FrancophonIA/ELRC3.0 huggingface dataset:
English: - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Mylan') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan')
Spanish: - Está tomando o ha tomado en los últimos 14 días otro medicamento conocido como inhibidor de la monoaminoxidasa (IMAO) (ver "Toma de Duloxetina Mylan con otros medicamentos").
English: Hard gastro-resistant capsule
Spanish: Cápsula dura gastrorresistente
English: Propylene glycol Strong ammonia solution Yellow iron oxide (E172)
Spanish: Solución de amoniaco fuerte Óxido de hierro amarillo (E-172)
English: Stomatitis Haematochezia Breath odour Microscopic colitis
Spanish: Estomatitis Hematoquecia Halitosis Colitis microscópica
English: • muscle pain, muscle spasm
Spanish: • Dolor muscular, espasmos musculares.
English: • chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
Spanish: • Dolor en el pecho, sensación de frío, sed, escalofríos, sensación de calor, alteración en la forma de caminar.
English: Dizziness, sensory disturbances (including paraesthesia or electric shock like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Spanish: Las reacciones más frecuentemente notificadas son mareos, alteraciones sensoriales (incluyendo parestesia o sensación de descarga eléctrica, especialmente en la cabeza), trastornos del sueño (incluyendo insomnio y sueños intensos), fatiga, somnolencia, agitación o ansiedad, náuseas y/o vómitos, temblores, cefalea, mialgia, irritabilidad, diarrea, hiperhidrosis y vértigo.
English: • painful urination, frequent urination
Spanish: • Dolor al orinar, orinar con frecuencia.
English: Very common
Spanish: Muy frecuentes Frecuentes
English: • contraction of the jaw muscle
Spanish: • Contracciones del músculo de la mandíbula.
English: Duloxetine Mylan may be taken with or without food.
Spanish: Toma de Duloxetina Mylan con alimentos, bebidas y alcohol Duloxetina Mylangen se puede tomar con o sin comida.
English: Hypromellose phthalate Diethyl phthalate
Spanish: Ftalato de hipromelosa
English: Polyuria
Spanish: Poliuria
English: • increased yawning
Spanish: • Aumento de bostezos.
English: Propylene glycol Sodium hydroxide Povidone
Spanish: Propilenglicol Hidróxido de sodio Povidona
English: The effect of duloxetine 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17
Spanish: El efecto de duloxetina 60 mg una vez al día en pacientes de edad avanzada (≥65 años) con depresión se examinó específicamente en un estudio, que mostró una diferencia estadísticamente significativa en la reducción de la puntuación en la escala HAMD17 de los pacientes tratados con duloxetina, en comparación con los tratados con placebo.
English: 30 mg capsules Capsule shell Brilliant blue (E133) Titanium dioxide (E171) Gelatin
Spanish: Cubierta de la cápsula Azul brillante (E-133) Dióxido de titanio (E-171) Gelatina
English: The 60 mg capsules have an opaque blue cap and opaque yellow body, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Spanish: Las cápsulas de 60 mg tienen una tapa azul opaca y un cuerpo amarillo opaco, marcados en tinta blanca con "MYLAN" sobre "DL 60" tanto en la tapa como en el cuerpo.
English: Duloxetine Mylan may be associated with sedation and dizziness.
Spanish: Duloxetina Mylan puede producir sedación y mareos.
English: Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Spanish: Tapa azul opaca y cuerpo amarillo de aproximadamente 21,7 mm marcados en tinta blanca con "MYLAN" sobre "DL 60" tanto en la tapa como en el cuerpo.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Spanish: Cubierta de la cápsula Azul brillante (E133) Óxido de hierro amarillo (E-172) Dióxido de titanio (E171) Gelatina
English: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Spanish: En pacientes con insuficiencia renal grave en hemodiálisis (aclaramiento de creatinina <30 ml/min) las concentraciones plasmáticas de duloxetina aumentan.
