866 resultados para Package inserts of medicines


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The statistical analysis of compositional data is commonly used in geological studies.As is well-known, compositions should be treated using logratios of parts, which aredifficult to use correctly in standard statistical packages. In this paper we describe thenew features of our freeware package, named CoDaPack, which implements most of thebasic statistical methods suitable for compositional data. An example using real data ispresented to illustrate the use of the package

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The statistical analysis of compositional data should be treated using logratios of parts,which are difficult to use correctly in standard statistical packages. For this reason afreeware package, named CoDaPack was created. This software implements most of thebasic statistical methods suitable for compositional data.In this paper we describe the new version of the package that now is calledCoDaPack3D. It is developed in Visual Basic for applications (associated with Excel©),Visual Basic and Open GL, and it is oriented towards users with a minimum knowledgeof computers with the aim at being simple and easy to use.This new version includes new graphical output in 2D and 3D. These outputs could bezoomed and, in 3D, rotated. Also a customization menu is included and outputs couldbe saved in jpeg format. Also this new version includes an interactive help and alldialog windows have been improved in order to facilitate its use.To use CoDaPack one has to access Excel© and introduce the data in a standardspreadsheet. These should be organized as a matrix where Excel© rows correspond tothe observations and columns to the parts. The user executes macros that returnnumerical or graphical results. There are two kinds of numerical results: new variablesand descriptive statistics, and both appear on the same sheet. Graphical output appearsin independent windows. In the present version there are 8 menus, with a total of 38submenus which, after some dialogue, directly call the corresponding macro. Thedialogues ask the user to input variables and further parameters needed, as well aswhere to put these results. The web site http://ima.udg.es/CoDaPack contains thisfreeware package and only Microsoft Excel© under Microsoft Windows© is required torun the software.Kew words: Compositional data Analysis, Software

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Raman spectroscopy has become a widespread technique for the analysis ofpharmaceutical solid forms. The application proposed here is the investigationof counterfeit medicines. This serious global issue requires quick and accurateidentification methods to fight against this phenomenon. Thanks to its chemicalselectivity, rapidity of analysis and potential of generating repeatable spectralprofiles, Raman spectroscopy presents distinct advantages for the analysis ofcounterfeits. Combined with chemometric tools, the technique enablesthe detection, the determination of chemical composition and the profiling ofmedicine counterfeits.

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There are various methods to collect adverse events (AEs) in clinical trials. The methods how AEs are collected in vaccine trials is of special interest: solicited reporting can lead to over-reporting events that have little or no biological relationship to the vaccine. We assessed the rate of AEs listed in the package insert for the virosomal hepatitis A vaccine Epaxal(®), comparing data collected by solicited or unsolicited self-reporting. In an open, multi-centre post-marketing study, 2675 healthy travellers received single doses of vaccine administered intramuscularly. AEs were recorded based on solicited and unsolicited questioning during a four-day period after vaccination. A total of 2541 questionnaires could be evaluated (95.0% return rate). Solicited self-reporting resulted in significantly higher (p<0.0001) rates of subjects with AEs than unsolicited reporting, both at baseline (18.9% solicited versus 2.1% unsolicited systemic AEs) and following immunization (29.6% versus 19.3% local AEs; 33.8% versus 18.2% systemic AEs). This could indicate that actual reporting rates of AEs with Epaxal(®) may be substantially lower than described in the package insert. The distribution of AEs differed significantly between the applied methods of collecting AEs. The most common AEs listed in the package insert were reported almost exclusively with solicited questioning. The reporting of local AEs was more likely than that of systemic AEs to be influenced by subjects' sex, age and study centre. Women reported higher rates of AEs than men. The results highlight the need for detailing the methods how vaccine tolerability was reported and assessed.

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Prescription and over-the-counter drug abuse is an increasing concern in Iowa, and is the fastest growing form of youth substance abuse in America. Medicines can pose a danger to those who abuse them, and the improper disposal of pharmaceuticals can harm the environment.

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Tungsten carbide used in snowplow blades was studied from three manufacturers. The carbides were measured for common industry properties including specific gravity and hardness. In addition, an abrasion resistance was performed. There was no significant difference found in abrasion resistance between the Kenametal and the Valk carbides. The Bucyrus carbides showed improved abrasion resistance, but were outside industry specifications for specific gravity.

