FrancophonIA/ELRC3.0 huggingface dataset:
English: • The implementing measures for the falsified medicines legislation (public consultations on unique identifier finishes 27 April 2012, on GMP for active substances from non-EU countries finishes 23
Danish: • gennemførelsesforanstaltninger for lovgivningen om kopimedicin (den offentlige høring om entydig identifikator (med afslutning den 7. april 2012), den offentlige høring om god fremstillingspraksis i forbindelse med aktive stoffer fra lande uden for EU (med afslutning den 23. marts 2012) og den offentlige høring om principper og retningslinjer for god fremstillingspraksis i forbindelse med aktive stoffer (med afslutning den 20. april 2012))
English: • [EMA/177625/2012 Rev.1] Minutes from the Management Board Telematics Committee meeting held on 14 February 2012.
Danish: • [EMA/177625/2012 Rev.1] Referat af mødet i telematikudvalgets bestyrelse den 14. februar 2012.
English: • Consultation no. 15/2011 on the appointment of Esther Werner as CVMP alternate, proposed by Germany, ended, with observations from Members raised in respect of the candidate's expertise, on 3 January 2012.
Danish: • Høring nr. 15/2011 om udnævnelse af Esther Werner til suppleant i CVMP, indstillet af Tyskland, afsluttet, med bemærkninger fra medlemmerne vedrørende kandidatens ekspertise den 3. januar 2012.
English: The meeting also discussed that indicators measuring the quality of reports have to be developed over time, while recognising the difficulty in establishing and monitoring such indicators.
Danish: Mødedeltagerne drøftede også det forhold, at der bør udvikles indikatorer til måling af rapporternes kvalitet over tid.
English: [EMA/MB/121516/2012] The Board adopted the Agency's preliminary draft budget and the draft establishment plan for 2013.
Danish: [EMA/MB/121516/2012] Bestyrelsen vedtog agenturets foreløbige budgetforslag og udkastet til stillingsfortegnelse for 2013.
English: [EMA/MB/64234/2012] The Management Board adopted the revised policy on managing conflicts of interests of its members.
Danish: [EMA/MB/64234/2012] Bestyrelsen vedtog den reviderede politik for håndtering af interessekonflikter for medlemmerne.
English: • The implementing measures of the pharmacovigilance legislation (planned adoption in Q2 2012).
Danish: • gennemførelsesforanstaltninger for lovgivningen om lægemiddelovervågning (planlagt vedtagelse i andet kvartal af 2012)
English: [EMA/MB/945561/2011] The Management Board adopted the Agency's preliminary draft work programme 2013.
Danish: [EMA/MB/945561/2011] Bestyrelsen vedtog agenturets foreløbige udkast til arbejdsprogram for 2013.
English: However, patient representatives expressed their wish to see such hearings extended to other areas where patients have high expectations (e.g. unmet medical needs), where there is public concern (controversial media coverage), divergence between regulatory and HTA assessments, etc. Public hearings should address not just safety issues but also expected benefits of medicinal products.
Danish: hvor patienter har høje forventninger (f.eks. uopfyldte behov for behandling), hvor offentligheden nærer bekymring (kontroversiel mediedækning), divergens mellem lovgiveres og sundhedsteknologivurderingsorganers vurderinger osv.
English: a.) Preliminary draft work programme 2013
Danish: a) Foreløbigt udkast til arbejdsprogram for 2013
English: [EMA/MB/82882/2012] The Management Board noted the document outlining the preliminary budget for ICT project development and systems maintenance in 2013.
Danish: [EMA/MB/82882/2012] Bestyrelsen tog dokumentet om det foreløbige budget til udvikling af IKTprojekter og systemvedligeholdelse i 2013 til efterretning.
English: The meeting also noted the proposal about the timing between PRAC and CHMP/CMD(h) meetings.
Danish: Mødedeltagerne tog også forslaget om tidsintervaller mellem møder i PRAC og CHMP/CMD(h) til efterretning.
