FrancophonIA/ELRC3.0 huggingface dataset:
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 2.5mg Tablet
Spanish: Accord Healthcare Limited Methotrexat Accord Metotrexato 2,5mg Comprimido
English: Methotrexate Disodium 54.83mg Vial
Spanish: Metotrexato Disódico 54.83mg Vial
English: Methotrexat Ebewe Methotrexate Disodium 21.94mg/Ml
Spanish: Methotrexat Ebewe Metotrexato Disódico 21.94mg/Ml
English: Metotrexato Pfizer Methotrexate 25mg/Ml
Spanish: Methotrexate Pfizer Metotrexato 25mg/Ml
English: Methotrexate Disodium 5.48mg Tablet
Spanish: Metotrexato Disódico 5.48mg Comprimido
English: Metotrexato Pfizer Methotrexate 100mg Vial
Spanish: Metotrexato Pfizer Metotrexato 50mg Vial
English: Metotrexato Cipla Methotrexate 2.5mg Tablet
Spanish: Metotrexato Cipla Metotrexato 2,5mg Comprimido
English: Methotrexate Disodium 20mg/Ml
Spanish: Metotrexato Disódico 20mg/Ml
English: Methotrexate 2.5mg Tablet
Spanish: Metotrexato 2.5mg Comprimido
English: Methotrexate Teva Methotrexate 26mg/Ml
Spanish: Methotrexate Teva Metotrexato 26mg/Ml
English: Methotrexat Ebewe Methotrexate 2.5mg Tablet
Spanish: Methotrexat Ebewe Metotrexato 2.5mg Comprimido
English: Methotrexat Ebewe Methotrexate 10mg/Ml
Spanish: Methotrexat Ebewe Metotrexato 10mg/Ml
English: Methotrexate 7.5mg Tablet
Spanish: Metotrexato 7.5mg Comprimido
English: Methotrexat ”ebew e”
Spanish: Methotrexat ”ebewe”
English: Methotrexate Cipla Methotrexate 10mg Tablet
Spanish: Methotrexate Cipla Metotrexato 10mg comprimidos
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 50mg/20ml
Spanish: Accord Healthcare Limited Metotrexát Accord Metotrexato 50mg/20ml
English: Methotrexate Cipla Methotrexate 2.5mg Tablet
Spanish: Methotrexate Cipla Metotrexato 2.5mg Comprimido
English: Metotrexat Astron Methotrexate 25mg/0.5ml
Spanish: Metotrexat Astron Metotrexato 25mg/0.5ml
English: Methotrexate Disodium 5483mg Vial
Spanish: Metotrexato Disódico 5483mg Vial
English: Methotrexate Disodium 10mg Tablet
Spanish: Metotrexato Disódico 10mg Comprimido
English: Solution For Injection/Infusion
Spanish: Solución inyectable y para perfusión
English: Methotrexate Disodium 21.94mg/Ml
Spanish: Metotrexato Disódico 21.94mg/Ml
English: Methotrexate 5mg Tablet
Spanish: Metotrexato 5mg Comprimido
English: Methotrexate Disodium 7.5mg Tablet
Spanish: Metotrexato Disódico 7.5mg Comprimido
English: Methotrexate 100mg Vial
Spanish: Metotrexato 25mg Vial
English: Solution For Injection Intramuscular Use | Subcutaneous Use
Spanish: Solución inyectable Vía intramuscular | Vía subcutánea
English: Methotrexate 100mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use
Spanish: Metotrexato 100mg Vial Solución inyectable Vía intramuscular - Vía intratecal - Vía endovenosa
English: Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use
Spanish: Solución inyectable Vía intraarterial Vía intramuscular  Vía intratecal  Vía intravenosa
English: Methotrexate Teva Methotrexate 25mg/Ml
Spanish: Methotrexaat Teva Metotrexato 25mg/Ml
English: Methotrexate Disodium 2.5mg Tablet
Spanish: Metotrexato Disódico 2.5mg Comprimido
English: Solution For Injection Intraarticular Use | Intramuscular Use | Intrathecal Use | Intravenous Use
Spanish: Solución inyectable Intraarticular Use | Vía intramuscular - Vía intratecalVía endovenosa
English: Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use
Spanish: Vía intraarterial - Vía intramuscular - Vía intratecalVía endovenosa | Vía intraventricular
English: Methotrexat Ebewe Methotrexate 5mg Tablet
Spanish: Methotrexat Ebewe Metotrexato 5mg Comprimido
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 50mg/2ml
Spanish: Accord Healthcare Limited Methotrexat Accord Metotrexato 50mg/2ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/5ml
Spanish: Accord Healthcare Limited Methotrexat Accord Metotrexato 500mg/5ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 50mg/2ml
Spanish: Accord Healthcare Limited Metotrexato Accord Metotrexato 50mg/2ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/10ml
