natgillin/translations-raw huggingface dataset:
Nye data fra store kliniske undersøgelser tyder desuden på, at der er sammenhæng mellem blodets indhold af JC-virus-antistoffer ("antistofindeks") og risikoen for PML for patienter, der ikke har været i behandling med immundæmpende lægemidler (immunosuppressiva) før påbegyndelse af behandlingen med Tysabri. 
New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
London, den 19. marts 2008 Doc. 
London, 19 March 2008 Doc.
Dette forventes at være med til at forhindre beskadigelse af organerne. 
This is expected to help to prevent organ damage.
Det skulle leveres som kapsler. 
It was to be available as capsules.
Internationalt fællesnavn (INN): natriumeprodisat 
International non-proprietary name (INN): eprodisate sodium
Hvad er Kiacta? 
What is Kiacta?
Firmaet havde anmodet om, at den negative udtalelse blev taget op til fornyet overvejelse, men denne var endnu ikke afsluttet, da firmaet trak ansøgningen tilbage. 
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Det er en sjælden, livstruende sygdom, som opstår hos patienter med længerevarende betændelse, som oftest skyldes rheumatoid arthritis (leddegigt). 
This is a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
Virkningerne af Kiacta blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Kiacta were first tested in experimental models before being studied in humans.
Kiacta blev udpeget som lægemiddel til sjældne sygdomme den 31. juli 2001. 
Kiacta was designated an orphan medicinal product on 31 July 2001.
Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, hos hvem nyrefunktionen blev betydeligt forværret eller som døde i løbet af de to års behandling. 
The main measure of effectiveness was the number of patients whose kidney function got significantly worse or who died over two years of treatment.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Kiacta? 
What are the consequences of the withdrawal for patients in clinical trials with Kiacta?
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for KIACTA 
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for KIACTA
Selvom det blev antydet, at Kiacta muligvis er virksomt, konkluderede udvalget, at det var nødvendigt med en anden undersøgelse for at påvise lægemidlets virkning. 
Although there was a suggestion that Kiacta may be active, the Committee concluded that another study would be needed to demonstrate the medicine's effectiveness.
Kiacta er et lægemiddel, der indeholder det aktive stof dinatriumeprodisat. 
Kiacta is a medicine containing the active substance eprodisate disodium.
Den 13. marts 2008 meddelte Neurochem Luxco II SARL officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Kiacta til behandling af A- amyloidose (AA-amyloidose). 
On 13 March 2008, Neurochem Luxco II SARL officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kiacta for the treatment of amyloid A amyloidosis.
Virksomheden underrettede CHMP om, at den igangværende kliniske undersøgelse med Kiacta bliver afbrudt, så der kan udføres en anden undersøgelse for at sammenligne Kiacta med placebo. 
The company informed the CHMP that the ongoing clinical trial with Kiacta is being stopped, so that it can carry out a second study to compare Kiacta with placebo.
Hvad forventedes Kiacta anvendt til? 
What was Kiacta expected to be used for?
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Kiacta ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici. 
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Kiacta had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Kiacta til behandling af AA amyloidose. 
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Kiacta for the treatment of AA amyloidosis.
Efter en inspektion af stedet, hvor oplysningerne fra undersøgelsen var blevet analyseret, sætte udvalget spørgsmålstegn ved, om undersøgelsens resultater var pålidelige på grund af den måde analysen var blevet gennemført på. 
In addition, following an inspection of the site where the data from the study were analysed, the CHMP had concerns over the reliability of the study's findings because of the way the analysis was carried out.
Det aktive stof i Kiacta, dinatriumeprodisat, forventes at virke ved at påvirke dannelsen af AA-fibriller og dermed forhindre, at de aflejrer sig i organerne. 
The active substance in Kiacta, eprodisate disodium, is expected to work by interfering with the formation of fibrils of AA, preventing the deposits from building up in the organs.
