FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Onbrez Breezhaler therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Spanish: Se debe decidir si es necesario interrumpir la lactancia o interrumpir el tratamiento con Onbrez Breezhaler tras considerar el beneficio de la lactancia para el niño y el beneficio del tratamiento para la madre.
English: Common 1 Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Onbrez Breezhaler.
Spanish: Se han recibido informes de hipersensibilidad tras la experiencia de comercialización postautorización, en asociación con el uso de Onbrez Breezhaler.
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2adrenergic agonists.
Spanish: Aunque no suelen observarse efectos clínicamente relevantes sobre el sistema cardiovascular después de administrar Onbrez Breezhaler en las dosis recomendadas, tal y como ocurre con otros agonistas beta2-adrenérgicos, indacaterol debe utilizarse con precaución en pacientes con trastornos cardiovasculares (insuficiencia coronaria, infarto agudo de miocardio, arritmias cardiacas, hipertensión), con trastornos convulsivos o tirotoxicosis, y en pacientes que responden de forma inusual a los agonistas beta2-adrenérgicos.
English: Immediate hypersensitivity reactions have been reported after administration of Onbrez Breezhaler.
Spanish: Se han notificado reacciones de hipersensibilidad inmediatas tras la administración de Onbrez Breezhaler.
English: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler.
Spanish: La dosis recomendada consiste en la inhalación del contenido de una cápsula de 150 microgramos una vez al día, utilizando el inhalador de Onbrez Breezhaler.
English: Paediatric population There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years).
Spanish: Población pediátrica El uso de Onbrez Breezhaler en la población pediátrica (menores de 18 años) no es relevante.
English: You should not use Onbrez Breezhaler unless your doctor tells you so.
Spanish: No debe utilizar Onbrez Breezhaler a no ser que su médico se lo indique.
English: The mean of the maximum changes in blood glucose were similar between Onbrez Breezhaler and placebo.
Spanish: La variación media de las alteraciones máximas de glucemia resultaron similares con Onbrez Breezhaler y con placebo.
English: Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Spanish: Onbrez Breezhaler contiene el principio activo indacaterol el cual pertenece a un grupo de medicamentos denominados broncodilatadores.
English: What Onbrez Breezhaler looks like and content of the pack In this pack, you will find an inhaler, together with capsules in blisters.
Spanish: Aspecto de Onbrez Breezhaler y contenido del envase En este envase, podrá encontrar un inhalador, junto con cápsulas en blister.
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Onbrez Breezhaler at recommended therapeutic doses (see section 5.1).
Spanish: No se han observado efectos clínicamente relevantes sobre la prologación del intervalo QTc en ensayos clínicos con Onbrez Breezhaler a las dosis terapéuticas recomendadas (ver sección 5.1).
English: How long to continue your treatment with Onbrez Breezhaler Keep using your treatment with Onbrez Breezhaler for as long as your doctor tells you.
Spanish: Cuanto tiempo debe continuar su tratamiento con Onbrez Breezhaler Continúe usando su tratamiento con Onbrez Breezhaler durante el tiempo que su médico le indique.
English: If you use more Onbrez Breezhaler than you should If you have inhaled too much Onbrez Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit.
Spanish: Si ha inhalado demasiado Onbrez Breezhaler o si alguien usa sus cápsulas, informe a su médico inmediatamente o vaya al centro de urgencias más cercano.
English: The inhalation of the content of one 300 microgram capsule once a day, using the Onbrez Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD.
Spanish: Se ha demostrado que la inhalación del contenido de una cápsula de 300 microgramos una vez al día, utilizando el inhalador de Onbrez Breezhaler ofrece beneficios clínicos adicionales por lo que respecta a la dificultad para respirar, especialmente en pacientes con EPOC grave.
English: As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III study, there was no clinically relevant difference in the development of arrhythmic events monitored over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients receiving recommended doses of Onbrez Breezhaler treatment and those patients who received placebo or treatment with tiotropium.
