FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that Elonva's benefits are greater than its risks and it can be authorised for use in the EU..
Spanish: La Agencia Europea de Medicamentos concluyó que los beneficios de Elonva son mayores que sus riesgos y recomendó autorizar su uso en la UE.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elonva have been included in the summary of product characteristics and the package leaflet.
Spanish: Las recomendaciones y precauciones que deben seguir los profesionales sanitarios y los pacientes para un uso seguro y eficaz de Elonva se han incluido en la ficha técnica o resumen de las características del producto y en el prospecto.
English: Elonva (corifollitropin alfa)
Spanish: Elonva (corifolitropina alfa)
English: They will then be fertilised in a laboratory and the resulting embryo is implanted in the womb.
Spanish: A continuación se fecundan en el laboratorio y el embrión resultante se implanta en el útero.
English: Why is Elonva authorised in the EU?
Spanish: ¿Por qué se ha autorizado Elonva en la UE?
English: For more information about using Elonva, see the package leaflet or contact your doctor or pharmacist.
Spanish: Para mayor información sobre el uso de Elonva, consulte el prospecto o póngase en contacto con su médico o farmacéutico.
English: The main measure of effectiveness for these studies was the average number of eggs collected from each woman after treatment.
Spanish: El criterio principal de valoración de la eficacia en ambos estudios fue la media de óvulos recogidos de cada mujer después del tratamiento.
English: What are the risks associated with Elonva?
Spanish: ¿Cuáles son los riesgos asociados a Elonva?
English: As a result, a single dose of the medicine can be given to stimulate egg production for seven days, instead of daily injections that would be required with other FSH medicines.
Spanish: Como resultado, se puede administrar una dosis única del medicamento para estimular la producción de óvulos durante siete días, en lugar de las inyecciones diarias que requerirían otros fármacos basados en la FSH.
English: Elonva can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating fertility problems.
Spanish: Elonva solo se podrá dispensar con receta médica y el tratamiento deberá iniciarse bajo supervisión de un médico con experiencia en el tratamiento de los problemas de fertilidad.
English: It is used together with a gonadotrophin-releasing hormone (GnRH) antagonist (another type of medicine used in fertility treatments).
Spanish: Se utiliza junto con un antagonista de la hormona liberadora de la gonadotropina (GnRH) (otro tipo de medicamento empleado en los tratamientos de fertilidad).
English: Finally, as soon as three eggs are close to maturation, a single injection of a hormone called human chorionic gonadotropin (hCG) is given to release the mature eggs.
Spanish: Por último, en cuanto tres óvulos estén casi maduros, se aplicará una sola inyección de una hormona llamada gonadotropina coriónica humana (hCG) para liberar los óvulos maduros.
English: Side effects reported with Elonva are carefully evaluated and any necessary action taken to protect patients.
Spanish: Los efectos adversos notificados de Elonva se evalúan cuidadosamente y se adoptan las medidas que pudieran resultar necesarias para proteger a los pacientes.
English: Four or five days after the Elonva injection, depending on how the ovaries have responded, treatment is started with a GnRH antagonist, which prevents the ovaries from releasing their eggs too early.
Spanish: Cuatro o cinco días después de la inyección de Elonva, y en función de cómo hayan respondido los ovarios, se inicia el tratamiento con un antagonista de la GnRH, que impide que los ovarios liberen los óvulos prematuramente.
English: What benefits of Elonva have been shown in studies?
Spanish: ¿Qué beneficios ha demostrado tener Elonva en los estudios realizados?
English: Elonva is a hormonal medicine used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.
Spanish: Elonva es un medicamento hormonal indicado en mujeres que están sometidas a tratamientos de fertilidad para estimular el desarrollo de más de un óvulo maduro a la vez en los ovarios.
English: OHSS occurs when the ovaries over-respond to treatment, causing abdominal swelling and pain, nausea and diarrhoea.
Spanish: El SHO se produce cuando los ovarios responden excesivamente al tratamiento, provocando hinchazón y dolor abdominal, náuseas y diarrea.
English: It must also not be used in women with abnormal (not menstrual) bleeding from the vagina without a known cause, fibroids or malformations of the womb that would prevent pregnancy, primary ovarian failure, enlarged ovaries or ovaries with cysts, or in women with risk factors for OHSS such as polycystic ovarian syndrome.