Amyloid A-amyloidose skyldes, at der ophober sig uopløselige “fibriller” (fine tråde) af et protein kaldet ‘amyloid A' (AA) i kroppens organer. 
Amyloid A amyloidosis is caused by the build-up of insoluble ‘fibrils' (fine threads) of a protein called ‘amyloid A' (AA) in the organs of the body.
Hvordan forventes Kiacta at virke? 
How is Kiacta expected to work?
CHMP gav udtryk for betænkeligheder ved, at virkningen af Kiacta til behandling af AA-amyloidose ikke var blevet påvist i tilstrækkelig grad i den eneste hovedundersøgelse, som var blevet gennemført. 
The CHMP was concerned that the effectiveness of Kiacta in treating AA amyloidosis had not been demonstrated sufficiently in the single main study.
AA fremstilles i kroppen af et protein kaldet ‘serumamyloid A', der frigives af leverceller som reaktion på betændelse. 
AA is produced in the body from a protein called ‘serum amyloid A', which is released by liver cells in response to inflammation.
Kiacta forventedes anvendt til behandling af AA-amyloidose. 
Kiacta was expected to be used to treat amyloid A amyloidosis.
De alvorligste symptomer på sygdommen skyldes, at amyloid A aflejres i nyrerne og beskadiger dem. 
The most serious symptoms of the disease are caused by AA deposits building up in the kidneys and damaging them.
Kiactas virkning blev undersøgt i en hovedundersøgelse af 183 patienter med AA amyloidose. 
The effectiveness of Kiacta was studied in one main study involving 183 patients with AA amyloidosis, in which Kiacta was compared with placebo (a dummy treatment).
Pilisborosjenő 2097 Ungarn 
Pilisborosjenő 2097 Hungary
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE 
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Indehaver af markedsføringstilla delse 
Marketing Authorisation Holder
Der kan også være episoder med depression. 
They may also have episodes of depression.
Behandlingen må ikke vare længere end 12 uger. 
Treatment must not last longer than 12 weeks.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Aripiprazole Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR and risk management plan summary for Aripiprazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Til forebyggelse af maniske episoder hos voksne bør der fortsættes med samme dosis. 
To prevent manic episodes in adults, the same dose should be continued.
Aripiprazole Accord fås som tabletter (5, 10, 15 og 30 mg) og udleveres kun efter recept. 
Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aripiprazole Accord. 
This is a summary of the European public assessment report (EPAR) for Aripiprazole Accord.
Udvalget anbefalede, at Aripiprazole Accord godkendes til anvendelse i EU. 
The Committee recommended that Aripiprazole Accord be approved for use in the EU.
Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Accord anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible.
Det betyder, at Aripiprazole Accord svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Abilify. 
This means that Aripiprazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Virksomheden, der markedsfører Aripiprazole Accord, skal desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne, hvor det forklares, hvordan lægemidlet anvendes sikkert hos patienter mellem 13 og 17 år. 
In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Andre oplysninger om Aripiprazole Accord 
Other information about Aripiprazole Accord
Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Accord i kroppen. 
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Accord is broken down in the body.
Aripiprazol menes hovedsagelig at virke ved delvis stimulation (dvs. som en “partiel agonist”) af receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin). 
Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Hvilke fordele og risici er der forbundet med Aripiprazole Accord? 
What are the benefits and risks of Aripiprazole Accord?
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Aripiprazole Accord, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Aripiprazole Accord anvendes hos voksne til behandling af moderate til svære maniske episoder og forebyggelse af nye maniske episoder hos voksne, hos hvem lægemidlet tidligere har virket. 
Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aripiprazole Accord? 
What measures are being taken to ensure the safe and effective use of Aripiprazole Accord?
Det aktive stof i Aripiprazole Accord, aripiprazol, er et antipsykotisk lægemiddel. 
The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine.
• skizofreni, der er en psykisk sygdom, som giver forskellige symptomer, bl.a. i form af tanke- og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger. 
• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
• bipolar lidelse type I, en psykisk sygdom med skiftende episoder med abnormt højt humør (maniske episoder) og perioder med normalt humør. 
• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Abilify. 
Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Accord i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify.
Aripiprazole Accord aripiprazol 
Aripiprazole Accord aripiprazole
Det betyder, at aripiprazol aktiverer disse receptorer på samme måde som dopamin og 5-hydroxytryptamin, men ikke så kraftigt som neurotransmitterne. 
This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Aripiprazole Accord er et lægemiddel, der anvendes ved følgende psykiske sygdomme: 
Aripiprazole Accord is a medicine used in patients with the following mental illnesses:
Hvis du ønsker yderligere oplysninger om behandling med Aripiprazole Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Aripiprazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Da Aripiprazole Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
Because Aripiprazole Accord 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.
Aripiprazole Accord anvendes til patienter over 15 år 
Aripiprazole Accord is used in patients aged 15 years or over;
Det er ikke en praktisk vejledning i, hvordan Aripiprazole Accord bør anvendes. 
It is not intended to provide practical advice on how to use Aripiprazole Accord.
Hvad er Aripiprazole Accord, og hvad anvendes det til? 
What is Aripiprazole Accord and what is it used for?
Da Aripiprazole Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Abilify. 
Because Aripiprazole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Ved skizofreni er den anbefalede startdosis til voksne 10 eller 15 mg dagligt, efterfulgt af en vedligeholdelsesdosis på 15 mg én gang dagligt. 
For schizophrenia, the recommended starting dose is 10 or 15 mg per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR. 
For further information, see the Summary of Product Characteristics (also part of the EPAR).
Aripiprazole Accord anvendes desuden hos patienter over 13 år til behandling af moderate til svære maniske episoder i op til 12 uger 
Aripiprazole Accord is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Hvis du ønsker praktisk vejledning om anvendelsen af Aripiprazole Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Aripiprazole Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Hvorfor blev Aripiprazole Accord godkendt? 
Why is Aripiprazole Accord approved?
Til behandling af maniske episoder ved bipolar sygdom er den anbefalede startdosis til voksne 15 mg én gang dagligt. 
For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg once a day, either on its own or in combination with other medicines.
Til patienter mellem 15 og 17 år er startdosis 2 mg dagligt (hertil bruges et aripiprazol-produkt, der fås i flydende form). 
In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Aripiprazol bevirker derfor, at hjerneaktiviteten bliver mere normal, så de psykotiske eller maniske symptomer mindskes og ikke kommer igen. 
Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Til behandling af maniske episoder hos patienter mellem 13 og 17 år er startdosis 2 mg dagligt (hertil bruges et aripiprazol-produkt i flydende form). 
For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Aripiprazole Accord er et "generisk lægemiddel". 
Aripiprazole Accord contains the active substance aripiprazole and is a ‘generic medicine'.
Hvordan blev Aripiprazole Accord undersøgt? 
How has Aripiprazole Accord been studied?
Hvordan anvendes Aripiprazole Accord? 
How is Aripiprazole Accord used?
Hvordan virker Aripiprazole Accord? 
How does Aripiprazole Accord work?
Remicade fik en markedsføringstilladelse med gyldighed i hele EU den 13. august 1999. 
Remicade received a marketing authorisation valid throughout the EU on 13 August 1999.
Andre oplysninger om Remicade 
Other information about Remicade
Det anvendes, når andre lægemidler eller behandlinger har slået fejl, til voksne med følgende sygdomme: 
It is usually used when other medicines or treatments have failed, in adults with the following diseases:
Yderligere information om Remicade findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Remicade. 
Further information on Remicade can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Remicade.
Som for alle lægemidler, er data vedrørende brug af Remicade løbende overvåget. 
As for all medicines, data on the use of Remicade are continuously monitored.
Remicade alene og i kombination med azathioprin var mere effektivt end azathioprin alene. 
Remicade alone and in combination with azathioprine was more effective than azathioprine alone.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Remicade? 
