FrancophonIA/ELRC3.0 huggingface dataset:
English: 25% of the insulin lispro in Liprolog Mix25 KwikPen is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Spanish: En Liprolog Mix25 KwikPen se ha disuelto un 25% de insulina lispro en agua y funciona de un modo más rápido que la insulina humana normal porque la molécula de insulina se ha cambiado ligeramente.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, intermediate or long acting combined with fast acting.
Spanish: Grupo farmacoterapéutico: Fármacos usados en diabetes, insulinas y análogos; combinaciones de insulinas de acción intermedia o prolongada con insulinas de acción inmediata para inyección, código ATC: A10AD04.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Liprolog 100 units/ml KwikPen solution for injection Insulin lispro
Spanish: NOMBRE DEL MEDICAMENTO Y VÍA DE ADMINISTRACIÓN Liprolog KwikPen 100 unidades/ml solución inyectable Insulina lispro
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Spanish: El titular de la autorización de comercialización es Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Países Bajos.
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/017
Spanish: NÚMERO DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/017
English: 25% of the insulin lispro in Liprolog Mix25 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Spanish: En Liprolog Mix25 se ha disuelto un 25% de insulina lispro en agua y funciona de un modo más rápido que la insulina humana normal porque la molécula de insulina se ha cambiado ligeramente.
English: Common Uncommon Rare Very rare
Spanish: Muy raras
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/021
Spanish: NÚMERO DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/021
English: If you stop using Liprolog Mix25.
Spanish: Si interrumpe el tratamiento con Liprolog Mix25
English: The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and secured with aluminium seals.
Spanish: La suspensión se presenta en cartuchos de vidrio flint tipo I, sellados con un precinto de sellado de butilo o halobutilo y con un émbolo, que se aseguran con sellos de aluminio.
English: • If your dose is more than 30 units, you will need to give yourself more than one injection.
Spanish: • Si su dosis en mayor de 30 unidades, necesitará administrarse más de una inyección.
English: Before the first use store your Liprolog Mix25 in a refrigerator (2°C - 8°C).
Spanish: Antes de la primera utilización, guarde Liprolog Mix25 en nevera (entre 2ºC y 8ºC).
English: 50% of the insulin lispro in Liprolog Mix50 KwikPen is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Spanish: En Liprolog Mix50 KwikPen se ha disuelto un 50% de insulina lispro en agua y funciona de un modo más rápido que la insulina humana normal porque la molécula de insulina se ha cambiado ligeramente.
English: 50% of the insulin lispro in Liprolog Mix50 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Spanish: En Liprolog Mix50 se ha disuelto un 50% de insulina lispro en agua y funciona de un modo más rápido que la insulina humana normal porque la molécula de insulina se ha cambiado ligeramente.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Liprolog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen insulin lispro Each KwikPen delivers 1 - 60 units in steps of 1 units.
Spanish: Prospecto: información para el usuario Liprolog Mix50 KwikPen 100 unidades/ml suspensión inyectable en pluma precargada insulina lispro Cada KwikPen administra de 1 a 60 unidades en incrementos de 1 unidad.
English: The rapid onset and early peak of activity of Liprolog itself is observed following the subcutaneous administration of Liprolog Mix50.
Spanish: Tras la administración de Liprolog Mix50 por vía subcutánea, se observa un comienzo de acción rápido y un pico temprano de actividad similar al de Liprolog.
English: STATEMENT OF ACTIVE SUBSTANCE One ml solution contains 100 units of insulin lispro (equivalent to 3.5 mg).
Spanish: PRINCIPIO ACTIVO Un ml de solución contiene 100 unidades de insulina lispro (equivalente a 3,5 mg).
English: NAME OF THE MEDICINAL PRODUCT Liprolog Mix50 100 units/ml KwikPen suspension for injection in a pre-filled pen 50% insulin lispro and 50% insulin lispro protamine suspension
Spanish: Liprolog Mix50 KwikPen 100 unidades/ml suspensión inyectable en pluma precargada 50% de insulina lispro y 50% de suspensión de insulina lispro protamina
English: NAME OF THE MEDICINAL PRODUCT Liprolog Mix25 100 units/ml KwikPen suspension for injection in a pre-filled pen 25% insulin lispro and 75% insulin lispro protamine suspension
Spanish: Liprolog Mix25 KwikPen 100 unidades/ml suspensión inyectable en pluma precargada 25% de insulina lispro y 75% de suspensión de insulina lispro protamina
English: Instructions for Use Liprolog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen insulin lispro
Spanish: Manual del Usuario Liprolog Junior KwikPen 100 unidades/ml solución inyectable en pluma precargada insulina lispro
English: The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads, and are secured with aluminium seals.
