FrancophonIA/ELRC3.0 huggingface dataset:
English: After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure ( 11.1/ 9.2 mmHg, 11.3/ 9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus 7.4/ 6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg).
Spanish: Tras 8 semanas de tratamiento, cada una de las combinaciones mostró superioridad estadísticamente significativa a la monoterapia con amlodipino en la reducción de la presión arterial sistólica y diastólica (-11,1/-9,2 mmHg, -11,3/-9,3 mmHg con 40 mg/10 mg, 80 mg/10 mg frente a -7,4/-6,5 mmHg con 10 mg de amlodipino) y se alcanzó una normalización de las tasas de presión arterial diastólica más altas que comparado con la monoterapia (63,7 %, 66,5 % con 40 mg/10 mg, 80 mg/10 mg frente al 51,1 % con 10 mg de amlodipino).
English: Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased.
Spanish: Efectos adversos poco frecuentes (pueden afectar hasta 1 de cada 100 personas): Cambios de humor, alteraciones de la visión, pitidos en el oído, falta de aliento, estornudos/rinitis, pérdida de pelo, moratones poco habituales y sangrado (daño en las células rojas de la sangre), decoloración de la piel, aumento de la sudoración, dificultad al orinar, aumento de la necesidad de orinar durante la noche, engrandecimiento de los senos en hombres, dolor, aumento de peso, disminución de peso.
English: After 8 weeks of treatment, each of the combinations was statistically significantly superior to both amlodipine monotherapy doses in reducing systolic and diastolic blood pressures ( 13.6/ 9.4 mmHg, 15.0/ 10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus 6.2/ 5.7 mmHg, 11.1/ 8.0 mmHg with amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 42 %, 56.7 % with amlodipine 5 mg and 10 mg).
Spanish: Tras 8 semanas de tratamiento, cada una de las combinaciones mostró superioridad estadísticamente significativa a ambas dosis de amlodipino en monoterapia en la reducción de la presión arterial sistólica y diastólica (-13,6/-9,4 mmHg, -15,0/-10,6 mmHg con 40 mg/5 mg, 80 mg/5 mg frente a -6,2/-5,7 mmHg, -11,1/-8,0 mmHg con 5 mg y 10 mg de amlodipino) y se alcanzaron unas tasas de control de la presión arterial diastólica más altas comparado con las respectivas monoterapias (56,7 %, 63,8 % con 40 mg/5 mg y 80 mg/5 mg frente al 42 %, 56,7 % con 5 mg y 10 mg de amlodipino).
English: If you stop taking Twynsta
Spanish: Si interrumpe el tratamiento con Twynsta
English: • Medicines used to alter the way your immune system works (e.g. sirolimus, temsirolimus and everolimus).
Spanish: • Medicamentos utilizados para alterar el funcionamiento del sistema inmunitario (p. ej.,
English: Twynsta with food and drink Low blood pressure may be aggravated by alcohol.
Spanish: La disminución en la tensión arterial se puede ver agravada por el alcohol.
English: Twynsta 80 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on on Twynsta 40 mg/10 mg or Twynsta 80 mg/5 mg.
Spanish: Twynsta 80 mg/10 mg está indicado en adultos cuya presión arterial no puede controlarse adecuadamente sólo con Twynsta 40 mg/10 mg o Twynsta 80 mg/5 mg.
English: Very rare leukocytopenia, thrombocytopenia
Spanish: Muy raras leucocitopenia, trombocitopenia
English: Twynsta 40 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 10 mg alone.
Spanish: Twynsta 40 mg/10 mg está indicado en adultos cuya presión arterial no puede controlarse adecuadamente sólo con 10 mg de amlodipino.
English: Colloidal anhydrous silica Brilliant blue FCF (E133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate
Spanish: Óxido de hierro amarillo (E172)
English: In patients with mild to moderate hepatic impairment telmisartan/amlodipine should be administered with caution.
Spanish: Telmisartán/amlodipino debe administrarse con precaución en pacientes con insuficiencia hepática de leve a moderada.
English: INFORMATION IN BRAILLE Twynsta 80 mg/5 mg
Spanish: INFORMACIÓN EN BRAILLE Twynsta 80 mg/5 mg
English: INFORMATION IN BRAILLE Twynsta 40 mg/10 mg
Spanish: INFORMACIÓN EN BRAILLE Twynsta 40 mg/10 mg
English: Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.
