FrancophonIA/ELRC3.0 huggingface dataset:
English: When the receptors are activated, the breakdown of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.
Danish: Når receptorerne aktiveres, fremskyndes nedbrydningen af fedt, hvilket bidrager til at holde blodet fri for kolesterol og triglycerider.
English: It must also not be used in patients with gall bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate.
Danish: Det må heller ikke anvendes til patienter med galdeblæresygdom, kronisk eller akut pankreatitis (betændelse i bugspytkirtlen) eller til patienter, som tidligere har haft myopati (muskelsygdomme) eller rhabdomyolyse (nedbrydning af muskelfibre) efter behandling med et statin eller et fibrat.
English: What is the risk associated with Pravafenix?
Danish: Hvilken risiko er der forbundet med Pravafenix?
English: Why has Pravafenix been approved?
Danish: Hvorfor blev Pravafenix godkendt?
English: What is Pravafenix?
Danish: Hvad er Pravafenix?
English: What is Pravafenix used for?
Danish: Hvad anvendes Pravafenix til?
English: How has Pravafenix been studied?
Danish: Hvordan blev Pravafenix undersøgt?
English: What benefit has Pravafenix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pravafenix?
English: How is Pravafenix used?
Danish: Hvordan anvendes Pravafenix?
English: How does Pravafenix work?
Danish: Hvordan virker Pravafenix?
English: Ref. EMEA/263700/2008
Danish: Ref. EMA/263700/2008
English: What are the conclusions of the review?
Danish: Hvad er konklusionerne af vurderingen?
English: Until December 2007, it was also available in Belgium.
Danish: Indtil december 2007 kunne det også fås i Belgien.
English: London, 16 October 2009 Doc.
Danish: London, den 16. oktober 2009 Dok.
English: The European Commission issued a decision on 16 October 2009.
Danish: Europa-Kommissionen traf en afgørelse den 16. oktober 2009.
English: Nimesulide is available as branded and generic medicines in the following Member States: Austria, Bulgaria, the Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Danish: 2 Nimesulid kan fås som generiske lægemidler eller mærkevarelægemidler i de følgende medlemsstater: Østrig, Bulgarien, Tjekkiet, Cypern, Frankrig, Grækenland, Ungarn, Italien, Letland, Litauen, Malta, Polen, Portugal, Runænien, Slovakiet og Slovenien.
English: 1 Procedure under Article 107 of Directive 2001/83/EC, as amended.
Danish: 1 Procedure i henhold til artikel 107 i direktiv 2001/83/EF, med senere ændringer.
English: ‘Systemic formulations' are medicines that are given as a treatment throughout the body, such as tablets, solutions and suppositories.
Danish: "Systemiske formuleringer" er lægemidler, som gives som behandling i hele kroppen, f.eks. tabletter, opløsninger og suppositorier.
English: This process involves a consultation step with the Standing Committee for Medicinal Products for Human Use, a body of representatives from Member States.
Danish: Denne proces involverede en konsultationsprocedure med det Stående Udvalg for Humanmedicinske Lægemidler, en gruppe af repræsentanter fra medlemsstaterne.
English: This should be carried out in a separate ‘Article 31' referral procedure.
Danish: Det bør ske under en separat artikel 31 - indbringelsesprocedure.
English: Nimesulide is a non-selective non-steroidal anti-inflammatory drug (NSAID).
Danish: Nimesulid er en ikke-selektiv, ikke-steroid og betændelseshæmmende medicintype (NSAID).
English: The Committee has also reviewed the results of an Italian ‘simulation study', carried out by the Italian medicines regulatory authority.
Danish: Udvalget har også gennemgået resultaterne fra en italiensk "simuleringsundersøgelse" gennemført af de italienske lægemiddelmyndigheder.
English: Questions and answers on the outcome of the review of nimesulide-containing medicines1
Danish: Spørgsmål og svar i forbindelse med resultatet af vurderingen af lægemidler, som indeholder nimesulid1
English: The European Commission asked the Committee to prepare an opinion on whether the marketing authorisations for products containing nimesulide should be maintained, changed, suspended or withdrawn across the EU.
