natgillin/translations-raw huggingface dataset:
Sweden Eql Pharma Ab
Eql Pharma Ab
Norway Orifarm Generics A-S
Orifarm Generics A-S
Spain Pensa Pharma, S.A
Pensa Pharma, S.A
Greece Verisfield (Uk) Ltd
Verisfield (Uk) Ltd
Greece Bennett Pharmaceutical S.A.
Bennett Pharmaceutical S.A.
Germany Chem Affairs Deutschland Gmbh Metformdoc
Chem Affairs Deutschland Gmbh Metformdoc
Norway Merck Sharp & Dohme Ltd.
Merck Sharp & Dohme Ltd.
Germany Heumann Pharma Gmbh & Co. Generica Kg
Heumann Pharma Gmbh & Co. Generica Kg
Germany Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Germany Axcount Generika Gmbh
Axcount Generika Gmbh
Special Concept Development (Uk) Ltd
Ühendkuningriik Special Concept Development (Uk) Ltd
Spain Teva Pharma S.L.U
Teva Pharma S.L.U
Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Ühendkuningriik Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Slovenia Lek Pharmaceuticals D.D.
Lek Pharmaceuticals D.D.
Germany Actavis Deutschland Gmbh & Co. Kg
Actavis Deutschland Gmbh & Co.
Bulgaria Berlin-Chemie Ag сиофор
Berlin-Chemie Ag сиофор
Greece Merck A.E.
Merck A.E.
Germany Merck Serono Gmbh
Merck Serono Gmbh
Slovenia Belupo D.O.O.
Belupo D.O.O.
Metformin Hydrochloride 1g Tablet
Metformiinvesinikkloriid 1g Tablett
Hungary Goodwill Pharma Ltd
Goodwill Pharma Ltd
Metformin Hydrochloride 1000mg/1117 Mg
Metformiinvesinikkloriid 1000mg/1117 Mg
Slovenia Medis, D.O.O.
Medis, D.O.O.
Spain Sandoz Farmacéutica, S.A.
Sandoz Farmacéutica, S.A.
Finland Aurobindo Pharma (Malta) Limited Metformin Aurobindo
Aurobindo Pharma (Malta) Limited Metformin Aurobindo
Germany Mylan Dura Gmbh
Mylan Dura Gmbh
Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories Ltd
Ühendkuningriik Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories Ltd
Ireland Mcdermott Laboratories Ltd
Mcdermott Laboratories Ltd
France Merck Santé S.A.S.
Prantsusmaa Merck Santé S.A.S.
500mg Tablet
500mg Tablett
Croatia Sandoz D.O.O.
Sandoz D.O.O.
Milpharm Limited
Ühendkuningriik Milpharm Limited
Slovakia Sandoz Pharmaceuticals D.D.
Sandoz Pharmaceuticals D.D.
Ireland Rowex Ltd
Rowex Ltd
Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories
Ühendkuningriik Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories
Norway Takeda Pharma A-S
Takeda Pharma A-S
France Bluefish Pharmaceuticals Ab
Prantsusmaa Bluefish Pharmaceuticals Ab
Belgium Merck N.V.-S.A.
Luksemburg Merck N.V.-S.A.
Austria Genericon Pharma Gesellschaft M.B.H.
Genericon Pharma Gesellschaft M.B.H.
Modified-Release Tablet
Toimeainet modifitseeritult vabastav tablett
United Medley Pharma Limited
Ühendkuningriik Medley Pharma Limited
Iceland Boehringer Ingelheim International Gmbh
Boehringer Ingelheim International Gmbh
Finland Hexal A-S
Hexal A-S
Latvia Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Norway Boehringer Ingelheim International Gmbh
Boehringer Ingelheim International GmbH
Genus Pharmaceuticals Ltd.
Ühendkuningriik Genus Pharmaceuticals Ltd.
Metformin Hydrochloride Ph. Eur.
Metformiinvesinikkloriid Ph. Eur.
Germany Winthrop Arzneimittel Gmbh
Winthrop Arzneimittel Gmbh
Prolonged-Release Tablet
Toimeainet prolongeeritult vabastav tablett
United Mercury Pharmaceuticals Ltd.
