FrancophonIA/ELRC3.0 huggingface dataset:
English: Certain medicines may increase the risk of side effects of Posaconazole AHCL by increasing the amount of Posaconazole AHCL in the blood.
Spanish: Algunos medicamentos pueden aumentar el riesgo de efectos adversos de Posaconazol AHCL por aumentar la cantidad de Posaconazol AHCL en la sangre.
English: Look at the list of medicines given above that must not be taken while you are taking Posaconazole AHCL.
Spanish: Consulte la lista proporcionada anteriormente con los medicamentos que no debe usar mientras esté tomando Posaconazol AHCL.
English: Each dose of Posaconazole AHCL should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.
Spanish: Cada dosis de Posaconazol AHCL debe administrarse durante o inmediatamente después de una comida, o un suplemento alimenticio, en pacientes que no pueden tolerar comida para aumentar la absorción oral y para garantizar una exposición adecuada.
English: Posaconazole AHCL must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
Spanish: Posaconazol AHCL no se debe administrar con medicamentos que sean sustratos del CYP3A4 y que prolonguen el intervalo QTc (ver secciones 4.3 y 4.5).
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz and cimetidine
Spanish: Antibacterianos de rifamicina (rifampicina, rifabutina), ciertos anticonvulsivantes (fenitoína, carbamazepina, fenobarbital, primidona), efavirenz y cimetidina
English: Proportion (%) of patients with proven/probable IFIs On-treatment periodb
Spanish: Porcentaje (%) de pacientes con IFI probadas/probables Durante el periodo de tratamientob
English: Posaconazole concentrations may be significantly lowered in combination; therefore, concomitant use with posaconazole should be avoided unless the benefit to the patient outweighs the risk (see section
Spanish: Las concentraciones de posaconazol se pueden reducir de forma significativa con la combinación; por lo tanto, el uso concomitante con posaconazol se debe evitar salvo que el beneficio para el paciente supere el riesgo (ver sección 4.5).
English: Posaconazole AHCL may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Spanish: Posaconazol AHCL posiblemente aumente el riesgo de efectos adversos de otros medicamentos aumentando la cantidad de éstos en la sangre.
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (1.7 times the 400 mg twice daily regimen based on steady-state plasma concentrations in healthy volunteers) or female rats at a dose up to 45 mg/kg (2.2 times the 400-mg twice daily regimen).
Spanish: Posaconazol no tuvo efecto sobre la fertilidad de ratas macho a dosis de hasta 180 mg/kg (1,7 veces la pauta de 400 mg dos veces al día, basada en las concentraciones plasmáticas en equilibrio en voluntarios sanos), ni sobre la fertilidad de ratas hembra a dosis de hasta 45 mg/kg (2,2 veces la pauta de 400 mg dos veces al día).
English: What Posaconazole AHCL is and what it is used for
Spanish: Qué es Posaconazol AHCL y para qué se utiliza
English: Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/mL) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/mL).
Spanish: Tras la administración de 800 mg al día de posaconazol en dosis fraccionadas para el tratamiento de infecciones fúngicas invasoras, las concentraciones mínimas plasmáticas medias de 12 pacientes de 8 - 17 años de edad (776 ng/ml) fueron similares a las concentraciones de 194 pacientes de 18 - 64 años de edad (817 ng/ml).
English: Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during co-administration with posaconazole.
Spanish: Se recomienda la monitorización frecuente de reacciones adversas y toxicidad relacionadas con agentes antirretrovirales que son sustratos de CYP3A4 durante la administración concomitante con posaconazol.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of oral suspension contains 40 mg of posaconazole.
Spanish: COMPOSICIÓN CUALITATIVA Y CUANTITATIVA Cada ml de suspensión oral contiene 40 mg de posaconazol.
English: Treatment of azole-susceptible Oropharyngeal Candidiasis (OPC) A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azolesusceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Spanish: Se realizó un estudio aleatorizado, ciego para el evaluador y controlado, en pacientes infectados por VIH con candidiasis orofaríngea sensible a azoles (en la mayoría de los pacientes estudiados se había aislado C. albicans en la evaluación basal).
