FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kengrexal on 23 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Kengrexal den 23. marts 2015.
English: Nearly all patients also took aspirin and/or other blood-thinning medicines.
Danish: Næsten alle patienterne fik også aspirin og/eller andre blodfortyndende lægemidler.
English: This is a summary of the European public assessment report (EPAR) for Kengrexal.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kengrexal.
English: The full EPAR and risk management plan summary for Kengrexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Kengrexal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: At the discretion of the doctor, the infusion may be continued for up to four hours.
Danish: Efter lægens skøn kan infusionen fortsætte i op til 4 timer.
English: A risk management plan has been developed to ensure that Kengrexal is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Kengrexal anvendes så sikkert som muligt.
English: However, the way this study was designed was considered inadequate to show a clear benefit in these patients, and the company did not pursue this use as part of the application.
Danish: På grund af sin opbygning blev denne undersøgelse imidlertid anset for utilstrækkelig til at vise en klar fordel for disse patienter, og virksomheden beholdt ikke denne anvendelse som en del af ansøgningen.
English: What is Kengrexal and what is it used for?
Danish: Hvad er Kengrexal, og hvad anvendes det til?
English: Treatment should be started before the PCI procedure, and the infusion should be continued for at least 2 hours or until the procedure is over, whichever is longer.
Danish: Behandlingen bør påbegyndes før PCI-indgrebet, og infusionen bør fortsætte i mindst to timer, eller indtil proceduren er afsluttet, hvis denne varer længere end to timer.
English: Why is Kengrexal approved?
Danish: Hvorfor blev Kengrexal godkendt?
English: What measures are being taken to ensure the safe and effective use of Kengrexal?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kengrexal?
English: Treatment starts with an injection into a vein at a dose of 30 micrograms per kilogram bodyweight, which should last less than a minute; this is followed immediately after by an infusion at a rate of 4 micrograms per kilogram each minute.
Danish: Behandlingen begynder med en injektion i en vene af en dosis på 30 µg/kg legemsvægt, som bør vare i under et minut; derefter gives der straks en infusion med en hastighed på 4 µg/kg i minuttet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kengrexal's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Kengrexal opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Kengrexal
Danish: Andre oplysninger om Kengrexal
English: At the end of the infusion, patients should be switched to maintenance treatment by mouth with clopidogrel, ticagrelor or prasugrel.
Danish: Når infusionen er afsluttet, skal patienterne skifte til vedligeholdelsesbehandling gennem munden med clopidogrel, ticagrelor eller prasugrel.
English: The medicine can only be obtained with a prescription and should be given in a hospital setting.
Danish: Lægemidlet udleveres kun efter recept og bør gives i hospitalsomgivelser.
English: Regarding Kengrexal's safety profile, the CHMP noted that the incidence of bleeding was higher for Kengrexal than for clopidogrel, but this was expected given the greater effectiveness of the medicine, and was offset by the fact that the activity of Kengrexal wore off quickly once the infusion was stopped.
Danish: Vedrørende sikkerhedsprofilen af Kengrexal bemærkede CHMP, at forekomsten af blødning var højere for Kengrexal end for clopidogrel, men dette var forventeligt i betragtning af lægemidlets større effektivitet og blev opvejet af, at aktiviteten af Kengrexal hurtigt aftog efter ophør af infusionen.
English: What are the risks associated with Kengrexal?
Danish: Hvilke risici er der forbundet med Kengrexal?
English: It is not intended to provide practical advice on how to use Kengrexal.
Danish: Det er ikke en praktisk vejledning i, hvordan Kengrexal bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kengrexal, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Kengrexal, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The fact that the medicine is given into a vein is considered useful in patients who cannot swallow and cannot take treatments by mouth.
Danish: Det forhold, at lægemidlet indgives i en vene, anses for nyttigt hos patienter, der ikke kan synke og ikke kan indtage medicin gennem munden.
