FrancophonIA/ELRC3.0 huggingface dataset:
English: Miglustat Dipharma works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Danish: Miglustat Dipharma virker ved at hæmme et enzym, som kaldes 'glucosylceramidsyntase', som er ansvarlig for det første trin i omdannelsen af de fleste glycosphingolipider.
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Danish: Kvalme, opkastning, abdominal distension/ubehag, obstipation, dyspepsi
English: Male patients should use reliable birth control methods during their treatment with Miglustat Dipharma and for 3 months after finishing treatment.
Danish: Mandlige patienter bør anvende pålidelige præventionsmidler under behandling med Miglustat Dipharma og i 3 måneder efter, at behandlingen er afsluttet.
English: There is limited experience with the use of miglustat in Niemann-Pick type C disease patients under the age of 4 years.
Danish: Der er begrænset erfaring med anvendelsen af miglustat til patienter under 4 år med Niemann-Picks sygdom, type C.
English: Pack size of 84x1 capsules in perforated unit dose blisters.
Danish: Pakningsstørrelse på 84x1 kapsler i perforeret enkeltdosisblister.
English: For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Danish: • Ved Niemann-Picks sygdom, type C: Til voksne og unge (over 12 år) er den sædvanlige dosis på to kapsler (200 mg) tre gange dagligt (morgen, eftermiddag og aften).
English: Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Danish: Miglustat Dipharma er indiceret til oral behandling af voksne patienter med let til moderat Gauchers sygdom, type 1.
English: There was a mean increase of 22.2 × 109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Danish: Der var en gennemsnitlig forøgelse af trombocyttallet på 22.2 × 109/l og en gennemsnitlig forøgelse af hæmoglobinkoncentrationen på 0.95 g/dl.
English: • Miglustat Dipharma is used to treat mild to moderate type 1 Gaucher disease in adults.
Danish: • Miglustat Dipharma anvendes til behandling af let til moderat Gauchers sygdom, type 1, hos voksne.
English: You must use effective birth control while taking Miglustat Dipharma.
Danish: De skal benytte effektiv prævention, mens De tager Miglustat Dipharma.
English: Until further information is available, before seeking to conceive, male patients should cease Miglustat Dipharma and maintain reliable contraceptive methods for a further 3 months.
Danish: Indtil yderligere informationer er tilgængelige, bør mandlige patienter, før de søger at undfange, ophøre med Miglustat Dipharma og konsekvent anvende præventive metoder i yderligere 3 måneder.
English: Miglustat Dipharma should not be taken during breast-feeding.
Danish: Miglustat Dipharma bør ikke tages under amning.
English: Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Danish: Miglustat Dipharma må kun bruges til behandling af patienter, hvor enzymsubstitutionsterapi ikke er egnet (se pkt.
English: Contents of the pack and other information What Miglustat Dipharma contains
Danish: Pakningsstørrelser og yderligere oplysninger Miglustat Dipharma indeholder:
English: If you do get any of these effects reported above, please seek medical advice from your doctor as soon as possible.
Danish: Hvis De får nogle af disse bivirkninger, skal De søge rådgivning hos lægen så hurtigt som muligt.
English: There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years).
Danish: Der foreligger ingen tilgængelige farmakokinetiske data for patienter med leverinsufficiens, børn og unge med Gauchers sygdom, type 1, eller ældre (>70 år).
English: Miglustat Dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Danish: Miglustat Dipharma er indiceret til behandling af progressive neurologiske manifestationer hos voksne patienter og pædiatriske patienter med Niemann-Picks sygdom, type C (se pkt.
English: In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Danish: Hos patienter med en justeret kreatinin-clearance på 50-70 ml/min/1.73 m2 bør indgivelsen starte med en dosis på 100 mg to gange dagligt hos patienter med Gauchers sygdom, type 1 og en dosis på 200 mg to gange dagligt (justeret efter legemsoverflade hos patienter under 12 år) hos patienter med Niemann-Picks sygdom, type C.
English: What you need to know before you take Miglustat Dipharma Do not take Miglustat Dipharma:
Danish: Det skal De vide, før De begynder at tage Miglustat Dipharma Tag ikke Miglustat Dipharma
English: - if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for miglustat eller et af de øvrige indholdsstoffer i Miglustat Dipharma
English: Miglustat Dipharma 100 mg hard capsules
Danish: Miglustat Dipharma 100 mg hårde kapsler
English: Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters and reduces fertility (see sections 4.6 and 5.3).
