FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness, called ‘combined remission', was the closing of abnormal external openings together with lack of fluid collections of more than 2 cm associated with internal passages (since these are likely to re-open the fistula).
Danish: Virkningen blev hovedsageligt målt på "kombineret remission", som omfatter lukning af unormale eksterne åbninger samt fravær af indre kanaler, der er større end 2 cm og fyldt med væske (eftersom de kan få fistlen til at åbnes igen).
English: For more information about treatment with Alofisel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Alofisel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company that markets Alofisel will provide educational material for healthcare professionals on how to give the medicine correctly and on the possibility of passing on an infection to the patient.
Danish: Den virksomhed, der markedsfører Alofisel, skal udarbejde undervisningsmateriale til sundhedspersoner vedrørende korrekt administration af lægemidlet og risikoen for at smitte patienten med en infektion.
English: Alofisel contains the active substance darvadstrocel, which comprises stem cells removed from fat tissue of adult donors.
Danish: Alofisel indeholder det aktive stof darvadstrocel, der består af stamceller, som er taget fra fedtvæv hos voksne donorer.
English: The most common side effects with Alofisel (which may affect up to 1 in 10 people) are anal abscess (a swollen area with a collection of pus), proctalgia (anal pain), anal fistula and pain during treatment.
Danish: De hyppigste bivirkninger ved Alofisel (som kan forekomme hos op til 1 ud af 10 patienter) er bylder i endetarmen (hævet område med pusansamling), smerter i endetarmen eller ved endetarmsåbningen, fistler ved endetarmen og smerter under behandlingen.
English: Alofisel is made up of ‘mesenchymal stem cells' from the fat tissue of a donor.
Danish: Alofisel består af mesenkymale stamceller fra fedtvævet fra en donor.
English: Alofisel should be given only by specialist doctors experienced in the diagnosis and treatment of the condition for which it is used.
Danish: Alofisel bør kun gives af speciallæger med erfaring i diagnosticering og behandling af den lidelse, som lægemidlet er rettet mod. Lægemidlet udleveres kun efter recept.
English: The patient is given an anaesthetic (either to put the patient to sleep or to numb the treatment area).
Danish: Patienten får et bedøvelsesmiddel (helbedøvelse eller lokalbedøvelse af behandlingsområdet).
English: For practical information about using Alofisel, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Alofisel, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Alofisel used?
Danish: Hvordan anvendes Alofisel?
English: What benefits of Alofisel have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Alofisel?
English: How does Alofisel work?
Danish: Hvordan virker Alofisel?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alofisel have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Alofisel.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration
English: 30 film-coated tablets in blisters
Danish: 30 filmovertrukne tabletter i blistere
English: This dose may need to be increased after one or two weeks.
Danish: Det kan være nødvendigt at forhøje denne dosis efter en eller to uger.
English: The marketing authorisation was renewed on 18 August 2003 and on 18 August 2008.
Danish: Tilladelsen blev fornyet den 18. august 2003 og den 18. august 2008.
English: The recommended starting dose is 0.5 mg.
Danish: Den anbefalede startdosis er 0,5 mg.
English: The dose is adjusted to give the best control.
Danish: Dosis justeres for at opnå den bedste kontrol.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prandin to Novo Nordisk A/S on 29 January 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prandin til Novo Nordisk A/S den 29. januar 2001.
English: Prandin is taken before meals, normally up to 15 minutes before each main meal.
Danish: Prandin tages inden måltidet, normalt op til 15 minutter før hvert hovedmåltid.
English: This document is a summary of the European Public Assessment Report (EPAR).
Danish: Dette dokument er et sammendrag af den Europæiske Offentlige Vurderingsrapport (EPAR).
English: Prandin is a medicine that contains the active substance repaglinide.
Danish: Prandin er et lægemiddel, der indeholder det aktive stof repaglinid.
English: Other information about Prandin:
Danish: Andre oplysninger om Prandin:
English: The raised insulin levels returned to normal after the meal.
Danish: De forhøjede insulinkoncentrationer blev normale igen efter måltidet.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRANDIN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PRANDIN EPAR - sammendrag for offentligheden
English: The full EPAR for Prandin is available here.
