FrancophonIA/ELRC3.0 huggingface dataset:
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: En caso de considerarse adecuado, se debe garantizar la reanudación del tratamiento contra la hepatitis B. No se recomienda interrumpir el tratamiento en pacientes con enfermedad hepática avanzada o cirrosis ya que la exacerbación de la hepatitis tras el tratamiento puede provocar una descompensación hepática.
English: • Provides information on how to take Emtricitabine/Tenofovir Mylan
Spanish: • Proporciona información sobre cómo tomar Emtricitabina/Tenofovir disoproxilo Mylan
English: If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Mylan, another tablet should be taken.
Spanish: Si se vomita en el plazo de 1 hora después de tomar Emtricitabina/Tenofovir disoproxilo Mylan, se debe tomar otro comprimido.
English: AUC: ↓ 28% (↓ 34 to ↓ 20) Cmax: ↓ 38% (↓ 46 to ↓ 29)
Spanish: AUC: ↓ 28% (↓ 34 a ↓ 20) Cmax: ↓ 38% (↓ 46 a ↓ 29)
English: Cmin: ↑ 63% (↑ 45 to ↑ 84)
Spanish: Cmin: ↑ 63% (↑ 45 a ↑ 84)
English: once daily.
Spanish: 2 años.
English: Cmax: ↑ 38% (↑ 14 to ↑ 67)
Spanish: Cmax: ↑ 38% (↑ 14 a ↑ 67)
English: AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25)
Spanish: AUC: ↓ 27% (↓ 35 a ↓ 18) Cmax: ↓ 37% (↓ 48 a ↓ 25)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Spanish: COMPOSICIÓN CUALITATIVA Y CUANTITATIVA Cada comprimido recubierto con película contiene 200 mg de emtricitabina y 245 mg de tenofovir disoproxilo (equivalente a 300 mg de tenofovir disoproxilo maleato).
English: The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Spanish: No se ha establecido la seguridad de tenofovir disoproxilo cuando se administra de forma concomitante con ledipasvir/sofosbuvir, sofosbuvir/velpatasvir o sofosbuvir/velpatasvir/voxilaprevir y un potenciador farmacocinético.
English: Cmin: ↑ 29% (↑ 15 to ↑ 44)
Spanish: Cmin: ↑ 29% (↑ 15 a ↑ 44)
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z score, and 0.184 and 0.027 in total body BMD Z score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Spanish: Los cambios medios en la semana 48 (final de la fase de aleatorización) fueron 0,032 y 0,087 en la puntuación Z de la DMO de la columna lumbar, y −0,184 y
English: Cmax: ↑ 55% (↑ 43 to ↑ 68) Cmin: ↑ 39% (↑ 31 to ↑ 48)
Spanish: Cmax: ↑ 55% (↑ 43 a ↑ 68) Cmin: ↑ 39% (↑ 31 a ↑ 48)
English: Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets emtricitabine/tenofovir disoproxil
Spanish: Emtricitabina/Tenofovir disoproxilo Mylan 200 mg/245 mg comprimidos recubiertos con película EFG Emtricitabina/tenofovir disoproxilo
English: Placebo Emtricitabine/tenofovir disoproxil
Spanish: Placebo Emtricitabina/tenofovir disoproxilo
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Spanish: AUC: ↓ 25% (↓ 42 a ↓ 3) Cmax: ↓ 28% (↓ 50 a ↑ 5) Cmin: ↓ 26% (↓ 46 a ↑ 10)
English: AUC: ↓ 12% (↓ 16 to ↓ 8) Cmax: ↓ 16% (↓ 22 to ↓ 10) Cmin: ↓ 15% (↓ 12 to ↓ 9)
Spanish: Rifampicina/Tenofovir disoproxilo Tenofovir: AUC: ↓ 12% (↓ 16 to ↓ 8) Cmax: ↓ 16% (↓ 22 to ↓ 10) Cmin: ↓ 15% (↓ 12 to ↓ 9)
English: If you vomit less than 1 hour after taking Emtricitabine/Tenofovir disoproxil Mylan, take another tablet.