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Työn tarkoituksena oli tutkia kartonkipohjaisten pakkausmateriaalien läpäisyominaisuuksia sekä pakkausten tiiveyteen vaikuttavia tekijöitä. Työssä verrattiin skaivatun ja skaivaamattoman raakareunan sekä tölkkien pohjaratkaisujen ominaisuuksia vesihöyryn- ja hapen läpäisevyydessä, kun käytetty kartonki oli molemmin puolin polymeeripäällystetty. Tiiveysominaisuuksia tutkittiin myös vuotomittauksin, värjäyksin ja elektronimikroskoopilla. Kuivan elintarvikkeen säilytystestillä ja kilpailijapakkausanalyyseillä oli tarkoituksena myös saada selville eri pakkausmateriaalien ja pakkauksien läpäisevyys- ja tiiveysominaisuuksia. Pakkauksen saumoilla oli yhtä suuri tai suurempi vaikutus vesihöyryn läpäisyssä kuin itse materiaalilla, kun pakkaus oli molemmin puolin polymeeripäällystetty kartonkikuppi. Skaivatun sauman vesihöyrynläpäisy oli vain 4-10 % pienempi kuin raakareunallisen sauman. Pakkauksen ulkopuolisten raakareunojen suojaaminen pienensi vesihöyrynläpäisevyyttä 30 %. Kun pakkauksen sisäpuolen raaka-reuna oli suojattu teipillä, saumoilla ei ollut niin suurta vaikutusta vesihöyryn läpäisyyn verrattuna materiaaliin. Raakareunan määrällä tölkin pohjassa tai pienillä vuodoilla tölkin saumoissa ei ollut merkitystä vesihöyryn läpäisyyn. Hapenläpäisyssä oli tärkeää ehyt barrierkerros. Polymeerisen barrierkerroksen reiät ja sauman skaivaus vaikuttivat enemmän kuin vesihöyryn läpäisyssä. Mitä enemmän tölkin pohjassa oli raakareunaa, sitä suurempi oli sen hapenläpäisy. Pakkauksen konvertointi, koneen säädöt ja lämmön kohdistus, ovat saattaneet aiheuttaa värjäyksellä havaitut barrierkerroksen mikroreiät. Kaupalliset kuiva-ainepakkaukset sisälsivät pääasiassa alumiinilaminaatin vesihöyryn, hapen ja valon suojana, kun tuotteena oli maitojauhetta ja rasvaa sisältävä elintarvike. Kuitenkin, jos pakkausmateriaali sisälsi vain ohuen sumutetun alumiinikerroksen, sen barrieriominaisuus ei ollut yhtä hyvä kuin alumiinilaminaatin. Äidinmaidonkorvikkeen säilytystestissä seurattiin eri analyysein tuotteen laatua kolmen kuukauden säilytyksen ajan. Pakkauksen vesihöyryn läpäisyominaisuus osoittautui tärkeimmäksi, sillä kosteuden vaikutus tuotteen laadun heikkenemisessä oli suurin. Hapen vaikutus on myös olennainen ja siten hyvä hapenestokerros sekä tiiveys ovat myös tärkeitä pakkauksen ominaisuuksia.

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Suojakaasupakkaaminen (MAP) on yleistynyt viime aikoina, koska sen avulla voidaan säilöä tuoreita tai vähän käsiteltyjä elintarvikkeita pidempään. Suurin syy hyllyiän pidentymiseen on hiilidioksidin aiheuttama mikrobien kasvun hidastuminen. Toisaalta huolena on patogeenisten mikrobien lisääntyminen anaerobisissa olosuhteissa. Pidempi säilyvyys voidaan saavuttaa myös käyttämällä vähemmän lisä- ja säilöntäaineita. Samalla suojakaasupakkaaminen kuitenkin vähentää myös pilaantuneiden tuotteiden määrää. Eniten suojakaasua käytetään lihan pakkaamisessa. Suojakaasupakkaamisessa elintarvikepakkaukseen syötetään normaalista huoneilmasta poikkeava kaasuseos. Pääasiassa kaasuseos koostuu hiilidioksidista, hapesta ja typestä. Lisäksi voidaan käyttää pieniä määriä hiilimonoksidia, argonia ja rikkidioksidia. Kaasuseoksen koostumus määräytyy elintarvikkeiden ominaisuuksien ja vaatimusten perusteella. Halutun kaasukoostumuksen tulee säilyä pakkauksessa muutamasta päivästä muutamaan kuukauteen riippuen elintarvikkeesta. Siksi tärkein pakkaukselta vaadittava ominaisuus on riittävä kaasutiiveys ja erityisesti hapenläpäisevyys. Koska suurin osa suojakaasupakkauksista on tällä hetkellä muovisia, tutkittiin kokeellisessa osiossa kartonkipakkausten tiiveysominaisuuksia. Kokeet tehtiin vertailemalla erilaisten vuoka- ja kansimateriaalien vaikutusta pakkausten tiiveyteen. Vuokien onnistuminen oli suurin yksittäinen tuloksiin vaikuttanut tekijä. Epäonnistuneen vuoan vaikutukset näkyivät myös saumauksessa, koska saumaustyökalun ja vuoan piti sopia yhteen. Lisäksi näkymättömät mikroreiät hankaloittivat todellisten vuotokohtien paikallistamista. Vuototestausten perusteella materiaaleille löydettiin kuitenkin viitteelliset optimiparametrit. Tärkein saumauksessa vaikuttanut tekijä oli sopivan saumauslämpötilan valinta. Prässättyjen vuokien laatu oli epätasainen. Siksi erityisesti rinnakkaisten kansitus- ja hapenläpäisymittausten väliset erot olivat merkitseviä. Lisäksi prässäys laski materiaalien hapenläpäisyominaisuuksia. Yksittäisten vuokien tiiveysominaisuudet täyttivät kuitenkin kaupallisille kaasupakkauksille asetetut vaatimukset. Vesihöyrynläpäisevyydessä materiaalin vesihöyrynläpäisy oli merkittävämpää kuin vesihöyryn kulkeutuminen vuotokohtien tai epäonnistuneiden saumojen kautta.

