FrancophonIA/ELRC3.0 huggingface dataset:
English: Dosage adjustments of simvastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for simvastatin).
Spanish: Puede requerirse un ajuste de la dosis de simvastatina cuando se coadministra con Atripla (ver Ficha Técnica o Resumen de las Características del Producto para simvastatina).
English: Valproic acid/Efavirenz (250 mg b.i.d./600 mg q.d.)
Spanish: Ácido valproico/Efavirenz (250 mg c/12 h/600 mg c/24 h)
English: Switching from a PI-based antiretroviral regimen
Spanish: Cambio desde una pauta con antirretroviral, inhibidor de la proteasa
English: Dosage adjustments of pravastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for pravastatin).
Spanish: Puede requerirse un ajuste de la dosis de pravastatina cuando se coadministra con Atripla (ver Ficha Técnica o Resumen de las Características del Producto para pravastatina).
English: Pravastatin/Emtricitabine
Spanish: Pravastatina/Emtricitabina
English: Atripla and valproic acid can be co-administered without dose adjustment.
Spanish: Pueden coadministrarse Atripla y ácido valproico sin ajuste de dosis.
English: Maraviroc/Tenofovir disoproxil (300 mg b.i.d./245 mg q.d.)
Spanish: Maraviroc/Tenofovir disoproxilo (300 mg c/12 h/245 mg c/24 h)
English: Pravastatin:
Spanish: Pravastatina:
English: Bupropion/Tenofovir disoproxil
Spanish: Bupropión/Tenofovir disoproxilo
English: Voriconazole/Efavirenz (200 mg b.i.d./400 mg q.d.)
Spanish: Voriconazol/Efavirenz (200 mg c/12 h/400 mg c/24 h)
English: Atripla and paroxetine can be co-administered without dose adjustment.
Spanish: Atripla y paroxetina pueden administrarse concomitantemente sin ajustar la dosis.
English: Dosage adjustments of atorvastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for atorvastatin).
Spanish: Puede requerirse un ajuste de la dosis de atorvastatina cuando se coadministra con Atripla (ver Ficha Técnica o Resumen de las Características del Producto para atorvastatina).
English: • tiredness
Spanish: • cansancio
English: Rifampicin/Emtricitabine
Spanish: Rifampicina/Emtricitabina
English: Itraconazole/Efavirenz (200 mg b.i.d./600 mg q.d.)
Spanish: Itraconazol/Efavirenz (200 mg c/12 h/600 mg c/24 h)
English: Atripla and rosuvastatin can be co-administered without dose adjustment.
Spanish: Atripla y rosuvastatina pueden ser coadministradas sin ajuste de dosis.
English: AUC: ↓ 54% Cmax: ↓ 45%
Spanish: AUC: ↓ 54 % Cmáx: ↓ 45 %
English: DMPA/Tenofovir disoproxil
Spanish: DMPA/Tenofovir disoproxilo
English: CARDIOVASCULAR AGENTS Calcium Channel Blockers Diltiazem/Efavirenz (240 mg q.d./600 mg q.d.)
Spanish: FÁRMACOS CARDIOVASCULARES Calcioantagonistas Diltiazem/Efavirenz (240 mg c/24 h/600 mg c/24 h)
English: Vigabatrin/Efavirenz Gabapentin/Efavirenz
Spanish: Vigabatrina/Efavirenz Gabapentina/Efavirenz
English: ANTICONVULSANTS Carbamazepine/Efavirenz (400 mg q.d./600 mg q.d.)
Spanish: ANTICONVULSIVANTES Carbamazepina/Efavirenz (400 mg c/24 h/600 mg c/24 h)
English: Clarithromycin/Efavirenz (500 mg b.i.d./400 mg q.d.)
Spanish: Claritromicina/Efavirenz (500 mg c/12 h/400 mg c/24 h)
English: Ethinyloestradiol+Norgestimate/Efavirenz (0.035 mg+0.25 mg q.d./600 mg q.d.)
