FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential of telotristat ethyl as an inducer of CYP3A4 was not assessed at concentrations expectable at the intestinal level, due to its low solubility in vitro.
Danish: Grundet lav opløselighed in vitro er potentialet for telotristatethyl som inducer af CYP3A4 ikke blevet undersøgt ved de koncentrationer, som kan forventes i tarmsystemet.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Reproduktionstoksicitet er set i dyreforsøg (se pkt.
English: Constipation was reported in 5.7% of patients (4/70) in the telotristat ethyl 250 mg group and in 4.2% of patients (3/71) in the placebo group.
Danish: Forstoppelse blev rapporteret hos 5,7 % af patienterne (4/70) i telotristatethyl 250 mg gruppen og hos 4,2 % af patienterne (3/71) i placebogruppen.
English: Other medicines and Xermelo
Danish: Brug af anden medicin sammen med Xermelo
English: The mean u5-HIAA excretion at baseline was 69.1 mg/24hours in the 250 mg group (n=17) and
Danish: Den gennemsnitlige u5-HIAA udskillelse ved baseline var 69,1 mg/24 timer i 250 mg gruppen (n = 17) og 84,8 mg/24 timer i placebogruppen (n = 22).
English: In patients treated at 250 mg tid, a slight accumulation of telotristat levels was observed with a median accumulation ratio based on AUC0-4h of 1.55 [minimum, 0.25; maximum, 5.00; n=11; week 12], with a high inter-subject variability (%CV = 72%).
Danish: Median akkumulationsratio baseret på AUC0-4h var 1,55 [minimum, 0.25; maksimum, 5,00; n=11; uge 12], variabiliteten imellem forsøgspersonerne var høj (% CV = 72 %).
English: a. Analysis of covariance including treatment group and urinary 5-HIAA stratification at randomisation as fixed effects, and the baseline number of BM as a fixed covariate.
Danish: CL=konfidensgrænse; SD=standardafvigelse; tid=tre gange dagligt a. Analyse af kovariant inklusive behandlingsgruppe og urin 5-HIAA stratifikation ved randomisering som fixed-effekt, og baseline antal afføringer som en fast kovariant.
English: Telotristat reduces bowel movement (BM) frequency.
Danish: Telotristat reducerer afføringsfrekvensen.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Danish: Fortæl lægen eller apotekspersonalet, hvis du oplever en af følgende bivirkninger:
English: Each tablet contains 168 mg of lactose (as anhydrous).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver tablet indeholder 168 mg lactose (vandfri).
English: Abdominal distension was reported in 7.1% of patients (5/70) receiving telotristat ethyl 250 mg tid, versus 4.2% in the placebo group (3/71).
Danish: Udspilingen af abdomen blev rapporteret for 7,1 % af patienterne (5/70) som fik telotristatethyl 250 mg 3 gange dagligt, mod 4,2 % i placebogruppen (3/71).
English: How Xermelo works
Danish: Sådan virker Xermelo
English: How to take Xermelo
Danish: Sådan skal du tage Xermelo
English: Reduced exposures were not observed in a 12◦week double-blind, placebo-controlled, randomised,
Danish: Nedsat eksponering blev ikke observeret i et 12 ugers dobbeltblindet, placebokontrolleret, randomiseret multicenter klinisk studie hos voksne patienter med karcinoid syndrom i langtidsvirkende SSA behandling.
English: In rats, there were no adverse effects on male and female fertility.
Danish: Hverken hos han- eller hunrotter var der bivirkninger relateret til fertilitet.
English: Gammaglutamyltransferase increasedb
Danish: Lever og galdeveje Forhøjet gammaglutamyltransferaseb
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A-1°B
Danish: Alameda Fernão Lopes, n° 16A-1°B 1495 - 190 Algés
English: Acid Reducers
Danish: Syrereducerende lægemidler
English: Package leaflet: Information for the patient Xermelo 250 mg film-coated tablets telotristat ethyl This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Xermelo 250 mg filmovertrukne tabletter
English: This is approximately 14 times the human exposure (AUC total) at the maximum recommended human dose (MRHD) of 750 mg/day for the active metabolite LP-778902.
