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En los pacientes con miopatía asociada al tratamiento con telbivudina, no se ha encontrado un patrón uniforme en relación al grado o tiempo de elevación de la creatinquinasa.

Among patients with telbivudine-associated myopathy, there has not been a uniform pattern with regard to the degree or timing of creatine kinase elevations.

Last Update: 2008-03-04
Subject: Medical
Usage Frequency: 1
Quality:
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La mayoría de las elevaciones de creatinquinasa fueron asintomáticas y por lo general, los valores de creatinquinasa disminuyeron en la siguiente visita con el tratamiento continuado.
http://www.emea.europa.eu/

Most creatine kinase elevations were asymptomatic and creatine kinase values typically decreased by the next visit on continued treatment.
http://www.emea.europa.eu/

Last Update: 2012-04-10
Subject: Pharmaceuticals
Usage Frequency: 1
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En el análisis en conjunto de 104 semanas de tratamiento, se observaron elevaciones de creatinquinasa de grado 3/ 4 (> 7x LSN) en el 12,6% de los pacientes tratados con telbivudina y en el 4,0% de los pacientes tratados con lamivudina.
http://www.emea.europa.eu/

In the pooled analysis, by 104 weeks of treatment Grade 3/ 4 creatine kinase elevations (> 7x ULN) occurred in 12.6% of telbivudine-treated patients and 4.0% of lamivudine-treated patients.
http://www.emea.europa.eu/

Last Update: 2012-04-10
Subject: Pharmaceuticals
Usage Frequency: 1
Quality:
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En el estudio pivotal NV-02B-007 (GLOBE), tanto la raza caucásica como valores de creatinquinasa pretratamiento más elevados se identificaron en ambos grupos de tratamiento, como factores predictivos para las elevaciones grado 3/ 4 a las 104 semanas.
http://www.emea.europa.eu/

In the pivotal study NV-02B-007 (GLOBE), higher pre-treatment CK values and Caucasian race were identified in both treatment groups as predictive factors for Grade 3/ 4 elevations by 104 weeks.
http://www.emea.europa.eu/

Last Update: 2012-04-10
Subject: Pharmaceuticals
Usage Frequency: 1
Quality:

Las reacciones adversas más frecuentes con al menos una posible relación con telbivudina fueron elevaciones de creatinquinasa en sangre de grado 3/ 4 (6,8%), fatiga (4,4%), cefalea (3,0%) y náuseas (2,6%).
http://www.emea.europa.eu/

The most common adverse events with at least a possible relation to telbivudine were grade 3/ 4 blood creatine kinase elevations (6.8%), fatigue (4.4%), headache (3.0%) and nausea (2.6%).
http://www.emea.europa.eu/

Last Update: 2012-04-10
Subject: Pharmaceuticals
Usage Frequency: 1
Quality:

En cualquier paciente que presente mialgias difusas inexplicables, sensibilidad muscular, debilidad muscular o miositis (definida como miopatía con evidencia histológica de daño muscular), deberá considerarse la miopatía, definida como dolor muscular y/ o debilidad muscular inexplicable persistente, independientemente del grado de incrementos en los niveles de creatinquinasa.
http://www.emea.europa.eu/

Myopathy, defined as persistent unexplained muscle aches and/ or muscle weakness regardless of the degree of increases in creatine kinase levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness, muscle weakness or myositis (defined as myopathy with histological evidence of muscle damage).
http://www.emea.europa.eu/

Last Update: 2012-04-10
Subject: Pharmaceuticals
Usage Frequency: 1
Quality:

En el estudio pivotal, tanto la raza caucásica como valores de creatinquinasa pretratamiento más elevados se identificaron en ambos grupos de tratamiento, como factores predictivos para las elevaciones grado 3/4 durante el primer año de tratamiento.

In the pivotal study, higher pre-treatment CK values and Caucasian race were identified in both treatment groups as predictive factors for Grade 3/4 elevations during the first year of treatment.

Last Update: 2008-03-04
Subject: Medical
Usage Frequency: 1
Quality:
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Se observaron elevaciones de creatinquinasa de grado 3/4 ( 7 x LSN) en el 7,5% de los pacientes tratados con telbivudina y en el 3,1% de los pacientes tratados con lamivudina al cabo de 52 semanas de tratamiento.

6 Grade 3/4 creatine kinase elevations ( 7 x ULN) occurred in 7.5% of telbivudine-treated patients and 3.1% of lamivudine-treated patients by week 52.

Last Update: 2008-03-04
Subject: Medical
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.

En cualquier paciente que presente mialgias difusas inexplicables, sensibilidad o debilidad muscular, deberá considerarse la miopatía, definida como dolor muscular y/o debilidad muscular inexplicable persistente, independientemente del grado de incrementos en los niveles de creatinquinasa.

Myopathy, defined as persistent unexplained muscle aches and/or muscle weakness regardless of the degree of increases in creatine kinase levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness or muscle weakness.

Last Update: 2008-03-04
Subject: Medical
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.

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