Ühendkuningriik Mercury Pharmaceuticals Ltd.
Croatia Merck D.O.O
Merck D.O.O
Belgium Sandoz N.V.
Luksemburg Sandoz N.V.
Germany Stadapharm Gmbh
Stadapharm Gmbh
Metwest Pharmaceuticals Limited Metformin Metwest Pharmaceuticals
Ühendkuningriik Metwest Pharmaceuticals Limited Metformin Metwest Pharmaceuticals
Sweden Mylan Ab
Mylan Ab
United Tillomed Laboratories Ltd
Ühendkuningriik Tillomed Laboratories Ltd
Crescent Pharma Limited
Ühendkuningriik Crescent Pharma Limited
Powder For Solution For Injection Or Infusion
Süste-/infusioonilahuse pulber
Germany T&d Pharma Gmbh
T&d Pharma Gmbh
United Morningside Healthcare Ltd
Ühendkuningriik Morningside Healthcare Ltd
Ireland Merck Serono Ltd.
Ühendkuningriik Merck Serono Ltd.
Cyprus Delorbis Pharmaceuticals Ltd
Delorbis Pharmaceuticals Ltd Neomid
Poland Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Zaklady FarmaceutycznePolpharma-Spolka Akcyjna
Metformin 1000mg Tablet
Metformin 1000mg Tablett
Metformin 850mg Tablet
Metformin 850mg Tablett
Austria Ratiopharm Arzneimittel VertriebsGmbh
Ratiopharm Arzneimittel Vertriebs-Gmbh
Austria Arcana Arzneimittel Gmbh
Arcana Arzneimittel Gmbh
Metformin Hydrochloride 170mg/Ml
Metformiinvesinikkloriid 170mg/Ml
Germany Aurobindo Pharma Gmbh
Aurobindo Pharma Gmbh
Poland Sandoz Gmbh
Sandoz Gmbh
Finland Sandoz A-S
Sandoz A-S
France Ratiopharm Gmbh
Prantsusmaa Ratiopharm Gmbh
Germany Teva Gmbh
Teva Gmbh
Italy
Hispaania
Austria Stada Arzneimittel Gmbh
Stada Arzneimittel Gmbh
Metformin 500mg Tablet
Metformin 500mg Tablett
Metformin Embonate 700mg Tablet
Metformiin Embonaat700mg Tablett
Germany Abz-Pharma Gmbh
Abz-Pharma Gmbh
Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Metformiinvesinikkloriid 400mg Kapsel, Glibenclamide 2.5mg Kapsel
Germany Aaa-Pharma Gmbh
Aaa-Pharma Gmbh
Slovenia Merck D.O.O.
Merck D.O.O.
Metformin Hydrochloride 1000mg
Metformiinvesinikkloriid 1000mg
Sandoz Ltd
Ühendkuningriik Sandoz Ltd
Romania Generics [uk] Limited
Ühendkuningriik Generics [uk] Limited
Germany Hormosan Pharma Gmbh
Hormosan Pharma Gmbh
Germany Dexcel Pharma Gmbh
Dexcel Pharma Gmbh
Slovakia Actavis Group Ptc Ehf.
Ühendkuningriik Actavis Group Ptc Ehf.
Germany Biomo Pharma Gmbh
Biomo Pharma Gmbh
Metformin Hydrochloride 500ml/5 Ml
Metformiinvesinikkloriid 500ml/5 Ml
Greece Farmasyn S.A.
Farmasyn S.A.
