FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 × 15 mg tablets and 7 × 45 mg tablets in card packaging 14 × 15 mg tablets and 14 × 45 mg tablets in card packaging 28 × 15 mg tablets and 28 × 45 mg tablets in card packaging
Spanish: 7 comprimidos de 15 mg y 7 comprimidos de 45 mg en caja tarjetero 14 comprimidos de 15 mg y 14 comprimidos de 45 mg en caja tarjetero 28 comprimidos de 15 mg y 28 comprimidos de 45 mg en caja tarjetero
English: Headache, Dizziness
Spanish: Erupción, Prurito
English: Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Spanish: Jinarc 30 mg comprimidos + Jinarc 60 mg comprimidos Comprimido de 30 mg: azul, redondo (diámetro: 8 mm), ligeramente convexo, grabado con el texto «OTSUKA» y «30» en una cara.
English: Jinarc 90 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Spanish: Jinarc 90 mg comprimidos + Jinarc 30 mg comprimidos: blísteres con o sin caja tarjetero con 14 (7 comprimidos de la dosis más alta + 7 comprimidos de la dosis más baja), 28 (14 comprimidos de la dosis más alta + 14 comprimidos de la dosis más baja) o 56 (28 comprimidos de la dosis más alta + 28 comprimidos de la dosis más baja) comprimidos.
English: Anaphylactic shock,
Spanish: Shock anafiláctico, Erupción generalizada
English: Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Spanish: Cada comprimido de 45 mg contiene aproximadamente 12 mg de lactosa (en forma de monohidrato).
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets
Spanish: Jinarc 15 mg comprimidos + Jinarc 45 mg comprimidos 14 comprimidos en 1 blíster de PVC/papel de aluminio con 7 comprimidos de 15 mg y 7 comprimidos de 45 mg
English: Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Spanish: Cada comprimido de 60 mg contiene aproximadamente 16 mg de lactosa (en forma de monohidrato).
English: Each 60 mg tablet contains 60 mg tolvaptan.
Spanish: Cada comprimido de 60 mg contiene 60 mg de tolvaptán.
English: Each Jinarc 15 mg tablet contains 15 mg tolvaptan.
Spanish: Cada comprimido de Jinarc de 15 mg contiene 15 mg de tolvaptán.
English: Each 45 mg tablet contains 45 mg of tolvaptan.
Spanish: Cada comprimido de 45 mg contiene 45 mg de tolvaptán.
English: Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Spanish: Cada comprimido de 90 mg contiene aproximadamente 24 mg de lactosa (en forma de monohidrato).
English: Jinarc 15 mg tablets tolvaptan
Spanish: Jinarc 15 mg comprimidos tolvaptán
English: Each 90 mg tablet contains 90 mg tolvaptan.
Spanish: Cada comprimido de 90 mg contiene 90 mg de tolvaptán.
English: Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Spanish: Cada comprimido de 30 mg contiene aproximadamente 70 mg de lactosa (en forma de monohidrato).
English: Each Jinarc 30 mg tablet contains 30 mg tolvaptan.
Spanish: Cada comprimido de Jinarc de 30 mg contiene 30 mg de tolvaptán.
English: • dry mouth
Spanish: • sequedad bucal
English: Jinarc 30 mg tablets tolvaptan
Spanish: Jinarc 30 mg comprimidos tolvaptán
English: Each Jinarc 60 mg tablet contains 60 mg tolvaptan.
Spanish: Cada comprimido de Jinarc de 60 mg contiene 60 mg de tolvaptán.
English: Each 15 mg tablet contains 15 mg tolvaptan.
Spanish: Cada comprimido de 15 mg contiene 15 mg de tolvaptán.
English: Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
Spanish: Jinarc 30 mg comprimidos Jinarc 90 mg comprimidos tolvaptán
English: • liver function abnormal
Spanish: • función hepática anómala
English: Each 30 mg tablet contains 30 mg tolvaptan.
