FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.
Danish: Det kan mildne symptomerne at behandle med afkøling og administration af NSAID og antihistaminer.
English: 3 hours after application 70.9% 6 hours after application 69.3% 9 hours after application 63.8% 12 hours after application 56.7% Day 29 p-value
Danish: 3 timer efter applikation 70,9% 32,8% 71,1% 6 timer efter applikation 69,3% 32,0% 64,8% 9 timer efter applikation 63,8% 29,7% 66,9% 12 timer efter applikation 56,7% 30,5% 53,5% Dag 29 p-værdi
English: Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.
Danish: Polypropylen (PP)/termoplastisk polyolefin (TPO)/højdensitet polyethylen (HDPE) og et børnesikret PP-lukke (polypropylen).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Use of Mirvaso when taking these medicines may result in a fall in blood pressure.
Danish: Der kan forekomme blodtryksfald, når Mirvaso bruges sammen med disse lægemidler.
English: Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol, sodium hydroxide, purified water.
Danish: Hjælpestoffer: Carbomer, methylparahydroxybenzoat (E218), phenoxyethanol, glycerol, titandioxid, propylenglycol, natriumhydroxid, renset vand.
English: Vehicle Gel n=63
Danish: Placebo-gel n=63
English: As a precautionary measure, it is preferable to avoid the use of Mirvaso during pregnancy.
Danish: For en sikkerheds skyld bør Mirvaso undgås under graviditeten.
English: Mirvaso should not be used during breast-feeding.
Danish: Mirvaso må ikke anvendes under amning.
English: Cutaneous use only.
Danish: Kun til kutan anvendelse.
English: Mirvaso Gel n=142
Danish: Placebo-gel n=142
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Laboratoires Galderma
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Mirvaso 3 mg/g gel brimonidine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Mirvaso 3 mg/g gel brimonidin
English: - blood pressure lowering medicine such as beta-blockers or calcium channel blockers (e.g.
Danish: - blodtrykssænkende medicin såsom betablokkere eller calciumantagonister (f.eks. propranolol,
English: Also, tell your doctor if you are taking any of the following medicines: - medicines used for the treatment of pain, sleep disorders, or anxiety disorders - medicines used for the treatment of psychiatric disorders (chlorpromazine) or used for hyperactivity (methylphenidate) or used for high blood pressure (reserpine).
Danish: Fortæl også lægen, hvis du tager nogle af følgende lægemidler: - medicin til behandling af smerter, søvnforstyrrelser eller angst.
English: - The other ingredients are carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water.
Danish: - Øvrige indholdsstoffer: carbomer, methylparahydroxybenzoat (E218), phenoxyethanol, glycerol, titandioxid, propylenglycol (E1520), natriumhydroxid, renset vand.
English: Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water.
Danish: Hjælpestoffer: Carbomer, methylparahydroxybenzoat (E218), phenoxyethanol, glycerol, titandioxid, propylenglycol (E1520), natriumhydroxid, renset vand.
English: Erythema and flushing
Danish: Erytem og rødme
English: NAME OF THE MEDICINAL PRODUCT Mirvaso 3 mg/g gel brimonidine
Danish: LÆGEMIDLETS NAVN Mirvaso 3 mg/g gel brimonidin
English: Vehicle Gel n=128
Danish: Placebo-gel n=128
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure.
Danish: Polyethylen (PE)/copolymer/aluminium (Al)/copolymer/polyethylen (PE) polyethylenlaminerede tuber med et HDPE-hoved (højdensitet polyethylen) og et børnesikret PP-lukke (polypropylen).
English: How to use Mirvaso
Danish: Sådan skal du bruge Mirvaso
English: Respiratory, thoracic and mediastinal disorders
Danish: Svimmelhed* Sjælden Hypotension* Luftveje, thorax og mediastinum Ikke almindelig
English: Uncommon Dry mouth
Danish: Tilstoppet næse
English: Uncommon side effects (may affect up to 1 in 100 people): - acne - dry mouth - feeling cold in hands and feet - feeling hot - headache - nasal congestion - swelling of the eyelid - urticaria - dizziness
Danish: - kold fornemmelse i hænder og fødder - varmefølelse - hovedpine - tilstoppet næse - hævet øjenlåg - nældefeber - svimmelhed
English: Propylene glycol (E1520) Sodium hydroxide Purified water
Danish: Propylenglycol (E1520)
English: Galderma Laboratorium GmbH
Danish: Laboratoires Galderma Z.I.