English: Minutes of the 75th meeting of the Management Board
Danish: Liste over deltagere i bestyrelsens 75.
English: • [EMA/MB/137391/2012] Overview of implementing rules to Staff Regulations signed by the MB Chair during the period from 7 October 2011 to 29 February 2012.
Danish: • [EMA/MB/137391/2012] Oversigt over gennemførelsesbestemmelser til personalevedtægten, underskrevet af bestyrelsesformanden, for perioden fra den 7. oktober 2011 til den 29. februar
English: Identifying different arrangements that would address this concern and that would also enable the Board to discuss documents, amend them and resubmit them for adoption at the same meeting would add to the effective conduct of business.
Danish: Møderne vil kunne afvikles mere effektivt, såfremt der indføres andre ordninger til afhjælpning af dette problem, som gør det muligt for bestyrelsen at drøfte dokumenter, ændre dem og fremlægge dem igen til vedtagelse på samme møde.
English: The mandate of the nominee commenced on 9 December 2011.
Danish: Mandatet startede den 9. december 2011.
English: [EMA/154320/2012] The Management Board endorsed the breach of trust procedure on conflicts of interests for scientific-committee members and experts.
Danish: [EMA/154320/2012] Bestyrelsen godkendte proceduren for tillidsbrud i forbindelse med interessekonflikter for medlemmer af videnskabelige udvalg og eksperter.
English: The mandate of the nominee commenced on 27 January 2012.
Danish: Mandatet startede den 27. januar 2012.
English: The mandate of the nominee commenced on 4 January 2012.
Danish: Mandatet startede den 4. januar 2012.
English: • Consultation no. 02/2012 on the appointment of Outi Maki-Ikola as CHMP member, proposed by Finland, ended on 26 January 2012.
Danish: • Høring nr. 02/2012 om udnævnelse af Outi Maki-Ikola til medlem i CVMP, indstillet af Finland, afsluttet den 26. januar 2012.
English: b.) Preliminary draft budget and establishment plan 2013
Danish: b) Foreløbigt budgetforslag og udkast til stillingsfortegnelse 2013
English: It was also argued that the knowledge obtained about a product in the pre-authorisation stage is important for PRAC rapporteurship.
Danish: Det blev også fremført, at det er vigtigt, at PRAC-rapportørerne i fasen forud for godkendelsen har kendskab til et produkt.
English: • EMA/135591/2012 Annual report 2011 of the Agency's Audit Advisory Committee.
Danish: • [EMEA/MB/135591/2012] Årsberetning for 2011 fra agenturets rådgivende revisionsudvalg.
English: [EMA/513078/2010] The Management Board endorsed the amendments to the revised conflicts of interests policy for Committee members and experts.
Danish: [EMA/513078/2010] Bestyrelsen godkendte ændringerne i den reviderede politik for håndtering af interessekonflikter for udvalgsmedlemmer og eksperter.
English: Report from the Heads of Medicines Agencies
Danish: Rapport fra lægemiddelstyrelsescheferne
English: [EMA/154547/2012] The Board noted the analysis on the implementation of the revised conflicts of interests policy for Committee members and experts.
Danish: [EMA/154547/2012] Bestyrelsen tog analysen af gennemførelsen af den reviderede politik for håndtering af interessekonflikter for udvalgsmedlemmer og eksperter til efterretning.
English: • Consultation no. 13/2011 on the appointment of Merete Blixenkrone-Moller as CVMP alternate, proposed by Denmark, ended on 8 December 2011.
Danish: • Høring nr. 13/2011 om udnævnelse af Merete Blixenkrone-Møller til suppleant i CVMP, indstillet af Danmark, afsluttet den 8. december 2011.
English: • Consultation no. 01/2012 on the appointment of Ingunn Hagen Westgaard as CHMP alternate, proposed by Norway, ended on 26 January 2012.