Spanish: Accord Healthcare Limited Metotrexato Accord Metotrexato 1000mg/10ml
English: Intravenous Use | Subcutaneous Use
Spanish: Vía endovenosa | Vía subcutánea
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 5000mg/50ml
Spanish: Accord Healthcare Limited Metotrexato Accord Metotrexato 5000mg/50ml
English: Solution For Injection Intramuscular Use | Intravenous Use
Spanish: Solución inyectable Vía intramuscular | Vía endovenosa
English: Netherlands Accord Healthcare Limited Methotrexaat Accord
Spanish: Accord Healthcare Limited Methotrexaat Accord
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 5000mg/50ml
Spanish: Accord Healthcare Limited Methotrexat Accord Metotrexato 5000mg/50ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 500mg/5ml
Spanish: Accord Healthcare Limited Metotrexato Accord Metotrexato 500mg/5ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml
Spanish: Accord Healthcare Limited Methotrexat Accord Metotrexato 1000mg/10ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/40ml
Spanish: Accord Healthcare Limited Metotrexato Accord Metotrexato 1000mg/40ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/10ml
Spanish: Accord Healthcare Limited Metotreksat Accord Metotrexato 1000mg/10ml
English: Solution For Injection Intramuscular Use | Intravenous Injection | Subcutaneous Use
Spanish: Solución inyectable Vía intramuscular | Inyección endovenosa | Vía subcutánea
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/20ml
Spanish: Accord Healthcare Limited Methotrexat Accord Metotrexato 500mg/20ml
English: Methotrexate 10mg Tablet
Spanish: Metotrexato 10mg comprimidos
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 50mg/2ml
Spanish: Accord Healthcare Limited Metotreksat Accord Metotrexato 50mg/2ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 5000mg/50ml
Spanish: Accord Healthcare Limited Metotreksat Accord Metotrexato 5000mg/50ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 500mg/20ml
Spanish: Accord Healthcare Limited Metotrexato Accord Metotrexato 500mg/20ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 500mg/5ml
Spanish: Accord Healthcare Limited Metotreksat Accord Metotrexato 500mg/5ml
English: Intramuscular Use | Subcutaneous Use
Spanish: Vía intramuscular | Vía subcutánea
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml
Spanish: Accord Healthcare Limited Methotrexat Accord Metotrexato 1000mg/40ml
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 1000mg/40ml
Spanish: Accord Healthcare Limited Metotrexát Accord Metotrexato 1000mg/40ml
English: Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use
Spanish: Solución inyectable Vía intraarterial | Intradiscal Use| Vía intramuscular - Vía endovenosa - Vía subcutánea
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 500mg/20ml
Spanish: Accord Healthcare Limited Metotrexát Accord Metotrexato 500mg/20ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 50mg/2ml
Spanish: Accord Healthcare Limited Metotrexat Accord Metotrexato 50mg/2ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/10ml
Spanish: Accord Healthcare Limited Metotrexat Accord Metotrexato 1000mg/10ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/40ml
Spanish: Accord Healthcare Limited Metotreksat Accord Metotrexato 1000mg/40ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 500mg/20ml
Spanish: Accord Healthcare Limited Metotreksat Accord Metotrexato 500mg/20ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 500mg/5ml
Spanish: Accord Healthcare Limited Metotrexat Accord Metotrexato 500mg/5ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 5000mg/50ml
Spanish: Accord Healthcare Limited Metotrexat Accord Metotrexato 5000mg/50ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 500mg/20ml
Spanish: Accord Healthcare Limited Metotrexat Accord Metotrexato 500mg/20ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/40ml
Spanish: Accord Healthcare Limited Metotrexat Accord Metotrexato 1000mg/40ml
English: These measures will help protect the environment.
