natgillin/translations-raw huggingface dataset:
Bivirkninger rapporteret for Miglustat Dipharma vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Miglustat Dipharma are carefully evaluated and any necessary action taken to protect patients.
• 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. 
• 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.
Miglustat Dipharma anvendes til behandling af de neurologiske symptomer på sygdommen (symptomer, der påvirker hjernen og nerverne). 
Miglustat Dipharma is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Lægemidlet udleveres kun efter recept, og behandlingen bør følges af læger med erfaring i håndtering af Gauchers sygdom. 
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.
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. 
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.
Begge sygdomme forårsager en ophobning af fedtstoffer, der kaldes glycosphingolipider i kroppen. 
Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
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. 
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.
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. 
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.
Som for alle lægemidler bliver data vedrørende brug af Miglustat Dipharma løbende overvåget. 
As for all medicines, data on the use of Miglustat Dipharma are continuously monitored.
Miglustat Dipharma anvendes til behandling af to arvelige sygdomme, der påvirker den måde, kroppen håndterer fedt på. 
Miglustat Dipharma is used to treat two inherited diseases that affect the way the body handles fats.
Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Miglustat Dipharma. 
As for every medicine, the company provided studies on the quality of Miglustat Dipharma.
Ved at forhindre enzymet i at virke kan miglustat mindske produktionen af glucosylceramid i cellerne og derved reducere symptomerne på Gauchers sygdom, type 1. 
By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Miglustat Dipharma anvendes til patienter, der ikke kan få standardbehandlingen enzymerstatningsbehandling (ERT) 
Miglustat Dipharma is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
En oversigt over Miglustat Dipharma, og hvorfor det er godkendt i EU 
An overview of Miglustat Dipharma and why it is authorised in the EU
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Miglustat Dipharma? 
What measures are being taken to ensure the safe and effective use of Miglustat Dipharma?
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. 
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.
Hvilke fordele og risici er der forbundet med Miglustat Dipharma? 
What are the benefits and risks of Miglustat Dipharma?
Miglustat Dipharma er et "generisk lægemiddel". 
Miglustat Dipharma is a ‘generic medicine'.
Til Niemann-Picks sygdom type C er det to kapsler tre gange dagligt for patienter i alderen 12 år og derover. 
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.
Miglustat Dipharma fås som kapsler (100 mg), der tages gennem munden. 
Miglustat Dipharma is available as 100 mg capsules to be taken by mouth.
Miglustat Dipharma anvendes til behandling af følgende patienter: 
Miglustat Dipharma is used to treat the following patients:
Dette enzym har betydning for det første trin i dannelsen af glucosylceramid. 
This enzyme is involved in the first step of the production of glucosylceramide.
Andre oplysninger om Miglustat Dipharma 
Other information about Miglustat Dipharma
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. 
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.
Det aktive stof i Miglustat Dipharma, miglustat, blokerer virkningen af enzymet glucosylceramidsyntase. 
The active substance in Miglustat Dipharma, miglustat, blocks an enzyme called glucosylceramide synthase.
Hvad er Miglustat Dipharma, og hvad anvendes det til? 
What is Miglustat Dipharma and what is it used for?
Miglustat Dipharma er beregnet til langtidsbehandling. 
Miglustat Dipharma is intended for long-term use.
Hvorfor blev Miglustat Dipharma godkendt i EU? 
Why is Miglustat Dipharma authorised in the EU?
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. 
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.
Det medfører, at et glycosphingolipid kaldet glucosylceramid ophobes flere steder i kroppen, f.eks. i milten, leveren og knoglerne. 
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.
Hvordan blev Miglustat Dipharma undersøgt? 
How has Miglustat Dipharma been studied?
Hvordan anvendes Miglustat Dipharma? 
How is Miglustat Dipharma used?
Hvordan virker Miglustat Dipharma? 
How does Miglustat Dipharma work?
[nedenstående, aktuelt godkendte indikationer skal slettes (den specifikke ordlyd af indikationen kan variere fra produkt til produkt)] 
[the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Bilag III Ændringer til relevante afsnit i produktresuméer og indlægssedler 
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Alle henvisninger til ovennævnte indikationer skal slettes i de relevante afsnit i indlægssedlerne. 
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
• Symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk svækkelse hos ældre (eksklusive Alzheimers sygdom og andre demenssygdomme) 
• Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
• Profylaktisk mod migrænehovedpine Alle henvisninger til ovennævnte indikationer skal slettes i de øvrige afsnit i produktresuméerne. 
