866 resultados para Package inserts of medicines


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Pós-graduação em Educação - IBRC

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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The objective was to evaluate the effect of thermocycling on the color variation of three different composite resins . We studied was Resin Enamel on 3 levels : ( Esthetic X , Opallis and Venus ) ; Resin Dentin in three levels : ( Esthetic X , Opallis and Venus ) and Thermocycling on level 1 : ( 3,000 cycles ) ; variable was the change of color gauged by spectrophotometry . 60 specimens , subdivided into 6 groups were made : GI - Esthetic X Enamel ; GII - Esthetic X dentin ; GIII - Opallis Enamel ; GIV - Opallis dentin ; GV - Enamel and GVI Venus - Venus dentin . The specimens were prepared with a matrix to standardize samples . The inserts of incrementally resins and polymerized with a halogen light Ultralux unit ( Dabi Atlante , Brazil ) with a power of 450mW / cm ² . After fabrication , underwent color reading with a UV Visible Spectrophotometer reflection , UV -2450 ( Shimadzu , Kyoto , Japan ) , with the changes calculated by the system CIE L * a * b * . Then isolates were stored in artificial saliva at 35 ° C ± 2 ° C during 3 months containers being subjected to the effects of thermal cycling for 3000 cycles over the range of 5C to 55C . Again subjected to chromatic evaluation. For the analysis of the results of color change of the studied resins was applied ANOVA two factors at 5 % . The results showed a statistically equal resins enamel GI and GV ( p = 0.79 ) ; the same was not observed for GI and G III resins , where the color change was higher for resin G III ( p = 0.0000002 ) . The same was observed between G III and GV , where the resin enamel G III showed a statistically superior to the color change ( p = 0.0000005 ) Average . Resins to dentin was there a statistical equality between the materials studied . We conclude that the resins studied change in color and resin enamel G III was the most suffered major color changes after aging by thermocycling .

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It is known that a high microbial count can compromise the stability of medicines, thus reducing their therapeutic efficacy. This work tried to demonstrate that the microbial contamination can be directly related to the inadequate handling of the medicines stored in homes, making it possible to draw strategies to reduce the possible risks of medical therapy offering correct information and advising. The objective of this work was to evaluate the quality of the medicines containing paracetamol found in the residences of Américo Brasiliense-SP, using the microbial analysis of non-sterile method described in the Brazilian Pharmacopoeia (1988). The medicine samples (30 samples) were obtained directly from the interviewed local residents, who had received new medicine bottles of the same product. An analysis of viable microorganisms (bacteria and fungus) was carried out to identify pathogens found in the collected samples. Although 90% of the analyzed samples have shown some microbial contamination, the results indicated the absence of pathogenic microorganisms, and the total count of viable microorganisms was below the maximum value for non-sterile (104 UFC/g or mL). It was also verified that the local residents stored the medicines in appropriate places, according to the orientations received when they bought the medicines in pharmacies and drugstores, showing the importance of information for the correct use and conservation of pharmaceuticals.

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Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.

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The present study aims to identify families who have stock and are making use of medications, as well as assess the conditions of storage, security and use of these drugs. The study was conducted in a city of São Paulo, the interviews were conducted in households enrolled in one of ten units of the Estratégia de Saúde da Família (ESF) that the city provides and the sample was defined by means of stratified random sampling (134households, IC 95%). Data collection was conducted through interviews with a semistructured questionnaire during the first half of 2011. We interviewed 118 (88.0%) households, of which 112 (95.0%) had medications that were stored n insecure or inadequate places in 75.4% of households, non-prescription self-medication was a common practice in 46 (47 4%) households, and lack of identification and security of medications stored was observed in 60 (53.6%) households. Most households had stock of medicines, which were done improperly or unsecure, or have specialties with lack of identification and security, which can lead to poisoning or e ineffective therapy. The Pharmaceutical Assistance under SUS lacks social initiatives, with actions directed for medications users, which can be supplied by the presence of the pharmacist in the ESF, essential for the promotion of racional use of medicines, that, through the Pharmaceutical Care, can identify, correct and prevent possible problems related to drugs.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. LAY ABSTRACT: Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.

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PURPOSE OF REVIEW: Because propofol is the sedative preferred by gastroenterologists, we focus this review on gastroenterologist-directed propofol sedation, provide simulations of the respiratory depressant effect of different dosing protocols and give a perspective on future developments in computer-assisted sedation techniques. RECENT FINDINGS: Propofol use by nonanesthesiologists remains a contraindication in the package insert of propofol in most countries. Sedation guidelines produced by the American Society of Gastroenterology partially contradict those produced by the American Society of Anesthesiologists for sedation by nonanesthesiologists, whereas the German guidelines were developed with anesthesiologists involved. The use of fospropofol, recently approved by the US Food and Drug Administration for sedation, is considered an alternative to propofol by some gastroenterologists. Methodological errors in earlier pharmacological studies have to be solved before widespread use of fospropofol is justified, however. Our simulations show that dosing protocols with small boluses administered at reasonable intervals induce less respiratory depression than large boluses. Interindividual variability of propofol-induced respiratory depression is illustrated by different pharmacokinetic and dynamic parameter sets used in the simulation. Two computer-assisted propofol infusion systems are currently being investigated. They not only incorporate the target effect but also the side effects, which may limit respiratory depression. SUMMARY: Propofol use by gastroenterologists may be well tolerated if appropriate patient selection, staff training, monitoring and low-dose sedation protocols are applied.

