under 18 years who require high doses of anthracyclines and who are therefore at greater risk of harmful effects on the heart, the Committee agreed that the contraindication should be lifted for this group.
Danish: Der er imidlertid et lille antal patienter under 18 år, der behøver høje doser af antracykliner, og som derfor har større risiko for skadevirkning på hjertet, hvorfor udvalget vedtog, at kontraindikationen skal ophæves for denne gruppe.
English: The way in which dexrazoxane protects the heart is not entirely clear, but may be linked to the way the medicine attaches to charged iron particles that are involved in the processes that make anthracyclines harmful to the heart muscle.
Danish: Hvordan dexrazoxan beskytter hjertet, er ikke helt klart, men kan have sammenhæng med, hvordan lægemidlet bindes til ladede jernpartikler, der medvirker ved de processer, der gør antracykliner skadelige for hjertemuskulaturen.
English: However ANSM and the concerned Member States were unable to reach agreement on whether the contraindication could be removed just for children and adolescents treated with high cumulative doses of anthracyclines, and, on 31 January 2017, France referred the matter to the CHMP for arbitration.
Danish: ANSM og de berørte medlemsstater var imidlertid ikke i stand til at nå til enighed om, hvorvidt kontraindikationen kunne slettes alene for børn og unge, der var behandlet med høje samlede doser antracykliner, og den 31. januar 2017 indbragte Frankrig sagen for CHMP med henblik på voldgift.
English: CHMP therefore concluded that the product information should state that the medicine is contraindicated in patients under 18 years old who are intended to receive a total cumulative dose of less than 300 mg of doxorubicin per m2 body surface or an equivalent dose of another anthracycline medicine.
Danish: CHMP konkluderede derfor, at det i produktinformationen skal anføres, at lægemidlet er kontraindiceret hos patienter under 18 år, som påtænkes at skulle have en samlet totaldosis på mindre end 300 mg doxorubicin pr. m2 legemsoverflade eller en tilsvarende dosis af et andet lægemiddel af antracyklintypen.
English: Based on evaluation of the currently available data, and the scientific discussion within the Committee, the CHMP concluded that the benefits and risks of Cardioxane have not been established in children under the age of 18 years, in whom it is not licensed, particularly given that most young patients do not receive the high total doses of anthracyclines that can cause damage to the heart.
Danish: På baggrund af gennemgang af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene og risiciene ved Cardioxane ikke er fastlagt hos børn under 18 år, som det ikke er godkendt til, især på baggrund af, at de fleste unge patienter ikke får de høje samlede doser af antracykliner, der kan medføre skade på hjertet.
English: Cardioxane is a medicine used in adults with breast cancer to prevent long-term harmful effects on the heart caused by treatment with the anthracycline cancer medicines doxorubicin and epirubicin.
Danish: Cardioxane er et lægemiddel, der anvendes til voksne med brystkræft for at forhindre langsigtede skadelige virkninger på hjertet som følge af behandling med doxorubicin og epirubicin, som er kræftlægemidler af antracyklintypen.
English: The grounds for the referral were the concerns of the UK that removing the contraindication in patients less than 18 years old receiving a high cumulative dose of anthracyclines was not justified given the remaining uncertainties regarding the safety and effectiveness of Cardioxane in this population, particularly given the previous decision of the CHMP regarding dexrazoxane medicines.
Danish: Begrundelsen for indbringelsen var Det Forenede Kongeriges betænkelighed ved, at sletning af kontraindikationen for patienter under 18 år, der fik en høj samlet dosis antracykliner, ikke var velbegrundet på grund af tilbageblivende usikkerhed om sikkerheden og effektiviteten af Cardioxane hos denne patientgruppe, især på baggrund af CHMP's tidligere afgørelse vedrørende lægemidler indeholdende dexrazoxan.
English: The contraindication should however remain in children and adolescents who are given lower cumulative doses of anthracyclines.
Danish: Kontraindikationen bør dog bibeholdes for børn og unge, der får lavere samlede doser af antracykliner.
English: The Agency had been asked to arbitrate on the removal of the contraindication for children and adolescents treated with high cumulative doses of cancer medicines called anthracyclines.
Danish: Agenturet var blevet anmodet om at voldgive vedrørende sletningen af kontraindikationen for børn og unge, der er behandlet med høje samlede doser af kræftlægemidler af typen antracykliner.
English: Because of concerns that it might increase the risk of second cancers developing long after treatment, the CHMP reviewed the medicine2 in September 2011 and recommended on the basis of the evidence at that time that use of medicines containing dexrazoxane to protect the heart should be explicitly contraindicated in children and adolescents.
