FrancophonIA/ELRC3.0 huggingface dataset:
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, and O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Spanish: Tenofovir alafenamida mostró actividad antiviral en cultivos celulares frente a todos los grupos del VIH-1 (M, N y O), incluidos los subtipos A, B, C, D, E, F y G (valores de CE50 comprendidos entre 0,10 y 12,0 nM) y demostró actividad específica de las cepas frente al VIH-2 (valores de CE50 comprendidos entre 0,91 y 2,63 nM).
English: Symtuza 800 mg/150 mg/200 mg/10 mg tablets darunavir/cobicistat/emtricitabine/tenofovir alafenamide
Spanish: Symtuza 800 mg/150 mg/200 mg/10 mg comprimidos darunavir/cobicistat/emtricitabina/tenofovir alafenamida
English: Please contact your doctor whenever you develop a rash.
Spanish: Por favor, consulte con su médico si presenta una erupción.
English: Symtuza should not be administered concomitantly with medicinal products containing tenofovir disoproxil (as fumarate, phosphate or succinate), lamivudine, or adefovir dipivoxil used for the treatment of HBV infection.
Spanish: Symtuza no se debe administrar de forma concomitante con medicamentos que contengan tenofovir disoproxilo (como fumarato, fostato o succinato), lamivudina o adefovir dipivoxil, que se utilizan para el tratamiento de la infección por el VHB.
English: Bleeding in haemophiliac patients
Spanish: Hemorragias en pacientes hemofílicos
English: Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see sections 4.4 and 4.6).
Spanish: Por tanto, no se debe iniciar el tratamiento con Symtuza durante el embarazo, y las mujeres que se queden embarazadas durante el tratamiento con Symtuza se deben cambiar a un tratamiento alternativo (ver secciones 4.4 y 4.6).
English: In HIV infected patients treated with CART, immune reactivation syndrome has been reported.
Spanish: Se ha notificado síndrome de reactivación inmune en pacientes infectados por el VIH tratados con TARC.
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Spanish: Si procede, puede estar justificado iniciar un tratamiento para la hepatitis B. En los pacientes con enfermedad hepática avanzada o cirrosis, no se recomienda la interrupción del tratamiento dado que la exacerbación de la hepatitis postratamiento puede conducir a una descompensación hepática.
English: Symtuza should not be administered concomitantly with medicinal products containing tenofovir disoproxil (e.g. fumarate, phosphate, or succinate), lamivudine, or adefovir dipivoxil used for the treatment of HBV infection.
Spanish: Symtuza no se debe administrar de forma concomitante con medicamentos que contengan tenofovir disoproxilo (p. ej., fumarato, fosfato o succinato), lamivudina o adefovir dipivoxil, que se utilizan para el tratamiento de la infección por el VHB.
English: In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Spanish: In vitro, tenofovir alafenamida no es metabolizado por CYP1A2, CYP2C8, CYP2C9, CYP2C19 ni CYP2D6.
English: Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see sections 4.2 and 4.6).
Spanish: Por tanto, no se debe iniciar el tratamiento con Symtuza durante el embarazo y las mujeres que se queden embarazadas durante el tratamiento con Symtuza se deben cambiar a un tratamiento alternativo (ver secciones 4.2 y 4.6).
English: Based on theoretical considerations DRV/COBI may increase ergot derivative exposure.
Spanish: Basándose en consideraciones teóricas, DRV/COBI puede aumentar la exposición a los derivados ergotamínicos.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Spanish: Al contrario que ritonavir, cobicistat no es un inductor de CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 o UGT1A1.
English: Rifampicin to treat some infections such as tuberculosis Pimozide, lurasidone, quetiapine or sertindole to treat psychiatric conditions Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Spanish: Alcaloides ergotamínicos como ergotamina, dihidroergotamina, ergometrina y metilergonovina para tratar las migrañas
English: Atorvastatin (10 mg once daily): atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Spanish: AUC de atorvastatina ↑ 290% Cmax de atorvastatina ↑ 319% Cmin de atorvastatina ND
English: Always take Symtuza exactly as your doctor or pharmacist has told you.
