FrancophonIA/ELRC3.0 huggingface dataset:
English: France Biogaran
Spanish: Biogaran
English: Chelonia Healthcare Limited
Spanish: Reino Unido Chelonia Healthcare Limited Glyformin
English: Bulgaria Berlin-Chemie Ag сиофор
Spanish: Berlin-Chemie Ag сиофор
English: Metformin Hydrochloride Bp 500mg
Spanish: Metformina hidrocloruro Bp 500 mg
English: Merck B.V.
Spanish: Países Bajos Merck B.V.
English: Slovakia Stada Arzneimittel Ag
Spanish: Eslovaquia Stada Arzneimittel Ag
English: Germany Ratiopharm Gmbh
Spanish: Alemania Ratiopharm Gmbh
English: Metformin Hydrochloride Aurobindo Pharma
Spanish: Metformin Hydrochloride Aurobindo Pharma (Malta)
English: Finland Merck Santé S.A.S.
Spanish: Finlandia Merck Santé S.A.S.
English: Finland Vitabalans Oy
Spanish: Finlandia Vitabalans Oy
English: Greece Generics Pharma Hellas Ltd
Spanish: Generics Pharma Hellas Ltd Metformin Generics
English: Sandoz Ltd
Spanish: Reino Unido Sandoz Ltd
English: Germany Aliud Pharma Gmbh
Spanish: Alemania Aliud Pharma Gmbh
English: Bulgaria Sandoz Pharmaceuticals D.D.
Spanish: Sandoz Pharmaceuticals D.D.
English: Slovakia Merck Santé S.A.S.
Spanish: Eslovaquia Merck Santé S.A.S.
English: Metformin Hydrochloride 1000mg
Spanish: Metformina hidrocloruro 1000 mg
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Spanish: Metformin Wockhardt Uk Ltd Metformina hidrocloruro 500mg comprimido
English: Metformin Hydrochloride Morningside Healthcare
Spanish: Morningside Healthcare Ltd Metformin Hydrochloride Morningside Healthcare
English: Finland Stada Arzneimittel Ag
Spanish: Finlandia Stada Arzneimittel Ag
English: Germany Juta Pharma Gmbh
Spanish: Alemania Juta Pharma Gmbh
English: Germany Iip - Institut Für Industrielle Pharmazie Forschungs- Und
Spanish: Alemania Iip -Institut Für Industrielle Metsop
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Spanish: Metformin Wockhardt Uk Ltd Metformina hidrocloruro 850mg comprimido
English: Ireland Mcdermott Laboratories Ltd
Spanish: Mcdermott Laboratories Ltd Gerformin
English: Metformine Hcl Usv Europe Metformin Hydrochloride 850mg Tablet
Spanish: Metformine Hcl Usv Europe Metformina hidrocloruro 850mg comprimido
English: Germany Biomo Pharma Gmbh
Spanish: Alemania Biomo Pharma Gmbh
English: Metformin Hydrochloride 170mg/Ml
Spanish: Metformina hidrocloruro 170 mg/ml
English: Metformin 500mg Tablet
Spanish: Metformina 500 mg comprimido
English: Metformin Hydrochloride 100mg/Ml
Spanish: Metformina hidrocloruro 100 mg/ml
English: Romania Laboratori Guidotti S.P.A.
Spanish: Rumanía Laboratori Guidotti S.P.A.
English: Denmark Vitabalans Oy
Spanish: Dinamarca Vitabalans Oy
English: Metformin Hydrochloride 500ml/5 Ml
Spanish: Metformina hidrocloruro 500 ml/5 ml
English: Romania Generics [uk] Limited
Spanish: Rumanía Generics [uk] Limited
English: Metformine Hcl Usv Europe Metformin Hydrochloride 500mg Tablet
Spanish: Metformine Hcl Usv Europe Metformina hidrocloruro 500mg comprimido
English: Slovenia Laboratori Guidotti S.P.A.
Spanish: Eslovenia Laboratori Guidotti S.P.A.
English: Metformin Hydrochloride 500mg Film Film-Coated Tablet
Spanish: Metformina hidrocloruro 500mg película Comprimido recubierto con película
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution
Spanish: Metformina hidrocloruro 850mg sobre Polvo para solución oral
English: Metformin Chelonia Healthcare Metformin Hydrochloride Bp 500mg
Spanish: Reino Unido Chelonia Healthcare Limited Metformin CheloniaHealthcare Metformina hidrocloruro Bp 500mg
English: United Morningside Healthcare Ltd
Spanish: Reino Unido Morningside Healthcare Ltd Metabet Sr
English: Germany Hormosan Pharma Gmbh
Spanish: Alemania Hormosan Pharma Gmbh
English: Greece Farmasyn S.A.