• Prophylaxis of migraine headache All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
• Akut retinopati af vaskulær oprindelse 
• Acute retinopathies of vascular origin
• Supplerende behandling af Raynauds syndrom 
• Ancillary treatment of Raynaud's syndrome
• Supplerende behandling af claudicatio intermittens ved symptomatisk perifer arteriel okklusiv sygdom (PAOD stadie II) 
• Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)
A. Produktresuméer 
A. Summary of Product Characteristics
• Supplerende behandling af synsnedsættelse og synsfeltforstyrrelser, der formodes at have vaskulær oprindelse 
• Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
B. Indlægssedler 
4.1 Therapeutic indications
Anvendelsesområder 
B. Package Leaflet
Dette blev afspejlet i produktinformationen, så denne informerer sundhedspersoner og patienter tilstrækkeligt herom. 
This was reflected in the product information in order to adequately inform healthcare providers and patients.
PRAC reviderede derfor indikationen i henhold hertil. 
The PRAC therefore revised the indication accordingly.
Som resultat af gennemgangen anbefalede PRAC suspendering af markedsføringstilladelserne for disse produkter. 
As a result of the review, the PRAC recommended the suspension of the marketing authorisations of these products.
PRAC's anbefaling 
PRAC recommendation
Bilag II Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne 
Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
PRAC fandt oplysningerne om den kliniske udvikling af acipimox meget begrænsede, og bemærkede, at der ikke var udført undersøgelser af de kliniske udfald. 
The PRAC considered that the clinical development data on acipimox was very limited and noted that no clinical outcome studies were conducted.
PRAC vedtog desuden, at acipimox ikke burde være indiceret til at øge HDL-C eller til kardiovaskulær profylakse i henhold til de nyere data, der rejser tvivl om sammenhængen mellem forhøjelse af HDL-C-niveauet og nedsættelse af kardiovaskulær sygdomsrisiko. 
The PRAC also agreed that acipimox should not be indicated for increasing HDL-C or for cardiovascular prevention in line with the recent data casting doubts on the association between elevating HDL-C levels and reducing the risk of cardiovascular disease.
Efter gennemførelsen af disse procedurer var PRAC af den opfattelse, at betænkelighederne vedrørende kombinationsprodukterne også kan være relevante for monokomponentprodukterne, hvorfor Sundhedsstyrelsen i Danmark indledte en gennemgang i henhold til artikel 31 i direktiv 2001/83/EF for at vurdere betydningen af dataene fra HPS2-THRIVE for benefit/risk-forholdet for disse produkter og fremsætte en anbefaling om, hvorvidt markedsføringstilladelserne for dem burde opretholdes, ændres, suspenderes eller inddrages, og om udlevering af lægemidlet burde forbydes. 
Following the conclusion of these procedures, the PRAC was of the view that the concerns regarding the combination products may also be of relevance for the mono-component products and the Danish Health and Medicines Authority therefore initiated a review under Article 31 of Directive 2001/83/EC to assess the impact of the HPS2-THRIVE data on the benefitrisk balance of these products and to give its recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked and if the supply of the medicinal product should be prohibited.
De foreliggende sikkerhedsdata for acipimox, herunder data om nicotinsyre fra HPS2-THRIVE, viste, at sikkerhedsprofilen af acipimox er velkarakteriseret. 
The safety data available for acipimox, including data on nicotinic acid obtained from HPS2-THRIVE, showed that the safety profile of acipimox is well characterised.
De indledende resultater af HPS2-THRIVE-undersøgelsen viste, at undersøgelsen ikke nåede sit primære endepunkt (reduktion af risiko for større vaskulære hændelser såsom hjerteanfald og slagtilfælde), og at der var en statistisk signifikant stigning i forekomsten af ikke-fatale, men alvorlige bivirkninger i gruppen på nicotinsyre/laropiprant i forhold til placebogruppen. 
The preliminary results of the HPS2-THRIVE study showed that the study did not meet its primary endpoint (reduction of the risk of major vascular events such as heart attack and stroke) as well as a statistically significant increase in the incidence of non-fatal but serious adverse events in the nicotinic acid/laropiprant group compared to the placebo group.
PRAC bemærkede endvidere, at de foreliggende data ifølge eksperterne ikke havde større betydning for sikkerhedsprofilen af acipimox. 
The PRAC also noted that according to the experts, the current data available did not have any major impact on the safety profile of acipimox.
