FrancophonIA/ELRC3.0 huggingface dataset:
English: Slovenia Lek Pharmaceuticals D.D.
Slovenian: Lek Pharmaceuticals D.D.
English: Metformin Hydrochloride Sandoz Ltd
Slovenian: Hydrochloride Sandoz Ltd
English: Slovenia Medis, D.O.O.
Slovenian: Medis, D.O.O.
English: Belgium Teva Pharma Belgium N.V.-S.A Metformine Teva
Slovenian: Teva Pharma Belgium N.V.-S.A
English: Croatia Sandoz D.O.O.
Slovenian: Sandoz D.O.O.
English: France Cristers
Slovenian: Cristers
English: Ireland Mcdermott Laboratories Ltd
Slovenian: Mcdermott Laboratories Ltd
English: Finland Hexal A-S
Slovenian: Hexal A-S
English: Metformin Hydrochloride Arcana Arzneimittel Gmbh
Slovenian: Hydrochloride Arcana Arzneimittel Gmbh
English: Ireland Rowex Ltd
Slovenian: Rowex Ltd
English: France Biogaran
Slovenian: Biogaran
English: Austria Genericon Pharma Gesellschaft M.B.H.
Slovenian: Genericon Pharma Gesellschaft M.B.H.
English: Spain Sandoz Farmacéutica, S.A.
Slovenian: Sandoz Farmacéutica, S.A.
English: France Sanofi-Aventis France
Slovenian: Sanofi-Aventis France Metformine Zentiva
English: Germany Stadapharm Gmbh
Slovenian: Stadapharm Gmbh
English: Croatia Merck D.O.O
Slovenian: Merck D.O.O
English: Slovakia Sandoz Pharmaceuticals D.D.
Slovenian: Sandoz Pharmaceuticals D.D.
English: Metformin Hydrochloride 1000mg/1117 Mg
Slovenian: Metformine Hcl Cf metforminijev klorid 1.000 mg/1117 Mg
English: Sweden Mylan Ab
Slovenian: Mylan Ab
English: Metformin Hydrochloride Generics [uk]
Slovenian: Generics [uk] Limited Metformin Hydrochloride Generics [uk]
English: Poland Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Slovenian: Zaklady Farmaceutyczne -Polpharma- Spolka Akcyjna
English: Hungary Goodwill Pharma Ltd
Slovenian: Goodwill Pharma Ltd Formet
English: Germany Winthrop Arzneimittel Gmbh
Slovenian: Winthrop Arzneimittel Gmbh
English: Laboratórios Basi - Indústria Farmacêutica, S.A.
Slovenian: Laboratórios BasiIndústria Farmacêutica, S.A.
English: Germany T&d Pharma Gmbh
Slovenian: T&d Pharma Gmbh
English: Germany Chem Affairs Deutschland Gmbh Metformdoc
Slovenian: Chem Affairs Deutschland Gmbh
English: Metformin 850mg Tablet
Slovenian: Metforminij 850 mg tableta
English: Germany Merck Serono Gmbh
Slovenian: Merck Serono Gmbh Glucophage
English: Fourrts (Uk) Pharmacare Limited Metformin Fourrts (Uk) Pharmacare
Slovenian: Metformin Fourrts (Uk) Pharmacare
English: Austria Ratiopharm Arzneimittel VertriebsGmbh
Slovenian: Ratiopharm Arzneimittel Vertriebs-Gmbh
English: Polpharma- Spolka Akcyjna
Slovenian: Zaklady Farmaceutyczne -Polpharma-Spolka Akcyjna
English: Germany Abz-Pharma Gmbh
Slovenian: Abz-Pharma Gmbh
English: Latvia Ratiopharm Gmbh
Slovenian: Ratiopharm Gmbh
English: Metformine Arrow
Slovenian: Metformine Arrow Generiques
English: Stada Arzneimittel Ag
Slovenian: Stada Arzneimittel Ag Metformin Stada
English: Finland Sandoz A-S
Slovenian: Sandoz A-S
English: Germany Teva Gmbh
Slovenian: Teva Gmbh
English: Metformin Chelonia Healthcare Metformin Hydrochloride Bp 500mg
Slovenian: Metformin Chelonia Healthcare metforminijev klorid Bp 500 mg
English: Tillomed Laboratories Ltd
Slovenian: Tillomed Laboratories Ltd Orabet
English: Spain Ratiopharm Espana Sa
Slovenian: Ratiopharm Espana Sa Metformina Ratio
English: Poland Sandoz Gmbh
Slovenian: Sandoz Gmbh
English: Metformin Embonate 700mg Tablet
Slovenian: Metforminijev embonat 700 mg tableta tableta
English: Metformin 1000mg Tablet
Slovenian: Metforminij 1.000 mg tableta
English: Germany Aaa-Pharma Gmbh
Slovenian: Aaa-Pharma Gmbh
English: Metformin Hydrochloride Tillomed Laboratories
Slovenian: Tillomed Laboratories Ltd Metformin Hydrochloride Tillomed Laboratories
English: Bulgaria Generics [uk] Limited метформин дженерикс
Slovenian: Generics [uk] Limited Metformin
English: Metformin Hydrochloride 1g Tablet
Slovenian: Metformin metforminijev klorid 1 g tableta
English: Germany Glenmark Arzneimittel Gmbh
Slovenian: Glenmark Arzneimittel Gmbh
English: Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Slovenian: Bidiab metforminijev klorid 400 mg kapsula, glibenklamid 2,5 mg kapsula kapsula
English: Spain Almus Farmaceutica S.A
Slovenian: Almus Farmaceutica S.A Metformina Almus
English: Slovenia Merck D.O.O.
