FrancophonIA/ELRC3.0 huggingface dataset:
English: The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
Spanish: Se ha demostrado in vitro que la formación de O-desmetil gefitinib es vía CYP2D6.
English: Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1)
Spanish: Conjuntivitis, blefaritis y sequedad ocular*, principalmente leve (CTC grado 1)
English: Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp).
Spanish: Principios activos que pueden incrementar las concentraciones plasmáticas de gefitinib Estudios in vitro han mostrado que gefitinib es un sustrato de la glipoproteína p (Pgp).
English: Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA
Spanish: • Aumento del enzima hepático alanina aminotransferasa en los análisis de sangre; si este incremento es demasiado elevado, su médico puede recomendarle que deje de tomar IRESSA.
English: Non-Asians
Spanish: No Asiáticos
English: Circulating Tumour DNA (ctDNA)
Spanish: ADN Tumoral Circulante (ADNtc)
English: At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5).
Spanish: Al inicio del tratamiento con un inhibidor del CYP3A4, los pacientes deben ser cuidadosamente monitorizados para detectar reacciones adversas a gefitinib (ver sección 4.5).
English: Primary endpoint overall survival abc
Spanish: Variable principal supervivencia global abc
English: In individual patients with CYP2D6 poor metaboliser genotype, treatment with a potent CYP3A4 inhibitor might lead to increased plasma levels of gefitinib.
Spanish: En pacientes con un genotipo metabolizador lento del CYP2D6, el tratamiento con un inhibidor potente del CYP3A4 podría elevar las concentraciones plasmáticas de gefitinib.
English: HR 0.68 [0.58 to 0.81] 6.6 m vs 5.8 m p<0.0001
Spanish: HR 0,68 [0,58 a 0,81] 6,6 m vs 5,8 m p<0,0001
English: If concomitant treatment with a potent CYP2D6 inhibitor is initiated, the patient should be closely monitored for adverse reactions.
Spanish: Si se inicia tratamiento concomitante con un inhibidor potente del CYP2D6, el paciente debe ser cuidadosamente monitorizado para detectar posibles reacciones adversas.
English: Asians
Spanish: Asiáticos
English: One ILD-type event was fatal, and this occurred in a patient receiving gefitinib.
Spanish: Una reacción del tipo de la EPI fue mortal, y le ocurrió a un paciente que recibía gefitinib.
English: Warnings and precautions Talk to your doctor or pharmacist before taking IRESSA if you have ever had any other lung problems.
Spanish: Consulte a su médico o farmacéutico antes de empezar a tomar IRESSA si tiene o ha tenido cualquier otro problema de pulmón.
English: Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Spanish: Los medicamentos que causan elevación prolongada significativa en el pH gástrico, como los inhibidores de la bomba de protones y antagonistas-H2 pueden reducir la biodisponibilidad y las concentraciones plasmáticas de gefitinib, y por lo tanto su eficacia.
English: if you are breast-feeding.
Spanish: si está en periodo de lactancia.
English: Anorexia mild or moderate (CTC grade 1 or 2)
Spanish: Anorexia leve o moderada (CTC grado 1 ó 2)
English: Primary endpoint Progression free survival (PFS)
Spanish: Variable principal Supervivencia libre de progresión (SLP)
English: Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4).
Spanish: La enfermedad pulmonar intersticial (EPI) ha ocurrido en el 1,3% de los pacientes, con frecuencia grave (CTC grado 3-4).
English: Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Spanish: En el 1,3% de pacientes que reciben gefitinib, se ha observado EPI, que puede ser de aparición aguda, y que en algunos casos ha sido mortal (ver sección 4.8).
English: 9.8 v. 13.1 Female
Spanish: 9,8 v. 13,1 Mujer 4,4 v. 4,6 Varón
English: Numbers in square brackets are 95% confidence intervals for HR N Number of patients randomised.
Spanish: Los números entre corchetes son intervalos de confianza al 95% para HR.
English: Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4).
Spanish: En voluntarios sanos, el tratamiento previo con rifampicina (un potente inductor del CYP3A4) redujo el AUC medio de gefitinib en un 83% (ver sección 4.4).
