natgillin/translations-raw huggingface dataset:
3 hætteglas med pulver til injektionsvæske, opløsning / 3 ampuller med solvens.
3 vials of powder for solution for injection / 3 ampoules of solvent.
10 hætteglas med pulver til injektionsvæske, opløsning / 10 ampuller med solvens.
10 vials of powder for solution for injection / 10 ampoules of solvent.
Hold sprøjten i den ene hånd, og tag den åbne ampul op; indfør kanylen og træk al solvens op.
• Draw up the solvent: Attach the reconstitution needle to the syringe, with the syringe in one hand, pick up the open ampoule, insert the needle and draw up all of the solvent.
Vurderet ud fra arealet under kurven (AUC), som er direkte proportionalt med den administrerede dosis, udviser Lutropin alfa lineær farmakokinetik.
Lutropin alfa shows linear pharmacokinetics, as assessed by area under curve (AUC) which is directly proportional to the dose administered.
1 hætteglas med pulver til injektionsvæske, opløsning / 1 ampul med solvens.
1 vial of powder for solution for injection / 1 ampoule of solvent.
Vand til injektionsvæsker s.c.
Water for injection
Amning Luveris er ikke indiceret under amning.
Breast-feeding Luveris is not indicated during breast-feeding.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER LUVERIS 75 IE, HÆTTEGLAS
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, VIALS
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER LUVERIS 75 IE, HÆTTEGLAS MED SOLVENS
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, SOLVENT VIALS
London E14 9TP Storbritannien
1082 MA Amsterdam The Netherlands
3 hætteglas med pulver til injektionsvæske, opløsning / 3 hætteglas med solvens.
3 vials of powder for solution for injection / 3 vials of solvent.
10 hætteglas med pulver til injektionsvæske, opløsning / 10 hætteglas med solvens.
10 vials of powder for solution for injection / 10 vials of solvent.
56 Marsh Wall London E14 9TP Storbritannien
Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands
• Afhængigt af dit respons, kan din læge evt. øge dosis af FSH fortrinsvis med 37,5 - 75 IE og med 7 til 14 dages mellemrum.
• According to your response, your doctor may increase your dose of FSH by preferably
1 hætteglas med pulver til injektionsvæske, opløsning / 1 hætteglas med solvens.
1 vial of powder for solution for injection / 1 vial of solvent.
“Bivirkninger”).
Possible side effects
MF (EU)-nummer (Særnavn) Navn Styrke
MA (EU) number (Invented) name Strength
Lægemiddelform Administration Emballage Paknings-størrelse
Pharmaceutical form
5 ml t r
5 ml l t o r
Grækenland Vocate φαρμακευτικη αε
Greece Vocate φαρμακευτικη αε
Bilag I Liste over nationalt godkendte lægemidle
Annex I List of nationally authorised medicinal products
Grækenland Alapis Abee
Greece Alapis Abee
Grækenland Rafarm Sa.
Greece Rafarm Sa.
Grækenland Sanofi-Aventis Aebe
Greece Sanofi-Aventis Aebe
Storbritannien Teva Uk Limited
Teva Uk Limited
Grækenland Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
Greece Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
Grækenland Merck A.E.
Greece Merck A.E.
Storbritannien Relon Chem Limited
Relon Chem Limited
Storbritannien Consilient Health Limited
United Consilient Health Limited
Grækenland Verisfield (Uk) Ltd
Greece Verisfield (Uk) Ltd
Grækenland Generics Pharma Hellas Ltd
Greece Generics Pharma Hellas Ltd
Storbritannien Fourrts (Uk) Pharmacare Limited Metformin Fourrts (Uk) Pharmacare
Fourrts (Uk) Pharmacare Limited Metformin Fourrts (Uk) Pharmacare
Teva Denmark A/S
Denmark Teva Denmark A-S
Dispergibel tablet
Dispersible Tablet
Luxembourg S.A. Menarini Benelux N.V.
Belgium S.A. Menarini Benelux N.V.
Grækenland Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Greece Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Storbritannien Chelonia Healthcare Limited
Chelonia Healthcare Limited
Storbritannien Arrow Generics Limited - Transferred To Actavis Group Ptc Ehf
Arrow Generics LimitedTransferred To Actavis Group Ptc Ehf
Janssen-Cilag International NV
Norway Janssen-Cilag International Nv
Metforminhydrochlorid Ph. Eur.
Metformin Hydrochloride Ph. Eur.
Grækenland Bennett Pharmaceutical S.A.
Greece Bennett Pharmaceutical S.A.
Metformin Embonat 700mg Tablet
Metformin Embonate 700mg Tablet
Grækenland Farmasyn S.A.
Greece Farmasyn S.A.
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.