FrancophonIA/ELRC3.0 huggingface dataset:
English: However, if you take more Neoclarityn than you were told to, tell your doctor, pharmacist or nurse immediately.
Spanish: No obstante, si toma más Neoclarityn del que le han dicho, dígaselo a su médico, farmacéutico o enfermero inmediatamente.
English: However, if you take more Neoclarityn oral solution than you were told to, tell your doctor, pharmacist or nurse immediately.
Spanish: No obstante, si toma más Neoclarityn solución oral del que le han dicho, dígaselo a su médico, farmacéutico o enfermero inmediatamente.
English: If you take more Neoclarityn orodispersible tablet than you should Take Neoclarityn orodispersible tablet only as prescribed for you.
Spanish: Si toma más Neoclarityn comprimidos bucodispersables del que debe Tome Neoclarityn comprimidos bucodispersables únicamente como su médico le ha indicado.
English: Neoclarityn is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Spanish: Neoclarityn también se utiliza para aliviar los síntomas asociados con la urticaria (enfermedad de la piel provocada por una alergia).
English: Neoclarityn with food, drink and alcohol Neoclarityn may be taken with or without a meal.
Spanish: Toma de Neoclarityn con alimentos, bebidas y alcohol Neoclarityn se puede tomar con independencia de las comidas.
English: EU/1/00/161/059 30 ml with 1 spoon EU/1/00/161/060 50 ml with 1 spoon EU/1/00/161/061 60 ml with 1 spoon EU/1/00/161/062 100 ml with 1 spoon EU/1/00/161/063 120 ml with 1 spoon EU/1/00/161/064 150 ml with 1 spoon EU/1/00/161/067 150 ml with 1 oral syringe EU/1/00/161/065 225 ml with 1 spoon EU/1/00/161/066 300 ml with 1 spoon
Spanish: EU/1/00/161/059 30 ml con 1 cucharilla EU/1/00/161/060 50 ml con 1 cucharilla EU/1/00/161/061 60 ml con 1 cucharilla EU/1/00/161/062 100 ml con 1 cucharilla EU/1/00/161/063 120 ml con 1 cucharilla EU/1/00/161/064 150 ml con 1 cucharilla EU/1/00/161/067 150 ml con 1 jeringa para uso oral EU/1/00/161/065 225 ml con 1 cucharilla EU/1/00/161/066 300 ml con 1 cucharilla
English: Neoclarityn orodispersible tablet is packed in unit dose blisters in packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.
Spanish: Neoclarityn comprimidos bucodispersables se presenta en blisters unidosis en envases de 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 y 100 dosis de comprimidos bucodispersables.
English: At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Neoclarityn were reported in 3 % of patients in excess of those treated with placebo.
Spanish: A la dosis recomendada, en ensayos clínicos que involucraban a adultos y adolescentes en una serie de indicaciones que incluían rinitis alérgica y urticaria idiopática crónica, se notificaron reacciones adversas con Neoclarityn en un 3 % de pacientes más que en los tratados con placebo.
English: How to take Neoclarityn orodispersible tablet
Spanish: Cómo tomar Neoclarityn comprimidos bucodispersables
English: Neoclarityn is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Spanish: Neoclarityn está indicado en adultos y adolescentes a partir de 12 años de edad para el alivio de los síntomas asociados con: - rinitis alérgica (ver sección 5.1) - urticaria (ver sección 5.1)
English: Children 6 through 11 years of age: The recommended dose is 5 ml (one 5 ml spoonful) of oral solution once a day.
Spanish: Niños de 6 a 11 años de edad La dosis recomendada es 5 ml (una cucharada de 5 ml) de solución oral una vez al día.
English: Name and address of the manufacturer responsible for batch release for orodispersible tablet
Spanish: Nombre y dirección del fabricante responsable de la liberación de los lotes de los comprimidos bucodispersables
English: Adults and adolescents (12 years of age and over) The recommended dose of Neoclarityn is 10 ml (5 mg) oral solution once a day.
Spanish: Adultos y adolescentes (a partir de 12 años de edad) La dosis recomendada de Neoclarityn es 10 ml (5 mg) de solución oral una vez al día.
English: Neoclarityn is an antiallergy medicine that does not make you drowsy.
Spanish: Neoclarityn es un medicamento antialérgico que no produce somnolencia.