Slovenian: Merck D.O.O.
English: Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Slovenian: Laboratórios AzevedosIndústria Farmacêutica, S.A.
English: Austria Arcana Arzneimittel Gmbh
Slovenian: Arcana Arzneimittel Gmbh
English: Metformin 500mg Tablet
Slovenian: Metforminij 500 mg tableta
English: Amneal Pharma Europe Limited Metformina Amneal
Slovenian: Amneal Pharma Europe Limited
English: France Ranbaxy Pharmacie Generiques Metformine Ranbaxy
Slovenian: Ranbaxy Pharmacie Generiques
English: Metformin Tillomed Laboratories
Slovenian: Tillomed Laboratories Ltd Metformin Tillomed Laboratories
English: Laboratórios Anova - Produtos Farmacêuticos Lda
Slovenian: Laboratórios AnovaProdutos Farmacêuticos Lda
English: Metformin 850mg Film
Slovenian: Metformina Azevedos metforminij 850 mg film
English: Greece Farmasyn S.A.
Slovenian: Farmasyn S.A.
English: Prolonged-Release Tablet
Slovenian: tablete s podaljšanim sproščanjem
English: Metformina Galena
Slovenian: Metformina Galena tableta
English: Aurobindo Pharma (Malta) Limited Metformin Hydrochloride Aurobindo Pharma (Malta)
Slovenian: Metformin Hydrochloride Aurobindo Pharma (Malta) Limited
English: Germany Axcount Generika Gmbh
Slovenian: Axcount Generika Gmbh Metformin Axcount
English: Metformin Hydrochloride Bp 500mg
Slovenian: Glyformin metforminijev klorid Bp 500 mg
English: Austria 1a Pharma Gmbh
Slovenian: 1a Pharma Gmbh
English: Metformin Hydrochloride 500mg G
Slovenian: Metformax metforminijev klorid 500 mg G
English: Coated Tablet
Slovenian: Metifor tableta
English: Denmark Stada Arzneimittel Ag
Slovenian: Stada Arzneimittel Ag Stadamet
English: Labesfal Genéricos, S.A.