Spanish: Tampoco debe utilizarse en mujeres con hemorragia vaginal (no menstrual) sin causa conocida, fibromas o malformaciones del útero que impidan el embarazo, insuficiencia ovárica primaria, ensanchamiento ovárico u ovarios con quistes, o en mujeres con factores de riesgo para SHO, como el síndrome ovárico policístico.
English: Seven days after the Elonva injection, if further ovarian stimulation is needed, injections of another medicine similar to Elonva, but suitable for daily injection, may be given.
Spanish: Siete días después de la inyección de Elonva, si se necesita una mayor estimulación de los ovarios, podrán administrarse inyecciones de otro medicamento similar a Elonva, pero adecuado para inyección diaria.
English: In three main studies involving 3,292 women who needed to have ovarian stimulation, Elonva treatment has been shown to be as effective as treatment with follitropin beta (an FSH medicine also used to stimulate the ovaries).
Spanish: En tres estudios principales realizados en 3 292 mujeres con necesidad de estimulación ovárica, el tratamiento con Elonva se reveló tan eficaz como el tratamiento con folitropina beta (un medicamento basado en la FSH que también se utiliza para estimular los ovarios).
English: Elonva contains the active substance corifollitropin alfa.
Spanish: Elonva contiene el principio activo corifolitropina alfa.
English: Elonva must not be used in patients with tumours of the ovary, breast, womb, pituitary (a gland located at the base of the brain that produces FSH) or hypothalamus (a region of the brain).
Spanish: Elonva no debe usarse en pacientes con tumores de ovario, mama, útero, hipófisis (una glándula situada en la base del cerebro que produce FSH) o hipotálamo (una región del cerebro).
English: Around 39% of those who received Elonva became pregnant compared with 38% of those treated with follitropin beta.
Spanish: Alrededor del 39% de las mujeres tratadas con Elonva quedaron embarazadas, frente al 38% en el caso de las tratadas con folitropina beta.
English: What is Elonvaand what is it used for?
Spanish: ¿Qué es Elonva y para qué se utiliza?
English: Elonva is available as a solution for injection.
Spanish: Elonva se presenta en forma de solución inyectable.
English: In corifollitropin alfa, a peptide (a short chain of amino acids) is attached to the FSH to prolong its activity in the body.
Spanish: En la corifolitropina alfa se añade un péptido (una cadena corta de aminoácidos) a la FSH para prolongar su actividad en el organismo.
English: The study in women over 60 kg had an additional main effectiveness measure which was the number of women with a successful early pregnancy.
Spanish: El estudio en mujeres que pesaban más de 60 kg tenía un criterio principal adicional de valoración de la eficacia: el número de mujeres que quedaron embarazadas en una fase temprana.
English: An overview of Elonva and why it is authorised in the EU
Spanish: Información general sobre Elonva y sobre los motivos por los que se autoriza su uso en la UE
English: The active substance in Elonva, corifollitropin alfa, is similar to follicle stimulating hormone (FSH), a natural hormone in the body.
Spanish: El principio activo de Elonva, la corifolitropina alfa, es similar a la hormona foliculoestimulante (FSH), una hormona natural presente en el organismo.
English: The most common side effects with Elonva (which may affect up to 1 in 10 people) are headache, nausea (feeling sick), tiredness, pelvic pain and discomfort, breast tenderness and ovarian hyperstimulation syndrome (OHSS).
Spanish: Los efectos adversos más frecuentes de Elonva (observados en uno de cada 10 pacientes) son dolor de cabeza, náuseas (ganas de vomitar), cansancio, dolor y molestias pélvicas, hipersensibilidad de los senos y síndrome de hiperestimulación ovárica (SHO).
English: One of the studies involved women weighing 60 kg or less who received a 100-microgram dose of Elonva, and a second study involved women weighing above 60 kg who received a 150-microgram dose.
Spanish: Uno de los estudios contó con mujeres que pesaban 60 kg o menos y que recibieron una dosis de 100-microgramos de Elonva, mientras que en un segundo estudio participaron mujeres con un peso superior a 60 kg a los que se administró una dosis de 150-microgramos.