Danish: Dette er ca. 14 gange den humane eksponering (AUC-total) for den maksimalt anbefalede humane dosis (MRHD) på 750 mg/dag for den aktive metabolit LP-778902.
English: Pregnancy and breast-feeding
Danish: Graviditet, amning og frugtbarhed
English: Patients with a mean reduction of at least 1.5 BM per day: 46.7% (telotristat ethyl 250 mg) and 20.0% (placebo);
Danish: Andelen af patienter, som rapporterede reduktion i den daglige afføringsfrekvens i forhold til baseline (gennemsnit over 12 uger) var: - Patienter med en gennemsnitlig reduktion på mindst 1 afføring om dagen: 66,7 % (telotristatethyl 250 mg) og 31,1 % (placebo) - Patienter med en gennemsnitlig reduktion på mindst 1,5 afføringer om dagen: 46,7 % (telotristatethyl 250 mg) og 20,0 % (placebo) - Patienter med en gennemsnitlig reduktion på mindst 2 afføringer om dagen: 33,3 % (telotristatethyl 250 mg) og 4,4 % (placebo).
English: • feeling or being sick (unexplained nausea or vomiting), abnormally dark urine, yellow skin or eyes,
Danish: • uforklarlig kvalme eller opkast, unormalt mørk urin, gul hud eller gule øjne, smerter øverst til højre i maven.
English: This is approximately 21 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Danish: Dette er ca. 21 gange den humane eksponering (AUC total) ved MRHD på 750 mg/dag for den aktive metabolit LP-778902.
English: This is approximately 20 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Danish: Dette er ca. 20 gange den humane eksponering (AUC total) ved MRHD på 750 mg/dag for den aktive metabolit-LP-778902.
English: This is approximately 0.4 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Danish: Dette er ca. 0,4 gange den humane eksponering (AUC-total) for MRHD på 750 mg/dag for den aktive metabolit LP-778902.
English: Abdominal paina, nausea
Danish: Mave-tarm-kanalen Mavesmertera, kvalme
English: However, 100% compliance has still not been achieved.
Danish: Der er dog endnu ikke opnået 100 % overholdelse.
English: They were transmitted to the European Commission for approval.
Danish: De blev fremsendt til Europa-Kommissionen til godkendelse.
English: London, 17 June 2008
Danish: London, den 17. juni 2008
English: Early dialogue with sponsors
Danish: Tidlig dialog med sponsorer
English: System or process (Status in 2006)
Danish: System eller proces (status i 2006)
English: Vaccination is seen as an important method of control.
Danish: Vaccination betragtes som en vigtig kontrolmetode.
English: Bulgaria and Romania joined the EU on 1 January 2007.
Danish: Bulgarien og Rumænien kom med i EU den 1. januar 2007.
English: A decision was taken to extend the pilot phase into 2008.
Danish: Det blev besluttet at forlænge pilotfasen til ind i 2008.
English: At this stage, there is no suggestion that there is a general trend for decreasing activity in this area, but the level of activity will continue to be monitored.
Danish: På dette stadium er der intet, der tyder på, at der er en generel tendens i retning af dalende aktivitet på dette område, men aktivitetsniveauet vil fortsat blive overvåget.
English: More procedures finalised, in shorter time
Danish: Flere procedurer afsluttet - på kortere tid
English: 2.5 Parallel distribution
Danish: 2.5 Paralleldistribution
English: Following this meeting, it was concluded that joint meetings would be held at least once a year, and that representatives from each group would attend meetings of the other group.
Danish: Efter mødet blev det besluttet at afholde fælles møder mindst en gang om året, og at repræsentanter fra hver gruppe skulle deltage i den anden gruppes møder.
