FrancophonIA/ELRC3.0 huggingface dataset:
English: Sanofi - Produtos Farmaceuticos Lda
Danish: Sanofi - Produtos Farmaceuticos Lda Metformina Zentiva
English: Metformin Hydrochloride 1000mg/1117 Mg
Danish: Metforminhydrochlorid 1000mg/1117 Mg
English: United Morningside Healthcare Ltd
Danish: Storbritannien Morningside Healthcare Ltd
English: Ireland Merck Serono Ltd.
Danish: Storbritannien Merck Serono Ltd.
English: Germany Stadapharm Gmbh
Danish: Stadapharm Gmbh
English: United Mercury Pharmaceuticals Ltd.
Danish: Storbritannien Mercury Pharmaceuticals Ltd.
English: Portugal
Danish: Irland
English: Germany Winthrop Arzneimittel Gmbh
Danish: Winthrop Arzneimittel Gmbh
English: Sweden Mylan Ab
Danish: Mylan Ab
English: United Tillomed Laboratories Ltd
Danish: Storbritannien Tillomed Laboratories Ltd
English: Germany T&d Pharma Gmbh
Danish: T&d Pharma Gmbh
English: Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories Ltd
Danish: Metformin Hydrochloride Pinewood Laboratories Ltd
English: Crescent Pharma Limited
Danish: Storbritannien Crescent Pharma Limited
English: France Cristers
Danish: Cristers
English: Metformin Accedo Swiss Caps Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformin Accedo Swiss Caps Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Poland Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Danish: Zaklady FarmaceutycznePolpharma-Spolka Akcyjna
English: Germany Aurobindo Pharma Gmbh
Danish: Aurobindo Pharma Gmbh
English: France Biogaran
Danish: Biogaran
English: Romania Generics [uk] Limited
Danish: Storbritannien Generics [uk] Limited
English: Germany Teva Gmbh
Danish: Teva Gmbh
English: Latvia Ratiopharm Gmbh
Danish: Ratiopharm Gmbh
English: Austria Arcana Arzneimittel Gmbh
Danish: Arcana Arzneimittel Gmbh
English: Poland Sandoz Gmbh
Danish: Sandoz Gmbh
English: Finland Sandoz A-S
Danish: Sandoz A-S
English: Germany Abz-Pharma Gmbh
Danish: Abz-Pharma Gmbh
English: Finland Actavis Group Ptc Ehf.
Danish: Storbritannien Actavis Group Ptc Ehf.
English: Metformin Hydrochloride 1000mg
Danish: Metforminhydrochlorid 1000mg
English: Austria Stada Arzneimittel Gmbh
Danish: Stada Arzneimittel Gmbh
English: Germany Glenmark Arzneimittel Gmbh
Danish: Glenmark Arzneimittel Gmbh
English: Italy
Danish: Letland
English: Amneal Pharma Europe Limited Metformina Amneal
Danish: Amneal Pharma Europe Limited
English: Metformin Hydrochloride 170mg/Ml
Danish: Metforminhydrochlorid 170mg/Ml
English: Germany Aaa-Pharma Gmbh
Danish: Aaa-Pharma Gmbh
English: Metformin Hydrochloride Glenmark Generics Europe
Danish: Storbritannien Glenmark Generics (Europe) Limited Metformin Hydrochloride Glenmark Generics Europe
English: Slovenia Merck D.O.O.
Danish: Merck D.O.O.
