IntroductionHeadache and migraine adverse events are common concerns in the administration of intravenous immune globulins (IVIG). Trials of IVIG for primary immunodeficiency (PI) are typically small and have reported headache and migraine data inconsistently.MethodsWe analyzed headache and migraine in pooled data from three pivotal trials of Gammaplex® 5% and 10% in PI (NCT00278954 from January 18, 2006; NCT01289847 from January 27, 2011; NCT01963143 from September 13, 2013). The trials were pooled in a retrospective analysis that included two 12-month open-label non-comparative trials of the 5% IVIG product and one 6-month open-label crossover bioequivalence trial comparing the 5% IVIG and 10% IVIG products. The population included adult and pediatric patients, who received IVIG infusions of 300-800 mg/kg/infusion every 21 or 28 days using a 15-minute rate escalation protocol.ResultsIn total, 1482 infusions were administered to 123 patients, with 94.6% of infusions achieving the maximum infusion rate. At least one product-related headache was reported in 6.1% (90/1482) of infusions. At least one product-related migraine was reported in 0.5% (7/1482) of infusions. Headache rates were higher for adults vs pediatric patients, females vs males, and 21-day vs 28-day dosing schedules, but were similar for the 5% and 10% IVIG products. Most headaches and migraines occurred during or within 72 hours of the infusion. Rates decreased after the first few infusions.DiscussionPatients receiving this IVIG product on a 15-minute rate escalation protocol had low rates of headache and migraine for both the 5% and 10% formulations.
This article aims to develop a prototype of an automated filler of semi-liquid and viscous food products. The initial idea stemmed from the observation of the reality faced by agroindustries during the packaging of food. As to the objectives of the methodology is classified as exploratory, the approach referred to the qualitative method and the method of procedure was the comparison. With respect, techniques, were based on the development of product design, prototyping and statistical control of process-City. As a result of the work was performed the prototype of the product and also the assembly of automated filler of semi-liquid and viscous food products. The electropneumatic was the system used to automate the process of filling. After construction, the prototype was put to the test tests where we used the statistical process control tool to measure the results, with the Agribusiness Educational Society Três de Maio. Through the test results was possible to evaluate the operation and the accuracy of the automated process filling offered a substantial advantage over the manual of filling process of this product type. As well, it was found that potted samples have not met the limits of tolerance, according to Ordinance No.
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