natgillin/translations-raw huggingface dataset:
Grækenland Pharmanel Commercial Pharmaceutical S.A. 
Greece Pharmanel Commercial Pharmaceutical S.A.
Metforminhydrochlorid 1g Tablet 
Metformin Hydrochloride 1g Tablet
Storbritannien Milpharm Limited 
Milpharm Limited
Metformine Hcl/Glibenclamid Sandoz 
Metformine Hcl/Glibenclamide Sandoz
Storbritannien Special Concept Development (Uk) Ltd 
Special Concept Development (Uk) Ltd
Tablet med modificeret udløsning 
Modified-Release Tablet
Metformina Glibenclamid Sandoz 
Metformina Glibenclamide Sandoz
Luxembourg Merck N.V.-S.A. 
Belgium Merck N.V.-S.A.
Luxembourg Sandoz N.V. 
Belgium Sandoz N.V.
Storbritannien Genus Pharmaceuticals Ltd. 
Genus Pharmaceuticals Ltd.
Boehringer Ingelheim International GmbH 
Iceland Boehringer Ingelheim International Gmbh
Storbritannien Metwest Pharmaceuticals Limited Metformin Metwest Pharmaceuticals 
Metwest Pharmaceuticals Limited Metformin Metwest Pharmaceuticals
Storbritannien Medley Pharma Limited 
United Medley Pharma Limited
Metforminhydrochlorid 1000mg/1117 Mg 
Metformin Hydrochloride 1000mg/1117 Mg
Storbritannien Morningside Healthcare Ltd 
United Morningside Healthcare Ltd
Storbritannien Merck Serono Ltd. 
Ireland Merck Serono Ltd.
Storbritannien Mercury Pharmaceuticals Ltd. 
United Mercury Pharmaceuticals Ltd.
Irland 
Portugal
Storbritannien Tillomed Laboratories Ltd 
United Tillomed Laboratories Ltd
Storbritannien Crescent Pharma Limited 
Crescent Pharma Limited
Metformin Accedo Swiss Caps Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformin Accedo Swiss Caps Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Storbritannien Generics [uk] Limited 
Romania Generics [uk] Limited
Storbritannien Actavis Group Ptc Ehf. 
Finland Actavis Group Ptc Ehf.
Metforminhydrochlorid 1000mg 
Metformin Hydrochloride 1000mg
Letland 
Italy
Amneal Pharma Europe Limited 
Amneal Pharma Europe Limited Metformina Amneal
Metforminhydrochlorid 170mg/Ml 
Metformin Hydrochloride 170mg/Ml
Storbritannien Glenmark Generics (Europe) Limited Metformin Hydrochloride Glenmark Generics Europe 
Metformin Hydrochloride Glenmark Generics Europe
Metforminhydrochlorid 400mg Kapsel, Glibenclamid 2.5mg Kapsel 
Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Metformin Chelonia Healthcare Metforminhydrochlorid Bp 500mg Filmovertrukket tablet 
Metformin Chelonia Healthcare Metformin Hydrochloride Bp 500mg
Metforminhydrochlorid 850mgg 
Metformin Hydrochloride 850mgg
Metformin Wockhardt Uk Ltd Metforminhydrochlorid 850mg Tablet Overtrukket tablet 
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Metformin Wockhardt Uk Ltd Metforminhydrochlorid 500mg Tablet Overtrukket tablet 
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Metforminhydrochlorid 850mg 
Metformin Hydrochloride 850mg
Metformin Hcl Plus Pharmacie Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Grækenland Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont 
Greece Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
Metforminhydrochlorid 500ml/5 Ml 
Metformin Hydrochloride 500ml/5 Ml
Metforminhydrochlorid 500mg Film Filmovertrukket tablet 
Metformin Hydrochloride 500mg Film Film-Coated Tablet
Storbritannien Sandoz Ltd 
Sandoz Ltd
Metforminhydrochlorid 1000mg Tablet, Saxagliptin 2.5mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Metforminhydrochlorid 1000mg Tablet, Linagliptin 2.5mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Metforminhydrochlorid 850mg Tablet, Alogliptin 25mg Tablet 
Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Metforminhydrochlorid 850mg Tablet, Dapagliflozin 5mg Tablet 
Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Metforminhydrochlorid 1000mg Tablet, Empagliflozin 12.5mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Metformine Arrow Generiques Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metforminhydrochlorid 850mg Tablet, Linagliptin 2.5mg Tablet 
Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Metforminhydrochlorid 850mg Tablet, Saxagliptin 2.5mg Tablet 
Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Metforminhydrochlorid 1000mg Tablet, Sitagliptin 50mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Storbritannien Aurobindo Pharma Limited 
Romania Aurobindo Pharma Limited
Metforminhydrochlorid 1000mg Tablet Tablet 
Metformin Hydrochloride 1000mg Tablet Tablet
Metforminhydrochlorid 100mg/Ml 
Metformin Hydrochloride 100mg/ Ml
Metforminhydrochlorid 100mg/ Ml 
Metformin Hydrochloride 100mg/Ml
Metforminhydrochlorid 1000mg Tablet, Dapagliflozin 5mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Metforminhydrochlorid 850mg Tablet, Alogliptin 12.5mg Tablet 
Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Metforminhydrochlorid 1000mg Tablet Dispergibel tablet 
Metformin Hydrochloride 1000mg Tablet Dispersible Tablet
Metforminhydrochlorid 500mgg 
Metformin Hydrochloride 500mgg
Metforminhydrochlorid 500mg Enheder 
Metformin Hydrochloride 500mg Units
