FrancophonIA/ELRC3.0 huggingface dataset:
English: Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Spanish: Ciprofloxacina Germed Ciprofloxacino Hidrocloruro Monohidrato 873mg
English: Levofloxacine Mylan Levofloxacin 250mg Tablet
Spanish: Levofloxacine Mylan Levofloxacino 250 mg Comprimido
English: Levofloxacino Sandoz Levofloxacin 500mg Tablet
Spanish: Levofloxacino Sandoz Levofloxacino 500 mg Comprimido
English: Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet
Spanish: Ciprofloxacina Sandoz Ciprofloxacino 750 mg Comprimido
English: Ciprofloxacina Tecnigen Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Spanish: Ciprofloxacina Labesfal Ciprofloxacino Hidrocloruro Monohidrato 582mg
English: Ciprofloxacina Tecnigen Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Spanish: Ciprofloxacina Labesfal Ciprofloxacino Hidrocloruro Monohidrato 291mg
English: Moxifloxacino Sandoz Moxifloxacin 400mg Tablet
Spanish: Moxifloxacino Sandoz Moxifloxacino 400 mg Comprimido
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 250mg Tablet
Spanish: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Clorhidrato de ciprofloxacino 250 mg Comprimido
English: Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Spanish: Ciprofloxacine Sandoz Ciprofloxacina 750 mg Comprimido
English: Levofloxacine Sandoz Levofloxacin 250mg Tablet
Spanish: Levofloxacine Sandoz Levofloxacino 250 mg Comprimido
English: Moxifloxacino Mylan Moxifloxacin 400mg Tablet
Spanish: Moxifloxacino Mylan Moxifloxacino 400 mg Comprimido
English: Solution For Infusion Infusion
Spanish: Solución para perfusión Perfusión
English: Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Spanish: Ciprofloxacin Sandoz Ciprofloxacina 750 mg Comprimido
English: Levofloxacina Angelini
Spanish: Levofloxacine Ranbaxy
English: Ciprofloxacino Sandoz Ciprofloxacin 500mg Tablet
Spanish: Ciprofloxacino Sandoz Ciprofloxacino 500 mg Comprimido
English: Levofloxacina Sandoz Levofloxacin 500mg Tablet
Spanish: Levofloxacina Sandoz Levofloxacino 500 mg Comprimido
English: Levofloxacin Hemihydrate 500mg/100 Ml
Spanish: Levofloxacino hemihidrato 500 mg/100 ml
English: Moxifloxacina Sandoz Moxifloxacin 400mg Tablet
Spanish: Moxifloxacina Sandoz Moxifloxacino 400 mg Comprimido
English: Ciprofloxacina Mylan Ciprofloxacin 250mg Tablet
Spanish: Ciprofloxacina Mylan Ciprofloxacino 250 mg Comprimido
English: Ofloxacin 200mg Tablet
Spanish: Ofloxacino 200 mg Comprimido
English: Ciprofloxacina Tecnigen Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Spanish: Ciprofloxacina Labesfal Ciprofloxacino Hidrocloruro Monohidrato 873mg
English: Levofloxacina Mylan Levofloxacin 500mg Tablet
Spanish: Levofloxacina Mylan Levofloxacino 500 mg Comprimido
English: Ciprofloxacine Mylan Ciprofloxacin 250mg Tablet
Spanish: Ciprofloxacine Mylan Ciprofloxacina 250 mg Comprimido
English: Moxifloxacina Mylan Moxifloxacin 400mg Tablet
Spanish: Moxifloxacina Mylan Moxifloxacino 400 mg Comprimido
English: Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Spanish: Arcana Arzneimittel Gmbh Levofloxacin Arcana Levofloxacino 250 mg/50 ml
English: Moxifloxacin 436.32mg Tablet Film-Coated Tablet
Spanish: Moxifloxacino 436,32 mg Comprimido
English: Belgium Teva Pharma Belgium N.V./S.A Levofloxacine Teva
Spanish: Teva Pharma Belgium N.V./S.A Levofloxacine Teva Levofloxacino 500 mg
English: Levofloxacine Sandoz Levofloxacin 500mg Tablet
Spanish: Levofloxacine Sandoz Levofloxacino 500 mg Comprimido