English: Kengrexal was shown to be more effective than clopidogrel taken by mouth at reducing the occurrence of these events: 4.7% of patients (257 out of 5,470 patients) given Kengrexal had an event or died compared with 5.9% (322 out of 5,469 patients) of patients given clopidogrel.
Danish: 4,7 % af patienterne (257 ud af 5 470 patienter), der fik Kengrexal, kom ud for en hændelse eller døde, sammenlignet med 5,9 % (322 ud af 5 469 patienter) af dem, der fik clapidogrel.
English: Kengrexal is a blood-thinning medicine used to reduce the occurrence of problems caused by blood clots, such as heart attack.
Danish: Kengrexal er et blodfortyndende lægemiddel, der anvendes til at nedsætte forekomsten af problemer forårsaget af blodpropper, såsom hjertetilfælde.
English: The active substance in Kengrexal, cangrelor, is an antiplatelet medicine.
Danish: Det aktive stof i Kengrexal, cangrelor, er et antitrombocytmiddel.
English: It must also not be used in patients who have had a stroke or mini stroke (transient ischaemic attack or TIA).
Danish: Det må heller ikke anvendes hos patienter, som har haft slagtilfælde eller forbigående slagtilfælde (transitorisk iskæmisk attak, TIA).
English: Kengrexal must not be used in patients who are actively bleeding or who are at an increased risk of bleeding because of a bleeding disorder, recent major surgery or trauma, or uncontrolled high blood pressure.
Danish: Kengrexal må ikke anvendes hos patienter, der har aktiv blødning, eller som har forhøjet blødningsrisiko på grund af en blødningsforstyrrelse, nylig større operation eller skade, eller ukontrolleret blodtryksforhøjelse.
English: The medicine has been shown to be beneficial at reducing problems caused by blood clots in patients undergoing PCI who have not received previous treatment with P2Y12 inhibitors.
Danish: Lægemidlet er påvist at være gavnligt til at mindske problemer forårsaget af blodpropper hos patienter, der får foretaget PCI og ikke tidligere er behandlet med P2Y12-hæmmere.
English: Kengrexal contains the active substance cangrelor.
Danish: Kengrexal indeholder det aktive stof cangrelor.
English: Kengrexal should be given by a doctor who is experienced in the treatment of coronary disease or in PCI procedures.
Danish: Kengrexal bør ordineres af en læge med erfaring i behandling af koronarsygdom eller i PCI-procedurer.
English: Kengrexal is given to patients who have not been treated before the procedure with other blood-thinning medicines called ‘P2Y12 inhibitors' (clopidogrel, ticagrelor or prasugrel) taken by mouth, and for whom treatment with these medicines is not possible or desirable.
Danish: Kengrexal bruges hos patienter, der før indgrebet ikke har fået andre blodfortyndende lægemidler af typen "P2Y12-hæmmere" (clopidogrel, ticagrelor eller prasugrel) indtaget gennem munden, og hos hvem det ikke er muligt eller hensigtsmæssigt at behandle med disse lægemidler.
English: The most common side effects with Kengrexal (which may affect up to 1 in 10 people) include mild and moderate bleeding and dyspnoea (difficulty breathing).
Danish: De hyppigste bivirkninger ved Kengrexal (som kan forekomme hos op til 1 ud af 10 personer) er let til moderat blødning og vejrtrækningsbesvær (dyspnø).
English: For more information about treatment with Kengrexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kengrexal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Kengrexal was also investigated in one study in which it was given before surgery to patients who had been previously treated with blood-thinning medicines taken by mouth.
Danish: Kengrexal blev desuden anvendt i en undersøgelse, hvor det blev indgivet inden operationen til patienter, der tidligere havde fået blodfortyndende lægemidler indtaget gennem munden.
English: Kengrexal was compared with clopidogrel taken by mouth in one main study involving over 11,000 adults with coronary artery disease who were undergoing PCI.
Danish: Kengrexal blev sammenlignet med clopidogrel indtaget gennem munden i én hovedundersøgelse med over 11 000 voksne med koronar-kar-sygdom, der fik foretaget PCI.
