FrancophonIA/ELRC3.0 huggingface dataset:
English: Each prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
Danish: Hver depottablet indeholder 8 mg fesoterodinfumarat, som svarer til 6,2 mg fesoterodin.
English: Dyspepsia;
Danish: Depottablet.
English: • not being able to control when you empty your bladder (called urgency incontinence)
Danish: • hvis du ikke er i stand til at tømme blæren helt (urinretention)
English: Dizziness; Headache
Danish: Svimmelhed; hovedpine
English: • pain in the stomach
Danish: • smerter i halsen
English: Each prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
Danish: Hver depottablet indeholder 4 mg fesoterodinfumarat, som svarer til 3,1 mg fesoterodin.
English: Fesoterodine 8 mg
Danish: Fesoterodin 8 mg
English: Uncommon (may affect up to 1 in 100 people)
Danish: Almindelige (forekommer hos mellem 1 og 10 ud af 100 personer)
English: TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets
Danish: TOVIAZ 4 mg depottabletter TOVIAZ 8 mg depottabletter
English: • wind (flatulence)
Danish: • oppustethed (afgang af tarmluft)
English: The pharmacokinetics of fesoterodine are not significantly influenced by age and gender.
Danish: Alder og køn påvirker ikke fesoterodins farmakokinetik signifikant.
English: What TOVIAZ looks like and contents of the pack
Danish: TOVIAZ udseende og pakningsstørrelser
English: EU/1/07/386/015 30 prolonged-release tablets EU/1/07/386/016 90 prolonged-release tablets
Danish: EU/1/07/386/015 30 depottabletter EU/1/07/386/016 90 depottabletter
English: TOVIAZ 4 mg prolonged-release tablets fesoterodine fumarate
Danish: TOVIAZ 4 mg depottabletter fesoterodinfumarat
English: The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FT'.
Danish: 8 mg-tabletterne er blå, ovale, bikonvekse, filmovertrukne og er på den ene side præget med bogstaverne ‘FT'.
English: Potent CYP3A4 inducers
Danish: Stærke CYP3A4-induktorer
English: EU/1/07/386/013 30 prolonged-release tablets EU/1/07/386/014 90 prolonged-release tablets
Danish: EU/1/07/386/013 30 depottabletter EU/1/07/386/014 90 depottabletter
English: TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Danish: TOVIAZ 8 mg depottabletter fesoterodinfumarat
English: - certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or spasm and to prevent travel sickness like medicines containing metoclopramide.
Danish: - Medicin, der indeholder det aktive stof amantadin (der bruges til behandling af Parkinsons syge) - Visse typer medicin til at fremme fordøjelsen, lindre mavekramper eller -spasmer og til at forhindre køresyge, f.eks. medicin, der indeholder metoclopramid - Visse typer medicin til behandling af psykiske lidelser, f.eks. antidepressiva og neuroleptika.
English: The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS'.
Danish: 4 mg-tabletterne er lyseblå, ovale, bikonvekse, filmovertrukne og er på den ene side præget med bogstaverne ‘FS'.
English: TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved outwards on both sides, filmcoated tablets, and engraved on one side with the letters ‘FS'.
Danish: TOVIAZ 4 mg depottabletter er lyseblå, ovale, buede udad på begge sider, filmovertrukne og på den ene side præget med bogstaverne ‘FS'.
English: TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated tablets, and engraved on one side with the letters ‘FT'.
Danish: TOVIAZ 8 mg depottabletter er blå, ovale, buede udad på begge sider, filmovertrukne og på den ene side præget med bogstaverne ‘FT'.
English: Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine.
Danish: TOVIAZ 8 mg tabletter En depottablet indeholder fesoterodinfumarat 8 mg svarende til 6,2 mg fesoterodin.
English: If you take more TOVIAZ than you should
Danish: Hvis du har taget for meget TOVIAZ
English: Flatulence, Gastroesophage al reflux
Danish: Ubehag i maven; flatulens; gastroøsofageal refluks
English: - Concomitant administration of a potent CYP2D6 inhibitor (see sections 4.5 and 5.2).
Danish: 4.2 og 4.5) - samtidig behandling med potent CYP2D6-hæmmer (se pkt.
English: It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed during treatment with TOVIAZ.
Danish: Du må ikke tage TOVIAZ, hvis du ammer, da man ikke ved, om fesoterodin udskilles i modermælken hos mennesker.
English: Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine.
Danish: TOVIAZ 4 mg tabletter En depottablet indeholder fesoterodinfumarat 4 mg svarende til 3,1 mg fesoterodin.