Spanish: Farmasyn S.A.
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
Spanish: Metformina hidrocloruro 1000mg sobre Polvo para solución oral
English: Romania Berlin-Chemie Ag
Spanish: Rumanía Berlin-Chemie Ag
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 850mg Tablet
Spanish: Metformin Hcl Plus Pharmacie Metformina hidrocloruro 850mg comprimido
English: Austria Hexal Pharma Gmbh
Spanish: Hexal Pharma Gmbh
English: Metformina Mylan Generics Metformin Hydrochloride 850mg Tablet
Spanish: Metformina Mylan Generics Metformina hidrocloruro 850mg comprimido
English: Metformin Lich Winthrop Arzneimittel
Spanish: Alemania Winthrop Arzneimittel Gmbh Metformin Lich Winthrop Arzneimittel
English: Latvia Ratiopharm Gmbh
Spanish: Ratiopharm Gmbh
English: France Sandoz
Spanish: Sandoz
English: Denmark Stada Arzneimittel Ag
Spanish: Dinamarca Stada Arzneimittel Ag
English: Slovakia Vitabalans Oy
Spanish: Eslovaquia Vitabalans Oy
English: Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Spanish: Metformina hidrocloruro 400 mg cápsula, Glibenclamida 2,5 mg cápsula
English: Orodispersible Film
Spanish: Limited comprimido película
English: Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Spanish: Laboratórios AzevedosIndústria Farmacêutica, S.A.
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 500mg Tablet
Spanish: Metformin Hcl Plus Pharmacie Metformina hidrocloruro 500mg comprimido
English: Germany Laboratori Guidotti S.P.A.
Spanish: Alemania Laboratori Guidotti S.P.A.
English: Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Spanish: Metformin Crescent Pharma Metformina hidrocloruro 500mg comprimido
English: Germany Berlin-Chemie Ag
Spanish: Alemania Berlin-Chemie Ag
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
Spanish: Metformina hidrocloruro 500mg sobre Polvo para solución oral
English: Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Saxagliptina 2,5 mg comprimido
English: Metformin Hydrochloride 850mgg
Spanish: Metformina hidrocloruro 850 mgg
English: Germany Bluefish Pharmaceuticals Ab
Spanish: Alemania Bluefish Pharmaceuticals Ab Metformin Bluefish
English: Metformin Hydrochloride 500mg/5 Ml
Spanish: Metformina hidrocloruro 500 mg/5 ml
English: Finland Aurobindo Pharma (Malta) Limited Metformin Aurobindo
Spanish: Dinamarca Aurobindo Pharma Limited Metformin Aurobindo
English: Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Spanish: Metformin Crescent Pharma Metformina hidrocloruro 850mg comprimido
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Spanish: Metformin/Glibenklamid Lek Metformina hidrocloruro 500mg comprimido, Glibenclamida 2,5 mg comprimido
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Spanish: Metformin/Glibenklamid Lek Metformina hidrocloruro 500mg comprimido, Glibenclamida 5 mg comprimido
English: Slovakia Laboratori Guidotti S.P.A.
Spanish: Eslovaquia Laboratori Guidotti S.P.A.
English: Denmark Bluefish Pharmaceuticals Ab
Spanish: Dinamarca Bluefish Pharmaceuticals Ab Metformin Bluefish
English: Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Linagliptina 2,5 mg comprimido
English: Unipessoal Lda
Spanish: Unipessoal Lda comprimido película
English: Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Saxagliptina 2,5 mg comprimido
English: Metformin Hydrochloride 500mg G
Spanish: Metformina hidrocloruro 500 mg G
English: Slovakia Actavis Group Ptc Ehf.
Spanish: Eslovaquia Actavis Group Ptc Ehf.
English: Metformine Hcl Usv Europe Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Spanish: Metformine Hcl Usv Europe Metformina hidrocloruro 1000mg comprimido
English: Metformina Mylan Generics Metformin Hydrochloride 500mg Tablet
Spanish: Metformina Mylan Generics Metformina hidrocloruro 500mg
English: Finland Actavis Group Ptc Ehf.
