FrancophonIA/ELRC3.0 huggingface dataset:
English: • in patients who had not received chemotherapy before, patients who had wild-type KRAS in their tumours lived for longer without their disease getting worse when they received Erbitux in addition to chemotherapy including irinotecan (9.9 months compared with 8.4 months, on average).
Spanish: • en pacientes que no habían recibido quimioterapia anteriormente, los pacientes que presentaban KRAS de tipo invasivo en sus tumores vivieron más tiempo sin que la enfermedad empeorara cuando se les administró Erbitux además de la quimioterapia con irinotecan (9,9 meses frente a 8,4 meses por término medio).
English: Patients who had failed both oxaliplatin and irinotecan treatment lived for an average of 3.6 months without their disease getting worse with Erbitux, compared with 1.9 months in those receiving best supportive care alone (the treatment of symptoms but not the cancer itself).
Spanish: En pacientes en los que había fracasado tanto el tratamiento con oxaliplatino como con irinotecan, la enfermedad tardó en empeorar un promedio de 3,6 meses con Erbitux y 1,9 meses en los pacientes que recibieron el mejor tratamiento de soporte solo (el tratamiento de los síntomas pero no del cáncer).
English: Patients who had failed oxaliplatin treatment lived for an average of 4.0 months without their disease getting worse with Erbitux plus irinotecan, compared with 2.6 months in those receiving irinotecan alone.
Spanish: Aquellos pacientes en los que había fracasado el tratamiento con oxaliplatino vivieron un promedio de 4,0 meses sin que su enfermedad empeorara cuando se les administró Erbitux en combinación con irinotecán, frente a los 2,6 meses que vivieron aquellos que recibieron sólo irinotecán.
English: For metastatic cancer of the colon or rectum, Erbitux was studied in six main studies:
Spanish: La eficacia de Erbitux en el tratamiento del cáncer colorrectal metastásico se ha analizado en seis estudios principales:
English: What is Erbitux used for?
Spanish: ¿Para qué se utiliza Erbitux?
English: In patients receiving Erbitux in combination with oxaliplatin-containing chemotherapy (FOLFOX) patients with wild-type RAS lived for longer without their disease getting worse compared with patients on FOLFOX alone (12.0 months compared with 5.8 months, on average).
Spanish: En los pacientes a los que se administró Erbitux con quimioterapia a base de oxaliplatino (FOLFOX) los pacientes con RAS de tipo invasivo vivieron más tiempo sin que la enfermedad empeorase, frente a los pacientes que a los que se administró FOLFOX en monoterapia (12,0 meses frente a 5,8 como promedio).
English: How does Erbitux work?
Spanish: ¿Cómo actúa Erbitux?
English: How is Erbitux used?
Spanish: ¿Cómo se usa Erbitux?
English: One of the studies also looked at the results separately in patients whose tumours carried wild-type forms of all RAS genes and patients with mutated forms of any RAS gene.
Spanish: En uno de los estudios también se examinaron por separado los resultados en pacientes cuyos tumores llevaban formas invasivas de todos los genes RAS y pacientes con formas mutadas de de cualquier gen RAS. Cuando los genes RAS (como KRAS) mutan, pueden estimular el crecimiento de las células cancerosas sin conexión a EGFR, por lo que no cabe esperar que Erbitux sea de gran ayuda.
English: In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation).
Spanish: Erbitux se administra en combinación con radioterapia (tratamiento con radiación) en el tratamiento del cáncer localmente avanzado (cuando el tumor ha crecido pero no se ha extendido).
English: How has Erbitux been studied?
Spanish: ¿Qué tipo de estudios se han realizado con Erbitux?