English: • having to empty your bladder more often than usual (called increased urinary frequency)
Danish: • hvis du har svært ved at tømme blæren helt (f.eks. på grund af forstørret blærehalskirtel)
English: • Gastric retention
Danish: • Ventrikelretention
English: In patients with severe renal impairment (GFR < 30 ml/min), Cmax and AUC are increased 2.0 and 2.3-fold, respectively.
Danish: Hos patienter med svært nedsat nyrefunktion (GFR < 30 ml/min.)
English: Outer carton 8 mg
Danish: Yderpakning 8 mg
English: Weak CYP3A4 inhibitors
Danish: Svage CYP3A4-hæmmere
English: Outer carton 4 mg
Danish: Yderpakning 4 mg
English: TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Danish: TOVIAZ 4 mg depottabletter TOVIAZ 8 mg depottabletter fesoterodinfumarat
English: Posology
Danish: Dosisøgning
English: Pharyngolaryng eal pain; Cough; Nasal dryness
Danish: Smerter i hals og svælg; hoste; tørhed i næsen
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret TOVIAZ til dig personligt.
English: Potent CYP3A4 inhibitors
Danish: Potente CYP3A4-hæmmere
English: Do not take TOVIAZ: - if you are allergic to fesoterodine or to peanut or soya or to any of the other ingredients of
Danish: • hvis du er allergisk over for fesoterodin, over for jordnødder eller soja eller et af de øvrige indholdsstoffer i TOVIAZ (angivet i afsnit 6) (se afsnit 2 ”TOVIAZ indeholder lactose og sojaolie”)
English: CAP = centrally authorised product.
Danish: CAP = centralt godkendt produkt.
English: EUR thousand
Danish: 1 000 EUR
English: These types of treatment remain a priority area for the companion-animal health sector.
Danish: Disse typer behandling er fortsat et prioriteret indsatsområde for sektoren for smådyrs sundhed.
English: Submitted Positive opinions Negative opinions Withdrawals Commission decisions
Danish: Indsendte Positive udtalelser Negative udtalelser Tilbagetrækninger Kommissionens afgørelser
English: There was a 5% decrease to 91 applications for initial evaluation of medicines.
Danish: Der var et fald på 5 % til 91 ansøgninger om indledende vurdering af lægemidler.
English: These relate to 73 applications by active substance, representing an increase of 16% compared to 2009.
Danish: Heraf drejede 73 ansøgninger sig om aktivt stof, svarende til en stigning på 16 % sammenholdt med 2009.
English: Eight requests were for minor use/minor species (MUMS)/limited markets.
Danish: Otte anmodninger drejede sig om mindre udbredte sygdomme/mindre arter (MUMS)/begrænsede markeder.
English: It is extracted from the milk of rabbits that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Danish: Det udvindes af mælk fra kaniner, der har fået tilført et gen (DNA), der sætter dem i stand til at producere humant protein i deres mælk.
English: EMA budget evolution
Danish: Udviklingen i EMA's budget
English: These errors, which occurred primarily due to the rapid diversification of the Agency's activities, contributed to the European Parliament's vote to postpone the discharge for the 2009 budget - the first time this has happened since the Agency was established, in 1995.
Danish: Disse fejl, der primært opstod som følge af den hurtige diversificering af agenturets aktiviteter, bidrog til EuropaParlamentets afstemning om at udsætte dechargen for 2009-budgettet - hvilket er første gang, dette er sket siden agenturets oprettelse i 1995.
English: A report on the evaluation of the Agency, carried out by Ernst & Young, was published at the beginning of the year.
Danish: Der blev i begyndelsen af året offentliggjort en rapport om evalueringen af agenturet, udført af Ernst & Young.
English: I am pleased to report that the Agency has now addressed all of the errors, and we expect a successful discharge of the budget in the near future.
Danish: Det er en glæde for mig at kunne meddele, at agenturet nu har taget hånd om alle de opståede fejl, og vi forventer, at der kan meddeles decharge for budgettet i den nærmeste fremtid.
English: • New pharmacovigilance legislation is adopted by European Parliament.
Danish: • Ny lovgivning om lægemiddelovervågning vedtages af Europa-Parlamentet.
English: Throughout the year, we worked to develop a new five-year strategy for the Agency - the 'Road map to 2015', adopted by the Management Board and published in December - which should help to ensure the Agency is fit to tackle the challenges ahead.
Danish: Vi arbejdede i løbet af hele året på at tilrettelægge en ny femårsstrategi for agenturet - “Køreplan frem til 2015”, der blev vedtaget af bestyrelsen og offentliggjort i december - der skulle være med til at sikre, at agenturet trimmes til at takle udfordringerne fremadrettet.