Danish: Europa-Kommissionen bad Udvalget om at udarbejde en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende nimesulid burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU.
English: The CHMP opinion adopted in September 2007 was transmitted to the European Commission so that it could issue a final decision.
Danish: CHMP's udtalelse, som blev vedtaget i september 2007, blev videresendt til Europa-Kommissionen, som skulle træffe en endelig afgørelse.
English: Why was nimesulide reviewed?
Danish: Hvorfor blev nimesulid vurderet igen?
English: Products containing nimesulide have been available since 1985 and are authorised in a number of Member States2.
Danish: Lægemidler, som indeholder nimesulid, har været på markedet siden 1985 og er godkendt i et antal medlemsstater2.
English: This type of referral is used when it is of ‘Community interest' (for the benefit of all Member States) to have a common view on the benefit-risk balance of a medicine.
Danish: Denne type indbringelse anvendes, når det er af "interesse for fællesskabet" (til fordel for alle medlemsstater) at få en samlet vurdering af forholdet mellem fordele og ulemper for et lægemiddel.
English: However, the CHMP further concluded that the benefits and risks of nimesulide should be assessed in a wider context.
Danish: Imidlertid konkluderede CHMP desuden, at fordele og risici ved nimesulid burde bedømmes i et bredere perspektiv.
English: 3 The details on the actions taken by the EMEA and of their outcome can be found in the question-and-answer document published in September 2007.
Danish: 3 Oplysninger om EMA's foranstaltninger og resultaterne heraf kan ses i dokumentet med spørgsmål og svar, som blev udgivet i september 2007.
English: The simulation took the impact of patients switching to alternative painkiller medicines into account.
Danish: Simuleringen tog påvirkningen fra patienter, som skiftede til alternativ smertestillende medicin, med i betragtning.
English: It is used to treat acute (short-term) pain, and the symptoms of painful osteoarthritis (swelling in the joints) and primary dysmenorrhoea (period pains).
Danish: Det anvendes til at behandle akutte (kortvarige) smerter og symptomer på smertefuld osteoarthritis (hævelse i leddene) og primær dysmenoré (menstruationssmerter).
English: Because of the severity of the side effects, the European Commission recommended that further measures be taken to ensure that the risk of these side effects is lowered.
Danish: På grund af sværhedsgraden af bivirkningerne anbefalede Europa-Kommissionen, at der blev truffet yderligere foranstaltninger til at sikre, at risikoen for disse bivirkninger blev reduceret.
English: The review of the liver-related safety of ‘systemic formulations' of medicines containing nimesulide has been completed.
Danish: Vurderingen af den leverrelaterede sikkerhed af "systemiske formuleringer" af lægemidler, som indeholder nimesulid, er afsluttet.
English: At the end of the review in September 2007, the CHMP concluded that the available data did not support a suspension of all marketing authorisations in Europe.
Danish: Da vurderingen var afsluttet i september 2007, konkluderede CHMP, at de tilgængelige data ikke berettigede en suspension af alle markedsføringstilladelser i Europa.
English: The Commission also made it clear that the companies that market nimesulide-containing medicines should inform doctors about the medicines' risks.
Danish: Kommissionen gjorde det også klart, at virksomheder, som markedsfører lægemidler, som indeholder nimesulid, skal informere læger om lægemidlets risici.
English: The European Commission noted that, in some Members States, nimesulide was restricted to second-line treatment.
Danish: EuropaKommissionen bemærkede, at nimesulid i nogle medlemsstater var begrænset til andetvalgsbehandling.
English: This review should 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 Article 107 procedure.
Danish: Vurderingen burde omfatte alle de potentielle risici ved lægemidlet, særligt risikoen for bivirkninger, som påvirker maven og tarmene, som ikke var omfattet af den oprindelige artikel 107-procedure.
English: The European Commission endorsed the CHMP opinion with a further restriction to limit the use of these medicines to ‘second-line' (used when at least one other medicine has failed).