Spanish: De esta forma, ayudará a proteger el medio ambiente.
English: It is not a treatment for your illness.
Spanish: No es un tratamiento para su enfermedad.
English: • difficulty speaking
Spanish: • dificultad para hablar
English: You will not have to store this medicine.
Spanish: No tendrá que almacenar este medicamento.
English: 18 months.
Spanish: 18 meses.
English: No other interaction studies have been performed.
Spanish: No se han realizado otros estudios de interacciones.
English: From a microbiological point of view, the product should be used immediately.
Spanish: Desde un punto de vista microbiológico, el producto debe utilizarse inmediatamente.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Spanish: Sin embargo, en caso de sobredosis, usted recibirá el tratamiento apropiado.
English: The dose may be divided up into smaller amounts.
Spanish: La dosis puede dividirse en cantidades más pequeñas.
English: Date of first authorisation: 19 November 2014 Date of latest renewal:
Spanish: Fecha de la primera autorización: 19 de noviembre de 2014 Fecha de la última renovación:
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Spanish: Se debe presentar un PGR actualizado: • A petición de la Agencia Europea de Medicamentos.
English: It will be the smallest quantity necessary to get the desired information.
Spanish: Esta será la cantidad mínima necesaria para obtener la información deseada.
English: Other sources of information
Spanish: Otras fuentes de información
English: Children and adolescents
Spanish: Niños y adolescentes
English: The following side effects may happen with this medicine:
Spanish: Pueden producirse los siguientes efectos adversos con este medicamento:
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 and 12.
Spanish: Este medicamento no debe mezclarse con otros, excepto con los mencionados en las secciones 6.6 y 12.
English: That means it is essentially ‘sodium-free'.
Spanish: Esto significa que está prácticamente «libre de sodio».
English: This medicine is not for use in children and adolescents under 18 years of age because it has not been studied in this age group.
Spanish: Este medicamento no debe utilizarse en niños y adolescentes menores de 18 años, ya que no se ha estudiado en este grupo de edad.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Spanish: Si no se utiliza inmediatamente, los tiempos y condiciones de almacenamiento antes del uso son responsabilidad del usuario.
English: The place depends on the type of tumour.
Spanish: El sitio depende del tipo de tumor.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Spanish: IDENTIFICADOR ÚNICO - CÓDIGO DE BARRAS 2D No procede.
English: These people will take special care for the safe use of this product and will keep you informed of their actions.
Spanish: Esas personas pondrán especial cuidado en el uso seguro de este producto y le informarán de sus acciones.
English: Uncommon (may affect up to 1 in 100 people):
Spanish: Poco frecuentes (pueden afectar a hasta 1 de cada 100 pacientes):
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Spanish: Este medicamento se almacena bajo la responsabilidad del especialista en instalaciones apropiadas.
English: Remove the strip from the chamber, let it dry and cut it in half.
Spanish: Sacar la tira de la cámara, dejarla secar y cortarla por la mitad.
English: Individual benefit/risk justification
Spanish: Justificación del riesgo/beneficio individual
English: • frequent or urgent need to urinate
Spanish: • necesidad frecuente o urgente de orinar
English: System Organ Class (SOC)
Spanish: Clasificación de órganos del sistema (SOC)
English: The following information is intended for the specialist only.
Spanish: La siguiente información está destinada únicamente al especialista.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Spanish: Interacción con otros medicamentos y otras formas de interacción
English: No data are available.
Spanish: No se dispone de datos.
English: Total volume: ________mL
Spanish: Volumen total: ________ml
English: Do not vent.
Spanish: No ventear.
English: The content of the kit before extemporary preparation is not radioactive.
Spanish: El contenido del equipo antes de la preparación extemporánea no es radiactivo.
English: Origin Line 1 cm from Bottom
Spanish: Línea del origen 1 cm desde la base
English: If at any time in the preparation of this medicinal product the integrity of this vial is compromised it should not be used.