Danish: Undersøgelser på rotter har vist, at miglustat har en negativ effekt på spermatogenese og spermparametre samt nedsætter fertiliteten (se pkt.
English: Thrombocytopenia Metabolism and nutrition disorders Very common
Danish: Metabolisme og ernæring Meget almindelig
English: If you stop taking Miglustat Dipharma
Danish: Hvis De holder op med at tage Miglustat Dipharma
English: In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Danish: Ved in vitro undersøgelser er der desuden påvist en hæmmende funktion på en non- lysosomal glucosylceramidase.
English: Miglustat Dipharma 100 mg hard capsules miglustat
Danish: Miglustat Dipharma 100 mg hårde kapsler miglustat
English: If you forget to take Miglustat Dipharma
Danish: Hvis De har glemt at tage Miglustat Dipharma
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Miglustat Dipharma and maintain reliable contraceptive methods for 3 months thereafter.
Danish: Indtil yderligere information foreligger, tilrådes det, at mandlige patienter, før konception, seponerer Miglustat Dipharma og anvender sikre kontraceptionsmetoder 3 måneder herefter (se pkt.
English: Do not breast-feed while you are taking Miglustat Dipharma.
Danish: De må ikke amme, mens De tager Miglustat Dipharma.
English: Other medicines and Miglustat Dipharma
Danish: Brug af anden medicin sammen med Miglustat Dipharma
English: Each hard capsule contains 100 mg miglustat.
Danish: Hver hård kapsel indeholder 100 mg miglustat.
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma.
Danish: Mandlige patienter skal sørge for pålidelige præventionsmidler, så længe de tager Miglustat Dipharma.
English: In patients with an adjusted creatinine clearance of 30-50 ml/min/1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Danish: Hos patienter med en justeret kreatinin-clearance på 30-50 ml/min/1.73 m2 bør indgivelsen starte med en dosis på 100 mg én gang dagligt hos patienter med Gauchers sygdom, type 1 og en dosis på 100 mg to gange dagligt (justeret efter legemsoverflade hos patienter under 12 år) hos patienter med NiemannPicks sygdom, type C. Anvendelse til patienter med svær nyreinsufficiens (kreatinin-clearance < 30 ml/min/1.73 m2) kan ikke anbefales (se pkt.
English: Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Dipharma; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Danish: Fordel/risiko-balancen ved fortsat behandling skal revurderes på individuel basis.
English: Check with your doctor or pharmacist if you are not sure.For typer 1 Gaucher disease: For adults the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Danish: • Ved Gauchers sygdom, type 1: Til voksne, er den sædvanlige dosis én kapsel (100 mg) tre gange dagligt (morgen, eftermiddag og aften).
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma (see sections 4.4 and 5.3).
Danish: Mandlige patienter bør anvende sikre kontraceptionsmetoder, mens de tager Miglustat Dipharma (se pkt.
English: Hepatic impairment Miglustat has not been evaluated in patients with hepatic impairment.
Danish: Leverinsufficiens Miglustat er ikke evalueret hos patienter med leverinsufficiens.
English: Breast-feeding
Danish: Thrombocytopenia
English: The benefit of treatment with miglustat for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with miglustat.
Danish: Fordelen ved behandling af neurologiske manifestationer med miglustat hos patienter med NiemannPicks sygdom, type C, skal regelmæssigt evalueres f.eks. hver 6. måned.
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical trials in patients treated with miglustat 100 mg t.i.d.
Danish: Knoglemanifestationer blev evalueret i 3 open-label kliniske undersøgelser hos patienter med Gauchers sygdom type 1, der blev behandlet med miglustat 100 mg 3 gange dagligt i op til 2 år (n=72).
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Dipharma (see section 4).
Danish: Hvis De lider af diarré under behandlingen med Miglustat Dipharma, vil Deres læge muligvis sætte Deres dosis ned, f.eks. til én kapsel (100 mg) én eller to gange dagligt (se pkt.
English: How to take Miglustat Dipharma
Danish: Sådan skal De tage Miglustat Dipharma
English: Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with miglustat.