English: United Kingdom Teva Uk Limited
Spanish: Teva Uk Limited
English: Oral Drops, Solution Oral Use
Spanish: Gotas orales en solución Vía oral
English: United Kingdom Norton Healthcare Ltd T/A Ivax
Spanish: Norton Healthcare Ltd T/A Ivax
English: United Kingdom Noridem Enterprises Ltd Sodium Valproate Noridem Enterprises
Spanish: Noridem Enterprises Ltd Valproato sódico Noridem Enterprises
English: Intravenous Use
Spanish: Vía intravenosa
English: Valproate Magnesium 10000mg/100 Ml
Spanish: Valproato magnésico 10000 mg/100 ml
English: Prolonged-Release Granules
Spanish: Granulado de liberación prolongada
English: Sodium Valproate Wockhardt Uk
Spanish: Valproato sódico Wockhardt Uk
English: Valproate Semisodium 269.1mg Tablet
Spanish: Valproato semisódico 269,1 mg comprimido
English: Valproic Acid 43.38mg/Ml
Spanish: Ácido valproico 43,38 mg/ml
English: United Kingdom Winthrop Pharmaceuticals Uk Ltd
Spanish: Winthrop Pharmaceuticals Uk Ltd
English: Powder And Solvent For Solution For Injection
Spanish: Polvo y disolvente para solución inyectable
English: ácido Valpróico Generis Valproic Acid 400mg/4 Ml
Spanish: ácido Valpróico Generis Ácido valproico 400 mg/4 ml
English: Valproate Semisodium 538.2mg Tablet
Spanish: Valproato semisódico 538,2 mg comprimido
English: Prolonged-Release Capsule
Spanish: Cápsula de liberación prolongada
English: Gastro-Resistant Capsule
Spanish: Cápsula gastrorresistente
English: Valproic Acid 50mg/Ml
Spanish: Ácido valproico 50 mg/ml
English: United Kingdom Aventis Pharma Ltd Epilim Chrono
Spanish: Aventis Pharma Ltd Epilim Chrono
English: Capsule, Soft
Spanish: Cápsula blanda
English: Prolonged-Release Granules In Sachet
Spanish: Granulado de liberación prolongada en sobres
English: Sodium Valproate Wockhardt
Spanish: Valproato sódico Wockhardt
English: Depakine Chrono 500 Valproic Acid 145.14mg Tablet, Sodium
Spanish: Depakine Chrono 500 Ácido valproico 145,14 mg comprimido,
English: ácido Valproico G.E.S Sodium Valproate 400mg Vial
Spanish: ácido Valproico G.E.S Valproato sódico 400 mg vial
English: United Kingdom Aventis Pharma Ltd Depakote
Spanish: Aventis Pharma Ltd Depakote
English: Sodium Valproate Bp 200mg
Spanish: Valproato sódico Bp 200 mg
English: Sodium Valproate Winthrop
Spanish: Valproato sódico Winthrop
English: Solution For Injection Intravenous Use
Spanish: Solución inyectable y para perfusión intravenosa
English: Natriumvalproat Aristo Sodium Valproate 300mg G
Spanish: Natriumvalproat Aristo Valproato sódico 300 mg G
English: United Kingdom Aventis Pharma Ltd Epilim
Spanish: Aventis Pharma Ltd Epilim
English: Sodium Valproate 400mg Vial
Spanish: Valproato sódico 400 mg vial
English: Concentrate For Solution For Injection/Infusion
Spanish: Concentrado para solución inyectable y para perfusión
English: Powder And Solvent For Solution For Injection/Infusion
Spanish: Polvo y disolvente para solución inyectable y para perfusión
English: Sodium Valproate Ivax Sodium Valproate 200mg/5 Ml
Spanish: Valproato sódico Ivax Valproato sódico 200 mg/5 ml
English: Modified-Release Capsule, Hard
Spanish: Cápsula dura de liberación modificada
English: Valproate Semisodium 250mg Tablet
Spanish: Valproato Semisódico 250 mg comprimido
English: Modified-Release Tablet Oral Use
Spanish: Comprimido de liberación modificada
English: Gastro-Resistant Capsule, Hard
Spanish: Cápsula dura gastrorresistente
English: Sodium Valproate 300mg Suppository
Spanish: Valproato sódico 300 mg supositorio
English: Valproic Acid 87mg G, Sodium Valproate 200mg Tablet
Spanish: Ácido valproico 87 mg G, Valproato sódico 200 mg comprimido
English: Gastro-Resistant Capsule, Soft