English: Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Danish: Metforminhydrochlorid 400mg Kapsel, Glibenclamid 2.5mg Kapsel
English: Germany Hormosan Pharma Gmbh
Danish: Hormosan Pharma Gmbh
English: Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories
Danish: Metformin Hydrochloride Pinewood Laboratories
English: Metformin Chelonia Healthcare Metformin Hydrochloride Bp 500mg
Danish: Metformin Chelonia Healthcare Metforminhydrochlorid Bp 500mg Filmovertrukket tablet
English: France Ranbaxy Pharmacie Generiques Metformine Ranbaxy
Danish: Ranbaxy Pharmacie Generiques
English: Germany Dexcel Pharma Gmbh
Danish: Dexcel Pharma Gmbh
English: Metformin Hydrochloride 850mgg
Danish: Metforminhydrochlorid 850mgg
English: Germany Biomo Pharma Gmbh
Danish: Biomo Pharma Gmbh
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Danish: Metformin Wockhardt Uk Ltd Metforminhydrochlorid 850mg Tablet Overtrukket tablet
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Danish: Metformin Wockhardt Uk Ltd Metforminhydrochlorid 500mg Tablet Overtrukket tablet
English: Metformin Hydrochloride 850mg
Danish: Metforminhydrochlorid 850mg
English: Germany Aliud Pharma Gmbh
Danish: Aliud Pharma Gmbh
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformin Hcl Plus Pharmacie Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Greece Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
Danish: Grækenland Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
English: Metformin Hydrochloride 500ml/5 Ml
Danish: Metforminhydrochlorid 500ml/5 Ml
English: Metformin Hydrochloride 500mg Film Film-Coated Tablet
Danish: Metforminhydrochlorid 500mg Film Filmovertrukket tablet
English: France Sandoz
Danish: Sandoz
English: Austria Hexal Pharma Gmbh
Danish: Hexal Pharma Gmbh
English: Sandoz Ltd
Danish: Storbritannien Sandoz Ltd
English: Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Saxagliptin 2.5mg Tablet
English: Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Linagliptin 2.5mg Tablet
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Alogliptin 25mg Tablet
English: Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Dapagliflozin 5mg Tablet
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Empagliflozin 12.5mg Tablet
English: Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformine Arrow Generiques Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Linagliptin 2.5mg Tablet
English: Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Saxagliptin 2.5mg Tablet
English: Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Sitagliptin 50mg Tablet
English: Romania Aurobindo Pharma Limited
Danish: Storbritannien Aurobindo Pharma Limited
English: Metformin Hydrochloride 1000mg Tablet Tablet
Danish: Metforminhydrochlorid 1000mg Tablet Tablet
English: Metformin Hydrochloride 100mg/ Ml
Danish: Metforminhydrochlorid 100mg/Ml
English: Metformin Hydrochloride 100mg/Ml
Danish: Metforminhydrochlorid 100mg/ Ml
English: Austria 1a Pharma Gmbh
Danish: 1a Pharma Gmbh
English: Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Dapagliflozin 5mg Tablet
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Alogliptin 12.5mg Tablet
English: Metformin Hydrochloride 1000mg Tablet Dispersible Tablet
Danish: Metforminhydrochlorid 1000mg Tablet Dispergibel tablet
English: Metformin Hydrochloride 500mgg
Danish: Metforminhydrochlorid 500mgg
English: Metformin Hydrochloride 500mg Units
Danish: Metforminhydrochlorid 500mg Enheder
English: Metformin Hydrochloride 1000µg Tablet Film-Coated Tablet
Danish: Metforminhydrochlorid 1000µg Tablet Filmovertrukket tablet
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 850mg Tablet
Danish: Metformin Hcl Plus Pharmacie Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Danish: Ljubljana Metformin/Glibenklamid Lek Metforminhydrochlorid 500mg Tablet, Glibenclamid 5mg Tablet
English: Metformin Hydrochloride 1000mg Film Film-Coated Tablet
Danish: Metforminhydrochlorid 1000mg Film Filmovertrukket tablet
English: Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Danish: Metformin Crescent Pharma Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Norway Rosemont Pharmaceuticals Limited Metformin Rosemont
Danish: Rosemont Pharmaceuticals Limited Metformin Rosemont
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Empagliflozin 5mg Tablet
English: Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Danish: Metformin Lindopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Metformin Hydrochloride 500mg/5 Ml
Danish: Metforminhydrochlorid 500mg/5 Ml
English: Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Danish: Metformin Lindopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Canagliflozin 150mg Tablet
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
Danish: Metforminhydrochlorid 1000mg Brev Pulver til oral opløsning i brev
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Empagliflozin 12.5mg Tablet
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Danish: Ljubljana Metformin/Glibenklamid Lek Metforminhydrochlorid 500mg Tablet, Glibenclamid 2.5mg Tablet
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Empagliflozin 5mg Tablet
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
Danish: Metforminhydrochlorid 500mg Brev Pulver til oral opløsning i brev
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution In Sachet
Danish: Metforminhydrochlorid 850mg Brev Pulver til oral opløsning i brev
English: Tolife - Produtos Farmacêuticos, S.A.