Danish: Europa-Kommissionen godkendte CHMP's udtalelse med en yderligere restriktion om at begrænse brugen af lægemidlerne til "andet valg" (anvendes, når mindst ét andet lægemiddel ikke har haft nogen virkning).
English: Nimesulide was reviewed by the CHMP in 2007 because of concerns with liver injury.
Danish: Nimesulid blev vurderet af CHMP i 2007 på grund af bekymringer for leverskader.
English: However, it recommended that some restrictions should be placed on the way these medicines are prescribed, including limiting the pack size to 30 doses, and that the information provided to doctors and patients be amended to limit the risk of liver injury
Danish: Udvalget anbefalede imidlertid, at der skulle være visse restriktioner af måden, disse lægemidler udleveres på, herunder at begrænse pakningsstørrelserne til 30 doser, og at information til læger og patienter skulle ændres for at begrænse risikoen for leverskader3.
English: This study used existing reports of the rate of side effects with all NSAIDs to simulate the possible effect that a suspension of nimesulide would have on the rates of side effects affecting the stomach and gut.
Danish: Denne undersøgelse benyttede eksisterende rapporter om hyppigheden af bivirkninger med alle NSAID'er for at simulere den mulige effekt, en suspension af nimesulid ville have på forekomsten af bivirkninger, som påvirker maven og tarmene.
English: The review was an article 107 procedure triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, mainly because of liver problems.
Danish: Vurderingen var en procedure under artikel 107, som var udløst af beslutningen fra Irlands lægemiddelmyndigheder i maj 2007 om at suspendere markedsføringstilladelserne for systemiske lægemidler, som indeholdt nimesulid, primært på grund af leverproblemer.
English: The CHMP noted that the only additional measures taken by Member States were changes to the prescription status or reimbursement levels for nimesulide-containing medicines.
Danish: CHMP bemærkede, at de eneste yderligere forholdsregler, medlemsstaterne havde truffet, var ændringer i udleveringsbestemmelserne eller tilskudsniveauet for lægemidler, som indeholder nimesulid.
English: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines still outweigh their risks, and that there is a need to restrict their use to ensure that the risk of patients developing liver problems is kept to a minimum.
Danish: Det Europæiske Lægemiddelagenturs Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at den gavnlige virkning af disse lægemidler stadig er større end risiciene, og at der er et behov for at begrænse brugen af disse lægemidler for at sikre, at risikoen for, at patienter udvikler leverproblemer, holdes på et minimum.
English: In the latest review, the CHMP has looked at all the reports of side effects affecting the liver in patients taking nimesulide reported since April 2007, including those from Ireland.
Danish: I den seneste udtalelse har CHMP set på alle bivirkningsrapporter siden april 2007 om leverpåvirkning hos patienter, som tager nimesulid, inklusive rapporter fra Irland.
English: This suggested that the measures recommended in September 2007, including the changes to the prescribing information, were appropriate to reduce the risk of liver problems associated with nimesulide.
Danish: Det tydede på, at forholdsreglerne, som blev anbefalet i september 2007, inklusive ændringerne i udleveringsinformationen, var relevante med hensyn til at reducere risikoen for leverproblemer i forbindelse med nimesulid.
English: Based on the additional information reviewed, the CHMP has not changed its conclusions from September 2007, namely 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: Baseret på den yderligere information, der er vurderet, har CHMP ikke ændret sin konklusion fra september 2007 om, at fordelen ved systemiske formuleringer af nimesulid stadig er større end risiciene, forudsat at brugen af disse lægemidler begrænses for at sikre, at risikoen for, at patienter udvikler leverproblemer, holdes på et minimum.
English: The restriction was therefore added into the prescribing information for nimesulide-containig medicines.
Danish: Begrænsningen blev derfor tilføjet udleveringsoplysningerne for lægemidler, som indeholder nimesulid.
English: The Committed has also looked at whether Member States took additional measures to those proposed by the CHMP in September 2007, in order to minimise the risk of liver problems in patients using nimesulide-containing medicines.