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ETHNOPHARMACOLOGICAL RELEVANCE: The aim of this survey was to describe which traditional medicines (TM) are most commonly used for non-communicable diseases (NCD - diabetes, hypertension related to excess weight and obesity) in Pacific islands and with what perceived effectiveness. NCD, especially prevalent in the Pacific, have been subject to many public health interventions, often with rather disappointing results. Innovative interventions are required; one hypothesis is that some local, traditional approaches may have been overlooked. MATERIALS AND METHODS: The method used was a retrospective treatment-outcome study in a nation-wide representative sample of the adult population (about 15,000 individuals) of the Republic of Palau, an archipelago of Micronesia. RESULTS: From 188 respondents (61% female, age 16-87, median 48,), 30 different plants were used, mostly self-prepared (69%), or from a traditional healer (18%). For excess weight, when comparing the two most frequent plants, Morinda citrifolia L. was associated with more adequate outcome than Phaleria nishidae Kaneh. (P=0.05). In case of diabetes, when comparing Phaleria nishidae (=Phaleria nisidai) and Morinda citrifolia, the former was statistically more often associated with the reported outcome "lower blood sugar" (P=0.01). CONCLUSIONS: Statistical association between a plant used and reported outcome is not a proof of effectiveness or safety, but it can help select plants of interest for further studies, e.g. through a reverse pharmacology process, in search of local products which may have a positive impact on population health.

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Customers are more and more interested in the environmental impacts of the products they purchase. Different labels give the required environmental information to consumers and the labels might affect to the consuming decisions. The European Union has set a plan for sustainable consuming, which encourages industry and commerce to calculate carbon footprints for the products. A term “carbon footprint” means carbon dioxide emissions across the product lifecycle. In this thesis, carbon footprints are calculated for two different fibre-based packages. In the end, greenhouse gas emissions from fibre-package production are compared to greenhouse gas emissions from PET bottle production. The data for mill processes is exact and monitored in the mill. In addition, data was gathered from raw material and material suppliers, customers, official records, KCL-eco databases and literature. The data for PET bottle is sourced from literature. End-of-life operations affect greatly on the carbon footprint of a fibre-based package. The results show that the carbon footprint is smallest when used packages are recycled. Recycling saves also natural resources. If used packages are not recyclable for some reason, it is recommended to use them in energy production. Through waste incineration fossil fuels could be substituted and greenhouse gas emissions avoided.

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This work focuses on the study of the determination on the possibilities of controlling the required moisture within the inside of film sealed packages. The task is based on the challenges faced by fresh food producers in actualizing a longer product shelf-life coupled with the growing complex desires coming from consumers in the aspect of quality. One way to realize this is by proper evaluation on the use of the flexible plastic films through permeation measurements on the required amount of moisture penetrating through the plastic film with the application of microperforation. A packaging material requires proper interaction on moisture transmission, between the product and the outside environment. The plastic film material that stands between, fresh fruits, vegetables and the outside environment could have appropriate respiration rates through possible micro holes. This work simulates similar process with the aid of water vapor transmission rate (WVTR) experiment using anhydrous CaCl2 as the desiccant, in studying the WVTR values of various perforated film materials at different conditions of storage (standard, fridge, and tropical conditions). However, the results showed absorption rates of water vapor at various conditions in grams of H2O/m2/24h.

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The importance of package design as a marketing tool is growing as the competition in retail environment increases. However, there is a lack of studies on how each element of package design affects consumer decisions in different countries. The objective of this thesis is to study the role of package design to Japanese consumers. The research was conducted through an experiment with a sample of 37 Japanese female participants. They were divided into two groups and were given different tasks: one group had to choose a chocolate for themselves, and the other for a group of friends. The participants were presented with 15 different Finnish chocolate boxes to choose from. The qualitative data was gathered through observation and semi-structured interviews. In addition, data from questionnaires was quantified and all the data was triangulated. The empirical results suggest that visual elements strongly affect the decision making of Japanese consumers. Image was the most important element which acted as both, a visual and an informational aspect in the experiment. Informational elements on the other hand have little effect, especially when the context is written in a foreign language. However, informational elements affected participants who were choosing chocolates for a group of friends. A unique finding was the importance of kawaii (cuteness) to Japanese consumers.