English: Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Spanish: Principios activos cuyas concentraciones plasmáticas pueden ser alteradas por gefitinib Estudios in vitro han mostrado que gefitinib presenta un potencial limitado para inhibir el CYP2D6.
English: Values presented are for IRESSA versus carboplatin/paclitaxel.
Spanish: Los valores presentados son para IRESSA frente a carboplatino/paclitaxel.
English: Pack size of 30 film-coated tablets.
Spanish: Tamaño de envase de 30 comprimidos recubiertos con película.
English: A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Spanish: En la rata se observó una reducción en la fertilidad en hembras para una dosis de 20 mg/kg/día.
English: Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Spanish: Enfermedad pulmonar intersticial (1,3%), a menudo torácicos y mediastínicos grave (CTC grado 3-4).
English: Hepatotoxicity and liver impairment
Spanish: Hepatotoxicidad e insuficiencia hepática
English: Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Spanish: Las sustancias que causan elevación prolongada significativa en el pH gástrico pueden reducir las concentraciones plasmáticas de gefitinib y por lo tanto reducir su eficacia.
English: CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
Spanish: Los inductores del CYP3A4 pueden aumentar el metabolismo de gefitinib y disminuir sus concentraciones plasmáticas.
English: If it is less than 12 hours until your next dose: skip the missed tablet.
Spanish: • Si quedan menos de 12 horas hasta su próxima dosis: no tome el comprimido olvidado.
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided.
Spanish: Debe evitarse la administración concomitante de medicamentos que induzcan el CYP3A4 (por ejemplo fenitoína, carbamazepina, rifampicina, barbitúricos o la Hierba de San Juan/ Hypericum perforatum).
English: 30 film-coated tablets.
Spanish: 30 comprimidos recubiertos con película.
English: EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Spanish: En un análisis multivariable de 786 pacientes caucásicos se ha observado que las características clínicas de no fumador, histología de adenocarcinoma, y sexo femenino son predictores independientes del estado de mutación positiva del EGFR* (ver Tabla 7).
English: IRESSA 250 mg tablets gefitinib
Spanish: IRESSA 250 mg comprimidos gefitinib
English: No specific dose adjustment is recommended in patients with known CYP2D6 poor metaboliser genotype, but these patients should be closely monitored for adverse events (see section 5.2).
Spanish: En pacientes que se conoce presentan genotipo metabolizador lento del CYP2D6 no está recomendado un ajuste de dosis específico, pero estos pacientes deben ser cuidadosamente monitorizados para detectar posibles reacciones adversas (ver sección 5.2).
English: Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Spanish: En voluntarios sanos, el tratamiento previo con itraconazol (un inhibidor potente del CYP3A4) dio lugar a un aumento de un 80% en el AUC medio de gefitinib.
English: Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Spanish: Tabla 5 Resultados de eficacia para gefitinib versus docetaxel en el ensayo INTEREST Población
English: Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Spanish: En voluntarios sanos, la administración concomitante de gefitinib y ranitidina a una dosis que producía elevaciones prolongadas en el pH gástrico ≥ 5 dio lugar a una reducción del AUC medio de gefitinib de un 47% (ver secciones 4.4 y 5.2).
English: Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Spanish: Principios activos que pueden disminuir las concentraciones plasmáticas de gefitinib Los principios activos que inducen la actividad del CYP3A4 pueden aumentar el metabolismo y disminuir las concentraciones plasmáticas de gefitinib y por lo tanto reducir la eficacia de éste.
English: Very common: side effects (may affect more than 1 in 10 people) Diarrhoea
Spanish: Muy frecuentes: pueden afectar a más de 1 de cada 10 personas
English: IRESSA contains sodium
Spanish: IRESSA contiene sodio
English: Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration
Spanish: Necrosis hepatocelular e infiltración de macrófagos sinusoidales eosinofílicos
English: 40/235 (17%) of females are M+ 35/551 (6%) of males are M+
Spanish: 40/235 (17%) de las mujeres son M+ 35/551 (6%) de los varones son M+ *de los siguientes estudios: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
English: Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Spanish: Tabla 4 Resultados de calidad de vida para gefitinib versus carboplatino/paclitaxel en el ensayo IPASS
English: Bleeding (such as nose bleed or blood in your urine) Protein in your urine (shown in a urine test)
Spanish: • Hemorragia (como sangrado por la nariz o sangre en su orina)
English: Dry, red or itchy eyes
Spanish: • Sequedad, enrojecimiento o picor de ojos
English: FACT-LFunctional assessment of cancer therapy-lung LCS Lung cancer subscale
Spanish: LCS Subescala de cáncer de pulmón (“Lung cancer subscale”).
