FrancophonIA/ELRC3.0 huggingface dataset:
English: They are marked ‘GSCL7' on one side; and ‘100' on the other.
Spanish: Los comprimidos muestran la leyenda “GSCL7” grabada en una cara y la leyenda “100” en la otra cara.
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: NOMBRE DEL MEDICAMENTO Lamictal y nombres asociados (ver el Anexo I) 25 mg comprimidos [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: Lamictal 2 mg dispersible/chewable tablets are round.
Spanish: Los comprimidos dispersables/masticables de Lamictal 2 mg son redondos.
English: Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets.
Spanish: Lamictal y nombres asociados (ver Anexo I) 25 mg comprimidos dispersables/masticables.
English: (Starter pack 42 tablets, non-valproate add-on therapy - calender pack showing day numbers): 1 2 3 4 5 6 7 (1 pocket)
Spanish: (Envase de iniciación 42 comprimidos, terapia adicional sin valproato - envase con calendario mostrando el número de días):
English: STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 100 mg lamotrigine
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido dispersable/masticable contine 100 mg de lamotrigina
English: Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets.
Spanish: Lamictal y nombres asociados (ver Anexo I) 2 mg comprimidos dispersables/masticables.
English: 100 mg Dispersible/Chewable Tablets
Spanish: 100 mg comprimidos dispersables/masticables
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: NOMBRE DEL MEDICAMENTO Lamictal y nombres asociados (ver el Anexo I) 50 mg comprimidos [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets.
Spanish: Lamictal y nombres asociados (ver Anexo I) 50 mg comprimidos dispersables/masticables.
English: STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 50 mg lamotrigine
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido dispersable/masticable contine 50 mg de lamotrigina
English: They are marked ‘GSCL5' on one side; and ‘25' on the other.
Spanish: Los comprimidos muestran la leyenda “GSCL5” grabada en una cara y la leyenda “25” en la otra cara.
English: STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 2 mg lamotrigine
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido dispersable/masticable contine 2 mg de lamotrigina
English: HOW TO STORE LAMICTAL
Spanish: CONSERVACIÓN DE LAMICTAL
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: Lamictal y nombres asociados (ver el Anexo I) 100 mg comprimidos dispersables/masticables [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets.
Spanish: Lamictal y nombres asociados (ver Anexo I) 5 mg comprimidos dispersables/masticables.
English: 200 mg Dispersible or chewable Tablet
Spanish: 200 mg Comprimidos dispersables o masticables
English: 100 mg Dispersible or chewable Tablet
Spanish: 100 mg Comprimidos dispersables o masticables
English: White to off-white, elongated, biconvex tablet with a blackcurrant odour, marked “GS CL2” on one side and “5” on the other.
Spanish: Comprimidos dispersables/masticables de 5 mg: comprimidos de blancos a blanquecinos, alargados, biconvexos, ranurados, con olor a grosella negra, con la leyenda “GS CL2” grabada en una cara y la leyenda “5” en la otra cara.Los comprimidos pueden estar ligeramente moteados.
English: White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL5” on one side “25” on the other.
Spanish: Comprimidos dispersables/masticables de 25 mg: comprimidos de blancos a blanquecinos, de múltiples caras, superelípticos, no ranurados, con olor a grosella negra, con la leyenda “GS CL5” grabada en una cara y la leyenda “25” en la otra cara.
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: Lamictal y nombres asociados (ver el Anexo I) 2 mg comprimidos dispersables/masticables [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: Lamictal y nombres asociados (ver el Anexo I) 200 mg comprimidos dispersables/masticables [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: Always use Lamictal exactly as your doctor has told you to.
Spanish: Siga exactamente las instrucciones de administración de Lamictal indicadas por su médico.
English: 25 mg Dispersible/Chewable Tablets
Spanish: 25 mg Comprimidos dispersables o masticables
English: If you have missed taking a dose of Lamictal: Î Ask your doctor for advice on how to start taking it again.
Spanish: Î Pregunte a su médico para que le explique cómo empezar otra vez el tratamiento.
English: 25 mg dispersible/chewable tablets:
Spanish: 25 mg comprimidos dispersables/masticables.
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: Lamictal y nombres asociados (ver el Anexo I) 50 mg comprimidos dispersables/masticables [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: Lamictal y nombres asociados (ver el Anexo I) 25 mg comprimidos dispersables/masticables [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Spanish: Lamictal y nombres asociados (ver el Anexo I) 5 mg comprimidos dispersables/masticables [Ver Anexo I - Para completar a nivel nacional] Lamotrigina
English: BOTTLE
Spanish: Placebo
English: Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamictal should be gradually decreased over a period of two weeks.