English: Eye disorders
Danish: Øjenlågsødem
English: What Mirvaso is and what it is used for What you need to know before you use Mirvaso How to use Mirvaso
Danish: Det skal du vide, før du begynder at bruge Mirvaso Sådan skal du bruge Mirvaso Bivirkninger
English: 3 hours after application 22.8% 6 hours after application 26.6% 9 hours after application 20.3% 12 hours after application 21.5% Day 29 p-value
Danish: 3 timer efter påføring 6 timer efter påføring 9 timer efter påføring 12 timer efter påføring Dag 29 p-værdi
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes: EU/1/13/904/004
Danish: Polyethylen (PE)/copolymer/aluminium (Al)/copolymer/polyethylen (PE) polyethylenlaminerede tuber (polyfoil):
English: Aggravated erythema, flushing and skin burning sensation have been reported during the post-marketing period (see section 4.4).
Danish: De er typisk af let til moderat sværhedsgrad og kræver sædvanligvis ikke seponering af behandling.Forværret erytem, rødme og sviende fornemmelse i huden er blevet rapporteret i perioden efter markedsføringen (se pkt.
English: Hypotension*
Danish: Fertilitet
English: Gastrointestinal disorders
Danish: Natriumhydroxid
English: Posology
Danish: Mundtørhed
English: If any of the above applies to you, or if you are unsure, talk to your doctor.
Danish: Kontakt lægen, hvis et af disse punkter passer på dig, eller hvis du har mistanke om det.
English: 4.7 Effects on ability to drive and use machines
Danish: Virkning og anvendelse
English: Alternates (and other participants)
Danish: Suppleanter (og andre deltagere)
English: • Revised draft agenda version 3.0.
Danish: • Revideret udkast til dagsorden version 3.0.
English: Project 2014 - move to new premises
Danish: Projekt 2014 - flytning til nye lokaler
English: Substances of human origin (SoHO)
Danish: Stoffer af menneskelig oprindelse (SoHO)
English: Not represented
Danish: Ikke repræsenteret
English: The document had been redacted and published on the Agency's website.
Danish: Dokumentet var blevet redigeret og offentliggjort på agenturets websted.
English: In the current financial situation, the contribution is not likely to be increased.
Danish: I den nuværende finansielle situation var det usandsynligt, at bidraget ville blive forøget.
English: New topic coordinators were requested.
Danish: Nye emnekoordinatorer blev efterlyst.
English: European and international collaboration on these issues is important in order to achieve a positive outcome on this topic.
Danish: Europæisk og internationalt samarbejde om disse spørgsmål var væsentligt for at opnå et positivt resultat på området.
English: This item (for information) was deferred to the next meeting.
Danish: Dette punkt (til orientering) blev udsat til næste møde.
English: The European Commission has decided to take over the responsibilities for SoHO activities.
Danish: Europa-Kommissionen havde besluttet at overtage ansvaret for SoHO-aktiviteterne.
English: The Agency signed a lease agreement for new premises in October 2011.
Danish: Agenturet underskrev en lejeaftale om nye lokaler i oktober 2011.
English: Most of the preparatory stages of the commitment procedures relating to the two projects have been completed.
Danish: De fleste forberedende faser af forpligtelsesprocedurerne vedrørende de to projekter var gennemført.
English: This is then followed by a signal management procedure.
Danish: Dette følges op af en signalstyringsprocedure.
English: • Minutes from the 1st meeting of the working group on substances of human origin.
Danish: • Referat fra det første møde i arbejdsgruppen om stoffer af menneskelig oprindelse.
English: Members raised a number of considerations in this respect.
Danish: Medlemmerne påpegede en række hensyn i denne forbindelse.
English: • Communication about the network during international meetings, emphasising the complementarity of the EU system.
Danish: • Kommunikation om netværket under internationale møder, med vægt på komplementariteten i EUsystemet.
English: 9 February 2012
Danish: 9. februar 2012
English: The Board decided to vote on whether to adopt the policy as proposed.
Danish: Bestyrelsen besluttede at stemme om, hvorvidt politikken skulle vedtages som foreslået.
English: These factors are beyond the reach of regulators.
Danish: Disse faktorer lå uden for lovgivernes rækkevidde.
English: The Board noted that the surplus from 2010 was included in the budget.
Danish: Bestyrelsen bemærkede, at overskuddet fra 2010 var inkluderet i budgettet.
English: Members underlined that transparency is of significant importance in this area.
