FrancophonIA/ELRC3.0 huggingface dataset:
English: What were the CHMP's main concerns that led to the refusal
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om markedsføringstilladelse?
English: The effects of Zeftera were first tested in experimental models before being studie The company presented results of two main studies involving adults with complicated ski tissue infections.
Danish: Virkningerne af Zeftera blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: or infusion (drip into a vein).
Danish: Zeftera er et pulver, der anvendes til at fremstille en infusionsvæske, opløsning (drop i en vene).
English: These subsequent inspections showed that the studies had not been conducted in ‘good clinical practice' (GCP) in some beneficial to patients, the CHMP was concerned about how reliable the results were.
Danish: Efterfølgende inspektioner viste, at undersøgelserne på visse lokaliteter ikke var blevet gennemført i overensstemmelse med "god klinisk praksis" (GCP).
English: In November 2008, the CHMP gave a positive opinion on Zeftera, recomm marketing authorisatio study sites by the Food and Drug Administration (FDA) in the United States of A concerns over the way the main clinical studies were conducted.
Danish: I november 2008 gav CHMP en positiv udtalelse om Zeftera med anbefaling om udstedelse af markedsføringstilladelse.
English: Although the study results suggested that the medicine was ttee e medicine should
Danish: Selv om undersøgelsesresultaterne tydede på, at lægemidlet var gavnligt for patienterne, havde CHMP betænkeligheder ved resultaternes pålidelighed.
English: t may request a the opinion within 15 days of receipt of notification of this negative opinion.
Danish: Ansøgeren anmodede om en revurdering af udtalelsen.
English: The Committee therefore that the European Commission stop the authorisation process for the medicine wh inspections were carried out.
Danish: Udvalget modtog imidlertid efterfølgende oplysning om en inspektion af undersøgelseslokaliteterne ved det amerikanske Food and Drug Administration (FDA), som førte til, at CHMP afbrød godkendelsesprocessen for lægemidlet.
English: Zeftera is a powder that is made up into a solution f substance ceftobiprole.
Danish: Det indeholder det aktive stof ceftobiprol.
English: ending that it be granted n. However, the Committee later received information about an inspection of merica that identified requested ile further compliance with sites.
Danish: Under revurderingen undersøgte CHMP yderligere analyser af dataene fra undersøgelserne og inspektionerne.
English: The oral solution may be mixed in a glass of water before it is taken.
Danish: Den orale opløsning kan blandes i et glas vand, før den indtages.
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Danish: Sekundær generalisering forekommer, når denne overaktivitet senere når ud til hele hjernen.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Danish: Det er den type epilepsi, hvor en for stor elektrisk aktivitet i den ene side af hjernen medfører symptomer som pludselige stødvise bevægelser i den ene side af kroppen, forvrænget hørelse, lugtesans eller syn, følelsesløshed eller pludselig frygt.
English: Lower doses are used in patients who have problems with their kidneys (such as older patients).
Danish: Lavere doser anvendes til patienter, som har problemer med nyrerne (f.eks. ældre patienter).
English: The full EPAR for Levetiracetam ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Levetiracetam ratiopharm findes på EMA's websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Danish: Det er stadig uklart, hvordan levetiracetam præcis virker, men det synes at interferere med et protein kaldet synaptisk vesikel-protein 2A, som findes i mellemrummene mellem nerverne og er involveret i frigivelse af kemiske signalstoffer fra nervecellerne.
English: Epilepsy is caused by excessive electrical activity in the brain.
Danish: Epilepsi skyldes for stor elektrisk aktivitet i hjernen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam ratiopharm.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Levetiracetam ratiopharm.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam ratiopharm on 26 August 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam ratiopharm den 26. august 2011.
English: • partial-onset seizures with or without generalisation in patients from one month of age;
Danish: • Partiel epilepsi med eller uden generalisering hos patienter over 1 måned
English: It is available as oblong tablets (250 mg, 500 mg, 750 mg and 1000 mg) and as an oral solution (100 mg/ml).
Danish: Det fås som aflange tabletter (250 mg, 500 mg, 750 mg og 1 000 mg) og som oral opløsning (100 mg/ml).
English: The oral solution is recommended when starting treatment in children under six years old or weighing less than 25 kg.
Danish: Den orale opløsning anbefales, når behandling startes hos børn under seks år eller børn, som vejer under 25 kg.
English: For more information about treatment with Levetiracetam ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levetiracetam ratiopharm, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This helps Levetiracetam ratiopharm to stabilise electrical activity in the brain and prevent seizures.
Danish: Det er med til at bevirke, at Levetiracetam ratiopharm kan stabilisere den elektriske aktivitet i hjernen og forhindre anfald.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam ratiopharm.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam ratiopharm.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Danish: • primært generaliserede tonisk-kloniske anfald (alvorlige krampeanfald med bevidstløshed) hos patienter over 12 år med idiopatisk generaliseret epilepsi (den type epilepsi, som menes at have en genetisk årsag).
