FrancophonIA/ELRC3.0 huggingface dataset:
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for Aripiprazole Accord is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Spanish: Episodios maníacos en el Trastorno Bipolar I: la dosis de inicio recomendada de Aripiprazol Accord es de 15 mg administrada como una única dosis diaria independientemente de las comidas en monoterapia o terapia combinada (ver sección 5.1).
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Spanish: Tromboembolismo venoso (incluyendo embolismo pulmonar y
English: NAME OF THE MARKETING AUTHORISATION HOLDER Accord
Spanish: NOMBRE DEL TITULAR DE LA AUTORIZACIÓN DE LA COMERCIALIZACIÓN Accord
English: (for 100's count) Do not throw away any medicines via wastewater or household waste.
Spanish: Los medicamentos no se deben tirar por los desagües ni a la basura.
English: • slower heart beat,
Spanish: • latido cardiaco más lento;
English: • high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite, and feeling weak) or family history of diabetes fits (seizures) since your doctor may want to monitor you more closely
Spanish: • niveles altos de azúcar en sangre (caracterizado por síntomas como sed excesiva, aumento de la cantidad de orina, aumento de apetito y sensación de debilidad) o antecedentes familiares de diabetes;
English: In the pooled trials, the incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) in aripiprazole-treated patients was 27/46 (58.7 %) and 258/298 (86.6 %), respectively.
Spanish: En los ensayos conjuntos, la incidencia de niveles séricos bajos de prolactina en mujeres (< 3 ng/ml) y hombres (< 2 ng/ml) en los pacientes tratados con aripiprazol fue 27/46 (58,7 %) y 258/298 (86,6 %), respectivamente.
English: Irritability associated with autistic disorder in paediatric patients (see section 4.2) Aripiprazole was studied in patients aged 6 to 17 years in two 8-week, placebo-controlled trials [one flexible-dose (2-15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week open-label trial.
Spanish: Irritabilidad asociada con el trastorno autista en pacientes pediátricos (ver sección 4.2) Aripiprazol fue estudiado en pacientes de 6 a 17 años en dos ensayos clínicos de 8 semanas de duración, controlados con placebo [uno de dosis flexible (2-15 mg / día) y uno de dosis fija (5, 10 o 15 mg / día)], y en un ensayo clínico abierto de 52 semanas de duración.
English: Manic episodes in Bipolar I Disorder
Spanish: Episodios maníacos en pacientes con Trastorno Bipolar I
English: Aripiprazole Accord 5/10/15/30 mg tablets are available in perforated unit dose blister packs (Aluminium/Aluminium) containing 14 x 1, 28 x 1, 49 x 1, 56 x 1, or 98 x 1 tablet.
Spanish: Aripiprazol Accord se presenta en blísters unidosis perforados (aluminio/aluminio) envasados en cajas que contienen 14 x 1, 28 x 1, 49 x 1, 56 x 1 o 98 x 1 comprimidos.
English: - 30 day (for HDPE 30's count) - 100 day (for HDPE 100's count)
Spanish: Período de validez después de la primera apertura: - 30 días (para frasco de HDPE de 30 comprimidos) - 100 días (para frasco de HDPE de 100 comprimidos)
English: Blood glucose fluctuation Increased creatine phosphokinase
Spanish: Fluctuación de la glucosa en sangre Creatinfosfoquinasa en sangre elevada
English: Schizophrenia: the recommended starting dose for Aripiprazole Accord is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Spanish: Esquizofrenia: la dosis recomendada de inicio de Aripiprazol Accord es de 10 o 15 mg/día con una dosis de mantenimiento de 15 mg/día administrada como una única dosis diaria independientemente de las comidas.
English: Blood glucose increased Glycosylated haemoglobin increased
Spanish: Glucosa elevada en sangre Hemoglobina glicosilada aumentada
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema,
Spanish: Reacción alérgica (p. ej., reacción anafiláctica, angioedema, incluyendo inflamación de la lengua, edema de la lengua, edema del rostro, prurito o urticaria)
English: Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Spanish: Se han notificado casos de síndrome serotoninérgico en pacientes en tratamiento con aripiprazol, especialmente en casos de tratamiento concomitante con otros medicamentos serotoninérgicos como ISRS/IRSN o con medicamentos conocidos por aumentar las concentraciones de aripiprazol (ver sección 4.8).
