FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of these studies were used to draw up the recommendations on how the medicine should be used.
Spanish: Los resultados de estos estudios se utilizaron para extraer recomendaciones sobre el modo de utilizar el medicamento.
English: Paxene paclitaxel EPAR summary for the public
Spanish: Paxene paclitaxel Resumen del EPAR para el público general
English: In some cases, these were significantly better than with standard anticancer therapy.
Spanish: En algunos casos, esas tasas fueron significativamente mejores que con el tratamiento anticanceroso habitual.
English: The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long they survived.
Spanish: El principal criterio de eficacia fue el número de pacientes cuyo cáncer respondió al tratamiento, el tiempo que transcurrió sin que la enfermedad empeorara y cuánto tiempo sobrevivieron.
English: Paclitaxel blocks the cell's ability to break down the ‘skeleton' that allows cells to divide and multiply.
Spanish: El paclitaxel bloquea la capacidad de la célula para romper el «esqueleto» que permite la división y multiplicación celulares.
English: Paxene also affects non-cancer cells such as blood cells, which causes side effects.
Spanish: Paxene afecta también a las células no cancerosas, como las células sanguíneas, con los consiguientes efectos secundarios.
English: With the skeleton still in place the cell cannot divide, and eventually die.
Spanish: Mientras este esqueleto permanece en su sitio, la célula no puede dividirse y acaba muriendo.
English: The most common side effects with Paxene (seen in more than 1 patient in 10) are infection, severe neutropenia (very low levels of neutrophils, a type of white blood cell), severe leucopenia (very low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), myelosuppression (a condition when the bone marrow cannot make enough blood cells), minor hypersensitivity reactions (allergic reactions), loss of appetite, neuropathy (nerve damage), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness), hypotension (low blood pressure), nausea (feeling sick), vomiting, diarrhoea, mucosal inflammation (inflammation of the moist body surfaces), constipation, stomatitis (inflammation of the lining of the mouth), abdominal (tummy) pain, alopecia (hair loss), arthralgia (joint pain), myalgia (muscle pain), asthenia (weakness), pain and oedema (swelling).
Spanish: Los efectos secundarios más frecuentes de Paxene (observados en más de uno de cada 10 pacientes) son infección, neutropenia grave (pocos neutrófilos, un tipo de glóbulos blancos), leucopenia grave (pocos glóbulos blancos), trombocitopenia (pocas plaquetas), anemia (pocos glóbulos rojos), mielosupresión (una enfermedad en la que la médula ósea no puede producir suficientes células sanguíneas), reacciones menores de hipersensibilidad (reacciones alérgicas), pérdida del apetito, neuropatía (trastorno nervioso), parestesia (sensaciones anómalas como pinchazos y agujetas), somnolencia, hipotensión (presión arterial baja), náuseas, vómitos, diarrea, inflamación de las mucosas (inflamación de las zonas húmedas del cuerpo), estreñimiento, estomatitis (inflamación de la mucosa de la boca), dolor abdominal, alopecia (caída del cabello), artralgia (dolor en las articulaciones), mialgia (dolor muscular), astenia (debilidad), dolor y edema (hinchazón).
English: Paxene has been studied in 107 patients with Kaposi's sarcoma, 312 patients with metastatic breast cancer, 120 patients with metastatic ovarian cancer, over 900 patients with advanced ovarian cancer and over 1,000 patients with lung cancer.
Spanish: Paxene se ha estudiado en 107 pacientes con sarcoma de Kaposi, 312 pacientes con cáncer de mama metastásico, 120 pacientes con cáncer de ovarios metastásico, más de 900 pacientes con cáncer de ovarios avanzado y más de 1 000 pacientes con cáncer de pulmón.
English: • metastatic breast cancer, when other treatments have failed or cannot be used.
Spanish: • cáncer de mama metastásico cuando otros tratamientos han fracasado o no pueden utilizarse.