Spanish: Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico o farmacéutico.
English: Tell your doctor if you take: - Amlodipine, diltiazem, disopyramide, felodipine, flecainide, mexiletine, nicardipine, nifedipine, propafenone, lidocaine, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Spanish: Informe a su médico si está tomando: - Amlodipino, diltiazem, disopiramida, felodipino, flecainida, mexiletina, nicardipino, nifedipino,
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Spanish: Tenofovir alafenamida no es un inhibidor de CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ni CYP2D6 in vitro.
English: Based on theoretical considerations DRV/COBI may increase buprenorphine and/or norbuprenorphine plasma concentrations.
Spanish: Basándose en consideraciones teóricas, DRV/COBI puede aumentar las concentraciones plasmáticas de buprenorfina y/o norbuprenorfina.
English: The combination of avanafil and Symtuza is contraindicated (see section 4.3).
Spanish: La combinación de avanafilo y Symtuza está contraindicada (ver sección 4.3).
English: ANTI-DEPRESSANTS Herbal supplements St. John's wort
Spanish: ANTIDEPRESIVOS Medicamentos a base de plantas Hierba de San Juan o Hipérico
English: Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets darunavir/cobicistat/emtricitabine/tenofovir alafenamide
Spanish: Symtuza 800 mg/150 mg/200 mg/10 mg comprimidos recubiertos con película darunavir/cobicistat/emtricitabina/tenofovir alafenamida
English: Caution should be exercised when clarithromycin is combined with Symtuza.
Spanish: Se recomienda precaución cuando se combine claritromicina con Symtuza.
English: Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see sections 4.2 and 4.4).
Spanish: No se debe iniciar el tratamiento con Symtuza durante el embarazo y las mujeres que se queden embarazadas durante el tratamiento con Symtuza se deben cambiar a un tratamiento alternativo (ver secciones 4.2 y 4.4).
English: CALCIUM CHANNEL BLOCKERS Amlodipine
Spanish: ANTAGONISTAS DE LOS CANALES DEL CALCIO Amlodipino
English: HIV-1 Treatment experienced Patients
Spanish: Pacientes con VIH-1 tratados previamente
English: Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Spanish: No se espera que cobicistat sea un inhibidor de CYP1A2, CYP2B6, CYP2C8, CYP2C9 o CYP2C19.
English: It is not recommended to co-administer Symtuza with simeprevir.
Spanish: No se recomienda la administración conjunta de Symtuza y simeprevir.
English: Co-administration of Symtuza and these anticonvulsants is contraindicated (see section 4.3).
Spanish: La administración conjunta de Symtuza y estos antiepilépticos está contraindicada (ver sección 4.3).
English: Concomitant use of Symtuza with lovastatin and simvastatin is contraindicated (see section 4.3).
Spanish: El uso concomitante de Symtuza con lovastatina y simvastatina está contraindicado (ver sección 4.3).
English: Subjects with ≥1 emergent RAM, n (%) Protease
Spanish: Pacientes con ≥1 MAR emergente,n
English: - immune reconstitution inflammatory syndrome.
Spanish: • síndrome inflamatorio de reconstitución inmune.
English: • allergic reactions such as nettle rash (urticaria), itching, decreased appetite (anorexia)
Spanish: • reacciones alérgicas, como urticaria, picor
English: The combination of rifampicin and Symtuza is contraindicated (see section 4.3).
Spanish: La combinación de rifampicina y Symtuza está contraindicada (ver sección 4.3).
English: (CYP3A and/or P-glycoprotein inhibition)
Spanish: (inhibición de CYP3A y/o glucoproteína-P)
English: Lipid Parameter Baseline Median
Spanish: Mediana Basal
English: Based on theoretical considerations DRV/COBI may increase plasma concentrations of these analgesics.
Spanish: Basándose en consideraciones teóricas, DRV/COBI puede aumentar las concentraciones plasmáticas de estos analgésicos.