Danish: Der er observeret let nedsat thrombocyttal uden associeret blødning hos nogle patienter med Niemann
English: adjusted for body surface area resulted in Cmax and AUCτ values which were approximately two fold those attained after 100 mg t.i.d.
Danish: Dosis til børn på 200 mg 3 gange dagligt, justeret i forhold til legemsoverflade, resulterede i Cmax- og AUCτ-værdier, som var på ca. det dobbelte af det, som blev opnået efter 100 mg 3 gange dagligt hos patienter med Gauchers sygdom, type 1, hvilket er i overensstemmelse med miglustats dosis-lineære farmakokinetik.
English: Printing ink
Danish: Trykfarve
English: No.
Danish: Nej.
English: Why not?
Danish: Hvorfor ikke?
English: Please note that this is an unofficial acronym.
Danish: Bemærk, at dette er et uofficielt akronym.
English: The Agency will reply in the same language.
Danish: Agenturet vil svare på samme sprog.
English: These are not always on the same days as the national holidays in the United Kingdom or other Member States.
Danish: Dette er ikke altid på de samme dage som de nationale helligdage i Det Forenede Kongerige eller andre medlemsstater.
English: Sales are dealt with at a national level.
Danish: Salg behandles på nationalt plan.
English: Fees are adjusted each year for inflation.
Danish: Gebyrerne justeres hvert år for inflation.
English: 13 February 2017
Danish: 13. februar 2017
English: Each EPAR includes a summary for the public
Danish: Hver EPAR omfatter et sammendrag for offentligheden.
English: Each organisation is re-evaluated every two years.
Danish: Alle organisationer revurderes hvert andet år.
English: Frequently asked questions EMA/527628/2011
Danish: Ofte stillede spørgsmål EMA/527628/2011
English: Please give as much background information as possible to help us answer your query effectively.
Danish: Du bedes give så mange baggrundsoplysninger som muligt for at hjælpe os med at besvare din forespørgsel effektivt.
English: EMA/527628/2011 Rev. 1 Directorate
Danish: EMA/527628/2011 Rev. 1 Direktionen
English: When is the Agency open?
Danish: Hvornår er agenturet åbent?
English: These frequently asked questions are also available in all EU languages.
Danish: Disse ofte stillede spørgsmål er også tilgængelige på alle EU-sprog.
English: • authorised through national procedures and not centrally through EMA.
Danish: • er godkendt ved nationale procedurer og ikke centralt via EMA.
English: The medicine you are looking for may be:
Danish: Det kan være, at det lægemiddel, du søger:
English: These are publicly available.
Danish: Disse erklæringer er offentligt tilgængelige.
English: Journalists and other representatives of the press should contact our press office directly at press@ema.europa.eu.
Danish: Journalister og andre repræsentanter for pressen skal kontakte vores pressekontor direkte på press@ema.europa.eu.
English: What acronym should I use for the Agency?
Danish: Hvilket akronym skal jeg bruge for agenturet?
English: The Agency's normal business hours are 9.00am to 5.30pm, Monday to Friday.
Danish: Agenturets normale åbningstider er mandag til fredag fra kl. 9.00 til 17.30.
English: These are also published on EMA's homepage.
Danish: Disse offentliggøres også på EMA's hjemmeside.
English: Each member and expert make an annual declaration of their financial interests.
Danish: Alle medlemmer og eksperter afgiver hvert år en erklæring om deres økonomiske interesser.
English: The Agency's old acronym of 'EMEA' should not be used any longer.
Danish: Det tidligere akronym for agenturet, "EMEA", må ikke længere bruges.
English: The European Medicines Agency does not control:
Danish: Det Europæiske Lægemiddelagentur kontrollerer ikke følgende:
English: • cosmetics.
Danish: • Kosmetik.
English: The European Commission follows the opinion of the Agency in almost all cases.
Danish: Europa-Kommissionen følger agenturets anbefaling i næsten alle tilfælde.
English: Questions about pricing, sales and patents
Danish: Spørgsmål om prisfastsættelse, salg og patenter
English: Citizens can submit questions to the Agency in any official EU language.
Danish: Borgerne kan indsende spørgsmål til agenturet på alle de officielle EU-sprog.