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of duloxetine 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Spanish: En un ensayo abierto no controlado a largo plazo, la disminución del dolor en pacientes que respondieron a un tratamiento agudo de 8 semanas con 60 mg de duloxetina una vez al día se mantuvo durante otros 6 meses.
English: The 30 mg capsules have an opaque blue cap and opaque white body, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Spanish: Las cápsulas de 30 mg tienen una tapa azul opaca y un cuerpo blanco opaco, marcados en tinta dorada con "MYLAN" sobre "DL 30" tanto en la tapa como en el cuerpo.
English: Opaque blue cap and opaque white body approximately 15.9 mm, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Spanish: Tapa azul opaca y cuerpo blanco opaco de aproximadamente 15,9 mm, marcados en tinta dorada con "MYLAN" sobre "DL 30" tanto en la tapa como en el cuerpo.
English: Hyponatraemia
Spanish: Hiperpotasemia
English: Duloxetine Mylan may make you feel sleepy or dizzy.
Spanish: Durante el tratamiento con Duloxetina Mylan puede que se sienta somnoliento o mareado.
English: Puh/Tel: +358 20 720 9555
Spanish: Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
English: • increased sweating, (itchy) rash
Spanish: • Aumento de sudoración, erupción (picor).
English: There may be loss of feeling in the affected area, or sensations such as touch,
Spanish: Puede haber una pérdida de sensibilidad en el área afectada, o puede ocurrir que al tocar la zona o ponerla en contacto con calor, frío o presión se produzca dolor).
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Spanish: Duloxetina Mylan 30 mg cápsulas duras gastrorresistentes Duloxetina Mylan 60 mg cápsulas duras gastrorresistentes duloxetina (como hidrocloruro)
English: Malaise
Spanish: Ansiedad
English: Hard gastro-resistant capsules
Spanish: Cápsulas duras gastrorresistentes
English: PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules.
Spanish: Blíster perforado unidosis de PVC/PE/PVdC/Aluminio que contiene 7 x 1 y 28 x 1 cápsulas duras gastrorresistentes.
English: • blurred eyesight
Spanish: • Visión borrosa.
English: White ink
Spanish: Tinta blanca comestible
English: What Duloxetine Mylan looks like and contents of the pack Duloxetine Mylan is hard gastro-resistant capsule.
Spanish: Duloxetina Mylan es una cápsula dura gastrorresistente.
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 7 x 1, 28 x 1 and 30 x 1 hard gastro-resistant capsules.
Spanish: Blíster perforado unidosis de PVC/PCTFE/Aluminio u OPA/Aluminio/PVC - Aluminio que contiene 28 x 1, 30 x 1 y 100 x 1 cápsulas duras gastrorresistentes.
English: Dizziness Lethargy Tremor Paraesthesia
Spanish: Mareos Letargo Temblores Parestesia
English: Hepatic failure Jaundice
Spanish: Insuficiencia hepática
English: Gold ink
Spanish: Tinta dorada comestible
English: Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
Spanish: Cada cápsula contiene 30 mg o 60 mg de duloxetina (como hidrocloruro).
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules
Spanish: Duloxetina Mylan 30 mg cápsulas duras gastrorresistentes Duloxetina Mylan 60 mg cápsulas duras gastrorresistentes
English: Vascular disorders
Spanish: Gastritis Disfagia
English: PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Spanish: Blíster de PVC/PE/PVdC/Aluminio que contiene 14, 28, 49 y 98 cápsulas duras gastrorresistentes y multienvases que contienen 98 (2 envases de 49) cápsulas duras gastrorresistentes.
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 14, 28, 84, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Spanish: Blíster de PVC/PCTFE/Aluminio u OPA/Aluminio/PVC - Aluminio que contiene 14, 28, 84 y 98 cápsulas duras gastrorresistentes y multienvases que contienen 98 (2 envases de 49) cápsulas duras gastrorresistentes.