Metforminhydrochlorid 1000µg Tablet Filmovertrukket tablet 
Metformin Hydrochloride 1000µg Tablet Film-Coated Tablet
Metformin Hcl Plus Pharmacie Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformin Hcl Plus Pharmacie Metformin Hydrochloride 850mg Tablet
Ljubljana Metformin/Glibenklamid Lek Metforminhydrochlorid 500mg Tablet, Glibenclamid 5mg Tablet 
Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Metforminhydrochlorid 1000mg Film Filmovertrukket tablet 
Metformin Hydrochloride 1000mg Film Film-Coated Tablet
Metformin Crescent Pharma Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Metforminhydrochlorid 850mg Tablet, Empagliflozin 5mg Tablet 
Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Metformin Lindopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Metforminhydrochlorid 500mg/5 Ml 
Metformin Hydrochloride 500mg/5 Ml
Metformin Lindopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Metforminhydrochlorid 1000mg Tablet, Canagliflozin 150mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Metforminhydrochlorid 1000mg Brev Pulver til oral opløsning i brev 
Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
Metforminhydrochlorid 850mg Tablet, Empagliflozin 12.5mg Tablet 
Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Ljubljana Metformin/Glibenklamid Lek Metforminhydrochlorid 500mg Tablet, Glibenclamid 2.5mg Tablet 
Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Metforminhydrochlorid 1000mg Tablet, Empagliflozin 5mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Metforminhydrochlorid 500mg Brev Pulver til oral opløsning i brev 
Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
Metforminhydrochlorid 850mg Brev Pulver til oral opløsning i brev 
Metformin Hydrochloride 850mg Sachet Powder For Oral Solution In Sachet
Metformin Crescent Pharma Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Metforminhydrochlorid 850mg Tablet, Sitagliptin 50mg Tablet 
Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Metforminhydrochlorid 1000mg Tablet, Canagliflozin 50mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Metforminhydrochlorid 850mg Tablet, Canagliflozin 50mg Tablet 
Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Metforminhydrochlorid 850mg Tablet, Canagliflozin 150mg Tablet 
Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Metformin Hcl Plus Pharmacie Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformin Hcl Plus Pharmacie Metformin Hydrochloride 500mg Tablet
Metforminhydrochlorid 1000mg Tablet, Glibenclamid 5mg Tablet 
Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Metforminhydrochlorid 500mg 
Metformin Hydrochloride 500mg
Metforminhydrochlorid 850mg Tablet, Pioglitazon 15mg Tablet 
Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Metforminhydrochlorid 2.5mg Tablet, Glibenclamid 500mg Tablet 
Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Metforminhydrochlorid 400mg Tablet, Glibenclamid 2.5mg Tablet 
Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Metforminhydrochlorid 400mg Tablet, Glibenclamid 5mg Tablet 
Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Storbritannien Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals 
Ireland Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Metforminhydrochlorid 500mg Tablet, Glibenclamid 5mg Tablet 
Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Metformin Hcl Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Metforminhydrochlorid 500mg Tablet, Glibenclamid 2.5mg Tablet 
Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Metformin-Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin Hcl Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Hcl Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformine Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformine Hcl Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformine Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin-Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Metforminhydrochlorid 500mg G Depottablet 
Metformin Hydrochloride 500mg G
Metformin Hcl Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformine Hcl Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformine Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformina Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet 
Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformina Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Holland 
Kingdom
Metformine Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet 
Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformina Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet 
Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
28 Table 
Pack size
7 Tablets 
Pharmaceutical Form Route of Administration
Visse patienter blev behandlet i op til fem et halvt år. 
Some patients were treated for up to five and a half years.
Det fås som kapsler (100 mg). 
It is available as capsules (100 mg).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zavesca den 20. november 2002. 
