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Services
Translation, Editing/proofreading
Expertise
Specializes in:
Livestock / Animal Husbandry
Science (general)
Nuclear Eng/Sci
Medical: Cardiology
Medical (general)
Manufacturing
Human Resources
Chemistry; Chem Sci/Eng
Also works in:
Marketing / Market Research
Medical: Pharmaceuticals
Medical: Instruments
Medical: Health Care
Genetics
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Rates
English to Spanish - Rates: 0.06 - 0.10 USD per word
English to Spanish: Arthritis & Rheumatism General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Glucosamine has attracted a lot of interest as a specific drug for osteoarthritis (OA). Pharmacologic treatment of the disease is in fact dominated by the use of nonspecific analgesics or antiinflammatory agents, including nonsteroidal antiinflammatory drugs (NSAIDs) that have shown modest, although sound, symptomatic efficacy over short-term treatment courses, but no relevant effect during long-term use (1) and a poor risk/benefit ratio (2). Conversely, glucosamine ap- pears to be safe (3). In addition, well-conducted clinical research with a particular form of glucosamine sulfate has shown clinically relevant symptom modification over medium-term treatment of knee OA (4).
Translation - Spanish La glucosamina ha atraído mucho interés como droga específica para la osteoartritis (OA). El tratamiento farmacológico de la enfermedad es un hecho dominado por el uso de agentes analgésicos o antiinflamatorios, incluyendo las drogas antiinflamatorias no esteroideas (AINES) que han demostrado una eficacia sintomática modesta pero sólida, durante cursos de tratamiento a corto plazo (1) y un escaso cociente de beneficio/riesgo (2). Por otro lado, glucosamina parece ser segura (3). Además, la investigación clínica bien realizada con una particular forma de sulfato de glucosamina ha mostrado una modificación clínicamente relevante de los síntomas durante el tratamiento a mediano plazo de la OA de rodilla (4).
English to Spanish: PSUR LEVONORGESTREL
Source text - English Periodic Safety Update Report for Period covered by this report:
LEVONORGESTREL 01 January 2011 – 23 December 2014
CONFIDENTIAL 12/ 230
1. INTRODUCTION
This report is a safety update on levonorgestrel compiled for regulatory authorities by XXXXX. It was drawn up in accordance with the ‘Guideline on good pharmacovigilance practices, Module VII – Periodic safety update report’.
XXXXX’s first authorisation for levonorgestrel was granted on XXXXX. The European Union reference date of the product is 09 May 1990.
This Periodic Safety Update Report (PSUR) summarises all relevant safety data received by XXXXX from world-wide sources during the period from 01 January 2011 – 23 December 2014.
The report covers the products containing levonorgestrel as active ingredient with the following formulation, strengths and route of administration:
Translation - Spanish RESUMEN EJECUTIVO
Este informe es una actualización de seguridad de levonorgestrel recopilada para las autoridades regulatorias por XXXXXXr. El mismo fue preparado de conformidad con la “Normativa para las buenas prácticas de farmacovigilancia, Módulo VII – Informe periódico actualizado de seguridad”.
La primera autorización de XXXXX para levonorgestrel fue otorgada el XXXXX. La fecha de referencia del producto para la Unión Europea es 09 de mayo de 1990.
Este Informe Periódico Actualizado de Seguridad (PSUR por sus siglas en inglés) resume toda la información relevante de seguridad recibida por XXXXXX de sus fuentes a nivel mundial, durante el período del 01 de enero de 2011 hasta el 23 de diciembre de 2014.
El informe abarca los productos que contienen levonorgestrel como principio activo con la siguiente formulación, concentraciones y vía de administración:
English to Spanish: BACTALERT Triptorelina
Source text - English Concern: lntroduction of a rapid method (BacT-ALERT) as an alternative to the standard Pharmacopoeia for sterility testing the pharmaceutical preparations of triptorelin pamoate - powder for suspension for injection 3.75 mg, 11.25 mg and 22.5 mg
Dear Madam/Sir
By means of this letter, we XXXXXXX SA located at Rue du Levant, 146, 1920 Martigny- Switzerland, manufacturer of the pharmaceutical preparations of triptorelin pamoate - powder far suspension far injection 3.75 mg, 11.25 mg and 22.5 mg present the fallowing change - notification.