English: Levetiracetam ratiopharm can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Danish: Levetiracetam ratiopharm kan anvendes alene til patienter over 16 år, som for nylig har fået stillet diagnosen epilepsi, til at behandle partiel epilepsi med eller uden sekundær generalisering.
English: Levetiracetam ratiopharm can also be used as an add-on to other anti-epileptic medicines to treat:
Danish: Levetiracetam ratiopharm kan også anvendes som tillægsbehandling til andre lægemidler mod epilepsi til at behandle:
English: This means that Levetiracetam ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Levetiracetam ratiopharm ligner et referencelægemiddel, som allerede er godkendt i EU, nemlig Keppra.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam ratiopharm has been shown to have comparable quality and to be bioequivalent to Keppra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Levetiracetam ratiopharms kvalitet svarer til Keppra og er bioækvivalent med Keppra.
English: Because Levetiracetam ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Eftersom Levetiracetam ratiopharm er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses fordele og risici for at være de samme som for referencelægemidlet.
English: Because Levetiracetam ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Danish: Eftersom Levetiracetam ratiopharm er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet, Keppra.
English: This can be increased up to 21 mg/kg twice a day.
Danish: Dosis kan øges til op til 21 mg/kg to gange dagligt.
English: The Committee recommended that Levetiracetam ratiopharm be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Levetiracetam ratiopharm.
English: In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Danish: Hos spædbørn på 1-6 måneder er startdosis 7 mg/kg to gange dagligt med den orale opløsning.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Keppra.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Danish: • myoklone anfald (korte, stødlignende bevægelser af en muskel eller muskelgruppe) hos patienter over 12 år med juvenil myoklon epilepsi
English: When Levetiracetam ratiopharm is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Levetiracetam ratiopharm anvendes som tillægsbehandling til en anden epilepsibehandling, er startdosis hos patienter over 12 år, og som vejer mere end 50 kg, 500 mg to gange dagligt.
English: When Levetiracetam ratiopharm is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Levetiracetam ratiopharm anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: The daily dose can be increased up to 1500 mg twice a day.
Danish: Den daglige dosis kan øges til op til 1 500 mg to gange dagligt.
English: Levetiracetam ratiopharm tablets are swallowed with liquid.
Danish: Levetiracetam ratiopharm-tabletter synkes med væske.
English: Levetiracetam ratiopharm is a medicine that contains the active substance levetiracetam.
Danish: Levetiracetam ratiopharm er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: Other information about Levetiracetam ratiopharm
Danish: Andre oplysninger om Levetiracetam ratiopharm:
English: The active substance in Levetiracetam ratiopharm, levetiracetam, is an anti-epileptic medicine.
Danish: Det aktive stof i levetiracetam ratiopharm, levetiracetam, er et lægemiddel mod epilepsi.
English: What are the benefits and risks of Levetiracetam ratiopharm?
Danish: Hvilken fordel og risiko er der forbundet med Levetiracetam ratiopharm?
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1500 mg twice a day.
Danish: Dosis kan alt efter patientens respons sættes yderligere op hver anden uge til en maksimal dosis på 1 500 mg to gange dagligt.
English: Levetiracetam ratiopharm is a ‘generic medicine'.
Danish: Levetiracetam ratiopharm er et generisk lægemiddel.
English: Why has Levetiracetam ratiopharm been approved?
Danish: Hvorfor blev Levetiracetam ratiopharm godkendt?
English: How has Levetiracetam ratiopharm been studied?
Danish: Hvordan blev Levetiracetam ratiopharm undersøgt?
English: What is Levetiracetam ratiopharm used for?
Danish: Hvad anvendes Levetiracetam ratiopharm til?
English: How is Levetiracetam ratiopharm used?
Danish: Hvordan anvendes Levetiracetam ratiopharm?
English: What is Levetiracetam ratiopharm?
Danish: Hvad er Levetiracetam ratiopharm?
English: This commitment is reflected in the Agency's work programme and budget.
Danish: Denne indsats er afspejlet i agenturets arbejdsprogram og budget.
English: It is expected that the latter two pieces of legislation will come into effect during 2009.
Danish: Det forventes, at de sidste to retsakter vil træde i kraft i løbet af 2009.
English: 1 Benchmarking of European medicines agencies (BEMA).
Danish: 1 Benchmarking af europæiske lægemiddelagenturer (BEMA).
English: Safety-monitoring of medicines is an area that is continuously being scrutinised, developed and strengthened.
Danish: Sikkerhedsovervågning af lægemidler er et område, der løbende vurderes nøje, udvikles og styrkes.