English: EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015 EU/1/15/1010/016 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053
Spanish: EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015 EU/1/15/1010/016 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 7, 14, 28, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Spanish: Blíster de PVC/PCTFE/Aluminio u OPA/Aluminio/PVC - Aluminio que contiene 7, 14, 28 y 98 cápsulas duras gastrorresistentes y multienvases que contienen 98 (2 envases de 49) cápsulas duras gastrorresistentes.
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules duloxetine
Spanish: Duloxetina Mylan 30 mg cápsulas duras gastrorresistentes duloxetina
English: 60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride).
Spanish: 60 mg Cada cápsula contiene 60 mg de duloxetina (como hidrocloruro).
English: EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047
Spanish: EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044
English: BLISTER INNER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
Spanish: ENVASE INTERNO DEL MULTIENVASE DE BLÍSTERES PARA CÁPSULAS DURAS GASTRORRESISTENTES DE 60 MG, SIN BLUE BOX
English: Galactorrhoea Hyperprolactinaemia Postpartum haemorrhage
Spanish: Hiperprolactinemia
English: Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine
Spanish: Duloxetina Mylan 60 mg cápsulas duras gastrorresistentes duloxetina
English: BLISTER INNER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
Spanish: ENVASE INTERNO DEL MULTIENVASE DE BLÍSTERES PARA CÁPSULAS DURAS GASTRORRESISTENTES DE 30 MG, SIN BLUE BOX
English: BLISTER OUTER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Spanish: ENVASE EXTERNO DEL MULTIENVASE DE BLÍSTERES PARA CÁPSULAS DURAS GASTRORRESISTENTES DE 60 MG, CON BLUE BOX
English: Hepatic impairment
Spanish: Escalofríos Malestar
English: BOTTLE LABEL FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Spanish: ETIQUETA PARA FRASCOS DE 60 mg CÁPSULAS DURAS GASTRORRESISTENTES
English: 30 mg capsules Each capsule contains 30 mg of duloxetine (as hydrochloride).
Spanish: 30 mg Cada cápsula contiene 30 mg de duloxetina (como hidrocloruro).
English: BLISTER OUTER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Spanish: ENVASE EXTERNO DEL MULTIENVASE DE BLÍSTERES PARA CÁPSULAS DURAS GASTRORRESISTENTES DE 30 MG, CON BLUE BOX
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 28 x 1, 30 x 1 and 100 x 1 hard gastro resistant capsules PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 28 x 1 hard gastro-resistant capsules.
Spanish: Blíster de PVC/PE/PVdC/Aluminio que contiene 7, 14, 28, 49 y 98 cápsulas duras gastrorresistentes y multienvases que contienen 98 (2 envases de 49) cápsulas duras gastrorresistentes.Blíster perforado unidosis de PVC/PCTFE/Aluminio u OPA/Aluminio/PVC - Aluminio que contiene 7 x 1, 28 x 1 y 30 x 1 cápsulas duras gastrorresistentes.
English: BOTTLE CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Spanish: ESTUCHE DE CARTÓN PARA FRASCOS DE 60 mg CÁPSULAS DURAS GASTRORRESISTENTES
English: BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Spanish: ESTUCHE DE CARTÓN PARA FRASCOS DE 30 mg CÁPSULAS DURAS GASTRORRESISTENTES
English: Anaphylactic reaction
Spanish: Mioclonía Acatisia
English: • dizziness, tingling feelings like pins and needles or electric shock like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Spanish: somnolencia, sensación de inquietud o agitación, sensación de ansiedad, malestar (náuseas o vómitos), temblor, dolores de cabeza, dolor muscular, sensación de irritabilidad, diarrea y sudoración excesiva o vértigo.
English: BOTTLE LABEL FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Spanish: ETIQUETA PARA FRASCOS DE 30 mg CÁPSULAS DURAS GASTRORRESISTENTES
English: EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053 EU/1/15/1010/054
Spanish: Cápsulas 60 mg EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015 EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053 EU/1/15/1010/054
English: Mylan BV Dieselweg 25
Spanish: Dieselweg 25
English: Blood pressure increase Flushing
Spanish: Trastornos vasculares Aumento de la tensión arterial Rubor
English: How to store Duloxetine Mylan
Spanish: Conservación de Duloxetina Mylan
English: Interstitial lung disease
Spanish: Estreñimiento Diarrea
English: Cardiac disorders
Spanish: Trastornos cardíacos Palpitaciones
English: • muscle tightness, muscle twitching
Spanish: • Rigidez muscular, espasmos musculares.