English: Based on theoretical considerations (systemic) dexamethasone is expected to decrease darunavir and/or cobicistat plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que la dexametasona (sistémica) reduzca las concentraciones plasmáticas de darunavir y/o cobicistat.
English: Removing the child resistant cap
Spanish: Cómo quitar el tapón a prueba de niños
English: At baseline, median plasma HIV-1 RNA was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm
Spanish: En el momento basal, la mediana del ARN del VIH-1 en plasma era de 4,7 log10 copias/ml, la mediana del recuento de linfocitos CD4+ era de 456 células/mm (intervalo: 95-1,110) y la mediana del porcentaje de CD4+ era del 23 % (intervalo: 7-45 %).
English: Increased creatine phosphokinase (CPK), myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Spanish: Con el uso de inhibidores de la proteasa del VIH, sobre todo en combinación con ITIAN, se han descrito elevaciones de la creatina fosfocinasa (CPK), mialgias, miositis y, en raras ocasiones, rabdomiólisis.
English: Based on theoretical considerations clarithromycin is expected to increase darunavir and/or cobicistat plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que claritromicina aumente las concentraciones plasmáticas de darunavir y/o cobicistat.
English: Co-administration of St. John's wort and Symtuza is contraindicated (see section 4.3)
Spanish: La administración conjunta de Hierba de San Juan o Hipérico y Symtuza está contraindicada (ver sección 4.3)
English: Alfuzosin to treat enlarged prostate
Spanish: Alfuzosina para tratar la hiperplasia de próstata
English: Based on theoretical considerations DRV/COBI may increase methadone plasma concentrations.
Spanish: Basándose en consideraciones teóricas, DRV/COBI puede aumentar las concentraciones plasmáticas de metadona.
English: (CYP3A and/or P-gp induction)
Spanish: (inducción de CYP3A y/o gp-P)
English: 111-1921 x 10
Spanish: 6 células/mm 3 (intervalo 111-1921 x 10
English: • if you have had problems with your liver, including hepatitis B or C infection.
Spanish: • Si ha tenido problemas de hígado, incluida la infección de la hepatitis B o C. Su médico evaluará la gravedad de su enfermedad hepática antes de decidir si puede tomar Symtuza.
English: Therapeutic drug monitoring of the immunosuppressive agent must be done when co-administration with Symtuza occurs.
Spanish: En caso de administración conjunta con Symtuza, se deberá realizar un control terapéutico del medicamento inmunosupresor.
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mL Missing data during window but on trial Virologic response (HIV-1-RNA < 50 copies/mL; Snapshot Analysis) by subgroup, n/N (%)
Spanish: Respuesta virológica (ARN del VIH-1 <50 copias/ml; Análisis Snapshot) por subgrupos, n/N (%)
English: CD4+ cell count mean change from baseline
Spanish: Variación media del recuento de linfocitos CD4+ respecto al valor basal
English: • if you have haemophilia.
Spanish: • Si padece hemofilia.
English: ART-experienced patients
Spanish: Pacientes de edad avanzada
English: Based on theoretical considerations these antimycobacterials are expected to decrease darunavir and/or cobicistat and/or tenofovir alafenamide plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que estos antimicobacterianos reduzcan las concentraciones plasmáticas de darunavir y/o cobicistat y/o tenofovir alafenamida.
English: HIV-1 Treatment naïve Patients
Spanish: Pacientes con VIH-1 sin tratamiento previo
English: It is used in adults and adolescents aged 12 years and older who weigh at least 40 kg. Symtuza contains four active substances:
Spanish: Se utiliza en adultos y adolescentes de 12 años de edad y mayores, con un peso mínimo de 40 kilogramos.
English: Based on theoretical considerations DRV/COBI is expected to increase these sedative/hypnotic plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos sedantes/hipnóticos.
English: Based on theoretical considerations DRV/COBI may alter warfarin plasma concentrations.
Spanish: Basándose en consideraciones teóricas, DRV/COBI puede alterar las concentraciones plasmáticas de warfarina.