English: However, if you take more Neoclarityn orodispersible tablet than you were told to, tell your doctor, pharmacist or nurse immediately.
Spanish: No obstante, si toma más Neoclarityn comprimidos bucodispersables del que le han dicho, dígaselo a su médico, farmacéutico o enfermero inmediatamente.
English: Do not take Neoclarityn oral solution - if you are allergic to desloratadine, or to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Spanish: No tome Neoclarityn solución oral - si es alérgico a desloratadina o a cualquiera de los demás componentes de este medicamento
English: Neoclarityn orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Spanish: Neoclarityn comprimidos bucodispersables también se utiliza para aliviar los síntomas asociados con la urticaria (enfermedad de la piel provocada por una alergia).
English: In adult and adolescent patients with allergic rhinitis, Neoclarityn tablets were effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Spanish: En pacientes adultos y adolescentes con rinitis alérgica, Neoclarityn comprimidos fue eficaz en el alivio de síntomas tales como estornudos, rinorrea y picor nasal, así como escozor, lagrimeo y enrojecimiento ocular y picor de paladar.
English: Elevations of liver enzymes, increased bilirubin, hepatitis
Spanish: Elevaciones de enzimas hepáticas, aumento
English: BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 TABLETS
Spanish: CAJA DE 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 COMPRIMIDOS
English: Neoclarityn orodispersible tablet is an antiallergy medicine that does not make you drowsy.
Spanish: Neoclarityn comprimidos bucodispersables es un medicamento antialérgico que no produce somnolencia.
English: If you stop taking Neoclarityn If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Spanish: Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico, farmacéutico o enfermero.
English: Adults and adolescents (12 years of age and over) The recommended dose of Neoclarityn is one 5 mg orodispersible tablet placed in the mouth once a day.
Spanish: Adultos y adolescentes (a partir de 12 años de edad) La dosis recomendada de Neoclarityn es un comprimido bucodispersable de 5 mg colocado en la boca una vez al día.
English: EU/1/00/161/001 1 tablet EU/1/00/161/002 2 tablets EU/1/00/161/003 3 tablets EU/1/00/161/004 5 tablets EU/1/00/161/005 7 tablets EU/1/00/161/006 10 tablets EU/1/00/161/007 14 tablets EU/1/00/161/008 15 tablets EU/1/00/161/009 20 tablets EU/1/00/161/010 21 tablets EU/1/00/161/011 30 tablets EU/1/00/161/012 50 tablets EU/1/00/161/013 100 tablets
Spanish: EU/1/00/161/001 1 comprimido EU/1/00/161/002 2 comprimidos EU/1/00/161/003 3 comprimidos EU/1/00/161/004 5 comprimidos EU/1/00/161/005 7 comprimidos EU/1/00/161/006 10 comprimidos EU/1/00/161/007 14 comprimidos EU/1/00/161/008 15 comprimidos EU/1/00/161/009 20 comprimidos EU/1/00/161/010 21 comprimidos EU/1/00/161/011 30 comprimidos EU/1/00/161/012 50 comprimidos EU/1/00/161/013 100 comprimidos
English: In patients with allergic rhinitis, Neoclarityn was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Spanish: En pacientes con rinitis alérgica, Neoclarityn fue eficaz en el alivio de síntomas tales como estornudos, rinorrea y picor nasal, así como escozor, lagrimeo y enrojecimiento ocular y picor de paladar.
English: Neoclarityn tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
Spanish: En ensayos clínicos, Neoclarityn comprimidos administrado a una dosis diaria única de 7,5 mg en adultos y adolescentes no afectó a la actividad psicomotriz.
English: The safety and efficacy of Neoclarityn 2.5 mg orodispersible tablets in children below the age of 6 years have not been established.
Spanish: No se ha establecido la seguridad y eficacia de Neoclarityn 2,5 mg comprimidos bucodispersables en niños menores de 6 años de edad.
English: Neoclarityn oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap. For all packages except the 150 ml bottle, a measuring spoon is provided, marked for doses of 2.5 ml and 5 ml.
Spanish: Neoclarityn solución oral está disponible en frascos de 30, 50, 60, 100, 120, 150, 225 y 300 ml, con un tapón a prueba de niños.
English: In patients with allergic rhinitis, Neoclarityn tablets were effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Spanish: En pacientes con rinitis alérgica, Neoclarityn comprimidos fue eficaz en el alivio de síntomas tales como estornudos, rinorrea y picor nasal, así como escozor, lagrimeo y enrojecimiento ocular y picor de paladar.