Spanish: Finlandia Actavis Group Ptc Ehf.
English: Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Spanish: Metformine Arrow Generiques Metformina hidrocloruro 1000mg comprimido
English: Denmark Actavis Group Ptc Ehf.
Spanish: Dinamarca Actavis Group Ptc Ehf.
English: Germany Glenmark Arzneimittel Gmbh
Spanish: Alemania Glenmark Arzneimittel Gmbh Metformin Glenmark
English: Metformin Hydrochloride 850mg
Spanish: Metformina hidrocloruro 850 mg
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Empagliflozina 12,5 mg comprimido
English: Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Spanish: Metformin Hydrochloride Rosemont Pharmaceuticals
English: Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Linagliptina 2,5 mg comprimido
English: Metformin Hydrochloride 500mgg
Spanish: Metformina hidrocloruro 500 mgg
English: Metformin Relonchem Metformin Hydrochloride 500mg Tablet
Spanish: Metformin Relonchem Metformina hidrocloruro 500mg comprimido
English: Aurobindo Pharma Limited
Spanish: Aurobindo Pharma (Malta) Limited
English: Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Dapagliflozina 5 mg comprimido
English: Slovenia Vitabalans Oy
Spanish: Eslovenia Vitabalans Oy
English: Metformin Relonchem Metformin Hydrochloride 850mg Tablet
Spanish: Metformin Relonchem Metformina hidrocloruro 850mg comprimido
English: Metformina Mylan Generics Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Spanish: Metformina Mylan Generics Metformina hidrocloruro 1000mg comprimido
English: Slovenia Berlin-Chemie Ag
Spanish: Eslovenia Berlin-Chemie Ag
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Empagliflozina 12,5 mg comprimido
English: Sweden Mylan Ab
Spanish: Mylan Ab
English: Slovakia Berlin-Chemie Ag
Spanish: Eslovaquia Berlin-Chemie Ag
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Spanish: Metformin Hcl Plus Pharmacie Metformina hidrocloruro 1000mg comprimido
English: Slovakia Bluefish Pharmaceuticals Ab
Spanish: Eslovaquia Bluefish Pharmaceuticals Ab Metformin Bluefish
English: Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Dapagliflozina 5 mg comprimido
English: Austria 1a Pharma Gmbh
Spanish: 1a Pharma Gmbh
English: Romania Bluefish Pharmaceuticals Ab
Spanish: Rumanía Bluefish Pharmaceuticals Ab Metformin Bluefish
English: Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Sitagliptina 50 mg comprimido
English: Metformin Hydrochloride 1g Tablet
Spanish: Metformina hidrocloruro 1g comprimido Comprimido de liberación prolongada
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution In Sachet
Spanish: Metformina hidrocloruro 850mg sobre Polvo para solución oral en sobre
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Spanish: Metformin Hcl Ratiopharm Metformina hidrocloruro 500mg comprimido
English: Wörwag Pharma Gmbh & Co. Kg Metfogamma
Spanish: Wörwag Pharma Gmbh & Co. Kg
English: Romania Wörwag Pharma Gmbh & Co. Kg Metfogamma
Spanish: Rumanía Wörwag Pharma Gmbh & Co. Kg
English: Coated Tablet
Spanish: Comprimido recubierto
English: Metformin Hydrochloride 500mg
Spanish: Metformina hidrocloruro 500 mg
English: Metformin Hydrochloride 1000mg Tablet Tablet
Spanish: Metformina hidrocloruro 1000 µg comprimido
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Spanish: Metformina hidrocloruro 400 mg comprimido, Glibenclamida 2,5 mg comprimido
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution In Sachet
Spanish: Metformina hidrocloruro 1000mg sobre Polvo para solución oral en sobre
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Alogliptina 25 mg comprimido
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Canagliflozina 50 mg comprimido
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution In Sachet
Spanish: Metformina hidrocloruro 500mg sobre Polvo para solución oral en sobre
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Spanish: Metformin Hcl Ratiopharm Metformina hidrocloruro 850mg comprimido
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Spanish: Metformina hidrocloruro 500 mg comprimido, Glibenclamida 2,5 mg comprimido
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Alogliptina 12,5 mg comprimido
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Canagliflozina 150 mg comprimido
English: Germany Tad Pharma Gmbh
Spanish: Alemania Tad Pharma Gmbh
English: Aurobindo Pharma (Malta) Limited Metformin Hydrochloride Aurobindo Pharma (Malta)