English: In a clinical trial in healthy subjects, a stronginhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively.
Spanish: En un ensayo clínico en sujetos sanos, un inhibidor potente del CYP3A4 (ketoconazol) aumentó el AUC y la Cmax de aripiprazol en 63 % y 37 %, respectivamente, y aumentó el AUC y la Cmax de dehidro-aripiprazol en 77 % y 43 %, respectivamente.
English: If you forget to take Aripiprazole Accord
Spanish: Si olvidó tomar Aripiprazol Accord
English: How to take Aripiprazole Accord
Spanish: Cómo tomar Aripiprazol Accord
English: When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced to the recommended dose (see section 4.5).
Spanish: Cuando se dejA el tratamiento combinado con inductores del CYP3A4, la dosis de aripiprazol se debe entonces reducir a la dosis recomendada (ver sección 4.5).
English: • fast heart beat,
Spanish: • latido cardiaco acelerado;
English: • life-threatening irregular heart beat,
Spanish: • latido cardiaco irregular potencialmente mortal;
English: Upon discontinuation of strong CYP3A4 inducers, the dosage of aripiprazole should be reduced to the recommended dose.
Spanish: En cuanto se suspendan los inductores potentes de CYP3A4 la dosis de aripiprazol debe ser reducida a la dosis recomendada.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for Aripiprazole Accord is 10 mg/day administered on a once-a-day schedule without regard to meals.
Spanish: Episodios maníacos en el Trastorno Bipolar I en adolescentes de 13 años o más: la dosis recomendada para Aripiprazol Accord es 10 mg/día administrada una vez al día independientemente de las comidas.
English: Aripiprazole Accord 5/10/15 mg tablets are available in HDPE bottle with PPCRC closure containing 30 or 100 tablets.
Spanish: Aripiprazol Accord 5/10/15 mg comprimidos se encuentran disponibles en frascos de HDPE con tapa PPCRC con 30 o 100 comprimidos
English: In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2 % for aripiprazole-treated patients and 15.7 % for placebo-treated patients.
Spanish: En la fase de mantenimiento a largo plazo de 26 semanas de duración de un ensayo controlado con placebo, la incidencia de SEP fue de 18,2 % en pacientes tratados con aripiprazol y de 15,7 % en pacientes tratados con placebo.
English: Schizophrenia in adolescents aged 15 years and older: the recommended dose for Aripiprazole Accord is 10 mg/day administered on a once-a-day schedule without regard to meals.
Spanish: Esquizofrenia en adolescentes de 15 años y más: la dosis recomendada para Aripiprazol Accord es 10 mg/día administrada como una única dosis diaria independientemente de las comidas.
English: Aripiprazole Accord 5/10/15 mg tablets are also available in HDPE bottle with PPCRC closure containing 30 or 100 tablets.
Spanish: Aripiprazol Accord 5/10/15 mg comprimidos también viene en frascos de HDPE con tapa PPCRC que contienen 30 y 100 comprimidos.
English: Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Spanish: Adicción patológica al juego y otros trastornos del control de los impulsos Los pacientes pueden experimentar un aumento de los impulsos, especialmente los de la adicción al juego, e incapacidad de controlarlos mientras están tomando aripiprazol.
English: To allow the start of the treatment at a low dose you can use an alternative formulation (oral solutionliquid) more suitable than Aripiprazole Accord.The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Spanish: Para iniciar el tratamiento con una dosis baja, se puede usar una formulación alternativa (solución oral líquida) más adecuada que Aripiprazol Accord.
English: EU/1/15/1045/011- 30 tablets EU/1/15/1045/012- 100 tablets
Spanish: EU/1/15/1045/011 - 30 comprimidos EU/1/15/1045/012 - 100 comprimidos
English: Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets
Spanish: Aripiprazol Accord 5 mg comprimidos EFG Aripiprazol Accord 10 mg comprimidos EFG Aripiprazol Accord 15 mg comprimidos EFG Aripiprazol Accord 30 mg comprimidos EFG
English: EU/1/15/1045/017- 30 tablets EU/1/15/1045/018- 100 tablets
Spanish: EU/1/15/1045/017 - 30 comprimidos EU/1/15/1045/018 - 100 comprimidos
English: In a long term 26-week placebo-controlled trial, the incidence of EPS was 19 % for aripiprazole-treated patients and 13.1 % for placebo-treated patients.