Spanish: La solución se presenta en cartuchos de vidrio flint tipo I, sellados con un precinto de sellado de butilo o halobutilo y con un émbolo, que se aseguran con sellos de aluminio.
English: What Liprolog KwikPen looks like and contents of the pack Liprolog 100 units/ml KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection.
Spanish: Liprolog Junior KwikPen 100 unidades/ml solución inyectable es una solución estéril, transparente, incolora, acuosa y contiene 100 unidades de insulina lispro en cada mililitro de solución inyectable (100 unidades/ml).
English: Package leaflet: Information for the user Liprolog 200 units/ml KwikPen, solution for injection in a pre-filled pen insulin lispro Each KwikPen delivers 1 - 60 units in steps of 1 units.
Spanish: Prospecto: información para el usuario Liprolog KwikPen 200 unidades/ml solución inyectable en pluma precargada insulina lispro Cada KwikPen administra de 1 a 60 unidades en incrementos de 1 unidad.
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/019
Spanish: NÚMERO DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/019
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/002
Spanish: NÚMEROS DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/002
English: • Check the number in the Dose Window.If you see “0” in the Dose Window, you have received the full amount you dialled.
Spanish: Si ve un “0” en la Ventana de Dosificación, se ha administrado la cantidad total que marcó.
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/018
Spanish: NÚMERO DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/018
English: What Liprolog looks like and contents of the pack Liprolog 100 units/ml, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection.
Spanish: Liprolog 100 unidades/ml solución inyectable es una solución estéril, transparente, incolora, acuosa y contiene 100 unidades de insulina lispro en cada mililitro de solución inyectable (100 unidades/ml).
English: Before the first use store your Liprolog Mix50 in a refrigerator (2°C - 8°C).
Spanish: Antes de la primera utilización, guarde Liprolog Mix50 en nevera (entre 2ºC y 8ºC).
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/004
Spanish: NÚMEROS DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/004
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/028
Spanish: NÚMERO DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/028
English: Liprolog Mix50 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Spanish: Liprolog Mix50 KwikPen 100 unidades/ml suspensión inyectable es una suspensión blanca, estéril y contiene 100 unidades de insulina lispro en cada mililitro de suspensión inyectable (100 unidades/ml).
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/028
Spanish: NÚMEROS DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/028
English: Before the first use store your Liprolog KwikPen in a refrigerator (2°C - 8°C).
Spanish: Antes de la primera utilización, guarde Liprolog KwikPen en nevera (entre 2ºC y 8ºC).
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/001
Spanish: NÚMEROS DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/001
English: Outer Needle Shield
Spanish: Protector Externo de la Aguja
English: The rapid onset and early peak of activity of insulin lispro is observed following the subcutaneous administration of Liprolog Mix25.
Spanish: Tras la administración de Liprolog Mix25 por vía subcutánea, se observa el rápido comienzo de acción y el pico temprano de insulina lispro.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Liprolog 100 units/ml KwikPen, solution for injection in a pre-filled pen insulin lispro Each KwikPen delivers 1 - 60 units in steps of 1 units.
Spanish: Prospecto: información para el usuario Liprolog KwikPen 100 unidades/ml solución inyectable en pluma precargada insulina lispro Cada KwikPen administra de 1 a 60 unidades en incrementos de 1 unidad.
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/003
Spanish: NÚMEROS DE AUTORIZACIÓN DE COMERCIALIZACIÓN EU/1/01/195/003
English: What Liprolog 100 units/ml Junior KwikPen solution for injection contains - The active substance is insulin lispro.
Spanish: Composición de Liprolog Junior KwikPen 100 unidades/ml solución inyectable - El principio activo es insulina lispro.
English: Liprolog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Spanish: Liprolog Mix25 100 unidades/ml suspensión inyectable es una suspensión blanca, estéril que contiene 100 unidades de insulina lispro en cada mililitro de suspensión inyectable (100 unidades/ml).