Metformine Hcl Usv Europe Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Hcl Usv Europe Metformiinvesinikkloriid 1000mg Tablett Õhukese polümeerikattega tablett
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Metformin Wockhardt Uk Ltd Metformiinvesinikkloriid 850mg Tablettt
Germany Aliud Pharma Gmbh
Aliud Pharma Gmbh
Metformine Hcl Usv Europe Metformin Hydrochloride 850mg Tablet
Metformine Hcl Usv Europe Metformiinvesinikkloriid 850mg Tablett Õhukese polümeerikattega tablett
Portugal
Rumeenia
Austria Hexal Pharma Gmbh
Hexal Pharma Gmbh
Metformin Hydrochloride 850mgg
Metformiinvesinikkloriid 850mgg
Latvia Ratiopharm Gmbh
Ratiopharm Gmbh
Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Metformin Hydrochloride Rosemont Pharmaceuticals
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Empagliflosiin 12.5mg Tablett
Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Linagliptiin 2.5mg Tablett
Metformin Hydrochloride 100mg/ Ml
Metformiinvesinikkloriid 100mg/ Ml
Metformin Hydrochloride 100mg/Ml
Metformiinvesinikkloriid 100mg/Ml
Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Metformin/Glibenklamid Lek Metformiinvesinikkloriid 500mg Tablett, Glibenclamide 5mg Tablett
Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Alogliptiin 25mg Tablett
Metformin Hydrochloride 500mg/5 Ml
Metformiinvesinikkloriid 500mg/5 Ml
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Metformin Wockhardt Uk Ltd Metformiinvesinikkloriid 500mg Tablett Kaetud tablett
Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Linagliptiin 2.5mg Tablett
Austria 1a Pharma Gmbh
1a Pharma Gmbh
Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Metformin/Glibenklamid Lek Metformiinvesinikkloriid 500mg Tablett, Glibenclamide 2.5mg Tablett
Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Dapagliflosizin 5mg Tablett
Metformine Hcl Usv Europe Metformin Hydrochloride 500mg Tablet
Metformine Hcl Usv Europe Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 850mg
Metformiinvesinikkloriid 850mg
Metformin Hydrochloride 500mg Units
Metformiinvesinikkloriid 500mg Üksused
Metformin Hydrochloride 500mgg
Metformiinvesinikkloriid 500mgg
Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Alogliptiin 12.5mg Tablett
Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Empagliflosiin 12.5mg Tablett
Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Pioglitasoon 15mg Tablett
Metformina Mylan Generics Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformina Mylan Generics Metformiinvesinikkloriid 1000mg Tablett Õhukese polümeerikattega tablett
Romania Aurobindo Pharma Limited
Ühendkuningriik Aurobindo Pharma Limited
Metformina Mylan Generics Metformin Hydrochloride 500mg Tablet
Metformina Mylan Generics Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Sitagliptiin 50mg Tablett
Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Dapagliflosiin 5mg Tablett
Germany Juta Pharma Gmbh
Juta Pharma Gmbh
Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Glibenclamide 5mg Tablett
Germany Tad Pharma Gmbh
Tad Pharma Gmbh
Metformin Hydrochloride 1000mg Tablet Dispersible Tablet
Metformiinvesinikkloriid 1000mg Tablett Dispergeeritav tablett
Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Metformin Medley Pharma Metformiinvesinikkloriid 500mg Tablett Tablett
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Empagliflosiin 5mg Tablett
Metformin Hydrochloride 1000mg Tablet Prolonged-Release Tablet
Metformiinvesinikkloriid 1000mg Tablett Toimeainet prolongeeritult vabastav tablett
Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Metformin Medley Pharma Metformiinvesinikkloriid 850mg Tablett Tablett
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Kanagliflosiin 150mg Tablett
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Kanagliflosiin 50mg Tablett
Metformina Mylan Generics Metformin Hydrochloride 850mg Tablet
Metformina Mylan Generics Metformiinvesinikkloriid 850mg Tablett Suus dispergeeruv ravimkile
Eood
Leedu
Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Metformin Lindopharm Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformin Relonchem Metformin Hydrochloride 500mg Tablet
Metformin Relonchem Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Metformiinvesinikkloriid 400mg Tablett, Glibenclamide 2.5mg Tablett
Metformin Hydrochloride 500mg G
Metformiinvesinikkloriid 500mg
Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Empagliflosiin 5mg Tablett
Metformin Hydrochloride 1000mg Tablet Tablet
Metformiinvesinikkloriid 1000mg Tablett Kihisev tablett
Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Metformiinvesinikkloriid 500mg Tablett, Glibenclamide 2.5mg Tablett
Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Sitagliptiin 50mg Tablett
Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin Hcl Ratiopharm Metformiinvesinikkloriid 850mg Tablett Õhukese polümeerikattega tablett
Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin Hcl Ratiopharm Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Metformiinvesinikkloriid 400mg Tablett, Glibenclamide 5mg Tablett
Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Metformiinvesinikkloriid 2.5mg Tablett, Glibenclamide 500mg Tablett
Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Metformiinvesinikkloriid 500mg Tablett, Glibenclamide 5mg Tablett
Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin Hcl Ratiopharm Metformiinvesinikkloriid 1000mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Kanagliflosiin 150mg Tablett
Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Metformin Lindopharm Metformiinvesinikkloriid 850mg Tablett Õhukese polümeerikattega tablett
Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin-Ratiopharm Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin-Ratiopharm Metformiinvesinikkloriid 850mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 500mg Film Film-Coated Tablet
Metformiinvesinikkloriid 500mg Tablett Kaetud tablett
Germany Denk Pharma Gmbh & Co. Kg Metfo
Denk Pharma Gmbh & Co.
Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Kanagliflosiin 50mg Tablett
Metformin Relonchem Metformin Hydrochloride 850mg Tablet
Metformin Relonchem Metformiinvesinikkloriid 850mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Metformiinvesinikkloriid 1000mg Tablett, Saksagliptiin 2.5mg Tablett
Metformine Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Hcl Ratiopharm Metformiinvesinikkloriid 1000mg Tablett Õhukese polümeerikattega tablett
Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin Ratiopharm Metformiinvesinikkloriid 850mg Tablett Õhukese polümeerikattega tablett
Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Mylan Pharma Metformiinvesinikkloriid 1000mg Tablett Õhukese polümeerikattega tablett
Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin Ratiopharm Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformine Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformine Hcl Ratiopharm Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformin Glenmark
Glenmark Arzneimittel Gmbh Metformin Glenmark
Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin Ratiopharm Metformiinvesinikkloriid 1000mg Tablett Õhukese polümeerikattega tablett
Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformina Ratiopharm Metformiinvesinikkloriid 1000mg Tablett Õhukese polümeerikattega tablett
Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformina Ratiopharm Metformiinvesinikkloriid 500mg Tablett Õhukese polümeerikattega tablett
Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformina Ratiopharm Metformiinvesinikkloriid 850mg Tablett Õhukese polümeerikattega tablett
Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Metformiinvesinikkloriid 850mg Tablett, Saksagliptiin 2.5mg Tablett
Some patients were treated for up to five and a half years.
Osa patsiente raviti kuni viis ja pool aastat.
It is available as capsules (100 mg).
Seda turustatakse kapslitena (100 mg).
• Gaucher disease;
• Gaucher' tõbi;
Zavesca is intended for long-term use.
Zavesca on ette nähtud pikaajaliseks kasutamiseks.
The main part of the study lasted for a year, but 13 patients carried on receiving the medicine for a further two years.
Uuringu põhiosa kestis üks aasta, kuid 13 patsienti said ravimit veel kaks aastat.
The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Euroopa Komisjon andis Zavesca müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. novembril
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.
Ka verenäitajad paranesid mõnevõrra: hemoglobiini sisaldus suurenes keskmiselt 0,26 g/dl võrra ja trombotsüütide sisaldus suurenes 8,29 miljoni võrra milliliitri kohta.
As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
Et ettevõte esitas nõutud lisateabe, tühistati 23. augustil 2012 müügiloa erandkorras väljastatus.
EPAR summary for the public miglustat
Kokkuvõte üldsusele miglustaat
The company also presented the results of a survey of 66 patients treated with Zavesca.
Ettevõte esitas samuti Zavescaga ravitud 66 patsiendi uuringu tulemused.
Zavesca is used to treat the following patients:
Zavescat kasutatakse järgmiste patsientide ravis:
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:
Harvikravimite komitee arvamuste kokkuvõtted Zavesca kohta on ameti veebilehel aadressil ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
The full EPAR for Zavesca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst Zavesca kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
Esialgu kiideti Zavesca heaks erandkorras, sest haigus esineb harva ja ravimi heakskiitmise ajal ei olnud piisavalt teavet.
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.
Efektiivsuse põhinäitaja oli muutus patsiendi sakaadiliste horisontaalsete silmaliigutuste kiiruses pärast üheaastast ravi, kuid vaadeldi ka teisi neuroloogilisi sümptomeid, nagu patsiendi neelamisvõime ja vaimsed võimed.