English: In the studies, Paxene was used with other anticancer medicines and compared with other treatments.
Spanish: En los estudios, Paxene se utilizó con otros medicamentos anticancerosos y se comparó con otros tratamientos.
English: What benefit has Paxene shown during the studies?
Spanish: ¿Qué beneficio ha demostrado tener Paxene durante los estudios?
English: It must not be used in women who are pregnant or breastfeeding.
Spanish: El medicamento tampoco debe administrarse a mujeres embarazadas o que amamantan.
English: Paxene must not be used in patients with severe liver disease, severe uncontrolled infections or low levels of neutrophils.
Spanish: Paxene no debe administrarse a pacientes con enfermedades graves del hígado, infecciones incontroladas y graves o niveles bajos de neutrófilos.
English: Paxene also increased how long patients survived for some types of cancer.
Spanish: Paxene también aumentó el tiempo que los pacientes sobrevivieron con algunos tipos de cáncer.
English: The full EPAR for Paxene is available here.
Spanish: El texto completo del EPAR de Paxene puede encontrarse aquí.
English: Treatment with Paxene improved the response rates for various types of cancer.
Spanish: El tratamiento con Paxene mejoró las tasas de respuesta para varios tipos de cáncer.
English: As Paxene is very similar to another authorised medicine containing paclitaxel called Taxol, the studies supporting the use of Taxol were used to support the use of Paxene.
Spanish: Paxene es muy parecido a otro medicamento autorizado que contiene paclitaxel llamado Taxol, y los estudios que avalan el uso de este último se emplearon también para avalar el uso de Paxene.
English: Paxene should not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients.
Spanish: Paxene no debe utilizarse en personas hipersensibles (alérgicas) al paclitaxel o a cualquiera de los demás componentes.
English: The dose of Paxene, how often it is given and how long treatment continues depend on the type of cancer being treated and which other anticancer medicines are being given together with Paxene.
Spanish: La dosis de Paxene, la frecuencia con la que se administra y la duración del tratamiento dependen del tipo de cáncer que se vaya a tratar y del resto de medicamentos que se vayan a administrar junto con Paxene.
English: The Committee recommended that Paxene be given marketing authorisation.
Spanish: En consecuencia, el Comité recomendó que se autorizase su comercialización.
English: Treatment with Paxene should be given by an oncologist (cancer specialist) in a specialised cancer ward.
Spanish: El tratamiento con Paxene debe ser administrado por un oncólogo (especialista en cáncer) en una unidad especializada en tratamientos oncológicos.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Paxene's benefits are greater than its risks for treatment of advanced AIDS-related Kaposi's sarcoma, metastatic breast cancer, advanced cancer of the ovary in combination with cisplatin, metastatic cancer of the ovary where platinum-containing combination therapy has failed, and non-small cell lung cancer.
Spanish: El Comité de Medicamentos para Uso Humano (CHMP) decidió que los beneficios de Paxene son mayores que sus riesgos en el tratamiento del sarcoma avanzado de Kaposi vinculado al SIDA, el cáncer metastático de mama, el cáncer avanzado de ovarios en combinación con cisplatino, el cáncer metastático de ovarios en que haya fracasado un tratamiento combinado que contenga platino y el cáncer de pulmón no microcítico.
English: What is the risk associated with Paxene?
Spanish: ¿Cuál es el riesgo asociado a Paxene?
English: Paxene is given as an infusion lasting three hours, or occasionally 24 hours.
Spanish: Paxene se administra en perfusión durante tres horas y, en algunas ocasiones, durante 24 horas mediante una bomba de perfusión cada dos a tres semanas.
English: To prevent severe allergic reactions, all patients must first be treated with corticosteroids to reduce inflammation, antihistamines to reduce swelling and itchiness, and H2 antagonists to reduce stomach acid.