Spanish: En un ensayo controlado con placebo a largo plazo, de 26 semanas, la incidencia de SEP fue de 19 % para pacientes tratados con aripiprazol y 13,1 % para pacientes tratados con placebo.
English: When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased (see section 4.5).
Spanish: Cuando se deja el tratamiento combinado con inhibidores del CYP3A4 o CYP2D6, se debe aumentarla dosis de aripiprazol (ver sección 4.5).
English: Hydroxypropylcellulose Magnesium stearate Indigo carmine aluminium lake (E132)
Spanish: Lactosa monohidrato Celulosa microcristalina Almidón de maíz Hidroxipropilcelulosa Estearato de magnesio Índigo carmín (E 132)
English: Aripiprazole Accord 5/10/15/30 mg tablets are available in Aluminium/Aluminium perforated unit dose blister in pack-sizes of 14x1, 28x1, 49x1, 56x1 or 98x1 tablet.
Spanish: Aluminio/Aluminio perforados unidosis en cajas de 14x1, 28x1, 49x1, 56x1 o 98x1 comprimidos.
English: Aripiprazole Accord contains lactose
Spanish: Aripiprazol Accord contiene lactosa
English: HDPE bottle pack should be used within 30 days after first opening.
Spanish: El frasco de HDPE se debe usar dentro de los 30 días tras su primera apertura (para el frasco de 30 comprimidos
English: In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 37.0 % and 59.4 %, respectively.
Spanish: En dos ensayos a largo plazo en pacientes adolescentes (13-17 años), los pacientes con esquizofrenia y trastorno bipolar tratados con aripiprazol, la incidencia de niveles bajos de prolactina en suero en mujeres (< 3 ng/ml) y hombres (< 2 ng/ml) fue de 37,0 % y 59,4 %, respectivamente.
English: Hydroxypropylcellulose Magnesium stearate Iron oxide yellow (E172)
Spanish: Lactosa monohidrato Celulosa microcristalina Almidón de maíz Hidroxipropilcelulosa Estearato de magnesio Óxido de hierro amarillo (E 172)
English: In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0 % and 53.3 %, respectively.
Spanish: En la población pediátrica bipolar (10-17 años) con exposición de hasta 30 semanas, la incidencia de niveles séricos de prolactina bajos en mujeres (< 3 ng/ml) y en hombres (< 2 ng/ml) fue 28,0 % y 53,3 %, respectivamente.
English: Aripiprazole Accord 10 mg/ 30 mg tablets
Spanish: Aripiprazol Accord 10 mg / 30 mg comprimidos
English: Hydroxypropylcellulose Magnesium stearate Iron oxide red (E172)
Spanish: Lactosa monohidrato Celulosa microcristalina Almidón de maíz Hidroxipropilcelulosa Estearato de magnesio Óxido de hierro rojo (E 172)
English: In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 25.6 % and 45.0 %, respectively.
Spanish: En la población adolescente con esquizofrenia (13-17 años) con exposición al aripiprazol de 5 a 30 mg hasta por 72 meses, la incidencia de bajos niveles de prolactina en suero en mujeres (< 3 ng/ml) y hombres (< 2 ng/ml) fue de 25,6 % y 45,0 %, respectivamente.
English: In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 29.5 % and 48.3 %, respectively.
Spanish: En la población de adolescentes con esquizofrenia (13-17 años) con exposición de hasta 2 años, la incidencia de niveles séricos de prolactina bajos en mujeres (< 3 ng/ml) y en hombres (< 2 ng/ml) fue 29,5 % y 48,3 %, respectivamente.
English: • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Spanish: somnolencia, torpeza, inquietud, sensación de estar bebido, fiebre, sudoración o rigidez muscular);
English: If you stop taking Aripiprazole Accord
Spanish: Si interrumpe el tratamiento con Aripiprazol Accord
English: Aripiprazole Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Spanish: Aripiprazol Accord 15 mg comprimidos son comprimido redondos no recubiertos de color amarillo de aproximadamente 7,14 mm de diámetro, biconvexos, grabados con “A15” en una cara, y lisos en la otra.