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits
Spanish: somnolencia, torpeza, inquietud, sensación de estar bebido, fiebre, sudoración o rigidez muscular),
English: Palpitations
Spanish: Hepatitis
English: Other medicines and Duloxetine Mylan
Spanish: Composición de Duloxetina Mylan
English: 30 mg capsules EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007 EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047 EU/1/15/1010/048
Spanish: Cápsulas 30 mg EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007 EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028
English: • throat tightness, nose bleeds
Spanish: • Espasmos de la garganta, sangrado de la nariz.
English: Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712
Spanish: Tel: +34 900 102 712
English: BLISTER CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Spanish: ESTUCHE DE CARTÓN PARA BLÍSTERS PARA CÁPSULAS DURAS GASTRORRESISTENTES 30 mg
English: BLISTER CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Spanish: ESTUCHE DE CARTÓN PARA BLÍSTERS PARA CÁPSULAS DURAS GASTRORRESISTENTES 60 mg
English: If you stop taking Duloxetine Mylan
Spanish: Si toma más Duloxetina Mylan del que debe
English: 28 x 1 hard gastro-resistant capsules 30 x 1 hard gastro-resistant capsules 100 x 1 hard gastro-resistant capsules
Spanish: 14 cápsulas duras gastrorresistentes 28 cápsulas duras gastrorresistentes 49 cápsulas duras gastrorresistentes 84 cápsulas duras gastrorresistentes 98 cápsulas duras gastrorresistentes 28x1 cápsulas duras gastrorresistentes 30x1 cápsulas duras gastrorresistentes 100x1 cápsulas duras gastrorresistentes
English: Muscle tightness Muscle twitching
Spanish: Tensión muscular Fasciculaciones musculares
English: Chest pain Feeling abnormal Feeling cold Thirst
Spanish: Dolor torácico Sensación anómala
English: BLISTER FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Spanish: BLÍSTER PARA CÁPSULAS DURAS GASTRORRESISTENTES 60 mg
English: BLISTER FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Spanish: BLÍSTER PARA CÁPSULAS DURAS GASTRORRESISTENTES 30 mg
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicants and marketing authorisation holders in the member states
Spanish: Anexo I Relación de los nombres del medicamento, forma farmacéutica, dosis, vía de administración, solicitantes, titulares de la autorización de comercialización en los estados miembros
English: Belgium Magenta Pharma Consulting
Spanish: Magenta Pharma Consulting
English: Pharmaceuticals Limited
Spanish: Reino Unido Mercury Pharmaceuticals Limited
English: ARROW GENERIQUES 26, avenue Tony Garnier
Spanish: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
English: Astellas Pharma BV, Erasmus Park, Square Marie Curie 50, Building 5, 1st floor
Spanish: Astellas Pharma BV, Erasmus Park, Square Marie Curie 50, Building 5, 1st floor 1070 Brussels Belgium
English: 2-4, rue Lionel Terray 92500 RueilMalmaison
Spanish: NOVARTIS PHARMA SAS 2-4, rue Lionel Terray 92500 Rueil-Malmaison FRANCE
English: LABORATOIRE AGUETTANT 1, rue Alexander Fleming
Spanish: rue Alexander Fleming
English: Addiscombe Road, Croydon, Surrey CR0 0XT, United Kingdom
Spanish: Croydon, Surrey CR0
English: ASTELLAS PHARMA Square Marie Curie
Spanish: ASTELLAS PHARMA Square Marie Curie 50 1 Building 5
English: Solution for infusion Intravenous use
Spanish: Solución para perfusión
English: Intravenous use
Spanish: LABORATOIRE AGUETTANT
English: Astellas Pharma B.V. Sylviusweg 62
Spanish: Sylviusweg 62
English: Belgium
Spanish: FRANCE
English: United Kingdom
Spanish: The Netherlands
English: The European Commission issued a decision on 30 September 2010.
