FrancophonIA/ELRC3.0 huggingface dataset:
English: It works by blocking certain enzymes called cyclo-oxygenases, which produce prostaglandins, substances that are involved in pain and inflammation processes.
Spanish: El ketorolaco es un antiinflamatorio no esteroideo (AINE) que actúa bloqueando unas enzimas llamadas ciclooxigenasas, que producen prostaglandinas, sustancias que intervienen en el dolor y en el proceso inflamatorio.
English: How is Omidria used?
Spanish: ¿Cómo se usa Omidria?
English: When applied to the eye, phenylephrine makes the muscle of the iris contract (tighten) and allows the pupil to widen.
Spanish: Cuando se aplica en el ojo, la fenilefrina contrae el músculo del iris y permite la dilatación pupilar, lo que facilita la cirugía de cataratas.
English: Blisters: 3 years Bottles: 3 years
Spanish: Blísters: 3 años Frascos: 3 años
English: Smoking could decrease the amount of AZILECT in the blood.
Spanish: Fumar podría disminuir la cantidad de AZILECT en la sangre.
English: What AZILECT is and what it is used for
Spanish: Qué es AZILECT y para qué se utiliza
English: AZILECT may be taken with or without food.
Spanish: AZILECT se puede tomar con o sin alimentos.
English: Therefore, AZILECT is not recommended for use under the age of 18.
Spanish: Por tanto, AZILECT no está recomendado a menores de 18 años.
English: If you take more AZILECT than you should
Spanish: Si toma más AZILECT del que debe
English: The safety and efficacy of AZILECT in children and adolescents have not been established.
Spanish: No se ha establecido la seguridad y eficacia de AZILECT en niños y adolescentes.
English: Other medicines and AZILECT
Spanish: Otros medicamentos y AZILECT
English: What AZILECT is and what it is used for What you need to know before you take AZILECT How to take AZILECT
Spanish: Qué es AZILECT y para qué se utiliza Qué necesita saber antes de empezar a tomar AZILECT Cómo tomar AZILECT
English: Do not stop taking AZILECT without first talking to your doctor.
Spanish: No interrumpa el tratamiento con AZILECT sin consultar antes con su médico.
English: Decreased appetite
Spanish: - Disminución del apetito.
English: You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and the unborn child are not known.
Spanish: Debe evitar tomar AZILECT si está embarazada, ya que se desconocen los efectos de AZILECT sobre el embarazo y el feto.
English: Take the AZILECT carton/ blister or bottle with you to show the doctor or pharmacist.
Spanish: Lleve consigo la caja/blíster o el frasco de AZILECT para mostrárselo al médico o al farmacéutico.
English: Tablet 30 tablets
Spanish: Comprimido 30 comprimidos
English: AZILECT helps to increase and sustain levels of dopamine in the brain.
Spanish: AZILECT ayuda a incrementar y mantener los niveles de dopamina en el cerebro.
English: Adverse reactions are listed below in Tables 1 and 2 by system organ class and frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Spanish: Las reacciones adversas se enumeran en las Tablas 1 y 2 según la clasificación de órganos del sistema y por frecuencias utilizando la siguiente convención: 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
English: Skin carcinoma
Spanish: Carcinoma de piel
English: The recommended dose of AZILECT is 1 tablet of 1 mg taken by mouth once daily.
Spanish: La dosis recomendada de AZILECT es de 1 comprimido de 1 mg tomado por la boca, una vez al día.
English: The use of AZILECT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Spanish: Debe evitarse el uso de AZILECT junto con antidepresivos que contengan fluoxetina o fluvoxamina.
English: This might be enhanced if you take other medicines to treat the symptoms of your Parkinson's disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking AZILECT.
Spanish: Esto podría aumentar si toma otros medicamentos para tratar los síntomas de la enfermedad de Parkinson, si toma medicamentos que pueden provocarle somnolencia o si consume alcohol durante el tratamiento con AZILECT.