English: Do not take Neoclarityn orodispersible tablet - if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Spanish: No tome Neoclarityn comprimidos bucodispersables - si es alérgico a desloratadina o a cualquiera de los demás componentes de este medicamento
English: Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.
Spanish: Envases de 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 ó 100 comprimidos.
English: The safety and efficacy of Neoclarityn 5 mg film-coated tablets in children below the age of 12 years have not been established.
Spanish: No se ha establecido la seguridad y eficacia de Neoclarityn 5 mg comprimidos recubiertos con película en niños menores de 12 años de edad.
English: The safety and efficacy of Neoclarityn 5 mg orodispersible tablets in children below the age of 12 years have not been established.
Spanish: No se ha establecido la seguridad y eficacia de Neoclarityn 5 mg comprimidos bucodispersables en niños menores de 12 años de edad.
English: Do not take Neoclarityn - if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Spanish: No tome Neoclarityn - si es alérgico a desloratadina o a cualquiera de los demás componentes de este medicamento
English: EU/1/00/161/035 5 orodispersible tablets EU/1/00/161/036 6 orodispersible tablets EU/1/00/161/037 10 orodispersible tablets EU/1/00/161/038 12 orodispersible tablets EU/1/00/161/039 15 orodispersible tablets EU/1/00/161/040 18 orodispersible tablets EU/1/00/161/041 20 orodispersible tablets EU/1/00/161/042 30 orodispersible tablets EU/1/00/161/043 50 orodispersible tablets EU/1/00/161/044 60 orodispersible tablets EU/1/00/161/045 90 orodispersible tablets EU/1/00/161/046 100 orodispersible tablets
Spanish: EU/1/00/161/035 5 comprimidos bucodispersables EU/1/00/161/036 6 comprimidos bucodispersables EU/1/00/161/037 10 comprimidos bucodispersables EU/1/00/161/038 12 comprimidos bucodispersables EU/1/00/161/039 15 comprimidos bucodispersables EU/1/00/161/040 18 comprimidos bucodispersables EU/1/00/161/041 20 comprimidos bucodispersables EU/1/00/161/042 30 comprimidos bucodispersables EU/1/00/161/043 50 comprimidos bucodispersables EU/1/00/161/044 60 comprimidos bucodispersables EU/1/00/161/045 90 comprimidos bucodispersables EU/1/00/161/046 100 comprimidos bucodispersables
English: Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Spanish: En ensayos clínicos, Neoclarityn comprimidos administrado a una dosis diaria única de 7,5 mg no afectó a la actividad psicomotriz.
English: EU/1/00/161/047 5 orodispersible tablets EU/1/00/161/048 6 orodispersible tablets EU/1/00/161/049 10 orodispersible tablets EU/1/00/161/050 12 orodispersible tablets EU/1/00/161/051 15 orodispersible tablets EU/1/00/161/052 18 orodispersible tablets EU/1/00/161/053 20 orodispersible tablets EU/1/00/161/054 30 orodispersible tablets EU/1/00/161/055 50 orodispersible tablets EU/1/00/161/056 60 orodispersible tablets EU/1/00/161/057 90 orodispersible tablets EU/1/00/161/058 100 orodispersible tablets
Spanish: EU/1/00/161/047 5 comprimidos bucodispersables EU/1/00/161/048 6 comprimidos bucodispersables EU/1/00/161/049 10 comprimidos bucodispersables EU/1/00/161/050 12 comprimidos bucodispersables EU/1/00/161/051 15 comprimidos bucodispersables EU/1/00/161/052 18 comprimidos bucodispersables EU/1/00/161/053 20 comprimidos bucodispersables EU/1/00/161/054 30 comprimidos bucodispersables EU/1/00/161/055 50 comprimidos bucodispersables EU/1/00/161/056 60 comprimidos bucodispersables EU/1/00/161/057 90 comprimidos bucodispersables EU/1/00/161/058 100 comprimidos bucodispersables
English: How to store Neoclarityn oral solution
Spanish: Conservación de Neoclarityn solución oral
English: Neoclarityn oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 1 year of age and older.
Spanish: Neoclarityn solución oral alivia los síntomas asociados con la rinitis alérgica (inflamación de las fosas nasales provocada por una alergia, por ejemplo, fiebre del heno o alergia a ácaros del polvo) en adultos, adolescentes y niños a partir de 1 año de edad.