Spanish: Si vomita antes de que transcurra 1 hora tras haber tomado Emtricitabina/Tenofovir disoproxilo Mylan, tome otro comprimido.
English: NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets
Spanish: NOMBRE DEL MEDICAMENTO Emtricitabina/Tenofovir disoproxilo Mylan 200 mg/245 mg comprimidos recubiertos con película EFG
English: If serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving Emtricitabine/tenofovir disoproxil, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Spanish: Si se confirma que el valor de fosfato sérico es <3,0 mg/dl (0,96 mmol/l) en cualquier paciente pediátrico que reciba emtricitabina/tenofovir disoproxilo, la evaluación de la función renal ha de repetirse dentro de una semana, incluyendo mediciones de la concentración de glucosa en sangre, potasio en sangre y glucosa en orina (ver sección 4.8, tubulopatía proximal).
English: Cmax: ↑ 47% (↑ 37 to ↑ 58) Cmin: ↑ 47% (↑ 38 to ↑ 57)
Spanish: Cmax: ↑ 47% (↑ 37 a ↑ 58) Cmin: ↑ 47% (↑ 38 a ↑ 57)
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
Spanish: AUC: ↓ 34% (↓ 41 a ↓ 25) Cmax: ↓ 34% (↓ 41 a ↑ 25) Cmin: ↓ 34% (↓ 43 a ↑ 24)
English: Cmin: ↑ 45% (↑ 27 to ↑ 64)
Spanish: Cmin: ↑ 45% (↑ 27 a ↑ 64)
English: AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
Spanish: AUC: ↑ 32% (↑ 25 a ↑ 38) Cmax: ↔
English: A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Spanish: 250 mg, junto con tenofovir disoproxilo se ha asociado con un elevado número de casos de fallo virológico tras la evaluación de varias combinaciones empleadas en el tratamiento de la infección por VIH-1.
English: Hepatic impairment
Spanish: Enfermedad hepática
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 60 mL/min in any individual receiving emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Spanish: Si el valor del fosfato sérico es <1,5 mg/dl (0,48 mmol/l) o el aclaramiento de creatinina disminuye <60 ml/min en cualquier individuo que reciba emtricitabina/tenofovir disoproxilo para la profilaxis preexposición, la evaluación de la función renal se ha de repetir en la siguiente semana, incluyendo niveles de concentración de glucosa en sangre, potasio en sangre y glucosa en orina (ver sección 4.8, tubulopatía proximal).
English: AUC: ↑ 96% (↑ 74 to ↑ 121) Cmax: ↑ 68% (↑ 54 to ↑ 84) Cmin: ↑ 118% (↑ 91 to ↑ 150)
Spanish: AUC: ↑ 96% (↑ 74 a ↑ 121) Cmax: ↑ 68% (↑ 54 a ↑ 84) Cmin: ↑ 118% (↑ 91 a ↑ 150)
English: How to take Emtricitabine/Tenofovir disoproxil Mylan 4.
Spanish: Cómo tomar Emtricitabina/Tenofovir disoproxilo Mylan 4.
English: Tell your doctor if you have had kidney disease, or if tests have shown kidney problems.
Spanish: Si ha tenido enfermedad renal, o si los análisis han mostrado problemas renales, dígaselo a su médico.
English: Cmax: ↑ 42% (↑ 27 to ↑ 57) Cmin: ↔
Spanish: Cmax: ↑ 42% (↑ 27 a ↑ 57) Cmin: ↔
English: Seroconversions / N Relative Risk Reduction (95% CI)b
Spanish: Reducción del riesgo relativo (IC del 95%)b
English: Cmin: ↑ 48% (↑ 34 to ↑ 63)
Spanish: Cmin: ↑ 48% (↑ 34 a ↑ 63)
English: • joint aches and pains (especially of the hip, knee and shoulder)
Spanish: Son signos de osteonecrosis: - rigidez articular - molestias o dolor articular (especialmente en cadera, rodilla y hombro) - dificultad de movimiento
English: Emtricitabine/tenofovir disoproxil
Spanish: Emtricitabina/tenofovir disoproxilo
English: AUC: ↓ 4% (↓ 9 to ↑ 0) Cmax: ↓ 6% (↓ 13 to ↑ 0) Cmin: ↓ 2% (↓ 9 to ↑ 6)
Spanish: AUC: ↓ 4% (↓ 9 a ↑ 0) Cmax: ↓ 6% (↓ 13 a ↑ 0) Cmin: ↓ 2% (↓ 9 a ↑ 6)
English: Exacerbations of hepatitis after discontinuation of treatment: In HBV infected patients, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4).