Spanish: La dosis de lamotrigina se deberá reducir de forma gradual durante un período de 2 semanas a menos que, por motivos de seguridad (p. ej. aparición de erupción cutánea), se requiera una retirada brusca de la misma.
English: This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are withdrawn
Spanish: Esta pauta posológica debe utilizarse cuando se retiren fármacos administrados concomitantemente que inhiban o induzcan significantemente la glucuronidación de lamotrigina
English: 50 mg Dispersible or chewable Tablet
Spanish: 50 mg Comprimidos dispersables o masticables
English: 5 mg Dispersible/Chewable Tablets
Spanish: 25 mg Comprimidos dispersables/masticable s
English: 2 mg dispersible/chewable tablets:
Spanish: Comprimidos dispersables/masticables de 2 mg:
English: (Starter pack 21 tablets, valproate add-on therapy - calender pack showing day numbers): 1 3 5 7 9 11 13 (one pocket)
Spanish: (Envase de iniciación 21 comprimidos, terapia adicional con valproato - envase con calendario mostrando el número de días):
English: Other information about Tredaptive:
Spanish: Otras informaciones sobre Tredaptive:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Tredaptive a Merck Sharp & Dohme Limited el 3 de julio de 2008.
English: Tredaptive is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
Spanish: Tredaptive no está recomendado para niños y adolescentes de menos de 18 años, ya que no hay información sobre su seguridad y su eficacia en este grupo de edad.
English: The full EPAR for Tredaptive can be found here.
Spanish: El texto completo del EPAR de Tredaptive puede encontrarse aquí.
English: The starting dose of Tredaptive is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Spanish: La dosis inicial de Tredaptive es de un comprimido una vez al día durante cuatro semanas, aumentándose después a dos comprimidos una vez al día.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TREDAPTIVE EPAR summary for the public
Spanish: INFORME PÚBLICO EUROPEO DE EVALUACIÓN (EPAR) TREDAPTIVE Resumen del EPAR para el público general
English: ‘Modified-release' means that the two active substances are released at different rates from the tablet over a few hours.
Spanish: "Liberación modificada" significa que los dos principios activos se liberan del comprimido a velocidades distintas a lo largo de unas cuantas horas.
English: The Committee recommended that Tredaptive be given marketing authorisation.
Spanish: En consecuencia, recomendó que se autorizase su comercialización.
English: The tablets must be swallowed whole, and should not be split, broken, crushed or chewed.
Spanish: Los comprimidos deben tragarse enteros, sin partirlos, romperlos, machacarlos, ni masticarlos.
English: It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin).
Spanish: Se empleó inicialmente como medicamento para modificar las concentraciones de grasas en sangre a mediados de los años cincuenta pero su uso se ha visto limitado por los efectos secundarios que produce, especialmente los sofocos (enrojecimiento de la piel).
English: What benefit has Tredaptive shown during the studies?
Spanish: ¿Qué beneficio ha demostrado tener Tredaptive durante los estudios?
English: The effects of Tredaptive were first tested in experimental models before being studied in humans.
Spanish: Los efectos de Tredaptive se probaron en modelos de laboratorio antes de estudiarse en seres humanos.
English: The most common side effect with Tredaptive (seen in more than 1 patient in 10) is flushing.
Spanish: El efecto secundario más frecuente de Tredaptive (observado en más de 1 de cada 10 pacientes) son los sofocos.
English: It should be used with caution in patients who have problems with their kidneys and should not be used in patients with liver problems.
Spanish: Debe administrarse con precaución a los pacientes con problemas de riñón y no debe utilizarse en los que tengan problemas de hígado.
English: Tredaptive is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Spanish: Tredaptive se administra normalmente junto con una estatina (el medicamento que se emplea normalmente para reducir el colesterol) cuando la eficacia de dicha estatina en solitario es insuficiente.
English: They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
Spanish: Se contó con un total de 2.349 pacientes que estaban tomando Tredaptive o ácido nicotínico.
English: The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
Spanish: El segundo estudio mostró que las concentraciones de colesterol LDL se reducían aún más cuando se administraba Tredaptive con simvastatina (reducción del 48%), en comparación con Tredaptive solo (reducción del 17%) o con la simvastatina sola (reducción del 37%).
English: What is the risk associated with Tredaptive?
Spanish: ¿Cuál es el riesgo asociado a Tredaptive?
English: Two studies looked at the effectiveness of Tredaptive in modifying blood fat levels.
Spanish: En dos de los estudios se examinó la eficacia de Tredaptive para modificar los valores de las grasas en sangre.