Danish: På grund af betænkelighed ved, at dette kan tænkes at øge risikoen for, at der opstår en anden kræftsygdom længe efter behandlingen, gennemgik CHMP i september 2011 lægemidlet2 og anbefalede på grundlag af den daværende dokumentation, at lægemidler, der
English: 20 January 2012
Danish: Den 20. januar 2012
English: It has been used to treat:
Danish: Det er blevet anvendt til at behandle:
English: The European Commission issued a decision on 20 January 2012.
Danish: Europa-Kommissionen traf en afgørelse den 20. januar 2012.
English: Systemic nimesulide medicines are available in the following Member States: Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Danish: Systemiske lægemidler indeholdende nimesulid er tilgængelige i følgende medlemsstater: Bulgarien, Tjekkiet, Cypern, Frankrig, Grækenland, Ungarn, Italien, Letland, Litauen, Malta, Polen, Portugal, Rumænien, Slovakiet og Slovenien.
English: What is nimesulide?
Danish: Hvad er nimesulid?
English: All information can be found on the Agency website under Regulatory > Human medicines > Referral procedures> Final decisions
Danish: Alle oplysninger er tilgængelige på agenturets hjemmeside på adressen Regulatory > Human medicines > Referral procedures> Final decisions
English: What are the recommendations for patients and prescribers?
Danish: Hvilke anbefalinger blev der fremsat til patienter og ordinerende læger?
English: Medicines containing nimesulide have been available since 1985 and are authorised in a number of Member States.
Danish: Lægemidler indeholdende nimesulid har været tilgængelige siden 1985 og er godkendt i en række medlemsstater.
English: They are only available with a prescription.
Danish: De udleveres kun efter recept.
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Danish: Resultatet af en procedure i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer
English: Nimesulide-containing medicines are authorised but not marketed in Austria and in Ireland.
Danish: Lægemidler indeholdende nimesulid er godkendt, men ikke markedsført, i Østrig og Irland.
English: 1 Article 107 of Directive 2001/83/EC as amended.
Danish: 1 Artikel 107 i direktiv 2001/83/EF, med senere ændringer.
English: Nimesulide is a non-selective non-steroidal anti-inflammatory drug (NSAID).
Danish: Nimesulid er et ikke-selektivt, ikke-steroidt antiinflammatorisk lægemiddel (NSAID).
English: Why was nimesulide reviewed?
Danish: Hvorfor blev nimesulid revurderet?
English: • acute (short-term) pain,
Danish: • akutte (kortvarige) smerter
English: The European Medicines Agency has completed a review of the safety and effectiveness of systemic medicines containing nimesulide (capsules, tablets, suppositories and powder or granules for oral suspension).
Danish: Det Europæiske Lægemiddelagentur har gennemgået sikkerheden og virkningen af systemiske lægemidler indeholdende nimesulid (kapsler, tabletter, suppositorier og pulver eller granulat til oral suspension).
English: • Patients who have any questions should speak to their doctor or pharmacist.
Danish: • Patienter, der ønsker yderligere oplysninger, bør tale med lægen eller apotekspersonalet.
English: It also reviewed data from the published literature, including published clinical studies, reviews and overviews and combined analyses of results from various studies (pooled analyses and meta-analyses).
Danish: Det gennemgik desuden data fra litteraturen, herunder offentliggjorte kliniske undersøgelser, oversigtsartikler og kombinerede analyser af resultater fra forskellige undersøgelser (poolede analyser og metaanalyser).
English: Consequently, on 19 January 2010, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of nimesulide and to issue an opinion on whether the marketing authorisations for systemic medicine containing nimesulide should be maintained, varied, suspended or withdrawn across the European Union.
Danish: Følgelig anmodede Europa-Kommissionen den 19. januar 2010 CHMP om at foretage en fyldestgørende vurdering af benefit/risk-forholdet for nimesulid og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for systemiske lægemidler indeholdende nimesulid bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: • primary dysmenorrhoea (period pains).
Danish: • primær dysmenorré (menstruationssmerter).
English: The Committee noted that the studies looking into the effectiveness of nimesulide in acute pain relief have shown that it is as effective as other NSAID pain killers such as diclofenac, ibuprofen and naproxen.
Danish: Udvalget bemærkede, at de undersøgelser, der havde vedrørt effektiviteten af nimesulid til akut smertelindring, havde vist, at det er lige så effektivt som andre smertestillende NSAID som diclofenac ibuprofen og naproxen.
English: Nimesulide was reviewed in 2007 because of concerns with liver injury.
Danish: Nimesulid blev vurderet af CHMP i 2007 på grund af betænkelighed vedrørende leverskader.
English: The Committee reviewed available post marketing data from spontaneous reports of side effects, individual study reports and epidemiological (population-based) studies.
Danish: Udvalget gennemgik de foreliggende data, der var fremkommet efter markedsføring fra spontane bivirkningsindberetninger, individuelle undersøgelsesrapporter og epidemiologiske undersøgelser (undersøgelser baseret på befolkningsgrupper).