Spanish: han aparecido evidencias clínicas y de laboratorio de hepatitis, tras la interrupción del tratamiento (ver sección 4.4).
English: Use of emtricitabine/tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Spanish: Debe evitarse el uso de emtricitabina/tenofovir disoproxilo si en la actualidad o recientemente se está administrando un medicamento nefrotóxico.
English: Cmax: ↑ 25% (↑ 8 to ↑ 45) Cmin: ↔
Spanish: Cmax: ↑ 25% (↑ 8 a ↑ 45) Cmin: ↔
English: ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol /Tenofovir disoproxil
Spanish: Norgestimato/Etinilestradiol/ Tenofovir disoproxilo
English: • You must be HIV negative before you start to take this medicine to reduce the risk of getting HIV.
Spanish: • Usted no debe estar infectado por VIH antes de comenzar a tomar Emtricitabina/Tenofovir disoproxilo Mylan para reducir el riesgo de contraer VIH.
English: Relative Risk Reduction (95% CI)b a P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Spanish: Los valores de p de SARNP hacen referencia a la hipótesis nula de que la eficacia difería entre los estratos de subgrupos (SARNP, no SARNP).
English: • changes to your urine Rare side effects
Spanish: • cambios en su orina
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Spanish: Se han notificado casos de osteonecrosis, especialmente en pacientes con infección avanzada por VIH y/o exposición prolongada a la TARC, aunque se considera que la etiología es multifactorial (incluyendo uso de corticosteroides, consumo de alcohol, inmunodepresión grave, índice de masa corporal elevado).
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 50 mL/min in any patient receiving, emtricitabine/tenofovir disoproxil renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Spanish: Si el valor del fosfato sérico es <1,5 mg/dl (0,48 mmol/l) o el aclaramiento de creatinina disminuye <50 ml/min en cualquier paciente que reciba emtricitabina/tenofovir disoproxilo, la evaluación de la función renal ha de repetirse en la siguiente semana, incluyendo niveles de concentración de glucosa en sangre, potasio en sangre y glucosa en orina (ver sección 4.8, tubulopatía proximal).
English: Cmin: ↑ 42% (↑ 37 to ↑ 49)
Spanish: Cmin: ↑ 42% (↑ 37 a ↑ 49)
English: The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
Spanish: El aumento de la exposición a tenofovir podría potenciar las reacciones adversas asociadas a tenofovir, incluyendo alteraciones renales.
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Spanish: Cada comprimido recubierto con película contiene 200 mg de emtricitabina y 245 mg de tenofovir disoproxilo (equivalente a 300 mg de tenofovir disoproxilo maleato).
English: Ethinyl oestradiol:
Spanish: Etinilestradiol:
English: Adherence Substudy
Spanish: Participantes del subestudio de adherenciab
English: FTC/tenofovir disoproxil Groupa
Spanish: FTC/tenofovir disoproxiloa Grupo de tenofovir disoproxiloa Subestudio de adherencia
English: • drowsiness
Spanish: • erupción
English: • Whenever possible, Emtricitabine/Tenofovir disoproxil Mylan should be taken with food.
Spanish: Toma de Emtricitabina/Tenofovir disoproxilo Mylan con alimentos y bebidas • Cuando sea posible, Emtricitabina/Tenofovir disoproxilo Mylan debe tomarse con alimentos.