English: Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: N04BD02
Spanish: Grupo farmacoterapéutico: antiparkinsonianos, inhibidores de la monoamino oxidasa B. código, ATC: N04BD02
English: How to take AZILECT
Spanish: Cómo tomar AZILECT
English: Elderly No change in dose is required for elderly patients (see section 5.2).
Spanish: No es necesario cambiar la dosis en pacientes de edad avanzada (ver sección 5.2).
English: There is no relevant use of AZILECT in children and adolescents.
Spanish: El uso de AZILECT en niños y adolescentes no es relevante.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Spanish: LISTA DE EXCIPIENTES FORMA FARMACEUTICA Y CONTENIDO DEL ENVASE
English: The recommended dose of rasagiline is 1 mg (one tablet of AZILECT) once daily, to be taken with or without levodopa.
Spanish: La dosis recomendada de rasagilina es de 1 mg (un comprimido de AZILECT) una vez al día, que debe tomarse con o sin levodopa.
English: These symptoms may resemble those observed with non-selective MAO inhibitors.
Spanish: Estos síntomas tienen cierta similitud con los observados en los inhibidores de la MAO no selectivos.
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets
Spanish: 7 comprimidos 10 comprimidos 28 comprimidos 30 comprimidos 100 comprimidos 112 comprimidos
English: Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
Spanish: Los síntomas notificados tras una sobredosis de AZILECT fueron estado de ánimo ligeramente eufórico (forma leve de manía), presión sanguínea muy elevada y síndrome serotoninérgico (ver sección 4).
English: Not known: frequency cannot be estimated from the available data - Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
Spanish: Frecuencia no conocida: no puede estimarse a partir de los datos disponibles - Presión sanguínea elevada.
English: In a single-dose study healthy volunteers received 20 mg/day and in a ten-day study healthy volunteers received 10 mg/day.
Spanish: En un estudio de dosis única, los voluntarios sanos recibieron 20 mg/día de rasagilina, y en un estudio de 10 días, los voluntarios sanos recibieron 10 mg/día de rasagilina.
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
Spanish: La rasagilina se metaboliza principalmente por dos vías: N-dealquilación y/o hidroxilación con formación de 1-aminoindano, 3-hidroxi-N-propargil-1-aminoindano y 3-hidroxi-1-aminoindano.
English: What you need to know before you take AZILECT Do not take AZILECT
Spanish: Qué necesita saber antes de empezar a tomar AZILECT No tome AZILECT
English: If you forget to take AZILECT
Spanish: Si olvidó tomar AZILECT
English: In post-marketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
Spanish: En el periodo de poscomercialización hubo un caso de elevación de la presión sanguínea en un paciente que usaba el vasoconstrictor oftálmico hidrocloruro de tetrahidrozolina mientras tomaba rasagilina.
English: The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets.
Spanish: Los comprimidos se presentan en envases blíster de 7, 10, 28, 30, 100 y 112 comprimidos o en un frasco con 30 comprimidos.
English: Levodopa and other Parkinson's disease medicinal products
Spanish: Levodopa y otros medicamentos para la enfermedad de Parkinson
English: If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine treatment.
Spanish: Si usted está empezando su tratamiento con AZILECT, debe esperar al menos 5 semanas desde la interrupción del tratamiento con fluoxetina.
English: If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping AZILECT treatment.
Spanish: Si usted está empezando su tratamiento con fluoxetina o fluvoxamina, debe esperar al menos 14 días desde de la interrupción del tratamiento con AZILECT.
English: There is no relevant use of AZILECT in the paediatric population in the indication Parkinson's disease.
Spanish: El uso de AZILECT en la población pediátrica para la indicación de enfermedad de Parkinson no es relevante.
English: Very common (may affect more than 1 in 10 people) - Involuntary movements (dyskinesia) - Headache
Spanish: Muy frecuentes (pueden afectar a más de 1 de cada 10 personas) - Movimientos involuntarios (discinesia).
