FrancophonIA/ELRC3.0 huggingface dataset:
English: It can be used in diarrhoea in combination with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce clinical signs of the disease in calves of over one week of age and young, non-lactating cattle.
Danish: Det kan anvendes ved diarré i kombination med oral rehydreringsbehandling (lægemidler, der indgives gennem munden for at genoprette væskebalancen i kroppen) med henblik på at mindske kliniske sygdomssymptomer hos kalve, der er mere end én uge gamle, og hos ungkvæg, som ikke er diegivende.
English: Metacam was comparable to the control product in providing supportive treatment of acute mastitis in cattle.
Danish: Metacam var sammenligneligt med kontrolbehandlingen, da det understøttede behandlingen for akut mastitis hos kvæg.
English: Metacam injection in cattle significantly improved clinical signs of respiratory infection and reduced fever compared with antibiotics alone.
Danish: Injektion med Metacam hos kvæg forbedrede de kliniske symptomer på luftvejsinfektion og reducerede feber sammenlignet med antibiotika alene.
English: Metacam injection was compared with vedaprofen (another NSAID) for pain relief associated with equine colic in 269 horses.
Danish: Metacam som injektion blev sammenlignet med vedaprofen (et andet NSAID) til lindring af koliksmerter hos 269 heste.
English: What benefits of Metacam have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Metacam?
English: Moreover, it is used to alleviate pain and inflammation in acute and chronic musculo-skeletal disorders.
Danish: Det anvendes desuden til lindring af smerter og inflammation ved akutte og kroniske muskuloskeletale lidelser.
English: A study was carried out in cats with acute musculo-skeletal disorders.
Danish: Der blev gennemført en undersøgelse, der omfattede katte med akutte muskuloskeletale lidelser.
English: How is Metacam used?
Danish: Hvordan anvendes Metacam?
English: The studies with chronic locomotor disorders showed Metacam to be effective.
Danish: I undersøgelserne af kroniske lidelser i bevægeapparatet viste Metacam sig at være virksomt.
English: In dogs and cats, occasional side effects of Metacam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, apathy (lack of vitality) and kidney failure.
Danish: Hos hunde og katte er de bivirkninger, der undertiden ses med Metacam, dem, der normalt ses med NSAID'er, såsom nedsat appetit, opkastning, diarré, blod i afføringen og apati (mangel på vitalitet) samt nyresvigt.
English: Metacam improved lameness in horses at day 14 and at the final follow-up examination 2-4 days later than the vedaprofen treated group whilst the second study showed Metacam to be comparable to vedaprofen.
Danish: Metacam gav bedre resultater end vedaprofen mod halten hos heste på dag 14 og ved den endelige opfølgningsundersøgelse 2-4 dage senere.
English: Metacam oral suspension was studied for treatment of musculoskeletal disorders associated with lameness in two studies and compared to treatment with vedaprofen.
Danish: Metacam som oral suspension til behandling af muskuloskeletale lidelser forbundet med halten var genstand for to undersøgelser, hvor det blev sammenlignet med vedaprofen.
English: A study in 150 piglets was carried out to compare the effects of Metacam injection with placebo when given before castration.
Danish: En undersøgelse omfattende 150 smågrise blev gennemført for at sammenligne virkningen af Metacam som injektion med en uvirksom behandling inden kastration.
English: In very rare cases, in dogs, haemorrhagic diarrhoea (bloody diarrhoea), haematemesis (vomiting blood) or gastrointestinal ulceration (ulcer in the gut) have been reported.
Danish: I meget sjældne tilfælde er der hos hunde indberettet blodig diarré, opkastning af blod (hæmatemese) eller sår i mave-tarmsystemet (gastrointestinal ulceration).
English: Metacam is available as an oral (taken by mouth) suspension, a solution for injection and chewable tablets.
Danish: Metacam fås som oral suspension (til indtagelse gennem munden), injektionsvæske og tyggetabletter.
English: The effectiveness of Metacam injection, in combination with antibiotic therapy, was studied in cattle with acute respiratory infection.
Danish: Virkningen af injektion med Metacam i kombination med antibiotikabehandling blev undersøgt hos kvæg med akut luftvejsinfektion.
English: Metacam injection in combination with antibiotic therapy was investigated in a study involving 240 cattle with acute mastitis.
Danish: Metacam som injektion i kombination med antibiotikabehandling var genstand for en undersøgelse, hvori der indgik 240 stykker kvæg med akut mastitis.
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis (inflammation of the lower part of the gut) have been reported.
