FrancophonIA/ELRC3.0 huggingface dataset:
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should under no circumstances be administered intravascularly or intradermally.
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg no debe, bajo ninguna circunstancia, administrarse por vía intravascular o intradérmica.
English: Split influenza virus, inactivated, containing antigen equivalent to A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Spanish: Virus de la gripe fraccionados, inactivados, que contienen antígeno equivalente a: Cepa similar a:A/VietNam/1194/2004 (H5N1) (NIBRG-14)
English: In a clinical study, subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Spanish: En un ensayo clínico, se administró a sujetos de 18-60 años una dosis de vacuna adyuvada con AS03 conteniendo 3,75 µg de HA derivada de A/Vietnam/1194/2004, o bien derivada de A/Indonesia/05/2005, 6 meses después de haber sido primovacunados con una o dos dosis de vacuna adyuvada con AS03 conteniendo 3,75 µg de HA derivada de A/Vietnam/1194/2004 el día 0 ó los días 0 y 21.
English: Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines.
Spanish: Por lo tanto, Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg no se debe administrar al mismo tiempo que otras vacunas.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 years old.
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg es una vacuna para adultos a partir de los 18 años de edad.
English: You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Spanish: Usted recibirá dos dosis de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg.
English: The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Spanish: El volumen de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg (5 ml) una vez mezclada corresponde a 10 dosis de la vacuna.
English: No post-marketing surveillance data are available following Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg administration.
Spanish: No se disponen de datos de farmacovigilancia postcomercialización tras la administración de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg debe utilizarse de acuerdo con las recomendaciones oficiales.
English: These side effects may occur with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Spanish: Estos efectos adversos pueden ocurrir con Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg.
English: In a different study in 50 subjects aged 18-60 years the anti-HA antibody seroprotection rates 21 days after the second dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against A/Turkey/Turkey/1/2005.
Spanish: días después de la administración de la segunda dosis de la vacuna adyuvada con AS03 conteniendo 3,75 µg de HA derivada de A/Vietnam/1194/2004 fueron del 20% frente a la cepa A/Indonesia/5/2005, del 35% frente a la cepa A/Anhui/01/2005 y del 60% de la cepa frente a la A/Turkey/Turkey/1/2005.
English: A complete vaccination course with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two doses.
Spanish: El ciclo de vacunación completa con Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg consiste en dos dosis.
English: There are no data regarding the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
Spanish: No hay datos relativos a la utilización de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg durante el periodo de lactancia.
English: Suspension for emulsion for injection 50 vials: suspension
Spanish: 50 viales: suspensión
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Spanish: En otro ensayo clínico, 39 sujetos de 18-60 años que habían recibido catorce meses antes dos dosis de vacuna adyuvada con AS03 conteniendo 3,75 µg de HA derivada de A/Vietnam/1194/2004 los dias 0 y 21, recibieron una dosis de vacuna adyuvada con AS03 conteniendo 3,75 µg de HA derivada de A/Indonesia/05/2005.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg suspensión y emulsión para emulsión inyectable Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada)
English: There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
Spanish: No hay información acerca del uso de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg en mujeres embarazadas o durante el periodo de lactancia.
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for
Spanish: Qué es Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg y para qué se utiliza
English: PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Spanish: Presentación de Informes Periódicos de Seguridad (IPSs) cuando se utilice Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg durante la pandemia de gripe:
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg suspensión para emulsión inyectable Vacuna antigripal prepandémica (H5N1)
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection.
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg suspensión y emulsión para emulsión inyectable.
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Spanish: Qué es Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg y para qué se utiliza Antes de usar Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg Cómo usar Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg
English: Do not have Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg if any of the above apply to you.
Spanish: No use Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg en caso de encontrarse en cualquiera de las situaciones anteriores.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg está formado por dos envases:
English: There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines.
Spanish: No hay datos sobre el uso simultáneo de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg con otras vacunas.
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Spanish: Conservación de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados,
English: Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Spanish: Tenga especial cuidado con Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Spanish: Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg suspensión para emulsión inyectable IM
English: Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose
Spanish: Respuesta immune frente a A/Indonesia/5/2005
English: The side effects listed below have occurred with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in clinical studies:
Spanish: Los efectos adversos que se listan a continuación han ocurrido en ensayos clínicos con Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg:
English: One pack of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of:
Spanish: Un envase de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg contiene:
English: Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Spanish: Emulsión para emulsión inyectable para Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg.