Spanish: Para prevenir reacciones alérgicas, los pacientes deberán ser tratados primero con corticosteroides (para reducir la inflamación), antihistamínicos (para reducir la hinchazón y el picor) y con antagonistas H2 (para reducir el ácido del estómago).
English: The active substance in Paxene, paclitaxel, belongs to the group of anticancer medicines known as the taxanes.
Spanish: El principio activo de Paxene, el paclitaxel, pertenece al grupo de medicamentos contra el cáncer que se denominan taxanos.
English: • non-small cell lung cancer, in combination with cisplatin, when patients cannot have surgery or radiation therapy.
Spanish: • cáncer de pulmón no microcítico, en combinación con cisplatino, en pacientes que no son candidatos a intervención quirúrgica ni a radioterapia.
English: • advanced AIDS-related Kaposi's sarcoma (a skin cancer often found in AIDS patients), when treatment with anthracyclines (another type of anticancer medicine) has failed;
Spanish: • sarcoma avanzado de Kaposi vinculado al SIDA (un cáncer de piel que suele darse en pacientes con SIDA), cuando ha fracasado el tratamiento con antraciclinas (otro tipo de medicamento contra el cáncer);
English: What is Paxene?
Spanish: ¿Qué es Paxene?
English: Why has Paxene been approved?
Spanish: ¿Por qué se ha aprobado Paxene?
English: For the full list of all side effects reported with Paxene, see the Package Leaflet.
Spanish: La lista completa de efectos secundarios comunicados sobre Paxene puede consultarse en el prospecto.
English: Paxene is a concentrate that is made up into a solution for infusion (drip into a vein).
Spanish: Paxene es un concentrado con el que se prepara una solución para perfusión (goteo en vena) que contiene el principio activo paclitaxel.
English: • metastatic cancer of the ovary, when other treatments such as platinum-containing combination therapy have failed;
Spanish: • cáncer metastático de ovarios, cuando han fracasado otros tratamientos (como los tratamientos combinados que contienen platino);
English: • advanced cancer of the ovary (when the cancer has started to spread out of the ovary), in combination with cisplatin (another anticancer medicine);
Spanish: • cáncer avanzado de ovarios (cuando el cáncer ha empezado a extenderse más allá de los ovarios),
English: What is Paxene used for?
Spanish: ¿Para qué se utiliza Paxene?
English: How does Paxene work?
Spanish: ¿Cómo actúa Paxene?
English: Paxene is an anticancer medicine.
Spanish: Paxene es un medicamento contra el cáncer indicado para el tratamiento de las siguientes enfermedades:
English: How is Paxene used?
Spanish: ¿Cómo se usa Paxene?
English: How has Paxene been studied?
Spanish: ¿Qué tipo de estudios se han realizado con Paxene?
English: Cutaneous Solution
Spanish: Solución cutánea
English: Isotretinoin 500µg G Gel
Spanish: Isotretinoína 500 µg G Gel
English: Adapalene 1mgg
Spanish: Adapaleno 1 mgg
English: Pharmaceuticals Ireland
Spanish: Allergan Pharmaceuticals Ireland
English: Teva Magyarország Zrt
Spanish: Teva Magyarország Zrt Isotretinoin Teva
English: Tretinoina Same Savoma Medicinali
Spanish: Savoma Medicinali Spa Tretinoina Same Savoma Medicinali
English: Arrow Generiques Acnetrait
Spanish: Arrow Generiques
English: Roche (Magyarország) Kft Roaccutan
Spanish: Roche (Magyarország) Kft
English: Genus Pharmaceuticals
Spanish: Acitretin Genus Pharmaceuticals
English: Topical Application
Spanish: Aplicación tópica
English: Ratiopharm Arzneimittel Vertriebs-Gmbh
Spanish: Ratiopharm Arzneimittel VertriebsGmbh
English: Laboratorios Galderma SaSucursal Em Portugal
Spanish: Laboratorios Galderma Sa - Sucursal Em Portugal
English: Pharmaceuticals Limited
Spanish: Genus Pharmaceuticals Limited
English: Isotretinoin Generics [uk]
Spanish: Generics [uk] Limited Isotretinoin Generics [uk]
English: Galderma (Uk) Limited
Spanish: Galderma (Uk) Limited Differin
English: Acitretin 10mg
Spanish: Acitretina 10 mg
English: Laboratoires Bailleul Sa
Spanish: Laboratoires Bailleul Sa Erylik
English: Isotretinoin 1mg G Cream
Spanish: Isotretinoína 1 mg G Crema
English: Isotretinoin Ranbaxy (Uk)
Spanish: Ranbaxy (Uk) Limited Isotretinoin Ranbaxy (Uk)
English: Adapalene 1mg G
Spanish: Adapaleno 1 mg G
English: Pharmaceuticals Polska Sp. Z O.O.
