natgillin/translations-raw huggingface dataset:
De hyppigste bivirkninger ved Zonegran (som optræder hos flere end 1 ud af 10 patienter) er appetitløshed, uro, irritabilitet, omtågethed, depression, ataksi (forstyrrelse i koordineringen af muskelbevægelserne), svimmelhed, hukommelsessvækkelse, somnolens (søvnighed), diplopi (dobbeltsyn) og mindsket indhold af bikarbonat i blodet. 
The most common side effects with Zonegran (seen in more than 1 patient in 10) are loss of appetite, agitation, irritability, confusion, depression, ataxia (an inability to co-ordinate muscle movements), dizziness, memory impairment, somnolence (sleepiness), diplopia (double vision) and decreased blood bicarbonate levels; although the safety profile is similar in children and adults, some side effects are reported more frequently in children than in adults.
Efter en uge kan dosis sættes op til 50 mg to gange dagligt og derefter yderligere sættes op 100 mg ad gangen hver uge, afhængigt af patientens respons. 
After one week the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week, depending on the patient's response.
Af patienterne på carbamazepin var 74,7 % anfaldsfrie i seks måneder. 
The percentage of patients on carbamazepine who were seizure-free for six months was 74.7%.
Zonegran anvendes til behandling af patienter med partielle anfald (epileptiske anfald, der udløses i en del af hjernen), herunder patienter med sekundær generalisering (dvs. anfald, der efterfølgende breder sig til hele hjernen). 
Zonegran is used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Hos børn blev antallet af anfald mindst halveret hos 50 % af de patienter, der fik Zonegran, sammenlignet med 31 % hos dem, der fik placebo. 
In children, the number of seizures was at least halved in 50% of the patients taking Zonegran, compared with 31% of those taking placebo.
Hvilken risiko er der forbundet med Zonegran? 
What is the risk associated with Zonegran?
Hvorfor blev Zonegran godkendt? 
Why has Zonegran been approved?
Zonegran må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for zonisamid, over for andre af indholdsstofferne eller over for sulfonamider (såsom visse antibiotika). 
Zonegran must not be used in people who are hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Efter én eller to uger kan den daglige dosis gradvist øges med 1 mg pr. kg legemsvægt hver uge eller hver anden uge, indtil en egnet dosis er nået. 
After one or two weeks, the daily dose may be increased in steps of 1 mg per kg every one or two weeks until an appropriate dose is reached.
Der er forekommet alvorligt udslæt hos patienter, som fik Zonegran, herunder tilfælde af Stevens-Johnsons syndrom (en svær, livstruende allergisk hud- og slimhindereaktion). 
Severe rashes have occurred in patients taking Zonegran, including cases of Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction affecting the skin and mucous membranes).
Hyppigheden af anfald hos voksne, der fik 500 mg Zonegran dagligt, faldt i gennemsnit med 51 % sammenholdt med 16 % hos dem, der fik placebo. 
Adults taking 500 mg Zonegran per day had an average reduction in seizure frequency of 51%, compared with 16% in those taking placebo.
Hvad er Zonegran? 
What is Zonegran?
I voksenundersøgelsen var det primære effektmål ændringen i hyppigheden af partielle anfald i tidsrummet fra de 12 uger før behandlingens start til den 18-ugers periode, hvor patienterne fik en fast dosis. 
In the study involving adults, the main measure of effectiveness was the change in the frequency of partial seizures between the 12 weeks before treatment started and the 18-week period when a stable dose was used.
Den fuldstændige liste over indberettede bivirkninger ved Zonegran fremgår af indlægssedlen. 
For the full list of all side effects reported with Zonegran, see the package leaflet.
Når Zonegran anvendes som tillægsbehandling til voksne, der allerede er under behandling, er den anbefalede startdosis 25 mg to gange dagligt. 
When Zonegran is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
I børneundersøgelsen var det primære effektmål andelen af patienter, der som minimum oplevede et halvering i antallet af anfald i tidsrummet fra de otte uger før behandlingens start til den 12-ugers periode, hvor patienterne fik en fast dosis. 