Danish: • Høring nr. 01/2012 om udnævnelse af Ingunn Hagen Westgaard til suppleant i CVMP, indstillet af Norge, afsluttet den 26. januar 2012.
English: • Consultation no. 14/2011 on the appointment of Ugne Zymantaite as CVMP alternate, proposed by Lithuania, ended on 19 December 2011.
Danish: • Høring nr. 14/2011 om udnævnelse af Ugne Zymantaite til suppleant i CVMP, indstillet af Litauen, afsluttet den 19. december 2011.
English: • A discussion on the concept of public hearing and transparency.
Danish: • Begreberne offentlig høring og gennemsigtighed
English: A gap of one week between PRAC and CHMP/CMD(h) meetings was proposed.
Danish: Det blev foreslået, at møder i PRAC og CHMP/CMD(h) afholdes med en uges mellemrum.
English: • EMA/135587/2012 Annual report 2011 of the Agency's Internal Audit.
Danish: • [EMEA/MB/135587/2012] Årsberetning for 2011 fra agenturets interne revisionsudvalg.
English: Some outstanding work will be finalised by mid
Danish: Uafsluttet arbejde færdiggøres i midten af maj 2012.
English: • Written procedure for adoption of the 74th Management Board meeting minutes closed on 9 February 2011.
Danish: • Skriftlig procedure for vedtagelse af referat af bestyrelsens 74.
English: EMA/MB/221361/2012 Adopted Management Board
Danish: EMA/518102/2012 Vedtaget Bestyrelsen
English: Wednesday meeting, held on 21 March 2012
Danish: Mødet onsdag den 21. marts 2012
English: The meeting this year focussed on the following:
Danish: På mødet drøftedes følgende emner:
English: Thursday meeting, held on 22 March 2012
Danish: Mødet torsdag den 22. marts 2012
English: The mandate of the nominee commenced on 20 December
Danish: Mandatet startede den 20. december 2011.
English: The Board also set up a group for the analysis and assessment of the Executive Director's annual activity report 2011, with the following members: Xavier De Cuyper, Martina Cvelbar and Gro Wesenberg.
Danish: Medlemmer: Xavier De Cuyper, Martina Cvelbar og Gro Wesenberg.
English: Minutes from the 74th meeting, held on 15 December
Danish: Referat af det 74.
English: EU/1/14/967/001 Rezolsta
Danish: EU/1/14/967/001
English: 800 mg/150 mg Film-coated tablet Oral use
Danish: 800 mg/150 mg Filmovertrukken tablet
English: Strength
Danish: Rezolsta
English: Pharmaceutical Form
Danish: Lægemiddelform Administration Emballage Pakningsstørrelse
English: ANNEX A
Danish: Bilag A
English: MA (EU) number (Invented) name
Danish: MA (EU)-nummer (Sær)navn Styrke
English: Route of Administration
Danish: Lægemiddelform Administrationsvej
English: Immediate Packaging
Danish: Indre emballage Pakningsstørrelse
English: This risk increases further:
Danish: Denne risiko øges yderligere:
English: with increasing age; if you smoke.
Danish: med øget alder, hvis du ryger.
English: Venous thromboembolism can be fatal in 1-2% of cases.
Danish: Venetrombose kan være dødelig i 1-2 % af tilfældene.
English: - obesity (body mass index over 30 kg/m2).
Danish: - overvægt (body mass index over 30 kg/m2).
English: Time to relieve of symptoms is at least three months.
Danish: Tid til symptomlindring er mindst tre måneder.
English: The risk is not as high as the risk of developing a blood clot during pregnancy.
Danish: Risikoen er ikke så høj som risikoen for at udvikle en blodprop under graviditet.
English: Rarely serious permanent disabilities may occur or the blood clot may even be fatal.
Danish: Der kan i sjældne tilfælde forekomme alvorligt permanent handicap, og blodproppen kan endda være dødelig.