English: AZILECT contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Spanish: AZILECT contiene el principio activo rasagilina y está indicado para el tratamiento de la enfermedad de Parkinson en adultos.
English: Renal impairment No special precautions are required in patients with renal impairment.
Spanish: Insuficiencia renal No es necesario tomar precauciones especiales en pacientes con insuficiencia renal.
English: AZILECT is indicated in adults for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Spanish: AZILECT está indicado en adultos para el tratamiento de la enfermedad idiopática de Parkinson en monoterapia (sin levodopa) o en terapia coadyuvante (con levodopa) en pacientes con fluctuaciones de final de dosis.
English: *See section description of selected adverse reactions
Spanish: *Ver sección “Descripción de las reacciones adversas seleccionadas”
English: ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily (see section 4.5).
Spanish: ≤50 mg/día, trazodona ≤100 mg/día, citalopram ≤20 mg/día, sertralina ≤100 mg/día y paroxetina
English: AZILECT may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson's disease).
Spanish: AZILECT puede provocar somnolencia y hacer que se quede dormido repentinamente mientras realiza actividades cotidianas, especialmente si está tomando otros medicamentos dopaminérgicos (utilizados para tratar la enfermedad de Parkinson).
English: Each tablet contains 1 mg of rasagiline (as mesilate).
Spanish: Cada comprimido contiene 1 mg de rasagilina (como mesilato).
English: Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, but the following antidepressants and doses were allowed in the rasagiline trials: amitriptyline
Spanish: Los ensayos clínicos de rasagilina no permitieron el uso concomitante de fluoxetina o fluvoxamina con rasagilina; sin embargo, sí se permitieron los siguientes antidepresivos y dosis: amitriptilina
English: If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking AZILECT do not drive or operate machinery (see section 2).
Spanish: Si ha experimentado somnolencia y/o episodios de sueño repentino antes o durante el tratamiento con AZILECT, no conduzca ni utilice máquinas (ver sección 2).
English: - The active substance is rasagiline.
Spanish: - El principio activo es rasagilina.
English: AZILECT 1 mg tablets
Spanish: AZILECT 1 mg comprimidos.
English: For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotonin-norepinephrine reuptake inhibitors (SNRIs) in clinical trials, see section 4.8.
Spanish: Para el uso concomitante de rasagilina con inhibidores selectivos de la recaptación de serotonina (ISRS)/inhibidores selectivos de la recaptación de serotonina y noradrenalina (IRSN) en ensayos clínicos, ver sección 4.8.
English: Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Spanish: Síndrome serotoninérgico* Somnolencia diurna excesiva (SDE) y episodios de sueño repentino*
English: If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately.
Spanish: Si piensa que usted ha tomado más comprimidos de AZILECT de los que debe, informe inmediatamente a su médico o farmacéutico.
English: In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Spanish: En pacientes con enfermedad de Parkinson que recibieron rasagilina como terapia coadyuvante para el tratamiento crónico con levodopa, no se observó ningún efecto clínicamente significativo del tratamiento con levodopa sobre el aclaramiento de rasagilina.
English: Neoplasms benign, malignant and unspecified
Spanish: Neoplasias benignas, malignas y no
English: - If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
Spanish: - Si es alérgico a la rasagilina o a alguno de los demás componentes de este medicamento
English: Package leaflet: Information for the user AZILECT 1 mg tablets rasagiline
Spanish: Prospecto: información para el usuario AZILECT 1 mg comprimidos rasagilina
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
Spanish: En los ensayos clínicos realizados en pacientes con enfermedad de Parkinson, las reacciones adversas notificadas con mayor frecuencia fueron: cefalea, depresión, vértigo y gripe (influenza y rinitis) en monoterapia; discinesia, hipotensión ortostática, caída, dolor abdominal, náuseas y vómitos y sequedad de boca en terapia coadyuvante con levodopa; dolor musculoesquelético (como dolor cervical y lumbar) y artralgia en ambos tratamientos.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK
Spanish: INFORMACIÓN QUE DEBE FIGURAR EN EL EMBALAJE EXTERIOR ESTUCHE PARA ENVASES TIPO BLISTER
English: In patients taking AZILECT and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Spanish: En pacientes que toman AZILECT y/u otros medicamentos utilizados para tratar la enfermedad de Parkinson se han observado comportamientos tales como compulsiones, pensamientos obsesivos, ludomanía, gastos excesivos, comportamiento impulsivo y un impulso sexual anormalmente alto o un aumento de los pensamientos o sentimientos sexuales.