In the study in children, the main measure of effectiveness was the proportion of patients in whom the number of seizures was at least halved between the 8 weeks before treatment started and the 12-week period when a stable dose was used.
Hvilken fordel viser undersøgelserne, at der er ved Zonegran? 
What benefit has Zonegran shown during the studies?
Når Zonegran anvendes alene hos nydiagnosticerede voksne, er den anbefalede startdosis 100 mg én gang dagligt i to uger. 
When Zonegran is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Når der er nået en egnet dosis, kan Zonegran gives én eller to gange dagligt. 
Zonegran can be given once or twice a day after an appropriate dose is reached.
Hvordan blev Zonegran undersøgt? 
How has Zonegran been studied?
Zonegran virker desuden på signalstoffet gammaaminosmørsyre (GABA, et kemisk stof, der anvendes af nervecellerne i deres indbyrdes kommunikation). 
This reduces the chances of an epileptic fit. Zonegran also acts on the neurotransmitter gamma-aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Hvad anvendes Zonegran til? 
What is Zonegran used for?
Hvordan anvendes Zonegran? 
How is Zonegran used?
Når Zonegran anvendes som tillægsbehandling til børn fra seksårsalderen, der allerede er under behandling, afhænger dosis af legemsvægten. 
When Zonegran is used as an ‘add-on' to existing treatment in children aged 6 years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Hvordan virker Zonegran? 
How does Zonegran work?
Den 17. november 2011 
17 November 2011
Hvordan forventes de at virke? 
How are they expected to work?
Hvad forventedes lægemidlerne anvendt til? 
What were the medicines expected to be used for?
Virksomheden, der har indgivet ansøgningen, er Eli Lilly. 
The company that applied for the change to the authorisation is Eli Lilly.
Den fuldstændige europæiske offentlige vurderingsrapport for Ariclaim, Cymbalta og Xeristar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full European Public Assessment Report for Ariclaim, Cymbalta and Xeristar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
De omfatter ikke smerter fra indre organer som f.eks. mave og tarm. 
It does not include pain from internal organs such as the stomach and intestines.
Der var ligeledes ikke tilstrækkelig dokumentation for, at virkningen kunne opretholdes med tiden, som det er vigtigt ved langvarig sygdom. 
There was also insufficient evidence that its effect could be maintained over time, which is important when treating a long-term condition.
Der bliver ingen konsekvenser for anvendelsen af disse lægemidler til de godkendte indikationer, for hvilke der ikke er sket nogen ændring i benefit/risk-forholdet. 
There are no consequences on the use of these medicines in their approved indications, for which the balance of benefits and risks remains unchanged.
Hvilken dokumentation fremlagde virksomheden til støtte for ansøgningen? 
What did the company present to support its application?
Lægemidlerne forventes at virke på samme måde som de gør ved diabetisk perifer neuropati. 
The medicines are expected to work in the same way they do in diabetic peripheral neuropathy.
Desuden var der brug for flere oplysninger om duloxetins virkninger hos ældre patienter og dets sikkerhed ved anvendelse hos den tilsigtede patientgruppe, herunder ældre. 
In addition, more information was needed on the effects of duloxetine in elderly patients and its safety in the intended patients including the elderly.
CHMP konstaterede, at undersøgelserne ikke havde bevist, at duloxetin ville have en relevant fordel ved den ansøgte indikation. 
The CHMP noted that the studies had not proven that duloxetine would provide a relevant benefit in the indication applied for.
Udvalget konkluderede imidlertid, at dets betænkeligheder fortsat ikke var tilstrækkeligt imødekommet, og fastholdt sin oprindelige negative udtalelse, som anbefalede afslag på ansøgningen om ændring af markedsføringstilladelserne. 
The Committee concluded however that its concerns had still not been adequately addressed and confirmed its initial negative opinion recommending the refusal of a change to the marketing authorisations.
Somatiske smerter er smerter fra krop pens overflader (f.eks. huden) eller fra muskuloskeletalt væv (skeletmuskler, knogler og led). 
Somatic pain is from the body surfaces (such as skin) or musculoskeletal tissues (such as skeletal muscles, bone and joints).
Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om ændring af markedsføringstilladelserne? 