Danish: Udvalget har også set på, om medlemsstaterne traf yderligere forholdsregler end dem, som CHMP foreslog i september 2007, for at minimere risikoen for leverproblemer hos patienter, som tager lægemidler, der indeholder nimesulid.
English: The Standing Committee could not reached an agreement, and, on 8 February 2008, the European Commission therefore asked the CHMP to further consider its opinion, taking new data on the risk of liver problems into account, in particularly new data supplied by Ireland, and looking at ways of minimising the risk associated with nimesulide.
Danish: Det Stående Udvalg kunne ikke nå til enighed, og den 8. februar 2008 bad Europa-Kommissionen derfor CHMP om at genoverveje sin udtalelse under hensyntagen til nye data om risikoen for
English: Invented name Strength Pharmaceutical Form Route of administration
Danish: Særnavn Styrke Lægemiddelform
English: Further information on EndolucinBeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om EndolucinBeta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: EndolucinBeta received a marketing authorisation valid throughout the EU on 6 July 2016.
Danish: EndolucinBeta fik en markedsføringstilladelse med gyldighed i hele EU den 6. juli 2016.
English: However, the quantity of EndolucinBeta to be used is very small and therefore these risks are considered low.
Danish: Den anvendte mængde af EndolucinBeta er imidlertid meget lille, hvorfor disse risici anses for at være lave.
English: These tumours affect hormonesecreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Danish: Denne type svulster udgår fra hormonproducerende celler i mange dele af kroppen, bl.a. bugspytkirtlen, tarmen, mavesækken og lungerne.
English: The most common side effects with EndolucinBeta (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Danish: De hyppigste bivirkninger ved EndolucinBeta (der kan forekomme hos mere end 1 ud af 10 patienter) er anæmi (lavt antal røde blodlegemer), trombocytopeni (lavt antal blodplader), leukopeni (lavt antal leukocytter (en type hvide blodlegemer)), lymfopeni (lavt antal lymfocytter, en type hvide blodlegemer), kvalme, opkastning og midlertidigt let hårtab.
English: EndolucinBeta is never given to a patient on its own.
Danish: EndolucinBeta indgives aldrig alene til en patient.
English: The Agency concluded that the benefits of EndolucinBeta outweigh the risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved EndolucinBeta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The doctor will ensure that the expected benefit to the patients of using EndolucinBeta outweigh the risks linked to the radioactivity.
Danish: Lægen vil sikre, at patientens forventede fordel af at anvende EndolucinBeta opvejer risiciene ved radioaktiviteten.
English: Side effects reported with EndolucinBeta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for EndolucinBeta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: EndolucinBeta (lutetium (177Lu) chloride) EMA/554249/2018
Danish: EndolucinBeta (lutetium(177Lu)-chlorid) EMA/554249/2018
English: What measures are being taken to ensure the safe and effective use of EndolucinBeta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af EndolucinBeta?
English: Other information about EndolucinBeta
Danish: Andre oplysninger om EndolucinBeta
English: As for all medicines, data on the use of EndolucinBeta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af EndolucinBeta løbende overvåget.
English: Information on how to minimise the risks is included in the product information for EndolucinBeta.
Danish: Oplysninger om, hvordan risiciene minimeres, findes i produktinformationen for EndolucinBeta.
English: As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from EndolucinBeta.
Danish: Som ved alle materialer til radioaktiv mærkning af lægemidler er der risici forbundet med eksponering for radioaktivitet fra EndolucinBeta.
English: EndolucinBeta is only used by specialists who have experience in radiolabelling.
Danish: EndolucinBeta anvendes kun af specialister med erfaring i radioaktiv mærkning.
English: An overview of EndolucinBeta and why it is authorised in the EU
Danish: En oversigt over EndolucinBeta, og hvorfor det er godkendt i EU
English: Radiolabelling with EndolucinBeta takes place in a laboratory.
Danish: Radioaktiv mærkning med EndolucinBeta sker i laboratoriet.