English: Levofloxacina Ranbaxy Levofloxacin Hemihydrate 500mg
Spanish: Levofloxacina Ranbaxy Levofloxacino hemihidrato 500 mg/500 Mg
English: Levofloxacino Mabo
Spanish: Levofloxacino Tecnigen
English: Ciprofloxacin Hydrochloride 582.08mg Tablet
Spanish: Ciprofloxacin Tad Ciprofloxacino clorhidrato 582,08mg Comprimido
English: 250mg Tablet
Spanish: White 20 mg Comprimido
English: Netherlands Fairmed Healthcare Gmbh
Spanish: Países Bajos Fairmed Healthcare Gmbh Ciprofloxacine FairMed
English: Levofloxacina Accord Levofloxacin Hemihydrate 256.23mg Tablet
Spanish: Accord Healthcare Limited Levofloxacina Accord Levofloxacino hemihidrato 256,23 mg Comprimido
English: Ciprofloxacine Mylan Ciprofloxacin 500mg Tablet
Spanish: Ciprofloxacine Mylan Ciprofloxacina 500 mg Comprimido
English: Ciprofloxacina Sandoz Ciprofloxacin 500mg Tablet
Spanish: Ciprofloxacine Sandoz Ciprofloxacina 500 mg Comprimido
English: Ciprofloxacin Lactate 2mg/Ml
Spanish: Lactato de ciprofloxacino 2mg/ml
English: Levofloxacine Mylan Levofloxacin 500mg Tablet
Spanish: Levofloxacine Mylan Levofloxacino 500 mg Comprimido
English: Ciprofloxacine Alter
Spanish: Ciprofloxacine Evolugen
English: Ciprofloxacina Mylan Ciprofloxacin 500mg Tablet
Spanish: Ciprofloxacina Mylan Ciprofloxacino 500 mg Comprimido
English: Ciprofloxacina Sandoz Ciprofloxacin 250mg Tablet
Spanish: Ciprofloxacina Sandoz Ciprofloxacino 250 mg Comprimido
English: Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Spanish: Moxifloxacine Sandoz Moxifloxacino 400 mg Comprimido
English: Ciprofloxacín Sandoz Ciprofloxacin 250mg Tablet
Spanish: Ciprofloxacin Sandoz Ciprofloxacina 250 mg Comprimido
English: Moxifloxacine Krka
Spanish: Moxifloxacino Tevagen
English: Belgium Teva Pharma Belgium N.V./S.A Ciprofloxacine Teva
Spanish: Teva Pharma Belgium N.V./S.A Ciprofloxacine Teva Ciprofloxacina 100 mg Comprimido
English: Ciprofloxacino Tevagen Ciprofloxacin 750mg Tablet
Spanish: Ciprofloxacin Stada Ciprofloxacina 750 mg Comprimido
English: Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet
Spanish: Ciprofloxacín Sandoz Ciprofloxacino 500 mg Comprimido
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Spanish: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacino clorhidrato 873mg Comprimido
English: Ciprofloxacin Mylan Ciprofloxacin 500mg Tablet
Spanish: Ciprofloxacin Mylan Ciprofloxacino 500 mg Comprimido
English: Moxifloxacin Mylan Moxifloxacin 400mg Tablet
Spanish: Moxifloxacin Mylan Moxifloxacino 400 mg Comprimido
English: Ciprofloxacine Sandoz Ciprofloxacin 250mg Tablet
Spanish: Ciprofloxacine Sandoz Ciprofloxacina 250 mg Comprimido
English: Ciprofloxacin Actavis Ciprofloxacin 750mg Tablet
Spanish: Ciprofloxacin Actavis Ciprofloxacino 750 mg Comprimido
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Spanish: Levofloxacine Teva Levofloxacino hemihidrato 512,46 mg Comprimido
English: Moxifloxacine Mylan Moxifloxacin 400mg Tablet
Spanish: Moxifloxacine Mylan Moxifloxacino 400 mg Comprimido
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500mg Tablet
Spanish: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Clorhidrato de ciprofloxacino 500 mg Comprimido
English: Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Spanish: Ciprofloxacin Sandoz Ciprofloxacina 500 mg Comprimido
English: Ciprofloxacin Actavis Ciprofloxacin Lactate 2.544mg/Ml
Spanish: Ciprofloxacin Actavis Lactato de ciprofloxacina 2.544 mg/ml
English: Synoptis Pharma Sp Z O O Levofloxacin Genoptim Levofloxacin 500mg Tablet