Spanish: Cada comprimido de 30 mg contiene 30 mg de tolvaptán.
English: Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Spanish: Jinarc 30 mg comprimidos Jinarc 60 mg comprimidos tolvaptán
English: Each Jinarc 90 mg tablet contains 90 mg tolvaptan.
Spanish: Cada comprimido de Jinarc de 90 mg contiene 90 mg de tolvaptán.
English: Bilirubin increased
Spanish: Bilirrubina elevada
English: 30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Spanish: Azul, redondo (diámetro: 8 mm), ligeramente convexos, grabado con el texto «OTSUKA» y «30» en una cara.
English: Each Jinarc 45 mg tablet contains 45 mg tolvaptan.
Spanish: Cada comprimido de Jinarc de 45 mg contiene 45 mg de tolvaptán.
English: 7 × 30 mg tablets and 7 × 60 mg tablets in card packaging 14 × 30 mg tablets and 14 × 60 mg tablets in card packaging 28 × 30 mg tablets and 28 × 60 mg tablets in card packaging
Spanish: 7 comprimidos de 30 mg y 7 comprimidos de 60 mg en caja tarjetero 14 comprimidos de 30 mg y 14 comprimidos de 60 mg en caja tarjetero 28 comprimidos de 30 mg y 28 comprimidos de 60 mg en caja tarjetero
English: 7 × 30 mg tablets and 7 × 90 mg tablets in card packaging 14 × 30 mg tablets and 14 × 90 mg tablets in card packaging 28 × 30 mg tablets and 28 × 90 mg tablets in card packaging
Spanish: 7 comprimidos de 30 mg y 7 comprimidos de 90 mg en caja tarjetero 14 comprimidos de 30 mg y 14 comprimidos de 90 mg en caja tarjetero 28 comprimidos de 30 mg y 28 comprimidos de 90 mg en caja tarjetero
English: How to store Jinarc
Spanish: Conservación de Jinarc
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets
Spanish: Jinarc 30 mg comprimidos + Jinarc 90 mg comprimidos 14 comprimidos en 1 blíster de PVC/papel de aluminio con 7 comprimidos de 30 mg y 7 comprimidos de 90 mg
English: EU/1/15/1000/005 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablets (28 × 15 mg + 28 × 45 mg)
Spanish: EU/1/15/1000/005 14 comprimidos (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 comprimidos (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 comprimidos (28 × 15 mg + 28 × 45 mg)
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets
Spanish: Jinarc 30 mg comprimidos + Jinarc 60 mg comprimidos 14 comprimidos en 1 blíster de PVC/papel de aluminio con 7 comprimidos de 30 mg y 7 comprimidos de 60 mg
English: Each tablet contains 15 mg tolvaptan.
Spanish: Cada comprimido contiene 15 mg de tolvaptán.
English: 7 × 30 mg tablets and 7 × 60 mg tablets 14 × 30 mg tablets and 14 × 60 mg tablets 28 × 30 mg tablets and 28 × 60 mg tablets
Spanish: 7 comprimidos de 30 mg y 7 comprimidos de 60 mg 14 comprimidos de 30 mg y 14 comprimidos de 60 mg 28 comprimidos de 30 mg y 28 comprimidos de 60 mg
English: • fatigue
Spanish: • vómitos
English: 7 × 30 mg tablets and 7 × 90 mg tablets 14 × 30 mg tablets and 14 × 90 mg tablets 28 × 30 mg tablets and 28 × 90 mg tablets
Spanish: 7 comprimidos de 30 mg y 7 comprimidos de 90 mg 14 comprimidos de 30 mg y 14 comprimidos de 90 mg 28 comprimidos de 30 mg y 28 comprimidos de 90 mg
English: Co-administration with vasopressin analogues
Spanish: Por consiguiente, el efecto de los análogos de la vasopresina,
English: If you stop taking Jinarc
Spanish: Si interrumpe el tratamiento con Jinarc
English: Each tablet contains 30 mg of tolvaptan.
