FrancophonIA/ELRC3.0 huggingface dataset:
English: Lithuania Vitabalans Oy
Romanian: Republica Cehă Vitabalans Oy
English: Germany Biomo Pharma Gmbh
Romanian: Biomo Pharma Gmbh
English: Metformin Hydrochloride 500mg Film Film-Coated Tablet
Romanian: Clorhidrat de metformină 500mg Film Comprimat filmat
English: Metformin 1000mg Tablet
Romanian: Metformin 1000mg Comprimat
English: Savio S.R.L.
Romanian: I.B.N. Savio S.R.L.
English: Greece Farmasyn S.A.
Romanian: Farmasyn S.A.
English: Spain Generics [uk] Limited
Romanian: Marea Britanie Generics [uk] Limited
English: Germany Aliud Pharma Gmbh
Romanian: Aliud Pharma Gmbh
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 850mg Tablet
Romanian: Metformin Hcl Plus Pharmacie Clorhidrat de metformină 850mg Comprimat
English: France Bluefish Pharmaceuticals Ab
Romanian: Republica Cehă Bluefish Pharmaceuticals Ab
English: Sandoz Ltd
Romanian: Marea Britanie Sandoz Ltd
English: Dispersible Tablet
Romanian: Comprimat pentru dispersie orală
English: Metformin Hydrochloride 500mg/5 Ml
Romanian: Clorhidrat de metformină 500mg/5 Ml
English: Austria Hexal Pharma Gmbh
Romanian: Hexal Pharma Gmbh
English: Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Romanian: Metformin Lindopharm Clorhidrat de metformină 500mg Comprimat
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Empagliflozin 12.5mg Comprimat
English: Germany Heumann Pharma Gmbh & Co. Generica Kg
Romanian: Heumann Pharma Gmbh & Co.
English: Metformin Hydrochloride 1000mg Film Film-Coated Tablet
Romanian: Clorhidrat de metformină 1000mg Film Comprimat filmat
English: Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Romanian: Metformin Crescent Pharma Clorhidrat de metformină 500mg Comprimat
English: Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Dapagliflozin 5mg Comprimat
English: Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Saxagliptin 2.5mg Comprimat
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution
Romanian: Clorhidrat de metformină 850mg Plic Pulbere pentru soluţie orală
English: Metformin Hydrochloride 500mg Units
Romanian: Clorhidrat de metformină 500mg Unități
English: Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Linagliptin 2.5mg Comprimat
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 500mg Tablet
Romanian: Metformin Hcl Plus Pharmacie Clorhidrat de metformină 500mg Comprimat
English: Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Romanian: Metformin Lindopharm Clorhidrat de metformină 850mg Comprimat
English: Metformin Hydrochloride 100mg/Ml
Romanian: Clorhidrat de metformină 100mg/Ml
English: Metformin Hydrochloride 100mg/ Ml
Romanian: Clorhidrat de metformină 100mg/ Ml
English: Metformin 500mg Tablet
Romanian: Metformină 500mg Comprimat
English: Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Romanian: Metformin Crescent Pharma Clorhidrat de metformină 850mg Comprimat
English: Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Dapagliflozin 5mg Comprimat
English: Austria 1a Pharma Gmbh
Romanian: 1a Pharma Gmbh
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
Romanian: Clorhidrat de metformină 1000mg Plic Pulbere pentru soluţie orală
English: Lithuania Berlin-Chemie Ag
Romanian: Republica Cehă Berlin-Chemie Ag
English: Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Linagliptin 2.5mg Comprimat
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Alogliptin 12.5mg Comprimat
English: Slovakia Actavis Group Ptc Ehf.
Romanian: Marea Britanie Actavis Group Ptc Ehf.
English: Estonia Aurobindo Pharma Limited
Romanian: Marea Britanie Aurobindo Pharma Limited
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Alogliptin 25mg Comprimat
English: Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Saxagliptin 2.5mg Comprimat
English: Metformin 850mg Tablet
Romanian: Metformină 850mg Comprimat
English: Norway Rosemont Pharmaceuticals Limited Metformin Rosemont
Romanian: Rosemont Pharmaceuticals Limited Metformin Rosemont
English: Germany Denk Pharma Gmbh & Co. Kg Metfo
Romanian: Denk Pharma Gmbh & Co.
English: Metformin Hydrochloride 500mg G
Romanian: Clorhidrat de metformină 500mg
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Empagliflozin 12.5mg Comprimat
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Canagliflozin 150mg Comprimat
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Romanian: Metformin Hcl Plus Pharmacie Clorhidrat de metformină 1000mg Comprimat
English: Tolife - Produtos Farmacêuticos, S.A.