English: Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Spanish: Tredaptive es un medicamento que contiene dos principios activos: ácido nicotínico (también llamado niacina o vitamina B3) y laropiprant.
English: Tredaptive was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Spanish: Tredaptive se investigó en cuatro estudios principales realizados en pacientes con hipercolesterolemia o dislipidemia mixta.
English: The second study compared the combination of Tredaptive and simvastatin (a statin) with Tredaptive alone or simvastatin alone in 1,398 patients.
Spanish: En el segundo estudio se comparó la combinación de Tredaptive y simvastatina (una estatina) con Tredaptive solo o simvastatina sola en 1.398 pacientes.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Spanish: El Comité de Medicamentos de Uso Humano (CHMP) decidió que los beneficios de Tredaptive son mayores que sus riesgos en el tratamiento de la dislipidemia, especialmente de los pacientes con dislipidemia combinada mixta y en los que tienen hipercolesterolemia primaria.
English: Why has Tredaptive been approved?
Spanish: ¿Por qué se ha aprobado Tredaptive?
English: The two active substances in Tredaptive, nicotinic acid and laropiprant, have different modes of action.
Spanish: Los dos principios activos de Tredaptive, el ácido nicotínico y el laropiprant, tienen mecanismos de acción distintos.
English: The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Spanish: En el primero se comparó la eficacia de Tredaptive con la del ácido nicotínico solo o la de un placebo (un tratamiento ficticio) en la reducción de las concentraciones de colesterol LDL en un total de 1.613 pacientes.
English: Tredaptive should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Spanish: Tredaptive no debe administrarse a personas hipersensibles (alérgicas) al ácido nicotínico, al laropiprant o a cualquiera de los demás componentes del medicamento.
English: For the full list of all side effects reported with Tredaptive, see the Package Leaflet.
Spanish: La lista completa de efectos secundarios comunicados sobre Tredaptive puede consultarse en el prospecto.
English: In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
Spanish: En el primer estudio, esas concentraciones se redujeron en un 19% en los pacientes tratados con Tredaptive, frente a un 1% en los que recibieron placebo.
English: When the patient takes the tablet, laropiprant is released first into the bloodstream and blocks the PGD2 receptors.
Spanish: Al ingerirse el comprimido, primero se libera el laropiprant hacia la circulación y bloquea los receptores de la PGD2.
English: In Tredaptive tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Spanish: En los comprimidos de Tredaptive, el laropiprant está contenido en una capa y el ácido nicotínico en otra.
English: What is Tredaptive?
Spanish: ¿Qué es Tredaptive?
English: In the fourth study, flushing was seen on fewer days in patients taking Tredaptive than in those taking nicotinic acid alone.
Spanish: En el cuarto estudio, se observaron sofocos menos días en los pacientes tratados con Tredaptive que en los que recibieron ácido nicotínico solo.
English: Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Spanish: Tredaptive se utiliza añadido a la dieta y el ejercicio en pacientes con dislipidemia (concentración de grasa anormalmente alta en la sangre), especialmente en los pacientes con "dislipidemia combinada mixta" y en los pacientes con "hipercolesterolemia primaria".
English: Tredaptive is used on its own only in patients who cannot take statins.
Spanish: Tredaptive en monoterapia (es decir, sin una estatina) se utiliza únicamente en los pacientes que no pueden tomar estatina.
English: In the first and third studies, fewer patients taking Tredaptive reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Spanish: En los estudios primero y tercero hubo menos pacientes con sofocos moderados, graves o extremos entre los tratados con Tredaptive que entre los que recibieron ácido nicotínico solo.
English: Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Spanish: Tredaptive redujo eficazmente las concentraciones de colesterol LDL en sangre.
English: What is Tredaptive used for?
Spanish: ¿Para qué se utiliza Tredaptive?
English: How is Tredaptive used?
Spanish: ¿Cómo se usa Tredaptive?
English: How has Tredaptive been studied?
Spanish: ¿Qué tipo de estudios se han realizado con Tredaptive?
English: How does Tredaptive work?
Spanish: ¿Cómo actúa Tredaptive?
English: They will decide how much you need.
Spanish: Ellos decidirán que cantidad necesita.
English: - Difficulty sleeping (insomnia).
Spanish: - Dificultad para dormir (insomnio).
English: However, this finding is based on a very small sample (n=129 patients).
Spanish: Sin embargo, este hallazgo se basa en una muestra muy pequeña (n=129 pacientes).
English: Ask your pharmacist how to throw away medicines you no longer use.
Spanish: Pregunte a su farmacéutico cómo deshacerse de los envases que ya no necesita.