English: A series of conclusions were reached that will assist decisionmakers in the relevant organisations.
Danish: Man nåede frem til en række konklusioner, som vil hjælpe beslutningstagere i de relevante organisationer.
English: Paediatric Committee fully operational
Danish: Det Pædiatriske Udvalg helt operationelt
English: SME Office: supporting innovation among Europe's SMEs
Danish: SMV-kontor: støtte til innovation blandt Europas SMV'er
English: Bulgarian, Romanian and (following the expiry of the derogation) Maltese were successfully included in the translations framework.
Danish: Bulgarsk, rumænsk og (efter udløbet af undtagelsesperioden) maltesisk blev også inddraget i oversættelsesprocessen.
English: Thirty-seven of the 92 requests were refused.
Danish: 37 af de 92 anmodninger blev afvist.
English: Communication on safety issues between all stakeholders is also considered a high priority.
Danish: Kommunikation om sikkerhedsspørgsmål mellem interessenter blev også sat højt på dagsordenen.
English: Thirty-six procedures were finalised.
Danish: 36 procedurer blev afsluttet.
English: • We assure continual improvement of our processes and procedures, in accordance with recognised quality standards.
Danish: • Vi forbedrer løbende vores processer og procedurer i overensstemmelse med anerkendte kvalitetsstandarder.
English: The Agency strengthened its internal handling of requests for access to documents.
Danish: Agenturet styrkede sin interne behandling af anmodninger om adgang til dokumenter.
English: Forty medicines were tested as part of the 2007 programme.
Danish: 40 lægemidler blev afprøvet som led i programmet for 2007.
English: • We are strongly committed to public and animal health.
Danish: • Vi er stærkt engagerede i folkesundheden og dyrs sundhed.
English: EudraPharm was updated in 2007.
Danish: EudraPharm blev ajourført i 2007.
English: Assessment of new applications by the CVMP took an average of 200 days.
Danish: CVMP's vurdering af nye ansøgninger tog gennemsnitligt 200 dage.
English: 6 EMEA BUDGET AND STAFF
Danish: 6 EMEA'S BUDGET OG PERSONALE
English: Information about medicines in all EU languages
Danish: Information om lægemidler på alle EU-sprog
English: It is a great honour to be appointed to this post and I look forward to working with the members and all partners to advance the important work we undertake on behalf of citizens.
Danish: Det er en stor ære at være blevet udpeget til denne post, og jeg ser frem til at arbejde med medlemmerne og alle partnere og derigennem støtte det vigtige arbejde, som vi udfører på borgernes vegne.
English: As in previous years, the Agency and the Scientific Advice Working Party (SAWP) once again shortened the average time required for the delivery of scientific advice.
Danish: Som i de foregående år afkortede agenturet og arbejdsgruppen vedrørende videnskabelig rådgivning (SAWP) endnu engang den gennemsnitlige tid for levering af videnskabelig rådgivning.
English: Workshops, conferences, training
Danish: Workshopper, konferencer og uddannelse
English: These proposals require contributions from both the Agency and national competent authorities.
Danish: Disse forslag forudsætter bidrag fra både agenturet og de nationale kompetente myndigheder.
English: The majority of EU telematics systems were in use at the beginning of 2007.
Danish: Størstedelen af EU's telematiksystemer var taget i brug ved starten af 2007.
English: In collaboration with IFAH-Global, the EMEA hosted a Global Animal Health Conference on 15-16 November 2007.
Danish: I samarbejde med IFAH-Global var EMEA vært for en global konference om dyresundhed den 15.-16. november 2007.
English: However, it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions (Article 31 procedure).
Danish: Det bør dog ikke være det første valg ved behandling med nonsteroidalt antiinflammatorisk lægemiddel (NSAID) under disse forhold (proceduren i henhold til artikel 31).