English: Each 5 mg tablet contains 63 mg lactose (as monohydrate).
Spanish: Cada comprimido de 5 mg contiene 63 mg de lactosa (en forma de monohidrato) Aripiprazol Accord 10 mg comprimidos
English: Each 10 mg tablet contains 59 mg lactose (as monohydrate).
Spanish: Cada comprimido de 10 mg contiene 59 mg de lactosa (en forma de monohidrato) Aripiprazol Accord 15 mg comprimidos
English: Each 15 mg tablet contains 88 mg lactose (as monohydrate).
Spanish: Cada comprimido de 15 mg contiene 88 mg de lactosa (en forma de monohidrato) Aripiprazol Accord 30 mg comprimidos
English: INFORMATION IN BRAILLE Aripiprazole Accord 5 mg
Spanish: INFORMACIÓN EN BRAILLE Aripiprazol Accord 5 mg
English: (for 30's count) HDPE bottle pack should be used within 100 days after first opening.
Spanish: El frasco de HDPE se debe usar dentro de los 100 días tras su primera apertura (para los frascos de 100 comprimidos)
English: INFORMATION IN BRAILLE Aripiprazole Accord 30 mg
Spanish: INFORMACIÓN EN BRAILLE Aripiprazol Accord 30 mg
English: Aripiprazole Accord 30 mg tablets
Spanish: Aripiprazol Accord 30 mg comprimidos
English: Do not take Aripiprazole Accord
Spanish: No tome Aripiprazol Accord
English: Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Spanish: Aripiprazol Accord 10 mg comprimidos son comprimidos no recubiertos de color rosado de aproximadamente 8,1 mm de longitud y 4,6 mm de anchura en forma rectangular modificada, biconvexos, grabados con “A10” en una cara, y lisos en la otra.
English: Aripiprazole Accord 5 mg tablets
Spanish: Aripiprazol Accord 5 mg comprimidos
English: Aripiprazole Accord 30 mg tablets: each tablet contains 30 mg of aripiprazole.
Spanish: Aripiprazol Accord 30 mg comprimidos: Cada comprimido contiene 30 mg de aripiprazol.
English: Each 30 mg tablet contains 177 mg lactose (as monohydrate).
Spanish: Cada comprimido de 30 mg contiene 177 mg de lactosa (en forma de monohidrato) Para consultar la lista completa de excipientes, ver sección 6.1.
English: INFORMATION IN BRAILLE Aripiprazole Accord 10 mg
Spanish: INFORMACIÓN EN BRAILLE Aripiprazol Accord 10 mg
English: Aripiprazole Accord 10 mg tablets
Spanish: Aripiprazol Accord 10 mg comprimidos
English: Aripiprazole Accord 15 mg tablets
Spanish: Aripiprazol Accord 15 mg comprimidos
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets
Spanish: EU/1/15/1045/005 - 30 comprimidos EU/1/15/1045/006 - 100 comprimidos
English: Headache Sedation Somnolence Dizziness
Spanish: Acatisia Trastorno extrapiramidal Temblor Cefalea Sedación Somnolencia Mareo
English: Aripiprazole Accord 5 mg tablets: each tablet contains 5 mg of aripiprazole.
Spanish: Aripiprazol Accord 5 mg comprimidos: Cada comprimido contiene 5 mg de aripiprazol.
English: Aripiprazole Accord 10 mg tablets: each tablet contains 10 mg of aripiprazole.
Spanish: Aripiprazol Accord 10 mg comprimidos: Cada comprimido contiene 10 mg de aripiprazol.
English: How to store Aripiprazole Accord
Spanish: Conservación de Aripiprazol Accord
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole.
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 30 mg de aripiprazol.
English: (for 100's count) Open date:
Spanish: Fecha de apertura:
English: Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Spanish: Comprimido no recubierto de color rosado de aproximadamente 8,1 mm de longitud y 4,6 mm de anchura en forma rectangular modificada, biconvexo, grabado con “A10” en una cara, y liso en la otra.
English: Aripiprazole Accord 15 mg tablets: each tablet contains 15 mg of aripiprazole.
Spanish: Aripiprazol Accord 15 mg comprimidos: Cada comprimido contiene 15 mg de aripiprazol.