Slovenian: Labesfal Genéricos, S.A. Metformina Labesfal
English: Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Slovenian: Jentadueto metforminijev klorid 1.000 mg tableta, linagliptin 2,5 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Slovenian: Jentadueto metforminijev klorid 850 mg tableta, linagliptin 2,5 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Slovenian: Synjardy metforminijev klorid 850 mg tableta, empagliflozin 12,5 mg tableta
English: Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Slovenian: Focus Pharmaceuticals Limited
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Slovenian: Synjardy metforminijev klorid 1.000 mg tableta, empagliflozin 12,5 mg tableta
English: Germany Tad Pharma Gmbh
Slovenian: Tad Pharma Gmbh
English: Metformin Hydrochloride 170mg/Ml
Slovenian: Glucoformin metforminijev klorid 170 mg/ml peroralna raztopina
English: Germany Juta Pharma Gmbh
Slovenian: Juta Pharma Gmbh
English: Generics [uk] Limited
Slovenian: Generics [uk] Limited Metnova
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Slovenian: Metformin/Glibenklamid Lek metforminijev klorid 500 mg tableta, glibenklamid 5 mg tableta
English: Metformin Hydrochloride 850mgg
Slovenian: Metformin-Teva metforminijev klorid 850 mgg
English: Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Slovenian: Metformin Lindopharm metforminijev klorid 500 mg tableta
English: Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories
Slovenian: Pinewood Laboratories Limited
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Slovenian: Metformin/Glibenklamid Lek metforminijev klorid 500 mg tableta, glibenklamid 2,5 mg tableta
English: Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Slovenian: Metformin Lindopharm metforminijev klorid 850 mg tableta
English: Austria Merck Gesellschaft Mbh
Slovenian: Merck Gesellschaft Mbh Glucophage
English: Spain Teva Pharma S.L.U
Slovenian: Teva Pharma S.L.U Metformina Teva
English: Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Slovenian: Ebymect metforminijev klorid 850 mg tableta, dapagliflozin 5 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Slovenian: Synjardy metforminijev klorid 850 mg tableta, empagliflozin 5 mg tableta
English: Germany Biomo Pharma Gmbh
Slovenian: Biomo Pharma Gmbh Glucobon
English: United Kingdom
Slovenian: Nizozemska
English: Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Slovenian: Ebymect metforminijev klorid 1.000 mg tableta, dapagliflozin 5 mg tableta
English: Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Slovenian: Velmetia metforminijev klorid 1.000 mg tableta, sitagliptin 50 mg tableta
English: Metformin Hydrochloride Ph. Eur.
Slovenian: Metformin Sandoz Ltd metforminijev klorid Ph. Eur.
English: Metformin Hydrochloride 1000mg Tablet Tablet
Slovenian: Metformina Ciclum metforminijev klorid 1.000 mg tableta
English: Metformin Hydrochloride 100mg/Ml
Slovenian: Metformin/Alapis metforminijev klorid 100 mg/ ml peroralna raztopina
English: Metformin Hydrochloride 850mg
Slovenian: Metformin Sandoz metforminijev klorid 850 mg
English: Metformina Tevagen Teva
Slovenian: Teva Pharma S.L.U Metformina Tevagen Teva
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Slovenian: metforminijev klorid 400 mg tableta, glibenklamid 2,5 mg tableta tableta
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Slovenian: Synjardy metforminijev klorid 1.000 mg tableta, empagliflozin 5 mg tableta
English: Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Slovenian: Glucovance metforminijev klorid 1.000 mg tableta, glibenklamid 5 mg tableta
English: Metwest Pharmaceuticals Limited Metformin Metwest Pharmaceuticals
Slovenian: Metwest Pharmaceuticals Limited
English: Germany Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Slovenian: Hexal Pharma Gmbh Metformin Hexal
English: Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Slovenian: Ristfor metforminijev klorid 850 mg tableta, sitagliptin 50 mg tableta
English: Estonia Sandoz Gmbh
Slovenian: Sandoz Pharmaceuticals Gmbh
English: Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Slovenian: Komboglyze metforminijev klorid 1.000 mg tableta, saksagliptin 2,5 mg tableta
English: Metformin Galena
Slovenian: Metformin Galena tableta
English: Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Slovenian: Metformin-Ratiopharm metforminijev klorid 850 mg tableta
English: Metformin Medley Pharma
Slovenian: Medley Pharma Limited Metformin Medley Pharma tableta
English: Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Slovenian: Komboglyze metforminijev klorid 850 mg tableta, saksagliptin 2,5 mg tableta
English: Metformin Hydrochloride 500mg
Slovenian: Metformin Teva metforminijev klorid 500 mg G
English: Austria Stada Arzneimittel Gmbh
Slovenian: Stada Arzneimittel Gmbh Metformin Stada
English: Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Slovenian: Metformin-Ratiopharm metforminijev klorid 500 mg tableta
English: Metformina Mylan Generics Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Slovenian: Metformine Hcl Mylan metforminijev klorid 1.000 mg tableta disperzibilna tableta
English: Crescent Pharma Limited
Slovenian: Crescent Pharma Limited Metformin Crescent Pharma
English: Metformina Mylan Generics Metformin Hydrochloride 500mg Tablet
Slovenian: Metformine Hcl Mylan metforminijev klorid 500 mg tableta