English: Safety of medicines included in 7th Framework Programme
Danish: Lægemidlers sikkerhed med i det syvende rammeprogram
English: Good progress on implementing rules on access to documents
Danish: Gode fremskridt med gennemførelsen af regler for adgang til dokumenter
English: • We value the contribution of our partners and stakeholders to our work.
Danish: • Vi værdsætter vores partneres og interessenters bidrag til vores arbejde.
English: Certificates within the framework of cooperation with the World Health Organization and certificates for SMEs also increased.
Danish: Antallet af certifikater inden for rammerne af samarbejdet med Verdenssundhedsorganisationen og certifikater til SMV'er steg også.
English: These systems are evolving in line with communicated requirements.
Danish: Disse systemer udvikles i takt med de fremsatte krav.
English: Altogether, 5 referrals were carried out under this procedure.
Danish: I alt blev der indbragt fem sager i henhold til denne procedure.
English: Further development of interaction with healthcare professionals, patients and consumers
Danish: Videreudvikling af samspillet med sundhedssektoren, patienter og forbrugere
English: Specific criteria for veterinary medicines require further development.
Danish: De specifikke kriterier for veterinærlægemidler skal udvikles yderligere.
English: The first version of EudraGMP was launched in April 2007, and version 1.1 was released into production in December 2007.
Danish: Første version af EudraGMP blev lanceret i april 2007, og version 1.1 blev frigivet til produktion i december 2007.
English: 2007 was the fifth year of implementation of the EU telematics projects by the Agency.
Danish: 2007 var det femte år, hvor agenturet gennemførte EU's telematikprojekt.
English: Periodic safety update reports (PSURs)
Danish: Periodisk opdaterede sikkerhedsindberetninger (PSUR)
English: In summary, 2007 was a very productive year with intense activity in many areas, as you will note when you read the detail of this annual report.
Danish: Sammenfattende kan det siges, at 2007 var et meget produktivt år med intens aktivitet på mange områder, hvilket også vil fremgå af denne årsberetning.
English: CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
Danish: CAP EEA reports CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
English: Concept of risk-management plans firmly established
Danish: Begrebet risikostyringsplaner fuldstændig indført
English: • We promote the well-being, motivation and ongoing professional development of every member of the Agency.
Danish: • Vi fremmer velfærd, motivation og løbende faglig udvikling for alle medarbejdere i agenturet.
English: In addition to preliminary specification work for the next major upgrade, technical upgrades were implemented on the system.
Danish: Ud over det indledende specifikationsarbejde med den næste større opgradering blev der implementeret tekniske opgraderinger i systemet.
English: Twenty-nine internal and external recruitment procedures were carried out.
Danish: Der blev gennemført 29 interne og eksterne ansættelsesprocedurer.
English: • involves representatives of patients, healthcare professionals and other stakeholders in its work, to facilitate dialogue on issues of common interest;
Danish: • at inddrage repræsentanter for patienter, sundhedssektoren og andre berørte parter i sit arbejde for at fremme dialogen om spørgsmål af fælles interesse
English: 4 INSPECTIONS
Danish: 4 INSPEKTIONER
English: Three of the referrals were made under Article 33 and 3 were made under Article 35 of Directive 2001/82/EC.
Danish: Der blev indbragt tre sager i henhold til artikel 33 og 3 i henhold til artikel 35 i direktiv 2001/82/EF.
English: Sixty-seven percent of the Agency's revenue came from fee income.
Danish: 67 % af agenturets indtægter stammede fra gebyrer.
English: EPAR summaries for the public
Danish: EPAR - sammendrag for offentligheden
English: These corresponded to 85 applications with an average of 2 to 4 indications per application.
Danish: Det svarede til 85 ansøgninger med gennemsnitligt 2-4 indikationer pr. ansøgning.
English: Efforts to provide product-related information in all EU languages continued throughout 2007.
Danish: Arbejdet med at udarbejde produktinformation på alle EU-sprog fortsatte i 2007.