Spanish: Cada comprimido contiene 30 mg de tolvaptán.
English: EU/1/15/1000/014 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablets (28 × 15 mg + 28 × 45 mg)
Spanish: EU/1/15/1000/014 14 comprimidos (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 comprimidos (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 comprimidos (28 × 15 mg + 28 × 45 mg)
English: • nausea
Spanish: • mareo
English: 15 mg tablet: blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Spanish: Jinarc 15 mg comprimidos + Jinarc 45 mg comprimidos Comprimido de 15 mg: azul, triangular (lado mayor: 6,58 mm; lado menor: 6,20 mm), ligeramente convexos, grabado con el texto «OTSUKA» y «15» en una cara.
English: EU/1/15/1000/008 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablets (28 × 30 mg + 28 × 60 mg)
Spanish: EU/1/15/1000/008 14 comprimidos (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 comprimidos (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 comprimidos (28 × 30 mg + 28 × 60 mg)
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Spanish: Tél/Tel: +31 (0) 20 85 46 555
English: EU/1/15/1000/011 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablets (28 × 30 mg + 28 × 90 mg)
Spanish: EU/1/15/1000/011 14 comprimidos (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 comprimidos (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 comprimidos (28 × 30 mg + 28 × 90 mg)
English: EU/1/15/1000/020 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablets (28 × 30 mg + 28 × 90 mg)
Spanish: EU/1/15/1000/020 14 comprimidos (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 comprimidos (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 comprimidos (28 × 30 mg + 28 × 90 mg)
English: Otsuka Pharmaceutical Netherlands B.V. Teл: +31 (0) 20 85 46 555
Spanish: Teл: +31 (0) 20 85 46 555
English: EU/1/15/1000/017 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablets (28 × 30 mg + 28 × 60 mg)
Spanish: EU/1/15/1000/017 14 comprimidos (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 comprimidos (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 comprimidos (28 × 30 mg + 28 × 60 mg)
English: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
Spanish: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V.
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets
Spanish: 14 comprimidos en 1 blíster de PVC/papel de aluminio en caja tarjetero con 7 comprimidos de 15 mg y 7 comprimidos de 45 mg
English: • general weakness
Spanish: • debilidad general
English: Polydipsia
Spanish: Anafilaxia
English: Otsuka Pharmaceutical Netherlands B.V. Thλ: +31 (0) 20 85 46 555
Spanish: Thλ: +31 (0) 20 85 46 555
English: • dizziness
Spanish: • prurito
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets
Spanish: 28 comprimidos en 2 blísteres de PVC/papel de aluminio en caja tarjetero con 7 comprimidos de 30 mg y 7 comprimidos de 90 mg
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets
Spanish: 28 comprimidos en 2 blísteres de PVC/papel de aluminio en caja tarjetero con 7 comprimidos de 30 mg y 7 comprimidos de 60 mg
English: Serum sodium abnormalities
Spanish: Anomalías en la concentración sérica de sodio
English: Strength Pharmaceutical Form Route of Administration Packaging
Spanish: Forma farmacéutica Vía de administración Envase
English: EMEA Number
Spanish: Número EMEA Nombre
English: This summary was last updated in 07-2017.
Spanish: Fecha de la última actualización del presente resumen: 07-2017
English: The full EPAR for Clopidogrel TAD can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Spanish: El texto completo del EPAR de Clopidogrel TAD puede encontrarse asimismo en el sitio web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel TAD on 23 September 2009.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Clopidogrel TAD el 23 de septiembre de 2009.
English: It is not intended to provide practical advice on how to use Clopidogrel TAD.
Spanish: No está destinado a proporcionar consejos prácticos sobre cómo utilizar Clopidogrel TAD.
English: The standard dose is one 75-mg tablet once a day.