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Slovenian: Vokanamet metforminijev klorid 1.000 mg tableta, kanagliflozin 50 mg tableta
English: Metformina Labesfal
Slovenian: Metformina Amneal
English: Metformine Hcl Usv Europe Metformin Hydrochloride 500mg Tablet
Slovenian: Metformin Hydrochloride Glenmark Generics Europe metforminijev klorid 500 mg/5 ml peroralna raztopina
English: Metformin Relonchem Metformin Hydrochloride 500mg Tablet
Slovenian: Relon Chem Limited Metformin Relonchem metforminijev klorid 500 mg tableta
English: Norway Rosemont Pharmaceuticals Limited Metformin Rosemont
Slovenian: Rosemont Pharmaceuticals Limited
English: Metformin Hydrochloride 1000mg Tablet Prolonged-Release Tablet
Slovenian: Metformin Actavis Ptc metforminijev klorid 1.000 mg tableta tablete s podaljšanim sproščanjem
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Slovenian: Glucovance metforminijev klorid 500 mg tableta, glibenklamid 2,5 mg tableta
English: Metformina Mylan Generics Metformin Hydrochloride 850mg Tablet
Slovenian: Metformine Hcl Mylan metforminijev klorid 850 mg tableta
English: Normell
Slovenian: Norveška
English: Metformin Relonchem Metformin Hydrochloride 850mg Tablet
Slovenian: Metformin Heumann metforminijev klorid 850 mg tableta
English: Dispersible Tablet
Slovenian: Glucostop šumeča tableta
English: Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Slovenian: Metformin Ratiopharm metforminijev klorid 500 mg tableta
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Slovenian: Vokanamet metforminijev klorid 1.000 mg tableta, kanagliflozin 150 mg tableta
English: Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Slovenian: Metformin Ratiopharm metforminijev klorid 850 mg tableta
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Slovenian: Metformin Wockhardt Uk Ltd obložena tableta
English: Metformin Hydrochloride 500mg/5 Ml
Slovenian: Metformin Glenmark metforminijev klorid 500 mg/5 ml peroralna raztopina
English: Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Slovenian: Metformin Aaa-Pharma metforminijev klorid 850 mg tableta
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Slovenian: Glucovance metforminijev klorid 500 mg tableta, glibenklamid 5 mg tableta
English: Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Slovenian: Metformin Aaa-Pharma metforminijev klorid 500 mg tableta
English: Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Slovenian: Generics [uk] Limited Metformin Hydrochloride Arcana Arzneimittel Gmbh
English: Germany Aliud Pharma Gmbh
Slovenian: Aliud Pharma Gmbh Metformin
English: Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Slovenian: Metformine Arrow Lab metforminijev klorid 1.000 mg tableta
English: Germany Denk Pharma Gmbh & Co. Kg Metfo
Slovenian: Denk Pharma Gmbh & Co.
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Slovenian: Vokanamet metforminijev klorid 850 mg tableta, kanagliflozin 50 mg tableta
English: Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Slovenian: Metformin Ratiopharm metforminijev klorid 1.000 mg tableta
English: Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Slovenian: Metformina Ratiopharm metforminijev klorid 500 mg tableta
English: Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Slovenian: Metformina Ratiopharm metforminijev klorid 850 mg tableta
English: Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Slovenian: Metformina Ratiopharm metforminijev klorid 1.000 mg tableta
English: Metformin Hydrochloride 500ml/5 Ml
Slovenian: Metformin Hydrochloride Rosemont metforminijev klorid 500 ml/5 ml peroralna raztopina
English: Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Slovenian: Metformine Ratiopharm metforminijev klorid 850 mg tableta
English: Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Slovenian: Metformine Ratiopharm metforminijev klorid 1.000 mg tableta
English: Metformine Ratiopharm Metformin Hydrochloride 500mg Tablet
Slovenian: Metformine Ratiopharm metforminijev klorid 500 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Slovenian: Vokanamet metforminijev klorid 850 mg tableta, kanagliflozin 150 mg tableta
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution In Sachet
Slovenian: metforminijev klorid 500 mg vrečica prašek za peroralno raztopino v vrečici
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Slovenian: Takeda Pharma A-S Vipdomet metforminijev klorid 850 mg tableta, alogliptin 25 mg tableta
English: Metformin Hydrochloride 500mg Film Film-Coated Tablet
Slovenian: 500 mg tableta filmsko obložena tableta
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution In Sachet
Slovenian: metforminijev klorid 1.000 mg vrečica prašek za peroralno raztopino v vrečici
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution
Slovenian: metforminijev klorid 850 mg vrečica prašek za peroralno raztopino
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
Slovenian: metforminijev klorid 1.000 mg vrečica prašek za peroralno raztopino
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Slovenian: Takeda Pharma A-S Vipdomet metforminijev klorid 850 mg tableta, alogliptin 12,5 mg tableta
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
Slovenian: metforminijev klorid 500 mg vrečica prašek za peroralno raztopino
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Slovenian: Metformin Sandoz Ltd metforminijev klorid 850 mg tableta
English: It is available as capsules (100 mg).