Spanish: La Comisión Europea adoptó una decisión el 30 de septiembre de 2010.
English: What is Daivobet?
Spanish: ¿Qué es Daivobet?
English: Further treatment can be given under medical supervision.
Spanish: El tratamiento puede prolongarse bajo supervisión médica.
English: The company that markets these medicines is Leo Pharmaceutical Products.
Spanish: La empresa que fabrica estos medicamentos es Leo Pharmaceutical Products.
English: Jens Ersbøll (Denmark)
Spanish: Jens Ersbøll (Dinamarca)
English: The recommended treatment period for the ointment is four weeks.
Spanish: El período de tratamiento recomendado para la pomada es de cuatro semanas.
English: No more than 15 g of the gel or ointment should be used in one day.
Spanish: No deben utilizarse más de 15 g del gel o la pomada al día.
English: Daivobet ointment was authorised in some Member States through a mutual recognition procedure and in others through national procedures.
Spanish: Daivobet pomada ha sido autorizado en algunos Estados miembros con arreglo al procedimiento de reconocimiento mutuo y, en otros, con arreglo a procedimientos nacionales.
English: Daivobet gel was authorised via a decentralised procedure.
Spanish: Daivobet gel ha sido autorizado con arreglo a un procedimiento descentralizado.
English: Because of this, there are some differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Spanish: Esa es la razón de que existan algunas diferencias en los resúmenes de las características del producto (RCP), los etiquetados y los prospectos en los países donde se comercializan estos medicamentos.
English: Daivobet should be applied once a day on the affected areas of the skin.
Spanish: Daivobet debe aplicarse una vez al día sobre las zonas de la piel afectadas.
English: The European Medicines Agency has completed a review of Daivobet.
Spanish: La Agencia Europea de Medicamentos ha llevado a cabo una revisión de Daivobet.
English: Daivobet is also available in the EU under the trade name Dovobet.
Spanish: Daivobet se comercializa también en la UE con la denominación comercial Dovobet.
English: It is available as a gel and ointment and is used topically (applied on the skin).
Spanish: Se presenta en forma de gel y pomada para uso tópico (se aplica sobre la piel).
English: The Committee also harmonised a list of contra-indications related to skin conditions, including viral lesions of the skin, fungal or bacterial skin infections, parasitic infections and skin problems caused by tuberculosis or syphilis.
Spanish: El Comité ha armonizado también una lista de contraindicaciones relacionadas con enfermedades cutáneas, entre ellas lesiones víricas de la piel, infecciones fúngicas o bacterianas de la piel, infecciones parasitarias y problemas cutáneos causados por la tuberculosis o la sífilis.
English: On 10 March 2010, Leo Pharmaceutical Products referred Daivobet to the CHMP in order to harmonise the marketing authorisations for the product in the EU.
Spanish: El 10 de marzo de 2010, Leo Pharmaceutical Products remitió el asunto al CHMP con el fin de armonizar las autorizaciones de comercialización para Daivobet en la UE.
English: Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g) EMA/CHMP/466386/2010
Spanish: Preguntas y respuestas sobre Daivobet y denominaciones asociadas (calcipotriol/betametasona gel y pomada, 50 microgramos/0,5 mg por g) EMA/CHMP/466386/2010
English: The Committee also harmonised other sections of the SmPC, including the sections on special warnings, pregnancy and lactation and undesirable effects.
Spanish: Asimismo, el Comité ha armonizado otras secciones del RCP, como las relativas a advertencias especiales, embarazo y lactancias y reacciones adversas.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Daivobet in the European Union (EU).
Spanish: El Comité de Medicamentos de Uso Humano (CHMP) de la Agencia ha llegado a la conclusión de que es necesario armonizar la información sobre prescripción de Daivobet en la Unión Europea (UE).