Spanish: Teva Pharmaceuticals Polska Sp. Z O.O.
English: Adapalene 0.1%w/W Cream
Spanish: Adapaleno 0,1% w/W Crema
English: Tretinoin 15mg/30 G Cream
Spanish: Tretinoína 15 mg/30 G Crema
English: Adapalene 1mg G, Benzoyl Peroxide 25mg G
Spanish: Adapaleno 1 mg G, peróxido de benzoílo 25 mg G
English: Societe D'etudes Et De Recherches Pharmaceutiques (Serp)
Spanish: Societe D'etudes Et De Recherches
English: Almirall Hermal Gmbh
Spanish: Almirall Hermal Gmbh Aknenormin
English: Dexpanthenol 0.1mg G, Tretinoin 3µg G, Urea 1.2mg G
Spanish: Dexpantenol 0,1 mg G, tretinoína 3 µg G, urea 1,2 mg G
English: Adapalene 0.1%w/W Gel
Spanish: Adapaleno 0,1% w/W Gel
English: Tretinoin 0.3mg G, Urea 120mg G
Spanish: Tretinoína 0,3 mg G, urea 120 mg G
English: Isotretinoin 0.05%w/W Gel
Spanish: Isotretinoína 0,05% w/W Gel
English: Dermapharm Ag Keraderm
Spanish: Dermapharm Ag
English: Glaxosmithkline Aebe
Spanish: Glaxosmithkline Aebe Cehado
English: Galderma International
Spanish: Galderma International Differine
English: Roche Latvija Sia Roaccutane
Spanish: Roche Latvija Sia
English: Isotretinoin 10mgg
Spanish: Isotretinoína 10 mgg
English: Meda Pharma
Spanish: Meda Pharma Sas
English: Pharmaswiss česká Republika S.R.O.
Spanish: Pharmaswiss česká
English: Galderma Laboratorium Gmbh Epiduo
Spanish: Galderma Laboratorium Gmbh
English: Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Spanish: Laboratório MedinfarProdutos Farmacêuticos, S.A.
English: Tretinoin 0.05%w/W Gel
Spanish: Tretinoína 0,05% w/W Gel
English: Tazarotene 0.5mg G Gel
Spanish: Tazaroteno 0,5 mg G Gel
English: Adapalene 0.1% Gel
Spanish: Adapaleno 0,1%
English: Ziaja Ltd Zakład Produkcji Leków Sp Z O.O.
Spanish: Produkcji Leków Sp Z O.O.