Spanish: Efectos adversos raros (pueden afectar hasta 1 de cada 1.000 personas): Infección de la vejiga urinaria, sensación de tristeza (depresión), ansiedad, dificultad para dormirse, aturdimiento, daño de los nervios de las manos o los pies, sensación del tacto disminuida, alteraciones del gusto, temblores, vómitos, encías engrosadas, molestias del abdomen, sequedad de boca, eccema (una alteración de la piel), rojez en la piel, exantema, dolor de espalda, dolor de piernas, aumento de la necesidad de orinar durante la noche, malestar, aumento de los niveles de ácido úrico en sangre.
English: Twynsta 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg.
Spanish: Twynsta 80 mg/5 mg comprimidos puede administrarse a pacientes cuya presión arterial no puede controlarse adecuadamente con Twynsta 40 mg/5 mg.
English: INFORMATION IN BRAILLE Twynsta 40 mg/5 mg
Spanish: INFORMACIÓN EN BRAILLE Twynsta 40 mg/5 mg
English: Twynsta 80 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg .
Spanish: Twynsta 80 mg/5 mg está indicado en adultos cuya presión arterial no puede controlarse adecuadamente sólo con Twynsta 40 mg/5 mg.
English: INFORMATION IN BRAILLE Twynsta 80 mg/10 mg
Spanish: INFORMACIÓN EN BRAILLE Twynsta 80 mg/10 mg
English: Nervous system disorders Common dizziness
Spanish: Trastornos del sistema nervioso Frecuentes mareo
English: Twynsta 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on Twynsta 40 mg/10 mg or Twynsta 80 mg/5 mg.
Spanish: Twynsta 80 mg/10 mg comprimidos puede administrarse a pacientes cuya presión arterial no puede controlarse adecuadamente con Twynsta 40 mg/10 mg o con Twynsta 80 mg/5 mg.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 40 mg/5 mg comprimidos
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 80 mg/5 mg comprimidos
English: Do not take Twynsta
Spanish: No tome Twynsta
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/10 mg tablets
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 40 mg/10 mg comprimidos
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 80 mg/10 mg comprimidos
English: Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone.
Spanish: Twynsta 40 mg/5 mg está indicado en adultos cuya presión arterial no puede controlarse adecuadamente sólo con 5 mg de amlodipino.
English: Twynsta 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Spanish: Twynsta 40 mg/5 mg comprimidos puede administrarse a pacientes cuya presión arterial no puede controlarse adecuadamente con 5 mg de amlodipino solo.
English: : the event may be a chance finding or related to a mechanism currently not known : most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Spanish: : la mayoría de casos de función hepática anormal/trastorno hepático procedentes de la experiencia poscomercialización con telmisartán se dieron en pacientes japoneses.
English: Twynsta 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone.
Spanish: Twynsta 40 mg/10 mg comprimidos puede administrarse a pacientes cuya presión arterial no puede controlarse adecuadamente con 10 mg de amlodipino solo.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets telmisartan/amlodipine
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 80 mg/5 mg comprimidos telmisartán/amlodipino
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Spanish: Cada comprimido contiene 40 mg de telmisartán y 5 mg de amlodipino (como amlodipino besilato).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/10 mg
Spanish: INFORMACIÓN MÍNIMA A INCLUIR EN BLÍSTERS O TIRAS Blíster unidosis de 10 comprimidos - 40 mg/10 mg
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Spanish: Cada comprimido contiene 80 mg de telmisartán y 5 mg de amlodipino (como amlodipino besilato).
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Spanish: Cada comprimido contiene 80 mg de telmisartán y 10 mg de amlodipino (como amlodipino besilato).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/5 mg
Spanish: INFORMACIÓN MÍNIMA A INCLUIR EN BLÍSTERS O TIRAS Blíster unidosis de 10 comprimidos - 40 mg/5 mg
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Spanish: Cada comprimido contiene 40 mg de telmisartán y 10 mg de amlodipino (como amlodipino besilato).
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Spanish: Twynsta 40 mg/5 mg comprimidos son comprimidos ovalados de dos capas, azul y blanca, con el código A1 y el logo de la compañía grabados en la capa blanca.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets telmisartan/amlodipine
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 80 mg/10 mg comprimidos telmisartán/amlodipino
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Spanish: Twynsta 80 mg/5 mg comprimidos son comprimidos ovalados de dos capas, azul y blanca, con el código A3 y el logo de la compañía grabados en la capa blanca.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets telmisartan/amlodipine
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 40 mg/5 mg comprimidos telmisartán/amlodipino
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets)
Spanish: EU/1/10/648/001 (14 comprimidos) EU/1/10/648/002 (28 comprimidos) EU/1/10/648/003 (30 x 1 comprimidos) EU/1/10/648/004 (56 comprimidos) EU/1/10/648/005 (90 x 1 comprimidos) EU/1/10/648/006 (98 comprimidos)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 40 mg de telmisartán y 5 mg de amlodipino (como amlodipino besilato).