Romanian: Tolife - Produtos Farmacêuticos, S.A. Metformina Tolife
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution In Sachet
Romanian: Clorhidrat de metformină 1000mg Plic Pulbere pentru soluție orală în plic
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution In Sachet
Romanian: Clorhidrat de metformină 850mg Plic Pulbere pentru soluție orală în plic
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Canagliflozin 150mg Comprimat
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
Romanian: Clorhidrat de metformină 500mg Plic Pulbere pentru soluţie orală
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Empagliflozin 5mg Comprimat
English: Germany Juta Pharma Gmbh
Romanian: Juta Pharma Gmbh
English: Germany Tad Pharma Gmbh
Romanian: Tad Pharma Gmbh
English: Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Sitagliptin 50mg Comprimat
English: Wörwag Pharma Gmbh & Co. Kg Metfogamma
Romanian: Wörwag Pharma Gmbh & Co.
English: Metformin Hydrochloride 1000mg Tablet Prolonged-Release Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat cu eliberare prelungită
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Romanian: Lek Pharmaceuticals D.D. Ljubljana Metformin/Glibenklamid Lek Clorhidrat de metformină 500mg Comprimat, Glibenclamidă 5mg
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Canagliflozin 50mg Comprimat
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Empagliflozin 5mg Comprimat
English: Greece Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
Romanian: Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Canagliflozin 50mg Comprimat
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Romanian: Lek Pharmaceuticals D.D. Ljubljana Metformin/Glibenklamid Lek Clorhidrat de metformină 500mg Comprimat, Glibenclamidă 2.5mg
English: Metformin Hydrochloride Ph. Eur.
Romanian: Clorhidrat de metformină Ph.
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution In Sachet
Romanian: Clorhidrat de metformină 500mg Plic Pulbere pentru soluție orală în plic
English: Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Romanian: Metformin Focus Pharmaceuticals
English: Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Romanian: Metformine Arrow Generiques Clorhidrat de metformină 1000mg Comprimat
English: Ireland Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Romanian: Marea Britanie Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Romanian: Metformin Hcl Ratiopharm Clorhidrat de metformină 500mg Comprimat
English: Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Sitagliptin 50mg Comprimat
English: Slovenia Wörwag Pharma Gmbh & Co. Kg Metfogamma
Romanian: Republica Cehă Wörwag Pharma Gmbh & Co.
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Romanian: Metformin Hcl Ratiopharm Clorhidrat de metformină 850mg Comprimat
English: Metformin Hydrochloride 1000µg Tablet Film-Coated Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat filmat
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Romanian: Clorhidrat de metformină 500mg Comprimat, Glibenclamidă 2.5mg Comprimat
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Romanian: Clorhidrat de metformină 400mg Comprimat, Glibenclamidă 2.5mg Comprimat
English: Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Romanian: Metformin-Ratiopharm Clorhidrat de metformină 500mg Comprimat
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Romanian: Metformine Hcl Ratiopharm Clorhidrat de metformină 500mg Comprimat
English: Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Romanian: Clorhidrat de metformină 1000mg Comprimat, Glibenclamidă 5mg Comprimat
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Romanian: Clorhidrat de metformină 400mg Comprimat, Glibenclamidă 5mg Comprimat
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Romanian: Metformine Hcl Ratiopharm Clorhidrat de metformină 850mg Comprimat
English: Estonia Sandoz Gmbh
Romanian: Sandoz Pharmaceuticals Gmbh
English: Romania Generics [uk] Limited
Romanian: Republica Cehă Generics [uk] Limited
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Romanian: Clorhidrat de metformină 500mg Comprimat, Glibenclamidă 5mg Comprimat
English: Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Romanian: Clorhidrat de metformină 850mg Comprimat, Pioglitazonă 15mg Comprimat
English: Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Romanian: Metformin-Ratiopharm Clorhidrat de metformină 850mg Comprimat
English: Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Romanian: Clorhidrat de metformină 2.5mg Comprimat, Glibenclamidă 500mg Comprimat
English: Tevamet
Romanian: Xigduo
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Romanian: Metformin Hcl Ratiopharm Clorhidrat de metformină 1000mg Comprimat
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Romanian: Metformine Hcl Ratiopharm Clorhidrat de metformină 1000mg Comprimat
English: Eood
Romanian: Eucreas
English: Kingdom
Romanian: Spania
English: Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Romanian: Metformin Ratiopharm Clorhidrat de metformină 850mg Comprimat
English: Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Romanian: Metformine Ratiopharm Clorhidrat de metformină 1000mg Comprimat
English: Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Romanian: Metformina Ratiopharm Clorhidrat de metformină 850mg Comprimat
English: Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Romanian: Metformina Ratiopharm Clorhidrat de metformină 1000mg Comprimat
English: Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Romanian: Metformina Ratiopharm Clorhidrat de metformină 500mg Comprimat
English: Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Romanian: Metformine Ratiopharm Clorhidrat de metformină 850mg Comprimat
English: Metformine Ratiopharm Metformin Hydrochloride 500mg Tablet
Romanian: Metformine Ratiopharm Clorhidrat de metformină 500mg Comprimat
English: Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Romanian: Metformin Ratiopharm Clorhidrat de metformină 500mg Comprimat
English: Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Romanian: Metformin Ratiopharm Clorhidrat de metformină 1000mg Comprimat
English: Metformin Hydrochloride 1000mg
Romanian: Clorhidrat de metformină 1000µg Comprimat
English: It is available as capsules (100 mg).