English: Seroconversions / N
Spanish: Análisis por ITT modificado Seroconversiones / N
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108) Cmin: NC
Spanish: AUC: ↓ 4% (↓ 15 a ↑ 8) Cmax: ↑ 102% (↓ 96 a ↑ 108) Cmin: NC
English: Serum Herpes Simplex Virus Type 2 Infection, N (%) Urine Leukocyte Esterase Positive, N (%)
Spanish: Esterasa leucocitaria positiva en orina, N (%)
English: AUC: ↑ 65% (↑ 59 to ↑ 71) Cmax: ↑ 61% (↑ 51 to ↑ 72) Cmin: ↑ 115% (↑ 105 to
Spanish: AUC: ↑ 65% (↑ 59 a ↑ 71) Cmax: ↑ 61% (↑ 51 a ↑ 72) Cmin: ↑ 115% (↑ 105 a ↑ 126)
English: 30 film-coated tablets 30 x 1 film-coated tablets (unit pack) 90 x 1 film-coated tablets (unit pack) 100 x 1 film-coated tablets (unit pack)
Spanish: 100 x 1 comprimidos recubiertos con película (envase unitario).
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate)
Spanish: Cada comprimido recubierto con película contiene 200 mg de emtricitabina y 245 mg de tenofovir disoproxilo (equivalente a 300 mg de tenofovir disoproxilo maleato) 3.
English: Cmin: ↑ 42% (↑ 34 to ↑ 49)
Spanish: Cmin: ↑ 42% (↑ 34 a ↑ 49)
English: AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to
Spanish: AUC: ↑ 81% (↑ 68 a ↑ 94) Cmax: ↑ 77% (↑ 53 a ↑ 104) Cmin: ↑ 121% (↑ 100 a ↑ 143)
English: Do not stop taking Emtricitabine/Tenofovir disoproxil Mylan
Spanish: No interrumpa el tratamiento con Emtricitabina/Tenofovir disoproxilo Mylan
English: AUC: ↑ 50% (↑ 42 to ↑ 59) Cmax: ↑ 64% (↑ 54 to ↑ 74) Cmin: ↑ 59% (↑ 49 to ↑ 70)
Spanish: AUC: ↑ 50% (↑ 42 a ↑ 59) Cmax: ↑ 64% (↑ 54 a ↑ 74) Cmin: ↑ 59% (↑ 49 a ↑ 70)
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
Spanish: AUC: ↓ 4% (↓ 32 a ↑ 34) Cmax: ↓ 5% (↓ 27 a ↑ 24) Cmin: NC
English: • Provides information on how to store Emtricitabine/Tenofovir Mylan.
Spanish: • Proporciona información sobre cómo conservar Emtricitabina/Tenofovir disoproxilo Mylan
English: Hepatitis B virus (HBV) antiviral agents
Spanish: Fármacos antivirales contra el virus de la hepatitis B (VHB) Adefovir dipivoxil/Tenofovir disoproxilo
English: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑
Spanish: AUC: ↑ 98% (↑ 77 a ↑ 123) Cmax: ↑ 79% (↑ 56 a ↑ 104) Cmin: ↑ 163% (↑ 137 a ↑ 197)
English: Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes causes death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together.
Spanish: Cuando se toman juntos medicamentos que contienen tenofovir disoproxilo y didanosina, se han comunicado en raras ocasiones inflamación del páncreas y acidosis láctica (exceso de ácido láctico en la sangre) en algunos casos mortales.
English: Table 9: Efficacy in study CO-US-104-0380 (Partners PrEP)
Spanish: Tabla 9: Eficacia en el estudio CO-US-104-0380 (Partners PrEP) Placebo
English: How to take Emtricitabine/Tenofovir disoproxil Mylan
Spanish: Cómo tomar Emtricitabina/Tenofovir disoproxilo Mylan
English: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Spanish: McDermott Laboratories Limited bajo el nombre comercial de Gerard Laboratories y Gerard Laboratories bajo el nombre comercial de Mylan Dublin
English: While taking Emtricitabine/Tenofovir disoproxil Mylan to treat HIV or to reduce the risk of getting HIV:
Spanish: Cuando tome Emtricitabina/Tenofovir disoproxilo Mylan para tratar el VIH o reducir el riesgo de contraer VIH:
English: Co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Spanish: No se recomienda la administración concomitante de emtricitabina/tenofovir disoproxilo con didanosina (ver sección 4.4).
