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1.
Farm Hosp ; 36(5): 356-67, 2012.
Artigo em Espanhol | MEDLINE | ID: mdl-22459248

RESUMO

OBJECTIVE: The primary objective of the Spanish Multicentre Study for the Prevention of Medication Errors 2007-2011 was to increase patient safety by improving drug practices in 26 participating Spanish hospitals. The secondary objective was to ascertain the medication error rate. METHOD: We used a modified Barker and McConnell observation method. RESULTS: During 2007-2008, 21 009 observations were recorded In 23 hospitals; during 2008-2009, 11 320 observations were recorded in 10 hospitals; during 2009-2010, 6819 observations were recorded in 8 hospitals, and during 2010-2011, 5876 observations were recorded in six hospitals. Error rates, including medication time errors and failure to inform patients came to 21.7%, 33.3%, 35.6% and 25.7% in each of the years respectively. Excluding time errors, the rates were 18.2%, 32.2%, 33.4% and 23.5%; excluding failure to inform patients as well, rates dropped to 12.6%, 14.8%, 12.8% and 8.6%. STRATEGIES FOR IMPROVEMENT: a normalised drug administration timetable, normalised IV drug dilutions and rates, better drug administration coordination with mealtimes, electronic prescription, improved patient identification measures, adjusting doses for kidney function, drug reconciliation programmes and patient and drug bar code scanning. CONCLUSIONS: 1. The applied measures improved patient safety through better drug practices in participating EMOPEM hospitals. 2. Drug error rates obtained for this sample of Spanish hospitals are some of the highest published. They are significantly lower, however, when we exclude time errors and failure to inform the patient.


Assuntos
Erros de Medicação/prevenção & controle , Hospitais , Humanos , Erros de Medicação/estatística & dados numéricos , Sistemas de Medicação no Hospital/organização & administração , Segurança do Paciente/estatística & dados numéricos , Melhoria de Qualidade , Espanha/epidemiologia
2.
J Investig Allergol Clin Immunol ; 21(2): 108-12, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21462800

RESUMO

BACKGROUND: Desensitization has been used for some decades to treat patients with the allergenic drug when an alternative drug with similar efficacy and safety is not available. We present the results from a series of oncology patients desensitized at our hospital during the last 2 years. OBJECTIVE: To assess the efficacy of a new desensitization protocol in patients allergic to chemotherapy drugs. METHODS: We performed an observational retrospective study of 11 women (6 breast cancer and 5 ovarian cancer) who underwent our desensitization protocol. Four patients had immediate reactions to carboplatin, 3 to docetaxel, 3 to paclitaxel, and 1 to both docetaxel and paclitaxel. Premedication was administered in all cases. A 5-step protocol based on 5 different dilutions of the drugs was used. RESULTS: We performed 39 desensitization procedures: 14 to carboplatin, 3 to oxaliplatin, 16 to docetaxel, and 6 to paclitaxel. Eight patients tolerated the full dose in 36 procedures. One patient suffered an anaphylactic reaction to carboplatin that reverted with treatment. One patient had dyspnea after a paclitaxel cycle. One patient experienced dyspnea due to chronic pulmonary thromboembolism related to her disease. CONCLUSION: Desensitization is a useful procedure in patients who are allergic to their chemotherapy agents.


Assuntos
Antineoplásicos/imunologia , Dessensibilização Imunológica/métodos , Adulto , Idoso , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/imunologia , Hipersensibilidade a Drogas/tratamento farmacológico , Feminino , Humanos , Pessoa de Meia-Idade , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/imunologia , Estudos Retrospectivos , Resultado do Tratamento
3.
Histol Histopathol ; 24(12): 1551-61, 2009 12.
Artigo em Inglês | MEDLINE | ID: mdl-19795354