Danish: I meget sjældne tilfælde er der indberettet nedsat appetit, sløvhed, mavesmerter og inflammation i den nedre del af tarmsystemet (colitis).
English: A study was also carried out in cats with chronic musculo-skeletal disorders.
Danish: Der blev gennemført et studie, der omfattede katte med kroniske muskuloskeletale lidelser.
English: In cattle and pigs, Metacam is well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in most cattle studied in laboratory conditions.
Danish: Der forekom kun let og midlertidig hævelse på injektionsstedet efter subkutan administration hos størstedelen af det kvæg, der blev undersøgt under laboratoriebetingelser.
English: Dogs
Danish: Hunde
English: Horses
Danish: Heste
English: Pigs either received Metacam or a placebo injection.
Danish: Grisene modtog enten Metacam eller en uvirksom injektion.
English: In cattle, Metacam is used together with antibiotics, to reduce clinical signs such as fever and inflammation in acute (short-term) respiratory infection (infection of the lungs and airways).
Danish: Hos kvæg anvendes Metacam i kombination med passende antibiotikabehandling til mindskelse af kliniske sygdomssymptomer såsom feber og betændelse ved kortvarig (akut) infektion i lunger og luftveje (respiratorisk infektion).
English: In horses, Metacam is used to relieve pain associated with colic (abdominal pain) and to alleviate inflammation and pain in both acute and chronic (long-term) musculo-skeletal disorders (disorders affecting the muscles and bones).
Danish: Hos heste anvendes Metacam til lindring af smerter forbundet med mavesmerter (kolik) og til lindring af inflammation og smerter i forbindelse med både akutte og langvarige (kroniske) lidelser, der berører musklerne og knoglerne (muskuloskeletale lidelser).
English: Cats
Danish: Katte
English: Metacam injection was studied in 60 calves with one group receiving Metacam and local anaesthetic and one group receiving a placebo injection and local anaesthetic prior to dehorning.
Danish: En gruppe modtog Metacam og lokalanæstetikum, og en gruppe modtog en uvirksom injektion (placebo) og lokalanæstetikum inden afhorning.
English: A number of studies were conducted in dogs with acute and chronic locomotor disorders with both oral and injectable Metacam.
Danish: Der blev gennemført et antal undersøgelser med Metacam, som både oral- og injektionspræparat, hos hunde med akutte og kroniske lidelser i bevægeapparatet.
English: In cats, Metacam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spay operation), orthopaedic and minor soft tissue surgery.
Danish: Hos katte anvendes Metacam til mindskelse af postoperative smerter og inflammation efter sterilisering (ovariohysterektomi), ortopædkirurgi og mindre bløddelskirurgi.
English: Animals received either Metacam injection or a placebo injection.
Danish: Dyrene modtog enten en injektion med Metacam eller en uvirksom injektion.
English: How does Metacam work?
Danish: Hvordan virker Metacam?
English: Moreover, it is used to alleviate inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Danish: Det anvendes desuden til lindring af inflammation og smerter ved såvel akutte som kroniske lidelser i bevægeapparatet hos hunde.
English: In guinea pigs, Metacam is used to reduce post-operative pain after soft tissue surgery such as castration.
Danish: Hos marsvin anvendes Metacam til at reducere postoperativ smerte efter bløddelsoperationer som kastration.
English: In dogs, Metacam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Danish: Hos hunde anvendes Metacam til mindskelse af postoperative smerter og inflammation efter ortopædkirurgi (f.eks. operation i forbindelse med knoglebrud) og bløddelskirurgi.
English: Pigs
Danish: Grise
English: Both medicines were comparable in reducing pain associated with equine colic.
Danish: Ved kolik hos heste var de to lægemidler sammenlignelige med hensyn til at reducere smerter.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Danish: Prostaglandiner er stoffer, der udløser inflammation, smerter og væskeudskillelse fra blodkarrene under inflammation og feber (ekssudation).
English: Metacam oral suspension was comparable to ketoprofen in improving lameness and pain.
Danish: Med hensyn til bedring i halten og smerter var Metacam, oral suspension, sammenligneligt med ketoprofen.
English: On behalf of the Management Board, therefore, I would like to extend a warm welcome to them in advance.
Danish: Jeg vil derfor gerne på bestyrelsens vegne byde dem hjerteligt velkommen på forhånd.
English: Such questions usually arise during the research and development phase.
Danish: Sådanne spørgsmål opstår normalt i forsknings- og udviklingsfasen.
English: Many of the recommendations are now in the process of being implemented.
Danish: Mange af anbefalingerne er nu ved at blive gennemført i praksis.