Danish: Medlemmerne understregede, at gennemsigtighed var af væsentlig betydning på dette område.
English: Members expressed regret and dissatisfaction regarding the delay in the nomination process.
Danish: Der blev udtrykt beklagelse og utilfredshed med den forsinkede udnævnelsesproces.
English: They were also content with the fact that the meeting budget remains stable even though a new committee will be established in the middle of 2012.
Danish: De var også glade for, at mødebudgettet forblev stabilt, selv om der ville blive nedsat et nyt udvalg medio 2012.
English: It was recognised that a further debate with the European Commission and within the network should continue.
Danish: Man erkendte, at der skulle foregå en yderligere debat med EuropaKommissionen og i netværket.
English: Work is ongoing on improving procurement procedures.
Danish: Der arbejdedes fortsat på at forbedre indkøbsprocedurerne.
English: Similar issues could also happen in the area of veterinary medicines, and this could have important consequences (human health, animal health or economical concerns).
Danish: Der kunne opstå lignende problemer på området for lægemidler til dyr, og det kunne få alvorlige konsekvenser (for menneskers sundhed, dyrs sundhed eller økonomien).
English: There are many underlying drivers creating the problem, and many of those are not linked to globalisation.
Danish: Der var mange underliggende årsager til problemet, og mange af dem var ikke knyttet til globaliseringen.
English: The Board requires 24 votes in favour to adopt a decision.
Danish: Bestyrelsen krævede 24 stemmer for, for at den kunne vedtage en beslutning.
English: Overall, the budget is €15.9 million lower than the preliminary draft budget adopted in March 2011.
Danish: Samlet var budgettet 15,9 mio. EUR lavere end det foreløbige budgetforslag, der blev vedtaget i marts 2011.
English: The amendments clarify voting arrangements in cases where there is no clear consensus on a topic put forward for adoption.
Danish: Ændringerne præciserede stemmeafgivningen i tilfælde, hvor der ikke var klar konsensus om et emne, der blev forelagt til vedtagelse.
English: In this area, it was suggested to extend the period during which restrictions apply from two years to five years following the expiry of the conflict.
Danish: På dette område blev det foreslået at forlænge varigheden af begrænsningerne fra to år til fem år efter konfliktens ophør.
English: The reduction is largely due to a lower than requested EU contribution.
Danish: Nedsættelsen skyldtes hovedsagelig, at EU's bidrag blev lavere end ansøgt.
English: Financial compensation for Member States' participation in the linguistic checking of product related information: Fixed flat hourly cost for 2012
Danish: Økonomisk kompensation for medlemsstaternes deltagelse i den sproglige kontrol af produktrelateret information: faste timepriser for 2012
English: These TA posts will be financed bythe Agency's own resources (not from the EU contribution).
Danish: Disse midlertidige stillinger ville blive finansieret af agenturets egne midler (ikke EU-bidraget).
English: The report confirmed that the response time from rapporteurs on communicated signals shortened compared to the same period in 2010.
Danish: Rapporten bekræftede, at reaktionstiden fra rapportørerne om kommunikerede signaler var blevet kortere sammenlignet med samme periode i 2010.
English: The Agency carries out the validation of signals and informs rapporteurs.
Danish: Agenturet udfører valideringen af signalerne og informerer rapportørerne.
English: No additional conflicts of interests were declared.
Danish: Der blev ikke afgivet erklæring om yderligere interessekonflikter.
English: The Agency had taken action to remedy shortcomings identified earlier in the process.
Danish: Agenturet havde taget skridt til at afhjælpe mangler, der var opdaget tidligere i forløbet.
English: Discharge for the 2009 budget
Danish: Decharge for budgettet for 2009
English: The implementation of a number of activities will continue in 2013 and subsequent periods, depending on the availability of further funds.
Danish: Gennemførelsen af en række aktiviteter ville fortsætte i 2013 og de efterfølgende perioder afhængigt af, om der var yderligere midler til rådigheder.
English: The mandates of the current civil society members of the Board expire on 4 March 2012.
Danish: Mandatet for de nuværende bestyrelsesmedlemmer fra civilsamfundet udløber den 4. marts 2012.
English: Report on the Agency's procurement procedure and a proposed improvement action plan
Danish: Rapport om agenturets indkøbsprocedure og et forslag til forbedringshandlingsplan
English: The document was not adopted in its current form, and a revised policy will be submitted at the March 2012 meeting.
Danish: Dokumentet blev ikke vedtaget i sin aktuelle form, og en revideret politik ville blive forelagt på mødet i marts 2012.
