FrancophonIA/ELRC3.0 huggingface dataset:
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Type 2-diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere blodets glukoseniveau, eller når kroppen ikke kan udnytte insulin tilstrækkeligt effektivt.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Danish: Disse hormoner udskilles efter et måltid og stimulerer bugspytkirtlen til at producere insulin.
English: What are the risks associated with Vipidia?
Danish: Hvilken risiko er der forbundet med Vipidia?
English: When Vipidia is added to a sulphonylurea (a type of diabetes medicine) or insulin, the doctor may need to lower the dose of these medicines to reduce the risk of hypoglycaemia (low blood sugar level).
Danish: Når Vipidia føjes til et sulfonylurinstof (et lægemiddel mod sukkersyge) eller insulin, kan det være nødvendigt for lægen at nedsætte dosis af disse lægemidler for at reducere risikoen for hypoglycæmi (lavt blodsukkerindhold).
English: Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
Danish: Sammenlagt sænker disse processer blodsukkerniveauet og er derved med til at kontrollere type -2-diabetes.
English: Vipidia must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any DPP 4 inhibitor.
Danish: Vipidia må ikke anvendes til patienter, som er overfølsomme (allergiske) over for de aktive stoffer eller andre af indholdsstofferne, eller som tidligere har haft en alvorlig allergisk reaktion over for en DPP4hæmmer.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Danish: Det virker ved at blokere nedbrydningen af inkretinhormoner i kroppen.
English: For more information about treatment with Vipidia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vipidia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: HbA1c levels were measured after 26 weeks when Vipidia was used alone or added to other diabetes medicines, and after 52 weeks when Vipidia was compared with glipizide or pioglitazone.
Danish: HbA1c-mængderne blev målt efter 26 uger, når Vipidia blev anvendt alene eller som tillægsbehandling til andre lægemider mod sukkersyge, og efter 52 uger, når Vipidia blev sammenlignet med glipizid eller pioglitazon.
English: In two other studies, Vipidia was compared with the diabetes medicines glipizide and pioglitazone in patients who were already taking metformin.
Danish: I to andre undersøgelser blev Vipidia sammenlignet med antidiabetikaene glipizid og pioglitazon hos patienter, der allerede tog metformin.
English: The CHMP considered that the effects of Vipidia on HbA1c levels were similar to those of other DPP-4 inhibitors and were modest but clinically relevant.
Danish: CHMP var af den opfattelse, at Vipidias virkninger på HbA1c-niveauet svarede til dem, der sås ved andre DPP-4-hæmmere, og at de var beskedne, men klinisk relevante.
English: Five of the studies compared Vipidia with placebo (a dummy treatment), when used alone or added to other diabetes medicines, in patients in whom previous treatment had failed.
Danish: I fem af undersøgelserne blev Vipidia sammenlignet med placebo (en uvirksom behandling), når det blev anvendt alene eller som tillægsbehandling til andre lægemidler mod sukkersyge til patienter, der ikke havde haft effekt af tidligere behandling.
English: Regarding its safety, Vipidia's safety profile was consistent with that seen with other DPP-4 inhibitors.
Danish: Med hensyn til sikkerhed svarede sikkerhedsprofil til den, der sås ved andre DPP-4-hæmmere.
English: The recommended dose is 25 mg taken by mouth once daily, in combination with other diabetes medicines as prescribed by a doctor.
Danish: Den tages gennem munden én gang dagligt sammen med andre lægemidler mod diabetes, som er ordineret af en læge.
English: Vipidia was as least as affective as pioglitazone in lowering HbA1c when added to metformin, but the study comparing Vipidia with glipizide was not conclusive.
Danish: Vipidia var mindst ligeså effektivt som pioglitazone til at reducere mængden af HbA1c, når det blev tilføjet til metformin, men undersøgelsen, hvori Vipidia blev sammenlignet med glipizid, gav ikke overbevisende resultater.
English: In all studies Vipidia led to a decrease in HbA1c indicating that blood glucose levels had been reduced.
Danish: I alle undersøgelserne medførte Vipidia et fald i mængden af HbA1c, hvilket viser af blodglukoseniveauerne var blevet reduceret.
English: In all of the studies, the main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Danish: Det primære effektmål i alle undersøgelserne var ændringen i koncentrationen af glykosyleret hæmoglobin (HbA1c), hvilket er den procentdel af hæmoglobin i blodet, hvortil der er bundet glykose.
English: HbA1c levels give an indication of how well the blood glucose is controlled.
Danish: Mængden af HbA1c er et mål for, hvor godt blodsukkeret er reguleret.
English: Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Alogliptin nedsætter desuden leverens sukkerproduktion ved at øge insulinindholdet og sænke indholdet af hormonet glukagon.