English: AUC: ↑ 39% (↑ 33 to ↑ 44) Cmax: ↑ 55% (↑ 45 to ↑ 66) Cmin: ↑ 52% (↑ 45 to ↑ 59)
Spanish: AUC: ↑ 39% (↑ 33 a ↑ 44) Cmax: ↑ 55% (↑ 45 a ↑ 66) Cmin: ↑ 52% (↑ 45 a ↑ 59)
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1) Cmin: NC
Spanish: AUC: ↓ 7% (↓ 13 a ↓ 1) Cmax: ↓ 11% (↓ 20 a ↑ 1) Cmin: NC
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV is:
Spanish: La dosis recomendada de Emtricitabina/Tenofovir disoproxilo Mylan para reducir el riesgo de contraer VIH es:
English: Married to study partner Years living with study partner
Spanish: Casado con pareja del estudio Años viviendo con pareja del estudio 7,1 (3,0; 14,0) Años consciente de estado discordante
English: AUC: ↑ 40% (↑ 34 to ↑ 46) Cmax: ↑ 44% (↑ 33 to ↑ 55) Cmin: ↑ 84% (↑ 76 to ↑ 92)
Spanish: AUC: ↑ 40% (↑ 34 a ↑ 46) Cmax: ↑ 44% (↑ 33 a ↑ 55) Cmin: ↑ 84% (↑ 76 a ↑ 92)
English: Lamivudine and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Spanish: No se deben administrar de forma concomitante emtricitabina/tenofovir disoproxilo y lamivudina (ver sección 4.4).
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil (see section 4.8).
Spanish: Con el uso de tenofovir disoproxilo se han notificado fallo renal, insuficiencia renal, elevación de creatinina, hipofosfatemia y tubulopatía proximal, incluyendo síndrome de Fanconi.
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Spanish: La seguridad de tenofovir disoproxilo cuando se utiliza con ledipasvir/sofosbuvir y un potenciador farmacocinético (por ejemplo, ritonavir o cobicistat) no se ha establecido.
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6) Cmin: NC
Spanish: AUC: ↓ 2% (↓ 5 a ↑ 0) Cmax: ↓ 1% (↓ 7 a ↑ 6) Cmin: NC
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22) Cmin: NC
Spanish: AUC: ↓ 1% (↓ 8 a ↑ 6) Cmax: ↑ 7% (↓ 6 a ↑ 22) Cmin: NC
English: AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
Spanish: AUC: ↑ 40% (↑ 34 a ↑ 45) Cmax: ↑ 46% (↑ 39 a ↑ 54) Cmin: ↑ 70% (↑ 61 a ↑ 79)
English: Antiretrovirals
Spanish: Antimicobacterianos
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Spanish: La seguridad de tenofovir disoproxilo cuando se utiliza con sofosbuvir/velpatasvir y un potenciador farmacocinético (por ejemplo, ritonavir o cobicistat) no se ha establecido.
English: Darunavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Spanish: Darunavir/Ritonavir/Tenofovir disoproxilo (300 mg c/24 h/100 mg c/24 h/245 mg c/24 h)
English: Before taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Spanish: Antes de tomar Emtricitabina/Tenofovir disoproxilo Mylan para reducir el riesgo de contraer VIH:
English: Emtricitabine/Tenofovir disoproxil Mylan contains lactose
Spanish: Emtricitabina/Tenofovir disoproxilo Mylan contiene lactosa.