English: Neoclarityn given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Spanish: En ensayos clínicos, Neoclarityn administrado a una dosis diaria única de 7,5 mg no afectó a la actividad psicomotriz.
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn tablets were reported in 3 % of patients in excess of those treated with placebo.
Spanish: En ensayos clínicos, en un intervalo de indicaciones que incluyen rinitis alérgica y urticaria idiopática crónica, a la dosis recomendada de 5 mg diarios, se notificaron reacciones adversas con Neoclarityn comprimidos en un 3 % de pacientes más que en los tratados con placebo.
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn were reported in 3 % of patients in excess of those treated with placebo.
Spanish: En ensayos clínicos en un intervalo de indicaciones que incluyen rinitis alérgica y urticaria idiopática crónica, a la dosis recomendada de 5 mg diarios, se notificaron reacciones adversas con Neoclarityn en un 3 % de pacientes más que en los tratados con placebo.
English: Neoclarityn 2.5 mg orodispersible tablets
Spanish: Neoclarityn 2,5 mg comprimidos bucodispersables
English: Neoclarityn 5 mg tablet desloratadine
Spanish: Neoclarityn 5 mg comprimidos desloratadina
English: Neoclarityn 2.5 mg orodispersible tablets desloratadine
Spanish: Neoclarityn 2,5 mg comprimidos bucodispersables desloratadina
English: Neoclarityn relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Spanish: Neoclarityn alivia los síntomas asociados con la rinitis alérgica (inflamación de las fosas nasales provocada por una alergia, por ejemplo, fiebre del heno o alergia a ácaros del polvo) en adultos y adolescentes a partir de 12 años de edad.
English: Neoclarityn orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 6 years of age and older.
Spanish: Neoclarityn comprimidos bucodispersables alivia los síntomas asociados con la rinitis alérgica (inflamación de las fosas nasales provocada por una alergia, por ejemplo, fiebre del heno o alergia a ácaros del polvo) en adultos, adolescentes y niños a partir de 6 años de edad.
English: Neoclarityn 5 mg orodispersible tablets desloratadine
Spanish: Neoclarityn 5 mg comprimidos bucodispersables desloratadina
English: Neoclarityn 5 mg orodispersible tablets
Spanish: Neoclarityn 5 mg comprimidos bucodispersables
English: Neoclarityn orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Spanish: Neoclarityn comprimidos bucodispersables alivia los síntomas asociados con la rinitis alérgica (inflamación de las fosas nasales provocada por una alergia, por ejemplo, fiebre del heno o alergia a ácaros del polvo) en adultos y adolescentes a partir de 12 años de edad.
English: How to store Neoclarityn orodispersible tablet
Spanish: Conservación de Neoclarityn comprimidos bucodispersables
English: Date of first authorisation: 21 February 2005 Date of latest renewal: 19 January 2010
Spanish: Fecha de la primera autorización: 21/ febrero/2005 Fecha de la última renovación: 19/enero /2010
English: SE-141 75 Kungens Kurva Sweden
Spanish: SE-141 75 Kungens Kurva Suecia
English: How to prepare a new bottle of medicine for first time use:
Spanish: Cómo preparar un nuevo frasco del medicamento para utilizarlo por primera vez:
English: Important information about instructions for use:
Spanish: Información importante sobre las instrucciones de uso:
English: Follow the instructions below:
Spanish: Siga las instrucciones descritas a continuación:
English: The bottle adapter should not be removed.
Spanish: El adaptador del frasco no debe retirarse.
English: Orfadin must not be injected.
Spanish: Orfadin no se debe inyectar.
English: What Orfadin is and what it is used for
Spanish: Qué es Orfadin y para qué se utiliza
English: Other medicines and Orfadin
Spanish: Otros medicamentos y Orfadin
English: However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4“Possible side effects”).
Spanish: No obstante, si experimenta efectos adversos que afecten a la visión, no debe conducir ni utilizar máquinas hasta que su visión haya vuelto a la normalidad (ver sección 4 “Posibles efectos adversos”).
English: If you take more Orfadin than you should
Spanish: Si toma más Orfadin del que debe
English: Orfadin should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Spanish: No se debe utilizar Orfadin durante el embarazo a no ser que la situación clínica de la mujer requiera tratamiento con nitisinona.