RESUMO

Common concern about the biological effects of electromagnetic fields (EMF) is increasing with the expansion of X-band microwaves (MW). The purpose of our work was to determine whether exposure to MW pulses in this range can induce toxic effects on human astrocytoma cells. Cultured astrocytoma cells (Clonetics line 1321N1) were submitted to 9.6 GHz carrier, 90% amplitude modulated by extremely low frequency (ELF)-EMF pulses inside a Gigahertz Transversal Electromagnetic Mode cell (GTEM-cell). Astrocytoma cultures were maintained inside a GTEM-incubator in standard culture conditions at 37+/-0.1 degrees C, 5% CO2, in a humidified atmosphere. Two experimental conditions were applied with field parameters respectively of: PW 100-120 ns; PRF 100-800 Hz; PRI 10-1.25 ms; power 0.34-0.60 mW; electric field strength 1.25-1.64 V/m; magnetic field peak amplitude 41.4-54.6 microOe. SAR was calculated to be 4.0 x 10-4 W/Kg. Astrocytoma samples were grown in a standard incubator. Reaching 70-80% confluence, cells were transferred to a GTEM-incubator. Experimental procedure included exposed human astrocytoma cells to MW for 15, 30, 60 min and 24 h and unexposed sham-control samples. Double blind method was applied. Our results showed that cytoskeleton proteins, cell morphology and viability were not modified. Statistically significant results showed increased cell proliferation rate under 24h MW exposure. Hsp-70 and Bcl-2 antiapoptotic proteins were observed in control and treated samples, while an increased expression of connexin 43 proteins was found in exposed samples. The implication of these results on increased proliferation is the subject of our current research.


Assuntos
Astrocitoma/fisiopatologia , Proliferação de Células/efeitos da radiação , Campos Eletromagnéticos , Micro-Ondas , Astrocitoma/metabolismo , Astrocitoma/patologia , Bisbenzimidazol/metabolismo , Morte Celular/efeitos da radiação , Células Cultivadas , Corantes/metabolismo , Relação Dose-Resposta à Radiação , Técnica Indireta de Fluorescência para Anticorpo , Corantes Fluorescentes/metabolismo , Proteínas de Choque Térmico HSP70/metabolismo , Proteínas de Choque Térmico HSP70/efeitos da radiação , Humanos , Proteínas do Tecido Nervoso/metabolismo , Proteínas do Tecido Nervoso/efeitos da radiação , Propídio/metabolismo , Temperatura , Fatores de Tempo , Azul Tripano/metabolismo , Tubulina (Proteína)/metabolismo , Tubulina (Proteína)/efeitos da radiação
4.
Radiologia ; 49(5): 358-61, 2007.
Artigo em Espanhol | MEDLINE | ID: mdl-17910876

RESUMO

Cartilaginous lesions of the mediastinum are quite rare and primary cartilage forming tumors arising within the mediastinum are even more exceptional. Radiologic findings are unspecific. However, certain characteristics can orient the diagnosis. They are presented one mediastinal chondrosarcoma case in adult patient of patho-anatomical diagnosis. The findings described entail chest radiography, computed tomography and magnetic resonance.


Assuntos
Condrossarcoma Mesenquimal/diagnóstico , Neoplasias do Mediastino/diagnóstico , Feminino , Humanos , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X
5.
Radiología (Madr., Ed. impr.) ; 49(5): 358-361, sept. 2007. ilus
Artigo em Es | IBECS | ID: ibc-69705

RESUMO

Las lesiones cartilaginosas en el mediastino son muy infrecuentes y los tumores primarios formadores de cartílago que asientan en el mediastino son incluso más excepcionales. Los hallazgos radiológicos a menudo son inespecíficos. No obstante, existen ciertas características que nos pueden orientar hacia el diagnóstico.Presentamos un caso de condrosarcoma mediastínico en un paciente adulto cuyo diagnóstico se realizó por anatomía patológica. Describimos los hallazgos en la radiografía de tórax, tomografía computarizada y resonancia magnética


Cartilaginous lesions of the mediastinum are quite rare and primary cartilage forming tumors arising within the mediastinum are even more excepcional. Radiologic findings are unspecific. However, certain characteristicscan orient the diagnosis.They are presented one mediastinal chondrosarcoma case in adult patient of patho-anatomical diagnosis. The findings described entail chest radiography, computed tomography and magnetic resonance


Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , Condrossarcoma Mesenquimal/diagnóstico , Neoplasias do Mediastino/diagnóstico , Tomografia Computadorizada por Raios X , Imageamento por Ressonância Magnética
6.
Farm Hosp ; 30(1): 12-9, 2006.
Artigo em Espanhol | MEDLINE | ID: mdl-16569179