English: You and your doctor will have to consider all the things that would normally apply to the safe use of oral hormonal contraceptives
Danish: Du og din læge skal overveje alle de ting, som normalt gælder for sikker brug af orale hormonale svangerskabsforebyggende midler
English: In these situations it is advisable to discontinue use (in the case of elective surgery at least four weeks in advance) and not to resume until two weeks after complete remobilisation.
Danish: I disse situationer er det tilrådeligt at seponere præparatet (ved elektiv kirurgi mindst fire uger i forvejen) og først genoptage behandlingen to uger efter fuldstændig mobilisering.
English: Do not take <invented name>
Danish: Tag ikke <Produktnavn>
English: [The wording below should be inserted in this section] When should you contact your doctor
Danish: [Nedenstående formulering indsættes i dette punkt] Hvornår skal du kontakte lægen
English: It has a similar composition to that of a combined oral contraceptive (COC).
Danish: Sammensætningen svarer til sammensætningen af et kombineret oralt kontraceptivum (COC).
English: Your doctor may then advise you to use a different treatment:
Danish: Din læge kan i så fald råde dig til at få en anden behandling.
English: If any of the conditions/risk factors mentioned below is present, the benefits of the use of <invented name> should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using <invented name>.
Danish: Hvis nogle af de betingelser/risikofaktorer, der nævnes nedenfor, er til stede, bør fordelene ved anvendelse af <produktnavn> opvejes mod de mulige risici for den enkelte kvinde, og de skal diskuteres med kvinden, før hun beslutter sig for at begynde at bruge <produktnavn>.
English: If this applies to you, it is important to tell your doctor that you are using <invented name>, as the treatment may have to be stopped.
Danish: Hvis dette gælder for dig, er det vigtigt at fortælle lægen, at du tager <produktnavn>, da behandlingen måske skal stoppes.
English: An increase in frequency or severity of migraine during use of <invented name > (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of <invented name>.
Danish: En øget hyppighed eller sværhedsgrad af migræne under anvendelsen af <produktnavn> (som kan være prodromal for en cerebrovaskulær hændelse) kan være en årsag til øjeblikkelig seponering af <produktnavn>.
English: The excess risk of VTE is highest during the first year a woman starts <invented name> or when restarting or switching after a pill-free interval of at least a month.
Danish: Den ekstra risiko for VTE er størst i løbet af det første år, hvor kvinden bruger <produktnavn>, eller når hun genstarter eller skifter efter et p-pillefrit interval på mindst en måned.
English: Women using <invented name> should be specifically pointed out to contact their physician in case of possible symptoms of thrombosis.
Danish: Kvinder, der bruger <produktnavn>, skal specifikt informeres om at kontakte deres læge i tilfælde af mulige symptomer på trombose.
English: • if you are using another hormonal contraceptive
Danish: • hvis du bruger et andet hormonalt svangerskabsforebyggende middel
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer til relevante punkter i produktresuméet og indlægssedlen/indlægssedlerne
English: For example, a blood clot in an artery in the heart may cause a heart attack, or in the brain may cause a stroke.
Danish: For eksempel kan en blodprop i en arterie i hjertet forårsage et hjerteanfald, og en blodprop i hjernen kan forårsage et slagtilfælde.
English: Your doctor may tell you to stop using <invented name> several weeks before surgery or while you are less mobile.
Danish: Din læge kan fortælle dig, at du skal holde op med at tage <produktnavn> flere uger før en operation, eller mens du er mindre mobil.
English: The need to continue treatment should be evaluated periodically by the treating physician.
Danish: Behovet for at fortsætte behandlingen bør evalueres periodisk af den behandlende læge.
English: Circulatory disorders
Danish: Kredsløbssygdomme
English: • Epidemiological studies have shown that the incidence of VTE is 1.5 to 2 times higher in users of <invented name> than in users of levonorgestrel-containing combined oral contraceptives (COCs) and may be similar to the risk for desogestrel / gestodene / drospirenone-containing COCs.