English: Tretinoin 4mg G
Spanish: Tretinoína 4 mg G
English: Erythromycin 4g/100 G, Tretinoin 0.025g/100 G Gel
Spanish: Eritromicina 4 g/100 G, tretinoína 0,025 g/100 G
English: Acitretin 25mg Capsule Capsule
Spanish: Acitretina 25 mg cápsula Cápsula
English: Adapalene Teva Adapalene 0.1g G
Spanish: Adapaleno 0,1 g G
English: Glaxosmithkline (Cyprus) Limited Isotrexin
Spanish: Glaxosmithkline (Cyprus) Limited
English: Isotretinoin 20mgg
Spanish: Isotretinoína 20 mgg
English: Sapiens Pharmaceuticals Ltd Rotren
Spanish: Sapiens Pharmaceuticals Ltd
English: Tretinoin 500µg/Ml, DlAlpha Tocopherol Acetate 100µg/Ml
Spanish: Atrederm 0,05% Tretinoína 500 µg/Ml, Diacetato de alfa tocoferol 100 µg/ml
English: Isotretinoin 0.05g/100 G Gel
Spanish: Isotretinoína 0,05 g/100 G Gel
English: Pharmathen Hellas S.A.
Spanish: Pharmathen Hellas S.A. A-Cnotren
English: Tretinoin 250µg/Ml, DlAlpha Tocopherol Acetate 50µg/Ml
Spanish: Atrederm 0.025% Tretinoína 250 µg/Ml, Diacetato de alfa tocoferol 50 µg/ml
English: Tretinoin 0.25mg/Mg Cream
Spanish: Tretinoína 0,25 mg/Mg Crema
English: Isotretinoin 0.5mg G Cream
Spanish: Isotretinoína 0,5 mg G Crema
English: Adapalene 0.1g/100 G Cream
Spanish: Adapaleno 0,1 g/100 G Crema
English: B.V.
Spanish: N.V.
English: Hydrocortisone 10mg G, Tretinoin 1mg G,
Spanish: Hidrocortisona 10 mg G, tretinoína 1 mg G, hidroquinona 50 mg G
English: Isotretinoin Ratiopharm Isotretinoin 20mg
Spanish: Ratiopharm Gmbh Isotretinoin Ratiopharm Isotretinoína 20 mg
English: N.V. Roche S.A.
Spanish: Roche S.A.
English: Tretinoin 1mg G
Spanish: Tretinoína 1 mg G
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Retinoids containing medicinal products
Spanish: Anexo I Lista de medicamentos autorizados a nivel nacional
English: Tretinoin 0.05g/100 Ml
Spanish: Tretinoína 0,05 g/100 Ml
English: Isotretinoin Puren
Spanish: Isotretinoina Stiefel
English: Atrederm 0,05%
Spanish: Tretinoína 0,05%
English: Tazarotene 0.1mg/100 Gel
Spanish: Tazaroteno 0,1 mg/100 Mg Gel
English: Regiomedica Gmbh Regioderm Acitretin 25mg Capsule Capsule, Hard
Spanish: Acitretine Aurobindo Acitretina 25 mg cápsula Cápsula dura
English: Adapalene 0.1g/100 G Gel
Spanish: Adapaleno 0,1 g/100 G Gel
English: Isotretinoin Actavis Isotretinoin 5mg Capsule Capsule, Soft
Spanish: Isotretinoin Actavis Isotretinoína 5 mg cápsula Cápsula blanda
English: Actavis Group Ptc Acnenor
Spanish: Actavis Group Ptc Ehf.