English: The majority (377/600, [63 %]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5%]) GVHD at study start.
Spanish: La mayoría de los pacientes incluidos tenía al inicio del estudio EICH aguda de grado 2 o 3 (377/600, [63 %]) o EICH extensiva crónica (195/600, [32,5 %]).
English: Macrogolglycerol hydroxystearate
Spanish: Hidroxiestearato de macrogolglicerol
English: Xanthan gum (E415)
Spanish: Xantano (E415)
English: Name and address of the manufacturer(s) responsible for batch release
Spanish: Nombre y dirección del/de los fabricantes responsables de la liberación de los lotes
English: No special requirements
Spanish: No requiere medidas especiales.
English: It should be noted that the relationship between sirolimus trough concentration and AUC is changed during co- administration with posaconazole.
Spanish: Se debe tener en cuenta que la relación entre la concentración mínima y el AUC de sirolimus varía durante la administración concomitante de posaconazol.
English: Strawberry flavour (containing propylene glycol)
Spanish: Sabor a fresa (contiene propilenglicol)
English: Simeticone emulsion (containing polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid (E200), benzoic acid (E210) and sulfuric acid (E513))
Spanish: Emulsión de simeticona (que contiene polidimetilsiloxano, triestearato de polietilenglicol sorbitano, metilcelulosa, gel de sílice, estearato de polietilenglicol, ácido sórbico (E200), ácido benzoico (E210) y ácido sulfúrico (E513))
English: Caution should be used when prescribing Posaconazole AHCL to patients with hypersensitivity to other azoles.
Spanish: Posaconazol AHCL debe prescribirse con precaución a pacientes con hipersensibilidad a otros azoles.
English: The other ingredients in the suspension are macrogolglycerol hydroxystearate, sodium citrate dihydrate, citric acid monohydrate, simeticone emulsion (containing polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid (E200), benzoic acid (E210) and sulfuric acid (E513)), xanthan gum (E415), sodium benzoate (E211), liquid glucose, glycerol (E422), titanium dioxide (E171), strawberry flavour (containing propylene glycol) and purified water.
Spanish: - Los demás componentes de la suspensión son hidroxiestearato de macrogolglicerol, citrato de sodio dihidrato, ácido cítrico monohidrato, emulsión de simeticona (que contiene polidimetilsiloxano, triestearato de polietilenglicol sorbitano, metilcelulosa, gel de sílice, estearato de polietilenglicol, ácido sórbico (E200), ácido benzoico (E210) y ácido sulfúrico (E513)), xantano (E415), benzoato sódico (E211), glucosa líquida, glicerol (E422), dióxido de titanio (E171), sabor a fresa (contiene propilenglicol) y agua purificada.
English: What Posaconazole AHCL looks like and contents of the pack Posaconazole AHCL is a white to off-white free flowing suspension, packaged in amber glass bottle.
Spanish: Posaconazol AHCL es una suspensión oral blanca a blanquecina, de flujo libre, envasada en frascos de vidrio color ámbar.
English: Do not take Posaconazole AHCL - if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
Spanish: • es alérgico a posaconazol o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).
English: On the first day of treatment take 200 mg (one 5 mL spoonful) once.
Spanish: El primer día de tratamiento tome 200 mg (una cucharada de 5 ml) una vez.
English: Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Spanish: - aspergilosis invasora en pacientes con enfermedad resistente a amfotericina B o itraconazol, o en pacientes que son intolerantes a estos medicamentos; - fusariosis en pacientes con enfermedad resistente a amfotericina B, o en pacientes que son intolerantes a amfotericina B; - cromoblastomicosis y micetoma en pacientes con enfermedad resistente a itraconazol, o en pacientes que son intolerantes a itraconazol; - coccidioidomicosis en pacientes con enfermedad resistente a amfotericina B, itraconazol o fluconazol, o en pacientes que son intolerantes a estos medicamentos; - candidiasis orofaríngea: como terapia de primera línea en pacientes que presentan enfermedad grave o que están inmunodeprimidos, en los que se espera que la respuesta a la terapia tópica sea insuficiente.