Spanish: Efavirenz (0,035 mg+0,25 mg c/24 h./600 mg c/24 h)
English: Lopinavir/ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d./245 mg q.d.)
Spanish: Lopinavir/ritonavir/Tenofovir disoproxilo (400 mg c/12 h/ 100 mg c/12 h/245 mg c/24 h)
English: Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
Spanish: AUC: ↓ 37% (↓ 17 a ↓ 52) Cmax: ↓ 28% (↓ 7 a ↓ 44) Cmin: ↓ 37% (↓ 17 a ↓ 52)
English: EXP
Spanish: exantema
English: Darunavir/ritonavir/Efavirenz (300 mg b.i.d.
Spanish: Atazanavir/ritonavir/Efavirenz (400 mg c/24 h/
English: Ritonavir/Efavirenz (500 mg b.i.d./600 mg q.d.)
Spanish: Ritonavir/Efavirenz (500 mg c/12 h/600 mg c/24 h)
English: Paroxetine/Efavirenz (20 mg q.d./600 mg q.d.)
Spanish: Paroxetina/Efavirenz (20 mg c/24 h/600 mg c/24 h)
English: Rifampicin/Tenofovir disoproxil (600 mg q.d./245 mg q.d.)
Spanish: Rifampicina/Tenofovir disoproxilo (600 mg c/24 h/245 mg c/24 h)
English: Co-administration of Atripla with sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/ voxilaprevir is not recommended (see section 4.4).
Spanish: No se recomienda la administración concomitante de Atripla y sofosbuvir/velpatasvir o de sofosbuvir/velpatasvir/ voxilaprevir (ver sección
English: Antimycobacterials Rifabutin/Efavirenz (300 mg q.d./600 mg q.d.)
Spanish: Antimicobacterianos Rifabutina/Efavirenz (300 mg c/24 h/600 mg c/24 h)
English: Paroxetine/Tenofovir disoproxil
Spanish: Paroxetina/Tenofovir disoproxilo
English: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies.
Spanish: Se notifican frecuentemente reacciones adversas en pacientes que reciben 600 mg diarios de efavirenz durante los estudios clínicos cuyos síntomas incluyen los siguientes, aunque no están limitados a estos: mareo, insomnio, somnolencia, deterioro de la concentración, sueños anormales.
English: Rifampicin/Efavirenz (600 mg q.d./600 mg q.d.)
Spanish: Rifampicina/Efavirenz (600 mg c/24 h/600 mg c/24 h)
English: Fosamprenavir/ritonavir/Efavirenz (700 mg b.i.d./100 mg b.i.d./600 mg q.d.)
Spanish: Fosamprenavir/ritonavir/Efavirenz (700 mg c/12 h/100 mg c/12 h/ 600 mg c/24 h)
English: Atorvastatin/Emtricitabine
Spanish: Atorvastatina/Emtricitabina
English: The following side effects are common (these may affect up to 1 in 10 patients)
Spanish: Los siguientes efectos adversos son frecuentes (estos pueden afectar hasta 1 de cada 10 pacientes):
English: Simvastatin/Emtricitabine
Spanish: Simvastatina/Emtricitabina
English: - Diltiazem or similar medicines (called calcium channel blockers): When you start taking
Spanish: - Diltiazem o medicamentos similares (llamados calcioantagonistas): cuando inicie su tratamiento con Atripla, será necesario que su médico le ajuste la dosis del calcioantagonista.
English: Elderly
Spanish: Adultos
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Spanish: Sofosbuvir (400 mg c/24 h) + Efavirenz/Emtricitabina/Tenofovir disoproxilo (600 mg/200 mg/245 mg c/24 h)
English: Atazanavir/ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Spanish: Darunavir/ritonavir/Tenofovir disoproxilo (300 mg c/12 h*/100 mg c/12 h/ 245 mg c/24 h)
English: Atorvastatin:
Spanish: Atorvastatina:
English: Simvastatin/Efavirenz (40 mg q.d./600 mg q.d.)