English: These new members had not yet been appointed by the end of the year.
Danish: Disse nye medlemmer var endnu ikke udpeget ved årets udgang.
English: Probability of approval (%)
Danish: Sandsynlighed for godkendelse (%)
English: It is available in all official EU languages.
Danish: Den foreligger på alle de officielle EU-sprog.
English: The strategy is to concentrate on a small number of projects with high European added value.
Danish: Strategien skal koncentreres på et begrænset antal projekter med stor europæisk merværdi.
English: Second and third-level support
Danish: Support på andet og tredje niveau
English: Typically, this is done to benefit from price differentials.
Danish: Det sker typisk for at drage fordel af prisforskelle.
English: It is forwarded to the European Parliament, Council, Commission and Member States.
Danish: Beretningen fremsendes til Europa-Parlamentet, Rådet, Kommissionen og medlemsstaterne.
English: With the enlargement of the European Union in 2004, the number of official EU languages increased from 11 to 20.
Danish: Med EU's udvidelse i 2004 blev antallet af officielle EU-sprog forøget fra 11 til 20.
English: In my capacity as Chairman of the Management Board, I have noticed that Member States have a strong will to implement these goals.
Danish: Jeg er i min egenskab af bestyrelsesformand opmærksom på, at medlemsstaterne er meget opsat på at opfylde disse målsætninger.
English: This allows more efficient coordination of the network
Danish: Det gør det muligt at koordinere netværket mere effektivt.
English: Not in operation.
Danish: Ikke operationel.
English: Observers from the European Commission and from accession countries also participate in the monthly meetings.
Danish: Desuden deltager observatører fra Europa-Kommissionen og tiltrædelseslandene i de månedlige møder.
English: Two meetings with representatives from Member States were organised to identify existing systems.
Danish: Der blev afholdt to møder med repræsentanter for medlemsstaterne for at få afdækket eksisterende systemer.
English: Recruitment of new staff continued particularly from the new Member States.
Danish: Rekrutteringen af nye medarbejdere fortsatte - især fra de nye medlemsstater.
English: 24 May 2004 - Extraordinary meeting
Danish: 24. maj 2004 - Ekstraordinært møde
English: In brief, 2004 was a year of change, a year of hard work, but also a year of significant achievement.
Danish: 2004 var kort sagt et år med forandringer, et år med hårdt arbejde, men også et år med betydelige resultater.
English: The network within which the EMEA operates increased from 27 to 42 national competent authorities.
Danish: Det netværk, EMEA arbejder i, blev forøget fra 27 til 42 nationale ansvarlige myndigheder.
English: • All new Member States connected by 1 April 2004
Danish: • Alle nye medlemsstater var koblet på inden den 1. april 2004
English: • Infrastructure: the initial environments were put in place
Danish: • Infrastruktur: de indledende miljøer blev etableret
English: It is also important to strengthen pharmacoepidemiological research in individual Member States and at EU level.
Danish: Det er ligeledes vigtigt at styrke den farmakoepidemiologiske forskning i de enkelte medlemsstater og på EU-plan.
English: 1.79 % Portugal
Danish: Slovakiet 1,79 % Portugal
English: Budget for 2005 as adopted by the Management Board on 16.12.2004.
Danish: Budgettet for 2005 som vedtaget af bestyrelsen 16.12.2004.
English: 2.10 Parallel distribution
Danish: 2.10 Paralleldistribution
English: 1.8 Organisational changes to the Agency
Danish: 1.8 Organisatoriske ændringer i agenturet
English: Transitional period ended.
Danish: Overgangsperioden afsluttet.
English: The Agency finalised 340 notifications of change.
Danish: Agenturet færdigbehandlede 340 anmeldelser af ændringer.
English: Further details on both procedures can be found in section 2.6.
Danish: Begge procedurer er nærmere omhandlet under punkt 2.6.
English: 1.3 A long-term strategy for the EMEA
Danish: 1.3 En langsigtet strategi for EMEA
English: The positive effects of such initiatives should become visible from 2005 onwards.
Danish: De positive virkninger af disse initiativer skulle blive mærkbare fra og med 2005.
English: The opinion of the scientific committee is transmitted to the European Commission.
Danish: Udtalelsen fra det videnskabelige udvalg fremsendes til Europa-Kommissionen.
English: • The Experts database, comprising more than 3 500 European experts, was upgraded.
Danish: • Databasen over eksperter, der omfatter over 3 500 europæiske eksperter, blev opgraderet.
English: Rules of procedure for individual SAGs will follow, based on this document.