Spanish: Synoptis Pharma Sp Z O O Levofloxacin Genoptim
English: Moxifloxacin Sandoz Moxifloxacin Hydrochloride Film-Coated Tablet
Spanish: Moxifloxacin Sandoz Moxifloxacino hidrocloruro 400 mg Comprimido
English: No such enhancement was observed with gadoterate meglumine (Dotarem).
Spanish: No se observó este realce con el gadoterato de meglumina (Dotarem).
English: All animals should have had water from the same source
Spanish: Todos los animales deberían haber consumido agua de la misma procedencia.
English: Therefore this statement is not maintained.
Spanish: Por tanto, no se mantiene esta afirmación.
English: The authors could not provide a sound explanation for this.
Spanish: Los autores no pudieron ofrecer una explicación razonable para ello.
English: Other safety aspects
Spanish: Otros aspectos relativos a la seguridad
English: In addition, the repeated use of these products is most unlikely.
Spanish: Además, el uso repetido de estos productos es muy poco probable.
English: Neither would the introduction of educational material address this issue.
Spanish: Tampoco la introducción de material educativo resolvería este problema.
English: These effects might be delayed and subtle.
Spanish: Estos efectos pueden ser retardados y muy leves.
English: This clearly indicates that potential dechelation in the body is a recognised phenomenon.
Spanish: Esto indica claramente que la posible desquelación en el organismo es un fenómeno reconocido.
English: The experts at the ad-hoc expert meeting shared these same views.
Spanish: Los participantes en la reunión de expertos ad hoc compartieron esta misma opinión.
English: In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Spanish: No obstante, en caso de que se llevasen a cabo estos estudios, los pacientes estarían expuestos a los riesgos mientras no se complete la investigación en curso.
English: Higher relaxivity of Multihance
Spanish: Mayor relaxividad de Multihance
English: In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017.
Spanish: De conformidad con el artículo 107k de la Directiva 2001/83/CE, el CHMP examinó la recomendación del PRAC adoptada el 6 de julio de 2017.
English: • The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Spanish: • Por otra parte, la implantación en la práctica de estas medidas no se considera viable en el contexto clínico.
English: The linear compounds therefore particularly persist in the brain.
Spanish: Por tanto, los compuestos lineales son especialmente persistentes en el cerebro.
English: However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects.
Spanish: Sin embargo, demuestra la complejidad y las dificultades asociadas al objetivo de analizar los posibles efectos neurológicos.
English: This was discussed with clinical experts within an ad hoc expert group meeting that confirmed a possible association but this has not yet been demonstrated.
Spanish: Esto se debatió con expertos clínicos en una reunión de un grupo de expertos ad hoc en la que se confirmó una posible asociación, aunque por ahora no ha sido demostrada.
English: Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Spanish: Es poco probable que este tipo de estudios a largo plazo sean viables en un periodo razonable.
English: Premedication with antihistamines and corticosteroids could also be applied.
Spanish: También se puede administrar premedicación con antihistamínicos y corticosteroides.