Den 19. december 2012 blev Det Europæiske Lægemiddelagentur gjort opmærksom på de indledende resultater af en stor randomiseret klinisk undersøgelse (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE), der var beregnet til at fastlægge den supplerende fordel af en depotformulering af nicotinsyre (ERN)/laropiprant (LRPT) i forhold til placebo hos mere end 25 673 højrisikopatienter. 
On 19 December 2012, the European Medicines Agency was made aware of preliminary results from a large randomised clinical study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE) designed to assess the incremental benefit of extended release nicotinic acid (ERN)/laropiprant (LRPT) versus placebo in over 25,673 high-risk patients.
Alligevel fandt PRAC, at virkningen af acipimox var godtgjort til at sænke blodlipiderne hos patienter med visse former for hyperlipoproteinæmi. 
Nevertheless, the PRAC considered that the efficacy of acipimox in lowering blood lipids in patients with some forms of hyperlipoproteinaemia is demonstrated.
• PRAC vurderede den procedure i henhold til artikel 31 i direktiv 2001/83/EF, der var foranlediget af lægemiddelovervågningsdata for nicotinsyre og beslægtede stoffer og var indledt af Danmark, og besluttede at indskrænke proceduren til produkter indeholdende acipimox, der er det eneste højdosismiddel beslægtet med nicotinsyre, som er godkendt til lipidforstyrrelser i EU, 
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for nicotinic-acid and related substances initiated by Denmark and decided to restrict the scope of the procedure to products containing acipimox, the only high-dose nicotinic acid-related substance indicated in lipid disorders authorised in the EU;
Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) gennemgik alle foreliggende data for at vurdere de nævnte sikkerhedsmæssige problemer og betydningen heraf for benefit/risk-forholdet for de centralt godkendte kombinationsprodukter Tredaptive, Trevaclyn og Pelzont. 
A review of all available data was undertaken by the Pharmacovigilance Risk Assessment Committee (PRAC) to assess the above safety concerns and their impact on the benefit-risk balance of the centrally authorised combination products Tredaptive, Trevaclyn and Pelzont.
Efter gennemgang af listen over EU-produkter indeholdende nicotinsyre eller stoffer beslægtet hermed bemærkede PRAC, at acipimox er det eneste højdosismiddel, der stadig er godkendt i EU til lipidforstyrrelser, hvorfor proceduren blev indskrænket til produkter indeholdende acipimox. 
Having reviewed the list of EU products containing nicotinic acid or related substances, the PRAC noted that acipimox is the only high-dose substance indicated in lipid disorders still authorised in the EU and the scope of the procedure was therefore restricted to acipimox-containing products.
Størstedelen af de fundne bivirkninger afspejler sig i forvejen i produktinformationen for acipimox, og PRAC fandt, at de foreliggende data ikke viste nye sikkerhedsoplysninger af betydning for benefit/risk-forholdet for acipimox bortset en potentiel risiko for muskeltoksicitet, der blev taget i betragtning med tilføjelse af en advarsel i produktinformationen. 
Most identified adverse events are already reflected in the acipimox product information and the PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity, which was addressed by adding a warning to the product information.
Det bemærkedes, at acipimox var særlig nyttigt hos patienter, der enten ikke tåler et statin eller ikke opnår målværdierne for triglycerider med statinbehandling alene, og at det derfor kunne anvendes som et alternativ eller supplement for at sænke triglyceridniveauet hos sådanne patienter. 
It was noted that acipimox was of particular use in patients who either do not tolerate a statin or do not achieve triglyceride goals with statin therapy alone and could therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
PRAC tog desuden hensyn til synspunkterne hos de europæiske eksperter, der blev rådspurgt på et ad hoc-ekspertmøde, ifølge hvilke acipimox har en rolle som lipidsænkende behandling under forudsætning af veldefinerede rammer og indikationer såsom behandling af svær hypertriglyceridæmi, men kun som andet- eller tredjevalg. 
The PRAC also took into account the views of the European experts consulted in an Ad-Hoc expert meeting, according to which acipimox has a role as lipid-lowering therapy in well-defined settings and indications, such as the treatment of severe hypertriglyceridaemia but only as a second or third line agent.
Efter gennemgang af sagen anbefalede PRAC derfor ændring af markedsføringstilladelsen for produkter indeholdende acipimox. 
Having considered the matter, the PRAC therefore recommended the variation of the marketing authorisations for acipimox-containing medicinal products.