English: The most serious side effects with Kengrexal include severe and life-threatening bleeding and hypersensitivity (allergic) reactions.
Danish: De alvorligste bivirkninger ved Kengrexal er svær, livstruende blødning og allergiske reaktioner (hypersensitivitet).
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
Danish: Dette forhindrer blodpladerne i at blive "klæbrige" og nedsætter risikoen for blodpropper.
English: The main measure of effectiveness was based on the number of patients having an ‘event' such as a heart attack or clots in the heart blood vessels requiring intervention, or dying from any cause, in the 48 hours following PCI.
Danish: Virkningen blev hovedsagelig målt på antallet af patienter, der kom ud for en behandlingskrævende "hændelse", såsom et hjertetilfælde eller blodpropper i hjertets blodkar, eller som døde af en vilkårlig årsag i løbet af de første 48 timer efter PCI.
English: It is used together with aspirin in adults with coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart) who are undergoing percutaneous coronary intervention (PCI - a surgical procedure used to unblock narrowed blood vessels that supply the heart).
Danish: Det anvendes sammen med aspirin hos voksne, der har hjertesygdom forårsaget af forsnævring af de blodkar, der forsyner hjertet (koronar hjertesygdom), og som får foretaget et kirurgisk indgreb for at åbne de forsnævrede blodkar, der forsyner hjertet (PCI - perkutan koronar intervention).
English: Cangrelor stops the platelets sticking together by blocking a substance called ADP from attaching to their surface.
Danish: Cangrelor forhindrer blodpladerne i at klumpe sammen ved at forhindre stoffet ADP i at bindes til blodpladernes overflade.
English: How is Kengrexal used?
Danish: Hvordan anvendes Kengrexal?
English: For the full list of all side effects reported with Kengrexal, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Kengrexal fremgår af indlægssedlen.
English: What benefits of Kengrexal have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kengrexal?
English: For practical information about using Kengrexal, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kengrexal, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Kengrexal is available as a powder to be made up into a solution for injection and infusion (drip) into a vein.
Danish: Kengrexal fås som et pulver, der anvendes til at fremstille en injektionsvæske, som gives med drop i en vene (infusion).
English: This means that it helps to prevent blood cells called platelets from sticking together and forming blood clots, thus helping to prevent another heart attack.
Danish: Det vil sige, at det forhindrer blodpladerne (trombocytterne) i at klumpe sammen og danne blodpropper, hvorved nye hjertetilfælde forebygges.
English: How does Kengrexal work?
Danish: Hvordan virker Kengrexal?
English: 27 May 2013
Danish: Den 27. maj 2013
English: The European Commission issued a decision on 27 May 2013.
Danish: Europa-Kommissionen traf en afgørelse den 27. maj 2013.
English: What is Simvastatin Vale?
Danish: Hvad er Simvastatin Vale?
English: On 25 March 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Simvastatin Vale.
Danish: Den 25. marts 2013 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Simvastatin Vale.
English: Why was Simvastatin Vale reviewed?
Danish: Hvorfor blev Simvastatin Vale vurderet igen?
English: However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 29 January 2013.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges lægemiddelstyrelse indbragte den 29. januar 2013 sagen for CHMP til voldgift.
English: The CHMP therefore concluded that the benefits of Simvastatin Vale outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Simvastatin Vale opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse i de berørte medlemsstater.
English: Simvastatin Vale is used to treat certain forms of hypercholesterolaemia (high blood cholesterol levels) and to reduce the risk of heart disease and death in patients with atherosclerotic cardiovascular disease (where the arteries become narrower due to fatty materials building up on their inside walls) or diabetes.
Danish: Simvastatin Vale anvendes til behandling af visse former for hyperkolesterolæmi (for højt kolesteroltal i blodet) og til at nedsætte risikoen for hjertesygdom og død hos patienter med aterosklerotisk hjerte-karsygdom (hvor arterierne forsnævres på grund af aflejringer af fedtstoffer på karrenes indervægge) eller sukkersyge.