English: Tretinoin 0.5mg/Ml
Spanish: Tretinoína 0,5 mg/Ml
English: Acitretin 10mg Capsule Capsule
Spanish: Acitretina 10 mg cápsula Cápsula
English: Pharmachemie B.V Isotretinoïne Pch
Spanish: Pharmachemie B.V Isotretinoïne Pch Isotretinoína 20 mg cápsula Cápsula
English: Isotretinoin 0.5mgg
Spanish: Isotretinoína 0,5 mgg
English: Isotretinoin 0.5mg
Spanish: Isotretinoína 0,5 mg
English: Tretinoin 0.025g/100 G Cream
Spanish: Tretinoína 0,025 g/100 G Crema
English: Glaxosmithkline (Ireland) Limited Isotrexin
Spanish: Glaxosmithkline (Ireland) Limited
English: Adapalène Zentiva Adapalene 0.1g/100 G Gel
Spanish: Sanofi-Aventis France Adapalène Zentiva Adapaleno 0,1 g/100 G Gel
English: Meda Pharmaceuticals Ltd Atralin
Spanish: Meda Pharmaceuticals Ltd
English: Isosupra Lidose Isotretinoin 8mg Capsule Capsule, Hard
Spanish: Isotretinoína 8 mg cápsula Cápsula dura
English: Isotretinoin Teva
Spanish: Adapalene Teva
English: Tazarotene 1mg G Gel
Spanish: Tazaroteno 1 mg G
English: Erythromycin 20mgg, Isotretinoin 0.5mgg Gel
Spanish: Eritromicina 20 mgg, isotretinoína 0,5 mgg
English: Capsule
Spanish: Cápsula blanda
English: Clindamycin Phosphate 10mg G, Tretinoin 0.25mg G
Spanish: Clindamicina fosfato 10 mg G, Tretinoína 0,25 mg G
English: Regiomedica Gmbh Regioderm Acitretin 10mg Capsule Capsule, Hard
Spanish: Acitretine Aurobindo Acitretina 10 mg cápsula Cápsula dura
English: Tazarotene 0.05g/100 G Gel
Spanish: Tazaroteno 0,05 g/100 G Gel
English: Tretinoin 10mg Capsule Capsule, Soft
Spanish: Tretinoína 10 mg cápsula Cápsula blanda
English: Bulgaria неотигазон
Spanish: неотигазон
English: Carbamid + Vas Creme
Spanish: Ureotop + Vas
English: Isotretinoin 0.5mg G Gel
Spanish: Isotretinoína 0,5 mg G Gel
English: Tazarotene 0.1g/100 G Gel
Spanish: Tazaroteno 0,1 g /100 G Gel
English: Erythromycin 20mg G, Isotretinoin 0.5mg G Gel
Spanish: Eritromicina 20 mg G, isotretinoína 0,5 mg G
English: Tretinoin 0.25mg G Cream
Spanish: Tretinoína 0,25 mg G Crema
English: Clindamycin 10mg G, Tretinoin 0.025mg G Gel
Spanish: Clindamicina 10 mg G, tretinoína 0,025 mg G
English: Isotretinoin 0.05mg G Gel
Spanish: Isotretinoína 0,05 mg G Gel
English: Meda Pharma Sia Treclinac
Spanish: Meda Pharma Sia
English: Isotretinoin Alliance Pharmaceuticals Isotretinoin 5mg Capsule Capsule, Soft
Spanish: Isotretinoïne Mylan Isotretinoína 10 mg cápsula Cápsula blanda
English: Tretinoin 0.5mg G
Spanish: Tretinoína 0,5 mg/Mg
English: Erythromycin 20mg G, Isotretinoin 0.05mg G Gel
Spanish: Eritromicina 20 mg G, isotretinoína 0,05 mg G
English: Isotretinoin Sandoz Isotretinoin 20mg
Spanish: Isotretinoin Sandoz Ltd Isotretinoína 20 mg cápsula Cápsula blanda
English: Tretinoin 0.05g
Spanish: Tretinoína 0,05 g
English: Acitretin Genus Pharmaceuticals Acitretin 25mg Capsule Capsule, Hard
Spanish: Acitretina 25 mg cápsula Cápsula dura
English: Isotretinoin 10mg
Spanish: Isotretinoína 5 mg
English: Clindamycin 10mg G, Tretinoin 0.25mg G Gel
Spanish: Clindamicina 10 mg G, tretinoína 0,25 mg G
English: Isotretinoin Jenson Isotretinoin 5mg Capsule Capsule, Soft
Spanish: Generics [uk] Limited Isotretinoin Jenson Isotretinoína 5 mg cápsula Cápsula blanda
English: Laboratoires Smb S.A.