English: Quality defects reported Recalls Class 1 Class 2 Class 3
Danish: Tilbagekaldelser Klasse 1 Klasse 2 Klasse 3
English: In the lead-up to his departure, much effort was put into evaluating where the Agency currently stands and making preparations for the future.
Danish: I perioden op til hans afgang blev der sat mange kræfter ind på at evaluere, hvor agenturet står i øjeblikket, og forberede det på fremtiden.
English: The total number of inspections was 20% above the forecast, mainly due to an unexpected increase in the number of good-clinical-practice (GCP) inspections requested.
Danish: Det samlede antal inspektioner var 20 % over prognoserne, primært som følge af en uventet stigning i antallet af ønskede inspektioner vedrørende god klinisk praksis (GCP).
English: The distribution of types of variations changed significantly throughout the year as a consequence of the new legislation on variations.
Danish: Fordelingen af typer ændringer skiftede markant over hele året som en konsekvens af den nye lovgivning om ændringer.
English: In October, we published new rules on conflicts of interests, addressing our need to access Europe's best scientific experts while ensuring they have no financial or other interests that could affect their impartiality.
Danish: I oktober offentliggjorde vi nye regler for interessekonflikter, der forholdt sig til vores behov for at få adgang til Europas bedste videnskabelige eksperter, samtidig med at vi sikrede, at de ikke har nogen økonomiske eller andre interesser, der kunne påvirke deres upartiskhed.
English: An extensive outbreak of this bacterial disease, which is the causative agent of Q fever in man, occurred in the Netherlands in 2009.
Danish: Et omfattende udbrud af denne bakteriesygdom, der er den agens, der fremkalder Q-feber hos mennesker, opstod i Nederlandene i 2009.
English: Fees and other income
Danish: Gebyrer og andre indtægter
English: Office of the Executive Director
Danish: Den administrerende direktørs kontor
English: The CVMP therefore considered it appropriate to recommend that the product be authorised under exceptional circumstances on the basis of a positive benefit-risk balance while further studies are carried out to determine more precisely the efficacy in goats.
Danish: CVMP fandt det derfor passende at anbefale, at produktet tillades under ekstraordinære omstændigheder på basis af en positiv benefit/risk-balance, mens der gennemføres yderligere undersøgelser for mere præcist at få fastslået effekten hos geder.
English: The product is of major public-health interest in light of the shortage of the authorised medicine for the treatment of this disease.
Danish: Produktet er af stor interesse for folkesundheden i lyset af manglen på tilladt medicin til behandling af denne sygdom.
English: • EMA launches its new website.
Danish: • EMA lancerer sit nye websted.
English: It aims at ensuring that post-authorisation monitoring and effective risk-management are continuously applied to veterinary medicines throughout the EU.
Danish: Formålet hermed er at sikre, at overvågning og effektiv risikostyring efter godkendelse anvendes regelmæssigt på veterinærlægemidler i hele EU.
English: And in November, we took a major step forward in transparency, publishing a policy on access to documents that gives wider public access than ever before to the documents we hold concerning both human and veterinary medicines.
Danish: Og i november tog vi et stort skridt frem i forhold til gennemsigtighed og offentliggjorde en politik for aktindsigt i dokumenter, der giver offentligheden bredere adgang end nogensinde før til de dokumenter, som vi er i besiddelse af, både vedrørende humanmedicinske og veterinærmedicinske lægemidler.
English: The use of veterinary medicines in food-producing animals may result in the presence of residues in foodstuffs obtained from treated animals.
Danish: Anvendelsen af veterinærlægemidler i fødevareproducerende dyr kan føre til forekomsten af restkoncentrationer i levnedsmidler som følge af behandlede dyr.
English: These vaccines were authorised under exceptional circumstances to protect cattle and sheep against clinical signs, and to reduce or prevent transmission of serotypes 1, 2, 4 and 8 of the highly variable bluetongue virus.
Danish: Disse vacciner blev godkendt under ekstraordinære omstændigheder for at beskytte kvæg og får mod kliniske tegn, og for at reducere eller forebygge transmission af serotype 1, 2, 4 og 8 af den stærkt variable ”blue tongue”-virus.
English: Thomas left the Agency in December after ten successful years at its helm, overseeing the phenomenal growth of the Agency, not only in terms of sheer size, but also in the range of its activities.
Danish: Thomas forlod agenturet i december efter ti succesrige år ved roret, hvor han stod i spidsen for agenturets fantastiske vækst, ikke blot rent størrelsesmæssigt, men også med hensyn til omfanget af agenturets aktiviteter.