Danish: • Epidemiologiske studier har vist, at forekomsten af VTE er 1,5 til 2 gange højere hos brugere af <produktnavn> end hos brugere af levonorgestrel-indeholdende kontraceptiva af kombinationstypen (combined oral contraceptives, COC'er) og kan være sammenlignelig med risikoen for COC'er indeholdende desogestrel/gestoden/drospirenon.
English: Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins).
Danish: Hensigtsmæssig behandling med kontraceptivum bør påbegyndes på grund af den teratogene effekt af antikoagulantia (coumariner).
English: The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill.
Danish: Risikoen for at udvikle en blodprop i en vene er højst i løbet af det første år, hvor kvinden bruger p-piller.
English: • if you have a condition that may increase the risk of a blood clot in your arteries.
Danish: • hvis du har en sygdom, der kan øge risikoen for en blodprop i dine arterier.
English: Since <invented name> is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3).
Danish: Da <produktnavn> også er et hormonalt kontraceptivum, bør det ikke anvendes i kombination med andre hormonale kontraceptiva (se pkt.
English: The increased risk of thromboembolism in the puerperium must be considered (for information on ‘Pregnancy and lactation' see section 4.6).
Danish: Den øgede risiko for tromboemboli i puerperiet skal overvejes (for oplysninger om 'Graviditet og amning', se pkt.
English: • if you have problems with blood clotting (e.g. protein C deficiency)
Danish: • hvis du har problemer med blodets størkning (f.eks. protein C-mangel)
English: Duration of use Your doctor will tell you how long you need to keep taking <invented name>.
Danish: Behandlingsvarighed Din læge vil fortælle dig, hvor længe du skal fortsætte med at tage <produktnavn>.
English: The risk of blood clots in a vein in users of a combined pill increases further:
Danish: Risikoen for blodpropper i en vene hos brugere af p-piller af kombinationstypen øges yderligere:
English: In case of suspected or confirmed thrombosis, <invented name> use should be discontinued.
Danish: I tilfælde af mistænkt eller bekræftet trombose bør <produktnavn> seponeres.
English: In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician.
Danish: Hvis der opstår forværring eller opblussen, eller risikofaktorer for nogle af disse sygdomme opstår for første gang, skal kvinden informeres om kontakte sin læge.
English: This can happen in veins of the leg, the lung (a lung embolus), or any other organ.
Danish: Dette kan ske i venerne i benene, lungerne (lungeemboli) eller i et andet organ.
English: A full recovery is not always made and in 1-2% of cases, can be fatal.
Danish: Der opnås ikke altid fuldstændig helbredelse efter en blodprop, og 1-2 % af tilfældene er dødelige.
English: Symptoms of blood clots
Danish: Symptomer på blodpropper
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use.
Danish: Hvis en arvelig disposition mistænkes, bør kvinden henvises til en specialist for rådgivning, før der tages beslutning om anvendelse af hormonale kontraceptiva.
English: Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking < invented name >.
Danish: Lige efter en fødsel har kvinden en øget risiko for blodpropper, så du skal spørge lægen om, hvor hurtigt du kan begynde at tage <produktnavn> efter en fødsel.
English: A blood clot in a vein (known as a ‘venous thrombosis') can block the vein.
Danish: En blodprop i en vene (kaldes en 'venetrombose') kan blokere venen.
English: • Epidemiological studies have also associated the use of hormonal contraceptive with an increased risk for arterial (myocardial infarction, transient ischaemic attack) thromboembolism.
Danish: • Epidemiologiske studier har også forbundet anvendelse af hormonale kontraceptiva med en øget risiko for arteriel tromboemboli (myokardieinfarkt, transitorisk iskæmisk anfald).
English: The symptoms are described in section 2 ‘Blood clots (Thrombosis)'.
