FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 3 How to take [product name]
Danish: Afsnit 3 ”Sådan skal De tage [produktnavn]”
English: “-will be treated with [product name] for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.”
Danish: “- hvis du skal have langtidsbehandling med [produktnavn] og har eller tidligere har haft fibrotiske reaktioner (arvæv), der har påvirket dit hjerte.”
English: Section 2 “Before you take [product name]”: Do not take [product name] if you:
Danish: Afsnit 2 ”Det skal De vide, før De begynder at tage [produktnavn] Tag ikke pergolid
English: Cabergoline should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening (see Section 4.3).
Danish: Cabergolin bør seponeres, hvis ekkokardiografi viser ny eller forværret tilbageløb pga. hjerteklaplidelse, klapfunktionsindskrænkning eller fortykkelse af hjerteklap (se pkt.
English: “Very common side effect (affecting more than one person in ten): heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion).
Danish: Meget almindelig bivirkning (det sker hos mere end 1 ud af 10): lidelser i hjerteklapperne, f.eks. betændelse (perikardit) eller væskeansamlinger i hjertesækken (perikardieekssudat).
English: “Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Danish: ”Evidens for hjerteklaplidelse bestemt ved ekkokardiografi før start af behandling.”
English: In patients with valvular regurgitation, it is not known whether pergolide treatment might worsen the underlying disease.
Danish: Det vides ikke, hvorvidt pergolidbehandling kan forværre den underliggende sygdom hos patienter med tilbageløb pga. hjerteklaplidelse.
English: In patients with valvular regurgitation, it is not known whether cabergoline treatment might worsen the underlying disease.
Danish: Det vides ikke, hvorvidt cabergolinbehandling kan forværre den underliggende sygdom hos patienter med tilbageløb pga. hjerteklaplidelse.
English: “Do not take more than 3 <if relevant include colour of the tablet> tablets (3 x 1000 microgram tablets) per day.”
Danish: Tag ikke flere end 3 tabletter pr dag.
English: Therefore, during treatment, attention should be paid to the signs and symptoms of: Pleuro-pulmonary disease such as dyspnoea, shortness of breath, persistent cough or chest pain.
Danish: • Pleuropulmonal sygdom, såsom dyspnø, kortåndethed, vedvarende hoste eller brystsmerter.
English: 4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of the maximum dose to 3 mg/day
Danish: 4.2 Dosering og indgivelsesmåde Følgende bør overvejes, hvis relevant:
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR PERGOLIDE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT I INDLÆGSSEDLEN FOR PRODUKTER INDEHOLDENDE PERGOLID
English: 4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of the maximum dose to 3 mg/day.
Danish: 4.2 Dosering og indgivelsesmåde Følgende skal fremgå på passende måde:
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR PERGOLIDE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT I PRODUKTRESUMÉET FOR PRODUKTER INDEHOLDENDE PERGOLID
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CABERGOLINE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT I PRODUKTRESUMÉ OG INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE CABERGOLIN
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR CABERGOLINE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT I INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE CABERGOLIN
English: Ref. EMEA/CHMP/494914/2008
Danish: EMEA/CHMP/494917/2008
English: The procedure started on 22 March 2007.
Danish: Proceduren blev indledt den 22. marts 2007.
English: The Marketing Authorisation Holder provided supplementary information on 23 July 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte supplerende oplysninger den 23. juli 2007.
English: A Decision was issued by the European Commission on 3 September 2008.
Danish: Europa-Kommissionen vedtog en beslutning den 3. september 2008.
English: London, 3 September 2008 Doc.
Danish: London, den 3. september 2008 Ref. dok.
English: Cozaar Comp and associated names, 50/12.5 mg; 100/12.5 mg; 100/25 mg, film coated tablets is a fixed dose combination of losartan and hydrochlorothiazide.
Danish: Cozaar Comp og tilknyttede navne, 50/12,5 mg, 100/12,5 mg, 100/25 mg, filmovertrukne tabletter er en fastdosiskombination af losartan and hydrochlorothiazid.