English: To this effect the Committee recommended that treatment duration should be limited to a maximum of 15 days (packs were also limited to a two-week supply), that nimesulide should be restricted to second line treatment, and that doctors should be clearly informed of the risk.
Danish: Med henblik herpå anbefalede udvalget, at behandlingsvarigheden begrænses til højst 15 dage (pakningsstørrelsen blev ligeledes begrænset til to ugers forbrug), at brugen af nimesulid begrænses til andetvalgsbehandling, og at lægerne skal informeres tydeligt om risikoen.
English: To limit the risk of side effects affecting the liver, several restrictions have already been introduced in the past, including restriction to second line treatment, the use of lowest effective doses for the shortest possible duration, and a maximum duration of treatment for acute pain.
Danish: For at begrænse risikoen for bivirkninger fra leveren er der allerede tidligere indført flere begrænsninger, herunder begrænsninger til andetvalgsbehandling, brug af laveste effektive doser i kortest mulig tid og begrænset behandlingsvarighed for akutte smerter.
English: • Nimesulide should only be used as a second choice, and only in the treatment of acute pain or dysmenorrhoea.
Danish: • Nimesulid bør kun bruges som andetvalgsbehandling, og kun til behandling af akutte smerter eller dysmenorré.
English: The review procedure was triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, due to new information regarding cases of fulminant hepatic failure requiring liver transplantation.1 The Committee concluded that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum.
Danish: Denne gennemgang blev udløst af den irske lægemiddelstyrelses beslutning i maj 2007 om midlertidigt at suspendere markedsføringstilladelsen for systemiske lægemidler indeholdende nimesulid på grund af nye oplysninger om tilfælde af fulminant (voldsomt) transplantationskrævende leversvigt.1 Udvalget konkluderede, at fordelene ved systemiske formuleringer af nimesulid fortsat opvejer risiciene, forudsat at brugen af disse lægemidler indskrænkes, så det sikres, at risikoen for udvikling af leverproblemer holdes på et minimum.
English: It issued a recommendation that it should no longer be used for the treatment of painful osteoarthritis.
Danish: Udvalget udstedte en anbefaling om, at det ikke længere bør anvendes til behandling af smertefuld osteoartritis.
English: The Committee considered that the use of systemic nimesulide for the treatment of painful osteoarthritis, which is a chronic condition, will increase the risk of the medicines being used for long-term treatment with a consequent increase in the risk of liver injury.
Danish: Udvalget tog i betragtning, at anvendelsen af systemisk nimesulid til behandling af smertefuld osteoartritis, som er en kronisk sygdom, vil øge risikoen for, at lægemidlerne anvendes til langtidsbehandling med deraf følgende øget risiko for leverskade.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of nimesulide used systemically continue to outweigh its risks but that its use should be restricted to the treatment of acute pain and primary dysmenorrhoea.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved nimesulid fortsat opvejer risiciene, men at dets anvendelse bør indskrænkes til behandling af akutte smerter og primær dysmenorré.
English: The CHMP concluded that nimesulide was associated with an increased risk of liver toxicity compared with other anti-inflammatory treatments.
Danish: CHMP konkluderede, at nimesulid er forbundet med større risiko for levertoksicitet end andre antiinflammatoriske midler.
English: The CHMP also concluded that a fuller review of nimesulide was needed, that would look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original review.
Danish: CHMP konkluderede desuden, at nimesulid burde underkastes en mere omfattende gennemgang, som omfatter alle de potentielle risici ved lægemidlet, navnlig risikoen for bivirkninger fra maven og tarmene, hvilket ikke var omfattet af den oprindelige vurdering.
English: • painful osteoarthritis (swelling in the joints) ,
Danish: • smertefuld osteoartritis (hævede led)
English: The CHMP is now recommending, as a further restriction, that systemic nimesulide should no longer be used for treating painful osteoarthritis.
Danish: Som en yderligere begrænsning anbefaler CHMP nu, at systemisk nimesulid ikke længere anvendes til behandling af smertefuld osteoartritis.
English: • Patient currently receiving systemic nimesulide for painful osteoarthritis should consult their doctor in order to arrange alternative treatment.
Danish: • Patienter, der aktuelt er i behandling med systemisk nimesulid for smertefuld osteoartritis, bør kontakte lægen med henblik på at få aftalt et behandlingsalternativ.
English: In terms of safety, the Committee noted that nimesulide has the same risk of causing stomach and gut problems as other NSAIDs.
Danish: Hvad sikkerheden angår, bemærkede udvalget, at nimesulid giver samme risiko for mavetarmproblemer som andre NSAID.
English: • Prescribers should no longer prescribe systemic nimesulide for treating painful osteoarthritis.