What is the risk associated with Zavesca?
Mis riskid Zavescaga kaasnevad?
The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zavesca kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
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.
C-tüüpi Niemanni-Picki tõve korral on vähemalt 12-aastaste patsientide algannus kaks kapslit kolm korda ööpäevas, nooremate patsientide annus oleneb nende kaalust ja pikkusest.
What is Zavesca?
Mis on Zavesca?
Why has Zavesca been approved?
Miks Zavesca heaks kiideti?
Because the number of patients with these diseases is low, they are considered ‘rare', and Zavesca was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 October 2000 for type 1 Gaucher disease and on 16 February 2006 for Niemann-Pick type C disease.
Et nende haigustega patsiente on vähe ja neid haigusi esineb harva, nimetati Zavesca 18. oktoobril 2000 I tüüpi Gaucher' tõve ja 16. veebruaril 2006 C-tüüpi Niemanni-Picki tõve harvikravimiks.
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.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
• Niemann-Pick type C disease.
• C-tüüpi Niemanni-Picki tõbi.
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.
Nende hulka kuuluvad koordinatsioonivõime kadumine, sakaadiliste (aktiivse vaatlemisega seotud kiirete) silmaliigutuste häired, mis võivad halvendada nägemist, arengupeetus, neelamisraskused, lihastoonuse vähenemine, krambid ja õppimisraskused.
Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Zavescaga ravitakse haiguse neuroloogilisi (peaaju ja närve mõjutavaid) sümptomeid.
For the full list of all side effects reported with Zavesca, see the package leaflet.
Zavesca kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
For more information about treatment with Zavesca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Zavescaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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.
Zavesca efektiivsust C-tüüpi Niemanni-Picki tõve korral uuriti ühes põhiuuringus, milles osales 31 patsienti, kellest 12 olid alla 12-aastased.
• adults (aged 18 years and above) with mild to moderate type 1 Gaucher disease.
• vähemalt 18-aastased täiskasvanud kerge või mõõduka I tüüpi Gaucher' tõvega.
Zavesca is a medicine that contains the active substance miglustat.
Zavesca on ravim, mis sisaldab toimeainena miglustaati.
Zavesca must not be used in people who are hypersensitive (allergic) to miglustat or any of the other ingredients.
Zavescat ei tohi kasutada patsiendid, kes on miglustaadi või ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
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.
Eeldatavasti aeglustab või ennetab miglustaat sel viisil I tüüpi Gaucher' tõve sümptomite teket ja vähendab C-tüüpi Niemanni-Picki tõve sümptomeid.
Zavesca is used in patients who cannot receive the standard treatment of enzyme replacement therapy (ERT);
Zavescat kasutatakse patsientidel, keda ei saa ravida standardse ensüümiasendusraviga;
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).
Uuringus jälgiti Zavesca toimet maksa ja põrna suurusele ning verenäitajatele, nagu hemoglobiini (vere punaliblede valk, mis kannab hapnikku organismis laiali) ja trombotsüütide (vereliistakud ehk hüübimist soodustavad vererakud) sisaldus.
The recommended starting dose for type 1 Gaucher disease is one capsule three times a day.
Soovitatav algannus I tüüpi Gaucher' tõve korral on üks kapsel kolm korda ööpäevas.
In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
C-tüüpi Niemanni-Picki tõve uuringus oli silmaliigutuste paranemine Zavescaga ravitud patsientidel samalaadne kui neil, kes Zavesca ravi ei saanud.
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.
Selle haigusega patsientidel on ensüümi glükotserebrosidaasi vaegus, mistõttu koguneb eri kehaosadesse, näiteks põrna, maksa ja luudesse, glükosüültseramiidiks nimetatavat glükosfingolipiidi.
The benefits of Zavesca were maintained over three years of continuous treatment.
Zavesca kasulikkus säilis enam kui kolm aastat kestnud ravis.
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 kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on kehakaalu vähenemine, söögiisu vähenemine, värin, kõhulahtisus, kõhupuhitus ja kõhuvalu.