English: Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Spanish: Comprimido no recubierto de color azul de aproximadamente 8,1 mm de longitud y 4,6 mm de anchura en forma rectangular modificada, biconvexo, grabado con “A5” en una cara, y liso en la otra.
English: Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Spanish: Comprimido redondo no recubierto de color amarillo de aproximadamente 7,14 mm de diámetro, biconvexo, grabado con “A15” en una cara, y liso en la otra.
English: Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain.
Spanish: Comprimido redondo no recubierto de color amarillo de aproximadamente 9,1 mm de diámetro, biconvexo, grabado con “A30” en una cara, y liso en la otra.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 10 mg de aripiprazol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 5 mg de aripiprazol.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Accord 5 mg tablets Each tablet contains 5 mg of aripiprazole.
Spanish: COMPOSICIÓN CUALITATIVA Y CUANTITATIVA Aripiprazol Accord 5 mg comprimidos
English: When weak inhibitors of CYP3A4 (e.g., diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Spanish: Se pueden esperar pequeños aumentos de las concentraciones plasmáticas de aripiprazol cuando se utiliza de forma concomitante con inhibidores débiles del CYP3A4 (p- ej., diltiazem) o del CYP2D6 (p. ej., escitalopram).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole.
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 15 mg de aripiprazol.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole
Spanish: NOMBRE DEL MEDICAMENTO Aripiprazol Accord 30 mg comprimidos EFG aripiprazol
English: A, aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Spanish: En ensayos clínicos de tratamiento con aripiprazol, la incidencia de prolongación del intervalo QT fue comparable a placebo.Aripiprazol debe ser empleado con precaución en pacientes con antecedentes familiares de prolongación del intervalo QT (ver sección 4.8).
English: What Aripiprazole Accord tablets looks like and contents of the pack
Spanish: Conservación de Aripiprazol Accord Contenido del envase e información adicional
English: Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Spanish: Aspecto del producto y contenido del envase Aripiprazol Accord 5 mg comprimidos son comprimidos no recubiertos de color azul de aproximadamente 8,1 mm de longitud y 4,6 mm de anchura en forma rectangular modificada, biconvexos, grabados con “A5” en una cara, y lisos en la otra.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 15 mg tablets aripiprazole
Spanish: NOMBRE DEL MEDICAMENTO Aripiprazol Accord 15 mg comprimidos EFG aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets aripiprazole
Spanish: NOMBRE DEL MEDICAMENTO Aripiprazol Accord 5 mg comprimidos EFG aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole
Spanish: NOMBRE DEL MEDICAMENTO Aripiprazol Accord 10 mg comprimidos EFG aripiprazol
English: Aripiprazole Accord 30 mg tablets are pink colored, approximately 9.1 mm in diameter, round shaped,
Spanish: Aripiprazol Accord 30 mg comprimidos son comprimidos redondos no recubiertos de color amarillo de aproximadamente 9,1 mm de diámetro, biconvexos, grabados con “A30” en una cara, y lisos en la otra.
English: EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
Spanish: EU/1/15/1045/019 14x1 comprimidos EU/1/15/1045/020 28x1 comprimidos EU/1/15/1045/026 49x1 comprimidos EU/1/15/1045/021 56x1 comprimidos EU/1/15/1045/022 98x1 comprimidos
English: In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
Spanish: En dos ensayos en monoterapia de 3 semanas de duración, con titulación de la dosis y controlados con placebo, aripiprazol demostró una eficacia superior con respecto a placebo en la reducción de los síntomas maníacos más allá de las 3 semanas en pacientes que presentaban episodio maníaco o mixto de trastorno bipolar I. Estos ensayos incluyeron pacientes con o sin rasgos psicóticos y con o sin ciclación rápida.
English: EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
Spanish: EU/1/15/1045/013 14x1 comprimidos EU/1/15/1045/014 28x1 comprimidos EU/1/15/1045/025 49x1 comprimidos EU/1/15/1045/015 56x1 comprimidos EU/1/15/1045/016 98x1 comprimidos
English: EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
Spanish: EU/1/15/1045/001 14x1 comprimidos EU/1/15/1045/002 28x1 comprimidos EU/1/15/1045/023 49x1 comprimidos EU/1/15/1045/003 56x1 comprimidos EU/1/15/1045/004 98x1 comprimidos