The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
• Gauchers sygdom 
• Gaucher disease;
Andre oplysninger om Zavesca: 
Other information about Zavesca:
Hovedparten af undersøgelsen varede i et år, men 13 patienter blev ved med at modtage lægemidlet i yderligere to år. 
The main part of the study lasted for a year, but 13 patients carried on receiving the medicine for a further two years.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zavesca. 
This document is a summary of the European Public Assessment Report (EPAR) for Zavesca.
Da virksomheden havde indsendt de yderligere oplysninger, den var blevet anmodet om, overgik godkendelsen til normal status den 23. august 2012. 
As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
EPAR - sammendrag for offentligheden miglustat 
EPAR summary for the public miglustat
Zavesca anvendes til behandling af følgende patienter: 
Zavesca is used to treat the following patients:
Zavesca er beregnet til langvarig brug. 
Zavesca is intended for long-term use.
Der kunne også konstateres en lille forbedring af blodbilledet: mængden af hæmoglobin blev i gennemsnit øget med 0,26 g pr. deciliter og blodpladetallene med 8,29 mio. pr. milliliter. 
There were also small improvements in blood counts: on average, the levels of haemoglobin increased by 0.26 g per decilitre and platelet counts increased by 8.29 million per millilitre.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Zavesca. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zavesca.
Undersøgelsen viste, at Zavesca førte til en stabilisering eller et fald i andelen af symptomer, der blev værre, hos ca. trefjerdele af patienterne. 
The survey showed that Zavesca led to a stabilisation or a decrease in the rate at which symptoms got worse in about three-quarters of the patients.
• Niemann-Picks sygdom type C. 
• Niemann-Pick type C disease.
Dosen skal desuden midlertidigt reduceres hos patienter, der får diarré. 
The dose should also be reduced temporarily in patients who develop diarrhoea.
CHMP besluttede, at fordelene ved Zavesca opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse. 
The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
De gavnlige virkninger af Zavesca holdt i tre år med kontinuerlig behandling 
The benefits of Zavesca were maintained over three years of continuous treatment.
Virksomheden fremlagde også resultaterne af en spørgeundersøgelse blandt 66 patienter, der var blevet behandlet med Zavesca. 
The company also presented the results of a survey of 66 patients treated with Zavesca.
• voksne (18 år og derover) med let til moderat Gauchers sygdom type 1. 
• adults (aged 18 years and above) with mild to moderate type 1 Gaucher disease.
Zavesca er et lægemiddel, der indeholder det aktive stof miglustat. 
Zavesca is a medicine that contains the active substance miglustat.
Zavesca anvendes til behandling af de neurologiske symptomer på sygdommen (påvirkning af hjernen og nervesystemet). 
Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
I undersøgelsen af Gauchers sygdom type 1 forekom der en moderat reduktion af levervolumenet (12 %) og miltvolumenet (19 %) efter et år. 
In the study of type 1 Gaucher disease, there were moderate reductions in the size of the liver (12% reduction) and the spleen (19% reduction) after a year.
Den fuldstændige EPAR for Zavesca findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Zavesca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Der var dog tegn på forbedringer i evnen til at synke og den intellektuelle funktion hos patienter behandlet med Zavesca. 
However, there were signs of improvement in swallowing ability and intellectual function in the patients treated with Zavesca.
Hvis du ønsker yderligere oplysninger om behandling med Zavesca, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Zavesca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
I undersøgelsen sammenlignede man virkningen af standardbehandling suppleret med Zavesca med virkningen af standardbehandling alene. 
The study compared the effects of adding Zavesca to standard care with the effects of standard care alone.
Zavesca blev oprindelig godkendt under ”særlige omstændigheder”, da der kun var begrænsede oplysninger tilgængelige om lægemidlet på godkendelsestidspunktet, fordi sygdommene er sjældne. 
Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
I undersøgelsen af Niemann-Picks sygdom type C var forbedringen i øjenbevægelserne den samme for patienter, der var blevet behandlet med og uden Zavesca. 
In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
Zavesca anvendes til behandling af to arvelige sygdomme, der påvirker måden, hvorpå kroppen håndterer fedt. 
Zavesca is used to treat two inherited diseases that affect the way the body handles fats.
Zavesca må ikke anvendes til personer, der er overfølsomme (allergiske) over for miglustat eller andre af indholdsstofferne. 
Zavesca must not be used in people who are hypersensitive (allergic) to miglustat or any of the other ingredients.
Undersøgelsen så på Zavesca effekt på størrelsen af leveren, milten, og blodbilledet, f.eks. koncentrationen af hæmoglobin (et protein, som findes i de røde blodlegemer, der transporterer ilt rundt i kroppen) og blodplader (komponenter, som hjælper blodet med at størkne). 
