RESUMEN
BACKGROUND: Data on the burden of rotavirus gastroenteritis in Europe are needed to help understand the potential impact of introducing new rotavirus vaccines. MATERIALS AND METHODS: As part of prospective observational study (Rotavirus gastroenteritis Epidemiology and Viral types in Europe Accounting for Losses in Public Health and Society Study, REVEAL) conducted in 2004--2005 in seven European countries, we studied, the characteristics of acute gastroenteritis and rotavirus gastroenteritis in children less than 5 years in primary care, emergency room and hospital settings (Padova, Italy). RESULTS: A total of 757 children with acute gastroenteritis were included and enzyme-linked immunoabsorbent assay (ELISA) results were available for 725 cases. The overall estimated annual incidence for rotavirus gastroenteritis was 4.7%. Overall, rotavirus gastroenteritis was estimated to account for 43.6% of acute gastroenteritis cases. Among children with acute gastroenteritis (AGE) aged 6-23 months, 61.2% were rotavirus positive. Rotavirus gastroenteritis (RVGE) was responsible for 68.8% of hospitalizations, 61% of emergency consultations, and 33% of primary care consultations. The most prevalent serotype was G9 (84.4%) followed by G1 (11.8%). The relative risk for rotavirus gastroenteritis of being referred to hospital after an initial consultation in primary care was 3.37 (95% CI: 1.77-6.43) and 3.38 (95% CI: 2.28-5.01) for emergency room referral. Children with rotavirus gastroenteritis generally had more severe disease than children with rotavirus-negative gastroenteritis. CONCLUSION: Rotavirus accounts for a significant proportion of acute gastroenteritis cases in children less than 5 years in Italy, many of whom require frequent primary care consultations, or care in emergency room or hospital settings.
Asunto(s)
Gastroenteritis/epidemiología , Gastroenteritis/virología , Infecciones por Rotavirus/epidemiología , Rotavirus/aislamiento & purificación , Enfermedad Aguda , Preescolar , Atención a la Salud , Femenino , Gastroenteritis/terapia , Hospitalización , Humanos , Incidencia , Lactante , Italia/epidemiología , Masculino , Estudios Prospectivos , Rotavirus/clasificación , Infecciones por Rotavirus/terapia , Estaciones del Año , SerotipificaciónRESUMEN
SVP in glass ampoules are manufactured using two main different technological production processes: the open-ampoule process (O) and the closed-ampoule process (C). In principle, the open-ampoule production technology should lead to better controlled production process. To test this hypothesis and quantify the possible qualitative differences in the manufactured ampoules, a suitable experimental design was set up. The two ampoule production processes have been compared on the basis of the visible particulate burden. Two batches of ampoules filled with water for injections were produced for each type of process, following conventional industrial procedures. Two samples of 20,000 units were taken from each batch and inspected with different automatic inspection systems: two Brevetti CEA machines (S1, S2--light scattering) and two EISAI machines (S3, S4--light absorbtion). The comparison between the processes was based on the rejection percentage. On both inspection machines the open-ampoule production samples present rejection percentages (ranging from 0.154% to 1.248% rejection percentages) which, on average, are lower than those detected in closed-ampoule production (ranging from 1.434% to 3.86% rejection percentages). The difference between the two processes is even more marked if we also consider the data obtained using inspection machines S3 and S4. The substantial differences in performance of the four inspection machines stress the need to provide for adequate validation procedures.
Asunto(s)
Contaminación de Medicamentos/prevención & control , Embalaje de Medicamentos , Tecnología Farmacéutica/métodos , Estudios de Evaluación como Asunto , Vidrio , Infusiones Parenterales , Italia , Tecnología Farmacéutica/instrumentaciónRESUMEN
In this paper, we evaluated the influence of some glass ampoules characteristics that are critical as far as secondary particle contamination (visible and sub-visible) of small volume parenterals. Following characteristics were considered: snap-opening system (colour-break scoring and o.p.c.); break-point strength (high and low); dimensional characteristics (three types D1, D2, D3). According to the proper statistical design, 18 different batches of 2 ml ampoules filled with water for injection were manufactured; then sub-visible and visible particulate contamination generated on snap-opening the ampoules were examined. Sub visible particle counting was performed by the light-blockage method and visible particles counting by the membrane-filtration method. With regard to sub-visible particles, statistical analysis showed significant interactions of break-point strength with both ampoule dimensional characteristics and the type of snap-opening system. Break-point strength seems to have the greatest influence on the level of particulate contamination. Differences in ampoule snap-opening systems and dimensional characteristics exert a significant effect on the level of particle contamination only at high break-point strength. With regard to visible particles generated on snapping the ampoules, data are consistent with the findings of sub-visible particulate contamination. Ampoules manufactured according to DIN dimensional characteristics and with an o.p.c. snap-opening system provide the lowest particle burden.
Asunto(s)
Contaminación de Medicamentos/prevención & control , Embalaje de Medicamentos , Vidrio , SolucionesRESUMEN
Near-infra-red reflectance spectroscopy is used to determine the active ingredient concentration and water content of an antibiotic powder (ceftazidime pentahydrate). The validity of predictive models for active ingredient concentrations and water content, constructed by means of the multiple linear regression technique is discussed. A procedure is devised for the analysis of production samples, which, on account of the very limited range of concentrations, prove a difficult fit to the above-mentioned model. The results obtained in testing formulation samples from 1 year's industrial production are used to illustrate the potential of the technique.