PRAC konkluderede, at benefit/risk-forholdet for produkter indeholdende acipimox fortsat er positivt ved normale anvendelsesbetingelser under forudsætning af de vedtagne ændringer af produktinformationen. 
The PRAC concluded that the benefit-risk balance of acipimox-containing products remains favourable under normal conditions of use, subject to the agreed changes to the product information.
Efter gennemgang af PRAC's anbefaling af 7. november 2013 tog CMDh i henhold til artikel 107k i direktiv 2000/83/EF stilling til ændringen af betingelserne for markedsføringstilladelserne for acipimox, for hvilke de relevante afsnit af produktresuméet og indlægssedlerne fremgår af bilag III. 
The CMDh, having considered the PRAC recommendation pursuant to article 107k of Directive 2001/83/EC dated 7 November 2013, reached a position on the variation to the terms of the marketing authorisations of acipimox for which the relevant sections of the summary of product characteristics and package leaflets are set out in Annex III.
• PRAC gennemgik alle foreliggende data, herunder undersøgelser og publikationer om acipimox, besvarelserne fra markedsføringstilladelsesindehaveren samt relevante data om nicotinsyre, herunder AIM-HIGH- og HPS2-THRIVE-undersøgelserne, 
• The PRAC reviewed the totality of the available data, including studies and publications on acipimox, the MAH responses as well as relevant data on nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies;
Efter gennemgang af alle foreliggende data, herunder undersøgelser og publikationer om acipimox og data om det beslægtede stof nicotinsyre, herunder AIM-HIGH- og HPS2-THRIVE-undersøgelserne, fandt PRAC, at virkningen af acipimox til behandling af visse veldefinerede lipidforstyrrelser var godtgjort, og at acipimox derfor fortsat er et behandlingsalternativ ved lipidforstyrrelser karakteriseret af forhøjet plasmaniveau af triglycerider (hyperlipoproteinæmi Fredrickson type IV) eller af både triglycerider og kolesterol (hyperlipoproteinæmi Fredrickson type Iib). 
Having reviewed all the available data, including studies and publications on acipimox as well as data on the related substance nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies, the PRAC considered the efficacy of acipimox in the treatment of certain well-defined lipid disorders to be demonstrated and that acipimox therefore remains a treatment alternative in the management of lipid disorders characterised by elevated plasma levels of triglycerides (Fredrickson type IV hyperlipoproteinaemia), or both triglycerides and cholesterol
Ud fra de foreliggende data samt produktets nuværende anvendelse og på grundlag af råd fra eksperterne var PRAC imidlertid den opfattelse, at acipimox kun bør anvendes til nedsættelse af triglyceridniveauet hos patienter, der enten ikke tåler statin eller fibrater, eller som ikke opnår målværdierne for triglycerider med statin eller fibrater alene, hvorfor det bør anvendes som et alternativ eller supplement til at nedsætte triglyceridniveauet hos sådanne patienter. 
However, taking into account the available data as well as the current use of the product and on the basis of expert advice, the PRAC was of the opinion that acipimox should only be used to reduce triglyceride levels in patients who either do not tolerate statin or fibrates or who do not achieve triglyceride goals with statin or fibrate therapy alone and should therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
• PRAC fandt, at acipimox er effektivt til at nedsætte triglyceridindholdet hos patienter med hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IV) og med hyperkolesterolæmi og hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type Iib), men - på grundlag af den foreliggende evidens, herunder den nuværende kendskab til anvendelsen af acipimox - kun som andet- eller tredjevalg hos patienter, der ikke har responderet tilfredsstillende på andre midler såsom statin eller fibrater, 
• The PRAC considered that acipimox is efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia) but only, on the basis of available evidence including current medical knowledge on the use of acipimox, as a second or third line agent in patients who have not responded adequately to other treatments such as statin or fibrate treatment;
På grundlag af de foreliggende data fandtes acipimox at være effektivt til at sænke triglyceridniveauet hos patienter med hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IV) og signifikant superiort over placebo hos patienter med hyperkolesterolæmi og hypertriglyceridæmi (hyperlipoproteinæmi Fredrickson type IIb). 
Based on the available data, acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human)) har gennemgået PRAC's nedenstående anbefaling af 7. november 2013 for lægemidler indeholdende stoffer beslægtet med nicotinsyre (acipimox), der er indiceret til behandling af lipidforstyrrelser. 
The CMDh considered the below PRAC recommendation dated 7 November 2013 with regard to substances related to nicotinic acid (acipimox) indicated for the treatment of lipid disorders.