English: Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Danish: Losartan er en oralt aktiv angiotensin II (Ang-II) receptor-antagonist, der virker på AT1-receptor-undertypen og dermed blokerer for virkning af Ang-II i renin-angiotensin-systemets (RAS) kaskade.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar Comp and associated names International Non-Proprietary Name (INN): losartan + hydrochlorothiazide
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN INDBRINGELSE I HENHOLD TIL ARTIKEL 30 Cozaar Comp og tilknyttede navne Internationalt fællesnavn (INN): losartan + hydrochlorothiazid
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II sammen med det ændrede produktresumé, etiketteringen og indlægssedlen i bilag III.
English: Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Danish: Hydrochlorothiazid (HCTZ) er et thiazid-diuretikum, som også er blevet brugt som lægemiddel mod hypertension (højt blodtryk).
English: The losartan/hydrochlorothiazide combination is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Danish: Kombinationen af losartan og hydrochlorothiazid er indiceret til behandling af hypertension til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af losartan eller hydrochlorothiazid alene.
English: On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar Comp. and associated names.
Danish: Den 23. februar 2007 indbragte Danmark en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, for at harmonisere de nationalt godkendte produktresumeer, indlægsseddel og etikettering for lægemidlet Cozaar Comp. og tilknyttede navne.
English: During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
Danish: På mødet den 21.-24. april 2008 var CHMP, på baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget, af den opfattelse, at forslaget til harmonisering af produktresumeet, etiketteringen og indlægssedlen var acceptabelt og følgelig burde ændres.
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar Comp. and associated names.
Danish: CHMP afgav en positiv udtalelse den 24. april 2008, hvori udvalget anbefalede harmonisering af produktresumeet, etiketteringen og indlægssedlen vedrørende Cozaar Comp. og tilknyttede navne.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Cozaar Comp. and associated names approved across EU Member States, with respect to the following indications: Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide; As first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk; Reduction of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.
Danish: Behandling af hypertension til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af losartan eller hydrochlorothiazid, som det første skridt i behandlingen af patienter med moderat til alvorlig hypertension og til patienter med høj eller meget høj risiko for kardiovaskulære hændelser, reduktion af kardiovaskulær morbiditet og mortalitet hos hypertensive patienter med hypertrofi af venstre ventrikel.
English: What is Levact?
Danish: Hvad er Levact?
English: Why was Levact reviewed?
Danish: Hvorfor blev Levact revurderet?
English: The European Commission issued a decision on 7 July 2010.
Danish: Europa-Kommissionen traf en afgørelse den 7. juli 2010.
English: Harald Enzmann (Germany)
Danish: Harald Enzmann (Tyskland)
English: Jean-François Baurain (Belgium)
Danish: Jean-François Baurain (Belgien)
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Resultat af en indbringelsesprocedure i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer
English: Levact is also known as Ribomustin.
Danish: Levact er også kendt under navnet Ribomustin.
English: It is used to treat the following types of cancer:
Danish: Det anvendes til behandling af følgende kræftformer:
English: It binds to the DNA of cells while they are reproducing, which stops cell division.
Danish: Det binder sig til DNA i cellerne, mens disse reproducerer sig selv, hvorved celledelingen standses.
English: Bendamustine has been used in anticancer medicines in Germany since the early 1970s.
Danish: I Tyskland har bendamustin været anvendt i lægemidler mod kræft siden starten af 1970'erne.
English: The Committee therefore recommended that Levact be granted marketing authorisation in Germany and all concerned Member States for all the indications that were applied for.
Danish: Udvalget anbefalede derfor udstedelse af markedsføringstilladelse for Levact i Tyskland og i alle de berørte medlemsstater for alle de indikationer, som ansøgningen omhandlede.
English: Based on the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Levact outweigh its risks for the two indications for which objections were raised.
Danish: På grundlag af vurderingen af disse data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved Levact opvejer risiciene til de to indikationer, der blev gjort indsigelse imod.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levact and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Levact og relaterede navne.
English: As a result, the cancer cells cannot divide and the growth of tumours slows down.
Danish: Som et resultat heraf kan kræftcellerne ikke dele sig, hvilket hæmmer svulsternes vækst.
English: The grounds for the referral were that one Member State, the United Kingdom, could not approve the indication non-Hodgkin's lymphoma, and two Member States, Belgium and France, could not approve the indication multiple myeloma because not enough data on the effectiveness of this medicine were available to support these indications.