Spanish: Simvastatina/Efavirenz (40 mg c/24 h/600 mg c/24 h)
English: Diltiazem/Tenofovir disoproxil
Spanish: Diltiazem/Tenofovir disoproxilo
English: Pravastatin/Efavirenz (40 mg q.d./600 mg q.d.)
Spanish: Pravastatina/Efavirenz (40 mg c/24 h/600 mg c/24 h)
English: Simvastatin/Tenofovir disoproxil
Spanish: Rifabutina/Tenofovir disoproxilo
English: • chills
Spanish: • picor
English: Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Spanish: AUC: ↓ 75% (↓ 59 a ↓ 84) Cmax: ↓ 64% (↓ 57 a ↓ 69) Cmin: ↓ 62% (↓ 44 a ↓ 75)
English: NRTIs and NNRTIs NRTIs/Efavirenz
Spanish: ITIAN y ITINN ITIAN/Efavirenz
English: How to store Atripla
Spanish: Conservación de Atripla
English: Rosuvastatin/Emtricitabine
Spanish: Rosuvastatina/Emtricitabina
English: Buprenorphine/naloxone/Emtricitabine Interaction not studied.
Spanish: Atorvastatina/Tenofovir disoproxilo Interacción no estudiada.
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg b.i.d./600 mg q.d.)
Spanish: Maraviroc/Efavirenz (100 mg c/12 h/600 mg c/24 h)
English: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg q.d.)
Spanish: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg c/24 h.) + Efavirenz/Emtricitabina/Tenofovir disoproxilo (600 mg/200 mg/245 mg c/24 h.)
English: Mechanism of action and pharmacodynamic effects Efavirenz is an NNRTI of HIV-1.
Spanish: Efavirenz es un ITINN de VIH-1.
English: 6 years.
Spanish: 6 años.
English: Use only if no other alternative is available.
Spanish: Utilizar solo si no hay otra alternativa disponible.
English: Do not give this medicine to children under 12 years of age.
Spanish: No dé este medicamento a niños menores de 12 años.
English: The table is not all-inclusive.
Spanish: La tabla no es totalmente incluyente.
English: It also contains lactose.
Spanish: También contiene lactosa.
English: Date of first authorisation: 17 November 2014 Date of latest renewal: 01 August 2019
Spanish: Fecha de la primera autorización: 17 noviembre 2014 Fecha de la última renovación: 01 agosto 2019
English: • other liver problems apart from hepatitis C, for instance
Spanish: • otros problemas hepáticos aparte de la hepatitis C, por ejemplo
English: • If you are currently taking any of the following medicines:
Spanish: • Si está tomando actualmente alguno de los siguientes medicamentos:
English: Treatment duration was fixed in each study.
Spanish: La duración del tratamiento era fija en cada ensayo.
English: The final study report shall be submitted by:
Spanish: El informe final del estudio se presentará el:
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur.
Spanish: Por tanto, usted y su pareja deben tomar precauciones especiales en la actividad sexual si existe alguna posibilidad de que se produzca un embarazo.
English: e These are drugs within class where similar interactions could be predicted.
Spanish: e. Estos son fármacos dentro de una clase donde se pudieron predecir interacciones similares.
English: The clinical significance of this substitution is currently unknown.
Spanish: La trascendencia clínica de esta sustitución se desconoce actualmente.
English: The recommended dose is one tablet once a day.
Spanish: La dosis recomendada es un comprimido una vez al día.
English: The mechanism is not established.
Spanish: El mecanismo no está establecido.
English: Do not drive or operate machines if you feel tired after taking your medicine.
Spanish: No conduzca ni maneje máquinas si se siente cansado después de tomar el medicamento.
English: (Induction of CYP3A) Expected:
Spanish: (Inducción de CYP3A) Prevista:
English: Summary of the safety profile in adults
Spanish: Resumen del perfil de seguridad en adultos
English: Ask your doctor for effective contraceptive method suitable for you.
Spanish: Pregunte a su médico qué método anticonceptivo eficaz es adecuado para usted.
English: Effects of food
Spanish: Efectos de los alimentos
English: The effects of higher doses are not known.
Spanish: Se desconocen los efectos de dosis más altas.
English: The following pack sizes are available:
Spanish: Están disponibles los siguientes tamaños de envases:
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Spanish: Lleve consigo el frasco de comprimidos para describir con facilidad lo que ha tomado.
English: Like all medicines, this medicine may cause side effects.
Spanish: Al igual que todos los medicamentos, este medicamento puede producir efectos adversos.
English: The majority of patients (84%) had been infected through vertical transmission.
Spanish: La mayoría de los pacientes (el 84%) se habían infectado por transmisión vertical.
English: NS: not studied.
Spanish: NE: no estudiado.
English: The active metabolite is not observed.
Spanish: No se observa el metabolito activo.
English: > or = 75
Spanish: > o = 75
English: No effect = 1.00. b All interaction studies conducted in healthy volunteers.
Spanish: Ausencia de efecto = 1,00. b. Todos los ensayos de interacciones se realizaron en voluntarios sanos.
English: Then take the next dose at your usual time.
Spanish: A continuación, tome la siguiente dosis a la hora habitual.
English: The most common variant was Y93H.
Spanish: La variante más frecuente fue Y93H.
English: Treatment and duration
Spanish: Tratamiento y duración
English: h Bioequivalence/Equivalence boundary 80-125%.
Spanish: h. Límite de bioequivalencia/equivalencia del 80-125 %.
English: Ribavirin was discontinued in 15% of the patients.
Spanish: La ribavirina se interrumpió en el 15% de los pacientes.
English: g This study was conducted in the presence of another two direct-acting antiviral agents.
Spanish: g. Este estudio se realizó en presencia de otros dos fármacos antivirales de acción directa.
English: • you have diabetes.
Spanish: • padece diabetes.
English: AUC, Cmax, Cmina, b
Spanish: Cmax, Cmina,b
English: It is important not to miss a dose of this medicine.
Spanish: Es importante que no omita ninguna dosis de este medicamento.
English:  If this applies to you, do not take Harvoni and tell your doctor immediately.
Spanish: Si este es su caso, no tome Harvoni e informe a su médico inmediatamente.
English: • ongoing treatment for HIV infection, since your doctor may want to monitor you more closely.
Spanish: • tratamiento en curso por infección por el VIH, ya que tal vez su médico quiera controlarle más estrechamente.
English: Study 1468 (LEPTON)
Spanish: Ensayo 1468 (LEPTON)
English: Evidence of slow oxidative metabolism via an unknown mechanism has been observed.
Spanish: Se han observado datos indicativos de un metabolismo oxidativo lento a través de un mecanismo desconocido.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Spanish: No utilice este medicamento después de la fecha de caducidad que aparece en el frasco y la caja después de “CAD”.
English: The two studies were identical in study design.
Spanish: Los dos ensayos tenían un diseño idéntico.
English: * Patients lost to follow-up or who withdrew consent excluded.
Spanish: * Excluidos los pacientes perdidos para el seguimiento o que retiraron su consentimiento.
English: What Harvoni is and what it is used for
Spanish: Qué es Harvoni y para qué se utiliza
English: Do not take a double dose (two doses close together).
Spanish: No tome una dosis doble (dos dosis en un corto intervalo de tiempo).
English: The adverse reactions are listed below by body system organ class and frequency.
Spanish: Las reacciones adversas se incluyen a continuación según el sistema de clasificación de órganos y frecuencia.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Spanish: No se conoce la frecuencia de los siguientes efectos adversos (la frecuencia no puede estimarse a partir de los datos disponibles).
English: • Your doctor can decide if you should take Harvoni and for how long;
Spanish: • Su médico pueda decidir si debe tomar Harvoni y durante cuánto tiempo;
English: SVR12 was achieved in 18/18 patients.
Spanish: Se logró RVS12 en 18/18 pacientes.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Spanish: Se han demostrado efectos teratogénicos y/o embriocidas significativos en todas las especies animales expuestas a la ribavirina.
English: Such co-administration is not recommended.
Spanish: No se recomienda dicha administración concomitante.
English: Of the 155 patients enrolled, 1 patient discontinued treatment whilst on placebo.
Spanish: De los 155 pacientes inscritos, 1 paciente interrumpió el tratamiento mientras recibía placebo.
English: < 12 g/dL despite 4 weeks at reduced dose
Spanish: <12 g/dl a pesar de 4 semanas de tratamiento con la dosis reducida
English: 1.6-fold↑
Spanish: 1,6 veces↑
English: Harvoni [Outer packaging only]
Spanish: Harvoni [Embalaje exterior solamente]
English: The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Spanish: Los principios activos del medicamento actúan conjuntamente bloqueando dos proteínas diferentes que el virus necesita para crecer y reproducirse, lo que permite eliminar la infección permanentemente del organismo.
English: Consequently, consideration should be given to longer treatment for patients with uncertain subsequent retreatment options.
Spanish: En consecuencia, se debe contemplar un tratamiento más largo en pacientes con opciones inciertas de repetición del tratamiento.
English: It is very important that you read the “Pregnancy” section in the ribavirin package leaflet very carefully.
Spanish: Es muy importante que lea muy detenidamente la sección "Embarazo" del prospecto de ribavirina.
English: These medicines can decrease the amount of ledipasvir in your blood.
Spanish: Estos medicamentos pueden reducir la cantidad de ledipasvir presente en la sangre.
English: • The other ingredients are
Spanish: • Los demás componentes son:
English: Do not chew, crush or split the tablet as it has a very bitter taste.
Spanish: No mastique, machaque ni parta el comprimido, ya que tiene un sabor muy amargo.
English: As a precautionary measure, it is preferable to avoid the use of Harvoni during pregnancy.
Spanish: Como medida de precaución, es preferible evitar el uso de Harvoni durante el embarazo.
English: If you take more Harvoni than you should
Spanish: Si toma más Harvoni del que debe
English: It is very important that you also read the leaflets for the other medicines that you will be taking with Harvoni.
Spanish: Es muy importante que lea también los prospectos de los demás medicamentos que vaya a tomar con Harvoni.
English: Exposure to ledipasvir decreases with increasing body weight but the effect is not considered to be clinically relevant.
Spanish: La exposición a ledipasvir disminuye con el aumento del peso corporal pero el efecto no se considera clínicamente relevante.
English: Harvoni for 12 weeks.
Spanish: Harvoni durante 12 semanas.
English: Subsequently, the marketing authorisation holder (MAH) shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Spanish: Posteriormente, el titular de la autorización de comercialización presentará IPSs para este medicamento de conformidad con los requerimientos establecidos en la lista de fechas de referencia de la Unión (lista EURD) prevista en el artículo 107 quater, apartado 7, de la Directiva 2001/83/CE y publicados en el portal web europeo sobre medicamentos.
English: Stable replicons
Spanish: Replicones estables
English: Do not stop taking this medicine unless your doctor tells you to.
Spanish: No interrumpa el tratamiento con este medicamento a menos que su médico se lo indique.
English: Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
Spanish: Consulte inmediatamente a su médico si está tomando cualquier medicamento para tratar problemas de corazón y, durante el tratamiento, experimenta:
English: Limited data indicate that such NS5A mutations do not revert on long-term follow-up.
Spanish: Datos limitados indican que dichas mutaciones de NS5A no revierten durante el seguimiento a largo plazo.
English: • If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Spanish: • Si es alérgico a ledipasvir, sofosbuvir o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6 de este prospecto).