English: AZILECT 1 mg tablets rasagiline
Spanish: AZILECT 1 mg comprimidos rasagilina
English: Cerebrovascular Serotonin
Spanish: Síndrome serotoninérgico
English: Talk to your doctor before taking AZILECT - If you have any liver problems - You should speak with your doctor about any suspicious skin changes.
Spanish: - Debe hablar con su médico ante cualquier cambio sospechoso en la piel.
English: You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.
Spanish: Debe esperar al menos 14 días después de cesar el tratamiento con AZILECT y de iniciar el tratamiento con inhibidores de la MAO o petidina.
English: AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Spanish: AZILECT comprimidos se presenta en forma de comprimidos blancos o blanquecinos, redondos, planos y biselados, con la inscripción en relieve “GIL” y “1” en la parte inferior de una de las caras y liso en la otra cara.
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Spanish: Somnolencia diurna excesiva (SDE) y episodios de sueño repentino Rasagilina puede producir adormecimiento diurno, somnolencia y, ocasionalmente, especialmente si se administra con otros medicamentos dopaminérgicos, hacer que el paciente se quede dormido mientras realiza actividades de la vida diaria.
English: Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Spanish: Consulte a su médico antes de conducir o utilizar máquinas, ya que tanto la enfermedad de Parkinson como el tratamiento con AZILECT pueden afectar a su capacidad para realizar dichas actividades.
English: Uncommon (may affect up to 1 in 100 people) - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Spanish: Poco frecuentes (pueden afectar hasta 1 de cada 100 personas) - Ictus (accidente cerebrovascular).
English: Especially tell your doctor if you are taking any of the following medicines: - Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) - The antibiotic ciprofloxacin used against infections - The cough suppressant dextromethorphan - Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Spanish: Informe a su médico especialmente si está tomando alguno de los siguientes medicamentos: - Ciertos antidepresivos (inhibidores selectivos de la recaptación de serotonina, inhibidores selectivos de la recaptación de serotonina-noradrenalina, antidepresivos tricíclicos o tetracíclicos).
English: Do not take the following medicines while taking AZILECT: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease,
Spanish: No tome los siguientes medicamentos mientras esté tomando AZILECT: Inhibidores de la monoamino-oxidasa (MAO) (p. ej., para el tratamiento de la depresión o la enfermedad de Parkinson, o para otra indicación) incluyendo medicamentos y productos naturales sin prescripción, p. ej., la hierba de San Juan.
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Excessive daily sleepiness (hypersomnia, lethargy, sedation, sleep attacks, somnolence, sudden onset of sleep) can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Spanish: Somnolencia diurna excesiva (SDE) y episodios de sueño repentino En pacientes tratados con agonistas de la dopamina o con otros tratamientos dopaminérgicos se puede producir somnolencia diurna excesiva (hipersomnia, letargo, sedación, ataques de sueño, somnolencia, y/o sueño repentino).