English: Posaconazole AHCL 40 mg/mL oral suspension posaconazole
Spanish: Posaconazol AHCL 40 mg/ml suspensión oral EFG posaconazol
English: NAME OF THE MEDICINAL PRODUCT Posaconazole AHCL 40 mg/mL oral suspension
Spanish: NOMBRE DEL MEDICAMENTO Posaconazol AHCL 40 mg/ml suspensión oral EFG
English: Discard after 30 days of opening.
Spanish: Deberá desecharse al cabo de 30 días de su apertura inicial.
English: The absorption of posaconazole was significantly increased when posaconazole 400 mg (once daily) was administered during and immediately after the consumption of a high fat meal (~ 50 grams fat) compared to administration before a meal, with Cmax and AUC increasing by approximately 330 % and 360 %, respectively.
Spanish: Efecto de los alimentos sobre la absorción oral en voluntarios sanos La absorción de posaconazol se incrementó considerablemente al administrarse 400 mg de posaconazol (una vez al día) durante o inmediatamente después de consumir una comida rica en grasas (~ 50 gramos de grasa), comparado con la administración antes de una comida, aumentándose la Cmáx y AUC aproximadamente un 330 % y 360 % respectivamente.
English: How to store Posaconazole AHCL Contents of the pack and other information
Spanish: Conservación de Posaconazol AHCL Contenido del envase e información adicional
English: Non-Interchangeability between posaconazole tablets and Posaconazole AHCL Oral Suspension The tablet and oral suspension are not to be used interchangeably due to the differences between these two formulations in frequency of dosing, administration with food and plasma drug concentration achieved.
Spanish: El comprimido y la suspensión oral no se deben usar indistintamente, debido a las diferencias existentes entre estas dos formulaciones en cuanto a la frecuencia de dosificación, la administración con la comida y la concentración plasmática alcanzada del medicamento.
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
English: blurred vision, photophobia, visual acuity reduced
Spanish: visión borrosa, fotofobia, agudeza visual disminuida diplopía, escotoma
English: What you need to know before you take Posaconazole AHCL
Spanish: Qué necesita saber antes de empezar a tomar Posaconazol AHCL
English: Posaconazole AHCL contains glucose
Spanish: Posaconazol AHCL contiene glucosa
English: POLAND
Spanish: POLONIA
English: If you are not sure, talk to your doctor or pharmacist before taking Posaconazole AHCL.
Spanish: En caso de duda, consulte a su médico o farmacéutico antes de tomar Posaconazol AHCL.
English: LIST OF EXCIPIENTS Contains glucose.
Spanish: Contiene glucosa.
English: Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41 % and 50 %, respectively.
Spanish: Fenitoína Fenitoína (200 mg una vez al día) disminuyó la Cmáx y el AUC de posaconazol en un 41 % y un 50 %,
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Posaconazole AHCL.
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 AHCL.
English: If you forget to take Posaconazole AHCL
Spanish: Si olvidó tomar Posaconazol AHCL
English: Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Spanish: - pacientes que estén recibiendo quimioterapia de remisión-inducción para leucemia mielógena aguda (LMA) o síndromes mielodisplásicos (SMD), que se espera que desarrollen neutropenia prolongada y que presentan alto riesgo de desarrollar infecciones fúngicas invasoras; - receptores de trasplante de células madre hematopoyéticas (TCMH) que están recibiendo dosis altas de terapia inmunosupresora para la enfermedad injerto contra huésped, y que presentan alto riesgo de desarrollar infecciones fúngicas invasoras.
English: Posaconazole AHCL contains a medicine called posaconazole.
Spanish: Posaconazol AHCL contiene un medicamento llamado posaconazol, que pertenece a un grupo de medicamentos denominados "antifúngicos".
English: Do not take Posaconazole AHCL if any of the above apply to you.
Spanish: No tome Posaconazol AHCL si se encuentra en alguna de las circunstancias anteriores.
English: How to take Posaconazole AHCL
Spanish: Cómo tomar Posaconazol AHCL
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL contains 40 mg of posaconazole.