English: It is available as an oral suspension (20mg/5ml and 40mg/5ml).
Danish: Det leveres som en oral suspension (20 mg/5 ml og 40 mg/5 ml).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Simvastatin Vale outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved Simvastatin Vale er større end risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i følgende EU-medlemsstater: Østrig, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Nederlandene, Portugal, Spanien og Sverige samt Norge.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data were not needed because, based on the data submitted, Simvastatin Vale is expected to produce comparable levels of the active substance in the body as the reference medicine at both strengths.
Danish: Efter at have vurderet de aktuelt foreliggende data og de videnskabelige drøftelser i udvalget konkluderede CHMP, at der ikke var behov for supplerende oplysninger, fordi Simvastatin Vale ud fra de forelagte oplysninger forventes at frembringe samme niveauer af det aktive stof i kroppen som referencelægemidlet i begge styrker.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway).
Danish: Dette sker med henblik på udstedelse af en markedsføringstilladelse, der foruden i denne stat er gyldig i andre medlemsstater (de “berørte medlemsstater”, her Østrig, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Nederlandene, Portugal, Spanien og Sverige samt Norge).
English: Simvastatin Vale is a medicine that contains the active substance simvastatin.
Danish: Simvastatin Vale er et lægemiddel, der indeholder det aktive stof simvastatin.
English: The grounds for the referral were concerns about the data submitted to show that Simvastatin Vale is ‘bioequivalent' to the reference medicine, Zocor.
Danish: Begrundelsen for indbringelsen var betænkelighed ved de oplysninger, der var indsendt til dokumentation af, at Simvastatin Vale er “bioækvivalent” med referencelægemidlet, Zocor.
English: The active substance in Simvastatin Vale, simvastatin, belongs to a group of medicines called statins, the standard type of medicine used to reduce cholesterol.
Danish: Det aktive stof i Simvastatin Vale, simvastatin, tilhører lægemiddelgruppen statiner, som er den sædvanligt anvendte type kolesterolsænkende medicin.
English: Vale Pharmaceuticals Ltd submitted Simvastatin Vale to the United Kingdom's Medicines and Healthcare products Regulatory Agency for a decentralised procedure.
Danish: Vale Pharmaceuticals Ltd søgte godkendelse af Simvastatin Vale hos Det Forenede Kongeriges lægemiddelstyrelse ved en decentral procedure.
English: Simvastatin Vale is a generic medicine based on a ‘reference medicine' already authorised in the EU, called Zocor.
Danish: Det betyder, at Simvastatin Vale svarer til et “referencelægemiddel” (Zocor), som i forvejen er godkendt i EU.
English: However, some Member States considered that the higher strength of 40mg/5ml should have been used, in line with the current guideline on the investigation of bioequivalence.
Danish: I den bioækvivalensundersøgelse, der blev indsendt til støtte for ansøgningen, blev Simvastatin Vale, 20 mg/5 ml, sammenlignet med Zocor, tabletter, 20 mg. Nogle medlemsstater fandt imidlertid, at der i undersøgelsen burde have været anvendt den højere styrke på 40 mg/5 ml i overensstemmelse med de gældende retningslinjer for undersøgelse af bioækvivalens.
English: During this period no new patients should be initiated on treatment with meprobamate.
Danish: I denne periode bør ingen nye patienter sættes i behandling med meprobamat.
English: Any existing data is old and does not meet the current methodology requirements.
Danish: Alle foreliggende data er af ældre dato og opfylder ikke nutidige metodologiske krav.
English: The study period was defined as 1 October 2005 to 30 September 2010.
Danish: Undersøgelsen dækkede perioden 1. oktober 2005 til 13. september 2010.
English: Overall summary of the scientific evaluation of meprobamate-containing medicinal products for oral use (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder meprobamat til oral anvendelse (se bilag I)
English: Particularly, the use in the elderly remained considerable.
Danish: Navnlig havde anvendelsen hos ældre stadig et betydeligt omfang.