Spanish: Cápsula blanda gastrorresistente
English: Valproic Acid 145mg G, Sodium Valproate 333mg G
Spanish: Ácido valproico 145 mg G, Valproato sódico 333 mg G
English: Valproic Acid 217.75mg Sachet, Sodium Valproate 500.06mg Sachet
Spanish: Ácido valproico 217,75 mg sobre, Valproato sódico 500,06 mg sobre
English: Sodium Valproate 500mg
Spanish: Valproato sódico 500 mg
English: Valproate Retard Mylan Sodium Valproate 500mg Tablet
Spanish: Valproate Retard Mylan Valproato sódico 500 mg comprimido
English: Valproate Magnesium 500mg Tablet
Spanish: Valproato magnésico 500 mg Comprimido
English: Valpromide 300mg Tablet
Spanish: Valpromida 300 mg comprimido
English: Valproate Retard Mylan Sodium Valproate 300mg Tablet
Spanish: Valproate Retard Mylan Valproato sódico 300 mg comprimido
English: Valproat Neuraxpharm Sodium Valproate 60mg/Ml
Spanish: Valproat Neuraxpharm Valproato sódico 60 mg/ml
English: Sodium Valproate 300mg
Spanish: Valproato sódico 300 mg
English: Valproic Acid 72.61mg Sachet, Sodium Valproate 166.76mg Sachet
Spanish: Ácido valproico 72,61 mg sobre, Valproato sódico 166,76 mg sobre
English: Valproic Acid 290.27mg Sachet, Sodium Valproate 666.6mg Sachet
Spanish: Ácido valproico 290,27 mg sobre, Valproato sódico 666,6 mg sobre
English: Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Spanish: Austria sanofi-aventis GmbH Depakine Chronosphere Ácido valproico 72,61 mg sobre, Valproato sódico 166,76 mg sobre
English: Valproic Acid 29.03mg Sachet, Sodium Valproate 66.66mg Sachet
Spanish: Ácido valproico 29,03 mg sobre, Valproato sódico 66,66 mg sobre
English: Sodium Valproate 1000mg Container
Spanish: Valproato sódico 1000 mg envase
English: Valproate Magnesium 200mg Tablet
Spanish: Valproato Magnésico 200 mg comprimido
English: Valproic Acid 145.14mg Sachet, Sodium Valproate 333.3mg Sachet
Spanish: Ácido valproico 145,14 mg sobre, Valproato sódico 333,3 mg sobre
English: Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Spanish: Austria sanofi-aventis GmbH Depakine Chronosphere Ácido valproico 145,14 mg sobre, Valproato sódico 333,3 mg sobre
English: Valproat Neuraxpharm Sodium Valproate 300mg/Ml
Spanish: Valproat Neuraxpharm Valproato sódico 300 mg/ml
English: Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Spanish: Austria sanofi-aventis GmbH Depakine Chronosphere Ácido valproico 14,51 mg sobre, Valproato sódico 33,33 mg sobre
English: Valproate Semisodium 500mg Tablet
Spanish: Valproato Semisódico 500 mg comprimido
English: Sodium Valproate 300mg Capsule
Spanish: Valproato sódico 300 mg cápsula
English: Sodium Valproate 500mg Capsule
Spanish: Valproato sódico 500 mg cápsula
English: Sodium Valproate 200mg
Spanish: Valproato sódico 200 mg
English: Depakine Chrono 300 Valproic Acid 87mg Tablet, Sodium
Spanish: Depakine Chrono 300 Ácido valproico 87 mg comprimido, Valproato sódico 200 mg comprimido
English: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Spanish: Sanofi-Aventis Aebe Depakine Chronosphere Ácido valproico 72,61 mg sobre, Valproato sódico 166,76 mg sobre
English: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Spanish: Sanofi-Aventis Aebe Depakine Chronosphere Ácido valproico 29,03 mg sobre, Valproato sódico 66,66 mg sobre
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Spanish: Aventis Pharma Ltd Epilim Chronosphere Ácido valproico 217,75 mg sobre, Valproato sódico 500,06 mg sobre
English: Sodium Valproate 400mg Container
Spanish: Valproato sódico 400 mg envase
English: Sodium Valproate 150mg Capsule
Spanish: Valproato sódico 150 mg cápsula
English: Valproat Ratiopharm Valproic Acid 145mg G, Sodium Valproate
Spanish: Valproat Ratiopharm Ácido valproico 145 mg G, Valproato sódico 333 mg G