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Spanish: Las conclusiones detalladas de la reunión pueden consultarse en el documento adjunto 11 al informe de evaluación del PRAC.
English: The MAHs were also requested to update the safety specifications in the Risk Management Plans for these products to reflect these findings.
Spanish: También se solicitó a los TAC que actualizasen las especificaciones de seguridad en los Planes de Gestión del Riesgo de estos productos de forma que reflejasen estos hallazgos.
English: In view of the above, the PRAC concluded that:
Spanish: A la vista de estos datos, el PRAC concluyó que:
English: Impact of renal impairment
Spanish: Repercusión de la insuficiencia renal
English: Nephrogenic systemic fibrosis (NSF)
Spanish: Fibrosis sistémica nefrógena (FSN)
English: It should be noted that McDonald et al. (2017) reported very little Gd deposition.
Spanish: Cabe señalar que McDonald et al. (2017) notificaron un depósito muy escaso de Gd.
English: Thus, PRAC considered that the McDonald study did not change their previous conclusions and noted that this view is also supported by the ad-hoc expert group held on the 19th of June.
Spanish: Por este motivo, el PRAC consideró que el estudio de McDonald no alteraba sus conclusiones anteriores e indicó que esta posición también estaba respaldada por el grupo de expertos ad hoc reunido el 19 de junio.
English: Overall, the experts expressed divergent views concerning the risk minimisation measures.
Spanish: En general, los expertos manifestaron una divergencia de opiniones acerca de las medidas de minimización del riesgo.
English: The implemented risk minimisation measures appear to be effective based on annual reviews of spontaneous case reports.
Spanish: Las medidas de minimización del riesgo que se han implantado parecen ser eficaces, a la vista de las revisiones anuales de las notificaciones espontáneas de casos.
English: The long-term clinical consequences of such gadolinium retention are currently unknown.
Spanish: Actualmente se desconocen las consecuencias clínicas a largo plazo de esta retención de gadolinio.
English: NSF
Spanish: FSN
English: These areas are involved in the regulation of voluntary and involuntary movement; adverse events could potentially include events such as ataxia, tremors and other movement disorders.
Spanish: Estas regiones participan en la regulación del movimiento voluntario e involuntario; los acontecimientos adversos podrían consistir en ataxia, temblores y otros trastornos del movimiento.
English: Fatalities are extremely rare.
Spanish: La mortalidad es sumamente baja.
English: Despite worldwide use serious adverse reactions are rare; urticaria is the most common manifestation.
Spanish: A pesar de que se utiliza en todo el mundo, las reacciones adversas graves son raras; la urticaria es la manifestación más frecuente.
English: The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Spanish: La gran mayoría de estas reacciones no son graves y un pequeño porcentaje de pacientes experimentan reacciones de hipersensibilidad intensas.
English: National assessment
Spanish: Evaluación nacional
English: The PRAC considered that a 2nd ad-hoc expert meeting was warranted to address some of the aspects that formed part of the detailed grounds submitted by Bracco and GE Healthcare.
Spanish: El PRAC consideró que era necesaria una segunda reunión de expertos ad hoc para tratar algunos de los aspectos que formaban parte de los motivos detallados enviados por Bracco y GE Healthcare.
English: It is not fully clear how reliable the method of Gd quantification in tissue was.
Spanish: No está del todo clara la fiabilidad del método de cuantificación de Gd en el tejido.
English: Notwithstanding this, and given the detailed grounds provided by the MAHs, the PRAC carried out a new assessment of the available data in the context of the reexamination.
Spanish: A pesar de ello, y dados los motivos detallados expuestos por los TAC, el PRAC llevó a cabo una nueva evaluación de los datos disponibles en el contexto de la revisión.
English: Following the adoption of the PRAC recommendation during the March 2017 PRAC meeting, two MAHs (Bracco and GE Healthcare) expressed their disagreement with the initial PRAC recommendation.