English: Do not attach a needle to the syringe.
Spanish: No acople una aguja a la jeringa.
English: The dose that your doctor prescribes you should be given in ml of suspension and not in mg.
Spanish: La dosis recetada por su médico se debe administrar en ml de suspensión y no en mg.
English: No formal food interactions studies have been performed with Orfadin hard capsules.
Spanish: No se han realizado estudios formales de interacción con alimentos con Orfadin cápsulas duras.
English: The dose should be withdrawn and administered immediately after re-dispersion.
Spanish: La dosis se debe extraer y administrar inmediatamente después de volver a dispersar el producto.
English: How to prepare a dose of medicine
Spanish: Cómo preparar una dosis del medicamento
English: What Orfadin is and what it is used for What you need to know before you take Orfadin How to take Orfadin
Spanish: Qué es Orfadin y para qué se utiliza Qué necesita saber antes de empezar a tomar Orfadin Cómo tomar Orfadin
English: Re-dispersing is required before each use by vigorous shaking.
Spanish: Es necesario volver a dispersar el producto antes de cada uso mediante agitación vigorosa.
English: Each bottle contains 90 ml oral suspension.
Spanish: Cada frasco contiene 90 ml de suspensión oral.
English: Orfadin is also available as a 4 mg/ml oral suspension for paediatric patients who have difficulties swallowing capsules.
Spanish: Orfadin también está disponible como suspensión oral de 4 mg/ml para pacientes pediátricos que tienen dificultad para tragar cápsulas.
English: Talk to your doctor or pharmacist before taking Orfadin.
Spanish: Consulte a su médico o farmacéutico antes de empezar a tomar Orfadin.
English: If you start treatment by taking it with food, it is recommended that you carry on taking it with food throughout your course of treatment.
Spanish: Si comienza el tratamiento tomándolo junto con alimentos, se recomienda seguir este régimen a lo largo de todo el tratamiento.
English: Orfadin blocks the breakdown of tyrosine and the harmful substances are not formed.
Spanish: Orfadin bloquea la degradación de la tirosina, y las sustancias tóxicas no se forman.
English: How to prepare the dose to be administered
Spanish: Cómo preparar la dosis que se debe administrar
English: Oral suspension 90 ml
Spanish: Suspensión oral 90 ml
English: Orfadin is for oral use only.
Spanish: Orfadin es solo para administración por vía oral.
English: Orfadin may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin)
Spanish: Orfadin puede interferir con el efecto de otros medicamentos, tales como: - medicamentos para la epilepsia (como la fenitoína) - medicamentos contra la formación de coágulos de sangre (como la warfarina)
English: This is because the oral syringe which is used to withdraw the correct dose from the bottle is marked in ml.
Spanish: Esto es así porque la jeringa para uso oral que se debe utilizar para extraer del frasco la dosis correcta del producto está marcada en ml.
English: Dose-adjustment of these co-administered medicinal products may be needed (see section 4.5).
Spanish: Puede ser necesario ajustar la dosis de estos medicamentos administrados de forma concomitante (ver sección 4.5).
English: Do not breast-feed while taking this medicine, see section “Do not take Orfadin”.
Spanish: No dé el pecho mientras esté tomando este medicamento (ver sección “No tome Orfadin”).
English: Precautions to be taken before handling or administering the medicinal product No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.
Spanish: Precauciones a tomar antes de manipular o administrar el medicamento No se debe acoplar a la jeringa para uso oral ninguna aguja, tubo intravenoso o dispositivo para administración parenteral.
English: NTBC study (N=250) Number of patients at
Spanish: Estudio NTBC (N=250) Número de pacientes a
English: Age at onset of symptoms 1 year 2 years < 2 months > 2-6 months > 6 months
Spanish: Edad al comienzo de los síntomas 1 año 2 años < 2 meses > 2-6 meses > 6 meses
English: A population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Spanish: El análisis farmacocinético poblacional se ha realizado en un grupo de 207 pacientes con TH-1.
English: Orfadin contains sodium, glycerol and sodium benzoate
Spanish: Orfadin contiene sodio, glicerol y benzoato de sodio
English: Cleaning:
Spanish: Limpieza:
English: The capsules are packaged in plastic bottles with tamper-proof closures.
Spanish: Las cápsulas vienen envasadas en frascos de plástico con cierres inviolables.