English: As a result, the Agency has grown into a complex organisation that is heavily dependent on effective and efficient information and communication technologies.
Danish: Dermed er agenturet vokset til en kompleks organisation, der er stærkt afhængig af effektive informations- og kommunikationsteknologier.
English: This work is being carried out both in internal fora and within the framework of the Innovative Medicines Initiative.
Danish: Dette arbejde udføres både i interne fora og inden for rammerne af initiativet om innovative lægemidler.
English: This will constitute a significant part of the Agency's contribution to the new Community Animal Health Strategy, ‘Prevention is better than cure'.
Danish: Dette vil udgøre en væsentlig del af agenturets bidrag til Fællesskabets dyresundhedsstrategi, som har titlen “Det er bedre at forebygge end at helbrede”.
English: As can be seen from this work programme, activities in the field of recently implemented legislation on paediatric medicines remain complex and dynamic.
Danish: Som det fremgår af dette arbejdsprogram, er aktiviteterne i forbindelse med nylig gennemført lovgivning om pædiatriske lægemidler fortsat dynamiske og komplekse.
English: The Agency has been implementing various new parts of the pharmaceutical legislation over the course of a number of years.
Danish: Agenturet har gennemført mange nye dele af lægemiddellovgivningen over de sidste år.
English: Both initiatives attempt to improve medicinal product development processes and, therefore, are of importance to the Agency.
Danish: Begge initiativer har til formål at forbedre processerne for udvikling af lægemidler og har derfor betydning for agenturet.
English: The Agency will continue to focus on further streamlining these activities, including the development of a paediatric research network.
Danish: Agenturet vil fortsat fokusere på at strømline disse aktiviteter yderligere, herunder udviklingen af et pædiatrisk forskningsnetværk.
English: In addition, the year 2008 saw some quality issues with products whose active ingredients were manufactured outside the EU.
Danish: I 2008 opstod der endvidere en række kvalitetsproblemer med lægemidler indeholdende aktive stoffer, som var fremstillet uden for EU.
English: The EMEA has prepared for the creation of a new scientific committee - the Committee for Advanced Therapies - that will become fully operational in 2009.
Danish: EMEA har oprettet et nyt videnskabeligt udvalg - Udvalget for avancerede terapier - som bliver fuldt operationelt i 2009.
English: The Agency has been, and will continue to be, heavily involved in activities that support innovation and improve availability of medicines.
Danish: Agenturet har og vil fortsat være stærkt engageret i aktiviteter, som fremmer innovation og forbedrer udbuddet af lægemidler.
English: The Agency's priorities have been set considering these and other factors affecting the Agency in 2009, and will centre around:
Danish: Agenturets prioriteter er blevet fastlagt på grundlag af disse og andre faktorer, som vil påvirke agenturet i 2009, og de centrerer sig om:
English: The EMEA remains committed to improving the availability of veterinary medicines, and will focus its efforts in three major areas to achieve this.
Danish: EMEA arbejder fortsat på at forbedre udbuddet af veterinærmedicinske lægemidler og vil koncentrere sin indsats på tre vigtige områder for at nå dette mål.
English: Continuous fostering and developing of the scientific capacity of the network is therefore the EMEA's perennial objective.
Danish: Løbende fremme og udvikling af netværkenes videnskabelige kapacitet er derfor EMEA's til enhver tid gældende målsætning.
English: This year, the Agency will further support collaboration within the network and benchmarking activities (BEMA1), and will provide input into efforts aimed at strengthening the capacity of the network.
Danish: I år vil agenturet yderligere støtte samarbejdet om netværket og benchmarkingaktiviteterne (BEMA1) og bidrage til at styrke netværkets kapacitet.
English: Some of these objectives include improving the planning of scientific resources, progressing initiatives in the field of training and competence development, and assuring effective communication within the network.
Danish: Visse af disse målsætninger omfatter forbedring af planlægningen af de videnskabelige ressourcer, initiativer til fremskridt på området uddannelse og udvikling af kompetencer samt sikring af effektiv kommunikation i netværket.
English: Additionally, following internal preparatory work and consultation, the EMEA will adjust its organisational structure to enable the Agency to deliver on its mission in a more effective and efficient way.
Danish: Derudover vil EMEA efter interne forberedelser og rådføring tilpasse sin organisationsstruktur, så agenturet kan udføre sin opgave mere effektivt.
English: The Agency's work programme is shaped by a number of trends, scientific, political and other developments that will dominate the Agency's environment in 2009.
Danish: Agenturets arbejdsprogram er udarbejdet på baggrund af en række tendenser og udviklinger inden for videnskabelige, politiske og øvrige områder, som vil være dominerende på agenturets arbejdsområde i 2009.
English: As a result, the Agency will re-launch its website towards the end of 2009, and will begin work to ensure that all public-facing websites managed by the Agency are easy to use and access by external stakeholders.