English: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Spanish: Sanofi-Aventis Aebe Depakine Chronosphere Ácido valproico 290,27 mg sobre, Valproato sódico 666,6 mg sobre
English: Acido Valproico Sandoz Sodium Valproate 300mg Tablet
Spanish: Acido Valproico Sandoz Valproato sódico 300 mg comprimido
English: Valproate Retard Eg Valproic Acid 87mg Tablet, Sodium
Spanish: Valproate Retard Eg Ácido valproico 87 mg comprimido, Valproato sódico 199,8 mg comprimido
English: ácido Valpróico Sandoz Sodium Valproate 500mg Tablet
Spanish: ácido Valpróico Sandoz Valproato sódico 500 mg comprimido
English: Prolonged-Release Capsule, Hard
Spanish: Cápsula dura de liberación prolongada
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Spanish: Aventis Pharma Ltd Epilim Chronosphere Ácido valproico 72,61 mg sobre, Valproato sódico 166,76 mg sobre
English: Acido Valproico Sandoz Sodium Valproate 500mg Tablet
Spanish: Acido Valproico Sandoz Valproato sódico 500 mg comprimido
English: Sodium Valproate 500mg Container
Spanish: Valproato sódico 500 mg envase
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Spanish: Aventis Pharma Ltd Epilim Chronosphere Ácido valproico 14,51 mg sobre, Valproato sódico 33,33 mg sobre
English: ácido Valpróico Sandoz Sodium Valproate 300mg Tablet
Spanish: ácido Valpróico Sandoz Valproato sódico 300 mg comprimido
English: Valproat 1 A Pharma Sodium Valproate 150mg Tablet
Spanish: Valproat 1 A Pharma Valproato sódico 150 mg comprimido
English: ácido Valpróico Generis Valproic Acid 87mg Tablet, Sodium
Spanish: ácido Valpróico Generis Ácido valproico 87 mg comprimido, Valproato sódico 199,8 mg comprimido
English: Valproat 1 A Pharma Sodium Valproate 300mg Tablet
Spanish: Valproat 1 A Pharma Valproato sódico 300 mg comprimido
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Spanish: Aventis Pharma Ltd Epilim Chronosphere Ácido valproico 145,14 mg sobre, Valproato sódico 333,3 mg sobre
English: Espa-Valept Retard Sodium Valproate 300mg Tablet
Spanish: Espa-Valept Retard Valproato sódico 300 mg comprimido
English: Valproat Chrono Sandoz Sodium Valproate 300mg Tablet
Spanish: Valproat Chrono Sandoz Valproato sódico 300 mg comprimido
English: Depakine Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Spanish: Depakine Chronosphere Ácido valproico 217,75 mg sobre, Valproato sódico 500,06 mg sobre
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Spanish: Aventis Pharma Ltd Epilim Chronosphere Ácido valproico 29,03 mg sobre, Valproato sódico 66,66 mg sobre
English: Sodium Valproate 1000mg Sachet
Spanish: Valproato sódico 1000 mg sobre
English: Sodium Valproate Teva Sodium Valproate 500mg Tablet
Spanish: Valproato sódico Teva Valproato sódico 500 mg comprimido
English: Valproat Chrono Sandoz Sodium Valproate 500mg Tablet
Spanish: Valproat Chrono Sandoz Valproato sódico 500 mg comprimido
English: Valproát Chrono Sandoz Sodium Valproate 300mg Tablet
Spanish: Valproát Chrono Sandoz Valproato sódico 300 mg comprimido
English: Valproat 1 A Pharma Sodium Valproate 600mg Tablet
Spanish: Valproat 1 A Pharma Valproato sódico 600 mg comprimido
English: Valproát Chrono Sandoz Sodium Valproate 500mg Tablet
Spanish: Valproát Chrono Sandoz Valproato sódico 500 mg comprimido
English: Valproat Neuraxpharm Sodium Valproate 300mg Units
Spanish: Valproat Neuraxpharm Valproato sódico 300 mg unidades
English: Valproat 1 A Pharma Sodium Valproate 500mg Tablet
Spanish: Valproat 1 A Pharma Valproato sódico 500 mg comprimido
English: Valproate Retard Eg Valproic Acid 145mg Tablet, Sodium
Spanish: Valproate Retard Eg Ácido valproico 145 mg comprimido, Valproato sódico 333 mg comprimido