Danish: Den fuldstændige EPAR for Prandin findes her.
English: Another study looked at the effect of adding Prandin to metformin.
Danish: I en anden undersøgelse så man på virkningen af at føje Prandin til metformin.
English: It is available as round tablets (white: 0.5 mg; yellow: 1 mg; peach: 2 mg).
Danish: Des fås som runde tabletter (hvid: 0,5 mg, gul: 1mg, ferskenfarvet: 2mg).
English: Prandin should not be used in people who may be hypersensitive (allergic) to repaglinide or any of the other ingredients.
Danish: Prandin bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for repaglinid eller et af de øvrige indholdsstoffer.
English: The Committee recommended that Prandin be given marketing authorisation.
Danish: Udvalget anbefalede derfor udstedelse af markedsføringstilladelse for Prandin.
English: In the study where Prandin was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
Danish: I den undersøgelse, hvor Prandin blev føjet til metformin, var effekten af de to lægemidler som minimum additiv (svarende til de to lægemidler sammenlagt).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Prandin's benefits are greater than its risks for the treatment of type 2 diabetes.
Danish: Udvalget for humanmedicinske lægemidler (CHMP) konkluderede, at fordelene ved Prandin var større end risiciene ved behandling af type 2- diabetes.
English: Prandin has been studied in 45 ‘clinical pharmacology' studies (looking at how the medicine works in the body) and 16 clinical trials (looking at its effects in treating type 2 diabetes patients).
Danish: Prandin blev undersøgt i 45 klinisk-farmakologiske undersøgelser (hvor det blev undersøgt, hvordan lægemidlet virker i kroppen) og 16 kliniske undersøgelser (hvor man undersøgte virkningen til behandling af type 2-diabetespatienter).
English: Why has Prandin been approved?
Danish: Hvorfor blev Prandin godkendt?
English: Prandin doses may also need to be adjusted when given with some medicines used in heart conditions, and to treat pain, asthma and other conditions.
Danish: Doserne af Prandin skal muligvis justeres, når de gives sammen med andre lægemidler, der anvendes til hjertesygdomme, behandling af smerter, astma og andre sygdomstilstande.
English: A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Danish: Patientens blodglukose skal regelmæssigt kontrolleres af en læge for at fastsætte den effektive minimumsdosis.
English: What is the risk associated with Prandin?
Danish: Hvilke risici er der forbundet med Prandin?
English: Prandin is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Danish: Prandin anvendes til patienter, som har type 2-diabetes (ikke-insulinkrævende diabetes).
English: The full list is available in the Package Leaflet.
Danish: Den fuldstændige liste fremgår af indlægssedlen.
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 glukosekoncentration, eller når kroppen ikke kan udnytte insulinen effektivt.
English: It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘C-peptide' in their blood (a marker of type 1 diabetes).
Danish: Det må heller ikke anvendes til patienter, der har type 1-diabetes (insulinkrævende), og som ikke har ‘C-peptid' i blodet (en markør for type 1-diabetes).
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne måltes koncentrationen af et stof kaldet glykosyleret hæmoglobin (HbA1c), som giver en indikation af, hvor tilfredsstillende blodglukosen er reguleret.
English: It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels).
Danish: Det må heller ikke anvendes til patienter med diabetisk ketoacidose (høje koncentrationer af ketoner [syrer] i blodet), til patienter med svære leverproblemer eller til patienter, som også får gemfibrozil (et lægemiddel, der anvendes til at nedsætte blodets fedtindhold).
English: In all studies, Prandin led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines.
Danish: I alle undersøgelser medførte Prandin et fald i HbA1c-niveauet, hvilket tydede på, at blodglukosekoncentrationerne var blevet reguleret til et niveau, der svarede til det, der var iagttaget for de øvrige sammenligningspræparater.
English: The most common side effects with Prandin (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea.
Danish: De hyppigste bivirkninger ved Prandin (som optræder hos mellem 1 til 10 patienter ud af 100) er hypoglykæmi (lave blodglukosekoncentrationer, mavesmerter og diarré).