English: General EU contribution
Danish: Generelt EU-bidrag
English: As we look forward to 2011, I am sure that the Agency will take new challenges in its stride, including the appointment of a new Executive Director and the implementation of new legislative requirements, while continuing to fulfil its core business of protecting public and animal health in the European Union.
Danish: Når vi skuer frem mod 2011, er jeg sikker på, at agenturet vil påtage sig nye udfordringer, herunder udnævnelsen af en ny administrerende direktør og gennemførelsen af nye lovgivningskrav, samtidig med at det opfylder sin kernevirksomhed, nemlig at beskytte folke- og dyresundheden i EU.
English: Almost half (44) of all applications were for biosimilar or generic medicines and hybrid or informedconsent applications.
Danish: Næsten halvdelen (44) af alle ansøgninger drejede sig om bioækvivalente eller generiske lægemidler og hybride anvendelser eller anvendelser med informeret samtykke.
English: • EMA strengthens rules on conflicts of interests for its scientific experts.
Danish: • EMA styrker reglerne om interessekonflikter for dets videnskabelige eksperter.
English: With increases in workload in almost all areas, this was another busy year for the Agency.
Danish: Med en stigende arbejdsbyrde på næsten alle områder var der tale om endnu et travlt år for agenturet.
English: Orphan medicines are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Union, or where for economic reasons such medicines would not be developed without incentives.
Danish: Lægemidler til sjældne sygdomme er beregnet til diagnosticering, forebyggelse eller behandling af livstruende eller kronisk invaliderende lidelser, der ikke berører mere end fem ud af 10 000 personer i EU, eller hvor der af økonomiske årsager ikke ville blive udviklet sådanne lægemidler uden incitamenter.
English: We implemented a series of measures to strengthen the Agency's procurement procedures in 2010, following some technical errors that had occurred over the previous few years.
Danish: Vi gennemførte en række foranstaltninger, der skal styrke agenturets indkøbsprocedurer i 2010, og som fulgte i kølvandet af visse tekniske fejl, der var opstået over de foregående fem år.
English: The Agency provides scientific advice and protocol assistance to sponsors during the phase of research and development of medicinal products.
Danish: Agenturet tilvejebringer videnskabelig rådgivning og protokolbistand til sponsorer i lægemidlers forsknings- og udviklingsfase.
English: The year 2010 saw many changes at the European Medicines Agency, the most poignant of which was the departure of the Agency's Executive Director, Thomas Lönngren.
Danish: 2010 var året, hvor vi i Det Europæiske Lægemiddelagentur (EMA) oplevede mange forandringer, hvor den mest fremtrædende var Thomas Lönngrens afgang, agenturets administrerende direktør.
English: Referral procedures are used to resolve disagreements and address concerns among Member States.
Danish: Indbringelsesprocedurer anvendes til at løse uoverensstemmelser og håndtere bekymringer blandt medlemsstaterne.
English: Authorisation at EU level makes vaccines immediately available for use as part of national and transnational diseasecontrol campaigns against this highly virulent and contagious disease of domestic livestock.
Danish: Tilladelse på EUniveau gør vacciner umiddelbart tilgængelige for brug som led i national og transnationale kampagner for sygdomskontrol mod denne stærkt virulente og smitsomme sygdom for husdyrbestande.
English: Of the applications received, 46 related to new medicines, 12 of which were designated orphan medicines.
Danish: Af de modtagne ansøgninger vedrørte de 46 nye lægemidler, heraf 12 udpegede lægemidler til sjældne sygdomme.
English: Applications for maximum residue limits (MRLs)
Danish: Ansøgninger om maksimalgrænseværdier for restkoncentrationer (MRL)
English: • European Commission starts recruitment procedure for the EMA's new Executive Director.
Danish: • Europa-Kommissionen indleder en ansættelsesprocedure for stillingen som EMA's nye administrerende direktør.
English: • EMA and Massachusetts Institute of Technology launch a joint project on regulatory science.
Danish: • EMA og Massachusetts Institute of Technology lancerer et fælles projekt om “regulatory science”.
English: Number of inspections
Danish: Antal inspektioner
English: The Agency establishes maximum residue limits (MRLs) for pharmacologically active substances used to treat animals, to provide for the safe use of foodstuffs of animal origin, including meat, fish, milk, eggs and honey.
Danish: Agenturet fastsætter maksimale grænseværdier for restkoncentrationer (MRL) for farmakologisk aktive stoffer, der anvendes til behandling af dyr for at garantere sikker brug af animalske levnedsmidler, herunder kød, fisk, mælk, æg og honning.