English: Sodium Valproate Teva Sodium Valproate 200mg Tablet
Spanish: Valproato sódico Teva Valproato sódico 200 mg comprimido
English: Valproat Neuraxpharm Sodium Valproate 150mg Units
Spanish: Valproat Neuraxpharm Valproato sódico 150 mg unidades
English: Valproat Neuraxpharm Sodium Valproate 600mg Units
Spanish: Valproat Neuraxpharm Valproato sódico 600 mg unidades
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Spanish: Aventis Pharma Ltd Epilim Chronosphere Ácido valproico 290,27 mg sobre, Valproato sódico 666,6 mg sobre
English: ácido Valpróico Generis Valproic Acid 145mg Tablet, Sodium
Spanish: ácido Valpróico Generis Ácido valproico 145 mg comprimido, Valproato sódico 333 mg comprimido
English: Valproat Neuraxpharm Sodium Valproate 500mg Units
Spanish: Valproat Neuraxpharm Valproato sódico 500 mg unidades
English: Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Spanish: Depakine Chronosphere Ácido valproico 14,51 mg sobre, Valproato sódico 33,33 mg sobre
English: Natriumvalproaat Teva Valproic Acid 145mg G, Sodium Valproate
Spanish: Natriumvalproaat Teva Ácido valproico 145 mg G, Valproato sódico 333 mg G
English: Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Spanish: Depakine Chronosphere Ácido valproico 72.61 mg sobre, Valproato sódico 166,76 mg sobre
English: Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Spanish: Epilim Chronosphere Ácido valproico 72,61 mg sobre, Valproato sódico 166,76 mg sobre
English: Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Spanish: Depakine Chronosphere Ácido valproico 29,03 mg sobre, Valproato sódico 66,66 mg sobre
English: Depakine Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Spanish: Depakine Chronosphere Ácido valproico 290,27 mg sobre, Valproato sódico 666,6 mg sobre
English: It is not intended to provide practical advice on how to use Ucedane.
Spanish: No está destinado a proporcionar consejos prácticos sobre cómo utilizar Ucedane.
English: The initial daily dose of Ucedane should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Spanish: La dosis diaria inicial de Ucedane debe ser de 100 mg por kilogramo de peso corporal, pero pueden utilizarse hasta 250 mg/kg en caso necesario.
English: Other information about Ucedane
Spanish: Otras informaciones sobre Ucedane
English: Ucedane carglumic acid
Spanish: Ucedane ácido carglúmico
English: What measures are being taken to ensure the safe and effective use of Ucedane?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Ucedane?
English: Treatment may be started as early as the first day of life and the medicine is used for the patient's whole life.
Spanish: El tratamiento puede empezar el primer día de vida y se mantiene durante toda la vida del paciente.
English: The full EPAR for Ucedane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Spanish: El EPAR completo de Ucedane se puede consultar en la página web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Ucedane.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) para Ucedane.
English: What is Ucedane and what is it used for?
Spanish: ¿Qué es Ucedane y para qué se utiliza?
English: Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water.
Spanish: Ucedane se presenta en comprimidos dispersables (200 mg) que se deben dispersar (mezclar) en una pequeña cantidad de agua.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ucedane has been shown to have comparable quality and to be bioequivalent to Carbaglu.
Spanish: El Comité de Medicamentos de Uso Humano (CHMP) de la Agencia concluyó que, de conformidad con los requisitos de la UE, Ucedane ha demostrado tener una calidad comparable y ser bioequivalente a Carbaglu.