English: Members also asked to revise the wording of Article 2 (5) of the rules of procedure to clarify that civil society representatives can be elected as chair.
Danish: Medlemmerne bad også om en omformulering af artikel 2, stk. 5, i forretningsordenen for at præcisere, at civilsamfundets repræsentanter kunne vælges til formand.
English: Results of the study are expected in March 2012.
Danish: Resultaterne af undersøgelsen forventedes at foreligge i marts 2012.
English: A new member of the Committee is introduced to represent the business activities of the Agency.
Danish: Der tilførtes et nyt udvalgsmedlem til at repræsentere agenturets forretningsaktiviteter.
English: It is equally important to acknowledge that the organisation and management of such issues varies in different Member States due to diverse healthcare settings and alternatives that are available.
Danish: Det var ligeledes vigtigt at erkende, at organiseringen og forvaltningen af sådanne spørgsmål varierede fra medlemsstat til medlemsstat på grund af deres forskelligartede sundhedssystemer og de tilgængelige alternativer.
English: As an example, the Agency's staff do not attend events organised by the industry.
Danish: Eksempelvis deltog agenturets personale ikke i begivenheder, som industrien arrangerede.
English: Work on cooperation and capacity-building with the Agency's international partners is ongoing.
Danish: Der arbejdedes løbende på samarbejde og kapacitetsopbygning sammen med agenturets internationale partnere.
English: The Board asked to include aspects of today's discussion in the report in order to clarify relevant issues.
Danish: Bestyrelsen bad om at få inddraget aspekter af dagens diskussion i rapporten for at klarlagt relevante spørgsmål.
English: The ICT budget continues to show an increase in expenditure, which results in the decrease in the project development budget.
Danish: Ikt-budgettet udviste fortsat en stigning i udgifterne, hvilket bevirkede et fald i projektudviklingsbudgettet.
English: Topic coordinators were satisfied with the way the Agency is preparing for the Olympic period, both from the organisational and budget perspective.
Danish: Emnekoordinatorerne var tilfredse med den måde, hvorpå agenturet forberedte den olympiske periode, både organisatorisk og budgetmæssigt.
English: Members were concerned that this is a new initiative for the regulatory system and therefore requires thorough preparation in order to meet the significant expectations of stakeholders.
Danish: Medlemmerne var bekymrede over, at det var et nyt initiativ i lovgivningssystemet, som derfor krævede grundig forberedelse for at opfylde interessenternes væsentlige forventninger.
English: IAS strategic audit plan for 2012-2014
Danish: IAS's strategiske revisionsplan for 2012-2014
English: With regard to the financing of the implementation of the pharmacovigilance legislation, the European Commission intends to present a 'bridging budget' for the year 2013.
Danish: Med hensyn til finansiering af gennemførelsen af lovgivningen om lægemiddelovervågning agtede Europa-Kommissionen at forelægge et "overgangsbudget" for 2013.
English: A number of projects are under way that will see streamlining of certain procedures and the introduction of more quantifiable elements in the assessment process.
Danish: Der var en række projekter undervejs med henblik på strømlining af visse procedurer og indførelse af mere kvantificerbare elementer i vurderingsprocessen.
English: As more systems go into production, the fixed ICT costs will continue to increase.
Danish: Efterhånden som der kom flere systemer i produktion, ville de faste iktomkostninger fortsat stige.
English: The Agency and the network will need to consider ways of reducing the burden of fixed costs through the review and introduction of new technologies that have a cost-saving effect.
Danish: Agenturet og netværket ville blive nødt til at overveje, hvordan man kunne reducere de faste omkostninger ved at gennemgå og introducere nye teknologier, som havde en omkostningsbesparende virkning.
English: Early in 2012, information on activities to be taken forward in 2012 will be provided through the Agency's website and a new workshop for industry will be organised.
Danish: Tidligt i 2012 ville der på agenturets websted blive informeret om aktiviteter, der skulle fremmes i 2012, og der ville blive afholdt en ny workshop for erhvervslivet.
English: The European Commission reminded the Board of the fact that the EU contribution to the Agency's budget is a balancing contribution.
Danish: Europa-Kommissionen mindede bestyrelsen om, at EU's bidrag til agenturets budget var et udligningsbidrag.
English: If only one audit engagement can take place in 2012, the Management Board expressed a preference for the audit on planning and budgeting.
Danish: Hvis der kun kunne foretages én revision i 2012, så bestyrelsen helst, at det blev en revision af planlægning og budgettering.