RESUMO

OBJECTIVE: The aim of this cross-sectional national multicentric study was to determine the prevalence of hyperglycemia in patients with parenteral nutrition and to assess other clinical factors associated with this complication. METHOD: All Spanish hospital pharmacy services were invited to participate in the study. RESULTS: Twenty eight (28) pharmacy services agreed to participate. The study included 442 patients. The prevalence of hyperglycemia (plasma levels > 200 mg/dL) was 26.7%. Eighty four point two per cent of the patients received less than 3.5 mg/kg/minute of glucose, this infusion rate being considered as the safe threshold. In most patients, follow-up of glycemia was based on capillary blood determination with reactive strips and in 27.6% of the cases in which insulin was prescribed, it was added to the parenteral nutrition bag, in full or in part. No significant correlations were found between glycemia and the clinical factors studied (disorders, fever, medication), except for insulin. CONCLUSIONS: This national multicentric study of the prevalence of hyperglycemia among patients with parenteral nutrition, leaded by hospital pharmacists, was a joint effort aimed to better understand this metabolic complication. Findings are consistent with those reported by other authors and have allowed us to describe the current situation.


Assuntos
Hospitalização , Hiperglicemia/epidemiologia , Hiperglicemia/etiologia , Nutrição Parenteral/efeitos adversos , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência
7.
Farm. hosp ; 30(1): 12-19, ene.-feb. 2006. tab
Artigo em Es | IBECS | ID: ibc-045180

RESUMO

Objetivo: El objetivo de este estudio nacional transversal multicéntricofue evaluar la prevalencia de hiperglucemia en pacientescon nutrición parenteral y evaluar otros factores clínicos relacionadoscon esta complicación.Método: Se ofertó participar en el estudio a todos los serviciosde farmacia de los hospitales españoles.Resultados: Accedieron a participar 28 servicios de farmacia.El estudio incluyó 442 pacientes. La prevalencia de hiperglucemia(valores séricos > 200 mg/dL) se situó en el 26,7%. El 84,2% depacientes recibieron menos de 3,5 mg/kg/minuto de glucosa,velocidad de infusión postulada como umbral de seguridad. Elseguimiento mayoritario de la glucemia fue mediante determinaciónen sangre capilar con tiras reactivas y el 27,6% de los casosen que se pautó insulina, esta estaba aditivada en la bolsa de nutriciónparenteral, total o parcialmente. No se pudieron demostrarcorrelaciones significativas entre la glucemia y los factores clínicosestudiados (patologías, fiebre, medicación), pero sí con la insulina.Conclusiones: Este estudio multicéntrico nacional sobre laprevalencia de hiperglucemia en pacientes con nutrición parenteral,liderado por farmacéuticos de hospital, constituye un esfuerzointegrado para conocer mejor esta complicación metabólica. Losdatos descritos se sitúan dentro de los aportados por otros autoresy nos han permitido caracterizar la situación actual


Objective: The aim of this cross-sectional national multicentricstudy was to determine the prevalence of hyperglycemia inpatients with parenteral nutrition and to assess other clinical factorsassociated with this complication.Method: All Spanish hospital pharmacy services were invitedto participate in the study.Results: Twenty eight (28) pharmacy services agreed to participate.The study included 442 patients. The prevalence ofhyperglucemia (plasma levels > 200 mg/dL) was 26.7%. Eightyfour point two per cent of the patients received less than 3,5mg/kg/minute of glucose, this infusion rate being considered asthe safe threshold. In most patients, follow-up of glycemia wasbased on capillary blood determination with reactive strips and in27.6% of the cases in which insulin was prescribed, it was addedto the parenteral nutrition bag, in full or in part. No significantcorrelations were found between glycemia and the clinical factorsstudied (disorders, fever, medication), except for insulin.Conclusions: This national multicentric study of the prevalenceof hyperglycemia among patients with parenteral nutrition,leaded by hospital pharmacists, was a joint effort aimed to betterunderstand this metabolic complication. Findings are consistentwith those reported by other authors and have allowed us todescribe the current situation


Assuntos
Humanos , Nutrição Parenteral/efeitos adversos , Hiperglicemia/epidemiologia , Hospitalização/estatística & dados numéricos , Necessidades Nutricionais , Serviço de Farmácia Hospitalar/métodos
8.
Cienc. tecnol. pharm ; 10(4): 137-140, oct. 2000. graf
Artigo em Es | IBECS | ID: ibc-5000