What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisations?
Dette blev af patienterne registreret på en 11-punkts skala efter 12 eller 13 ugers behandling. 
The main measure of effectiveness was the change in the severity of pain, as recorded by the patients on an 11-point scale after 12 or 13 weeks of treatment.
Det virker ved at forhindre, at neurotransmitterne 5-hydroxytryptamin (der også kaldes serotonin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven. 
It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Ariclaim, Cymbalta og Xeristar er lægemidler, der indeholder det aktive stof duloxetin. 
Ariclaim, Cymbalta and Xeristar are medicines containing the active substance duloxetine.
De leveres som enterokapsler. 
They are available as gastroresistant capsules.
Den 28. juli 2011 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om ændring af markedsføringstilladelsen for lægemidlerne Ariclaim, Cymbalta og Xeristar, der indeholder duloxetin. 
On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Virksomheden meddelte CHMP, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser med Ariclaim, Cymbalta eller Xeristar hos patienter med kroniske somatiske smerter i Europa. 
The company informed the CHMP that there are currently no ongoing clinical trials with Ariclaim, Cymbalta and Xeristar in chronic somatic pain patients in Europe.
Virksomheden fremlagde resultater af fem hovedundersøgelser, der omfatter 839 patienter med kroniske somatiske smerter: To undersøgelser hos patienter med knæsmerter ved slidgigt (hævelse og smerter i leddene) og tre undersøgelser hos patienter med kroniske lændesmerter. 
The company presented results of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in patients with chronic low back pain.
Hvad er Ariclaim, Cymbalta and Xeristar? 
What are Ariclaim, Cymbalta and Xeristar?
Patienterne i undersøgelserne blev behandlet med duloxetin eller placebo (virkningsløs behandling), og hos nogle af patienterne blev behandlingen kombineret med NSAID. 
Patients in the studies were treated with duloxetine or placebo (a dummy treatment) with some patients taking them in combination with NSAIDs.
Ud over smerter ved diabetisk perifer neuropati anvendes Cymbalta og Xeristar også ved svær depression og generaliseret angst (varig angst eller nervøsitet i forbindelse med dagligdags aktivitet). 
In addition to pain due to diabetic peripheral neuropathy, Cymbalta and Xeristar are also used in major depression and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en revurdering af den første udtalelse og fastholdt den 17. november 2011 afslaget på ansøgningen om ændringen. 
After considering the grounds for this request, the CHMP re examined the initial opinion, and confirmed the refusal of the change to the marketing authorisations on 17 November 2011.
Som led i revurderingen tog udvalget stilling til anvendelsen af duloxetin hos en mindre gruppe af patienter: patienter, der har kroniske lændesmerter eller slidgigt (hævelse og smerter i leddene) af mindst moderat sværhed, og som ikke kan bruge NSAID. 
During the re-examination, the Committee considered the use of duloxetine in a smaller group of patients: patients with chronic low back pain or osteoarthritis (swelling and pain in the joints) of at least moderate severity who cannot use NSAIDS.
Ariclaim anvendes til smerter ved diabetisk perifer neuropati (beskadigelse af nerverne i arme og ben, hvilket kan forekomme hos patienter med diabetes). 
Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Ud over de godkendte anvendelser forventedes de tre lægemidler anvendt til behandling af moderate til svære kroniske (langvarige) somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID mod smerter (non-steroide antiinflammatoriske lægemidler). 
In addition to their approved uses, the three medicines were expected to be used to treat moderate to severe chronic (long-term) somatic pain in patients not regularly taking NSAID pain killers (non steroidal anti-inflammatory drugs).
Hvad sker der med Ariclaim, Cymbalta og Xeristar til de godkendte indikationer? 
What is happening with Ariclaim, Cymbalta and Xeristar for in their approved indications?
Det aktive stof duloxetin hæmmer genoptagelsen af serotonin og noradrenalin. 
The active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Ændringen vedrørte tilføjelse af en ny indikation: behandling af moderate til svære somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID. 
The change concerned the addition of a new indication, the treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly.
CHMP konkluderede derfor, at det ikke er påvist, at fordelene ved duloxetin opvejer risiciene til behandling af moderate til svære kroniske somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID. 
The CHMP therefore concluded that the benefits of duloxetine in the treatment of moderate to severe chronic somatic pain in patients not regularly taking NSAIDs had not been shown to outweigh its risks.
Når deres genoptagelse i nervecellerne blokeres, kan det derfor bedre smertesymptomerne. 
Since these neurotransmitters are involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may improve the symptoms of pain.
Lægemiddelform Administration Emballage Indhold Pakningsstørrrelse 
Immediate Packaging
Oral anvendelse flaske (HDPE) 
Content (concentration)
Undersøgelserne og programmerne vil fortsætte som planlagt. 
The trials and programmes will continue as planned.
• Langtidsundersøgelsen viste ikke, at medicinen var effektiv. 
• The long-term study did not show that the medicine was effective.
Firmaet, der har indgivet ansøgningen, er Les Laboratoires Servier. 
The company that applied is Les Laboratoires Servier.
Patienterne får ofte tilbagefald (når sygdommen vender tilbage, efter at den er blevet behandlet). 
Patients often suffer relapses (when the disease comes back after it has been treated).
EMEA/522430/2006 - opdatering 
EMEA/37021/2007 - update
Internationalt fællesnavn (INN): agomelatin 
International Non-proprietary Name (INN): agomelatine
Virkningerne af agomelatin blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of agomelatine were first tested in experimental models before being studied in humans.
Ansøgeren anmodede om en revurdering af udtalelsen, men trak denne anmodning tilbage, inden CHMP havde gennemført revurderingen. 
The applicant requested a reexamination of the opinion, but withdrew this request before the CHMP completed the re-examination.
Hvis du deltager i et klinisk forsøg eller et program for specialudlevering og har behov for yderligere information om din behandling, kan du kontakte den læge, der er ansvarlig for behandlingen. 
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Undersøgelserne så på kort- og langtidseffektiviteten af lægemidlet (korttidsundersøgelserne varede 68 uger, og langtidsundersøgelserne varede op til et år). 
They looked at the short- and long-term effectiveness of the medicine (short-term studies lasting 6-8 weeks and the longterm studies lasting up to a year).
Hovedsymptomerne er nedtrykt sindstilstand og tab/formindsket interesse eller glæde. 
The key symptoms are depressed mood and loss/diminished interest or pleasure.
De kan lide af en dyb følelse af tristhed, værdiløshed, miste interessen for deres yndlingsaktiviteter, få søvnforstyrrelser, få en følelse af, at alt går langsommere, blive angst og ændre vægt. 
They may suffer from deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Hvilken dokumentation har firmaet fremlagt til støtte for ansøgningen til CHMP? 
What documentation has been presented by the company to support the application to the CHMP?
London, 16/01/2007 Dok.ref. 
London, 18 November 2006 Doc.Ref.
Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede afslag på ansøgning om markedsføringstilladelse? 
What were the major concerns that led to the CHMP to recommend a refusal of the marketing authorisation?
Alle behandlede patienter led af svære depressive forstyrrelser, hvis sværhedsgrad blev vurderet ved brug af en standardiseret vurderingsskala (Hamiltons depressionsskala, HAM-D). 
All patients treated suffered from a major depressive disorder, the severity of which was assessed using a standard rating scale (the Hamilton Rating Scale for Depression, HAM-D).
Nogle forsøg omfattede en kontrolgruppe, hvor patienterne blev behandlet med fluoxetin eller paroxetin (andre lægemidler der anvendes mod depression). 
Some studies included a control group where patients were treated with fluoxetine or paroxetine (other medicines used in depression).
Effektiviteten blev målt ved vurdering af pointtallene i HAM-D vurderingsskalaen før undersøgelsen og efter afslutning af undersøgelsen. 
The effectiveness was measured by looking at the score in the HAM-D rating scale before and at the end of the study.
Dette betyder, at agomelatin stimulerer melatoninreceptorerne MT1 og MT2 (disse receptorer aktiveres normalt af et naturligt hormon, melatonin) og det blokerer 5-HT2C -receptorerne (disse receptorer aktiveres normalt af en kemisk budbringer, serotonin). 