English: Because Ucedane is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Spanish: Dado que Ucedane es un medicamento genérico y es bioequivalente al medicamento de referencia, sus beneficios y sus riesgos son los mismos que los del medicamento de referencia.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating patients with metabolic diseases such as NAGS deficiency.
Spanish: Este medicamento solo se podrá dispensar con receta médica y el tratamiento deberá iniciarlo un médico experimentado en el tratamiento de pacientes con enfermedades metabólicas como el déficit de NAGS.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Carbaglu, and do not need to be repeated for Ucedane.
Spanish: Ya se han llevado a cabo estudios sobre los beneficios y los riesgos del principio activo en el uso aprobado con el medicamento de referencia, Carbaglu, y no es necesario repetirlos con Ucedane.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ucedane have been included in the summary of product characteristics and the package leaflet.
Spanish: Las recomendaciones y precauciones que deben seguir los profesionales sanitarios y los pacientes para un uso seguro y eficaz de Ucedane se han incluido en la Ficha Técnica o Resumen de las Características del Producto y el Prospecto.
English: For more information about treatment with Ucedane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Spanish: Para más información sobre el tratamiento con Ucedane, lea el prospecto (también incluido en el EPAR) o consulte a su médico o farmacéutico.
English: Ucedane is a medicine used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with N-acetylglutamate synthase (NAGS) deficiency.
Spanish: Ucedane es un medicamento que se utiliza para el tratamiento de la hiperamonemia (niveles altos de amoniaco en la sangre) en pacientes con déficit de N-acetilglutamato sintasa (NAGS).
English: Why is Ucedane approved?
Spanish: ¿Por qué se ha aprobado Ucedane?
English: If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood.
Spanish: Cuando falta esta enzima, el amoniaco no puede descomponerse y se acumula en la sangre.
English: Ucedane therefore helps break down ammonia, reducing ammonia blood levels and its toxic effects.
Spanish: En consecuencia, Ucedane ayuda a descomponer el amoniaco, reduciendo así las concentraciones de amoniaco en sangre y sus efectos tóxicos.
English: Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia.
Spanish: Quienes padecen esta enfermedad crónica carecen de una enzima hepática llamada NAGS, que normalmente ayuda a descomponer el amoniaco.
English: The active substance in Ucedane, carglumic acid, is very similar in structure to N-acetylglutamate, which activates an enzyme that breaks down ammonia.
Spanish: El principio activo de Ucedane, el ácido carglúmico, tiene una estructura muy parecida a la del N-acetilglutamato, que activa una enzima que descompone el amoniaco.
English: For practical information about using Ucedane, patients should read the package leaflet or contact their doctor or pharmacist.
Spanish: Para más información sobre el tratamiento con Ucedane, el paciente debe leer el prospecto o consultar a su médico o farmacéutico.
English: What are the benefits and risks of Ucedane?
Spanish: ¿Qué beneficios ha demostrado tener y cuál es el riesgo asociado a Ucedane?
English: This means that Ucedane contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Carbaglu.
Spanish: Ucedane contiene el principio activo ácido carglúmico y es un «medicamento genérico», es decir, contiene el mismo principio activo y actúa de la misma forma que un «medicamento de referencia» ya autorizado en la Unión Europea (UE) llamado Carbaglu.
English: Therefore, the CHMP's view was that, as for Carbaglu, the benefit outweighs the identified risk.
Spanish: Por tanto, el CHMP consideró que, al igual que en el caso de Carbaglu, los beneficios son mayores que los riesgos identificados y recomendó autorizar su uso en la UE.
English: How is Ucedane used?
Spanish: ¿Cómo se usa Ucedane?
English: As for every medicine, the company provided studies on the quality of Ucedane.
Spanish: La compañía presentó estudios sobre la calidad de Ucedane, como se hace con todos los medicamentos.
English: How has Ucedane been studied?
Spanish: ¿Qué tipo de estudios se han realizado con Ucedane?
English: How does Ucedane work?
Spanish: ¿Cómo actúa Ucedane?
English: 500 mg
Spanish: 500 mg Comprimido
English: 100 tablets
Spanish: Frasco (polietileno de alta densidad) 100 comprimidos