Spanish: La dosis habitual es de un comprimido de 75 mg una vez al día.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Spanish: • padecen enfermedad arterial periférica (problema de flujo sanguíneo en las arterias);
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel TAD.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) de Clopidogrel TAD.
English: What measures are being taken to ensure the safe and effective use of Clopidogrel TAD?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Clopidogrel TAD?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel TAD 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 Clopidogrel TAD se han incluido en la Ficha Técnica o Resumen de las Características del Producto y el Prospecto.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel TAD has been shown to have comparable quality and to be bioequivalent to Plavix.
Spanish: La Agencia Europa de Medicamentos concluyó que, de conformidad con los requisitos de la UE, Clopidogrel TAD ha demostrado tener una calidad comparable y ser bioequivalente a Plavix.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Spanish: De este modo, las plaquetas dejan de «pegarse», con lo que se reduce el riesgo de que se formen coágulos de sangre y se ayuda a prevenir otro ataque cardíaco o infarto cerebral.
English: Clopidogrel TAD is available as tablets containing 75 mg clopidogrel.
Spanish: Clopidogrel TAD está disponible en comprimidos que contienen 75 mg de clopidogrel.
English: What is Clopidogrel TAD and what is it used for?
Spanish: ¿Qué es Clopidogrel TAD y para qué se utiliza?
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Spanish: Se utiliza en pacientes que presentan al menos un factor de riesgo de episodios vasculares como un ataque al corazón o un infarto cerebral, no pueden tomar antagonistas de la vitamina K (otros fármacos para evitar la formación de coágulos de sangre) y presentan un riesgo bajo de sufrir hemorragias.
English: For more information about treatment with Clopidogrel TAD, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Spanish: Para más información sobre el tratamiento con Clopidogrel TAD, lea el prospecto (también incluido en el EPAR) o póngase en contacto con su médico o farmacéutico.
English: Other information about Clopidogrel TAD
Spanish: Otras informaciones sobre Clopidogrel TAD
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Spanish: • sufren fibrilación auricular (contracciones rápidas e irregulares de las cavidades superiores del corazón), en cuyo caso deberá administrarse con aspirina.
English: Clopidogrel TAD can be started between seven days and six months after the stroke;
Spanish: Puede iniciarse la administración de Clopidogrel TAD entre siete días y seis meses después del infarto;
English: • recently had a myocardial infarction (heart attack).
Spanish: • pacientes que han sufrido recientemente un infarto de miocardio (ataque al corazón).
English: Because Clopidogrel TAD 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 Clopidogrel TAD es un medicamento genérico y es bioequivalente al medicamento de referencia, sus beneficios y riesgos son los mismos que los del medicamento de referencia.
English: Clopidogrel TAD can be started between a few days and 35 days after the attack;
Spanish: Puede iniciarse la administración de Clopidogrel TAD desde pocos días después del ataque hasta 35 días después;
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Spanish: • padecen un trastorno conocido como «síndrome coronario agudo», en cuyo caso deberá administrarse con aspirina (otro medicamento que previene la formación de coágulos sanguíneos).
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Spanish: En los casos de síndrome coronario agudo, el tratamiento empieza por lo general con una dosis de carga de cuatro comprimidos, seguida de una dosis estándar de 75 mg una vez al día durante al menos cuatro semanas (en el infarto de miocardio con «elevación del segmento ST») o hasta 12 meses (en la angina inestable o infarto de miocardio «sin ondas Q»).
English: Clopidogrel TAD can only be obtained with a prescription.
Spanish: Clopidogrel TAD solo se podrá dispensar con receta médica.
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Spanish: El síndrome coronario agudo agrupa problemas cardíacos como ataques al corazón y angina de pecho inestable (un tipo de dolor muy fuerte en el pecho).
English: Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up;
Spanish: Es posible que a algunos de estos pacientes se les haya implantado un resorte intravascular (un tubo corto) en una arteria para impedir que esta se cierre;
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Spanish: • han sufrido recientemente un infarto cerebral isquémico (infarto provocado por la falta de riego sanguíneo en una parte del cerebro).