English: • EMA and EUnetHTA Joint Action start collaboration on improving European public assessment reports (EPARs) for better contribution to relative effectiveness assessments.
Danish: • EMA og EUnetHTA Joint Action indleder et samarbejde om forbedring af europæiske offentlige vurderingsrapporter (EPAR) for et bedre bidrag til relative effektivitetsvurderinger.
English: • EMA and US FDA extend their confidentiality arrangement indefinitely.
Danish: • EMA og USA's FDA forlænger deres fortrolighedsaftale på ubestemt tid.
English: Pharmacovigilance and maintenance activities
Danish: Lægemiddelovervågning og vedligeholdelsesaktiviteter
English: The report praised the Agency for its efficiency and effectiveness in delivering high-quality scientific opinions on medicines for human and veterinary use, but also highlighted the need for the Agency, together with the European Commission and regulatory authorities in the Member States, to continue to adapt to future challenges and address new developments and responsibilities.
Danish: Rapporten komplimenterede agenturet for dets effektivitet i leveringen af videnskabelige udtalelser af høj kvalitet om human- og veterinærmedicinske lægemidler, men satte også spot på behovet for, at agenturet, sammen med Europa-Kommissionen, fortsætter med at tilpasse sig fremtidens udfordringer og forholder sig til nye udviklinger og ansvarsområder.
English: • EMA's SME Office wins award for 'Most significant contribution to mediscience sector'.
Danish: • EMA's SMV-kontor vinder pris for “Mest betydningsfulde bidrag til den medicinsk-videnskabelige sektor'.
English: On top of the increasing volume of core business activities, the Agency reached a number of important milestones during the course of the year.
Danish: Ud over den stigende mængde kernevirksomhedsaktiviteter nåede agenturet en række vigtige milepæle i årets løb.
English: In addition to the progress made in many priority areas, 2010 saw an increase in almost all areas of activity of the Agency's core business.
Danish: Ud over de fremskridt, der er gjort på mange prioriterede områder, oplevede agenturet i 2010 en stigning på næsten alle aktivitetsområder for agenturets nøglevirksomhed.
English: I am grateful for the hard work, dedication and support of all of the Agency's staff, the members of its committees, working parties and working groups, and the Management Board, who enabled the Agency to meet its commitments successfully, despite increases in workload throughout the year.
Danish: Jeg skylder stor tak til alle agenturets medarbejdere, medlemmerne af udvalgene og de forskellige arbejdsgrupper og bestyrelsen for deres store indsats, engagement og støtte, som alle gjorde det muligt for agenturet at leve op til sine forpligtelser med succes, og det på trods af det stigende arbejdspres i årets løb.
English: In July, we launched a new website for the Agency, giving our online audiences easier access to information on medicines, to guidelines, to regulatory and scientific advice, and to information on other Agency activities.
Danish: I juli lancerede vi agenturets nye websted, der giver onlinemålgrupper lettere adgang til oplysninger om lægemidler, til retningslinjer, til lovgivningsmæssig og videnskabelig rådgivning, og til oplysninger om andre af agenturets aktiviteter.
English: Biocides
Danish: Biocider
English: Initial applications (by medicinal product) Initial applications (by active substance)
Danish: Ansøgninger om indledende vurdering (efter lægemiddel) Ansøgninger om indledende vurdering (efter aktivt stof)
English: • EMA launches SME database to facilitate interaction between small and medium-sized enterprises.
Danish: • EMA lancerer en SMV-database, der skal lette interaktionen mellem små og mellemstore virksomheder.
English: It does this through inspections requested by the CHMP or CVMP in connection with the assessment of marketing-authorisation applications and/or the assessment of matters referred to these committees in accordance with EU legislation.
Danish: Det sker gennem inspektioner forlangt af CHMP eller CVMP i forbindelse med vurderingen af ansøgninger om markedsføringstilladelse og/eller vurderingen af forhold, der henvises til disse to udvalg i overensstemmelse med EU-lovgivningen.
English: • EMA adopts new fees for marketing-authorisation applications.
Danish: • EMA vedtager nye gebyrer for ansøgninger om markedsføringstilladelser.
English: • European Medicines Agency (EMA) launches consultation on its 'Road map to 2015'.
Danish: • Det Europæiske Lægemiddelagentur (EMA) lancerer en høring om sin “Køreplan frem til 2015”.
English: • EMA Management Board launches new 'Road map to 2015'.
Danish: • EMA's bestyrelse lancerer en ny 'Køreplan frem til 2015'.