Spanish: Si en cualquier momento durante la preparación de este medicamento se compromete la integridad de este vial el radiofármaco no debe utilizarse.
English: Their receipt, storage, use, transfer, and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Spanish: Su recepción, conservación, uso, trasferencia y eliminación están sujetos a las normas y/o licencias adecuadas del organismo oficial competente.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Spanish: Lea todo el prospecto detenidamente antes de empezar a usar este medicamento, porque contiene información importante para usted.
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Spanish: Para permitir actuar de forma inmediata en caso de emergencia, los medicamentos y equipo necesarios tales como tubo endotraqueal y ventilador deben estar disponibles inmediatamente.
English: The radiolabelled solution is stable for 6 hours at a maximum of 25°C.
Spanish: La solución radiomarcada es estable durante 6 horas a un máximo de 25 °C.
English: Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Spanish: Las categorías de frecuencia se definen de la siguiente manera: muy frecuentes (≥1/10); frecuentes (≥1/100 a <1/10); poco frecuentes (≥1/1.000 a <1/100); raras (≥1/10.000 a <1/1.000); muy raras (<1/10.000) y frecuencia no conocida (no puede estimarse a partir de los datos disponibles).
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Spanish: Se acepta la justificación para no incluir la información en Braille
English: d. Calculate the percent radiochemical purity (% RCP) as follows:
Spanish: d. Calcular el porcentaje de pureza radiactiva (% RCP) como sigue:
English: • The active substance is tilmanocept.
Spanish: • El principio activo es el tilmanocept.
English: Adverse reactions observed during clinical studies are listed below by frequency category.
Spanish: Las reacciones adversas observadas durante los estudios clínicos se indican más abajo por categoría de frecuencia.
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Spanish: Su médico y el médico nuclear han considerado que el beneficio clínico que usted obtendrá del procedimiento con el radiofármaco supera el riesgo de la radiación.
English: b Blood represents total body exposure segregated from independent measurements of other organs and tissues.
Spanish: b La sangre representa la exposición total del cuerpo a partir de medidas independientes de otros órganos y tejidos.
English: Elderly patients aged 65 or older (32%) were evaluated in clinical studies; no safety issues were identified.
Spanish: En los pacientes de 65 años o más (32 %) evaluados en los estudios clínicos no se identificaron problemas de seguridad.
English: Elderly population
Spanish: Población de edad avanzada
English: Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Spanish: Duración del procedimiento Su médico nuclear le informará sobre la duración habitual del procedimiento.
English: The total contents of the vial should not be administered to a single patient.
Spanish: No debe administrarse el contenido total del vial a un único paciente.
English: No dose adjustment is recommended based on age.
Spanish: No se recomiendan ajustes de la dosis en función de la edad.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Spanish: ANEXO I RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO
English: Other adverse reactions were uncommon, and of mild severity and short duration.
Spanish: Otras reacciones adversas fueron poco frecuentes, de intensidad leve y de corta duración.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Spanish: También puede comunicarlos directamente a través del sistema nacional de notificación incluido en el Apéndice V. Mediante la comunicación de efectos adversos puede contribuir usted a proporcionar más información sobre la seguridad de este medicamento.
English: CAUTION RADIOACTIVE MATERIAL
Spanish: PRECAUCIÓN MATERIAL RADIOACTIVO
English: • high levels of calcium in the blood
Spanish: • niveles altos de calcio en la sangre
English: The safety and efficacy of Lymphoseek in children and adolescents below the age of 18 years has not yet been established.
Spanish: Todavía no se ha determinado la eficacia y seguridad de Lymphoseek en niños y adolescentes menores de 18 años.
English: There are no data from the use of Lymphoseek in pregnant women.
Spanish: No se tienen datos sobre el uso de Lymphoseek en mujeres embarazadas.
English: Patient preparation
Spanish: Preparación del paciente
English: Appropriate aseptic precautions should be taken.
Spanish: Se deben tomar las precauciones asépticas apropiadas.
English: Driving and using machines
Spanish: Conducción y uso de máquinas
English: Vials are sealed under nitrogen; air or oxygen is harmful to the contents of the vial and therefore the vial should not be vented.