Spanish: Reino UnidoAurobindo Pharma Limited Metformin Hydrochloride Aurobindo Pharma
English: Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Pioglitazona 15 mg comprimido
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Canagliflozina 50 mg comprimido
English: Metformin Morningside Healthcare
Spanish: Reino Unido Morningside Healthcare Ltd Metformin Morningside Healthcare
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Empagliflozina 5 mg comprimido
English: Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Sitagliptina comprimido 50 mg comprimido
English: Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Spanish: Metformina hidrocloruro 2,5 mg comprimido, Glibenclamida 500 mg comprimido
English: Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Spanish: Metformin-Ratiopharm Metformina hidrocloruro 500mg comprimido
English: Bluefish Pharmaceuticals Ab
Spanish: Bluefish Pharmaceuticals Ab Metformine Bluefish
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Spanish: Metformina hidrocloruro 500 mg comprimido, Glibenclamida 5 mg comprimido
English: Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Spanish: Metformin-Ratiopharm Metformina hidrocloruro 850mg comprimido
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Spanish: Metformina hidrocloruro 400 mg cápsula, Glibenclamida 5 mg comprimido
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Empagliflozina 5 mg comprimido
English: Ireland Aurobindo Pharma Limited
Spanish: Finlandia Aurobindo Pharma (Malta) Limited
English: Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Spanish: Metformina hidrocloruro 1000 mg comprimido, Glibenclamida 5 mg comprimido
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Spanish: Metformina hidrocloruro 850 mg comprimido, Canagliflozina 150 mg comprimido
English: Germany Wörwag Pharma Gmbh & Co. Kg Metfogamma
Spanish: Alemania Wörwag Pharma Gmbh & Co. Kg
English: Metformin Bluefish
Spanish: Bluefish Pharmaceuticals Ab Metformin Bluefish
English: Slovenia Wörwag Pharma Gmbh & Co. Kg Metfogamma
Spanish: Eslovenia Wörwag Pharma Gmbh & Co. Kg
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Spanish: Metformin Hcl Ratiopharm Metformina hidrocloruro 1000mg comprimido
English: Slovakia Wörwag Pharma Gmbh & Co. Kg Metfogamma
Spanish: Eslovaquia Wörwag Pharma Gmbh & Co. Kg
English: Sweden Sandoz A-S
Spanish: Sandoz A-S
English: Germany Rosemont Pharmaceuticals Limited Metfoliquid Geriasan
Spanish: Alemania Rosemont Pharmaceuticals Limited
English: Sweden Generics [uk] Limited
Spanish: Países Bajos Generics [uk] Limited
English: Metwest Pharmaceuticals Limited Metformin Metwest Pharmaceuticals
Spanish: Reino Unido Metwest Pharmaceuticals Limited
English: Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Spanish: Metformin Ratiopharm Metformina hidrocloruro 500mg comprimido
English: Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Spanish: Metformina Ratiopharm Metformina hidrocloruro 500mg comprimido
English: Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Spanish: Metformina Ratiopharm Metformina hidrocloruro 850mg comprimido
English: Metformine Ratiopharm Metformin Hydrochloride 500mg Tablet
Spanish: Metformine Ratiopharm Metformina hidrocloruro 500mg comprimido
English: Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Spanish: Metformine Ratiopharm Metformina hidrocloruro 850mg comprimido
English: Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Spanish: Metformin Ratiopharm Metformina hidrocloruro 850mg comprimido
English: Metformina Bluefish
Spanish: Bluefish Pharmaceuticals Ab Metformina Bluefish
English: Romania Aurobindo Pharma Limited
Spanish: Rumanía Aurobindo Pharma Limited Metformin Aurobindo
English: Spain Generics [uk] Limited
Spanish: Reino Unido Generics [uk] Limited
English: Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Spanish: Metformine Ratiopharm Metformina hidrocloruro 1000mg comprimido
English: Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Spanish: Metformin Ratiopharm Metformina hidrocloruro 1000mg comprimido
English: Denmark Rosemont Pharmaceuticals Limited Metformin Rosemont
Spanish: Dinamarca Rosemont Pharmaceuticals Limited
English: Some patients were treated for up to five and a half years.
Spanish: Algunos pacientes fueron tratados durante más de un año y medio.