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Spanish: Tabla 6 Resultados de eficacia para gefitinib versus placebo en el ensayo ISEL Población
English: Numbers in square brackets are 95% confidence intervals for HR c Stratified log-rank test for overall; otherwise cox proportional hazards model d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth
Spanish: d La raza asiática excluye pacientes de origen indio y se refiere al origen racial de un grupo de pacientes y no necesariamente a su lugar de nacimiento.
English: Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Spanish: Tabla 3 Resultados de eficacia para gefitinib versus carboplatino/paclitaxel en el ensayo IPASS Población
English: In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Spanish: En aquellos casos en que se esté administrando el tratamiento de forma concomitante con inhibidores potentes del CYP3A4, el paciente debe ser cuidadosamente monitorizado para detectar posibles reacciones adversas a gefitinib.
English: EGFR Mutation+
Spanish: Mutación + EGFR
English: Elevations in aspartate aminotransferase, mainly mild to moderate
Spanish: Elevaciones de la aspartato aminotransferasa, principalmente leves a moderadas Elevaciones de la bilirrubina total, principalmente leves a moderadas
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Spanish: En algunos pacientes que toman warfarina junto con gefitinib se han notificado elevaciones en el Índice Internacional Normalizado (INR) y/o acontecimientos hemorrágicos (ver sección 4.5).
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate)
Spanish: • Aumento de bilirrubina y de otro enzima hepático conocido como aspartato aminotransferasa en los análisis de sangre; si este incremento es demasiado elevado, su médico puede recomendarle que deje de tomar IRESSA
English: INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Spanish: En algunos pacientes que toman concomitantemente warfarina se han notificado elevaciones del INR y/o acontecimientos hemorrágicos (ver sección 4.4).
English: Numbers in square brackets are 96% confidence interval for overall survival
Spanish: Los números entre corchetes son intervalos de confianza al 95% para la
English: Dry mouth*, predominantly mild (CTC grade 1)
Spanish: Sequedad de boca*, predominantemente leve (CTC grado 1)
English: Contains lactose and sodium, see package leaflet for further information.
Spanish: Contiene lactosa y sodio.
English: The proportion of ILD-type events with a fatal outcome was
Spanish: La proporción de reacciones adversas tipo EPI con resultado mortal fue de un 38,6%.
English: Stomatitis, predominantly mild in nature (CTC grade 1)
Spanish: Estomatitis, predominantemente de naturaleza leve (CTC grado 1)
English: Factors that predicted for presence of EGFR mutation p-value
Spanish: Valor de p Cocientes de mutación del EGFR
English: Measure
Spanish: Medida
English: 42.9 v. 20.0 EGFR Mutation+
Spanish: 6,2 v. 7,3 Global 42,9 v. 20,0 Mutación + EGFR 5,5 v. 9,1 Mutación - EGFR 23,7 v. 13,3 No fumador 3,9 v. 6,5 Fumador
English: Uncommon: side effects (may affect up to 1 in 100 people) Inflammation of the pancreas.
Spanish: Poco frecuentes: pueden afectar hasta 1 de cada 100 personas
English: How to store IRESSA
Spanish: Conservación de IRESSA
English: EGFR mutation-positive
Spanish: Mutación positiva EGFR
English: This may give the appearance of bruising or patches of non-blanching rash on the skin.