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Danish: Det anvendes sammen med diæt og motion til at sænke blodglukoseniveauerne (sukker) hos patienter, hvis hyperglykæmi (høje blodglukosekoncentrationer) ikke kan reguleres med diæt, vægttab og motion.
English: For the full list of all side effects seen with Prandin, see the Package Leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Prandin fremgår af indlægssedlen.
English: What benefit has Prandin shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, der er ved Prandin?
English: Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Danish: Prandin får bugspytkirtlen til at producere mere insulin i forbindelse med måltider og anvendes til regulering af type 2-diabetes.
English: Prandin may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Danish: Prandin kan også anvendes med metformin (et andet lægemiddel mod diabetes) til type 2diabetespatienter, hvis blodglukosekoncentrationer ikke er reguleret tilfredsstillende med metformin alene.
English: What is Prandin?
Danish: Hvad er Prandin?
English: Prandin is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Danish: Hvis patienten er skiftet fra et andet lægemiddel mod diabetes, er den anbefalede startdosis 1 mg. Prandin anbefales ikke til patienter under 18 år på grund af, at der mangler oplysninger om sikkerhed og virkning for denne aldersgruppe.
English: What is Prandin used for?
Danish: Hvad anvendes Prandin til?
English: Prandin can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Danish: Prandin kan også anvendes til type 2-diabetespatienter, hvis blodglukosekoncentrationer normalt reguleres tilfredsstillende med diæt, men hvor blodglukosekoncentrationen midlertidigt er ude af kontrol.
English: How has Prandin been studied?
Danish: Hvordan blev Prandin undersøgt?
English: Prandin produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal.
Danish: Prandin fremkaldte en tilfredsstillende insulinrespons på et måltid inden for 30 minutter, efter at en dosis var blevet indtaget af patienter med type 2-diabetes.
English: The main studies compared Prandin with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide).
Danish: I alt 2 156 patienter fik Prandin i alle undersøgelser under et. I hovedundersøgelserne blev Prandin sammenlignet med andre lægemidler, som anvendes til type 2diabetes (glibenclamid, glipizid eller gliclazid).
English: How is Prandin used?
Danish: Hvordan anvendes Prandin?
English: How does Prandin work?
Danish: Hvordan virker Prandin?
English: This overview was last updated in 06-2019
Danish: Denne oversigt blev sidst ajourført i 06-2019.
English: Miglustat Dipharma received a marketing authorisation valid throughout the EU on 18 February 2019.
Danish: Miglustat Dipharma fik en markedsføringstilladelse med gyldighed i hele EU den 18. februar 2019.
English: These include loss of coordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
Danish: Disse omfatter bl.a. tab af koordinationsevne, problemer med "sakkadiske" (hurtige) øjenbevægelser, der kan føre til nedsat syn, forsinket udvikling, synkebesvær, nedsat muskeltonus, anfald og indlæringsvanskeligheder.
English: • adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease.
Danish: • voksne (på 18 år og derover) med let til moderat Gauchers sygdom type 1.
English: Further information on Miglustat Dipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
Danish: Yderligere information om Miglustat Dipharma findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
English: The recommended starting dose for type-1 Gaucher disease is one capsule three times a day.
Danish: Den anbefalede startdosis til Gauchers sygdom type 1 er én kapsel tre gange dagligt.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har også udført et studie, der har vist, at det er "bioækvivalent" med referencelægemidlet.
English: For more information about using Miglustat Dipharma, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Miglustat Dipharma, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Miglustat Dipharma are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Miglustat Dipharma vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: • patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Danish: • patienter i alle aldre med Niemann-Pick type C-sygdom, en potentielt dødelig sygdom, hvor glycosphingolipider ophobes i celler i hjernen og andre steder i kroppen.
English: Miglustat Dipharma is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Danish: Miglustat Dipharma anvendes til behandling af de neurologiske symptomer på sygdommen (symptomer, der påvirker hjernen og nerverne).
English: The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør følges af læger med erfaring i håndtering af Gauchers sygdom.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Dipharma has been shown to have comparable quality and to be bioequivalent to Zavesca.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Miglustat Dipharma er af sammenlignelig kvalitet og er bioækvivalent med Zavesca.