English: Liprolog Mix50 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Spanish: Liprolog Mix50 100 unidades/ml suspensión inyectable es una suspensión blanca, estéril que contiene 100 unidades de insulina lispro en cada mililitro de suspensión inyectable (100 unidades/ml).
English: The rapid onset and early peak of activity of insulin lispro is observed following the subcutaneous administration of Liprolog Mix50.
Spanish: Tras la administración de Liprolog Mix50 por vía subcutánea, se observa el rápido comienzo de acción y el pico temprano de insulina lispro.
English: What Liprolog 100 units/ml KwikPen solution for injection contains - The active substance is insulin lispro.
Spanish: Composición de Liprolog KwikPen 100 unidades/ml solución inyectable - El principio activo es insulina lispro.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting.
Spanish: Grupo farmacoterapéutico: Fármacos usados en diabetes, insulinas y análogos de acción rápida para inyección, código ATC: A10AB04.
English: Liprolog Mix25 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Spanish: Liprolog Mix25 KwikPen 100 unidades/ml suspensión inyectable es una suspensión estéril, blanca, que contiene 100 unidades de insulina lispro en cada mililitro de suspensión inyectable (100 unidades/ml).
English: NAME OF THE MEDICINAL PRODUCT Liprolog 200 units/ml KwikPen solution for injection in a pre-filled pen Insulin lispro
Spanish: Liprolog KwikPen 200 unidades/ml solución inyectable en pluma precargada Insulina lispro
English: • flushed face
Spanish: • enrojecimiento facial
English: Replace the cap on the pen.
Spanish: Vuelva a colocar el capuchón en la pluma.
English: Do NOT use Liprolog 200 units/ml KwikPen - if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).
Spanish: Qué necesita saber antes de empezar a usar Liprolog KwikPen 200 unidades/ml NO use Liprolog KwikPen 200 unidades/ml - si es alérgico a la insulina lispro o a alguno de los demás componentes de este medicamento
English: Priming your Pen
Spanish: Preparando su pluma
English: Storing your pen
Spanish: Purgando su Pluma
English: Pen Body Dose Windo
Spanish: Botón de Dosificación
English: • feeling or being sick
Spanish: • náuseas o vómitos
English: • Always keep a spare pen and cartridges of Liprolog Mix50, in case you lose your pen or cartridges or they get damaged.
Spanish: • Tenga siempre plumas y cartuchos adicionales, por si pierde la pluma o los cartuchos, o se estropean.
English: • If the Dose Knob is hard to push;
Spanish: • Si es difícil presionar el Botón Dosificador; - Será más fácil inyectar si presiona el Botón Dosificador más despacio.
English: Dose Knob w
Spanish: Ganancia de peso2
English: • Always keep a spare pen and cartridges of Liprolog Mix25, in case you lose your pen or cartridges or they get damaged.
Spanish: • Tenga siempre jeringas y viales de Liprolog Mix25 adicionales, o plumas y cartuchos de más,
English: USER MANUAL KwikPen pre-filled insulin pen 100 units/ml
Spanish: MANUAL DEL USUARIO Liprolog KwikPen 100 unidades/ml solución inyectable en pluma precargada
English: France TEVA SANTE Le Palatin 1
Spanish: TEVA SANTE Le Palatin 1
English: Portugal Ciclum Farma Unipessoal, Lda.
Spanish: Ciclum Farma Unipessoal, Lda.
English: Germany HEXAL Aktiengesellschaft Industriestr.
Spanish: HEXAL Aktiengesellschaft Industriestr.
English: Belgium Eurogenerics NV Heizel Esplanade b22 1020 Brussel
Spanish: Eurogenerics NV Heizel Esplanade b22 1020 Brussel Belgium
English: 1 cours du Triangle 92936 Paris la Défense Cedex France
Spanish: 1 cours du Triangle 92936 Paris la Défense Cedex
English: Norway Teva Sweden AB Järnvägsgatan 11, Box 1070, 251 10 Helsingborg Sweden
Spanish: Teva Sweden AB Järnvägsgatan 11, Box 1070, 251 10 Helsingborg Sweden
English: Radlická 3185/1c 150 00 Prague
Spanish: Radlická 3185/1c
English: Belgium Sandoz NV/SA Telecom Gardens Medialaan 40
Spanish: Sandoz NV/SA Telecom Gardens Medialaan 40
English: Bad Vilbel D-61118
Spanish: Bad Vilbel D-61118 Germany
English: U Nákladového nádraží 10 CZ-130 00, Praha 3, Czech Republic
Spanish: República Checa Sandoz s.r.o U Nákladového nádraží 10 CZ-130 00, Praha 3, Czech Republic
English: Poland Sandoz GmbH Biochemiestrasse 10 Kundl, A-6250
Spanish: Sandoz GmbH Biochemiestrasse 10 Kundl, A-6250
English: Poland Teva Pharmaceuticals Polska Sp. z o.o.