English: Based on theoretical considerations DRV/COBI is expected to increase salmeterol plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de salmeterol.
English: HIV-1 RNA ≥ 50 copies/mL Virologic Failure Leading to Discontinuation Discontinued study drug due to other reasons and last available HIV-1 RNA ≥ 50 copies/mL
Spanish: Suspendieron el fármaco del estudio por otros motivos y último valor disponible de ARN del VIH-1 ≥ 50 copias/ml Sin datos virológicos Motivos
English: Based on theoretical considerations DRV/COBI is expected to increase these PDE-5 inhibitor plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos inhibidores de la PDE-5.
English: It is not recommended to co-administer Symtuza with boceprevir.
Spanish: No se recomienda la administración conjunta de Symtuza y boceprevir.
English: Amiodarone Dronedarone Ivabradine Quinidine Ranolazine
Spanish: Amiodarona Dronedarona Ivabradina Quinidina Ranolazina
English: Based on theoretical considerations bosentan is expected to decrease darunavir and/or cobicistat plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que bosentán reduzca las concentraciones plasmáticas de darunavir y/o cobicistat.
English: Based on theoretical considerations DRV/COBI is expected to increase digoxin plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de digoxina.
English: (CYP3A inhibition and/or transport)
Spanish: (inhibición y/o transporte de CYP3A)
English: Based on theoretical considerations DRV/COBI is expected to increase lumefantrine plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de lumefantrina.
English: Based on theoretical considerations St. John's wort is expected to decrease darunavir and/or cobicistat and/or tenofovir alafenamide plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que la Hierba de San Juan o Hipérico disminuya las concentraciones plasmáticas de darunavir y/o cobicistat y/o tenofovir alafenamida.
English: Based on theoretical considerations DRV/COBI is expected to increase these corticosteroid plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos corticosteroides.
English: Based on theoretical considerations DRV/COBI is expected to increase alfentanil plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de alfentanilo.
English: Based on theoretical considerations rifampicin is expected to decrease darunavir and/or cobicistat and/or tenofovir alafenamide plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que rifampicina reduzca las concentraciones plasmáticas de darunavir y/o cobicistat y/o tenofovir alafenamida.
English: Based on theoretical considerations DRV/COBI is expected to increase these neuroleptic plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos neurolépticos.
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Spanish: Durante el tratamiento antirretroviral se puede producir un aumento de peso y en los niveles de lípidos y glucosa en sangre.
English: Musculoskeletal and connective tissue disorders common arthralgia, myalgia uncommon osteonecrosis
Spanish: Stevens-Johnson frecuencia no conocida necrólisis epidérmica tóxica a, pustulosis exantemática generalizada aguda Trastornos musculoesqueléticos y del tejido conjuntivo frecuente artralgia, mialgia poco frecuente osteonecrosis
English: Edoxaban
Spanish: Omeprazol
English: Based on theoretical considerations DRV/COBI may alter norethindrone plasma concentrations.
Spanish: Basándose en consideraciones teóricas, DRV/COBI puede alterar las concentraciones plasmáticas de noretindrona.
English: Based on theoretical considerations DRV/COBI is expected to increase simeprevir plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de simeprevir.
English: Based on theoretical considerations DRV/COBI is expected to increase metformin plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de metformina.
English: The effects of other medicines might be influenced if you take Symtuza.
Spanish: Symtuza también puede influir sobre los efectos de otros medicamentos.
English: Primary PI/DRV
Spanish: Proteasa Transcriptasa inversa Primaria a IP/DRV TDF/TAF FTC
English: Based on theoretical considerations DRV/COBI is expected to increase colchicine plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de colchicina.
English: Based on theoretical considerations DRV/COBI is expected to increase these anti-depressant plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos antidepresivos.
English: • Remove the unscrewed cap.
Spanish: • Retire el tapón de rosca.
English: How to store Symtuza
Spanish: Conservación de Symtuza
English: No special hazard for humans was revealed in conventional studies of carcinogenic potential and toxicity to reproduction and development.