Danish: Forretningsordenen for de enkelte SAG fastsættes på grundlag af dette dokument.
English: Cooperation with EFSA
Danish: Samarbejde med EFSA
English: • Implementation of an improved activity-based budgeting database and budgetary planning
Danish: • implementering af en forbedret aktivitetsbaseret budgetdatabase og budgetplanlægning
English: New responsibilities under the revised legislation
Danish: Nye opgaver i medfør af den reviderede lovgivning
English: The EMEA plays a role in both procedures:
Danish: EMEA spiller en rolle i dem begge:
English: PSURs FUM - SO
Danish: PSUR FUM - SO
English: Competing risk analysis P-value = 0.02
Danish: Konkurrerende risikoanalyse, P-værdi = 0.02
English: A provisional Audit Advisory Committee was established in September 2004 with a number of external and internal members.
Danish: Der blev i september 2004 nedsat et foreløbigt rådgivende revisionsudvalg med en række eksterne og interne medlemmer.
English: These and other documents are available:
Danish: Disse og andre dokumenter:
English: Ten Member States acted as reference Member State in these procedures, compared with 9 in 2003.
Danish: 10 medlemsstater fungerede som referencemedlemsstater i disse procedurer mod 9 i 2003.
English: The group also adopted and revised a number of documents on the management of procedures.
Danish: Gruppen vedtog og reviderede desuden flere dokumenter om forvaltningen af procedurerne.
English: No decision on formal extension of the transitional period has been taken
Danish: Der er ikke truffet beslutning om forlængelse af overgangsperioden
English: No guidelines released or adopted.
Danish: Ingen retningslinjer er sendt til høring eller vedtaget.
English: This is still under investigation to see if it is an isolated incident.
Danish: Produktet undersøges fortsat for at få afgjort, om der var tale om et isoleret tilfælde.
English: • Cancer (5 new products)
Danish: • cancer (5 nye produkter)
English: There were also regular bilateral meetings between the EMEA and the secretaries of various interested parties.
Danish: Der var desuden regelmæssige bilaterale møder mellem EMEA og sekretærerne for de forskellige interesserede parter.
English: The Executive Director answered questions of the Committee members during the annual hearing in November 2004.
Danish: Den administrerende direktør besvarede spørgsmål fra udvalgsmedlemmerne ved den årlige høring i november 2004.
English: The Committee elected five new members, who joined in September 2004.
Danish: Udvalget indvalgte fem nye medlemmer, som tiltrådte i september 2004.
English: IQM adviser:
Danish: IQM-rådgiver:
English: This was the first time that such dialogue had occurred for a veterinary scientific advice procedure.
Danish: Det var første gang, en sådan dialog fandt sted i forbindelse med en procedure for videnskabelig rådgivning om et veterinærlægemiddel.
English: Interested parties
Danish: Interesserede parter
English: Method transfer problems occur in particular when the description of testing procedures by the companies is not sufficiently detailed.
Danish: Problemer med metodeoverførsel opstår bl.a. når virksomhedernes beskrivelse af afprøvningsprocedurerne ikke er tilstrækkeligt detaljeret.
English: The database now totals approximately 5 000 records.
Danish: Databasen indeholder nu ca. 5 000 registreringer i alt.
English: Following this, the European Commission asked the CHMP to carry out a further review at Community level.
Danish: Derefter anmodede Europa-Kommissionen CHMP om at foretage en fornyet undersøgelse på EU-plan.
English: It is, therefore, quite fitting that it was also the year in which the European Agency for the Evaluation of Medicinal Products changed its name to the European Medicines Agency.
Danish: Det er derfor ganske passende, at det også var det år, Det Europæiske Agentur for Lægemiddelvurdering skiftede navn til Det Europæiske Lægemiddelagentur.
English: The remaining 10 reports are in the process of finalisation and expected by the end of April 2005.
Danish: De resterende 10 rapporter er under udarbejdelse og forventes at foreligge i slutningen af april 2005.
English: Two major safety reviews
Danish: To større sikkerhedsundersøgelser
English: Every Member State now has one member on the Board.
Danish: Hver medlemsstat har nu en repræsentant i bestyrelsen.
English: Following the approval of this long-term strategy in December 2004, the Agency s operations now and over the next few years will centre on its implementation.
Danish: Efter denne langsigtede strategi blev godkendt i december 2004, vil agenturets aktiviteter nu og i de kommende par år være centreret om dens gennemførelse.
English: By the end of 2004, almost 10 % of the total of 335 EMEA staff members were nationals of one of the 10 new Member States.