What measures are being taken to ensure the safe and effective use of Remicade?
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Remicade opvejer risiciene, og det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Remicade's benefits are greater than its risks and it can be authorised for use in the EU.
Patienter, der får Remicade, skal have udleveret et særligt påmindelseskort. 
Patients who receive Remicade must be given a special reminder card.
En oversigt over Remicade, og hvorfor det er godkendt i EU 
An overview of Remicade and why it is authorised in the EU
Remicade indeholder det aktive stof infliximab. 
Remicade contains the active substance infliximab.
Bivirkninger rapporteret for Remicade vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Remicade are carefully evaluated and any necessary action taken to protect patients.
Virkningen af at tilføje Remicade til den eksisterende behandling er desuden blevet undersøgt hos 103 børn og unge med Crohns sygdom i alderen 6-17 år. 
The effects of adding Remicade to existing treatment have also been studied in 103 children and adolescents with Crohn's disease who were aged between 6 and 17 years.
For mere information om brug af Remicade, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Remicade, see the package leaflet or contact your doctor or pharmacist.
I et studie med 60 børn i alderen 6-17 år med colitis ulcerosa havde 73 % af patienterne reageret på behandlingen med Remicade i uge 8 (44 ud af 60). 
In a study with 60 children aged between 6 and 17 years with ulcerative colitis 73% of patients responded to treatment with Remicade at week eight (44 out of 60).
Remicade gives som en infusion, der varer 1-2 timer. 
Remicade is given as an infusion lasting one or two hours.
Et sjette studie med 508 voksne patienter så nærmere på antallet af patienter, hvis symptomer blev bedre, og som ikke havde behov for tillægsbehandling med kortikosteroider (andre lægemidler til behandling af Crohns sygdom). 
A sixth study in 508 adult patients looked at the number of patients whose symptoms improved and who did not need additional treatment with corticosteroids (other medicines used in Crohn's disease).
Patienterne blev behandlet i seks måneder med Remicade, et andet lægemiddel (azathioprin), eller en kombination af Remicade og azathioprin. 
The patients were treated for 6 months with Remicade, another medicine azathioprine, or the combination of Remicade and azathioprine.
Hvorfor blev Remicade godkendt i EU? 
Why is Remicade authorised in the EU?
For at mindske risikoen for bivirkninger ved infusionen kan patienterne få andre lægemidler før eller under behandlingen med Remicade, eller infusionen kan gives over længere tid. 
To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remicade or the infusion time may be slowed down.
Til de andre sygdomme er dosis 5 mg/kg legemsvægt. 
The dose is 5 mg per kilogram for the other diseases.
Ved leddegigtanvendes Remicade sædvanligvis i en dosis på 3 mg/kg legemsvægt, dog kan dosis om nødvendigt øges. 
Remicade is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Remicade anvendes desuden hos patienter mellem 6 og 17 år med svær, aktiv Crohns sygdom eller svær, aktiv ulcerøs kolitis, når andre lægemidler eller behandlinger ikke virker eller ikke kan anvendes. 
Remicade is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Colitis ulcerosa, ankyloserende spondylitis og psoriasisgigt For colitis ulcerosa (728 voksne), ankyloserende spondylitis (70 voksne) and psoriasisgigt (104 voksne) blev Remicade sammenlignet med placebo. 
Ulcerative colitis, ankylosing spondylitis and psoriatic arthritis For ulcerative colitis (728 adults), ankylosing spondylitis (70 adults) and psoriatic arthritis (104 adults), Remicade has been compared with placebo.
Hvilke risici er der forbundet med Remicade? 
What are the risks associated with Remicade?
Remicade er blevet undersøgt hos 1 432 patienter med leddegigt i to studier. 
Remicade has been studied in a total of 1,432 patients with rheumatoid arthritis in two studies.
Remicade må ikke anvendes til patienter med tuberkulose, andre svære infektioner eller moderat til svær hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen). 
Remicade must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).