Romanian: Este disponibil sub formă de capsule (100 mg).
English: Some patients were treated for up to five and a half years.
Romanian: Unii pacienţi au urmat tratamentul până la 5 ani şi jumătate.
English: As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
Romanian: Întrucât compania a pus la dispoziţie informaţiile suplimentare solicitate, „circumstanţele excepţionale” au încetat la 23 august 2012.
English: • Gaucher disease;
Romanian: • Boala Gaucher;
English: Other information about Zavesca:
Romanian: Alte informaţii despre Zavesca:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Romanian: Comisia Europeană a acordat o autorizaţie de introducere pe piaţă pentru Zavesca, valabilă pe întreg teritoriul Uniunii Europene, la 20 noiembrie 2002.
English: This document is a summary of the European Public Assessment Report (EPAR) for Zavesca.
Romanian: Prezentul document este un rezumat al Raportului public european de evaluare (EPAR) pentru 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.
Romanian: Partea principală a studiului a durat un an, însă 13 pacienţi au primit în continuare medicamentul timp de încă doi ani.
English: The company also presented the results of a survey of 66 patients treated with Zavesca.
Romanian: De asemenea, compania a prezentat rezultatele unui sondaj pe 66 de pacienţi care au fost trataţi cu Zavesca.
English: EPAR summary for the public miglustat
Romanian: Rezumat EPAR destinat publicului miglustat
English: The benefits of Zavesca were maintained over three years of continuous treatment.
Romanian: Beneficiile Zavesca s-au menţinut timp de 3 ani de tratament continuu.
English: Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
Romanian: Zavesca a fost iniţial autorizat în „circumstanţe excepţionale” deoarece informaţiile puse la dispoziţie la momentul aprobării erau limitate.
English: What is the risk associated with Zavesca?
Romanian: Care sunt riscurile asociate cu Zavesca?
English: For further information, see the summary of product characteristics (also part of the EPAR).
Romanian: Pentru informaţii suplimentare, consultaţi Rezumatul caracteristicilor produsului (care face parte, de asemenea, din EPAR).
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.
Romanian: Deoarece numărul pacienţilor cu aceste boli este scăzut, ele sunt considerate „rare”, iar Zavesca a fost desemnat „medicament orfan” (un medicament folosit în boli rar întâlnite) la 18 octombrie 2000 pentru boala Gaucher de tip I şi la 16 februarie 2006 pentru boala Niemann-Pick de tip C.
English: Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Romanian: Zavesca se utilizează pentru tratarea simptomelor neurologice ale bolii (simptome care afectează creierul şi nervii).
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.
Romanian: Documentul explică modul în care Comitetul pentru medicamente de uz uman (CHMP) a evaluat medicamentul, pentru a emite avizul în favoarea acordării autorizaţiei de introducere pe piaţă şi recomandările privind condiţiile de utilizare pentru Zavesca.
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.
Romanian: S-au înregistrat oarecare îmbunătăţiri în ceea ce priveşte numărul trombocitelor: în medie, concentraţia de hemoglobină a crescut cu 0,26 g pe decilitru, iar numărul trombocitelor a crescut cu 8,29 milioane pe mililitru.
English: What benefit has Zavesca shown during the studies?
Romanian: Ce beneficii a prezentat Zavesca pe parcursul studiilor?
English: For the full list of all side effects reported with Zavesca, see the package leaflet.
Romanian: Pentru lista completă a efectelor secundare raportate asociate cu Zavesca, consultaţi prospectul.
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.
Romanian: Sondajul a arătat că tratamentul cu Zavesca a dus la o stabilizare sau diminuare a ratei de agravare a simptomelor la aproximativ trei sferturi dintre pacienţi.
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.