English: As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
Spanish: Puesto que la compañía suministró la información adicional requerida, las "circunstancias excepcionales" finalizaron el 23 de agosto de 2012.
English: The dose should also be reduced temporarily in patients who develop diarrhoea.
Spanish: La dosis también deberá reducirse temporalmente en pacientes que desarrollen diarrea.
English: The main part of the study lasted for a year, but 13 patients carried on receiving the medicine for a further two years.
Spanish: La parte principal del estudio duró un año, pero 13 pacientes continuaron recibiendo el medicamento durante dos años más.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Zavesca el 20 de noviembre de 2002.
English: • Gaucher disease;
Spanish: • Enfermedad de Gaucher:
English: Zavesca is used to treat the following patients:
Spanish: Zavesca se utiliza para el tratamiento de los siguientes pacientes:
English: This document is a summary of the European Public Assessment Report (EPAR) for Zavesca.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) de Zavesca.
English: The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Spanish: El Comité decidió que los beneficios de Zavesca son mayores que sus riesgos y recomendó autorizar su comercialización.
English: The benefits of Zavesca were maintained over three years of continuous treatment.
Spanish: Los beneficios de Zavesca persistieron durante tres años de tratamiento continuo.
English: Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
Spanish: En un principio, Zavesca fue autorizado en «circunstancias excepcionales» ya que, por tratarse de una enfermedad rara, se disponía de información limitada sobre el medicamento en el momento de su autorización.
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.
Spanish: También se registraron ligeras mejoras en los recuentos sanguíneos: Como media, el nivel de hemoglobina aumentó un 0,26 g por decilitro, y el recuento de plaquetas en 8,29 millones por mililitro.
English: The company also presented the results of a survey of 66 patients treated with Zavesca.
Spanish: La empresa presentó también los resultados de un estudio con 66 pacientes tratados con Zavesca.
English: The survey showed that Zavesca led to a stabilisation or a decrease in the rate at which symptoms got worse in about three-quarters of the patients.
Spanish: El estudio mostró que con Zavesca se conseguía una estabilización o disminución de la tasa en la que los síntomas empeoraban en aproximadamente tres cuartos de los pacientes.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Spanish: Para ampliar información, véase el Resumen de características del producto (que también forma parte del EPAR).
English: EPAR summary for the public miglustat
Spanish: Resumen del EPAR para el público general miglustat
English: Other information about Zavesca:
Spanish: Otras informaciones sobre Zavesca
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.
Spanish: Dado el escaso número de personas que padecen estas enfermedades, se consideran «raras», y Zavesca fue designado «medicamento huérfano» (medicamento utilizado en enfermedades poco frecuentes) el 18 de octubre de 2000 para la enfermedad de Gaucher de tipo 1 y el 16 de febrero de 2006 para la enfermedad de Niemann Pick de tipo C.
English: The main measure of effectiveness was the change in the speed at which the patients made saccadic horizontal eye movements after a year, but the study also looked at other neurological symptoms such as the patients' ability to swallow and their intellectual function.
Spanish: El criterio principal de valoración de la eficacia fue la variación de la velocidad a la que los pacientes hacían movimientos oculares sacádicos horizontales después de un año de tratamiento, pero el estudio también observó otros síntomas neurológicos como la capacidad de los pacientes de tragar y su actividad intelectual.
English: Zavesca is intended for long-term use.
Spanish: Zavesca está concebido para una utilización prolongada.
English: What is the risk associated with Zavesca?
Spanish: ¿Cuál es el riesgo asociado a Zavesca?
English: Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Spanish: Zavesca se utiliza en el tratamiento de los síntomas «neurológicos» de la enfermedad (síntomas que afectan al cerebro y los nervios).
English: • adults (aged 18 years and above) with mild to moderate type 1 Gaucher disease.
Spanish: • adultos (mayores de 18 años) con la enfermedad de Gaucher de tipo 1 leve a moderada.
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.
Spanish: Para la enfermedad de Niemann-Pick de tipo C, la dosis es de dos cápsulas tres veces al día para pacientes de 12 años o más; en pacientes más jóvenes la dosis depende de su peso y su altura.
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.
Spanish: En él se explica cómo el Comité de Medicamentos de Uso Humano (CHMP) ha evaluado dicho medicamento y emitido un dictamen favorable para su autorización de comercialización así como unas recomendaciones sobre las condiciones de su uso.