English: Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Danish: Begge sygdomme forårsager en ophobning af fedtstoffer, der kaldes glycosphingolipider i kroppen.
English: Because Miglustat Dipharma 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: Da Miglustat Dipharma er et generisk lægemiddel, og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: This means that Miglustat Dipharma contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Danish: Det betyder, at Miglustat Dipharma indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Zavesca.
English: As for all medicines, data on the use of Miglustat Dipharma are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Miglustat Dipharma løbende overvåget.
English: Miglustat Dipharma is used to treat two inherited diseases that affect the way the body handles fats.
Danish: Miglustat Dipharma anvendes til behandling af to arvelige sygdomme, der påvirker den måde, kroppen håndterer fedt på.
English: As for every medicine, the company provided studies on the quality of Miglustat Dipharma.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Miglustat Dipharma.
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Danish: Ved at forhindre enzymet i at virke kan miglustat mindske produktionen af glucosylceramid i cellerne og derved reducere symptomerne på Gauchers sygdom, type 1.
English: Miglustat Dipharma is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
Danish: Miglustat Dipharma anvendes til patienter, der ikke kan få standardbehandlingen enzymerstatningsbehandling (ERT)
English: An overview of Miglustat Dipharma and why it is authorised in the EU
Danish: En oversigt over Miglustat Dipharma, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Miglustat Dipharma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Miglustat Dipharma?
English: Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Dipharma.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet Zavesca, og de behøver ikke blive gentaget for Miglustat Dipharma.
English: What are the benefits and risks of Miglustat Dipharma?
Danish: Hvilke fordele og risici er der forbundet med Miglustat Dipharma?
English: Miglustat Dipharma is a ‘generic medicine'.
Danish: Miglustat Dipharma er et "generisk lægemiddel".
English: For Niemann-Pick type-C disease, it is two capsules three times a day for patients aged 12 years and over; in younger patients, the dose depends on their weight and height.
Danish: Til Niemann-Picks sygdom type C er det to kapsler tre gange dagligt for patienter i alderen 12 år og derover.
English: Miglustat Dipharma is available as 100 mg capsules to be taken by mouth.
Danish: Miglustat Dipharma fås som kapsler (100 mg), der tages gennem munden.
English: Miglustat Dipharma is used to treat the following patients:
Danish: Miglustat Dipharma anvendes til behandling af følgende patienter:
English: This enzyme is involved in the first step of the production of glucosylceramide.
Danish: Dette enzym har betydning for det første trin i dannelsen af glucosylceramid.
English: Other information about Miglustat Dipharma
Danish: Andre oplysninger om Miglustat Dipharma
English: Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Dipharma outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Miglustat Dipharma opvejer de identificerede risici som for Zavesca, og at det kan godkendes til anvendelse i EU.
English: The active substance in Miglustat Dipharma, miglustat, blocks an enzyme called glucosylceramide synthase.
Danish: Det aktive stof i Miglustat Dipharma, miglustat, blokerer virkningen af enzymet glucosylceramidsyntase.
English: What is Miglustat Dipharma and what is it used for?
Danish: Hvad er Miglustat Dipharma, og hvad anvendes det til?
English: Miglustat Dipharma is intended for long-term use.
Danish: Miglustat Dipharma er beregnet til langtidsbehandling.
English: Why is Miglustat Dipharma authorised in the EU?
Danish: Hvorfor blev Miglustat Dipharma godkendt i EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Dipharma have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Miglustat Dipharma.
English: Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Danish: Det medfører, at et glycosphingolipid kaldet glucosylceramid ophobes flere steder i kroppen, f.eks. i milten, leveren og knoglerne.
English: How has Miglustat Dipharma been studied?
Danish: Hvordan blev Miglustat Dipharma undersøgt?
English: How is Miglustat Dipharma used?
Danish: Hvordan anvendes Miglustat Dipharma?
English: How does Miglustat Dipharma work?
Danish: Hvordan virker Miglustat Dipharma?
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Danish: [nedenstående, aktuelt godkendte indikationer skal slettes (den specifikke ordlyd af indikationen kan variere fra produkt til produkt)]
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Danish: Bilag III Ændringer til relevante afsnit i produktresuméer og indlægssedler