Danish: Begrundelserne for indbringelsen var, at en medlemsstat, Det Forenede Kongerige, ikke kunne godkende indikationen non-Hodgkins lymfom, og at to medlemsstater, Belgien og Frankrig, ikke kunne godkende indikationen multipelt myelom, eftersom der ikke forelå tilstrækkelige data om dette lægemiddels virkning til at støtte disse indikationer.
English: Levact is an anticancer medicine.
Danish: Levact er et lægemiddel mod kræft.
English: 14 January 2010 and 17 February 2010
Danish: 14. januar 2010 og 17. februar 2010
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 2 October 2009.
Danish: Medlemsstaterne kunne imidlertid ikke nå til enighed, og den tyske lægemiddelkontrolmyndighed indbragte den 2. oktober 2009 sagen for CHMP med henblik på voldgift.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) 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 Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Tyskland) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Belgien, Danmark, Finland, Frankrig, Irland, Italien, Luxembourg, Norge, Polen, Spanien og Det Forenede Kongerige).
English: 22 October 2009
Danish: 22. oktober 2009
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Levact outweigh its risks, and that the marketing authorisation can be granted in Germany and in the following Member States: Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Levact opvejede risiciene, og at der kan udstedes markedsføringstilladelse i Tyskland og i følgende medlemsstater: Østrig, Belgien, Danmark, Finland, Frankrig, Irland, Italien, Luxembourg, Norge, Polen, Spanien og Det Forenede Kongerige.
English: Astellas Pharma GmbH submitted Levact to the German medicines regulatory agency for a decentralised procedure.
Danish: Astellas Pharma GmbH indgav en ansøgning om Levact til den tyske lægemiddelkontrolmyndighed via den decentrale procedure.
English: The CHMP assessed the two clinical studies presented by the company to support the multiple myeloma and non-Hodgkin's lymphoma indications.
Danish: CHMP vurderede de to kliniske undersøgelser, som virksomheden havde fremlagt til støtte for indikationerne multipelt myelom og non-Hodgkins lymfom.
English: 18 March 2010
Danish: 18. marts 2010
English: Referral start date:
Danish: Startdato for indbringelse:
English: The active substance in Levact, bendamustine hydrochloride, belongs to a group of anticancer medicines called ‘alkylating agents'.
Danish: Det aktive stof i Levact, bendamustinhydrochlorid, tilhører en gruppe af lægemidler mod kræft, der kaldes "alkylerende midler".
English: 7 July 2010
Danish: 07. juli 2010
English: Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion)
Danish: Spørgsmål og svar vedrørende Levact og relaterede navne (bendamustinhydrochlorid, 2,5 mg/ml, pulver til koncentrat til infusionsvæske, opløsning)
English: • multiple myeloma (a cancer of the bone marrow) in combination with prednisone in patients older than 65 years who are not eligible for stem-cell transplantation and cannot be treated with thalidomide or bortezomib (other anticancer medicines).
Danish: • multipelt myelom (knoglemarvskræft) i kombination med prednison hos patienter over 65 år, som ikke er egnede til stamcelletransplantation, og som ikke kan behandles med thalidomid eller bortezomib (andre lægemidler mod kræft).
English: Opinion date:
Danish: Dato for udtalelse:
English: • non-Hodgkin's lymphoma (a cancer of the lymph tissue, part of the immune system) in patients whose cancer got worse during or following treatment containing rituximab (another anticancer medicine);
Danish: • non-Hodgkins lymfom (kræft i lymfevævet, som er en del af immunsystemet) hos patienter, hvis kræft er forværret under eller efter behandling med rituximab (et andet lægemiddel mod kræft)
English: • chronic lymphocytic leukaemia (a cancer of a type of white blood cell called lymphocytes) in patients for whom treatment with fludarabine (another anticancer medicine) is not appropriate;
Danish: • kronisk lymfatisk leukæmi (kræft i en type hvide blodlegemer, der kaldes lymfocytter) hos patienter, hvor behandling med fludarabin (et andet lægemiddel mod kræft) ikke er hensigtsmæssig
English: Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EMA/CHMP/735863/2009
Danish: Spørgsmål og svar vedrørende Levact og relaterede navne1 (bendamustinhydrochlorid, 2,5 mg/ml, pulver til koncentrat til infusionsvæske, opløsning)
English: Co-Rapporteur:
Danish: Medrapportør:
English: This is a summary of the European public assessment report (EPAR) for Trumenba.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trumenba.