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Einige mit geringen Schichtstärken arbeitende Concept Modellierer und Rapid Prototyping Anlagen können Modelle für das Feingießverfahren mit verlorenem Modell erzeugen. Verkörpern die verlorenen Modelle die Geometrie von Formeinsätzen für Spritzgießwerkzeuge, können über den Feinguss Formeinsätze aus Aluminium hergestellt werden. Untersuchungen zielten dabei auf die detailgetreue Umsetzung filigraner Teile mit Freiformgeometrien. Kleine Abmessungen im Grenzbereich zwischen klassischem Formenbau und Mikrofertigung wurden dabei realisiert. Das Fräsen dieser Formeinsätze oder Elektroden ist zum Teil nicht möglich oder führt zu erhöhtem Aufwand. Gleichzeitig konnten sehr kurze Durchlaufzeiten erreicht werden. Auf demselben Weg konnten auch Senkerodierelektroden gegossen werden, die beim Aufbau von Werkzeugen höherer Lebensdauer genutzt wurden. Werden unterschiedliche Varianten oder mehrere identische Einsätze oder Elektroden zum Beispiel für Mehrfachwerkzeuge benötigt, werden die Zeitvorteile noch deutlicher. Die Funktion beider dargestellter Wege konnte durch den Spritzguss von Versuchsserien erfolgreich demonstriert werden.

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Considerando el alto costo farmacológico de los tratamientos oncológicos actuales y de los anticuerpos monoclonales pautados para diferentes terapias que están apareciendo y que serán prácticamente lo único que se use en el futuro para diferentes diagnósticos, el Programa Oncológico Provincial cubre sin cargo alguno las necesidades de los pacientes atendidos en Hospitales Estatales, cumpliendo una función social, dispensando los medicamentos solicitados por el médico tratante, en forma confiable, segura, y con equidad para recibir el tratamiento adecuado en el momento oportuno. Los recursos que pueden ser destinados al gasto farmacéutico son limitados, por lo que es necesario racionalizar el consumo y priorizar en la asignación de estos recursos a las opciones que presentan mayores ventajas económicas, basada en mantener una mejor relación costo/beneficio, repercutiendo de manera directa en los enfermos y en la sociedad en general. En este trabajo, se analiza el sistema de adquisición de drogas oncológicas usado por el Programa Oncológico Provincial realizando una comparación entre el sistema de compras original y el adoptado por el Programa en el año 2005. Se evalúa el periodo 2001-2007, en base a diversos indicadores y datos estadísticos, para determinar si ha mejorado la calidad de las prestaciones, si ha disminuido la demanda contenida y si se ha logrado mejorar la relación costo / beneficio, controlando así el gasto sanitario global lo que constituiría una inversión rentable para el sistema de salud. Los resultados indican que el nuevo sistema adoptado por el Programa Provincial de Oncología ha mejorado la provisión de medicamentos y garantiza mayor calidad en las prestaciones, pero estos resultados pueden ser superados. También muestra la gravedad del problema de la utilización de los nuevos fármacos monoclonales.

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En este documento se detalla, la planificación y elaboración de un paquete que respeta el estándar S4 de programación en lenguaje R. El paquete consiste en una serie de métodos y clases para la generación de exámenes tipos test y soluciones a partir de un archivo xls, que hace las funciones de una base de datos. El diseño propuesto está orientado a objetos y desarrolla un conjunto de clases que representan los contenidos de una prueba de evaluación tipo test: enunciados, peguntas y respuestas. Se ha realizado una implementación sencilla de un prototipo con las funciones básicas necesarias para generar los tests. Además se ha generado la documentación necesaria para crear el paquete, esto significa que cada método tiene una página de ayuda, que se podrá consultar desde un terminal con R, dicha documentación incluye ejemplos de ejecución de cada método.---ABSTRACT---In this document is detailed the elaboration and development of a package that meets the standard S4 of programming language R. This package consists of a group of methods and classes used for the generation of test exams and their solutions starting from a xls format file wich plays the role of a data base at the same time. These classes have been grouped in a way that the user could have a complete and easy vision of them. This division has been done by using data storage and functions whose tasks are more or less the same. Furthermore, the necessary documentation to create this package has also been generated, that means that every method has a help page wich can be called from a R terminal if necessary. This documentation has examples of the execution of every method.

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O trabalho aborda a embalagem através de sua função de comunicação sob a perspectiva da comunicação integrada de marketing. Especificamente, aborda como a embalagem reproduz a mensagem da propaganda no ponto-de-venda detalhando, pelo objetivo geral de descrição, a análise e sistematização do processo de uso da embalagem como suporte de campanhas publicitárias expandindo o objetivo da comunicação integrada de marketing CIM. A metodologia consiste no método qualitativo com o procedimento de pesquisa descritiva aplicando as estratégias investigativas pesquisa bibliográfica, pesquisa documental e entrevista em profundidade que permitiram concluir que sob a perspectiva da comunicação integrada de marketing, a ampliação da função de comunicação da embalagem permite a reprodução da mensagem da propaganda no ponto de venda pelo estabelecimento da unificação de elementos entre as mensagens veiculadas na propaganda televisiva e embalagem.(AU)