English: The Agency is closed for holidays on various days throughout the year.
Danish: Agenturet holder ferielukket på forskellige dage i løbet af året.
English: These documents can be found on the webpages of the respective committees.
Danish: Disse dokumenter kan findes på de pågældende udvalgs websider.
English: How is the financial transparency of patient and consumer organisations evaluated?
Danish: Hvordan vurderes den økonomiske gennemsigtighed med hensyn til patient- og forbrugerorganisationer?
English: There are also two routes to allow companies to gain authorisation in more than one country: the mutual-recognition procedure and the decentralised procedure.
Danish: Virksomhederne kan også opnå godkendelse i mere end et land på to måder: den gensidige anerkendelsesprocedure og den decentrale procedure.
English: The Agency publishes the rules on these fees, including a list of the fees charged for each type of procedure.
Danish: Agenturet offentliggør reglerne om disse gebyrer, herunder en liste over de gebyrer, der opkræves for hver type procedure.
English: The Agency's Management Board is also made up of representatives of Member States and members nominated by the European Commission.
Danish: Agenturets bestyrelse består også af repræsentanter for medlemsstaterne og medlemmer, der er udpeget af Europa-Kommissionen.
English: The Agency is not responsible for patents on medicines: issues regarding patent law are not within the Agency's remit.
Danish: Agenturet er ikke ansvarligt for patenter på lægemidler: Spørgsmål vedrørende patentlovgivningen hører ikke under agenturets kompetenceområde.
English: This is a set of documents that explains the scientific conclusion reached by the Agency's Committees at the end of the evaluation process.
Danish: Det er en samling dokumenter, der forklarer den videnskabelige konklusion, som agenturets udvalg er nået frem til ved afslutningen af vurderingsprocessen.
English: Food supplements are evaluated at national level, usually by the authorities that deal with food safety and labelling.
Danish: Kosttilskud vurderes på nationalt plan, sædvanligvis af de myndigheder, der beskæftiger sig med fødevaresikkerhed og mærkning.
English: The members of the Agency's Management Board and scientific committees, and its experts and staff are not permitted to have financial or other interests in the pharmaceutical industry that could affect their impartiality.
Danish: Medlemmerne af agenturets bestyrelse og videnskabelige udvalg samt dets eksperter og personale må ikke have økonomiske eller andre interesser i lægemiddelindustrien, som kunne få indflydelse på deres upartiskhed.
English: • still in development and not yet authorised;
Danish: • stadig er under udvikling og endnu er ikke godkendt
English: Is the Agency's website available in languages other than English?
Danish: Er agenturets websted tilgængeligt på andre sprog end engelsk?
English: How are the Agency's committee members selected?
Danish: Hvordan vælges agenturets udvalgsmedlemmer?
English: To stay up to date with the latest news, features and publications from the Agency, you can subscribe to our RSS feeds or follow EMA on Twitter.
Danish: For at holde dig opdateret med de seneste nyheder, artikler og publikationer fra agenturet kan du tilmelde dig vores RSS-feeds eller følge os på Twitter.
English: It can also give scientific opinions on medicines at the request of Member States or the European Commission.
Danish: Det kan også afgive videnskabelige udtalelser om lægemidler på opfordring af medlemsstater eller EuropaKommissionen.
English: Most of the members of the Agency's six scientific committees are nominated by the Member States or the European Commission.
Danish: De fleste medlemmer af agenturets seks videnskabelige udvalg udpeges af medlemsstaterne eller Europa-Kommissionen.
English: The European Medicines Agency charges pharmaceutical companies fees for the services it provides.
Danish: Det Europæiske Lægemiddelagentur opkræver gebyrer hos lægemiddelvirksomhederne for de tjenesteydelser, som det udfører.
English: Are all medicines approved via the Agency?
Danish: Godkendes alle lægemidler via agenturet?
English: I am experiencing a side effect from a medicine.
Danish: Jeg oplever en bivirkning ved et lægemiddel.
English: • not classified as a medicine but as a medical device or a nutritional supplement, both of which are authorised at national level.
Danish: • ikke er klassificeret som et lægemiddel, men som medicinsk udstyr eller kosttilskud, der godkendes nationalt.
English: How can I get hold of a medicine that is not yet authorised?