Spanish: Esto puede tener la apariencia de hematoma o zonas de erupción cutánea que no desaparecen tras presionarlas.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ALUMINIUM FOIL LAMINATE FLOW WRAP
Spanish: BLÍSTER/ ENVOLTORIO TUBULAR DE LÁMINA DE ALUMINIO
English: IRESSA 250 mg film-coated tablets
Spanish: IRESSA 250 mg comprimidos recubiertos con película
English: Primary endpoint overall survival ab
Spanish: Variable principal supervivencia global ab
English: Asthenia, predominantly mild (CTC grade 1)
Spanish: Náuseas, principalmente leves (CTC grado 1)
English: IRESSA 250 mg film-coated tablets gefitinib
Spanish: IRESSA 250 mg comprimidos recubiertos con película gefitinib
English: Red or sore mouth
Spanish: • Enrojecimiento o dolor de boca
English: EGFR mutation-negative
Spanish: Mutación negativa EGFR
English: Common: side effects (may affect up to 1 in 10 people) Dry mouth
Spanish: Frecuentes: pueden afectar hasta 1 de cada 10 personas
English: Weakness
Spanish: • Debilidad
English: Respiratory, thoracic and mediastinal disorders
Spanish: Trastornos respiratorios, Frecuentes
English: The increase might be higher in individual patients with CYP2D6 poor metaboliser genotype.
Spanish: En pacientes con un genotipo metabolizador lento del CYP2D6 el aumento podría ser más alto.
English: EGFR Mutation
Spanish: Mutación - EGFR
English: Pancreatitis Gastrointestinal perforation
Spanish: • Perforación gastrointestinal.
English: Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1)
Spanish: Diarrea, principalmente leve o moderada (CTC grado 1 ó 2)
English: Odds of EGFR mutation
Spanish: Mutación desconocida del EGFR
English: Rare: side effects (may affect up to 1 in 1000 people) Inflammation of the blood vessels in the skin.
Spanish: Raros: pueden afectar hasta 1 de cada 1000 personas
English: Overall survival a,b
Spanish: Supervivencia global ab
English: Vomiting
Spanish: Proteinuria
English: What IRESSA contains The active substance is gefitinib.
Spanish: • El principio activo es gefitinib.
English: 4m p=0.1087
Spanish: 18,8 m vs 17,4 m p=0,1087
English: Bottle (glass)
Spanish: Frasco (vidrio)
English: 1 bottle +1 adaptor + 3 oral syringes
Spanish: 1 frasco adaptador para el frasco + 3 jeringas para uso oral
English: Strength Pharmaceutical form Route of administration
Spanish: Dosis Forma farmacéutica
English: EU/1/04/303/005 Orfadin 4 mg/ml
Spanish: 4 mg/ml
English: Immediate Packaging Content
Spanish: Tamaño del envase
English: MA (EU) number Invented name
Spanish: Denominación (de fantasía)
English: London, 23 July 2009 Doc.
Spanish: Londres, 23 de julio de 2009 Doc.
English: Ref. EMEA/448660/2009 EMEA/H/C/1041
Spanish: Ref. EMA/123949/2010 EMEA/H/C/1041
English: But, the company withdrew its application before responding to the questions.
Spanish: Sin embargo, la empresa retiró la solicitud antes de responder a las preguntas.
English: The company had to submit their responses to the Committee for Advanced Therapies (CAT) in line with new European Union regulations on advanced therapies.
Spanish: La empresa tenía que presentar sus respuestas al Comité de Terapias Avanzadas (CAT), de acuerdo con la nueva normativa de la Unión Europea en materia de terapias avanzadas.
English: Also, the company had not supplied enough evidence to demonstrate that the product was safe, that it could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Spanish: Además, la empresa no había aportado pruebas suficientes que demostraran que el producto era seguro, que podía fabricarse de forma fiable o que no sería perjudicial para el medio ambiente ni para las personas en contacto directo con el paciente.
English: In 2008, the CHMP had formulated a list of questions to be answered by the company.
Spanish: En 2008, el CHMP había presentado a la empresa una lista de preguntas.
English: It was to be used when the cancer was refractory (does not respond to treatment) or recurrent (keeps coming back).
Spanish: Estaba previsto utilizarlo cuando el cáncer fuera resistente (no respondiera al tratamiento) o recidivante (reapareciera).