Spanish: Teva Pharmaceuticals Polska Sp. z o.o.
English: Poland STADA Arzneimittel AG Stadastrasse 2-18
Spanish: STADA Arzneimittel AG Stadastrasse 2-18
English: B-Vilvoorde
Spanish: B-Vilvoorde Belgium
English: TEVA Pharmaceuticals Slovakia s.r.o.
Spanish: Eslovaquia TEVA Pharmaceuticals Slovakia s.r.o.
English: Sweden Sandoz A/S, , Edvard Thomsens Vej 14
Spanish: Sandoz A/S, , Edvard Thomsens Vej 14
English: 15 N.V Gogol Str. Sofia
Spanish: Teva Pharmaceuticals Bulgaria EOOD 15 N.V Gogol Str. Sofia
English: Latvia Sandoz d.d., Verovškova 57, SI-1000 Ljubljana,
Spanish: Sandoz d.d., Verovškova 57, SI-1000 Ljubljana, Slovenia
English: Belgium Pharmaceuticals Works Pharma SA
Spanish: Pharmaceuticals Works Pharma SA
English: Teva Pharmaceuticals CR s.r.o.
Spanish: República Checa Teva Pharmaceuticals CR s.r.o.
English: Denmark Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
Spanish: Dinamarca Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
English: France EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou
Spanish: EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France
English: Verovškova 57 SI1000 Ljubljana
Spanish: Verovškova 57 SI-1000 Ljubljana Slovėnia
English: Finland ratiopharm GmbH Graf-Arco-Strasse 3
Spanish: Finlandia ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
English: Latvia Teva Pharma B.V., Computerweg 10, 3542DR Utrecht, The Netherlands
Spanish: Teva Pharma B.V., Computerweg 10, 3542DR Utrecht, The Netherlands
English: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D.
Spanish: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal
English: Estonia Sandoz d.d.
Spanish: Sandoz d.d.
English: Estonia Pharmaceutical Works Polpharma S.A.
Spanish: Pharmaceutical Works Polpharma S.A.
English: Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19
Spanish: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
English: 00-113 Warszawa
Spanish: Emilii Plater 53 00-113 Warszawa Poland
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom
Spanish: Reino Unido Teva UK Limited, Brampton Road,
English: Germany ratiopharm GmbH Graf-Arco-Str. 3
Spanish: Alemania ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France
Spanish: 49, avenue Georges Pompidou
English: Finland Sandoz A/S Edvard Thomsens Vej 14 Copenhagen S 2300 Denmark
Spanish: Edvard Thomsens Vej 14 Copenhagen S 2300 Denmark
English: Latvia Pharmaceutical Works POLPHARMA SA, 19
Spanish: Eslovaquia Pharmaceutical Works POLPHARMA SA
English: Pelplinska Street,
Spanish: Hampden Park,
English: Denmark Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
Spanish: DK-2800 Kongens Lyngby, Denmark
English: Lithuania Pharmaceutical Works POLPHARMA S.A., 19 Pelplinska Street, Starogard Gdanski 83-200 Poland
Spanish: Pharmaceutical Works POLPHARMA S.A., 19 Pelplinska Street, Starogard Gdanski 83-200 Poland
English: 19, Pelplinska street
Spanish: 19, Pelpliňska Str.
English: Sandoz s.r.o
Spanish: Sandoz A/S
English: 19, Peplinska Street Starogar Gdanski
Spanish: Pharmaceutical Works Polpharma S.A 19, Peplinska Street Starogar Gdanski
English: Poland Pharmaceutical Works POLPHARMA SA 19, Pelplińska Street 83-200 Starogard Gdański Poland
Spanish: Pharmaceutical Works POLPHARMA SA 19, Pelplińska Street 83-200 Starogard Gdański Poland
English: Latvia Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street, 83-200 Starogard Gdański, Poland
Spanish: Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street, 83-200 Starogard Gdański, Poland
English: Orlistato Ciclum 60 mg
Spanish: Orlistato Ciclum 60 mg Cápsula dura
English: Estonia Teva Pharma B.V. Computerweg 10
Spanish: Teva Pharma B.V.