English: The most commonly reported adverse reaction in the mother is nausea (14 %).
Spanish: La reacción adversa reportada más frecuente en la madre es la náusea (14%).
English: Atosiban must not be used in the following conditions:
Spanish: No se debe emplear atosiban en las siguientes situaciones:
English: The following information is intended for healthcare professionals only: (See also section 3)
Spanish: Esta información está destinada únicamente a profesionales del sector sanitario: (Ver también sección 3).
English: - If your unborn baby has died.
Spanish: - Si su bebé ha muerto.
English: IV after dilution
Spanish: IV después de la dilución
English: - High blood sugar.
Spanish: - Aumento del azúcar en sangre.
English: - Fast heart beat.
Spanish: - Latido rápido del corazón.
English: Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
Spanish: Atosiban SUN se le administrará en un hospital por un médico, enfermera o comadrona.
English: - If you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions).
Spanish: - Si tiene algo llamado “eclampsia” que es similar a la “preeclampsia grave” pero además tiene convulsiones.
English: The diluted solution must be used within 24 hours.
Spanish: La solución diluida se debe utilizar en 24 horas.
English: - Being sick (vomiting).
Spanish: - Estar enfermo (vómitos).
English: - If your placenta is covering the birth canal.
Spanish: - Si su placenta tapona el canal del parto.
English: - If you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
Spanish: - Si usted o su bebé presentan otras condiciones que pudieran ser peligrosas para continuar con el embarazo.
English: Provides 0.75 mg/ml when diluted as recommended.
Spanish: Proporciona 0,75 mg/ml si se diluye tal como se recomienda.
English: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of atosiban depends on the assessment of fetal maturity.
Spanish: En caso de retraso del crecimiento intrauterino, la decisión de continuar o reiniciar la administración de atosiban dependerá de la evaluación de la madurez fetal.
English: - If your unborn baby (foetus) has an abnormal heart rate.
Spanish: - Si su bebé (feto) tiene un latido del corazón anormal.
English: What Atosiban SUN is and what it is used for
Spanish: Qué es Atosiban SUN y para qué se utiliza
English: This may increase the risk of lung oedema (accumulation of fluid in the lungs).
Spanish: Esto puede incrementar el riesgo de edema en el pulmón (acumulación de líquido en los pulmones).
English: Before using Atosiban SUN, the solution should be examined to ensure it is clear and free from particles.
Spanish: Antes de usar Atosiban SUN, se debe examinar la solución para asegurarse que está clara y libre de partículas.
English: - If your placenta is detaching from the wall of your womb.
Spanish: - Si su placenta se está separando de la pared de su matriz.
English: The safety and efficacy of atosiban in pregnant women aged less than 18 years have not been established.
Spanish: No se ha establecido la seguridad y eficacia de atosiban en mujeres embarazadas con una edad inferior a 18 años.
English: Mean value of volume of distribution was 18.3 ± 6.8 litres.
Spanish: El valor medio del volumen de distribución fue de 18,3 ± 6,8 litros.
English: Metabolite M1 is excreted in milk (see section 4.6).
Spanish: El metabolito M1 se excreta en la leche materna (ver sección 4.6).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Spanish: B. CONDICIONES O RESTRICCIONES DE SUMINISTRO Y USO Medicamento sujeto a prescripción médica restringida (ver Anexo I: Ficha Técnica o Resumen de las Características del Producto, sección 4.2).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Spanish: En ausencia de estudios de compatibilidad, esta especialidad farmacéutica no debe mezclarse con otras excepto las mencionadas en la sección 6.6.
English: - Allergic reactions.
Spanish: - Reacciones alérgicas.
English: Atosiban SUN contains atosiban.
Spanish: Atosiban SUN contiene atosiban.
English: - If you are pregnant with more than one baby.
Spanish: - Si está embarazada de más de un bebé.
English: No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the three-months toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
Spanish: No se observaron efectos sistémicos tóxicos durante los estudios de toxicidad intravenosa de dos semanas de duración (en ratas y perros), con dosis aproximadamente 10 veces más elevadas que la dosis terapéutica humana, ni durante los estudios de toxicidad de tres meses de duración en ratas y perros (hasta 20 mg/kg/día s.c.).
English: If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Spanish: Si es necesaria la administración simultánea de otros fármacos por vía intravenosa, es posible compartir la cánula intravenosa o bien, se puede utilizar otro sitio de administración intravenosa.
English: The frequency of adverse reactions listed below is defined using the following convention: 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).
Spanish: La frecuencia de las reacciones adversas se enumeran a continuación 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).