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Spanish: EU/1/10/648/001 (14 comprimidos) EU/1/10/648/002 (28 comprimidos) EU/1/10/648/003 (30 x 1 comprimidos) EU/1/10/648/004 (56 comprimidos) EU/1/10/648/005 (90 x 1 comprimidos) EU/1/10/648/006 (98 comprimidos) EU/1/10/648/007 (360 (4 x 90 x 1) comprimidos)
English: • The active substances are telmisartan and amlodipine.
Spanish: Composición de Twynsta - Los principios activos son telmisartán y amlodipino.
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Spanish: Twynsta 80 mg/10 mg comprimidos son comprimidos ovalados de dos capas, azul y blanca, con el código A4 y el logo de la compañía grabados en la capa blanca.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 40 mg de telmisartán y 10 mg de amlodipino (como amlodipino besilato).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Spanish: NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/10/648/007 (360 (4 x 90 x 1) comprimidos)
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg /10 mg tablets telmisartan/amlodipine
Spanish: NOMBRE DEL MEDICAMENTO Twynsta 40 mg/10 mg comprimidos telmisartán/amlodipino
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 80 mg de telmisartán y 5 mg de amlodipino (como amlodipino besilato).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 80 mg de telmisartán y 10 mg de amlodipino (como amlodipino besilato).
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Spanish: Comprimidos ovalados de dos capas, azul y blanca, con el código A1 y el logo de la compañía grabados en la capa blanca.
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Spanish: Twynsta 40 mg/10 mg comprimidos son comprimidos ovalados de dos capas, azul y blanca, con el código A2 y el logo de la compañía grabados en la capa blanca.
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Spanish: Comprimidos ovalados de dos capas, azul y blanca, con el código A3 y el logo de la compañía grabados en la capa blanca.
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets)
Spanish: EU/1/10/648/022 (14 comprimidos) EU/1/10/648/023 (28 comprimidos) EU/1/10/648/024 (30 x 1 comprimidos) EU/1/10/648/025 (56 comprimidos) EU/1/10/648/026 (90 x 1 comprimidos) EU/1/10/648/027 (98 comprimidos)
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Spanish: EU/1/10/648/022 (14 comprimidos) EU/1/10/648/023 (28 comprimidos) EU/1/10/648/024 (30 x 1 comprimidos) EU/1/10/648/025 (56 comprimidos) EU/1/10/648/026 (90 x 1 comprimidos) EU/1/10/648/027 (98 comprimidos) EU/1/10/648/028 (360 (4 x 90 x 1) comprimidos)
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Spanish: Comprimidos ovalados de dos capas, azul y blanca, con el código A4 y el logo de la compañía grabados en la capa blanca.
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets)
Spanish: EU/1/10/648/015 (14 comprimidos) EU/1/10/648/016 (28 comprimidos) EU/1/10/648/017 (30 x 1 comprimidos) EU/1/10/648/018 (56 comprimidos) EU/1/10/648/019 (90 x 1 comprimidos) EU/1/10/648/020 (98 comprimidos)
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Spanish: EU/1/10/648/015 (14 comprimidos) EU/1/10/648/016 (28 comprimidos) EU/1/10/648/017 (30 x 1 comprimidos) EU/1/10/648/018 (56 comprimidos) EU/1/10/648/019 (90 x 1 comprimidos) EU/1/10/648/020 (98 comprimidos) EU/1/10/648/021 (360 (4 x 90 x 1) comprimidos)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Spanish: NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/10/648/014 (360 (4 x 90 x 1) comprimidos)
English: How to store Twynsta
Spanish: Conservación de Twynsta
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Spanish: EU/1/10/648/008 (14 comprimidos) EU/1/10/648/009 (28 comprimidos) EU/1/10/648/010 (30 x 1 comprimidos) EU/1/10/648/011 (56 comprimidos) EU/1/10/648/012 (90 x 1 comprimidos) EU/1/10/648/013 (98 comprimidos) EU/1/10/648/014 (360 (4 x 90 x 1) comprimidos)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Spanish: NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/10/648/021 (360 (4 x 90 x 1) comprimidos)
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets)
Spanish: EU/1/10/648/008 (14 comprimidos) EU/1/10/648/009 (28 comprimidos) EU/1/10/648/010 (30 x 1 comprimidos) EU/1/10/648/011 (56 comprimidos) EU/1/10/648/012 (90 x 1 comprimidos) EU/1/10/648/013 (98 comprimidos)
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Spanish: Comprimidos ovalados de dos capas, azul y blanca, con el código A2 y el logo de la compañía grabados en la capa blanca.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/10 mg