Spanish: Cada ml contiene 40 mg de posaconazol.
English: The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
Spanish: 25 días para fluconazol/itraconazol.
English: - fits (convulsions) - nerve damage (neuropathy) - abnormal heart rhythm - shown up on a heart trace (ECG), palpitations, slow or fast heartbeat,
Spanish: • ritmo cardiaco anormal, detectado en un electrocardiograma (ECG), palpitaciones, latido cardiaco lento o rápido, presión arterial alta o baja
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Posaconazole AHCL.
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 AHCL.
English: Eye disorders Uncommon:
Spanish: Trastornos oculares Poco frecuentes: Raras:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Spanish: Toma de Posaconazol AHCL con otros medicamentos Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.
English: - bleeding into your stomach or gut - signs include vomiting blood or passing blood in your stool - a blockage in your gut (intestinal obstruction) especially in the “ileum”.
Spanish: • hemorragia en el estómago o el intestino, cuyos signos incluyen vomitar sangre o sangre en las heces
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 niger: 0,5 mg/l
English: torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
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: The following medicines may decrease the effectiveness of Posaconazole AHCL by decreasing the amount of Posaconazole AHCL in the blood: - rifabutin and rifampicin (used to treat certain infections).
Spanish: Los siguientes medicamentos pueden disminuir la efectividad de Posaconazol AHCL al reducir sus niveles en l a sangre:
English: OTHER SPECIAL WARNING(S), IF NECESSARY Posaconazole oral suspension and posaconazole tablets are NOT interchangeable.
Spanish: Posaconazol AHCL suspensión oral y posaconazol comprimidos NO se usan indistintamente.
English: flatulence, constipation, anorectal discomfort
Spanish: • tiritona, sensación habitual de malestar
English: INFORMATION IN BRAILLE Posaconazole AHCL
Spanish: Composición de Posaconazol AHCL
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension
Spanish: FORMA FARMACÉUTICA Y CONTENIDO DEL ENVASE
English: Talk to your doctor or pharmacist before taking Posaconazole AHCL - 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: Tell your doctor, 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: 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: If you take more Posaconazole AHCL than you should If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.
Spanish: Si está preocupado de que pueda haber tomado demasiada dosis, informe inmediatamente a su médico o profesional sanitario.
English: Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the
Spanish: La administración de dosis repetidas de fosamprenavir (700 mg dos veces al día durante 10 días) disminuyó la Cmáx y el AUC de posaconazol suspensión oral (200 mg una vez al día en el primer día, 200 mg dos veces al día en el segundo día, y después 400 mg dos veces al día durante 8 días) en un 21 % y 23 %, respectivamente.
English: Posaconazole AHCL 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: Do not breast-feed while taking Posaconazole AHCL.
Spanish: No dé el pecho mientras esté tomando Posaconazol AHCL, ya que puede pasar a la leche materna en pequeñas cantidades.
English: hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
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: vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth,
Spanish: • pérdida de apetito, dolor de estómago o malestar estomacal, flatulencia, boca seca, cambios en el sentido del gusto
English: First time treatment of Thrush
Spanish: Tratamiento de las Aftas por primera vez
English: diplopia, scotoma
Spanish: • tos, hipo
English: Chromoblastomycosis/Mycetoma, Coccidioidomycosis)
Spanish: "trasplante de células madre hematopoyéticas" (TCMH).
English: The doctor should instruct the patient on how to use the medicine properly.
Spanish: El médico debe indicar al paciente el modo de utilizar correctamente el medicamento.
English: Severe hypoglycaemia can lead to loss of consciousness and, in very extreme cases, to death.
Spanish: Una hipoglucemia grave puede conllevar la pérdida del conocimiento y, en casos muy extremos, la muerte.
English: Hypoglycaemia may be due to the medicine itself or other factors such as diet and exercise.
Spanish: La hipoglucemia puede deberse al propio medicamento o a otros factores, tales como la dieta y el ejercicio físico.
English: It can also be given with an infusion pump.
Spanish: Puede administrarse también con una bomba de perfusión.