Spanish: En un ensayo de fase III, doble ciego, controlado con placebo, de 26 semanas de duración y con 605 pacientes con EPOC, se demostró que no hubo diferencias clínicamente relevantes en el desarrollo de acontecimientos arritmogénicos durante el seguimiento de 24 horas al inicio del ensayo y hasta tres veces durante el periodo de tratamiento de 26 semanas, entre los pacientes que recibieron las dosis recomendadas de Onbrez Breezhaler y aquellos pacientes que recibieron placebo o tiotropio.
English: There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.
Spanish: No se dispone de datos sobre el uso de Onbrez Breezhaler en pacientes con insuficiencia hepática grave.
English: Onbrez Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Spanish: Onbrez Breezhaler se utiliza para facilitar la respiración de los pacientes adultos que tienen dificultades para respirar debido a una enfermedad pulmonar denominada enfermedad pulmonar obstructiva crónica (EPOC).
English: Onbrez Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies.
Spanish: La administración de 150 y 300 microgramos de Onbrez Breezhaler una vez al día, mejoró la función pulmonar de forma clínicamente significativa (medida como el volumen expiratorio forzado durante el primer segundo, FEV1) a lo largo de 24 horas en varios ensayos clínicos de eficacia y farmacodinamia.
English: The Onbrez Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Spanish: El programa de desarrollo clínico de fase III de Onbrez Breezhaler incluyó pacientes con un diagnóstico clínico de EPOC entre moderada y grave.
English: Do not use Onbrez Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Spanish: No use Onbrez Breezhaler - si es alérgico a indacaterol o a alguno de los demás componentes de este medicamento
English: In the event of deterioration of COPD during treatment with Onbrez Breezhaler, a reevaluation of the patient and of the COPD treatment regimen should be undertaken.
Spanish: Si la EPOC empeora durante el tratamiento con Onbrez Breezhaler, se debe evaluar de nuevo al paciente y al régimen de tratamiento de la EPOC.
English: What Onbrez Breezhaler is and what it is used for What you need to know before you use Onbrez Breezhaler How to use Onbrez Breezhaler Possible side effects
Spanish: Qué es Onbrez Breezhaler y para qué se utiliza Qué necesita saber antes de empezar a usar Onbrez Breezhaler Cómo usar Onbrez Breezhaler
English: The Onbrez Breezhaler inhaler provided with each new prescription should be used.
Spanish: Se debe utilizar el inhalador de Onbrez Breezhaler que se proporciona con cada nueva prescripción.
English: Your Onbrez Breezhaler pack: Each Onbrez Breezhaler pack contains: one Onbrez Breezhaler inhaler one or more blisters containing Onbrez Breezhaler capsules to be used in the inhaler.
Spanish: Su envase de Onbrez Breezhaler: Cada envase de Onbrez Breezhaler contiene: Un inhalador de Onbrez Breezhaler Uno o más blísters conteniendo cápsulas de Onbrez Breezhaler para utilizar con el inhalador.
English: SIA “Novartis Baltics” Tel: +371 67 887 070
Spanish: Latvija SIA “Novartis Baltics”Tel: +371 67 887 070
English: Effects on cardiac electrophysiology
Spanish: Efectos sobre la efectrofisiología cardiaca
English: Upon initiation of treatment with Onbrez Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Spanish: Tras el inicio del tratamiento con Onbrez Breezhaler, deben vigilarse estrechamente los niveles de glucosa en sangre en pacientes diabéticos.
English: Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Spanish: Onbrez Breezhaler está indicado para el tratamiento broncodilatador de mantenimiento de la obstrucción de las vías respiratorias en pacientes adultos con enfermedad pulmonar obstructiva crónica (EPOC).
English: Only use the capsules with the inhaler provided in this pack (Onbrez Breezhaler inhaler).
Spanish: Utilice las cápsulas únicamente con el inhalador que se proporciona en este envase (inhalador de Onbrez Breezhaler).
English: At the recommended doses, the adverse reaction profile of Onbrez Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Spanish: A las dosis recomendadas, el perfil de seguridad de Onbrez Breezhaler en pacientes con EPOC pone de manifiesto unos efectos sistémicos carentes de significación clínica debidos a la estimulación beta2-adrenérgica.
