FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Acesulfame potassium Mango flavour Magnesium stearate
Spanish: Lactosa monohidrato Celulosa microcristalina Crospovidona Hidroxipropil celulosa Sílice coloidal anhidro Croscarmelosa sódica Acesulfamo potásico Sabor mango Estearato de magnesio
English: • low levels of white blood cells,
Spanish: • niveles bajos de glóbulos blancos,
English: Aripiprazole Zentiva tablets contain lactose.
Spanish: Aripiprazol Zentiva comprimidos contiene lactosa.
English: In a clinical trial in healthy subjects, a strong inhibitor 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: Temperature regulation disorder (e.g. hypothermia, pyrexia)
Spanish: Trastorno de la regulación de la temperatura (p. ej., hipotermia, pirexia) Dolor torácico Edema periférico
English: Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13 - 17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).
Spanish: En un ensayo controlado con placebo a corto plazo en 302 adolescentes (13 - 17 años) con esquizofrenia, la frecuencia y el tipo de reacciones adversas fueron similares a los de los adultos, excepto las siguientes reacciones que se manifestaron con más frecuencia en adolescentes que en los adultos que recibieron aripiprazol (y con más frecuencia que con placebo): somnolencia/sedación y trastorno extrapiramidal fueron notificados como muy frecuentes (≥ 1/10), y sequedad de boca,
English: Pack size: 14, 28 or 49 orodispersible tablets Not all pack sizes may be marketed.
Spanish: Envases de 14, 28 o 49 comprimidos bucodispersables Puede que solamente estén comercializados algunos tamaños de envases.
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: Aripiprazole Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not intended for breaking the tablet.
Spanish: Aripiprazol Zentiva 10 mg, 30 mg comprimidos bucodispersables: La ranura no debe utilizarse para fraccionar el comprimido.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.
Spanish: Los demás componentes son lactosa monohidrato, celulosa microcristalina, crospovidona, hidroxipropil celulosa, silice coloidal anhidro, croscarmelosa sódica, estearato de magnesio.
English: • too much sugar in the blood,
Spanish: • niveles excesivamente altos de azúcar en sangre,
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: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Spanish: Con otros inhibidores potentes del CYP3A4, como itraconazol y los inhibidores de la proteasa VIH, se pueden esperar efectos similares y se deben administrar, por lo tanto, reducciones similares de dosis (ver sección 4.2).
English: • past experience with excessive gambling.
Spanish: • antecedentes de adicción al juego.
English: In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Spanish: En ensayos controlados con placebo, la incidencia de acatisia en pacientes con trastorno bipolar fue de 12,1 % en los tratados con aripiprazol y de 3,2 % en aquellos que recibieron placebo.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium, mango flavour, magnesium stearate.
Spanish: Los demás componentes son lactosa monohidrato, celulosa microcristalina, crospovidona, hidroxipropil celulosa, silice coloidal anhidro, croscarmelosa sódica, acesulfamo potásico, sabor mango, estearato de magnesio.
English: In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium.
Spanish: En otro ensayo, también de 12 semanas de duración, la incidencia de SEP fue de 26,6 % en pacientes tratados con aripiprazol y de 17,6 % para aquellos tratados con litio.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100,
Spanish: Episodios maníacos en el Trastorno Bipolar I en adolescentes de 13 años o más La frecuencia y el tipo de reacciones adversas en adolescentes con Trastorno Bipolar I fueron similares a los de los adultos excepto por las siguientes reacciones: muy frecuentes (≥ 1/10) somnolencia (23,0 %), trastorno extrapiramidal (18,4 %), acatisia (16,0 %), y fatiga (11,8 %); y frecuentes (≥ 1/100, < 1/10) dolor abdominal superior, aumento de la frecuencia cardíaca, aumento de peso, aumento del apetito, fasciculaciones musculares y disquinesia.
English: Zentiva Portugal, Lda Tel: +351210601360 PV-Portugal@zentiva.com
Spanish: Zentiva Portugal, Lda Tel: +351210601360
English: Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Spanish: Aumento de la gamma glutamil transferasa (GGT)
English: In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated patients.
Spanish: En otro ensayo controlado a largo plazo de 26 semanas, la incidencia de SEP fue de 14,8 % para pacientes tratados con aripiprazol y 15,1 % para pacientes tratados con olanzapina.