English: The outcome of the vote was as follows: 22 members in favour; 7 against; 2 abstained; 4 members sent their apologies for the meeting (votes by delegation and proxies can be found in the Annex).
Danish: Resultatet af afstemningen blev følgende: 22 medlemmer stemte for, 7 imod, 2 afholdt sig fra at stemme, 4 havde meldt afbud (stemmer afgivet ved stedfortræder og ved fuldmagt findes i bilaget).
English: The Management Board also adopted a revision of the grading of the 23 posts in accordance with Article 32 of the Agency's Financial Regulation.
Danish: Bestyrelsen vedtog også en revision af lønklassen for de 23 stillinger i overensstemmelse med artikel 32 i agenturets finansforordning.
English: The European Parliament granted the discharge for the implementation of the Agency's 2009 budget on 25 October 2011.
Danish: Europa-Parlamentet gav decharge til gennemførelsen af agenturets budget for 2009 den 25. oktober 2011.
English: However, it was explained that the definitions in this policy mirror those adopted for the policy on conflicts of interests of experts, and it would be appropriate to keep both policies in line.
Danish: Imidlertid blev det forklaret, at definitionerne i denne politik afspejlede dem, der blev vedtaget for politikken om interessekonflikter for eksperter, og at det ville være hensigtsmæssigt, at de to politikker var overensstemmende.
English: Other important areas of activity will include further strengthening the quality of the Agency's scientific work.
Danish: Blandt de øvrige vigtige aktivitetsområder var en yderligere skærpelse af kvaliteten af agenturets videnskabelige arbejde.
English: The report also showed an increase in requests for data from EudraVigilance, a significant increase of Member States working with the EudraVigilance Data Analysis System, and improved compliance with the legal timeframes for the transmission of individual case safety reports.
Danish: Rapporten viste også en stigning i anmodningerne om data fra EudraVigilance, en betydelig stigning i antal medlemsstater, der benyttede EudraVigilance Data Analysis System (EVDAS), og en bedre overholdelse af de lovbestemte tidsfrister for transmission af individuelle sikkerhedsrapporter.
English: However, the overall staffing of the Agency will remain at the previous year's level since the Agency will reduce the number of contract agents and seconded national experts by 23 full-time equivalents.
Danish: Imidlertid ville det samlede personaletal i agenturet ligge på samme niveau som året før, eftersom agenturet ville reducere antallet af kontraktansatte og udstationerede nationale eksperter med 23 fuldtidsækvivalenter.
English: 13 Lithuania 14 Malta
Danish: 12 Letland 13 Litauen 14 Malta
English: The Board wished to return to this topic at a future meeting.
Danish: Bestyrelsen ønskede at vende tilbage til emnet på et kommende møde.
English: In addition to his responsibilities as Deputy Executive Director, Andreas will continue in his position as Head of Administration Unit.
Danish: Ud over opgaverne som viceadministrerende direktør ville Andreas fortsat varetage funktionen som kontorchef for administrationen.
English: The European Commission also pointed out that the ICT budget should be revisited and that there is scope for reducing meetings and missions.
Danish: Europa-Kommissionen påpegede også, at ikt-budgettet burde revurderes, og at der var mulighed for at skære ned på møder og rejser.
English: Effort will also be made to enhance the coordination of the scientific committees in light of the increasing complexity of interaction following the establishment of the seventh committee, which will deal with pharmacovigilance topics.
Danish: Der ville også blive gjort en indsats for at styrke samordningen mellem de videnskabelige udvalg i lyset af det stadig mere komplekse samspil efter nedsættelsen af det syvende udvalg, som skulle behandle spørgsmål i forbindelse med lægemiddelovervågning.
English: However, the Board wishes to return to this question by the end of 2012.
Danish: Men bestyrelsen ønskede at vende tilbage til spørgsmålet ultimo 2012.
English: Meeting with Commissioner John Dalli and Director-General Paola Testori
Danish: Møde med kommissær John Dalli og generaldirektør Paola Testori
English: Interaction between the Agency and healthcare professionals a.) Framework for interaction between the Agency and healthcare professionals, and b.) Criteria to be fulfilled by healthcare professionals' organisations involved in Agency activities
Danish: Samspillet mellem agenturet og sundhedsfagpersoner a.) Ramme for samspillet mellem agenturet og sundhedsfagpersoner og b.) Kriterier, som skal være opfyldt af sundhedsfaglige organisationer, der deltager i agenturets aktiviteter