Spanish: Laboratoires Smb S.A. Isosupra Lidose
English: Tretinoin 0.1g
Spanish: Tretinoína 0,1 g
English: Tretinoin 0.05g/100g Cream
Spanish: Tretinoína 0,05 g/100g Crema
English: Tretinoin 0.03g/100 G, Urea 12g/100 G
Spanish: Louis Widmer Gmbh At Keratosis + Tretinoin Tretinoína 0,03 g/100 G, urea 12 g/100 G
English: Aebe
Spanish: Zanea
English: Meda Pharma Gmbh & Co. Kg акнатак 10 Acnatac 10
Spanish: Meda Pharma Gmbh & Co. Kg акнатак 10 Acnatac 10 Clindamicina fosfato 10 mg G, tretinoína 0,25 mg G
English: Acitretin Genus Pharmaceuticals Acitretin 10mg Capsule Capsule, Hard
Spanish: Acitretina 10 mg cápsula Cápsula dura
English: Tretinoin 0.05g/100 G Cream
Spanish: Tretinoína 0,05 g/100 G Crema
English: Panretin
Spanish: Atralin
English: Stiefel Laboratories Toctino
Spanish: Laboratoires Bailleul Sa Contracne
English: A-Cnotren
Spanish: Neotigason
English: Adapalene Zentiva Adapalene 0.1% Cream
Spanish: Sanofi-Aventis France Adapalene Zentiva Adapaleno 0,1%
English: Arzneimittel Gmbh Tretinoin 10mg Capsule Capsule, Soft
Spanish: Isotretinoïne Sandoz Isotretinoína 10 mg cápsula Cápsula blanda
English: Meda Pharmaceuticals S.A. Acnatac
Spanish: Meda Pharmaceuticals S.A.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Diacomit on 4 January 2007.
Spanish: La Comisión Europea concedió una autorización de comercialización condicional válida en toda la Unión Europea para Diacomit el 4 de enero de 2007.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Spanish: El criterio principal de valoración de la eficacia fue el número de pacientes que «respondieron» al tratamiento.
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Spanish: Después de iniciar el tratamiento con Diacomit, puede ser necesario reducir la dosis de clobazam.
English: GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain.
Spanish: GABA es la principal substancia en las células nerviosas responsable de la reducción de la actividad eléctrica en el cerebro.
English: The dose of valproate does not normally need to be adjusted.
Spanish: Normalmente no hace falta ajustar la dosis de valproato.
English: Other information about Diacomit
Spanish: Otras informaciones sobre Diacomit
English: It is available as capsules and sachets (250 and 500 mg).
Spanish: Se presenta en cápsulas y sobres (de 250 y 500 mg).
English: This type of epilepsy first appears in young children during the first year of life.
Spanish: Este tipo de epilepsia aparece inicialmente en el primer año de vida.
English: More patients responded to treatment with Diacomit than to placebo.
Spanish: Un mayor número de pacientes respondieron al tratamiento con Diacomit que al placebo.
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) de Diacomit.
English: Diacomit has been studied in two main studies involving 65 children between three and 18 years of age.
Spanish: Diacomit se ha estudiado en dos estudios principales con 65 niños de edades comprendidas entre 3 y 18 años.
English: It has been shown in experimental models to increase the levels of a ‘neurotransmitter' called gamma aminobutyric acid (GABA) in the brain.
Spanish: En modelos experimentales se ha demostrado que incrementa los niveles de un «neurotransmisor» llamado ácido gamma-aminobutírico (GABA) en el cerebro.
English: Treatment starts with a dose of 20 mg per kg bodyweight, which is gradually increased to the recommended dose over a number of weeks depending on the patient's age.
Spanish: El tratamiento se inicia con una dosis de 20 mg por kg de peso corporal, que se irá incrementando gradualmente hasta alcanzar la dosis recomendada a lo largo de varias semanas, dependiendo de la edad del paciente.