Danish: Symptomerne er beskrevet i punktet 'Blodpropper (trombose)'.
English: • Presence or history of cerebrovascular accident
Danish: • Aktuel eller tidligere cerebrovaskulær hændelse
English: Using a combined pill increases a woman's risk of developing such clots compared with a woman not taking any combined pill.
Danish: Brug af p-piller af kombinationstypen øger en kvindes risiko for at udvikle sådanne blodpropper, sammenlignet med en kvinde, der ikke tager p-piller af kombinationstypen.
English: • The user group of <invented name> is likely to include patients that may have an inherently increased cardiovascular risk such as that associated with polycystic ovarian syndrome.
Danish: • Det er sandsynligt, at brugergruppen af <produktnavn> omfatter patienter, der kan have en medfødt øget kardiovaskulær risiko, såsom hvad der er forbundet med polycystisk ovariesyndrom.
English: Antithrombotic treatment should be considered if the use of <invented name> has not been discontinued in advance.
Danish: Antitrombotisk behandling bør overvejes, hvis <produktnavn> ikke blev seponeret på forhånd.
English: • The use of <invented name> carries an increased risk of venous thromboembolism (VTE) compared with no use.
Danish: • Anvendelse af <produktnavn> medfører en øget risiko for venetrombose (VTE) sammenlignet med ingen brug.
English: <invented name> also works as an oral contraceptive.
Danish: <produktnavn> virker også som et svangerskabsforebyggende middel.
English: • There is an increased risk of thromboembolism for all women who use <invented name> (see section 4.4).
Danish: • Der er en øget risiko for tromboemboli hos alle kvinder, der bruger <produktnavn> (se pkt.
English: o diabetes affecting your blood vessels o very high blood pressure o a very high level of fat in your blood (cholesterol or triglycerides)
Danish: o sukkersyge (diabetes), der påvirker dine blodkar o meget højt blodtryk o et meget højt indhold af fedt i blodet (kolesterol eller triglycerider)
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use; - prolonged immobilisation, major surgery, any surgery to the legs, or major trauma.
Danish: Hvis en arvelig disposition mistænkes, bør kvinden henvises til en specialist for rådgivning, før der tages beslutning om anvendelse af hormonale kontraceptiva, - langvarig immobilisering, større operation, operation i benene eller større traume.
English: What you need to know before you use < invented name > [The wording below should be inserted in the relevant sections]
Danish: Det skal du vide, før du begynder at tage <Produktnavn> [Nedenstående formuleringer skal indsættes i de relevante punkter]
English: The need to continue treatment should be evaluated periodically by the treating physician (see section 4.2).
Danish: Behovet for at fortsætte behandlingen bør evalueres periodisk af den behandlende læge (se pkt.
English: • Symptoms of venous or arterial thrombosis or of a cerebrovascular accident can include: unusual unilateral leg pain and / or swelling; sudden severe pain in the chest, whether or not it radiates to the left arm; sudden breathlessness; sudden onset of coughing; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; vertigo; collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disturbances; ‘acute' abdomen
Danish: • Symptomer på venøs eller arteriel trombose eller på en cerebrovaskulær hændelse kan omfatte: usædvanlige, unilaterale bensmerter og/eller hævelse, pludselige stærke smerter i bryster, uanset om de stråler ud i den venstre arm eller ej, pludselig åndenød, pludseligt opstået hoste, en usædvanlig, svær, langvarig hovedpine, pludseligt delvist eller fuldstændigt synstab, diplopi, sløret tale eller afasi, vertigo, kollaps med eller uden fokalt krampeanfald, svaghed eller meget udpræget følelsesløshed, der pludseligt påvirker en side eller en del af kroppen, motoriske forstyrrelser, 'akut abdomen‘
English: The use of a combined pill has been connected with an increased risk of clots in the arteries.
Danish: Anvendelse af p-piller af kombinationstypen er blevet forbundet med en øget risiko for blodpropper i arterierne.