English: Further planned or ongoing studies are expected to provide more information on Trumenba's effectiveness.
Danish: Yderligere planlagte eller igangværende undersøgelser forventes at give flere oplysninger om Trumenbas effektivitet.
English: Other information about Trumenba
Danish: Andre oplysninger om Trumenba
English: The full EPAR for Trumenba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Trumenba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Trumenba can only be obtained with a prescription and should be used according to official recommendations.
Danish: Trumenba udleveres kun efter recept og bør anvendes i henhold til de officielle anbefalinger.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that based on available data Trumenba'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 Trumenba ud fra de tilgængelige data opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In patients at greater risk of invasive meningococcal disease, an additional booster dose may be considered later on.
Danish: Hos patienter med større risiko for invasiv meningokoksygdom kan det overvejes at give en supplerende boosterdosis senere.
English: Initial treatment may either involve 2 injections at least 6 months apart, or 2 injections at least 1 month apart followed by a third injection at least 4 months later.
Danish: Behandlingen kan enten bestå af 2 injektioner med mindst 6 måneders mellemrum eller 2 injektioner med mindst 1 måneds mellemrum efterfulgt af en tredje injektion mindst 4 måneder senere.
English: These proteins are fixed onto a compound containing aluminium (adsorbed), which helps to stabilise them, allowing the immune system to respond to them.
Danish: Disse proteiner fastgøres på et stof, der indeholder aluminium (adsorberet), hvorved de stabiliseres, så immunsystemet kan reagere på dem.
English: What measures are being taken to ensure the safe and effective use of Trumenba?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trumenba?
English: When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Danish: Når personen derefter udsættes for bakterierne, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe bakterierne og beskytte mod sygdommen.
English: Trumenba meningococcal group B vaccine (recombinant, adsorbed)
Danish: Trumenba meningokok gruppe B-vaccine (rekombinant, adsorberet)
English: The most common side effects with Trumenba (which may affect more than 1 in 10 people) are pain, redness or swelling at the site of the injection, headache, tiredness, chills, diarrhoea, nausea (feeling sick), and muscle or joint pain.
Danish: De mest almindelige bivirkninger ved Trumenba (kan forekomme hos mere end 1 ud af 10 personer) er ømhed, rødme eller hævelse på injektionsstedet, hovedpine, træthed, kulderystelser, diarré, kvalme og muskel- og ledsmerter.
English: Why is Trumenba approved?
Danish: Hvorfor blev Trumenba godkendt?
English: It is available in a pre-filled syringe and is given by injection into a muscle, preferably in the shoulder.
Danish: Trumenta fås i en fyldt sprøjte og gives ved injektion i en muskel, fortrinsvis i skulderen.
English: What is Trumenba and what is it used for?
Danish: Hvad er Trumenba, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Trumenba.
Danish: Det er ikke en praktisk vejledning i, hvordan Trumenba bør anvendes.
English: Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spinal cord) and septicaemia (blood infection).
Danish: Invasiv sygdom optræder, når disse bakterier spreder sig i kroppen og forårsager alvorlige infektioner såsom meningitis (betændelse i hinderne rundt om hjernen og rygmarven) og septikæmi (blodforgiftning).
English: Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.
Danish: Der blev også gennemført understøttende undersøgelser, der viste, at 2 doser af vaccinen gav næsten samme antistofrespons som 3 doser; selvom de beskyttende antistofniveauer faldt over tid, kunne de forbedres med en supplerende boosterdosis efter både 2- og 3-dosisbehandlingen.
English: What are the risks associated with Trumenba?
Danish: Hvilke risici er der forbundet med Trumenba?
English: For more information about treatment with Trumenba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Trumenba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The studies also looked at response to 10 other, secondary strains of N. meningitidis group B.
Danish: Undersøgelserne så også på reaktionen på 10 andre, sekundære stammer af N. meningitidis gruppe B.
English: Antibody responses were also seen against the 10 secondary strains and confirmed the responses seen with the 4 main strains.
Danish: Der sås også antistofrespons mod de 10 sekundære stammer, og responsen på de 4 hovedstammer blev bekræftet.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against them.
Danish: Når en person vaccineres, opfatter immunsystemet bakteriedelene i vaccinen som "fremmede" og danner antistoffer mod dem.
English: For the full list of all side effects and restrictions with Trumenba, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Trumenba fremgår af indlægssedlen.