English: The third study involved women in the age range 35 to 42 years weighing 50 kg or more who were given a 150-microgram dose of Elonva; the main measure of effectiveness in this study was the number of women with a successful early pregnancy, and 24 and 27% of women treated with Elonva and follitropin beta respectively became pregnant.
Spanish: En el tercer estudio participaron mujeres de entre 35 y 42 años con un peso a partir de 50 kg a las que se administró una dosis de 150 microgramos de Elonva; el principal criterio de valoración de la eficacia en este estudio fue el número de mujeres que habían logrado un embarazo precoz, y el 24 y el 27% de las mujeres tratadas con Elonva y con folitropina beta respectivamente quedaron embarazadas.
English: How is Elonva used?
Spanish: ¿Cómo se usa Elonva?
English: For the full list of side effects of Elonva, see the package leaflet.
Spanish: La lista completa de efectos adversos notificados de Elonva se puede consultar en el prospecto.
English: In the second study in women weighing above 60 kg, the average number of eggs collected from each woman was 13.8 in those treated with Elonva compared with 12.6 in those treated with follitropin beta.
Spanish: En el segundo estudio, en mujeres con un peso de más de 60 kg, la media de óvulos recogidos de cada mujer fue de 13,8 en las tratadas con Elonva y de 12,6 en las tratadas con folitropina beta.
English: In the first study in women weighing 60 kg or less, the number of eggs collected from each woman was 13.3 for those treated with Elonva and 10.6 for those treated with follitropin beta.
Spanish: En el primer estudio, con mujeres que pesaban 60 kg o menos, el número de óvulos recogidos de cada mujer fue de 13,3 en las tratadas con Elonva y de 10,6 en las tratadas con folitropina beta.
English: How does Elonva work?
Spanish: ¿Cómo actúa Elonva?
English: The patient or their partner may carry out the injection if they have been properly instructed.
Spanish: La propia paciente o su pareja podrán administrar la inyección si se les ha enseñado debidamente a hacerlo.
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Spanish: Anexo I Lista de los nombres, formas farmacéuticas, dosis del medicamento, vías de administración, titular(es) de la autorización de comercialización en los estados miembros
English: County Mayo IRELAND
Spanish: County Mayo Irland
English: Sweden Baxter Medical AB Box 63
Spanish: Baxter AB Box 63
English: 11 g/l amino acids and 1,25 mmol/l Ca.
Spanish: 11 g/l Aminoácidos and 1,25 mmol/l Ca.
English: Irland
Spanish: Irlanda
English: Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis
Spanish: Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis
English: Poland Baxter Polska SP. z o.o.
Spanish: Baxter Polska SP. z.o.o.
English: Baxter Healthcare GmbH, Stella-KleinLöw-Weg 15, A-1020 Wien, Austria
Spanish: Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Austria
English: Baxter SPA piazzale dell' industria 2000144-roma Italy
Spanish: Piazzale dell'Industria 20 00144 Roma Italy
English: Pouet de Camilo 2 Ribarroja del Turia (Valencia)
Spanish: Ribarroja del Turia (Valencia)
English: Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark
Spanish: Baxter A/S Gydevang 43 3450 Allerød Denmark
English: IP24 3SE United Kingdom
Spanish: Thetford IP24 3SE United Kingdom
English: 7,5 % 75 g / 1000 ml
Spanish: 7,5 % 75 9 I 1000 ml
English: Netherlands Baxter B.V., Kobaltweg 49, 3542
Spanish: Baxter B.V Kobaltweg 49
English: Romania BAXTER HEALTHCARE S.A.
Spanish: Baxter Healthcare S.A.
English: w/v
Spanish: Extraneal w/v
English: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeist of
Spanish: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis t of
English: Box 270 Valimotie 15A 00381 Helsinki,
Spanish: Baxter Oy P.O. Box 270 Valimotie 15A 00381 Helsinski Finland
English: Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alanine 951 mg/L, arginine 1071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1020 mg/L, lysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1393 mg/L, sodium chloride 5380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)-lactate 4480 mg/L
Spanish: Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alanine 951 mg/L, arginine 1071 mg/L, glicina 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1020 mg/L, Lisina hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1393 mg/L, Cloruro de sodio 5380 mg/L, Cloruro de calcio dihydrate 184 mg/L, Cloruro de magnesio hexahydrate 51 mg/L, S-Lactato de sodio 4480 mg/L
English: Germany Baxter Deutschland GmbH
Spanish: Baxter Deutschland GmbH Edisonstr.