Danish: Tolife - Produtos Farmacêuticos, S.A. Metformina Tolife
English: Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Danish: Metformin Crescent Pharma Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Sitagliptin 50mg Tablet
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Canagliflozin 50mg Tablet
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Canagliflozin 50mg Tablet
English: Germany Juta Pharma Gmbh
Danish: Juta Pharma Gmbh
English: Germany Tad Pharma Gmbh
Danish: Tad Pharma Gmbh
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Canagliflozin 150mg Tablet
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 500mg Tablet
Danish: Metformin Hcl Plus Pharmacie Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Danish: Metforminhydrochlorid 1000mg Tablet, Glibenclamid 5mg Tablet
English: Metformin Hydrochloride 500mg
Danish: Metforminhydrochlorid 500mg
English: Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Danish: Metforminhydrochlorid 850mg Tablet, Pioglitazon 15mg Tablet
English: Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Danish: Metformin Focus Pharmaceuticals
English: Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Danish: Metforminhydrochlorid 2.5mg Tablet, Glibenclamid 500mg Tablet
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Danish: Metforminhydrochlorid 400mg Tablet, Glibenclamid 2.5mg Tablet
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Danish: Metforminhydrochlorid 400mg Tablet, Glibenclamid 5mg Tablet
English: Germany Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Danish: Sandoz Pharmaceuticals Gmbh
English: Ireland Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Danish: Storbritannien Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Danish: Metforminhydrochlorid 500mg Tablet, Glibenclamid 5mg Tablet
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Danish: Metformin Hcl Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Danish: Metforminhydrochlorid 500mg Tablet, Glibenclamid 2.5mg Tablet
English: Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Danish: Metformin-Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformin Hcl Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Danish: Metformine Hcl Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Germany Denk Pharma Gmbh & Co. Kg Metfo
Danish: Denk Pharma Gmbh & Co.
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformine Hcl Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Tevamet
Danish: Xigduo
English: Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Danish: Metformin-Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Metformin Hydrochloride 500mg G
Danish: Metforminhydrochlorid 500mg G Depottablet
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Danish: Metformin Hcl Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Danish: Metformine Hcl Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Eood
Danish: Eucreas
English: Wörwag Pharma Gmbh & Co. Kg Metfogamma
Danish: Wörwag Pharma Gmbh & Co.
English: Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformina Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformin Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Danish: Metformine Ratiopharm Metforminhydrochlorid 1000mg Tablet Filmovertrukket tablet
English: Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Danish: Metformina Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Danish: Metformin Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Kingdom
Danish: Holland
English: Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Danish: Metformine Ratiopharm Metforminhydrochlorid 850mg Tablet Filmovertrukket tablet
English: Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Danish: Metformina Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Danish: Metformin Ratiopharm Metforminhydrochlorid 500mg Tablet Filmovertrukket tablet
English: Pack size
Danish: 28 Table
English: Pharmaceutical Form Route of Administration
Danish: 7 Tablets
English: Some patients were treated for up to five and a half years.
Danish: Visse patienter blev behandlet i op til fem et halvt år.
English: It is available as capsules (100 mg).
Danish: Det fås som kapsler (100 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zavesca den 20. november 2002.
English: • Gaucher disease;
Danish: • Gauchers sygdom
English: Other information about Zavesca:
Danish: Andre oplysninger om Zavesca:
English: The main part of the study lasted for a year, but 13 patients carried on receiving the medicine for a further two years.
Danish: Hovedparten af undersøgelsen varede i et år, men 13 patienter blev ved med at modtage lægemidlet i yderligere to år.
English: This document is a summary of the European Public Assessment Report (EPAR) for Zavesca.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zavesca.