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Spanish: El clopidogrel frena la agregación plaquetaria al impedir que una sustancia denominada ADP se adhiera a un receptor especial en la superficie de las plaquetas.
English: Clopidogrel TAD is a medicine used to prevent problems caused by blood clots in adults who have:
Spanish: Clopidogrel TAD es un medicamento indicado en adultos para prevenir problemas causados por los coágulos de sangre en
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel TAD is used together with aspirin, the dose of which should not be higher than 100 mg.
Spanish: En los casos de síndrome coronario agudo y fibrilación auricular, Clopidogrel TAD se administra conjuntamente con aspirina en una dosis máxima de 100 mg.
English: This means that Clopidogrel TAD is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Spanish: Clopidogrel TAD es un «medicamento genérico», es decir, Clopidogrel TAD es similar a un «medicamento de referencia» ya autorizado en la Unión Europea (UE) llamado Plavix.
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Spanish: La sangre se coagula porque unas células especiales de la sangre, las plaquetas, se agregan (se pegan unas a otras).
English: Because Clopidogrel TAD is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Spanish: Dado que Clopidogrel TAD es un medicamento genérico, los estudios se han limitado a realizar ensayos para demostrar que es biosimilar al medicamento de referencia, Plavix.
English: What are the benefits and risks of Clopidogrel TAD?
Spanish: ¿Qué beneficios ha demostrado tener y cuáles son los riesgos asociados a Clopidogrel TAD?
English: Clopidogrel TAD contains the active substance clopidogrel.
Spanish: Clopidrogrel TAD contiene el principio activo clopidogrel.
English: For practical information about using Clopidogrel TAD, patients should read the package leaflet or contact their doctor or pharmacist.
Spanish: Para más información sobre el tratamiento con Clopidogrel TAD, el paciente debe leer el prospecto o consultar a su médico o farmacéutico.
English: Why is Clopidogrel TAD approved?
Spanish: ¿Por qué se ha aprobado Clopidogrel TAD?
English: Therefore, the Agency's view was that, as for Plavix, the benefit outweighs the identified risk.
Spanish: Por tanto el CHMP consideró que, al igual que en el caso de Plavix, los beneficios son mayores que los riesgos identificados y recomendó autorizar su uso en la UE.
English: The active substance in Clopidogrel TAD, clopidogrel, is an inhibitor of platelet aggregation.
Spanish: El principio activo de Clopidogrel TAD, el clopidogrel, es un inhibidor de la agregación plaquetaria, es decir, ayuda a impedir la formación de coágulos sanguíneos.
English: How does Clopidogrel TAD work?
Spanish: ¿Cómo actúa Clopidogrel TAD?
English: How is Clopidogrel TAD used?
Spanish: ¿Cómo se usa Clopidogrel TAD?
English: How has Clopidogrel TAD been studied?
Spanish: ¿Qué tipo de estudios se han realizado con Clopidogrel TAD?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Spinraza on 30 May 2017.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Spinraza el 30 de mayo de 2017.
English: It is not intended to provide practical advice on how to use Spinraza.
Spanish: No está destinado a proporcionar consejos prácticos sobre cómo utilizar Spinraza.
English: This summary was last updated in 11-2017.
Spanish: Fecha de la última actualización del presente resumen: 11-2017
English: What measures are being taken to ensure the safe and effective use of Spinraza?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Spinraza?
English: In its assessment, the European Medicines Agency recognised the serious nature of the disease and the urgent need for effective treatments.
Spanish: En su evaluación, la Agencia Europea de Medicamentos reconoció la grave naturaleza de la enfermedad y la necesidad urgente de tratamientos eficaces.
English: This replaces the missing protein, thereby relieving the symptoms of the disease.
Spanish: De este modo, se repone la proteína que falta, con lo que se alivian los síntomas de la enfermedad.