English: Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg IM
Spanish: Emulsión para emulsión inyectable para Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg IM
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may
Spanish: • Inflamación temporal del cerebro y de los nervios causando dolor, debilidad y parálisis que pueden extenderse por el cuerpo
English: Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Spanish: Antes de usar Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine): • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may
Spanish: • Reacciones alérgicas que conducen a una peligrosa disminución de la presión sanguínea, que si no se tratan pueden conducir a colapso, coma y muerte
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Spanish: Cómo usar Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg
English: Important information about some of the ingredients of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Spanish: Información adicional Composición de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg
English: 7 days after 2nd dose
Spanish: 7 días después de la 2ª dosis N=47
English: Nervous system disorders
Spanish: Vía intramuscular
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains
Spanish: Conservación de Vacuna antigripal prepandémica (H5N1) (de virus fraccionados, inactivados, adyuvada) GlaxoSmithKline Biologicals 3,75 μg
English: PSURs
Spanish: CAD
English: Only do this once.
Spanish: Hágalo sólo una vez.
English: (See Table 1).
Spanish: (ver tabla 1).
English: Wait 5 to 15 minutes;
Spanish: Espere entre 5 y 15 minutos
English: Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017
Spanish: Fecha de la primera autorización: 13 de abril de 2012 Fecha de última renovación: 11 de enero de 2017
English: Note: There were some differences in analysis methods across the 3 studies.
Spanish: Nota: hubo algunas diferencias en los métodos de análisis entre los tres ensayos.
English: Patients should be advised to carefully read them.
Spanish: Se debe aconsejar a los pacientes que las lean atentamente.
English: The first dose is taken in 4 steps:
Spanish: La primera dosis se toma en cuatro pasos:
English: There are insufficient data in this population to support a recommendation for or against dose adjustment.
Spanish: No existe información suficiente sobre esta población para apoyar una recomendación a favor o en contra de un ajuste de dosis.
English: - Use a new inhaler each week.
Spanish: - Utilice un inhalador nuevo cada semana.
English: You must let it fully dry, this can take up to 24 hours.
Spanish: Deje que se seque del todo, lo cual puede requerir hasta 24 horas.
English: - Worsening of symptoms.
Spanish: - Empeoramiento de los síntomas.
English: This happens commonly, which may affect up to 1 in 10 people.
Spanish: Estos efectos son frecuentes y pueden afectar a 1 de cada 10 personas.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Spanish: Los datos actualmente disponibles están descritos en las secciones 4.8, 5.1 y 5.2; sin embargo no se puede hacer una recomendación posológica.
English: Your doctor will tell you how long to use this medicine for.
Spanish: Su médico le indicará cuánto tiempo debe usar este medicamento.
English: The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Spanish: El solicitante debe enviar un análisis periódico del estudio de FQ cada 6 meses durante 3 años y anualmente durante 2 años.
English: - Breathe out, and then breathe normally again.
Spanish: - Exhale aire y luego vuelva a respirar normalmente.
English: This effect was not noted in any other species and did not result in clinical signs.
Spanish: Este efecto no se observó en otras especies, ni produjo signos clínicos.
English: There are no data available for children under 12 years of age.
Spanish: No se dispone de datos en niños menores de 12 años.
English: Physiotherapy/exercise 4.
Spanish: Fisioterapia/ejercicio 4.
English: It also helps improve the condition of your lungs and your breathing.
Spanish: También ayuda a mejorar el estado de sus pulmones y su respiración.
English: Absolute mL
Spanish: ml absolutos
English: - Do not use a double dose to make up for a forgotten dose.
Spanish: - No tome una dosis doble para compensar las dosis olvidadas.
English: Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules.
Spanish: Repita los pasos 3 a 10 para cada una de las cápsulas - Siga estos pasos para cada una de las diez cápsulas.
English: Do not stop using your Bronchitol without talking to your doctor first, even if you feel better.
Spanish: No deje de utilizar Bronchitol sin hablar antes con su médico, aunque se sienta mejor.
English: Talk to your doctor if the cough won't go away or worries you.
Spanish: Consulte a su médico si la tos no desaparece o le preocupa.
English: This is because there is limited information in this group of people.
Spanish: Esa recomendación se debe a que la información disponible en este grupo de pacientes es limitada.
English: For patients receiving several respiratory therapies, the recommended order is:
Spanish: En los pacientes que reciben varios tratamientos distintos, el orden recomendado es el siguiente:
English: If the capsule has not emptied you may need to repeat steps 6 to 8.
Spanish: Si no se ha vaciado, repita los pasos 6 a 8.