English: Onbrez Breezhaler is a single-dose inhalation device.
Spanish: Onbrez Breezhaler es un dispositivo para inhalación de dosis única.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Onbrez Breezhaler at the recommended doses than on placebo.
Spanish: Durante los ensayos clínicos, se observó, por lo general, una mayor frecuencia (1-2%) de alteraciones clínicamente considerables de la glucemia en los pacientes tratados con Onbrez Breezhaler a las dosis recomendadas que con placebo.
English: Onbrez Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Spanish: Onbrez Breezhaler no debe utilizarse junto con otros agonistas beta2-adrenérgicos de larga duración ni con medicamentos que los contengan.
English: Onbrez Breezhaler contains lactose
Spanish: Onbrez Breezhaler contiene lactosa
English: Onbrez Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Spanish: No se ha investigado el uso de Onbrez Breezhaler en pacientes con diabetes mellitus no controlada.
English: Always keep the Onbrez Breezhaler inhaler and capsules in a dry place.
Spanish: Mantenga siempre el inhalador y las cápsulas de Onbrez Breezhaler en un lugar seco.
English: Onbrez Breezhaler has no or negligible influence on the ability to drive and use machines.
Spanish: La influencia de Onbrez Breezhaler sobre la capacidad para conducir y utilizar máquinas es nula o insignificante.
English: • Open the mouthpiece again, and remove the empty capsule by tipping it out of the capsule chamber.
Spanish: • Abra de nuevo la boquilla, y elimine la cápsula vacía extrayéndola del compartimento de la cápsula.
English: What you need to know before you use Onbrez Breezhaler
Spanish: Qué necesita saber antes de empezar a usar Onbrez Breezhaler
English: Breezhaler capsules with any other inhaler, and do not use Onbrez Breezhaler inhaler to take any other capsule medicine.
Spanish: No utilice las cápsulas de Onbrez Breezhaler con ningún otro inhalador, y no utilice el inhalador de Onbrez Breezhaler para tomar cualquier otro medicamento en cápsulas.
English: Other medicines and Onbrez Breezhaler
Spanish: Otros medicamentos y Onbrez Breezhaler
English: If paradoxical bronchospasm occurs Onbrez Breezhaler should be discontinued immediately and alternative therapy substituted.
Spanish: En caso de producirse, debe interrumpirse inmediatamente la administración de Onbrez Breezhaler y sustituirse por un tratamiento alternativo.
English: How to store Onbrez Breezhaler Contents of the pack and other information
Spanish: Conservación de Onbrez Breezhaler Contenido del envase e información adicional
English: The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Spanish: El inhalador de Onbrez Breezhaler le permitirá inhalar el medicamento contenido en una cápsula.
English: What Onbrez Breezhaler is and what it is used for
Spanish: Qué es Onbrez Breezhaler y para qué se utiliza
English: Show the pack of Onbrez Breezhaler.
Spanish: Muestre el envase de Onbrez Breezhaler.
English: What Onbrez Breezhaler contains - Each Onbrez Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Spanish: Composición de Onbrez Breezhaler - Cada cápsula de 150 microgramos de Onbrez Breezhaler contiene 150 microgramos de indacaterol como maleato de indacaterol.
English: Never wash the Onbrez Breezhaler inhaler with water.
Spanish: No lave nunca el inhalador de Onbrez Breezhaler con agua.
English: • When you start a new pack, only use the new Onbrez Breezhaler inhaler that is supplied in the pack.
Spanish: • Cuando inicie un nuevo envase, utilice únicamente el nuevo inhalador de Onbrez Breezhaler que se proporciona en el envase.
English: • Only use the Onbrez Breezhaler inhaler contained in this pack.
Spanish: • Utilice únicamente el inhalador de Onbrez Breezhaler contenido en este envase.
English: If you forget to use Onbrez Breezhaler
Spanish: Si olvidó usar Onbrez Breezhaler
English: The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in an Onbrez Breezhaler capsule.