Currently, the sterility testing of triptorelin embonate microgranules is perfarmed in an isolator and incubated according to the default standard from harmonized pharmacopoeia methods (EP Chapter 2.6.1 and USP). lt is proposed to use the BacT/ALERT system from bioMérieux as an alternative method.
The BacT / ALERT system is an automated microbial detection system based on colorimetric technology which detects microorganism growth by tracking C02 production. lt allows the achievement offast and accurate results far sterility testing of triptorelin embonate finished products without necessity of a
subculture.
The specifications remain unchanged since they do not depend on the method used far the detection.
The analytical method is updated to include the BacT/ALERT equipment.
Translation - Spanish Asunto: Introducción de un método rápido (BacT-ALERT) como alternativa al estándar de la Farmacopea, a fin de realizar la prueba de esterilidad de las preparaciones farmacéuticas de pamoato de triptorelina - polvo para suspensión inyectable 3,75 mg, 11,25 mg y 22,5 mg
Estimado Señor / Señora,
Por medio de la presente, quien suscribe XXXXXXX., ubicado en la Rue du Levant, 146, 1920 Martigny - Suiza, fabricantes de las preparaciones farmacéuticas de pamoato de triptorelina – polvo para suspensión inyectable de 3,75 mg, 11,25 mg y 22,5 mg presentamos la siguiente notificación de cambio.
Actualmente, la prueba de esterilidad de los micro-gránulos de embonato de triptorelina se desarrolla en un aislante y se incuba de acuerdo con el estándar predeterminado en los métodos armonizados de la farmacopea (EP [Farmacopea Europea] Capítulo 2.6.1 y USP [Farmacopea de los EE.UU.] ). Se propone el uso del sistema BacT/ALERT de bioMérieux como método alternativo.
El sistema BacT/ALERT es un sistema automatizado de detección microbiana basado en la tecnología colorimétrica, que detecta el crecimiento de los microorganismos mediante el rastreo de la producción de CO2. Esto permite el logro de resultados rápidos y precisos en la prueba de esterilidad de los productos terminados de embonato de triptorelina, sin necesidad de un sub-cultivo.
Las especificaciones permanecen sin cambios debido a que no dependen del método utilizado para la detección. El método analítico se actualizó para incluir el equipo BacT/ALERT
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Translation education
Graduate diploma - Proidiomas Caracas
Experience
Years of experience: 11. Registered at ProZ.com: May 2014.
Adobe Acrobat, Fluency, Microsoft Excel, Microsoft Office Pro, Microsoft Word, Pagemaker, Powerpoint, Trados Studio
CV/Resume
CV available upon request
Professional objectives
Meet new translation company clients
Get help with terminology and resources
Improve my productivity
Bio
I am an entrepreneur, middle age woman. I have double nationality: Spanish and Venezuelan. I have worked for a pharmaceutical laboratory for 18 years in two main areas: Human Resources and Marketing. I worked there as a bilingual secretary at first and lately as a Oncological Viral Manager (Intron-A). I got my degree in Marketing and Publicity. I got my certification as a translator in Proidiomas (former Fundeim, Central University of Venezuela). I worked there from 2010 to 2018 as an English teacher and a translator. I moved to Spain on October 2018. I have worked for some pharmaceutical laboratories in Venezuela, Argentina and India as a translator, basically in the health registration area (e.g., Bayer, Daiichi Sankyo, Servier, Nolver, Revlon, Asofarma (Argentina), Net Medical (India)). Recently, I have worked translations in the aeronautics area for Honeywell and I am currently working mainly for Acculing.com (USA). I have also translated some books through Babelcube available for selling on Amazon.
Expertise