English: MAO Inhibitors
Spanish: Inhibidores de la MAO
English: Contents of the pack and other information What AZILECT contains
Spanish: Contenido del envase e información adicional Composición de AZILECT
English: Fever, Malaise
Spanish: Fiebre Malestar
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Spanish: Poco frecuentes Frecuencia no conocida malignas y no especificadas (incl quistes y pólipos) Trastornos de la sangre y del sistema linfático
English: Abdominal pain, Constipation, Nausea and vomiting, Dry mouth
Spanish: Dolor abdominal Estreñimiento Náuseas y vómitos
English: What AZILECT looks like and contents of the pack
Spanish: Aspecto del producto y contenido del envase
English: If you stop taking AZILECT
Spanish: Si interrumpe el tratamiento con AZILECT
English: 21 February 2005
Spanish: Fecha de la primera autorización: 21/febrero/2005 Fecha de la última renovación: 21/septiembre/2009
English: EU/1/05/322/002 Yttriga vial (glass) 1 vial (flat bottom)
Spanish: vial (vidrio) 1 vial (con fondo plano)
English: (Invented) name Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/05/322/001 Yttriga vial (glass) 1 vial (V-shaped bottom)
Spanish: Tamaño del envase vial (vidrio) 1 vial (en forma de V)
English: 4 (4 x 1) prefilled syringes (multipack)
Spanish: 4 (4 x 1) jeringas precargadas (multienvase)
English: Autovia del Norte.
Spanish: Autovía del Norte.
English: Always wash your hands prior to performing the following procedures.
Spanish: Lávese siempre las manos antes de realizar los procedimientos siguientes.
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 20 July 2012
Spanish: Fecha de la primera autorización: 27 de Agosto de 1997 Fecha de la última renovación: 20 de julio de 2012
English: Desvio Algete, Km.
Spanish: Desvío Algete, Km.
English: The required dose is determined using the following formula:
Spanish: La dosis requerida se determina usando la siguiente fórmula:
English: It is important that the recommendations in section 4.2 be followed closely.
Spanish: Es importante que se sigan estrictamente las recomendaciones indicadas en la sección 4.2.
English: This is a verbatim term.
Spanish: p Este es un término textual.
English: BeneFIX can be used for all age groups.
Spanish: BeneFIX se puede utilizar en todos los grupos de edad.
English: Frequency of doses (hours)/Duration of Therapy (days)
Spanish: Frecuencia de dosis (horas) / Duración de terapia (días)
English: The solution should appear clear and colourless.
Spanish: La solución debe aparecer transparente e incolora.
English: Age Group (years)
Spanish: Grupo de edad (años)
English: X reciprocal of observed recovery
Spanish: x reciproca de la recuperación observada
English: What BeneFIX is and what it is used for
Spanish: Qué es BeneFIX y para qué se utiliza
English: Amount of BeneFIX per Vial
Spanish: Cantidad de BeneFIX por Vial
English: Administration (Intravenous Injection):
Spanish: Administración (Inyección intravenosa):
English: The parameters estimated using the final 2-compartment model are shown in Table 2.
Spanish: Los parámetros calculados mediante el modelo final de dos compartimentos se muestran en la Tabla 2.
English: Blood should not enter the syringe.
Spanish: La sangre no debe entrar en la jeringa.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25C.
Spanish: Se ha demostrado su estabilidad química y física durante 3 horas a temperaturas de hasta 25ºC.
English: These reactions are potentially life-threatening.
Spanish: Estas reacciones pueden potencialmente poner en riesgo la vida.
English: Note: If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted as per the previous instructions.
Spanish: Nota: Si utiliza más de un vial de BeneFIX para perfusión, cada vial debe ser reconstituido de acuerdo con las instrucciones anteriores.
English: BeneFIX should be injected intravenously over several minutes.
Spanish: BeneFIX debe ser inyectado intravenosamente durante varios minutos.
English: Do not use this medicine if you notice the solution is not clear or colourless.
Spanish: No utilice este medicamento si observa que la solución no es transparente o incolora.
English: (pre- and postoperative)
Spanish: (pre y post operatorio)
English: Safety analysis of 25 evaluable patients reflected a safety profile as expected.
Spanish: Los análisis de seguridad de 25 pacientes evaluables mostraron el perfil de seguridad esperado.
English: Lot See front label (Lot, Exp.)
Spanish: Ver parte frontal de la etiqueta (Lot, Exp)
English: 1, 28700 San Sebastian de los Reyes, Madrid Spain
Spanish: 1, 28700 San Sebastián de los Reyes, Madrid España