Spanish: Los estudios convencionales de potencial carcinogénico y toxicidad para la reproducción y el desarrollo no mostraron riesgos especiales para el ser humano.
English: These are: - raised blood sugar and worsening of diabetes - muscle pain, tenderness or weakness.
Spanish: • elevación del azúcar en sangre y empeoramiento de la diabetes
English: Based on theoretical considerations DRV/COBI is expected to increase these antiarrhythmic plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos antiarrítmicos.
English: Ranitidine
Spanish: Lactancia
English: Elderly
Spanish: Tioridazina
English: Based on theoretical considerations DRV/COBI is expected to increase these anti-neoplastic plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos antineoplásicos.
English: Pravastatin
Spanish: Noretindrona
English: Based on theoretical considerations DRV/COBI is expected to increase these immunosuppressant plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos inmunosupresores.
English: Based on theoretical considerations DRV/COBI is expected to increase these beta-blocker plasma concentrations.
Spanish: Basándose en consideraciones teóricas, se espera que DRV/COBI aumente las concentraciones plasmáticas de estos betabloqueantes.
English: FTC
Spanish: CAD
English: A higher dose may be needed in children.
Spanish: En niños puede ser necesario aumentar la dosis.
English: It is used in patients with the following conditions:
Spanish: Se utiliza en pacientes con los trastornos siguientes:
English: Other information about NovoSeven
Spanish: Otra información sobre NovoSeven
English: NovoSeven received a marketing authorisation valid throughout the EU on 23 February 1996.
Spanish: NovoSeven ha recibido una autorización de comercialización válida en toda la EU el 23 de febrero de
English: Further information on NovoSeven can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/novoseven.
Spanish: Puede encontrar información adicional sobre NovoSeven en la página web de la Agencia: ema.europa.eu/medicines/human/EPAR/novoseven.
English: What measures are being taken to ensure the safe and effective use of NovoSeven?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de NovoSeven?
English: As for all medicines, data on the use of NovoSeven are continuously monitored.
Spanish: Como para todos los medicamentos, los datos sobre el uso de NovoSeven se controlan permanentemente.
English: The European Medicines Agency decided that NovoSeven's benefits are greater than its risks and it can be authorised in the EU..
Spanish: La Agencia Europea de Medicamentos decidió que los beneficios de NovoSeven son mayores que sus riesgos y recomendó autorizar su uso en la UE.
English: The main measure of effectiveness was the number of bleeding episodes that were controlled effectively.
Spanish: El criterio principal de eficacia fue el número de episodios hemorrágicos que pudieron controlarse eficazmente.
English: Why is NovoSeven authorised in the EU?
Spanish: ¿Por qué se ha autorizado NovoSeven en la UE?
English: What is NovoSeven and what is it used for?
Spanish: ¿Qué es NovoSeven y para qué se utiliza?
English: It is available as a powder and solvent that are made up into a solution to be injected into a vein.
Spanish: Está disponible como polvo y disolvente con los que se prepara una solución que debe inyectarse en una vena.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoSeven 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 NovoSeven se han incluido en la Ficha Técnica o Resumen de las Características del Producto y el prospecto.
English: For more information about using NovoSeven, see the package leaflet or contact your doctor or pharmacist.
Spanish: Para mayor información sobre el uso de NovoSeven, consulte el prospecto o contacte con su médico o farmacéutico.
English: What are the risks associated with NovoSeven?
Spanish: ¿Cuáles son los riesgos asociados a NovoSeven?
English: • congenital factor VII deficiency;
Spanish: • deficiencia congénita del factor VII;
English: NovoSeven must not be used in people who are hypersensitive (allergic) to eptacog alfa, to mouse, hamster or cow proteins, or to any of the other ingredients.
Spanish: NovoSeven no se debe utilizar en personas que puedan ser hipersensibles (alérgicas) al eptacog alfa, a las proteínas de ratón, de hámster o de vaca, o a cualquiera de los demás componentes.