English: For practical information about using Vipidia, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning i anvendelsen af Vipidia, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Vipidia have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vipidia?
English: It is used, together with diet and exercise, as an addition to other diabetes medicines in adults with type 2 diabetes, to control their blood glucose (sugar) level.
Danish: Det anvendes til voksne med type 2diabetes sammen med diæt og motion som tillægsbehandling til andre lægemidler mod diabetes til regulering af blodglukoseniveauet (sukker).
English: For the full list of all side effects reported with Vipidia, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Vipidia fremgår af indlægssedlen.
English: By blocking the breakdown of incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Danish: Alogliptin forlænger inkretinhormoners virkning ved at blokere nedbrydningen af dem i blodet og stimulerer dermed bugspytkirtlen til at producere mere insulin, når blodsukkerniveauet er højt.
English: How is Vipidia used?
Danish: Hvordan anvendes Vipidia?
English: How does Vipidia work?
Danish: Hvordan virker Vipidia?
English: 8 January 2010
Danish: 8. januar 2010
English: Background information
Danish: Baggrundsoplysninger
English: Committee for medicinal products for veterinary use (CVMP)
Danish: Udvalget for Veterinærlægemidler (CVMP)
English: Tylosin is a macrolide antibiotic.
Danish: Tylosin er et makrolidantibiotikum.
English: The Decentralised Procedure NL/V/0127/001/DC started on 23 March 2007.
Danish: Den decentrale procedure NL/V/0127/001/DC blev indledt den 23. marts 2007.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II.
English: The final opinion was converted into a Decision by the European Commission on 8 January 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 8. januar
English: It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms.
Danish: Det har en antimikrobiel virkning, idet det hæmmer proteinsyntesen i følsomme mikroorganismer.
English: The referral procedure started on 14 May 2008.
Danish: Indbringelsesproceduren blev indledt den 14. maj 2008.
English: 1 Article 33(4) of Directive 2001/82/EC, as amended.
Danish: 1 Artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the reference member state was the Netherlands and the concerned member states (CMSs) were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Spain, Hungary, Ireland, Italy, Poland, Portugal, Romania and United Kingdom.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, med senere ændringer, hvor referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Østrig, Belgien, Bulgarien, Den Tjekkiske Republik, Tyskland, Danmark, Spanien, Ungarn, Irland, Italien, Polen, Portugal, Rumænien og Det Forenede Kongerige.
English: On 29 April 2008 the Netherlands referred the matter to the European Medicines Agency (the Agency) under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that tylosin may present a potential serious risk to the environment (risk to algae and to terrestrial plants).
Danish: Den 29. april 2008 indbragte Nederlandene sagen for Det Europæiske Lægemiddelagentur (EMEA) i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF som følge af de betænkeligheder, Tyskland havde givet udtryk for med hensyn til tylosins potentielle alvorlige risiko for miljøet (risiko for alger og terrestriske planter).
English: No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredients.
Danish: Udvalget gjorde sig ikke nogen overvejelser eller traf nogen beslutninger om, hvorvidt konklusionerne skulle gælde for andre tilladte lægemidler, der indeholder de samme aktive stoffer.
English: The rapporteur and co-rapporteur appointed were: Dr Cristina Muñoz Madero (Spain) and Dr Boris Kolar (Slovenia), respectively.
Danish: Som rapportør og medrapportør udpegedes henholdsvis dr. Cristina Muñoz Madero (Spanien) og dr. Boris Kolar (Slovenien).
English: The detailed grounds for the request were submitted to the Agency on 5 February 2009.
Danish: De detaljerede begrundelser for anmodningen blev fremsendt til EMEA den 5. februar 2009.
English: On 16 September 2008 the CVMP agreed a list of outstanding issues and the written explanations were provided by the applicant on 12 November 2008.
Danish: Den 16. september 2008 vedtog CVMP en liste over uafklarede spørgsmål, og ansøgeren fremsendte de skriftlige redegørelser den 12. november 2008.
English: Written explanations were provided by the applicant on 18 August 2008.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 18. august 2008.
English: Furthermore, the CVMP recommended the revocation of the marketing authorisations for the above-mentioned product already granted in Austria, Ireland, the Netherlands and the United Kingdom.
Danish: Desuden anbefalede CVMP en tilbagekaldelse af de markedsføringstilladelser for ovennævnte lægemiddel, som allerede er udstedt i Østrig, Irland, Nederlandene og Det Forenede Kongerige.
English: The re-examination procedure started on 6 February 2009 and oral explanations were given by Huvepharma NV on 10 March 2009.
Danish: Revurderingsproceduren blev indledt den 6. februar 2009, og Huvepharma NV afgav mundtlige redegørelser den 10. marts 2009.