English: Resource planning in the network
Danish: Ressourceplanlægning i netværket
English: The Agency participated in the preparation of the action plan, released in August 2007, for implementation of the Strategic Research Agenda.
Danish: Agenturet deltog i udarbejdelsen af handlingsplanen, som blev offentliggjort i august 2007 med henblik på gennemførelsen af den strategiske forskningsdagsorden.
English: The levels of activity in these areas increased again in 2007 (see chapter 2).
Danish: Aktivitetsniveauet på disse områder steg atter i 2007 (jf. kap.
English: I succeeded Professor Hannes Wahlroos, who had so successfully chaired the Management Board for the previous three years.
Danish: Min forgænger, professor Hannes Wahlroos, har med stor succes været formand for bestyrelsen i de foregående tre år.
English: The first SME workshop was held on 2 February 2007.
Danish: Den første workshop for SMV'er fandt sted den 2. februar 2007.
English: I look forward to continued progress and success in 2008.
Danish: Jeg glæder mig til et fremgangsrigt 2008.
English: Two good laboratory practice (GLP) (non-clinical) inspections were carried out.
Danish: Der blev foretaget to (ikke-kliniske) inspektioner af god laboratoriepraksis (GLP).
English: This is an increase of 18% compared to 2006.
Danish: Det er en stigning på 18 % i forhold til 2006.
English: This increase from 183 days in 2006 arose due to fewer accelerated procedures being completed in 2007.
Danish: Denne stigning fra 183 dage i 2006 skyldes, at der blev gennemført færre fremskyndede procedurer i 2007.
English: In this context, the CVMP adopted a positive opinion for an H7 avian-influenza vaccine.
Danish: I denne sammenhæng vedtog CVMP en positiv udtalelse for en H7-vaccine mod fugleinfluenza.
English: A medicine with a chemical structure resembling that of thalidomide.
Danish: • Et lægemiddel med en kemisk struktur, der ligner thalidomid.
English: EU enlargement
Danish: Udvidelsen af EU
English: Contra-indications, warnings and precautions for use
Danish: Kontraindikationer, advarsler og forsigtighedsregler for brug
English: 3.1 Scientific advice Level of activity in relation to scientific advice lower than expected
Danish: 3.1 Videnskabelig rådgivning Lavere aktivitetsniveau for videnskabelig rådgivning end forventet
English: EMEA/197729/2008/EN/FINAL
Danish: EMEA/421629/2008/DA/ENDELIG
English: 1.3 Stimulation of innovation
Danish: 1.3 Fremme af innovation
English: The first pilot was released in September.
Danish: Det første pilotprojekt blev frigivet i september.
English: The HMPC status report on the progress made in relation to the implementation of the Directive since its entry into force, which had been forwarded to the European Commission for the preparation of its draft communication, was published on the EMEA website.
Danish: HMPC's statusrapport om fremskridt med gennemførelsen af direktivet siden dets ikrafttrædelse, der var blevet sendt til Europa-Kommissionen som led i udarbejdelsen af udkastet til meddelelse, blev offentliggjort på EMEA's websted.
English: The EMEA had adopted a decision on 4 of the 10 opinions by the end of 2007.
Danish: EMEA havde ved udgangen af 2007 truffet afgørelse om fire af de ti udtalelser.
English: Inspections agencies that are not part of the national medicines agencies were added into the EudraNet.
Danish: Inspektionsmyndigheder, der ikke indgår i de nationale lægemiddelmyndigheder, kom med i EudraNet.
English: Risk-management plans (RMPs) are submitted as part of a new application or an application involving a significant change in the marketing authorisation.
Danish: Risikostyringsplaner indsendes som en del af en ny ansøgning eller en ansøgning, der indebærer en betydelig ændring i markedsføringstilladelsen.
English: Sponsors may request advice on whether their product can be classed as a medicinal product, thus being eligible for EMEA procedures.