English: • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
Spanish: • síndrome serotoninérgico (una reacción que puede causar sensación de intensa felicidad, somnolencia, torpeza, inquietud, sensación de estar bebido, fiebre, sudoración o rigidez muscular),
English: Aripiprazole Zentiva orodispersible tablets contain lactose.
Spanish: Aripiprazol Zentiva comprimidos bucodispersables contiene lactosa.
English: • chest pain,
Spanish: • dolor de pecho,
English: 102 37 Prague 10
Spanish: U Kabelovny 130 102 37 Prague 10 Czech Republic
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: Zentiva France Tél: +33 (0) 800 089 219 PV-France@zentiva.com
Spanish: Tél: +33 (0) 800 089 219 PV-France@zentiva.com
English: • not enough sodium in the blood,
Spanish: • niveles insuficientes de sodio en sangre,
English: • nervousness,
Spanish: • nerviosismo,
English: Neuroleptic Malignant Syndrome (NMS) Grand mal convulsion Serotonin syndrome Speech disorder
Spanish: Síndrome neuroléptico maligno (SNM) Convulsión del gran mal
English: Aripiprazole Zentiva contains sodium
Spanish: Aripiprazol Zentiva contiene sodio
English: Excipient with known effect: each orodispersible tablet contains 55.5 mg of lactose (as monohydrate) and 1.97 mg of sodium.
Spanish: Excipiente con efecto conocido: cada comprimido bucodispersable contiene 55,5 mg de lactosa (como monohidrato) y 1,97 mg de sodio.
English: Each orodispersible tablet contains 10 mg/15 mg/30 mg of aripiprazole.
Spanish: Cada comprimido bucodispersable contiene 10 mg/15mg/30 mg de aripiprazol.
English: • decreased number of or difficulty making bowel movements,
Spanish: • dificultad para evacuar o disminución de la frecuencia de las deposiciones (estreñimiento),
English: • Pain killers (such as tramadol and pethidine) used for pain relief
Spanish: • analgésicos (como tramadol y petidina) utilizados para aliviar el dolor;
English: LIST OF EXCIPIENTS Contains lactose and sodium.
Spanish: Contiene lactosa monohidrato y sodio.
English: Aripiprazole Zentiva with food, drink and alcohol This medicine can be taken regardless of meals.
Spanish: Toma de Aripiprazol Zentiva con alimentos, bebidas y alcohol
English: Excipient with known effect: each orodispersible tablet contains 111 mg of lactose (as monohydrate) and 3.93 mg of sodium.
Spanish: Excipiente con efecto conocido: cada comprimido bucodispersable contiene 111 mg de lactosa (como monohidrato) y 3,93 mg de sodio.
English: Luxembourg/Luxemburg Zentiva, k.s.
Spanish: Luxembourg/Luxemburg
English: Excipient with known effect: each tablet contains 198 mg of lactose (as monohydrate) and 5.62 mg of sodium.
Spanish: Excipiente con efecto conocido: cada comprimido contiene 198 mg de lactosa (como monohidrato) y 5,62 mg de sodio.
English: Excipient with known effect: each tablet contains 33 mg of lactose (as monohydrate) and 0.94 mg of sodium.
Spanish: Excipiente con efecto conocido: cada comprimido contiene 33 mg de lactosa (como monohidrato) y 0,94 mg de sodio.
English: • tiredness,
Spanish: • temblor,
English: • stomach discomfort,
Spanish: • malestar de estómago,
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: Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Magnesium stearate
Spanish: Lactosa monohidrato Celulosa microcristalina Crospovidona Hidroxipropil celulosa
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 72 meses, la incidencia de niveles bajos de prolactina en suero en mujeres (< 3 ng/ml) y hombres (< 2 ng/ml) fue de 25,6 % y 45,0 %, respectivamente.
English: • Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
Spanish: • antidepresivos o medicamentos a base de plantas utilizados para el tratamiento de la depresión y la ansiedad (como fluoxetina, paroxetina, venlafaxina, hierba de San Juan);
English: Excipient with known effect: each tablet contains 99 mg of lactose (as monohydrate) and 2.81 mg of sodium.
Spanish: Excipiente con efecto conocido: cada comprimido contiene 99 mg de lactosa (como monohidrato) y 2,81 mg de sodio.
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
English: Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium.
Spanish: Excipiente con efecto conocido: cada comprimido contiene 66 mg de lactosa (como monohidrato) y 1,87 mg de sodio.