Danish: Ved udgangen af 2004 var næsten 10 % af de i alt 335 ansatte i EMEA statsborgere i en af de 10 nye medlemsstater.
English: The new version of the database was made available to all national competent authorities.
Danish: Den nye version af databasen blev stillet til rådighed for alle de nationale ansvarlige myndigheder.
English: Time (days)
Danish: Tid (dage)
English: This was due partly to the increased number of meetings and partly to the reimbursement of meeting expenses for representatives from the new Member States.
Danish: Det skyldtes til dels det stigende antal møder, dels godtgørelse af mødeudgifter for repræsentanter for de nye medlemsstater.
English: • Adopted 2005 work programme and budget totalling 110 160 000, together with an establishment plan requesting 379 temporary-agent posts for 2005
Danish: • vedtagelse af arbejdsprogrammet for 2005 og budgettet på i alt 110 160 000 EUR samt en personalefortegnelse, der opererer med 379 nye midlertidige stillinger i 2005.
English: Implementation of 3-tier architecture with appropriate security and interface to Internet services for internal and remote services
Danish: Implementering af 3-lags arkitektur med den fornødne sikkerhed og grænseflade til internettjenester til interne tjenester og fjerntjenester
English: • Security: security policies were proposed for adoption
Danish: • Sikkerhed: sikkerhedspolitikker blev indstillet til vedtagelse
English: The enlargement of the European Union made it necessary to implement the Specific Mechanism in the existing notification procedure.
Danish: EU's udvidelse gjorde det nødvendigt at indføre en såkaldt "særlig mekanisme" i den eksisterende anmeldelsesprocedure.
English: 1.7 Corporate governance - Integrated management system
Danish: 1.7 Virksomhedsledelse - Integreret styringssystem
English: The mandate and work plan for the new group were published.
Danish: Den nye gruppes mandat og arbejdsplan er nu offentliggjort.
English: The Czech Republic was the first of the new Member States to transmit data to EudraVigilance.
Danish: Tjekkiet var den første nye medlemsstat, der fremsendte data til EudraVigilance.
English: Personnel and budget
Danish: Personale og budget
English: 6 Support activities
Danish: 6 Støtteaktiviteter
English: This document was released for the purpose of transparency and has no legal force with respect to Directive 2001/83/EC.
Danish: Dokumentet blev offentliggjort af hensyn til åbenheden og har ingen retskraft i relation til direktiv 2001/83/EF.
English: Archiving and backup of data
Danish: Arkivering og backup af data
English: These changes should increase the process efficiency and lead to shorter timelines.
Danish: Disse ændringer skulle gøre processen mere effektiv og medføre kortere sagsbehandlingstider.
English: The Agency also contributes to, and participates in, a number of multilateral forums, and has close relations with a number of non-EU competent authorities.
Danish: Agenturet bidrager desuden til og deltager i en række multilaterale fora og har tætte relationer til flere ansvarlige myndigheder uden for EU.
English: The IT development team provided a new version of the Experts database in 2004
Danish: IT-udviklingsgruppen leverede en ny version af databasen over eksperter i 2004
English: The other sections of the guideline were reviewed in 2004 and it is expected that the European Commission will publish an amended version in the first quarter of 2005.
Danish: De resterende afsnit af vejledningen blev revideret i 2004, og Europa-Kommissionen forventes af offentliggøre en ændret udgave i første kvartal af 2005.
English: The annual report for inspection activities is given in Chapter 4.
Danish: Årsberetningen om inspektionsvirksomheden findes i kapitel i 4.
English: It provides for the extension of marketing authorisations granted by one Member State to one or more other Member States identified by the applicant.
Danish: Den giver mulighed for at udvide markedsføringstilladelser udstedt af en medlemsstat til at gælde i en eller flere andre medlemsstater udpeget af ansøgeren.
English: Existing healthcare databases in Member States should also be used for pharmacovigilance purposes.
Danish: De eksisterende databaser på sundhedsområdet i medlemsstaterne bør også udnyttes i forbindelse med lægemiddelovervågningen.
English: In this context, the EMEA signed a contract in order to be supplied with a 50-desk disaster static recovery suite.
Danish: I denne forbindelse undertegnede EMEA en kontrakt om levering af en "50-desk disaster static recovery suite".
English: VMRFG members met with interested parties from the animal health industry 5 times during 2004, in February, April, June, September and December.
Danish: Medlemmer af VMRFG mødtes med interesserede parter fra veterinærlægemiddelindustrien fem gange i løbet af 2004, henholdsvis i februar, april, juni, september og december.