Romanian: Principalul indicator al eficacităţii a fost modificarea vitezei mişcărilor oculare sacadate orizontale ale pacienţilor după 1 an de tratament, însă studiul a evaluat şi alte simptome neurologice, cum ar fi capacitatea pacienţilor de a înghiţi şi funcţia lor intelectuală.
English: The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Romanian: CHMP a hotărât că beneficiile Zavesca sunt mai mari decât riscurile asociate şi a recomandat acordarea autorizaţiei de introducere pe piaţă pentru acest produs.
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.
Romanian: EPAR-ul complet pentru Zavesca este disponibil pe site-ul agenţiei: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zavesca must not be used in people who are hypersensitive (allergic) to miglustat or any of the other ingredients.
Romanian: Zavesca este contraindicat la persoanele care sunt hipersensibile (alergice) la miglustat sau la oricare dintre celelalte ingrediente.
English: The recommended starting dose for type 1 Gaucher disease is one capsule three times a day.
Romanian: Doza iniţială recomandată pentru boala Gaucher de tip I este de o capsulă administrată de trei ori pe zi.
English: • adults (aged 18 years and above) with mild to moderate type 1 Gaucher disease.
Romanian: • adulţi (cu vârsta de 18 ani şi peste) cu boala Gaucher de tip I uşoară până la moderată.
English: The dose should also be reduced temporarily in patients who develop diarrhoea.
Romanian: Doza trebuie redusă temporar şi la pacienţii la care apare diareea.
English: 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.
Romanian: Acestea includ lipsa coordonării, tulburări ale mişcărilor oculare „sacadate” (rapide) care pot duce la tulburări de vedere, întârzierea dezvoltării, dificultăţi de înghiţire, scăderea tonusului muscular, convulsii şi dificultăţi de învăţare.
English: Zavesca is used in patients who cannot receive the standard treatment of enzyme replacement therapy (ERT);
Romanian: Zavesca se utilizează la pacienţii care nu pot urma tratamentul standard de terapie de substituţie enzimatică (TSE);
English: Why has Zavesca been approved?
Romanian: De ce a fost aprobat Zavesca?
English: For more information about treatment with Zavesca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Romanian: Pentru mai multe informaţii referitoare la tratamentul cu Zavesca, citiţi prospectul (care face parte, de asemenea, din EPAR) sau adresaţi-vă medicului sau farmacistului.
English: Zavesca is a medicine that contains the active substance miglustat.
Romanian: Zavesca este un medicament care conţine substanţa activă miglustat.
English: In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
Romanian: În studiul privind boala Niemann-Pick de tip C, îmbunătăţirile privind mişcările oculare au fost asemănătoare la pacienţii trataţi cu sau fără Zavesca.
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:
Romanian: Rezumatul avizului Comitetului pentru medicamente orfane pentru Zavesca este disponibil pe site-ul agenţiei: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
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).
Romanian: Studiul a evaluat efectul pe care Zavesca îl are asupra volumului ficatului şi splinei şi asupra parametrilor sanguini, precum concentraţia de hemoglobină (o proteină care se găseşte în globulele roşii şi care transportă oxigenul în întregul organism) şi numărul trombocitelor (componente care ajută la coagularea sângelui).
English: This enzyme is involved in the first step of the production of glycosphingolipids.
Romanian: Această enzimă este implicată în prima etapă a producţiei de glicosfingolipide.
English: What is Zavesca?
Romanian: Ce este Zavesca?
English: 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.
Romanian: Pentru boala Niemann-Pick de tip C, doza recomandată este de două capsule de trei ori pe zi pentru pacienţii cu vârsta de 12 ani şi peste; la pacienţii mai tineri, doza depinde de greutate şi înălţime.
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.
Romanian: În studiul privind boala Gaucher de tip I, după un an de tratament s-a înregistrat o reducere moderată a volumului ficatului (reducere de 12%) şi a splinei (reducere de 19%).
English: Zavesca is intended for long-term use.
Romanian: Zavesca este destinat pentru tratamentul de lungă durată.
English: 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).
Romanian: Cele mai frecvente efecte secundare asociate cu Zavesca (observate la mai mult de 1 pacient din 10) sunt scăderea în greutate, scăderea poftei de mâncare, tremorul (tremurăturile), diareea, flatulenţa (gaze) şi durerile abdominale (de burtă).
English: • patients of all ages with Niemann-Pick type C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Romanian: • pacienţi de toate vârstele cu boala Niemann-Pick de tip C, o boală potenţial letală, în care glicosfingolipidele se acumulează în celulele creierului şi în alte părţi ale organismului.