English: Aripiprazole Zentiva 30 mg tablets are white to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Spanish: Los comprimidos de Aripiprazol Zentiva 30 mg son no recubiertos con forma de cápsula blancos o casi blancos grabados con “30” en una cara y una ranura en la otra con dimensiones aproximadas de 15,5 x 8 mm.
English: Diabetes mellitus Hyperglycaemia
Spanish: Hiperglucemia
English: Excipient with known effect: each orodispersible tablet contains 37 mg of lactose (as monohydrate) and 1.31 mg of sodium.
Spanish: Excipiente con efecto conocido: cada comprimido bucodispersable contiene 37 mg de lactosa (como monohidrato) y 1,31 mg de sodio.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo
Spanish: NOMBRE DEL TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN
English: Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets
Spanish: Aripiprazol Zentiva 5 mg comprimidos EFG Aripiprazol Zentiva 10 mg comprimidos EFG Aripiprazol Zentiva 15 mg comprimidos EFG Aripiprazol Zentiva 30 mg comprimidos EFG
English: Aripiprazole Zentiva 10 mg tablets
Spanish: Aripiprazol Zentiva 10 mg comprimidos
English: Aripiprazole Zentiva 30 mg tablets
Spanish: Aripiprazol Zentiva 30 mg comprimidos
English: Aripiprazole Zentiva 5 mg tablets
Spanish: Aripiprazol Zentiva 5 mg comprimidos
English: Aripiprazole Zentiva 30 mg tablets EU/1/15/1009/016
Spanish: Aripiprazol Zentiva 30 mg comprimidos EU/1/15/1009/016
English: Rhabdomyolysis Myalgia Stiffness
Spanish: Laringoespasmo Espasmo orofaríngeo
English: Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Spanish: Los comprimidos bucodispersables de Aripiprazol Zentiva 30 mg son redondos blancos o casi blancos grabados con “30” en una cara y una ranura en la otra con un diámetro aproximado de 10,2 mm.
English: • fainting,
Spanish: • sarpullido,
English: Aripiprazole Zentiva 10 mg orodispersible tablets White to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Spanish: Aripiprazol Zentiva 10 mg comprimidos bucodispersables Comprimidos redondos blancos o casi blancos grabados con “10” en una cara y una ranura en la otra con un diámetro aproximado de 7 mm.
English: What Aripiprazole Zentiva contains
Spanish: Aripiprazol Zentiva contiene lactosa
English: Aripiprazole Zentiva 15 mg tablets
Spanish: Aripiprazol Zentiva 15 mg comprimidos
English: • feeling aggressive,
Spanish: • agresividad,
English: Agitation
Spanish: Convulsiones
English: strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) a tendency to wander away.
Spanish: − atracón (ingesta de grandes cantidades de comida en un corto periodo de tiempo) o ingesta compulsiva (ingesta de más comida de lo normal y más de la necesaria para satisfacer el hambre);
English: White to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Spanish: Comprimidos redondos blancos o casi blancos grabados con “10” en una cara y una ranura en la otra con un diámetro aproximado de 8 mm.
English: Chest pain
Spanish: Rabdomiolisis Mialgia
English: • light-headedness,
Spanish: • fallo hepático,
English: Aripiprazole Zentiva 5 mg tablets EU/1/15/1009/001
Spanish: Aripiprazol Zentiva 5 mg comprimidos EU/1/15/1009/001
English: White to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Spanish: Comprimidos no recubiertos, con forma de cápsula, blancos o casi blancos, grabados con “30” en una cara y una ranura en la otra con dimensiones aproximadas de 15,5 x 8 mm.
English: • difficulty in passing urine,
Spanish: • dificultad para tragar,
English: CLINICAL PARTICULARS
Spanish: Trastornos psiquiátricos
English: Aripiprazole Zentiva 30 mg orodispersible tablets
Spanish: Aripiprazol Zentiva 30 mg comprimidos bucodispersables
English: Aripiprazole Zentiva 15 mg tablets EU/1/15/1009/011
Spanish: Aripiprazol Zentiva 15 mg comprimidos EU/1/15/1009/011
English: How to store Aripiprazole Zentiva
Spanish: Conservación de Aripiprazol Zentiva
English: Aripiprazole Zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Spanish: Los comprimidos de Aripiprazol Zentiva 15 mg son redondos no recubiertos de bordes biselados lisos, blancos o casi blancos grabados con “15” en una cara y planos en la otra cara, con un diámetro aproximado de 8,8 mm.