Spanish: Tras la adopción de la recomendación del PRAC durante su reunión de marzo de 2017, dos TAC (Bracco y GE Healthcare) expresaron su desacuerdo con la recomendación inicial del PRAC.
English: Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Spanish: Además, no es posible definir un plazo de tiempo durante el que no haya tiempo de que se manifieste un posible acontecimiento adverso.
English: Besides, as the variation was concluded in parallel to the PRAC review, the variation conclusions were understood as being without prejudice of the outcome of the ongoing EU review.
Spanish: Además, dado que la modificación finalizó paralelamente a la revisión del PRAC, se entiende que las conclusiones de la modificación son independientes del resultado de la revisión de la UE en curso.
English: The macrocyclic agent gadobutrol did not show hyperintensity after this time period.
Spanish: El MCGd macrocíclico gadobutrol no mostró hiperintensidad tras este mismo periodo de tiempo.
English: This dissociation is believed to be related to differences in the stability of the complexes among the various types of GdCAs (Spencer et al. 1997).
Spanish: Se cree que esta disociación está relacionada con las diferencias en la estabilidad de los complejos formados con los distintos tipos de MCGd (Spencer et al., 1997).
English: These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Spanish: Estas observaciones dejan abierta la posibilidad de que el método empleado para medir el Gd sea poco fiable en determinadas situaciones.
English: • To extend the posology to lower doses in specific applications and clinical settings where the advances in technology have shown that to be appropriate.
Spanish: • Ampliar la posología a dosis más bajas en aplicaciones y contextos clínicos específicos en los que se haya demostrado que los avances tecnológicos son adecuados.
English: Furthermore, the standard deviation of Gd content in the brain was extraordinary high for Gadovist.
Spanish: Además, la desviación estándar del contenido cerebral de Gd fue extraordinariamente elevada con Gadovist.
English: Skin prick testing could facilitate the identification of an alternative GdCA.
Spanish: Una prueba de punción cutánea podría facilitar la identificación de un MCGd alternativo.
English: Smith et al. 2017 described that stored Gd still decreases after one week so that obviously a transiently stored pool exists which is different from the material that persists long-term.
Spanish: Smith et al. en 2017 describieron que el Gd almacenado sigue disminuyendo al cabo de una semana, por lo que evidentemente existe un depósito transitorio, a diferencia de los materiales que persisten a largo plazo.
English: However, the PRAC considered that the knowledge about brain accumulation and its clinical consequences needed to be further investigated in the appropriate framework, requiring therefore a review at EU level.
Spanish: No obstante, el PRAC consideró que era necesario estudiar más a fondo los conocimientos sobre la acumulación en el cerebro y sus consecuencias clínicas en un marco adecuado, por lo que solicitó una revisión en el ámbito de la UE.
English: PRAC considered that it is highly unlikely that the release of Gd from gadodiamide is slower in vivo than in vitro.
Spanish: El PRAC consideró sumamente improbable que la liberación de Gd a partir de la gadodiamida sea más lenta in vivo que in vitro.
English: The PRAC confirmed it had considered the totality of the data submitted by the MAHs in the context of the initial referral procedure.
Spanish: El PRAC confirmó que había considerado la totalidad de los datos presentados por los TAC en el contexto del procedimiento de arbitraje inicial.
English: • The shape and size of the T1 signal is markedly different from the signal shape reported in two other recent publications, (Jost et al., 2016, and Robert et al., 2015) and it is not fully clear whether the region of enhanced signal indeed corresponds to the DN, or other regions in the brain.
Spanish: • La forma y el tamaño de la señal en T1 es notablemente distinta de la forma de la señal mostrada en otras dos publicaciones recientes, (Jost et al., 2016, y Robert et al., 2015) y no está del todo claro si la región del realce de la señal corresponde realmente al ND o a otras regiones cerebrales.
English: This is due to the range of potential outcomes of interest, the requirement for long term follow-up, and the heterogeneity of the patient population that undergoes MRI.