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal
Spanish: Edificio 10 Sintra Business Park,
English: Bd René Branquart 80, B-7860 Lessines Belgium
Spanish: Boulevard R. Branquart 80 7680 Lessines Belgium
English: Norfolk IP24 3SE
Spanish: IP24 3SE
English: 78310 Maurepas France
Spanish: Avenue louis Pasteur 78310 ZA de Coigneres 78310 Maurepas France
English: Ljubljana,
Spanish: Norfolk,
English: Slovenia Baxter d.o.o., Zelezna cesta 18 , Ljubljana, SI-1000, Slovenia
Spanish: Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, Slovenia
English: 4 to 1,1% acides aminés
Spanish: 4 to 1,1% Aminoácidos
English: Sweden Baxter Healthare SA Moneen Road
Spanish: Baxter Healthare SA Moneen Road Castlebar
English: DIOPHAR S.A.
Spanish: Baxter S.A.
English: 11,205 g / l 5.38 g / l 0.184 g / l
Spanish: 11.205 g/l 5.38 g/l 0.184 g/l 0.0508 g/l 4.48 g/l
English: D-85716
Spanish: D-85716 Unterschleißheim Germany
English: Baxter Healthcare Ltd.,
Spanish: Baxter Healthcare Ltd Caxton Way,
English: 1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Spanish: 1,36% w/v 0,538% w/v 0,448% w/v
English: Dianeal PD1 Glucose 1.36% w/v
Spanish: Dianeal PDl Glucose 1.36% w/v
English: 13.60 g/l glucose anhydrate
Spanish: 13.60 g/l Glucosa anhidra
English: Dianeal PD1 Glucose 2.27% w/v
Spanish: Dianeal PDl Glucose 2.27% w/v
English: Lithuania Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland
Spanish: República Checa Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland
English: Belgium Baxter SA Bld R Branquart 80 7860 Lessines Belgium
Spanish: B-7860 Lessines Belgium
English: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Spanish: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: 3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Spanish: 3,86% w/v 0,538% w/v 0,448% w/v
English: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Spanish: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Spanish: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Moneen Road,
Spanish: Zona Industrial da Abrunheira,
English: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Spanish: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Spanish: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,
Spanish: Thetford, Norfolk, IP24 3SE
English: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Spanish: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 3.86% w/v
Spanish: Dianeal PDl Glucose 3.86% w/v
English: Anhydrous glucose 38.6 g/L, sodium chloride 5.67 g/L, sodium lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Spanish: Glucosa anhidra 38.6 g/L, Cloruro de sodio 5.67 g/L, L-Lactato de sodio 3.92 g/L, Cloruro de calcio dihydrate 0,257 g/L, Cloruro de magnesio hexahydrate 0,152 g/L
English: Anhydrous glucose 22.7 g/L, sodium chloride 5.38 g/L, sodium-L(+) lactate 4.48 g/L, calcium chloride dihydrate 0.184 g/L, magnesium chloride hexahydrate 0.051 g/L
Spanish: Glucosa anhidra 22.7 g/L, Cloruro de sodio 5.38 g/L, L-Lactato de sodio 4.48 g/L, Cloruro de calcio dihydrate 0,184 g/L, Cloruro de magnesio hexahydrate 0,051 g/L
English: Anhydrous glucose 13.6 g/L, sodium chloride 5.38 g/L, sodium-L(+) lactate 4.48 g/L, calcium chloride dihydrate 0.184 g/L, magnesium chloride hexahydrate 0.051 g/L
Spanish: Glucosa anhidra 13.6 g/L, Cloruro de sodio 5.38 g/L, L-Lactato de sodio 4.48 g/L, Cloruro de calcio dihydrate 0,184 g/L, Cloruro de magnesio hexahydrate 0,051 g/L
English: Anhydrous glucose 38.6 g/L, sodium chloride 5.38 g/L, sodium-L(+) lactate 4.48 g/L, calcium chloride dihydrate 0.184 g/L, magnesium chloride hexahydrate 0.051 g/L
Spanish: Glucosa anhidra 38.6 g/L, Cloruro de sodio 5.38 g/L, L-Lactato de sodio 4.48 g/L, Cloruro de calcio dihydrate 0,184 g/L, Cloruro de magnesio hexahydrate 0,051 g/L
English: Anhydrous glucose 13.6 g/L, sodium chloride 5.67 g/L, sodium-L(+) lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Spanish: Glucosa anhidra 13.6 g/L, Cloruro de sodio 5.67 g/L, L-Lactato de sodio 3.92 g/L, Cloruro de calcio dihydrate 0,257 g/L, Cloruro de magnesio hexahydrate 0,152 g/L