English: The rapporteur and co-rapporteur appointed for the re-examination were: Dr Ruth Kearsley as the rapporteur and Dr Michael Holzhauser-Alberti as the co-rapporteur respectively.
Danish: Den udpegede rapportør og medrapportør for revurderingen var henholdsvis dr. Ruth Kearsley som rapportør og dr. Michael Holzhauser-Alberti som medrapportør.
English: On 24 December 2008, Huvepharma NV, notified the Agency of his intention to request the reexamination of the CVMP opinion.
Danish: Den 24. december 2008 meddelte Huvepharma NV EMEA, at virksomheden ville anmode om en revurdering af CVMP's udtalelse.
English: Furthermore, the CVMP recommended that the existing marketing authorisations for the abovementioned product should be revoked.
Danish: Desuden anbefalede CVMP en tilbagekaldelse af de eksisterende markedsføringstilladelser for ovennævnte lægemiddel.
English: The applicant, Huvepharma NV, submitted an application for a decentralised procedure for Pharmasin 100% W/W Water Soluble Granules and associated names indicated for oral use in pigs, chickens (broilers, pullets), turkeys and calves.
Danish: Ansøgeren, Huvepharma NV, indgav en ansøgning om en decentral procedure for Pharmasin 100 % w/w vandopløseligt granulat og tilknyttede navne, indiceret til oral anvendelse hos svin, kyllinger (slagtekyllinger og unghøns), kalkuner og kalve.
English: In line with the restrictions in legislation with respect to data on environmental risk, the Committee limited its considerations to the data presented by Huvepharma NV in the dossier for Pharmasin 100% W/W Water Soluble Granules and associated names.
Danish: I overensstemmelse med restriktionerne i lovgivningen med hensyn til miljørisikooplysninger begrænsede udvalget sine betragtninger til de oplysninger, som Huvepharma NV havde fremlagt i dossieret for Pharmasin 100 % w/w vandopløseligt granulat og tilknyttede navne.
English: During its 9-11 December 2008 meeting, the CVMP in light of the overall data submitted and the scientific discussion within the Committee, considered by consensus that the application did not satisfy the criteria for authorisation in respect of environmental risk.
Danish: På baggrund af alle de fremsendte oplysninger og den faglige drøftelse i udvalget vedtog CVMP med konsensus på mødet den 9.-11. december 2008, at ansøgningen ikke opfyldte godkendelseskriterierne med hensyn til miljørisikoen.
English: During its 10-12 March 2009 meeting, the Committee, having considered the grounds for appeal and the oral explanations provided by Huvepharma NV, concluded by consensus that its opinion of 10 December 2008 should not be revised and that the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names should be refused by the member states.
Danish: Efter at have drøftet begrundelserne for anmodningen om revurdering og de mundtlige redegørelser, som Huvepharma NV havde afgivet, vedtog udvalget med konsensus på mødet den 10.-12. marts 2009, at dets udtalelse af 10. december 2008 ikke skulle revideres, og at medlemsstaterne skulle give afslag på ansøgningen om markedsføringstilladelser for Pharmasin 100 % w/w vandopløseligt granulat og tilknyttede navne.
English: Therefore the CVMP recommended the refusal of the granting of the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names.
Danish: Derfor anbefalede CVMP afslag på ansøgningen om markedsføringstilladelser for Pharmasin 100 % w/w vandopløseligt granulat og tilknyttede navne.
English: Opinion following an Article 33(4)F F referral for Pharmasin 100% W/W Water Soluble Granules and associated names
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 33, stk. 41, om Pharmasin 100 % w/w vandopløseligt granulat og tilknyttede navne
English: This summary was last updated in 10-2016.
Danish: Dette sammendrag blev sidst ajourført i 10-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax on 19 February 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Thymanax den 19. februar 2009.
English: The full EPAR for Thymanax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Thymanax findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients with depression should be treated for at least six months to make sure that they are free of symptoms.
Danish: Patienter med depression skal behandles i mindst seks måneder for at sikre, at de er symptomfri.
English: However, no effect of fluoxetine or paroxetine was seen in two of these studies, making the results difficult to interpret.
Danish: Der blev imidlertid ikke set nogen virkning af fluoxetin eller paroxetin i to af disse undersøgelser, hvilket gør resultaterne vanskelige at tolke.
English: It works in two ways, by stimulating the MT1 and MT2 receptors and by blocking the 5-HT2C receptors in the brain.
Danish: Det virker på to måder, både ved at stimulere MT1- og MT2-receptorer og ved at blokere 5-HT2C-receptorer i hjernen.
English: Thymanax might also help to normalise the patient's sleep patterns.
Danish: Thymanax kan også hjælpe med at normalisere patientens søvnmønstre.