Danish: • Systemisk nimesulid bør ikke længere ordineres til behandling af smertefuld osteoartritis.
English: • Prescribers should review treatment of patients being treated for painful osteoarthritis with a view to choosing an appropriate alternative treatment.
Danish: • For patienter, der behandles for smertefuld osteoartritis, bør den ordinerende læge gennemgå behandlingen med henblik på valg af passende behandlingsalternativ.
English: A summary of the recommended changes will be published on the EMA website.
Danish: En sammenfatning af de anbefalede ændringer vil blive offentliggjort på EMA's websted.
English: More about the procedure
Danish: Yderligere information om proceduren
English: Metamizole-containing medicines are available in Austria, Belgium, Bulgaria, Croatia, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Danish: Memizolholdige lægemidler er tilgængelige i Østrig, Belgien, Bulgarien, Kroatien, Tjekkiet, Finland, Tyskland, Ungarn, Italien, Letland, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien.
English: They are marketed under a variety of names including Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin and Tempimet.
Danish: De markedsføres under en række forskellige navne, herunder Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin og Tempimet.
English: The review of metamizole was initiated on 31 May 2018 at the request of Poland, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af metamizol blev indledt den 31. maj 2018 på anmodning af Polen i medfør af Artikel 31 i direktiv 2001/83/EF.
English: • Patients who have any concerns about their medication should consult their doctor or pharmacist.
Danish: • Patienter, der har spørgsmål med hensyn til deres behandling, bør tale med deres læge eller apotekspersonalet.
English: 20 March 2019 EMA/191666/2019
Danish: 20. marts 2019 EMA/191666/2019
English: Metamizole (also known as dipyrone) is an analgesic medicine (painkiller) that can also relieve fever and muscle spasm.
Danish: Metamizol (også kendt som dipyron) er et smertestillende middel, der også kan lindre feber og muskelspasmer.
English: • Updated summaries of product characteristics (information for healthcare professionals) and package leaflets for patients which contain the new recommendations will be available nationally following the final legal decision issued by the European Commission.
Danish: • Opdaterede produktresuméer (oplysninger til sundhedspersoner) og indlægssedler til patienter, der indeholder de nye anbefalinger, vil være tilgængelige på nationalt plan, efter at Kommissionen har truffet en endelig retlig afgørelse.
English: EMA's recommendations include setting a maximum single dose by mouth of 1,000 mg, taken up to 4 times daily (a maximum daily dose of 4,000 mg), in patients from 15 years of age.
Danish: EMA's anbefalinger omfatter en maksimal enkeltdosis på 1.000 mg, der indtages gennem munden op til 4 gange dagligt (en maksimal daglig dosis på 4.000 mg) hos patienter fra 15 års-alderen.
English: E M A /191666/2019
Danish: EMA/191666/2019
English: The review was carried out by EMA's human medicines committee (CHMP) at the request of Poland, which was concerned by the substantial differences in the recommendations on the use of metamizole in different EU countries, given that it is known the medicine may occasionally cause severe side effects, such as effects on the blood.
Danish: Gennemgangen blev foretaget af EMA's udvalg for humanmedicinske lægemidler (CHMP) efter anmodning fra Polen, som var bekymret over, at der var betydelige forskelle i anbefalingerne vedrørende anvendelsen af metamizol i forskellige EU-lande, da lægemidlet som bekendt undertiden kan have alvorlige bivirkninger, f.eks. indvirkninger på blodet.
English: Although metamizole has been on the market for nearly a century, evidence of its effects in pregnancy and breastfeeding is scarce.
Danish: Selvom Metamizol har været på markedet i næsten et århundrede, er der kun begrænset evidens for dets virkninger i forbindelse med graviditet og amning.
English: The Agency reviewed the available information on the way the medicine is distributed in the body, how it works and the limited data on its effects on the unborn child or breast-fed infant.
Danish: Agenturet gennemgik de tilgængelige oplysninger om, hvordan lægemidlet fordeles i kroppen, hvordan det fungerer, og de begrænsede oplysninger om dets virkninger på fostre eller spædbørn, der ammes.
English: As a precaution, metamizole should not be used during breastfeeding because the infant may receive high amounts of the medicine in the milk relative to the infant's weight.
Danish: Som en sikkerhedsforanstaltning bør metamizol ikke anvendes under amning, da spædbarnet kan modtage for store mængder af lægemidlet gennem mælken i forhold til barnets vægt.
English: EMA's recommendations were forwarded to the European Commission, which issued a final legally binding decision valid across the EU on 20 March 2019.
Danish: EMA's anbefalinger blev fremsendt til Europa-Kommissionen, som vedtog en endelig juridisk bindende afgørelse med gyldighed i hele EU den 20. marts 2019.