English: The doctor may give you oxygen and medicines to help you breathe.
Spanish: El médico le facilitará oxígeno y medicamentos para ayudarle a respirar.
English: • acute bleeding ≥240 ml in a 24-hour period
Spanish: • hemorragia aguda ≥ 240 ml en un período de 24 horas
English: - Then twist the mouth-piece into the closed position - when it is closed you will hear a ‘click'.
Spanish: - A continuación gire la boquilla hasta la posición de cierre: cuando se cierre, escuchará un «clic».
English: FEV1 (95% CI)
Spanish: FEV1 (IC del 95 %)
English: ATC code: R05CB16
Spanish: Código ATC: R05CB16
English: Order of using this medicine
Spanish: Orden para el uso de este medicamento
English: Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Spanish: Antes del lanzamiento del medicamento en cada Estado miembro, el Titular de la Autorización de Comercialización acordará el contenido y el formato del material educativo con la autoridad competente nacional
English: You should avoid using this medicine if you are pregnant.
Spanish: No debería tomar este medicamento si está embarazada.
English: No formal interaction studies have been conducted.
Spanish: No se han realizado estudios de interacciones.
English: Do not try to loosen the capsule by pressing the piercing buttons again.
Spanish: No intente aflojar la cápsula pulsando de nuevo los botones de perforación.
English: As a precautionary measure, it is preferable to avoid the use of Bronchitol during pregnancy.
Spanish: Como medida de precaución, es preferible evitar el uso de Bronchitol durante el embarazo.
English: This is because piercing the capsule more than once may make it split or break-up.
Spanish: Si perfora la cápsula más de una vez, se puede rasgar o romper.
English: If this does not happen, the capsule may be stuck.
Spanish: Si no ocurre eso, es posible que la cápsula se haya atascado.
English: Inhale - Tilt your head back slightly.
Spanish: Inhale - Incline la cabeza ligeramente hacia atrás.
English: The inhaler device is to be replaced after one week of use.
Spanish: El inhalador se debe sustituir después de una semana de uso.
English: A massive/serious haemoptysis is considered to be:
Spanish: Se considera que una hemoptisis es masiva/grave si se presenta:
English: Repeat the inhalation to get your dose.
Spanish: Repita la inhalación para recibir la dosis.
English: As a result you may get a ‘productive cough', which also helps to remove mucus from your lungs.
Spanish: Como resultado puede aparecer una «tos productiva», que también ayuda a eliminar el moco de los pulmones.
English: Treatment dose (2-week packs) - You must use Bronchitol every day.
Spanish: Dosis de tratamiento (envases para 2 semanas) - Debe usar Bronchitol todos los días.
English: Inhaled antibiotics (if applicable)
Spanish: Antibióticos inhalados /si procede)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Spanish: Se invita a los profesionales sanitarios a notificar las sospechas de reacciones adversas a través del sistema nacional de notificación incluido en el Apéndice V*
English: 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 (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
Spanish: 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 (≥1/100 000 a <1/10 000) y frecuencia no conocida (no puede estimarse a partir de los datos disponibles).
English: If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual.
Spanish: Si olvidó usar Bronchitol - Si olvida una dosis, use el inhalador en cuanto se acuerde y siga usándolo como de costumbre.
English: The recommended dose of Bronchitol is 400 mg twice a day.
Spanish: La dosis recomendada de Bronchitol es de 400 mg dos veces al día.
English: Dornase alfa (if applicable) 5.
Spanish: Dornsasa alfa (si procede) 5.
English: A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide.
Spanish: Un pequeño porcentaje de manitol absorbido sistémicamente sufre metabolismo hepático para dar glucógeno y dióxido de carbono.
English: It must not be administered by any other route or using any other inhaler.
Spanish: No se debe administrar por ninguna otra vía, ni utilizando ningún otro inhalador.
English: There are no data on concomitant use of hypertonic saline with Bronchitol as it was excluded from the Phase 3 studies.
Spanish: No existen datos sobre el uso concomitante de solución salina hipertónica con Bronchitol, ya que se excluyó de los estudios de Fase 3.
English: The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients.
Spanish: Se ha evaluado el perfil de seguridad de Bronchitol en estudios clínicos con más de 1200 pacientes.
English: Cleaning the inhaler - Usually your inhaler will give you the correct dose of medicine for 7 days without needing cleaning.
Spanish: Limpieza del inhalador - Normalmente el inhalador le administrará la dosis correcta de medicación durante 7 días sin necesidad de limpieza.