Danish: Agenturet vil derfor lancere en ny udgave af sit websted i slutningen af 2009 og starter derfor med at sikre, at alle de websider, som henvender sig til offentligheden og administreres af agenturet, er lette at anvende og lette at få adgang til for de eksterne aktører.
English: At the same time, the EMEA has been allocating a significant part of its IT development and maintenance resources to the development and support of the EU Telematics systems.
Danish: Samtidig har EMEA afsat en væsentlig del af sine it-udviklings- og vedligeholdelsesressourcer til udvikling og bistand i forbindelse med EU's telematiksystemer.
English: This will have an effect on the workload in the field of inspections, both for the EMEA and for the national competent authorities, and will add a new dimension to the EMEA's international commitments.
Danish: Dette vil påvirke inspektionsarbejdets omfang for både EMEA og de nationale kompetente myndigheder, og det vil give EMEA's internationale forpligtelser en ny dimension.
English: The results of various process-improvement initiatives, process analyses and staff surveys show that it is now time for the Agency to refocus some of its IT resources on improving corporate information systems as a step towards a fully electronic working environment.
Danish: Resultaterne af en række procesforbedringsinitiativer, procesanalyser og undersøgelser blandt medarbejderstaben viser, at tiden er kommet for agenturet til at anvende en del af sine it-ressourcer på virksomhedsinformationssystemerne som et skridt hen mod et fuldt elektronisk arbejdsmiljø.
English: Preparatory work has been undertaken in 2008, and the Agency should be in a position to start commissioning pharmacoepidemiological studies in 2009.
Danish: Det forberedende arbejde fandt sted i 2008, og det skulle være muligt for agenturet at begynde at afgive bestillinger på lægemiddelepidemiologiske undersøgelser i 2009.
English: The Agency operates in a global regulatory environment that is characterised, among other trends, by an increasing number of clinical trials conducted in countries where it is perceived that the application of good clinical practice does not yet have traditions as well established as those in the European Union, the US and other developed countries.
Danish: Agenturet arbejder inden for en global lovgivningsramme, der bl.a. er kendetegnet ved tendenser som et stigende antal kliniske undersøgelser i lande, hvor anvendelsen af god klinisk praksis endnu ikke synes at være så veletableret som i landene i Den Europæiske Union, i USA og andre udviklede lande.
English: The Agency will coordinate the activities of its scientific committees with those of the network, to ensure the production of sound, scientific risk assessments that take into account the use of antibiotics in both man and animals.
Danish: Agenturet vil koordinere aktiviteterne i dets videnskabelige udvalg med aktiviteterne i netværket for at sikre, at der udarbejdes solide, videnskabelige risikovurderinger, som både tager højde for anvendelse af antibiotika til mennesker og til dyr.
English: In the field of innovation, the EMEA will dedicate its efforts and resources to the work of the Innovative Medicines Initiative and the European Technology Platform for Global Animal Health.
Danish: Inden for innovation vil EMEA rette sin indsats og sine ressourcer mod arbejdet med initiativet om innovative lægemidler og den europæiske teknologiplatform for global dyresundhed.
English: The European medicines network is vital to the Agency's ability to deliver on its public-health mission and objectives.
Danish: Det europæiske lægemiddelnetværk er en forudsætning for, at agenturet kan udføre sin opgave og nå sine mål på folkesundhedsområdet.
English: As scientists from European and other countries work in the area of biomarkers, translational medicine and nanotechnologies, the EMEA will provide scientific input into these novel fields of medicinal product development.
Danish: Da videnskabsfolk fra lande både i og uden for Europa arbejder med biomarkører, translationel medicin og nanoteknologier, vil EMEA komme med videnskabelige input på disse nye områder inden for udvikling af lægemidler.
English: First, the Agency will work with stakeholders to promote and facilitate authorisation through the centralised procedure of vaccines against major epizootic diseases of animals, particularly avian influenza, bluetongue and foot-and-mouth disease.
Danish: Først og fremmest vil agenturet samarbejde med aktørerne om at fremme og lette godkendelsen via den centrale procedure af vacciner mod alvorlige epizootier, navnlig fugleinfluenza, bluetongue og mundog klovsyge.
English: The Agency is experiencing continuing growth in the volume of work across various areas of its activities, including scientific advice, medicines for paediatric use, authorisation of vaccines against epidemic diseases of animals, transparency and international commitments, to name but a few.
Danish: Agenturet oplever en støt stigende arbejdsmængde på mange af sine arbejdsområder, herunder videnskabelig rådgivning, pædiatriske lægemidler, godkendelse af vacciner mod epidemiske sygdomme hos dyr, gennemsigtighed og internationale forpligtelser, blot for at nævne nogle få.