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French to Italian English to Spanish Portuguese to Italian Italian to Spanish Portuguese to Spanish French to Spanish Italian (monolingual) Spanish (monolingual) English (monolingual) Sardinian (monolingual) Portuguese (monolingual) French (monolingual)
Freelance translator and/or interpreter, Verified site user
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This person is not affiliated with any business or Blue Board record at ProZ.com.
Services
Translation, MT post-editing, Language instruction, Software localization, Editing/proofreading
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Specializes in:
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Also works in:
Science (general)
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Open to considering volunteer work for registered non-profit organizations
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Sample translations submitted: 1
English to Spanish: OTAC Pharmacy Procedure for ALL (Product Description and Storage Requirements for hIVIG) General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Procedure Identifier OTAC-Pharm-Procedure-2
Drug Manufacturer ALL
Document Name Product Description and Storage Requirements for hIVIG
Version 1.0
Status FINAL
Effective Date 24 MAY 2021
Page 1 of 2
OTAC Pharmacy Procedure for ALL
Product Description and Storage Requirements for hIVIG
Product Description
Anti-COVID-19 Hyperimmune Globulin (Human) IVIG (hIVIG). Ready-for-use liquid preparation.
Storage of Study Product hIVIG must be stored in refrigeration (2° to 8°C [36° to 46°F]). hIVIG vials/bags must be stored in original cartons. Do not freeze.
The refrigerator must be in a secure location and equipped with an electronic temperature monitoring system that:
• Continuously monitors the temperature
• Electronically records the temperature at set intervals throughout the day. It is recommended that the temperature is electronically recorded at least every 60 minutes; more frequent recordings allow for earlier detection of a temperature excursion.
It is strongly recommended that the temperature monitoring system is equipped with automated alerts that immediately notify pharmacy personnel of a temperature excursion.
If a temperature monitoring system does not have an electronic alarm that immediately sends an alert of a temperature excursion, the pharmacy must have a written plan in place to:
• Every morning, review the electronic temperature log from the previous night. If this is not possible:
The electronic temperature log from the previous night must be reviewed at the start of each day site(s) could potentially randomize a participant.
The goal is to minimize the amount of time study drug is out of temperature should an excursion occur and for the pharmacy to be resupplied as soon as possible if needed.
Delays in identifying a temperature excursion increase the chance of study drug being unusable and increase the length of time your site(s) may be required to temporarily close to randomization due to lack of available study drug.
• Verify temperatures did not deviate outside the required temperature range prior to preparing study treatment.
• Follow your institutional procedures for investigational study drug to document date/time temperature logs reviewed, including the person who reviewed the temperature logs and the time period the temperature was reviewed.
If a temperature excursion is identified, related to stored drug product, immediately follow the OTAC Pharmacy Procedure for reporting a temperature excursion (OTAC-Pharm-Procedure-5).
Translation - Spanish Identificador del OTAC-Pharm-Procedimiento-2
procedimientoFabricante del fármaco ALL
Nombre del Documento Descripción del producto y requisitos de almacenamiento para hIVIG
Versión 1.0
Estado FINAL
Fecha Efectiva 24 de mayo del 2021
Página 1de 2
Procedimiento de farmacia de la OTAC por ALL
Descripción del producto y requisitos de
Almacenamiento del producto de estudio.
hIVIG debe almacenarse en refrigeración (2° a 8°C [36° a 46°F]). Los viales/bolsas de hIVIG deben almacenarse en los cartones originales. No congelar.
El refrigerador debe estar en un lugar seguro y equipado con un sistema electrónico de control de la temperatura que:
• Monitoriza continuamente la temperatura
• Registra electrónicamente la temperatura a intervalos fijos a lo largo del día. Se recomienda que la temperatura se registre electrónicamente al menos cada 60 minutos; las grabaciones más frecuentes permiten detectar antes una excursión de temperatura.