English: EndolucinBeta itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and defects that are passed on to children.
Danish: EndolucinBeta er i sig selv radioaktivt og kan som alle andre radioaktive produkter medføre risiko for kræft og udvikling af arvelige defekter.
English: The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well documented in the scientific literature.
Danish: Det Europæiske Lægemiddelagentur fandt, at anvendelsen af lutetium (177Lu) til radioaktiv mærkning af lægemidler var veldokumenteret i den videnskabelige litteratur.
English: What is EndolucinBeta and what is it used for?
Danish: Hvad er EndolucinBeta, og hvad anvendes det til?
English: Why is EndolucinBeta authorised in the EU?
Danish: Hvorfor blev EndolucinBeta godkendt i EU?
English: Medicines radiolabelled with EndolucinBeta must not be used in women unless pregnancy has been ruled out.
Danish: Lægemidler, der er radioaktivt mærket med EndolucinBeta, må kun anvendes til kvinder, hos hvem graviditet er blevet udelukket.
English: Several published studies have established the usefulness of lutetium (177Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours.
Danish: En række offentliggjorte studier har fastslået nytten af lutetium (177Lu) til radioaktiv mærkning af lægemidler til brug ved diagnosticering og behandling af neuroendokrine svulster.
English: What are the risks associated with EndolucinBeta?
Danish: Hvilke risici er der forbundet med EndolucinBeta?
English: The active substance in EndolucinBeta, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation.
Danish: Det aktive stof i EndolucinBeta, lutetium (177Lu)-chlorid, er en radioaktiv forbindelse, der hovedsagelig udsender betastråling og små mængder gammastråling.
English: Information on restrictions that apply specifically to medicines radiolabelled with EndolucinBeta can be found in the package leaflets of those medicines.
Danish: Oplysninger om særlige begrænsninger for lægemidler, der er radioaktivt mærket med EndolucinBeta, findes i indlægssedlerne for de pågældende lægemidler.
English: EndolucinBeta is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Danish: EndolucinBeta bruges til radioaktiv mærkning af lægemidler, der er specielt udviklet til anvendelse med lutetium (177Lu)- chlorid.
English: For the list of all side effects and restrictions with EndolucinBeta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved EndolucinBeta fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of EndolucinBeta have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af EndolucinBeta.
English: How well EndolucinBeta works will largely depend on the medicine that it is used to radiolabel.
Danish: Effekten ved EndolucinBeta afhænger i vid udstrækning af det lægemiddel, som det anvendes til radioaktiv mærkning af.
English: How is EndolucinBeta used?
Danish: Hvordan anvendes EndolucinBeta?
English: Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example, the site of a tumour.
Danish: Formålet er at bringe radioaktiviteten frem til de steder i kroppen, hvor der er brug for den, f.eks. til en svulst.
English: The side effects with EndolucinBeta depend largely on the medicine it is used with and are described in that medicine's package leaflet.
Danish: Bivirkningerne ved EndolucinBeta afhænger hovedsagelig af det lægemiddel, det anvendes sammen med.
English: How does EndolucinBeta work?
Danish: Hvordan virker EndolucinBeta?
English: When a medicine radiolabelled with EndolucinBeta is given to a patient, it carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis).
Danish: Formålet med dette er enten at dræbe kræftceller (til behandlingsformål) eller at skabe billeder på en skærm (til diagnoseformål).
English: What benefits of EndolucinBeta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved EndolucinBeta?
English: EndolucinBeta contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines.
Danish: EndolucinBeta indeholder den radioaktive forbindelse lutetium (177Lu)-chlorid.
English: It is currently marketed in the entire European Union and world-wide in more than 10 countries, including USA and Japan.
Danish: Det markedsføres nu i hele Den Europæiske Union og i mere end 10 lande verden over, herunder USA og Japan.
English: The final opinion was converted into a Decision by the European Commission on 7 November 2005.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 7. november 2005.
English: International Non-Proprietary Name (INN): Perindopril
Danish: Internationalt fællesnavn ( INN): Perindopril