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Source text - English ). Treatment duration is defined as the time during which doses are administered plus time from last dose administered to next scheduled dose. The combined duration of antibiotics with activity against MRSA should not exceed 24 hours if given consecutively in the preceding 72 hours prior to first dose of study drug The treatment duration applies to any of the following timeframes:
• Within the 72-hour pre-enrollment period
• Started prior to the 72-hour pre-enrollment period and extended into this period
• Started during the 72-hour pre-enrollment period and extended into the study drug treatment period
Exception: Subjects who had greater than 24 hours of an antibiotic (other than linezolid, vancomycin or teicoplanin) that can have activity against MRSA, can be enrolled if they can show the following:
• MRSA isolate is non-susceptible to the antibiotic, or
• Institution's pattern of susceptibility indicates that the MRSA isolate is likely to not be susceptible to the antibiotic
• The subject has been treated for > 72 hours and was a documented treatment failure
Certain drugs with variable MRSA activity (e.g. fluoroquinolones, clindamycin, trimethoprim-sulfamethoxazole and tetracycline) may not be excluded if local susceptibility patterns will predict resistance and resistance is subsequently documented (Refer to Section 5.4.1).
7. Subjects who were treated with linezolid, vancomycin or teicoplanin with a treatment duration of more than 24 hours. The treatment duration applies to any of the following timeframes:
• Within the 72-hour pre-enrollment period
• Started prior to the 72-hour pre-enrollment period and extended into this period
• Started during the 72-hour pre-enrollment period and extended into the study drug treatment period
Subjects who were treated previously with linezolid, vancomycin or teicoplanin for the infection under study are excluded if they received a treatment duration of 72 hours or more of treatment and did not respond
8. Subjects with known or suspected necrotizing fasciitis, gas gangrene, gangrene, septic arthritis or osteomyelitis. Subjects may be enrolled if the area of osteomyelitis or gangrene has been or will be (within 72 hours of enrollment) resected (e.g. amputated) and an area of complicated skin/soft tissue infection requiring systemic antibiotic treatment remains. (If gangrene, evidence of critical ischemia must be ruled out as per Exclusion Criteria #9.)
9. Subjects with an infection involving a limb with evidence of critical ischemia in the affected limb defined as any of the following criteria:
• Absent or abnormal Doppler wave forms
• Toe blood pressure of
Translation - Spanish La duración del tratamiento se define como el tiempo durante el cual se administran las dosis más el tiempo desde la última dosis administrada hasta la próxima dosis programada. La duración combinada de actividad de antibióticos contra MRSA no debe exceder 24 horas si se administran consecutivamente en las 72 horas antes de la primera dosis de fármaco del estudio. La duración de tratamiento se aplica a cualquiera de los siguientes marcos de tiempo:
• Dentro del periodo preinscripción de 72 horas
• Iniciados antes del periodo preinscripción de 72 horas y prolongados durante este periodo
• Iniciados durante el periodo preinscripción de 72 horas y prolongados dentro del periodo de tratamiento con fármaco del estudio
Excepción: Sujetos que hayan recibido más de 24 horas de un antibiótico (distinto de linezolid, vancomicina o teicoplanina) que pueda tener actividad contra MRSA, podrán ser inscritos si se demuestra lo siguiente:
• Que la muestra de MRSA no es susceptible al antibiótico, o
• Que el patrón de susceptibilidad de la institución indica que la muestra de MRSA no tiene probabilidades de ser susceptible al antibiótico
• Si el sujeto ha sido tratado por ≥ 72 horas y se documentó como fallo del tratamiento
Ciertos fármacos con actividad variable contra MRSA (p. ej., fluoroquinolonas, clindamicina, trimetoprim-sulfametoxazol y tetraciclina) no pueden ser excluidos si los patrones de susceptibilidad local predicen resistencia y subsecuentemente se documenta la resistencia. (Consulte la Sección 5.4.1)
7. Sujetos tratados con linezolid, vancomicina o teicoplanina con duración de tratamiento mayor de 24 horas. La duración de tratamiento es aplicable a cualquiera de los siguientes marcos de tiempo:
• Dentro del periodo preinscripción de 72 horas
• Iniciados antes del periodo preinscripción de 72 horas y prolongados durante este periodo
• Iniciados durante el periodo preinscripción de 72 horas y prolongados dentro del periodo de tratamiento con fármaco del estudio
Los sujetos tratados previamente con linezolid, vancomicina o teicoplanina para la infección bajo estudio quedan excluidos si recibieron un tratamiento con duración de 72 horas o más y no respondieron.
8. Los sujetos con comprobación o sospecha de fasciitis necrotizante, gangrena gaseosa, gangrena, artritis séptica u osteomielitis. Los sujetos podrán ser inscritos si el área de osteomielitis o gangrena ha sido o será (en las 72 horas antes de la inscripción) sometida a resección (p. ej., amputación) y queda un área de infección cutánea complicada de piel/tejidos blandos que requiera de tratamiento sistémico con antibióticos. (En caso de gangrena, la evidencia de isquemia crítica debe ser descartada según el Criterio de Exclusión #9.)