Se recomienda encarecidamente que el sistema de control de temperatura esté equipado con alertas automatizadas que notifiquen inmediatamente al personal de la farmacia de una excursión de temperatura.
Si un sistema de control de la temperatura no tiene una alarma electrónica que envíe inmediatamente una alerta de una excursión de temperatura, la farmacia debe tener un plan escrito para:
• Cada mañana, revise el registro electrónico de temperatura de la noche anterior. Si esto no es posible:
El registro electrónico de la temperatura de la noche anterior debe ser revisado al comienzo de cada sitio(s) del día potencialmente podría aleatorizar un participante.
El objetivo es reducir al mínimo la cantidad de tiempo que el medicamento del estudio está fuera de temperatura en caso de que se produzca una excursión y para la farmacia para ser reabastecido tan pronto como sea posible si es necesario.
Los retrasos en la identificación de una excursión de temperatura aumentan la posibilidad de que el fármaco del estudio sea inutilizable y aumentan el tiempo en que su sitio(s) puede tener que cerrar temporalmente la aleatorización debido a la falta de fármaco del estudio disponible.
• Verificar que las temperaturas no se desvíen del rango de temperatura requerido antes de preparar el tratamiento del estudio.
• Siga sus procedimientos institucionales para el fármaco de estudio investigativo para documentar registros de temperatura de fecha/hora revisados, incluyendo la persona que revisó los registros de temperatura y el período de tiempo en que se revisó la temperatura.
Si se identifica una excursión de temperatura, relacionada con el medicamento almacenado, siga inmediatamente el Procedimiento de Farmacia OTAC para reportar una excursión de temperatura (OTAC-Pharm-Procedimiento-5).
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Translation education
Graduate diploma - Univeristà degli studi Cagliari
Experience
Years of experience: 4. Registered at ProZ.com: Nov 2020.
Spanish to Italian (Università degli Studi di Cagliari) Spanish to Italian (Università degli Studi di Cagliari) English to Italian (Università degli Studi di Cagliari) English to Spanish (Translators without borders)
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N/A
Software
Adobe Acrobat, Adobe Photoshop, memoQ, MemSource Cloud, Microsoft 365, Microsoft Excel, Microsoft Word, OmegaT, Powerpoint, Trados Studio
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Bio
My name is Fabio, and I am a translator and interpreter.
My native languages are Italian and Sardinian. I work translating from English > Italian, Spanish <> Italian, Sardinian > Italian, French > Italian and Portoguese > Italian
I've a Bachelor’s Degree in Cultural Linguistic Mediation gained at Università degli Studi di Cagliari (Cagliari, Italy); during my degree, I also participated in the Erasmus+ program, which allowed me to study Spanish Literature and Language at Universidad de Murcia (Murcia, Spain) (during which time I worked as a Head of Staff in the Coral Universitaria, with a team of 10 people from all over the world).
I am currently working as a freelance translator, copywriter and search evaluator for Appen, Translated, Top Content and Pinknoise and Blarlo.
And also as Social Media Manager for A.S.D Elmas c5.
I work actively since 2020 as a volunteer translator with Translators without Borders, a non-profit association that provide language services to humanitarian and social action organizations worldwide,. With more than 30,000 words translated in various topics such as Health, Medicine, Covid, School, Civil Rights and Children's Rights.
I have translated and reviewed mostly into Italian and Spanish, occasionally in English for clients from all over the globe.
I work with the cat tools Memsource, SDL Trados 2021, MemoQ, XTM and MateCat. I usually translate between 2500 and 3000 words per day and for revisions a maximum of 2000.
The specialities I translate vary from Health, Medicine, Covid, School, Civil Rights and Children's Rights, Sport and tourism. I also translate subject areas such as technical reports, user manuals, legal documents (resolutions, contracts), internet and e-commerce, IT and software, automotive, business letters and emails, tourism, pedagogy, home and children's product catalogues, telecommunications, marketing, etc.