English: Finally, the CHMP noted that there was insufficient information on the product's toxicity, its distribution in the body and the role of some genes and impurities found in the product.
Spanish: Por último, el CHMP señaló que no había información suficiente sobre la toxicidad del producto, su distribución en el organismo y la importancia de algunos genes e impurezas presentes en el producto.
English: This is a type of medicine that works by delivering genes into the body.
Spanish: Se trata de un tipo de medicamento que actúa administrando genes en el organismo.
English: The application was at day 120 of the procedure when the company withdrew.
Spanish: La solicitud se encontraba en el día 120 cuando fue retirada.
English: The new genes then make the body produce or stop the production of a protein which may help treat a disease.
Spanish: Los nuevos genes hacen después que el organismo produzca o deje de producir una proteína que puede ayudar a tratar una enfermedad.
English: Questions and answers on the withdrawal of the marketing authorisation application for Contusugene Ladenovec Gendux contusugene ladenovec
Spanish: Preguntas y respuestas sobre la retirada de la solicitud de autorización de comercialización de Contusugene Ladenovec Gendux contusugene ladenovec
English: Contusugene Ladenovec Gendux was expected to be used to treat squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Spanish: Contusugene Ladenovec Gendux iba a utilizarse para tratar el carcinoma epidermoide de cabeza y cuello (un tipo de cáncer que comienza en las células que revisten la boca, la nariz, la garganta o el oído).
English: The p53 protein normally contributes to the repair of damaged DNA, causes cell death when the DNA cannot be repaired and helps control the formation of blood vessels.
Spanish: La proteína p53 contribuye normalmente a la reparación del ADN dañado, causa la muerte celular cuando el ADN no puede repararse y ayuda a controlar la formación de vasos sanguíneos.
English: The p53 protein also reduces the formation of blood vessels supplying the cancer cells.
Spanish: La proteína p53 también reduce la formación de vasos sanguíneos que nutren a las células cancerosas.
English: The Committee was of the opinion that the company had not shown that Contusugene Ladenovec Gendux was beneficial to patients.
Spanish: En opinión del Comité, la empresa no había demostrado que Contusugene Ladenovec Gendux fuera beneficioso para los pacientes.
English: In one main study involving 123 patients with refractory or recurrent squamous cell carcinoma of the head and neck, Contusugene Ladenovec Gendux was compared with methotrexate (another anti-cancer medicine).
Spanish: En un estudio principal realizado en 123 pacientes con carcinoma epidermoide de cabeza y cuello recidivante o resistente, Contusugene Ladenovec Gendux se comparó con metotrexato (otro medicamento anticanceroso).
English: On 12 June 2009, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Contusugene Ladenovec Gendux for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Spanish: El 12 de junio de 2009, Gendux Molecular Limited notificó oficialmente al Comité de Medicamentos de Uso Humano (CHMP) que deseaba retirar su solicitud de autorización de comercialización de Contusugene Ladenovec Gendux, para el tratamiento del carcinoma epidermoide de cabeza y cuello recidivante o resistente.
English: Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
Spanish: Puesto que las células cancerosas contienen ADN dañado, la proteína p53 ayudará a reparar el ADN o bien causará la muerte celular.
English: The virus in Contusugene Ladenovec Gendux is an ‘adenovirus' that has been modified so that it does not cause disease in humans.
Spanish: El virus contenido en Contusugene Ladenovec Gendux es un «adenovirus» que se ha modificado para que no cause enfermedad en los seres humanos.
English: The effects of Contusugene Ladenovec Gendux were first tested in experimental models before being studied in humans.
Spanish: Los efectos de Contusugene Ladenovec Gendux se probaron en modelos de laboratorio antes de estudiarse en seres humanos.
English: Contusugene Ladenovec Gendux was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Spanish: Contusugene Ladenovec Gendux se desarrolló como un medicamento de terapia avanzada denominado «producto de genoterapia».
English: By increasing the production of the p53 protein, Contusugene Ladenovec Gendux was expected to cure or slow down the growth of the cancer.
Spanish: Al aumentar la producción de proteína p53, se esperaba que Contusugene Ladenovec Gendux curara el cáncer o retardara su crecimiento.