English: Orlistat Teva 120 mg 120 mg
Spanish: Orlistat Teva 120 mg 120 mg Cápsula dura
English: Orlistato Ciclum 120 mg
Spanish: Orlistato Ciclum 120 mg Cápsula dura
English: Slovėnia
Spanish: Estonia
English: Orlistat ratiopharm 120 mg
Spanish: Orlistat ratiopharm 120 mg Cápsula dura
English: Orlistat Sandoz 60 mg 60 mg
Spanish: Orlistat Sandoz 60 mg 60 mg Cápsula dura
English: Orlistato Ratiopharm 120 mg
Spanish: Orlistato Ratiopharm 120 mg Cápsula dura
English: Orlistat ratiopharm 60 mg
Spanish: Orlistat ratiopharm 60 mg Cápsula dura
English: Orlistat STADA 60 mg 60 mg
Spanish: Orlistat STADA 60 mg60 mg Cápsula dura
English: Orlistato Ratiopharm 60 mg
Spanish: Orlistato Ratiopharm 60 mg Cápsula dura
English: Starogard Gdański, Poland
Spanish: Gdaňski poland
English: Denmark
Spanish: Suecia
English: Finland Stada Arzneimittel AG Stadastrasse 2 - 18
Spanish: Stada Arzneimittel AG Stadastrasse 2 - 18 Bad Vilbel 61118
English: Orlistat Teva 60 mg 60 mg
Spanish: Orlistat Teva 60 mg 60 mg Cápsula dura
English: Urorec silodosin
Spanish: Urorec silodosina
English: The full EPAR for Urorec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Spanish: El EPAR completo de Urorec se puede consultar en la página web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Urorec
Spanish: Otras informaciones sobre Urorec
English: A risk management plan has been developed to ensure that Urorec is used as safely as possible.
Spanish: Se ha elaborado un plan de gestión de riesgos para garantizar que Urorec se administra de una forma lo más segura posible.
English: What measures are being taken to ensure the safe and effective use of Urorec?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Urorec?
English: Urorec is not recommended for patients with severe kidney problems.
Spanish: Urorec no se recomienda en los pacientes con problemas renales graves.
English: This is a summary of the European public assessment report (EPAR) for Urorec.
Spanish: El presente documento resume el Informe Público Europeo de Evaluación (EPAR) de Urorec.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Urorec on 29 January 2010.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Urorec el 29.01.10.
English: In the two studies where Urorec was compared only with placebo, the IPSS was around 21 points at the start of the study.
Spanish: En los dos estudios en los que Urorec se comparó únicamente con un placebo, la IPSS fue de unos 21 puntos al principio del estudio.
English: In addition, the company that makes Urorec will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Spanish: La empresa que produce Urorec deberá asegurarse de que los cirujanos oculares reciban información sobre el IFIS en todos los Estados miembros en los que vaya a comercializarse el fármaco.
English: The CHMP decided that Urorec's benefits are greater than its risks and recommended that it be given marketing authorisation.
Spanish: El CHMP decidió que los beneficios de Urorec son mayores que sus riesgos y recomendó autorizar su comercialización.
English: The most common side effect with Urorec (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Spanish: El efecto secundario más frecuente de Urorec (observado en más de uno de cada 10 pacientes) es una reducción de la cantidad de semen que se expulsa durante la eyaculación.
English: The effects of Urorec were first tested in experimental models before being studied in humans.
Spanish: Los efectos de Urorec se probaron en modelos de laboratorio antes de estudiarse en seres humanos.
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 Urorec.
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: For more information about treatment with Urorec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Spanish: Para mayor información sobre el tratamiento con Urorec, lea el prospecto (también incluido en el EPAR) o consulte a su médico o farmacéutico.
English: For the full list of all side effects and restrictions with Urorec, see the package leaflet.
Spanish: Para consultar la lista completa de efectos adversos y restricciones de Urorec, ver el prospecto.
English: Urorec was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH.
Spanish: Urorec fue más eficaz que el placebo y tan eficaz como la tamsulosina para reducir los síntomas de la HBP.