The study looked at the effect of Zavesca on the size of the liver and spleen, and at blood counts, such as the levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and platelets (components that help the blood to clot).
Der skal anvendes en lavere dosis til patienter med nedsat nyrefunktion. 
A lower dose should be used in patients with reduced kidney function.
Dette forventes at kunne forsinke eller forebygge udvikling af symptomer på Gauchers sygdom type 1 og reducere symptomerne på Niemann Picks sygdom type C. 
This is expected to slow down or prevent the development of the symptoms of type 1 Gaucher disease and to reduce the symptoms of Niemann-Pick type C disease.
Behandlingens virkning blev hovedsagelig bedømt på ændringen i den hastighed, hvormed patienterne foretog hurtige vandrette øjenbevægelser efter et års behandling, men undersøgelsen så også på andre neurologiske symptomer såsom patienternes evne til at synke og intellektuelle funktion. 
The main measure of effectiveness was the change in the speed at which the patients made saccadic horizontal eye movements after a year, but the study also looked at other neurological symptoms such as the patients' ability to swallow and their intellectual function.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Zavesca findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/Rare disease designations: 
The summaries of the opinions of the Committee for Orphan Medicinal Products for Zavesca on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Hvorfor blev Zavesca godkendt? 
Why has Zavesca been approved?
Hvilken risiko er der forbundet med Zavesca? 
What is the risk associated with Zavesca?
• patienter i alle aldre med Niemann-Picks sygdom type C, en potentielt dødelig sygdom, hvor glycosphingolipider ophobes i hjerneceller 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.
Yderligere oplysninger fremgår af produktresuméet (også en del af denne EPAR). 
For further information, see the summary of product characteristics (also part of the EPAR).
Dette enzym har betydning for det første trin i dannelsen af glycosphingolipider. 
This enzyme is involved in the first step of the production of glycosphingolipids.
Den anbefalede startdosis til behandling af voksne patienter med Gauchers sygdom type 1 er en kapsel tre gange dagligt. 
The recommended starting dose for type 1 Gaucher disease is one capsule three times a day.
Symptomerne omfatter tab af koordinationsevne, problemer med hurtige øjenbevægelser, hvilket kan medføre nedsat syn, forsinket udvikling, synkebesvær, nedsat muskeltonus, krampeanfald og indlæringsvanskeligheder. 
These include loss of co-ordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
De hyppigste bivirkninger ved Zavesca (som optræder hos flere end 1 ud af 10 patienter) er vægttab, nedsat appetit, rysten, diarré, luft i maven og mavesmerter. 
The most common side effects with Zavesca (seen in more than 1 patient in 10) are weight loss, decreased appetite, tremor (shaking), diarrhoea, flatulence (gas) and abdominal pain (stomach ache).
Zavesca til behandling af Niemann-Picks sygdom type C blev undersøgt i en hovedundersøgelse af 31 patienter, hvoraf 12 var under 12 år. 
For Niemann-Pick type C disease, Zavesca was studied in one main study involving 31 patients, 12 of whom were less than 12 years old.
Patienter med denne sygdom mangler et enzym, som kaldes glucocerebrosidase, hvilket medfører ophobning af et glycosphingolipid kaldet glucosylceramid i forskellige dele af kroppen, f.eks. 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.
Det aktive stof i Zavesca, miglustat, forhindrer et enzym kaldet glucosylceramidsyntase i at virke. 
The active substance in Zavesca, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Ved at forhindre enzymet i at virke kan miglustat reducere dannelsen af glycosphingolipider i cellerne. 
By preventing the enzyme from working, miglustat can reduce the production of glycosphingolipids in cells.
Behandlingen med Zavesca bør indledes og overvåges af læger med erfaring i behandling af patienter med Gauchers sygdom eller Niemann Picks sygdom type C. 
Treatment with Zavesca should be started and monitored by doctors who are experienced in the management of Gaucher or Niemann-Pick type C disease.
Hvad er Zavesca? 
What is Zavesca?
Zavesca anvendes, når patienten anses for uegnet til standardbehandling med enzymsubstitutionsbehandling, 
Zavesca is used in patients who cannot receive the standard treatment of enzyme replacement therapy (ERT);
Ved begge sygdomme ophobes et fedtstof kaldet glycosphingolipid i kroppen. 
Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Den fuldstændige liste over de indberettede bivirkninger ved Zavesca fremgår af indlægssedlen. 
For the full list of all side effects reported with Zavesca, see the package leaflet.