English: Akathisia Extrapyramidal disorder Tremor
Spanish: Acatisia Trastorno extrapiramidal Temblor Cefalea Sedación Somnolencia Mareo
English: If you stop taking Aripiprazole Zentiva
Spanish: Si interrumpe el tratamiento con Aripiprazol Zentiva
English: Aripiprazole Zentiva 30 mg orodispersible tablets EU/1/15/1009/027
Spanish: Aripiprazol Zentiva 30 mg comprimidos bucodispersables EU/1/15/1009/027
English: Aripiprazole Zentiva 10 mg tablets EU/1/15/1009/006
Spanish: Aripiprazol Zentiva 10 mg comprimidos EU/1/15/1009/006
English: Aripiprazole Zentiva 10 mg orodispersible tablets EU/1/15/1009/021
Spanish: Aripiprazol Zentiva 10 mg comprimidos bucodispersables EU/1/15/1009/021
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Spanish: Los comprimidos de Aripiprazol Zentiva 5 mg son redondos, no recubiertos, de bordes biselados lisos blancos o casi blancos grabados con “5” en una cara y planos en la otra con un diámetro aproximado de 6 mm.
English: 49 orodispersible tablets
Spanish: 14 comprimidos bucodispersables 28 comprimidos bucodispersables 49 comprimidos bucodispersables
English: Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets debossed ‘15' on one side and plain on the other side with diameter approx. 8 mm.
Spanish: Aripiprazol Zentiva 15 mg comprimidos bucodispersables Comprimidos redondos, de bordes biselados lisos, blancos o casi blancos grabados con “15” en una cara y planos en la otra cara con un diámetro aproximado de 8 mm.
English: • feeling anxious,
Spanish: • ansiedad,
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: Orodispersible tablet
Spanish: Comprimido bucodispersable.
English: Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole
Spanish: Aripiprazol Zentiva 10 mg comprimidos bucodispersables EFG Aripiprazol Zentiva 15 mg comprimidos bucodispersables EFG Aripiprazol Zentiva 30 mg comprimidos bucodispersables EFG
English: Aripiprazole Zentiva 15 mg orodispersible tablets EU/1/15/1009/024
Spanish: Aripiprazol Zentiva 15 mg comprimidos bucodispersables EU/1/15/1009/024
English: Slovenská republika Zentiva, a.s.
Spanish: Zentiva, a.s.
English: Aripiprazole Zentiva 10 mg tablets are white to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Spanish: Los comprimidos de Aripiprazol Zentiva 10 mg son redondos, no recubiertos, blancos o casi blancos grabados con “10” en una cara y con una ranura en la otra con un diámetro aproximado de 8 mm.
English: Aripiprazole Zentiva 15 mg orodispersible tablets
Spanish: Aripiprazol Zentiva 15 mg comprimidos bucodispersables
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 10 mg orodispersible tablets are white to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Spanish: Los comprimidos bucodispersables de Aripiprazol Zentiva 10 mg son redondos blancos o casi blancos grabados con “10” en una cara y una ranura en la otra con un diámetro aproximado de 7 mm.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 10 mg tablets aripiprazole
Spanish: Aripiprazol Zentiva 10 mg comprimidos bucodispersables
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets
Spanish: Aripiprazol Zentiva 10 mg comprimidos bucodispersables Cada comprimido bucodispersable contiene 10 mg de aripiprazol.
English: BATCH NUMBER
Spanish: Zentiva logo
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
English: White to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Spanish: Comprimidos no recubiertos, de bordes biselados lisos, redondos, blancos o casi blancos, grabados con “5” en una cara y planos en la otra con un diámetro aproximado de 6 mm.
English: White to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Spanish: Comprimidos no recubiertos, de bordes biselados lisos, redondos, blancos o casi blancos grabados con “15” en una cara y planos en la otra con un diámetro aproximado de 8,8 mm.
English: • difficulty swallowing,
Spanish: • dificultad para orinar,
English: • trembling,
Spanish: • calvicie,
English: Unopened vial: 4 years
Spanish: Vial sin abrir: 4 años
English: Errors in how you take this medicine may have serious health consequences.
Spanish: Los errores del modo de tomar este medicamento pueden tener graves consecuencias para la salud.
English: It is incompatible with dextrose solutions.
Spanish: Es incompatible con soluciones de dextrosa.
English: Date of first authorisation: 26 January 1999 Date of latest renewal: 26 January 2009
Spanish: Fecha de la primera autorización: 26/enero/1999 Fecha de la última renovación: 26/enero/2009