Spanish: El inhalador de Onbrez Breezhaler le permite inhalar el medicamento contenido en una cápsula de Onbrez Breezhaler.
English: When you start a new pack, use the new Onbrez Breezhaler inhaler that is supplied in the pack.
Spanish: Cuando inicie un nuevo envase, use el nuevo inhalador de Onbrez Breezhaler que se proporciona en el envase.
English: - Each Onbrez Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Spanish: - Cada cápsula de 300 microgramos de Onbrez Breezhaler contiene 300 microgramos de indacaterol como maleato de indacaterol.
English: The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 240 microgram indacaterol.
Spanish: La dosis liberada por la boquilla del inhalador es maleato de indacaterol equivalente a 240 microgramos de indacaterol.
English: Onbrez Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Spanish: La administración una vez al día de 150 microgramos y 300 microgramos de Onbrez Breezhaler, demostró mejorías clínicamente significativas de la función pulmonar.
English: Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Spanish: Durante el tratamiento con Onbrez Breezhaler, Interrumpa el uso del medicamento e informe a su médico inmediatamente si nota opresión en el pecho, tos, respiración jadeante o dificultad para respirar inmediatamente después de usar el medicamento.
English: Only use the Onbrez Breezhaler inhaler contained in this pack.
Spanish: Utilice únicamente el inhalador de Onbrez Breezhaler contenido en este envase.
English: INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER
Spanish: INSTRUCCIONES DE USO DEL INHALADOR DE ONBREZ BREEZHALER
English: Onbrez Breezhaler capsules must not be swallowed.
Spanish: Las cápsulas de Onbrez Breezhaler no deben tragarse.
English: Carton containing 10 capsules and one Onbrez Breezhaler inhaler.
Spanish: Cartonaje conteniendo 10 cápsulas y un inhalador de Onbrez Breezhaler.
English: Carton containing 30 capsules and one Onbrez Breezhaler inhaler.
Spanish: Cartonaje conteniendo 30 cápsulas y un inhalador de Onbrez Breezhaler.
English: Never place a Onbrez Breezhaler capsule directly into the mouthpiece of the Onbrez Breezhaler inhaler.
Spanish: No coloque nunca una cápsula de Onbrez Breezhaler directamente en la boquilla del inhalador de Onbrez Breezhaler.
English: How to use Onbrez Breezhaler
Spanish: Cómo usar Onbrez Breezhaler
English: Always use the new Onbrez Breezhaler inhaler that comes with your new pack.
Spanish: Utilice siempre el nuevo inhalador de Onbrez Breezhaler que viene incluido en cada nuevo envase.
English: Store in the blister in order to protect from moisture and only remove immediately before use.
Spanish: Conservar en el blíster para protegerlo de la humedad y extraer solo inmediatamente antes de usar.
English: What Onbrez Breezhaler is
Spanish: Qué es Onbrez Breezhaler
English: Do not swallow Onbrez Breezhaler capsules.
Spanish: No trague las cápsulas de Onbrez Breezhaler.
English: Never blow into the mouthpiece of the Onbrez Breezhaler inhaler.
Spanish: No sople nunca en la boquilla del inhalador de Onbrez Breezhaler.
English: Do not store the capsules in the Onbrez Breezhaler inhaler.
Spanish: No conserve las cápsulas en el inhalador de Onbrez Breezhaler.
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Spanish: Onbrez Breezhaler 150 microgramos polvo para inhalación (cápsula dura) Onbrez Breezhaler 300 microgramos polvo para inhalación (cápsula dura)
English: The usual dose is to inhale the content of one capsule each day.
Spanish: Cantidad de Onbrez Breezhaler que debe usar La dosis habitual es inhalar el contenido de una cápsula cada día.
English: Never take the Onbrez Breezhaler inhaler apart.
Spanish: No desmonte nunca el inhalador de Onbrez Breezhaler.