This means that agomelatine stimulates the melatonin receptors MT1 and MT2 (these receptors are normally activated by a natural hormone, melatonin) and it blocks the 5-HT2C receptors (these receptors are normally activated by a chemical messenger, serotonin).
Patienter med svære depressive forstyrrelser lider af humørforstyrrelser, der griber forstyrrende ind i dagligdagen. 
In major depressive disorder, patients have disturbances of mood that interfere with their everyday life.
Information om resultatet af denne genansøgning findes her. 
See here for information on the outcome of the resubmission
Den 27. juli 2006 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori det anbefalede at give afslag på ansøgningen om markedsføringstilladelse for lægemidlet Valdoxan/Thymanax, 25 mg filmovertrukne tabletter, beregnet til behandling af svære depressive forstyrrelser. 
On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a marketing authorisation for the medicinal product Valdoxan/Thymanax, 25 mg film-coated tablets intended for the treatment of major depressive disorder.
Hovedundersøgelserne omfattede flere end 2.400 patienter, der tog Valdoxan/Thymanax. 
The main studies involved more than 2,400 patients that took Valdoxan/Thymanax.
Valdoxan/Thymanax blev sammenlignet med en placebo (en uvirksom behandling). 
Valdoxan/Thymanax was compared with a placebo (a dummy treatment).
Valdoxan/Thymanax forventedes anvendt til brug hos voksne patienter til behandling af svære depressive forstyrrelser. 
Valdoxan/Thymanax was expected to be used in adult patients to treat major depressive disorder.
Valdoxan/Thymanax er orange-gule tabletter, der indeholder 25 mg af det aktive stof agomelatin. 
Valdoxan/Thymanax are orange-yellow tablets containing 25 mg of the active substance agomelatine.
SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for VALDOXAN/THYMANAX 
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING AUTHORISATION for VALDOXAN/THYMANAX
CHMP's største bekymring var, at effektiviteten af Valdoxan/Thymanax ikke var blevet tilstrækkeligt påvist: 
The major concern of the CHMP was that the effectiveness of Valdoxan/Thymanax had not been sufficiently shown:
Det aktive stof i Valdoxan/Thymanax, agomelatin, er en ‘melatoninagonist' og en ‘5-HT2Cantagonist'. 
The active substance in Valdoxan/Thymanax, agomelatine, is a ‘melatonergic agonist' and a ‘5-HT2C antagonist'.
På dette tidspunkt var CHMP af den opfattelse, at fordelene ved Valdoxan/Thymanax ikke opvejede risiciene. 
At this point in time, the CHMP was of the opinion that the benefits of Valdoxan/Thymanax did not outweigh its risks.
Firmaet har informeret CHMP om, at der ikke er konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser eller programmer for specialudlevering af Valdoxan/Thymanax. 
The Company has informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Valdoxan/Thymanax.
Hvad er Valdoxan/Thymanax? 
What is Valdoxan/Thymanax?
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser/ programmer for specialudlevering af Valdoxan/Thymanax? 
What are the consequences of the refusal for patients undergoing clinical trials/compassionate use programmes with Valdoxan/Thymanax?
Hvad forventedes Valdoxan/Thymanax anvendt til? 
What was Valdoxan/Thymanax expected to be used for?
Hvordan forventes Valdoxan/Thymanax at virke? 
How is Valdoxan/Thymanax expected to work?
CHMP anbefalede derfor afslag på markedsføringstilladelse for Valdoxan/Thymanax. 
Hence, the CHMP recommended that Valdoxan/Thymanax be refused marketing authorisation.
• Korttidsundersøgelsen viste, at medicinen har en virkning, men omfanget af denne gjorde det ikke muligt for udvalget at drage en sikker konklusion vedrørende lægemidlets effektivitet. 
• The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine's effectiveness The CHMP had no special concerns regarding the side effects associated with Valdoxan/Thymanax, as these could have been managed using the standard risk management tools.
Den maksimalt anbefalede dosishyppighed er én tablet dagligt. 
The maximum recommended dosing frequency is one tablet per day.