English: As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
Danish: Da virksomheden havde indsendt de yderligere oplysninger, den var blevet anmodet om, overgik godkendelsen til normal status den 23. august 2012.
English: EPAR summary for the public miglustat
Danish: EPAR - sammendrag for offentligheden miglustat
English: Zavesca is used to treat the following patients:
Danish: Zavesca anvendes til behandling af følgende patienter:
English: Zavesca is intended for long-term use.
Danish: Zavesca er beregnet til langvarig brug.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: Undersøgelsen viste, at Zavesca førte til en stabilisering eller et fald i andelen af symptomer, der blev værre, hos ca. trefjerdele af patienterne.
English: • Niemann-Pick type C disease.
Danish: • Niemann-Picks sygdom type C.
English: The dose should also be reduced temporarily in patients who develop diarrhoea.
Danish: Dosen skal desuden midlertidigt reduceres hos patienter, der får diarré.
English: The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Zavesca opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The benefits of Zavesca were maintained over three years of continuous treatment.
Danish: De gavnlige virkninger af Zavesca holdt i tre år med kontinuerlig behandling
English: The company also presented the results of a survey of 66 patients treated with Zavesca.
Danish: Virksomheden fremlagde også resultaterne af en spørgeundersøgelse blandt 66 patienter, der var blevet behandlet med Zavesca.
English: • adults (aged 18 years and above) with mild to moderate type 1 Gaucher disease.
Danish: • voksne (18 år og derover) med let til moderat Gauchers sygdom type 1.
English: Zavesca is a medicine that contains the active substance miglustat.
Danish: Zavesca er et lægemiddel, der indeholder det aktive stof miglustat.
English: Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Danish: Zavesca anvendes til behandling af de neurologiske symptomer på sygdommen (påvirkning af hjernen og nervesystemet).
English: 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.
Danish: I undersøgelsen af Gauchers sygdom type 1 forekom der en moderat reduktion af levervolumenet (12 %) og miltvolumenet (19 %) efter et år.
English: The full EPAR for Zavesca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zavesca findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: However, there were signs of improvement in swallowing ability and intellectual function in the patients treated with Zavesca.
Danish: Der var dog tegn på forbedringer i evnen til at synke og den intellektuelle funktion hos patienter behandlet med Zavesca.
English: For more information about treatment with Zavesca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: The study compared the effects of adding Zavesca to standard care with the effects of standard care alone.
Danish: I undersøgelsen sammenlignede man virkningen af standardbehandling suppleret med Zavesca med virkningen af standardbehandling alene.
English: Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
Danish: Zavesca blev oprindelig godkendt under ”særlige omstændigheder”, da der kun var begrænsede oplysninger tilgængelige om lægemidlet på godkendelsestidspunktet, fordi sygdommene er sjældne.
English: In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
Danish: I undersøgelsen af Niemann-Picks sygdom type C var forbedringen i øjenbevægelserne den samme for patienter, der var blevet behandlet med og uden Zavesca.
English: Zavesca is used to treat two inherited diseases that affect the way the body handles fats.
Danish: Zavesca anvendes til behandling af to arvelige sygdomme, der påvirker måden, hvorpå kroppen håndterer fedt.
English: Zavesca must not be used in people who are hypersensitive (allergic) to miglustat or any of the other ingredients.
Danish: Zavesca må ikke anvendes til personer, der er overfølsomme (allergiske) over for miglustat eller andre af indholdsstofferne.
English: 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).
Danish: 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).
English: A lower dose should be used in patients with reduced kidney function.
Danish: Der skal anvendes en lavere dosis til patienter med nedsat nyrefunktion.
English: 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.
Danish: Dette forventes at kunne forsinke eller forebygge udvikling af symptomer på Gauchers sygdom type 1 og reducere symptomerne på Niemann Picks sygdom type C.
English: 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.
Danish: 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.
English: 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:
Danish: 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:
English: Why has Zavesca been approved?
Danish: Hvorfor blev Zavesca godkendt?
English: What is the risk associated with Zavesca?
Danish: Hvilken risiko er der forbundet med Zavesca?