Spanish: Esto es debido a la gran variedad de posibles resultados de interés, a la necesidad de un seguimiento a largo plazo y a la heterogeneidad de la población de pacientes que se someten a RM.
English: • Gd retention was studied rather early (one week) after cessation of treatment so that detected Gd may not represent the long-term storage form.
Spanish: • La retención de Gd se estudió demasiado pronto (una semana) tras dejar de administrar el tratamiento, por lo que el Gd detectado no es representativo de una forma de retención a largo plazo.
English: Moreover, there is concern that gadolinium deposition could worsen existing inflammatory diseases, as accumulation in inflammatory lesions has been observed.
Spanish: Además, es preocupante el hecho de que el depósito de gadolinio pueda empeorar las enfermedades inflamatorias existentes, ya que se ha observado una acumulación en las lesiones inflamatorias.
English: For lifting the suspension, the PRAC recommended that MAHs should provide evidence:
Spanish: Para el levantamiento de la suspensión, el PRAC recomendó que los TAC debían presentar pruebas de:
English: These effects can be mimicked in vitro and will further diminish the stability of the GdCA complex in vivo.
Spanish: Estos efectos pueden reproducirse in vitro y reducirán en mayor medida la estabilidad del complejo de MCGd in vivo.
English: Overall summary of the scientific evaluation by the PRAC Background
Spanish: Resumen general de la evaluación científica del PRAC Antecedentes
English: Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Spanish: En concreto, no se pudo demostrar que los resultados del estudio influyeran directamente en el control del paciente.
English: With regards to the reference to previous assessment conducted at national level (type II variation to extend the indication of Multihance, UK/H/0234/001-002/II/038), it should be noted that the variation application assessment had a different scope than the Article 31 referral procedure and consequently these two procedures are based on a different set of data; therefore a different outcome can be justified.
Spanish: En cuanto a la referencia a las evaluaciones previas realizadas a escala nacional (modificación de tipo II para ampliar las indicaciones de Multihance, UK/H/0234/001-002/II/038), hay que tener en cuenta que la evaluación de la solicitud de modificación se hizo en un ámbito distinto al del procedimiento de arbitraje contemplado en el artículo 31 y, por tanto, estos dos procedimientos se fundamentan en conjuntos de datos distintos; esto puede justificar unos resultados diferentes.
English: Therefore, it can be concluded that renal impairment is not a requirement for Gd deposition, but it may however increase the amount of Gd deposited in the brain.
Spanish: Por tanto, se puede concluir que la insuficiencia renal no es un requisito para el depósito de Gd, pero puede aumentar la cantidad de Gd depositado en el cerebro.
English: The design of any future clinical study to investigate the long-term safety of GdCAs in patients would require large numbers of patients to have sufficient power to detect small adverse effects on cognition (cognitive disorders) or physical abilities (fine motor skills).
Spanish: El diseño de cualquier futuro estudio clínico dirigido a analizar la seguridad a largo plazo de los MCGd precisaría un gran número de pacientes para tener la potencia suficiente para detectar pequeños efectos adversos en la cognición (trastornos cognitivos) o las capacidades físicas (motricidad fina).
English: However, they described the TEM finding of electrondense lumps in the tissues of ProHance-treated animals which at first were assumed to be Gd deposits, obviously because they looked like them.
Spanish: No obstante, describieron el hallazgo por MET de masas electrodensas en los tejidos de los animales que recibieron Prohance, que en un primer momento atribuyeron a depósitos de Gd porque evidentemente es lo que parecían.
English: Also the restriction of the number of doses administered during the lifetime of a patient raises practical difficulties and therefore would not be effective.
Spanish: Igualmente, la restricción del número de dosis administradas a lo largo de la vida del paciente plantea dificultades prácticas, por lo que no sería eficaz.
English: Feasibility of clinical studies
Spanish: Viabilidad de los estudios clínicos