English: Treatment of HIV-1 infection
Spanish: Tratamiento de la infección por VIH-1 Profilaxis de preexposición
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11) Cmin: NC
Spanish: AUC: ↓ 9% (↓ 16 a ↓ 1) Cmax: ↓ 7% (↓ 22 a ↑ 11) Cmin: NC
English: About Emtricitabine/Tenofovir Mylan for a Pre-exposure Prophylaxis (PrEP) Indication'
Spanish: • Folleto informativo de la PrEP para los prescriptores titulados “Información de seguridad importante para los médicos acerca de Emtricitabina/Tenofovir disoproxilo Mylan para una indicación de profilaxis de preexposición (PrEP)”
English: Emtricitabine/Tenofovir Mylan to Reduce the Risk of getting Human Immunodeficiency Virus
Spanish: Emtricitabina/Tenofovir disoproxilo Mylan para reducir el riesgo de contraer la infección por
English: headache dizziness
Spanish: cefalea mareos
English: People who do have HIV must take this medicine in combination with other drugs.
Spanish: Las personas que tienen VIH deben tomar Emtricitabina/Tenofovir disoproxilo Mylan en combinación con otros medicamentos.
English: Risk Estimate for HIV-1 Protection: Detection Versus No Detection of Tenofovir
Spanish: Detección frente a no detección de Tenofovir
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Spanish: La seguridad de tenofovir disoproxilo cuando se utiliza con sofosbuvir/velpatasvir/voxilaprevir y un potenciador farmacocinético (por ejemplo, ritonavir o cobicistat) no se ha establecido.
English: • Reminders on what the individual should know before and while taking Emtricitabine/Tenofovir Mylan to reduce the risk of getting HIV infection
Spanish: • Folleto informativo de la PrEP para el individuo en riesgo titulado “Información importante acerca de Emtricitabina/Tenofovir disoproxilo Mylan para reducir el riesgo de contraer la infección por el Virus de Inmunodeficiencia Humana (VIH)”
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 de los niveles de glucosa y lípidos en la sangre.
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: Adefovir dipivoxil and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Spanish: No se deben administrar de forma concomitante emtricitabina/tenofovir disoproxilo y adefovir dipivoxil (ver sección 4.4).
English: Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔
Spanish: Emtricitabina: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Age (Yrs), Mean (SD) Race, N (%) Black/African American White Mixed/Other Asian Hispanic/Latino Ethnicity, N (%) Sexual Risk Factors at Screening
Spanish: Etnia hispana/latina, N (%) Factores de riesgo sexual en la selección Número de parejas en las 12 semanas anteriores, media (DE)
English: How to store Emtricitabine/Tenofovir disoproxil Mylan 6.
Spanish: Conservación de Emtricitabina/Tenofovir disoproxilo Mylan 6.
English: No dose adjustment of ribavirin is required.
Spanish: No se requiere ajuste de dosis de ribavirina.
English: While taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Spanish: Cuando tome Emtricitabina/Tenofovir disoproxilo Mylan para reducir el riesgo de contraer VIH:
English: Possible side effects: Very common side effects
Spanish: Efectos adversos muy frecuentes
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0) Cmin: NC
Spanish: Adefovir dipivoxil: AUC: ↓ 11% (↓ 14 a ↓ 7) Cmax: ↓ 7% (↓ 13 a ↓ 0) Cmin: NC
English: Film-coating
Spanish: Cubierta pelicular:
English: IMMUNOSUPPRESSANTS
Spanish: INMUNODEPRESORES
English: ANNEX II
Spanish: Grupo de
English: Uncommon side effects
Spanish: Efectos adversos raros
English: (see section 4, Possible side effects).
Spanish: (Ver sección 4.8).
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: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Spanish: El aumento de las concentraciones plasmáticas de tenofovir resultante de la coadministración de tenofovir disoproxilo, ledipasvir/sofosbuvir y atazanavir/ritonavir puede aumentar las reacciones adversas relacionadas con tenofovir disoproxilo, incluidos los trastornos renales.
English: Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to
Spanish: AUC: ↑ 142% (↑ 123 a ↑ 164) Cmax: ↑ 55% (↑ 41 a ↑ 71) Cmin: ↑ 301% (↑ 257 a ↑ 350)
English: It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Mylan .
Spanish: Si olvidó tomar Emtricitabina/Tenofovir disoproxilo Mylan Es importante que no olvide una dosis de Emtricitabina/Tenofovir disoproxilo Mylan.