English: Anhydrous glucose 22.7 g/L, sodium chloride 5.67 g/L, sodium-L(+) lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Spanish: Glucosa anhidra 22.7 g/L, Cloruro de sodio 5.67 g/L, L-Lactato de sodio 3.92 g/L, Cloruro de calcio dihydrate 0,257 g/L, Cloruro de magnesio hexahydrate 0,152 g/L
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Spanish: Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
English: Bulgaria BAXTER d.o.o.,Zelezna cesta 18, 1000
Spanish: BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia
English: Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK
Spanish: Thetford, Norfolk, IP24 3SE, United Kingdom
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Spanish: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
English: 13,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Spanish: Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
English: Dianeal PD4 med glucos 22,7 mg/ml
Spanish: Dianeal PD4 Glucose 22,7 mg/ml
English: Dianeal PD1 Glucose 2.27%w/v 22.7mg/ml
Spanish: Dianeal PD1 Glucose 2.27% (22,7 mg/ml).
English: Dianeal PD4 med glucos 38,6 mg/ml
Spanish: Dianeal PD4 Glucose 38,6 mg/ml
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aptivus on 25 October 2005.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Aptivus el 25 de octubre de 2005.
English: The full EPAR for Aptivus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Spanish: El EPAR completo de Aptivus se puede consultar en el sitio web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Aptivus:
Spanish: Otras informaciones sobre Aptivus:
English: This document is a summary of the European public assessment report (EPAR) for Aptivus.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) de Aptivus.
English: It is available as capsules (250 mg) and as an oral solution.
Spanish: Se presenta en cápsulas (250 mg) y en solución oral.
English: A risk management plan has been developed to ensure that Aptivus is used as safely as possible.
Spanish: Se ha elaborado un plan de gestión de riesgos para garantizar que Aptivus se administra de una forma lo más segura posible.
English: What measures are being taken to ensure the safe and effective use of Aptivus?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Aptivus?
English: In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day.
Spanish: En pacientes a partir de 12 años, la dosis recomendada de Aptivus es de 500 mg (dos cápsulas) dos veces al día.
English: All of the patients started treatment with the oral solution, but adolescents taking the full adult dose could switch to the capsules after four weeks.
Spanish: Todos los pacientes comenzaron el tratamiento con la solución oral, pero los adolescentes que tomaban la dosis completa de adulto pudieron pasar a las cápsulas transcurridas cuatro semanas.
English: Each dose of Aptivus must be taken with ritonavir and food.
Spanish: Todas las dosis de Aptivus deben tomarse junto con ritonavir y con alimentos.
English: The main measures of effectiveness were the number of patients who responded to treatment, and how long it took before treatment stopped working, during the first 48 weeks of treatment.
Spanish: Los principales criterios de valoración de la eficacia fueron el número de pacientes que respondieron al tratamiento, el tiempo transcurrido hasta que este dejó de funcionar, durante las primeras 48 semanas de tratamiento.
English: For more information about treatment with Aptivus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Spanish: Para mayor información sobre el tratamiento con Aptivus, lea el prospecto (también incluido en el EPAR) o consulte a su médico o farmacéutico.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aptivus.
Spanish: En él se explica cómo el Comité de Medicamentos de Uso Humano (CHMP) ha evaluado dicho medicamento y emitido un dictamen favorable a la autorización de comercialización y unas recomendaciones sobre las condiciones de su uso.
English: • medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood.
Spanish: • medicamentos que se metabolicen de la misma forma que Aptivus o el ritonavir y que sean nocivos cuando alcanzan una concentración elevada en la sangre.