English: By comparison, 308 serious and non-serious reports were recorded during the 2001 to 2006 period.
Danish: Til sammenligning blev der i perioden 2001-2006 registreret 308 alvorlige og ikkealvorlige indberetninger.
English: Oral formulations of meprobamate have been authorised in the EU as prescription-only products.
Danish: Orale formuleringer af meprobamat er godkendt i EU som receptpligtige produkter.
English: As a result, a procedure under article 107 of Directive 2011/83/EC was automatically initiated at European level for meprobamate-containing medicinal products for oral use.
Danish: Som følge heraf indledtes automatisk en procedure i henhold til artikel 107 i direktiv 2011/83/EF på europæisk plan for lægemidler indeholdende meprobamat til oral anvendelse.
English: Cases of accidental overdose (higher doses than recommended during several days) occurred in 9% of patients.
Danish: Accidentel overdosering (højere doser end anbefalet i flere dage) forekom blandt 9 % af patienterne.
English: This is of particular concern in the elderly population.
Danish: Dette giver navnlig anledning til betænkelighed for den ældre populations vedkommende.
English: The study period was defined as covering the period July 2009 to March 2011 and the resulting data was compared to data from the May 2006 to July 2009 period.
Danish: Undersøgelsen dækkede perioden fra juli 2009 til marts 2011, og de resulterende data blev sammenholdt med data fra perioden maj 2006 til juli 2009.
English: It is available as a single product or as fixed combinations with other substances.
Danish: Det er tilgængeligt som monokomponentprodukt og i faste kombinationer med andre stoffer.
English: Annex II Scientific conclusions and grounds for the suspension of the marketing authorisations presented by the EMA
Danish: Bilag II Videnskabelige konklusioner og begrundelse for suspenderingen af markedsføringstilladelserne fremlagt af EMA
English: As a consequence, they considered additional risk minimisation measures to be unnecessary.
Danish: Følgelig fandt de supplerende risikominimeringsforanstaltninger overflødige.
English: The overall reports involved patients over the age of 65 in 22% of cases and patients aged 75 and over in 13% of cases.
Danish: Totalt vedrørte rapporterne patienter over 65 år i 22 % af tilfældene og patienter over 75 år i 13 % af tilfældene.
English: This is comparable to the 15 fatalities (including 7 due to overdoses) recorded during the May 2006 to July 2009 period.
Danish: Dette tal er sammenligneligt med de 15 dødsfald (hvoraf 7 skyldes overdosering), der blev registreret i perioden fra maj 2006 til juli 2009.
English: This was confirmed by the analysis, which identified 9 cases of addiction/withdrawal during the study period (3 serious cases and 6 non-serious cases).
Danish: Dette bekræftedes af analysen, der viste 9 tilfælde af afhængighed/abstinenser i undersøgelsesperioden (tre alvorlige og seks ikke-alvorlige tilfælde).
English: An association with the use of meprobamate/aceprometazine was considered as possible in all cases.
Danish: I alle tilfældene blev sammenhæng med anvendelse af meprobamat/aceprometazin vurderet som mulig.
English: The most frequently encountered serious adverse events were comas (75 cases).
Danish: Den hyppigst optrædende alvorlige bivirkning var koma (75 tilfælde).
English: Afssaps therefore considered the benefit-risk of meprobamate-containing products to be unfavourable and notified the European Medicines Agency (EMA) and the Committee for Medicinal Products for Human Use (CHMP) on 25 July 2011 of its intention to suspend the French marketing authorisations of oral medicines containing meprobamate, effective as of January 2012.
Danish: Afssaps anså derfor benefit/risk-forholdet for produkter indeholdende meprobamat for ugunstigt og underrettede den 25. juli 2011 Det Europæiske Lægemiddelagentur (EMA) og Udvalget for Lægemidler til Mennesker (CHMP) om, at det havde til hensigt at suspendere de franske markedsføringstilladelser for orale lægemidler indeholdende meprobamat med virkning fra januar 2012.