Spanish: Los viales están sellados en atmósfera de nitrógeno; el aire y el oxígeno son perjudiciales para el contenido del vial y, por tanto, no debe ventearse.
English: • irritation or pain where the injection is given (including the breast and skin)
Spanish: • irritación o dolor en el lugar donde se administra la inyección (incluyendo la mama y la piel)
English: The following information is intended for medical or healthcare professionals only:
Spanish: Esta información está destinada únicamente a médicos o profesionales del sector sanitario:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Spanish: El Titular de la Autorización de Comercialización (TAC) presentará los informes periódicos de seguridad para este medicamento según los requerimientos establecidos en la lista de fechas de referencia de la Unión (lista EURD) prevista en el artículo 107 quater, apartado 7, de la Directiva 2001/83/CE y publicada en el portal web europeo sobre medicamentos.
English: Do not use if particulate matter and/or discoloration are seen.
Spanish: No usar si se observan partículas y/o cambio de color.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Spanish: La administración debe realizarse de forma que se minimice el riesgo de contaminación por el medicamento y la irradiación de los operadores.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Spanish: Hay normas estrictas sobre el uso, manipulación y eliminación de radiofármacos.
English: 5 vials
Spanish: 5 viales
English: • if you have kidney or liver problems (renal or heptatic disease)
Spanish: • si tiene problemas de riñón o hígado (enfermedad renal o hepática)
English: Netherlands
Spanish: Países Bajos
English: This means that it is used in breast cancer, melanoma or oral cavity cancers to help find out about your illness.
Spanish: Esto significa que se utiliza en el cáncer de mama, el melanoma o los carcinomas de la cavidad oral para ayudar a evaluar su enfermedad.
English: These reactions were temporally related to Lymphoseek administration and could be due to other medicinal products administered to patients or surgical procedures.
Spanish: Estas reacciones se relacionaron cronológicamente con la administración de Lymphoseek y pudieron deberse a otros medicamentos administrados a los pacientes o a los procedimientos quirúrgicos.
English: Lymphoseek will only be used in special controlled areas.
Spanish: Lymphseek se usará únicamente en áreas controladas especiales.
English: Follow appropriate radiation safety precautions during preparation and administration.
Spanish: Mantener las precauciones de seguridad radiológica adecuadas durante la preparación y administración.
English: Prior to preparation, determine the planned injection technique and the number of injections that will be used for a given patient.
Spanish: Antes de la preparación, defina la técnica de inyección prevista y el número de inyecciones que se administrará al paciente.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, and genotoxicity.
Spanish: Los datos de los estudios no clínicos no muestran riesgos especiales para los seres humanos según los estudios convencionales de farmacología de seguridad, toxicidad aguda y a dosis repetidas y genotoxicidad.
English: • All lymphatic mapping agents use elements of the lymphatic system for distribution.
Spanish: • Todos los agentes de detección linfática utilizan elementos del sistema linfático para su distribución.
English: This means that the doctor can make more than one injection in the area around the tumour.
Spanish: En ese caso, el médico le pondrá más de una inyección en la zona cercana al tumor.
English: Pack sizes The glass vials are supplied in a carton containing 1 or 5 vials.
Spanish: Presentaciones Los viales de vidrio se suministran en cajas de cartón que contienen 1 o 5 viales.
English: To normalize pressure, withdraw an equal volume of headspace gas.
Spanish: Para normalizar la presión, retirar un volumen igual de gas del espacio de cabeza.
English: Package Leaflet: Information for the Patient
Spanish: Prospecto: información para el paciente
English: 1083 HP Amsterdam
Spanish: 1083 HP Ámsterdam
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Spanish: Los procedimientos con radionucleidos llevados a cabo en mujeres embarazadas suponen además dosis de radiación para el feto.
English: g. Remove the needle, gently swirl the vial to mix the contents, and then let it stand at room temperature for at least 15 minutes.
Spanish: g. Retirar la aguja, agitar con rotación suavemente el vial para mezclar el contenido y dejarlo reposar a temperatura ambiente durante al menos 15 minutos.