Danish: Hvordan kan jeg få fat i et lægemiddel, der endnu ikke er godkendt?
English: They are not usually evaluated by medicines regulatory authorities, unless they contain a substance that has pharmacological activity or make a medicinal claim.
Danish: De vurderes normalt ikke af lægemiddelmyndighederne, medmindre de indeholder et stof, der har farmakologisk aktivitet eller tilskrives en medicinsk virkning.
English: The Agency's main responsibility is the protection and promotion of public and animal health, by carrying out scientific evaluations of medicines for human and veterinary use.
Danish: Agenturets hovedansvar er beskyttelse og fremme af folke- og dyresundheden ved hjælp af videnskabelige vurderinger af human- og veterinærmedicinske lægemidler.
English: Some content is translated into other official European Union (EU) languages, including public summaries and product information in European public assessment reports (EPARs), question-and-answer documents for the public, information on recruitment, work programmes and summaries of the annual report.
Danish: Noget indhold er oversat til andre officielle EU-sprog, f.eks. sammendrag for offentligheden og produktinformation i europæiske offentlige vurderingsrapporter (EPAR'er), dokumenter med spørgsmål og svar til offentligheden, information om rekruttering, arbejdsprogrammer og resuméer af årsberetningen.
English: The Agency does not have any commercial interests and does not get involved in the distribution of medicines.
Danish: Agenturet har ingen kommercielle interesser og er ikke involveret i distributionen af lægemidler.
English: How can I keep up to date with the Agency's opinions?
Danish: Hvordan kan jeg holde mig ajour med agenturets udtalelser?
English: The Agency publishes information about all the medicines it assesses as a European public assessment report (EPAR).
Danish: Agenturet offentliggør oplysninger om alle de lægemidler, det vurderer, i form af en europæisk offentlig vurderingsrapport (EPAR).
English: The Agency requires every patient and consumer organisation that it works with to provide financial statements, including details on donors and their contributions.
Danish: Agenturet kræver, at alle patient- og forbrugerorganisationer, som det samarbejder med, afgiver økonomiske redegørelser, herunder oplysninger om bidragsydere og disses bidrag.
English: Questions about competing interests and transparency
Danish: Spørgsmål om modstridende interesser og gennemsigtighed
English: These spontaneous reports of suspected side effects by healthcare professionals, patients or carers are used to continuously monitor the safety of medicines on the market and to ensure that their benefits continue to outweigh their risks.
Danish: Disse spontane indberetninger af formodede bivirkninger, der foretages af sundhedspersoner, patienter eller omsorgsgivere, anvendes med henblik på løbende overvågning af sikkerheden ved de lægemidler, der markedsføres, og for at sikre, at fordelene ved behandling hele tiden opvejer risiciene.
English: The Agency also publishes a monthly newsletter called 'human medicines highlights', which provides key information on the Agency's recent activities on human medicines.
Danish: Agenturet udgiver også et månedligt nyhedsbrev, "Human Medicines Highlights", med oplysninger om agenturets seneste aktiviteter inden for lægemidler til mennesker.
English: Can the Agency tell me when a medicine will be approved?
Danish: Kan agenturet oplyse mig om, hvornår et lægemiddel vil blive godkendt?
English: Questions about the Agency's website
Danish: Spørgsmål om agenturets websted
English: What type of information is available on a medicine evaluated by the Agency?
Danish: Hvilken type oplysninger foreligger der om et lægemiddel, der er blevet vurderet af agenturet?
English: If you would like to take part in a clinical trial, you should discuss it with your doctor or nurse, who may be able to refer you for a suitable trial.
Danish: Hvis du ønsker at deltage i en klinisk undersøgelse, bør du drøfte dette med din læge eller sygeplejerske, som eventuelt vil kunne henvise dig til en passende undersøgelse.
English: The Agency is not involved in recruiting volunteers for clinical trials.
Danish: Agenturet er ikke involveret i rekrutteringen af frivillige til kliniske undersøgelser.
English: If appropriate, please give the type of organisation you represent (e.g. patient organisation, pharmaceutical company, etc.)
Danish: Hvis det er relevant, bedes du angive, hvilken type organisation du repræsenterer (f.eks. patientorganisation, medicinalvirksomhed osv.).