9. Sujetos con infección que afecte un miembro con evidencia de isquemia crítica en el miembro afectado definida como cualquiera de los siguientes criterios:
• Formas de ondas Doppler anormal o ausente
• Presión en el dedo gordo del pie < 45 mm Hg
• Índice braquial de tobillo < 0.5
• Isquemia crítica evaluada por un cirujano vascular
10. Sujetos con enfermedad mortal subyacente rápida que no se espere sobrevivan para completar el estudio.
11. Sujetos con historia reciente de trasplante de médula ósea (en estancia hospitalaria post-trasplante).
12. Sujetos con feocromocitoma, hipertiroidismo no tratado, hipertensión no tratada o descontrolada o síndrome carcinoide.
13. Sujetos con verificación o sospecha de meningitis, endocarditis u otras infecciones endovasculares (p. ej., infecciones de injertos vasculares, acceso para hemodiálisis – derivaciones AV y fístulas.
14. Sujetos con SIDA clínico o conteo de células CD4 < 200 células/mm3 secundario a infección por HIV serán excluidos a menos que hayan estado bajo tratamiento con terapia anti-retroviral de alta actividad (HAART) y estén clínica e inmunológicamente estables (con conteos de CD4 de 100 a 200 y granulocitos ≥ 1000). Estos sujetos podrán ser inscritos a discreción del investigador y tras discusión del investigador con el monitor médico. Se debe confirmar que el sujeto no tenga una enfermedad mortal rápida y se espere sobreviva para completar el estudio y pueda ser dado de alto durante el curso de tratamiento. NOTA: Los sujetos que estén recibiendo profilaxia antimicrobiana con agente activo contra MRSA quedan excluidos.
English to Spanish: pharmaceutical protocol
Source text - English 4. INDICACIONES TERAPÉUTICAS
[TM], in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, including those with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance.
This indication is based on week 24 analyses from 2 randomised, double-blind, placebo-controlled Phase III trials in treatment-experienced patients with NNRTI resistance (present at screening and/or archived) and protease inhibitor (PI) resistance, where [TM] administered with a background regimen (BR) was statistically superior to placebo with a BR in terms of the proportion of patients achieving a confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml) and the increase in CD4 cell counts from baseline (see section 5).
Treatment history and, when available, resistance testing, should guide the use of [TM]. In patients who have experienced virological failure on an NNRTI- and nucleoside or nucleotide reverse transcriptase inhibitor (N[t]RTI)-containing regimen, [TM] is not recommended for use in combination with N(t)RTIs only.
5. FARMACOCINÉTICA Y FARMACODINAMIA EN HUMANOS
PHARMACOKINETIC PROPERTIES
The pharmacokinetic properties of etravirine have been evaluated in adult healthy subjects and in adult treatment-experienced HIV-1 infected patients. Exposure to etravirine was slightly lower in HIV-1 infected patients than in healthy subjects.
Absorption
An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of [TM] is unknown. After oral administration with food, the maximum plasma concentration of etravirine is generally achieved within 4 hours. In healthy subjects, the absorption of etravirine is not affected by co-administration of oral ranitidine or omeprazole, drugs that are known to increase gastric pH.
Effect of food on absorption
The exposure to etravirine is similar when taken following a standard normal caloric meal (561 kcal) or high-fat high caloric meal (1160 kcal). When compared to administration following a standard normal caloric meal, exposures decreased when etravirine was taken before a standard normal caloric meal (17%), following a croissant (20%), or fasted (51%). Therefore, to achieve optimal exposure, [TM] should be taken following a meal.
Distribution
Etravirine is approximately 99.9% bound to plasma proteins, primarily to albumin (99.6%) and α1-acid glycoprotein (97.66%-99.02%) in vitro. The distribution of etravirine into compartments other than plasma (e.g, cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Metabolism
In vitro experiments with human liver microsomes (HLMs) indicate that etravirine primarily undergoes oxidative metabolism by the hepatic cytochrome CYP450 (CYP3A) system and, to a lesser extent, by the CYP2C family followed by glucuronidation.
Elimination
After administration of a radiolabeled 14C-etravirine dose, 93.7% and 1.2% of the administered dose of 14C-etravirine could be retrieved in faeces and urine, respectively. Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in feces. Unchanged etravirine was not detected in urine. The terminal elimination half-life of etravirine was approximately 30-40 hours.
Additional information on special populations
Children and adolescents
The pharmacokinetics of etravirine in pediatric patients are under investigation. There are insufficient data at this time to recommend a dose.
Elderly
[TM], combinado con otros productos medicinales antirretrovirales, está indicado para tratar infección por virus de inmunodeficiencia humana tipo 1 (HIV-1) en pacientes adultos que han recibido tratamiento con antirretrovirales, incluyendo aquellos con resistencia a inhibidor no nucleósido de la transcriptasa inversa (NNRTI).
Esta indicación se basa en análisis realizado la semana 24 en 2 estudios doble ciego, aleatorios, controlados con placebo en Fase III en pacientes que habían recibido tratamiento y tenían NNRTI (presente en el tamizado y/o archivada) y resistencia a inhibidor de proteasa (PI), en los cuales [TM] administrado con un régimen de fondo fue estadísticamente superior a placebo con un régimen de fondo en términos de la proporción de pacientes que alcanzaron una carga viral no detectable confirmada (
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Bachelor's degree - unam, mexico
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Years of experience: 44. Registered at ProZ.com: Jul 2004.
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