English: What Onbrez Breezhaler is used for
Spanish: Para qué se utiliza Onbrez Breezhaler
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules
Spanish: Onbrez Breezhaler 150 microgramos polvo para inhalación (cápsula dura)
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Spanish: Onbrez Breezhaler 150 microgramos polvo para inhalación (cápsula dura) indacaterol
English: Onbrez Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo ( ) printed below the black bar.
Spanish: “IDL 150” impreso en negro por encima de una línea negra y el logotipo de la compañía ( ) impreso en negro por debajo de la misma.
English: Onbrez Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed above a blue bar and a blue company logo ( ) printed below the blue bar.
Spanish: “IDL 300” impreso en azul por encima de una línea azul y el logotipo de la compañía ( ) impreso en azul por debajo de la misma.
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Spanish: Onbrez Breezhaler 300 microgramos polvo para inhalación (cápsula dura) indacaterol
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules
Spanish: Onbrez Breezhaler 300 microgramos polvo para inhalación (cápsula dura)
English: If you have questions about how long to continue your treatment with Onbrez Breezhaler, talk to your doctor or pharmacist.
Spanish: Consulte a su médico o farmacéutico, si tiene dudas acerca de cuanto tiempo debe continuar su tratamiento con Onbrez Breezhaler.
English: Onbrez Breezhaler inhaler
Spanish: Inhalador de Onbrez Breezhaler
English: How to store Onbrez Breezhaler
Spanish: Conservación de Onbrez Breezhaler
English: It is not intended to provide practical advice on how to use Ontruzant.
Spanish: No está destinado a proporcionar consejos prácticos sobre cómo utilizar Ontruzant.
English: The full EPAR for Ontruzant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Spanish: El EPAR completo de Ontruzant se puede consultar en la página web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Ontruzant and what is it used for?
Spanish: ¿Qué es Ontruzant y para qué se utiliza?
English: Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Spanish: Los pacientes que toleran la primera perfusión de 90 minutos pueden recibir las posteriores en 30 minutos.
English: This is a summary of the European public assessment report (EPAR) for Ontruzant.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) para Ontruzant.
English: What measures are being taken to ensure the safe and effective use of Ontruzant?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Ontruzant?
English: Ontruzant can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Spanish: Ontruzant puede provocar cardiotoxicidad (daños en el corazón), incluida insuficiencia cardiaca (cuando el corazón no funciona como debería).
English: Other information about Ontruzant
Spanish: Otras informaciones sobre Ontruzant
English: The reference medicine for Ontruzant is Herceptin.
Spanish: El medicamento de referencia de Ontruzant es Herceptin.
English: In addition, a study involving 875 patients with early or locally advanced breast cancer looked at the effectiveness of Ontruzant and Herceptin.
Spanish: Además, en un estudio realizado en 875 pacientes con cáncer de mama precoz o localmente avanzado se investigó la eficacia de Ontruzant y Herceptin.
English: The study showed that 94% of women given Ontruzant and 93% of those given Herceptin survived without return or worsening of their disease when followed up for around 14 months.
Spanish: El estudio demostró que el 94 % de las mujeres tratadas con Ontruzant y el 93 % de las que recibieron Herceptin sobrevivieron sin que la enfermedad empeorase ni reapareciese durante un periodo de seguimiento aproximado de 14 meses.
English: This means that Ontruzant is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Spanish: Ontruzant es un «medicamento biosimilar», es decir, similar a otro medicamento biológico (el «medicamento de referencia») ya autorizado en la Unión Europea (UE).
English: Absence of invasive cancer cells was noted in the tissue removed at surgery in 52% of women given Ontruzant and 42% of those given Herceptin, but in the light of all the available information from the study this difference was not assessed to be relevant.
Spanish: Se constató la ausencia células cancerosas invasivas en el tejido extirpado durante la cirugía en el 52 % de las mujeres tratadas con Ontruzant y en el 42 % de las tratadas con Herceptin, pero teniendo en cuenta toda la información disponible del estudio, se consideró que esta diferencia no era relevante.
English: Ontruzant is a cancer medicine used to treat the following conditions:
Spanish: Ontruzant es un medicamento contra el cáncer que se utiliza para tratar las siguientes enfermedades: