FrancophonIA/ELRC3.0 huggingface dataset:
English: Steady-state plasma concentrations are attained by Day 6 at the 300 mg dose (once daily after twice daily loading dose at Day 1).
Spanish: Las concentraciones plasmáticas del estado de equilibrio se alcanzan antes del día 6 a la dosis de 300 mg (una vez al día, después de una dosis de "carga" dos veces al día el día 1).
English: In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
Spanish: En otro estudio en voluntarios sanos, la administración de dosis repetidas de posaconazol suspensión oral (200 mg dos veces al día durante 7 días) aumentó la Cmáx y el AUC de midazolam intravenoso (0,4 mg dosis única) en una media de 1,3 y 4,6 veces (intervalo de 1,7 a 6,4 veces), respectivamente; posaconazol suspensión oral 400 mg dos veces al día durante 7 días aumentó la Cmáx y el AUC de midazolam intravenoso en 1,6 y 6,2 veces (intervalo de 1,6 a 7,6 veces), respectivamente.
English: Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Spanish: Se debe evitar el uso concomitante de posaconazol con fenitoína e inductores similares (por ejemplo carbamazepina, fenobarbital, primidona), salvo que el beneficio para el paciente supere el riesgo.
English: Thereafter blood levels of ciclosporin should be monitored carefully during co-administration, and upon discontinuation of posaconazole treatment, and the dose of ciclosporin should be adjusted as necessary.
Spanish: A partir de entonces se deben controlar cuidadosamente los niveles sanguíneos de ciclosporina durante la administración concomitante y al suspender el tratamiento con posaconazol, y se debe ajustar la dosis de ciclosporina según sea necesario.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Spanish: Toma de Posaconazol Accord con otros medicamentos Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.
English: If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Accord.
Spanish: En caso de duda, consulte a su médico o farmacéutico antes de tomar Posaconazol Accord.
English: Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41% and 50%, respectively.
Spanish: Fenitoína (200 mg una vez al día) disminuyó la Cmáx y el AUC de posaconazol en un 41 % y un 50 %, respectivamente.
English: How to store Posaconazole Accord Contents of the pack and other information
Spanish: Conservación de Posaconazol Accord Contenido del envase e información adicional
English: Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient outweighs the risk.
Spanish: Se debe evitar el uso concomitante de posaconazol con efavirenz salvo que el beneficio para el paciente supere el riesgo.
English: hearing impairment
Spanish: • sentirse hinchado
English: The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day, thereafter.
Spanish: La dosis habitual es de 300 mg (tres comprimidos de 100 mg) dos veces al día el primer día, y posteriormente de 300 mg (tres comprimidos de 100 mg) una vez al día.
English: Non-Interchangeability between Posaconazole Accord tablets and posaconazole oral suspension
Spanish: No se permite el uso indistinto entre Posaconazol Accord comprimidos y posaconazol suspensión oral
English: - Candida albicans: S ≤0.06 mg/L, R >0.06 mg/L - Candida tropicalis: S ≤0.06 mg/L, R >0.06 mg/L - Candida parapsilosis: S ≤0.06 mg/L, R >0.06 mg/L
Spanish: • Candida albicans: S ≤0,06 mg/l, R >0,06 mg/l
English: Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
Spanish: En el estudio a 2 años en ratas se observó una fosfolipidosis pulmonar, que dio lugar a una dilatación y obstrucción de los alveolos.
English: Concomitant use of posaconazole and rifabutin and similar inducers (e.g. rifampicin) should be avoided unless the benefit to the patient outweighs the risk.
Spanish: El uso concomitante de posaconazol y rifabutina e inductores similares (por ejemplo rifampicina) se debe evitar salvo que el beneficio para el paciente supere el riesgo.
English: Posaconazole oral suspension
Spanish: Posaconazol suspensión oral
English: b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
Spanish: En el estudio 1899 era el periodo desde la aleatorización hasta la última dosis del medicamento de estudio más 7 días; en el estudio 316 era el periodo desde la primera dosis hasta la última dosis del medicamento de estudio más 7 días.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Posaconazole Accord.
Spanish: Si se encuentra en alguna de las circunstancias anteriores (o en caso de duda), consulte a su médico, farmacéutico o enfermero antes de tomar Posaconazol Accord.
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Spanish: Después de la administración de comprimidos de posaconazol las concentraciones plasmáticas de posaconazol pueden aumentar en algunos pacientes con el paso del tiempo.
English: Posaconazole is a potent inhibitor of CYP3A4.
Spanish: Efectos de posaconazol sobre otros medicamentos Posaconazol es un potente inhibidor del CYP3A4.
English: Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Spanish: Dosis de "carga" de 300 mg (tres comprimidos de 100 mg) dos veces al día el primer día y posteriormente 300 mg (tres comprimidos de 100 mg) una vez al día.
English: Based on average Cmin concentrations, a predicted average concentration (Cav) could be calculated for 186 subjects dosed with 300 mg. PK analysis in patients of Cav found that 81% of the subjects treated with the 300 mg once daily dose attained steady state predicted Cav between 500-2,500 ng/mL.
Spanish: El análisis para farmacocinética de Cm en pacientes encontró que el 81 % de los sujetos tratados con la dosis de 300 mg una vez al día alcanzó la Cm prevista en el estado de equilibrio de entre 500-2.500 ng/ml.
English: See Section 4 for more information
Spanish: Para obtener más información, ver sección 4.
English: Posaconazole Accord contains a medicine called posaconazole.
Spanish: Posaconazol Accord contiene un medicamento llamado posaconazol, que pertenece a un grupo de medicamentos denominados "antifúngicos".
English: Hydroxypropyl cellulose (E463) Propyl gallate (E310)
Spanish: Hidroxipropil celulosa (E463) Galato de propilo (E310) Celulosa microcristalina (E-460) Sílice coloidal anhidra
English: Repeat dose administration of posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Spanish: La administración de dosis repetidas de posaconazol suspensión oral (400 mg dos veces al día durante 16 días) aumentó la Cmáx y el AUC de sirolimus (2 mg dosis única) una media de 6,7 veces y 8,9 veces (intervalo de 3,1 a 17,5 veces), respectivamente, en sujetos sanos.
English: 96 gastro-resistant tablets
Spanish: 24 comprimidos gastrorresistentes 96 comprimidos gastrorresistentes
English: After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77% of the radiolabelled dose) with the major component being parent compound (66% of the radiolabelled dose).
Spanish: (77 % de la dosis radiomarcada), siendo el componente principal el compuesto parental (66 % de la dosis radiomarcada).
English: General disorders and administration site conditions Common:
Spanish: Trastornos generales y alteraciones en el lugar de administración Frecuentes: Poco frecuentes:
English: d: All randomized e: All treated
Spanish: Todos los aleatorizados e:
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Spanish: Después de la administración concomitante de posaconazol suspensión oral (400 mg dos veces al día) con atazanavir y ritonavir (300/100 mg una vez al día) durante 7 días en sujetos sanos la Cmáx y el AUC de atazanavir aumentaron una media de 1,5 y 2,5 veces (intervalo de 0,9 a 4,1 veces), respectivamente.
English: INFORMATION IN BRAILLE Posaconazole Accord 100 mg
Spanish: Posaconazol Accord 100 mg
English: For oral use.
Spanish: Vía oral
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold respectively.
Spanish: Después de la administración concomitante de posaconazol suspensión oral (400 mg dos veces al día) con atazanavir (300 mg una vez al día) durante 7 días en sujetos sanos la Cmáx y el AUC de atazanavir aumentaron una media de 2,6 y 3,7 veces (intervalo de 1,2 a 26 veces), respectivamente.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Posaconazole Accord.
Spanish: Si se encuentra en alguna de las circunstancias anteriores (o en caso de duda), consulte a su médico o farmacéutico antes de tomar Posaconazol Accord.
English: Do not take Posaconazole Accord if any of the above apply to you.
Spanish: No tome Posaconazol Accord si se encuentra en alguna de las circunstancias anteriores.
English: - some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbital or primidone).
Spanish: • algunos medicamentos utilizados para tratar o prevenir ataques incluyen: fenitoína,
English: altered medicine levels, blood phosphorus decreased, chest x-ray abnormal * Based on adverse reactions observed with the oral suspension, gastro-resistant tablets, and concentrate for solution for infusion.
Spanish: *Basadas en las reacciones adversas observadas con la suspensión oral, con los comprimidos gastrorresistentes y con el concentrado para solución para perfusión.
English: There is no paediatric experience with posaconazole tablets.
Spanish: No existe experiencia pediátrica con posaconazol comprimidos.
English: There is no experience with overdose of posaconazole tablets.
Spanish: No existe experiencia clínica relativa a la sobredosis de posaconazol comprimidos.
English: long QT syndrome§, electrocardiogram abnormal§, palpitations, bradycardia, supraventricular extrasystoles, tachycardia
Spanish: síndrome del QT prolongado§, electrocardiograma anormal§, palpitaciones, bradicardia, extrasístoles supraventriculares, taquicardia “torsade de pointes”, muerte repentina, taquicardia ventricular, parada cardiorrespiratoria, insuficiencia cardiaca, infarto de miocardio
English: Posaconazole Accord 100 mg gastro-resistant tablets posaconazole
Spanish: Posaconazol Accord 100 mg comprimidos gastrorresistentes posaconazol
English: NAME OF THE MEDICINAL PRODUCT Posaconazole Accord 100 mg gastro-resistant tablets
Spanish: NOMBRE DEL MEDICAMENTO Posaconazol Accord 100 mg comprimidos gastrorresistentes EFG
English: pancreatitis, abdominal distension, enteritis, epigastric discomfort, eructation, gastrooesophageal reflux disease, oedema mouth
Spanish: náuseas vómitos, dolor abdominal, diarrea, dispepsia, sequedad de boca, flatulencia, estreñimiento, molestia anorrectal pancreatitis, distensión abdominal, enteritis, malestar epigástrico, eructos, enfermedad por reflujo gastroesofágico, edema de la boca hemorragia gastrointestinal, íleo
English: menstrual disorder
Spanish: trastorno menstrual dolor de mama
English: - This medicine has been prescribed for you only.
Spanish: Cómo se administra este medicamento
English: thrombocytopenia, leukopenia, anaemia, eosinophilia, lymphadenopathy, splenic infarction
Spanish: neutropenia trombocitopenia, leucopenia, anemia, eosinofilia, linfadenopatía, infarto esplénico síndrome urémico hemolítico, púrpura trombocitopénica trombótica, pancitopenia, coagulopatía, hemorragia
English: cough, epistaxis, hiccups, nasal congestion, pleuritic pain, tachypnoea
Spanish: tos, epistaxis, hipo, congestión nasal, dolor pleurítico, taquipnea hipertensión pulmonar, neumonía intersticial, neumonitis
English: ● Risk Management Plan (RMP)
Spanish: • retención de líquidos (edema)
English: EUCAST ECOFF values: - Aspergillus flavus: 0.5 mg/L - Aspergillus fumigatus: 0.25 mg/L - Aspergillus nidulans: 0.5 mg/L - Aspergillus niger: 0.5 mg/L - Aspergillus terreus: 0.25 mg/L
Spanish: • Aspergillus fumigatus: 0,25 mg/l
English: If you forget to take Posaconazole Accord - If you forget a dose, take it as soon as you remember it. - However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule.
Spanish: • No obstante, si es casi la hora de la siguiente dosis, no tome la dosis omitida y reanude su programa de dosis habitual.
English: Ergot alkaloids
Spanish: Alcaloides del ergot
English: mouth ulceration, alopecia, dermatitis, erythema, petechiae
Spanish: erupción, prurito ulceración de la boca, alopecia, dermatitis, eritema, petequias síndrome de Stevens Johnson, erupción vesicular
English: How to store Posaconazole Accord
Spanish: Conservación de Posaconazol Accord
English: blurred vision, photophobia, visual acuity reduced
Spanish: visión borrosa, fotofobia, agudeza visualdisminuida diplopía, escotoma
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Spanish: pirexia (fiebre), astenia, fatiga edema, dolor, escalofríos, malestar general, malestar torácico, intolerancia a los medicamentos, sensación de inquietud, inflamación de mucosa edema de la lengua, edema de cara
English: Talk to your doctor or pharmacist before taking Posaconazole Accord - if you have had an allergic reaction to another antifungal medicine such as ketoconazole,
Spanish: • ha presentado una reacción alérgica a otro medicamento antifúngico, como ketoconazol,
English: What Posaconazole Accord contains The active substance is posaconazole.
Spanish: El principio activo es posaconazol.
English: A. terreus
Spanish: • eructos
English: Vinca alkaloids
Spanish: Alcaloides de la vinca
English: This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as: - patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS) - patients having “high- dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Spanish: • pacientes que presenten un sistema inmunitario débil como consecuencia de haber recibido quimioterapia para "leucemia mielógena aguda" (LMA) o "síndromes mielodisplásicos" (SMD)
English: which are given with ritonavir) - midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants) - diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure) - digoxin (used to treat heart failure) - Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Spanish: • midazolam, triazolam, alprazolam u otras "benzodiazepinas" (utilizados como sedantes o relajantes musculares)
English: pyrexia (fever), asthenia, fatigue
Spanish: • náuseas o vómitos (sentirse o estar enfermo), diarrea
English: The following medicines may decrease the effectiveness of Posaconazole Accord by decreasing the amount of Posaconazole Accord in the blood: - rifabutin and rifampicin (used to treat certain infections).
Spanish: Los siguientes medicamentos pueden disminuir la efectividad de Posaconazol Accord al reducir sus niveles en sangre:
English: OTHER SPECIAL WARNING(S), IF NECESSARY Posaconazole oral suspension and tablets are NOT interchangeable.
Spanish: Posaconazol Accord suspensión oral y comprimidos NO se usan indistintamente.
English: Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Spanish: Respuesta Global Éxito por especies Todas confirmadas micológicamente Aspergillus spp 2 A. fumigatus A. flavus A. terreus A. níger 2 Incluye otras especies menos frecuentes o especies desconocidas
English: hypotension, vasculitis
Spanish: • hemorragias nasales
English: A. fumigatus
Spanish: • desmayo
English: Stevens Johnson syndrome, vesicular rash Musculoskeletal and connective tissue disorders Uncommon:
Spanish: Trastornos musculoesqueléticos y del tejido conjuntivo Poco frecuentes:
English: convulsions, neuropathy, hypoaesthesia, tremor, aphasia, insomnia
Spanish: parestesia, mareo, somnolencia, cefalea, disgeusia convulsiones, neuropatía, hipoestesia, temblor, afasia, insomnio accidente cerebrovascular, encefalopatía, neuropatía periférica, síncope
English: Tell your doctor or pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment: - nausea or vomit (feeling or being sick), diarrhoea - signs of liver problems - these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests - allergic reaction.
Spanish: • signos de problemas hepáticos, que incluyen amarilleamiento de la piel o del blanco de los ojos, orina inusualmente oscura o heces pálidas, sentirse enfermo sin motivo aparente, problemas del estómago,
English: Other medicines and Posaconazole Accord
Spanish: Contenido del envase e información adicional Composición de Posaconazol Accord
English: Do not breast-feed while taking Posaconazole Accord.
Spanish: No dé el pecho mientras esté tomando Posaconazol Accord, ya que puede pasar a la leche materna en pequeñas cantidades.