Spanish: INFORMACIÓN QUE DEBE FIGURAR EN EL EMBALAJE EXTERIOR Estuche intermedio del envase múltiple de 360 comprimidos (4 packs de 90 x 1 comprimidos)-sin blue box - 40 mg/10 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Spanish: NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/10/648/028 (360 (4 x 90 x 1) comprimidos)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/5 mg
Spanish: INFORMACIÓN QUE DEBE FIGURAR EN EL EMBALAJE EXTERIOR Estuche intermedio del envase múltiple de 360 comprimidos (4 packs de 90 x 1 comprimidos)-sin blue box - 40 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/10 mg
Spanish: INFORMACIÓN QUE DEBE FIGURAR EN EL EMBALAJE EXTERIOR Etiqueta exterior del envase múltiple de 360 comprimidos (4 packs de 90 x 1 comprimidos) unidos-incluyendo la blue box - 40 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/5 mg
Spanish: INFORMACIÓN QUE DEBE FIGURAR EN EL EMBALAJE EXTERIOR Etiqueta exterior del envase múltiple de 360 comprimidos (4 packs de 90 x 1 comprimidos) unidos-incluyendo la blue box - 40 mg/5 mg
English: The three main studies involved a total of almost 113,000 people.
Spanish: En los tres estudios principales participaron casi un total de 113 000 personas.
English: The company also presented data from the published literature.
Spanish: La empresa presentó asimismo datos de la literatura publicada.
English: This subunit is not toxic by itself.
Spanish: Esta subunidad no es tóxica por sí sola.
English: Once prepared, the suspension should be drunk within two hours.
Spanish: Una vez preparada, la suspensión debe beberse antes de dos horas.
English: Other information about Dukoral:
Spanish: Otras informaciones sobre Dukoral:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral on 28 April 2004.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Dukoral el 28 de abril de 2004.
English: The course should be completed at least one week before potential exposure to cholera.
Spanish: El ciclo ha de completarse como mínimo una semana antes de la exposición potencial al cólera.
English: Because Dukoral has been in use in Sweden since 1991, the company presented the results of three main studies that had already been carried out in order to support the use of Dukoral.
Spanish: Dado que Dukoral se utiliza en Suecia desde 1991, la empresa presentó los resultados de tres estudios principales que ya se habían realizado para respaldar el uso de Dukoral.
English: The full EPAR for Dukoral can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Spanish: El EPAR completo de Dukoral puede consultarse en el sitio web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adults, two vaccine doses were shown to be as effective as three.
Spanish: Se demostró que, en el caso de los adultos, dos dosis de la vacuna eran tan eficaces como tres.
English: This document is a summary of the European public assessment report (EPAR) for Dukoral.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) de Dukoral.
English: Dukoral is a vaccine.
Spanish: Dukoral es una vacuna.
English: The Committee decided that Dukoral's benefits are greater than its risks and recommended that it be given marketing authorisation.
Spanish: El Comité decidió que los beneficios de Dukoral son mayores que sus riesgos y recomendó autorizar su comercialización.
English: Dukoral cholera vaccine (inactivated, oral)
Spanish: Vacuna contra el cólera (inactivada, oral)
English: The people in the final study also received a booster dose 10 to 12 months later.
Spanish: Las personas que participaron en el estudio final recibieron además una dosis de refuerzo de 10 a 12 meses más tarde.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to protect itself against a disease.
Spanish: Las vacunas actúan «enseñando» al sistema inmunitario (las defensas naturales del organismo) a protegerse de una enfermedad.
English: For more information about treatment with Dukoral, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Spanish: Para mayor información sobre el tratamiento con Dukoral, lea el prospecto (también incluido en el EPAR) o consulte a su médico o farmacéutico.
English: The studies took place in areas where cholera is found.
Spanish: Los estudios se realizaron en regiones en las que hay cólera.
English: Food, drink and other medicines taken by mouth should be avoided for one hour before and one hour after each dose of Dukoral.
Spanish: Debe evitarse la ingesta de alimentos, bebidas y otros medicamentos tomados por vía oral una hora antes y una hora después de la administración de cada dosis de Dukoral.
English: A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found.
Spanish: Se llevó a cabo otro estudio para demostrar que Dukoral podía producir anticuerpos en las personas que no proceden de regiones en las que hay cólera.