Slovenian: Na voljo je v obliki kapsul (100 mg).
English: Some patients were treated for up to five and a half years.
Slovenian: Nekateri bolniki so bili zdravljeni pet let in pol.
English: • Gaucher disease;
Slovenian: • Gaucherjeva bolezen;
English: As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
Slovenian: Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 23. avgusta 2012.
English: EPAR summary for the public miglustat
Slovenian: Povzetek EPAR za javnost miglustat
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zavesca, veljavno po vsej Evropski uniji, odobrila dne 20. novembra 2002.
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.
Slovenian: Prav tako je prišlo do manjšega izboljšanja krvnih parametrov: v povprečju se je raven hemoglobina povečala za 0,26 grama na deciliter, število trombocitov pa za 8,29 milijona na mililiter.
English: The recommended starting dose for type 1 Gaucher disease is one capsule three times a day.
Slovenian: Priporočeni začetni odmerek pri Gaucherjevi bolezni tipa 1 je ena kapsula trikrat na dan.
English: What benefit has Zavesca shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zavesca izkazalo med študijami?
English: The company also presented the results of a survey of 66 patients treated with Zavesca.
Slovenian: Družba je predstavila tudi rezultate ankete pri 66 bolnikih, ki so prejemali zdravilo Zavesca.
English: What is the risk associated with Zavesca?
Slovenian: Kakšna tveganja so povezana z zdravilom Zavesca?
English: • Niemann-Pick type C disease.
Slovenian: • Niemann-Pickova bolezen tipa C.
English: Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Slovenian: Zdravilo Zavesca se uporablja za zdravljenje nevroloških simptomov bolezni (simptomov, ki prizadenejo možgane in živce).
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.
Slovenian: Glavno merilo učinkovitosti je bila sprememba hitrosti, s katero je bolnik delal sunkovite vodoravne gibe z očmi po enem letu, v študiji pa so opazovali tudi druge nevrološke simptome, kot je bolnikova sposobnost požiranja in njegova intelektualna zmožnost.
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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zavesca, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Zavesca is used to treat the following patients:
Slovenian: Zdravilo Zavesca se uporablja za zdravljenje naslednjih bolnikov:
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:
Slovenian: Povzetki mnenj Odbora za zdravila sirote o zdravilu Zavesca so na voljo na spletni strani agencije na naslovu ema.europa.eu/Find medicine/Human medicines/Rare disease designation:
English: This document is a summary of the European Public Assessment Report (EPAR) for Zavesca.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zavesca.
English: The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Zavesca večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Other information about Zavesca:
Slovenian: Druge informacije o zdravilu Zavesca:
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.
Slovenian: V študiji Gaucherjeve bolezni tipa 1 je po enem letu prišlo do zmernega zmanjšanja velikosti jeter (12odstotno zmanjšanje) in vranice (19-odstotno zmanjšanje).
English: Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
Slovenian: Zdravilo Zavesca je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi dovoljenja na voljo le omejene informacije.
English: The dose should also be reduced temporarily in patients who develop diarrhoea.
Slovenian: Odmerek je treba začasno zmanjšati tudi pri bolnikih, pri katerih se pojavi driska.
English: The study compared the effects of adding Zavesca to standard care with the effects of standard care alone.
Slovenian: V študiji so učinke dodajanja zdravila Zavesca standardnemu zdravljenju primerjali z učinki samostojnega standardnega zdravljenja.
English: 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.
Slovenian: Ker je bolnikov s tema boleznima malo, veljata bolezni za redki, zato je bilo zdravilo Zavesca dne 18. oktobra 2000 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje Gaucherjeve bolezni tipa 1 in dne 16. februarja 2006 za zdravljenje Niemann-Pickove bolezni tipa C.
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).
Slovenian: V študiji so proučevali učinek zdravila Zavesca na velikost jeter in vranice ter krvne parametre, kot so ravni hemoglobina (proteina, ki se nahaja v rdečih krvnih celicah in prenaša kisik po telesu) ter trombocitov (celic, ki pomagajo pri strjevanju krvi).