English: pulmonary hypertension, interstitial pneumonia, pneumonitis
Spanish: hipertensión hipotensión, vasculitis embolismo pulmonar, trombosis venosa profunda
English: acute renal failure, renal failure, blood creatinine increased
Spanish: fallo renal agudo, fallo renal, creatinina elevada en sangre acidosis tubular renal, nefritis intersticial
English: high or low blood pressure - low blood pressure - inflammation of the pancreas (pancreatitis) - this may cause severe stomach pain - oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain - severe kidney problems - signs include passing more or less urine, that is a different colour than usual - high blood levels of creatinine - shown in blood tests - cough, hiccups - nose bleeds - severe sharp chest pain when breathing in (pleurritic pain) - swelling of lymph glands (lymphadenopathy) - reduced feeling of sensitivity especially on the skin - tremor - high or low blood sugar levels - blurred vision, sensitivity to light - hair loss (alopecia) - mouth ulcers - shivering, feeling generally unwell - pain, back or neck pain, pain in arms or legs - water retention (oedema) - menstrual problems (abnormal vaginal bleeding)
Spanish: pruebas de función hepática elevadas (ALT elevada, AST elevada, bilirrubina elevada, fosfatasa alcalina elevada, GGT elevada) lesión hepatocelular, hepatitis, ictericia, hepatomegalia, colestasis, toxicidad hepática, función hepática anormal insuficiencia hepática, hepatitis colestática, hepatoesplenomegalia, dolor a la palpación del hígado, asterixis
English: Fixed-time periodc
Spanish: Periodo de tiempo fijadoc
English: Posaconazole Accord can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them: - infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped; - infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped; - infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped; - infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.
Spanish: • infecciones causadas por un hongo llamado Coccidioides que no han mejorado durante el tratamiento con uno o varios medicamentos, amfotericina B, itraconazol o fluconazol, o cuando se ha tenido que interrumpir el tratamiento con estos medicamentos.
English: These medicines include: - vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer) - ciclosporin (used during or after transplant surgery) - tacrolimus and sirolimus (used during or after transplant surgery) - rifabutin (used to treat certain infections) - medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir,
Spanish: • medicamentos utilizados para tratar VIH llamados inhibidores de la proteasa (incluyendo lopinavir y atazanavir, que se administran con ritonavir)
English: Invasive aspergillosis
Spanish: • úlceras bucales
English: Elderly
Spanish: Cuartil
English: A. flavus
Spanish: • temblores
English: INTEGRILIN must not be used to treat patients with:
Spanish: INTEGRILIN no debe utilizarse en el tratamiento de pacientes con:
English: In the absence of compatibility studies, INTEGRILIN must not be mixed with other medicinal products except those mentioned in 6.6.
Spanish: En ausencia de estudios de compatibilidad, INTEGRILIN no debe mezclarse con otros medicamentos excepto con los mencionados en 6.6.
English: INTEGRILIN should not be used during pregnancy unless clearly necessary.
Spanish: INTEGRILIN no debe utilizarse durante el embarazo excepto si fuese claramente necesario.
English: According to epidemiological findings, a higher incidence of cardiovascular events has been associated with certain indicators, for instance:
Spanish: Según los hallazgos epidemiológicos, se ha asociado una mayor incidencia de acontecimientos cardiovasculares con ciertos indicadores, por ejemplo:
English: − Integrilin is not intended for use in children or adolescents less than 18 years of age.
Spanish: - Integrilin no debe emplearse en niños o adolescentes menores de 18 años.
English: What Integrilin is and what it is used for
Spanish: Qué es Integrilin y para qué se utiliza
English: − hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Spanish: − hipersensibilidad al principio activo o a alguno de los excipientes incluidos en la sección 6.1
English: It is not recommended for use in children and adolescents below 18 years of age, due to a lack of data on safety and efficacy.
Spanish: INTEGRILIN no está recomendado para uso en niños y adolescentes menores de 18 años de edad debido a la ausencia de datos sobre seguridad y eficacia.
English: Frequencies are defined as very common (≥1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Spanish: Las frecuencias se definen como: muy frecuentes (≥ 1/10); frecuentes (≥ 1/100 a < 1/10); poco frecuentes (≥ 1/1.000 a < 1/100); raras (≥ 1/10.000 a < 1/1.000); muy raras (< 1/10.000).