English: If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Spanish: Si está tomando alguno de estos medicamentos, su médico le dará un medicamento distinto para las úlceras de estómago, los ardores o el reflujo ácido o le recomendará cómo y cuándo tomar dicho medicamento.
English: d Lack of pharmacokinetics interaction bounds 70-143%.
Spanish: d. Límites de ausencia de interacción farmacocinética del 70-143 %.
English: If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice.
Spanish: Si toma accidentalmente una cantidad mayor que la dosis recomendada, se debe poner en contacto inmediatamente con su médico o el servicio de urgencias más cercano para que le asesoren.
English: 1200 mg/day
Spanish: 1.200 mg/día
English: Skin disorders Frequency Not known: Stevens-Johnson syndrome
Spanish: Trastornos de la piel Frecuencia no conocida: síndrome de Stevens-Johnson
English: • swelling of the face, lips, tongue or throat (angioedema).
Spanish: • hinchazón de la cara, los labios, la lengua o la garganta (angioedema).
English: The combination should be used with caution with frequent renal monitoring, if other alternatives are not available (see section 4.4).
Spanish: La combinación se debe utilizar con precaución y con monitorización renal frecuente, si no se dispone de otras alternativas (ver sección 4.4).
English: If overdose occurs the patient must be monitored for evidence of toxicity.
Spanish: En caso de sobredosis, se debe vigilar al paciente por si hay evidencia de toxicidad.
English: • you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).
Spanish: • toma actualmente o ha dejado de tomar hace pocos meses el medicamento amiodarona para tratar el ritmo cardiaco irregular (el médico podría considerar tratamientos alternativos si ha tomado este medicamento).
English: Polyvinyl alcohol
Spanish: Alcohol polivinílico
English: • Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, heartburn or acid reflux.
Spanish: • Pida consejo a un médico o farmacéutico si toma medicamentos utilizados para tratar las úlceras de estómago, los ardores o el reflujo ácido.
English: Hepatitis C is a virus that infects the liver.
Spanish: La hepatitis C es una infección viral del hígado.
English: Your doctor will tell you for how many weeks you should take Harvoni.
Spanish: Su médico le indicará durante cuántas semanas debe tomar Harvoni.
English: • Your doctor can confirm that your treatment has worked and you are free of the hepatitis C
Spanish: • Su médico pueda confirmar que el tratamiento ha funcionado y ya no tiene el virus de la hepatitis C.
English: Talk to your doctor or pharmacist before taking Harvoni if:
Spanish: Consulte a su médico o farmacéutico antes de empezar a tomar Harvoni si:
English: Genotype 2b 16-530b
Spanish: Genotipo 2b 16-530b
English: Ledipasvir is > 99.8% bound to human plasma proteins.
Spanish: Ledipasvir se une a las proteínas plasmáticas humanas en >99,8 %.
English: Not known angioedema
Spanish: No conocida angioedema
English: If you do miss a dose, work out how long it is since you last took your Harvoni:
Spanish: Si omite una dosis, calcule cuánto tiempo hace que tomó el último Harvoni:
English: This may make Harvoni work less well.
Spanish: Esto puede hacer que Harvoni funcione peor.
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP51
Spanish: Grupo farmacoterapéutico: antiviral de acción directa, código ATC: J05AP51
English: Unchanged ledipasvir is also the major species present in faeces.
Spanish: El ledipasvir inalterado también es la principal forma presente en las heces.
English: Race and gender
Spanish: Raza y sexo
English: In genotype 4, 5 and 6 infection, only small numbers of patients have been evaluated (total of 5 patients with failure).
Spanish: En cuanto a la infección por el genotipo 4, 5 y 6, solo se ha evaluado un número escaso de pacientes (un total de 5 pacientes con fracaso).
English: These should be taken at least 4 hours before or 4 hours after Harvoni;
Spanish: Estos medicamentos se deben tomar al menos 4 horas antes o 4 horas después de Harvoni;
English: Patients with a CPT score > 12 were excluded.
Spanish: Se excluyó a los pacientes con una puntuación CPT >12.