English: This is a summary of the European public assessment report (EPAR) for Thymanax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Thymanax.
English: If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together at bedtime.
Danish: Hvis der ikke er nogen bedring i symptomerne efter to uger, kan lægen øge dosis til to tabletter, som skal tages samtidig ved sengetid.
English: This is thought to lead to increases in the levels of the neurotransmitters dopamine and noradrenaline.
Danish: Dette menes at føre til, at niveauerne for neurotransmitterne, dopamin og noradrenalin, øges.
English: Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Danish: Symptomerne er ofte dyb nedtrykthed, manglende selvværd, manglende interesse for yndlingsaktiviteter, søvnforstyrrelser, følelse af at være gået i stå, angst og vægtændringer.
English: The recommended dose is one tablet once a day, taken at bedtime.
Danish: Den anbefalede dosis er en tablet én gang dagligt, som tages sammen med et måltid.
English: The active comparator groups were included to check that the study was able to measure the effectiveness of medicines in treating depression.
Danish: Grupperne med et aktivt sammenligningsstof blev inkluderet for at kontrollere, at undersøgelsen kunne måle, hvor effektive lægemidlerne var til behandling af depression.
English: The patient's liver function should be checked with blood tests before starting treatment and when the dose is increased, followed by further tests around 3, 6, 12 and 24 weeks later.
Danish: Patientens lever skal kontrolleres ved hjælp af blodprøver, inden behandlingen indledes, når dosis øges og efter cirka 3, 6, 12 og 24 ugers behandling.
English: Treatment should be discontinued immediately if the patient develops symptoms or signs of potential liver injury.
Danish: Behandlingen bør ophøre omgående, hvis patienten udvikler symptomer eller tegn på mulig leverskade.
English: Since dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain is believed to help relieve the symptoms of depression.
Danish: Da dopamin og noradrenalin medvirker til at styre sindstilstanden, menes en stigning i deres antal mellem nervecellerne i hjernen at medvirke til at lindre symptomerne på depression.
English: ‘Neurotransmitters' are chemicals that allow nerve cells to communicate with each other.
Danish: "Neurotransmittere" er kemiske signalstoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
English: Thymanax agomelatine
Danish: Thymanax agomelatin
English: However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Danish: Den anden undersøgelse viste imidlertid, at symptomerne kom igen hos 21 % af patienterne, som tog Thymanax i 24 uger (34 ud af 165) sammenlignet med 41 % af patienterne, som tog placebo (72 ud af 174).
English: Thymanax can only be obtained with a prescription and is available as tablets (25 mg).
Danish: Thymanax udleveres kun på recept og leveres som tabletter (25 mg).
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Danish: Svær depression er en sygdom, der giver humørforstyrrelser, som griber ind i patientens dagligdag.
English: However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
Danish: Da lægemidlet imidlertid har en ny virkningsmåde, få bivirkninger og en anderledes sikkerhedsprofil end de eksisterende antidepressive lægemidler, konkluderede udvalget, at Thymanax kan være en god behandling for nogle patienter, når blot deres leverfunktion bliver kontrolleret hyppigt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Thymanax's benefits in terms of treating depression might be lower than seen with other antidepressants.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at fordelene ved Thymanax med hensyn til behandling af depression kan være mindre end dem, der ses med andre antidepressive lægemidler.
English: The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM D).
Danish: Behandlingens virkning i disse fem undersøgelser blev hovedsagelig bedømt på ændringen af patienternes symptomer efter seks uger, målt på en standardskala for depression, som kaldes Hamilton Hamilton Depression Rating Scale (HAM-D).
English: Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Danish: Thymanax er blevet sammenlignet med placebo (en virkningsløs behandling) i fem kortvarige undersøgelser, som omfattede i alt 1 893 voksne med svær depression.
English: Therefore, the CHMP decided that Thymanax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Thymanax opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Other information about Thymanax
Danish: Andre oplysninger om Thymanax
English: In the first study, there was no difference between Thymanax and placebo in preventing symptoms from returning during 26 weeks of treatment.
Danish: I den første undersøgelse var der ingen forskel mellem Thymanax og placebo med hensyn til at forhindre, at symptomerne kom igen i løbet af de 26 ugers behandling.
English: What measures are being taken to ensure the safe and effective use of Thymanax?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Thymanax?
English: Thymanax is a medicine used to treat major depression in adults.
Danish: Thymanax anvendes til behandling af svær depression hos voksne.
English: The active substance in Thymanax, agomelatine, is an antidepressant.
Danish: Det aktive stof i Thymanax, agomelatin, er et antidepressivt middel.
English: Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Danish: Behandlingen bør ikke indledes eller ophøre hos patienter med anormale leverenzymer i blodet (over tre gange højere end det normale niveau).