Danish: Sponsorer kan få råd om, hvorvidt deres produkt kan klassificeres som et lægemiddel og dermed være berettiget til behandling i henhold til EMEA's procedurer.
English: Only a few reports were submitted electronically by marketing-authorisation holders, due to the majority of large veterinary pharmaceutical companies still being in the implementation and testing phase.
Danish: Kun enkelte indberetninger blev indsendt elektronisk af indehavere af markedsføringstilladelser, hvilket skyldtes, at de fleste større virksomheder i veterinærlægemiddelindustrien stadig befandt sig i gennemførelses- og testfasen.
English: The EMEA continued to invest in the professional development of staff.
Danish: EMEA fortsatte med at investere i medarbejdernes faglige udvikling.
English: • We communicate in an open, transparent manner with all of our partners, stakeholders and colleagues.
Danish: • Vi lægger stor vægt på åben, gennemsigtig kommunikation med alle vores partnere, interessenter og kolleger.
English: The first joint meeting with patients and healthcare professionals was held on 1 June 2007.
Danish: Det første fælles møde med repræsentanter for patientorganisationer og sundhedssektoren fandt sted den 1. juni 2007.
English: Activities in the area of supporting innovation and improving access to medicines yielded some very positive results in 2007.
Danish: Indsatsen for at støtte innovation og forbedre adgangen til lægemidler gav også meget positive resultater i 2007.
English: 5 EU TELEMATICS STRATEGY
Danish: 5 EU'S TELEMATIKSTRATEGI
English: 4.1 GMP, GCP, pharmacovigilance and GLP inspections Increased number of inspections
Danish: 4.1 GMP-, GCP-, lægemiddelovervågnings- og GLP-inspektioner Stigende antal inspektioner
English: In view of the possible accession of Croatia and Turkey, the Agency organised a conference in each of these countries to prepare the groundwork for their potential future integration into the European medicines network.
Danish: I lyset af Kroatiens og Tyrkiets mulige tiltrædelse afholdt agenturet en konference i hvert af disse lande for at berede grunden for deres eventuelle fremtidige integration i det europæiske lægemiddelnetværk.
English: 1.5 Transparency, communication and provision of information
Danish: 1.5 Gennemsigtighed, kommunikation og informationsformidling
English: • We support research and innovation to stimulate the development of better medicines.
Danish: • Vi støtter forskning og innovation for at fremme udviklingen af bedre lægemidler.
English: The number of staff employed at the EMEA was 441, in addition to which there were 124 seconded national experts and contract agents.
Danish: Antallet af medarbejdere hos EMEA var 441, hvortil kommer 124 udstationerede nationale eksperter og kontraktansatte.
English: In August 2007, the HMPC provided comments on the draft communication from the Commission to the Council and the European Parliament released for consultation in May 2007 on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products.
Danish: I august 2007 udarbejdede HMPC bemærkninger til udkastet til Europa-Kommissionens meddelelse til Rådet og Europa-Parlamentet, som blev fremlagt til høring i maj 2007, om erfaringer med anvendelsen af bestemmelserne i kapitel 2a i direktiv 2001/83/EF (indført ved direktiv 2004/24/EF) om specifikke bestemmelser for traditionelle plantelægemidler.
English: Ninety-five percent of requests for access to documents were processed within the established timelines.
Danish: 95 % af anmodningerne om adgang til dokumenter blev behandlet inden for de fastlagte tidsrammer.
English: A new risk-based approach to the selection of medicines and parameters for testing was discussed and agreed by the relevant working parties/groups for medicines for human use.
Danish: En ny risikobaseret tilgang til udvælgelsen af lægemidler og parametre for afprøvning blev drøftet og vedtaget af de relevante arbejdsgrupper for humanmedicinske lægemidler.
English: The CHMP concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions.
Danish: CHMP konkluderede, at piroxicam ikke længere bør bruges til behandling af kortvarige, smertefulde og inflammatoriske sygdomme.