RESUMO

Se realiza el estudio de compatibilidad galénica de una mezcla de propofol y midazolam con: objeto de determinar su posible formulación y acondicionamiento en jeringas precargadas previamente a la perfusión de la misma, o si por el contrario resulta necesaria su preparación extemporánea. En la muestra se llevan a cabo análisis del pH, del diámetro promedio y distribución de las gotitas lipídicas; así como un estudio fotomicrográfico y visual al inicio del ensayo y a intervalos de dos horas con objeto de detectar posibles variaciones significativas de dichos parámetros: Estas pueden resultar indicativas del grado de inestabilización físico-química del sistema. Las tomas de muestra se prolongan durante 36 horas que corresponden al vaciado de 3 jeringas precargadas con la emulsión anestésica previamente elaborada, en condiciones análogas a las de perfusión al paciente. La variación observada tanto en el pH como en el tamaño medio de gotitas, así como la ausencia de precipitados en el transcurso del ensayo, evidencian que no existen problemas de estabilidad físico-química de la mezcla anestésica en las condiciones habituales de aplicación a nivel hospitalario (AU)


Assuntos
Midazolam/síntese química , Seringas/provisão & distribuição , Seringas/normas , Anestésicos Intravenosos/farmacologia , Anestésicos Intravenosos/síntese química , Propofol/síntese química , Estabilidade de Medicamentos
9.
Pharm World Sci ; 21(6): 278-80, 1999 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-10658239

RESUMO

The cost of parenteral admixtures has an important impact on the hospital budget. Recently, a Viaflex with vial adapter (named 'minibag plus' in some countries) has been commercialized in order to facilitate parenteral admixture preparation. In the present study a preparation using Viaflex with a vial adapter has been economically compared with a preparation with a traditional Viaflex (without adapter) in a centralized unit or in nursing wards in a unit-dose drug distribution system. A cost-analysis was conducted from the hospital point of view. Direct costs were considered: these included supplies and human resources. Differences in the whole process between the two types of Viaflex were analysed. The process included: purchasing, reception, storage, medical order record, preparation in the Pharmacy Service (PS), delivery from the PS to the nursing unit, preparation by the nurse, return of unused material to the PS. Human resource costs were estimated by time counting and multiplying by the average salary. To estimate wasted material, drug and supplies delivered from the PS and returned to the PS were counted during 26 days. With the new Viaflex costs are reduced by 30% in comparison with drug dilution using the traditional Viaflex in a centralized unit of the PS, and by 13.4% in comparison with preparation with the traditional Viaflex in the nursing ward. In addition it can be estimated that contamination risk with the new Viaflex is lower than preparation in the nursing ward with the traditional Viaflex. Therefore, owing to its lower cost we recommend the use of Viaflex with vial adapter for drug dilution for those vials that are compatible with the system.


Assuntos
Embalagem de Medicamentos/economia , Sistemas de Medicação no Hospital/economia , Custos e Análise de Custo , Composição de Medicamentos , Infusões Parenterais , Soluções Farmacêuticas
10.
Aten Primaria ; 21(6): 377-82, 1998 Apr 15.
Artigo em Espanhol | MEDLINE | ID: mdl-9633137

RESUMO

OBJECTIVE: Analysis of the results obtained in terms of improvement in the continuity of care, its resolutive capacity and accessibility, in the framework of the organisational change brought about by the reorganisation of specialist care (RSC) in the Ciutat Vella Health Sector. DESIGN: A descriptive study of the reorganised model of specialist care introduced in 1995 and comparison between this and the previous model (1993) in terms of activity, further tests made, referral to hospital, filling in the clinical history and waiting-list. T SETTING: The experience involved 4 PCTs in the Ciutat Vella Health sector of Barcelona (covering 74,449 people). MEASUREMENTS AND MAIN RESULTS: The volume of visits was in general less in 1995, while other types of activity had been incorporated: minor surgery, cryotherapy, consultations and sessions. CONCLUSIONS: The model of RSC satisfies the basic objectives for which it was designed. It increased the specialist's ability to resolve the case within Primary Care. It improved user accessibility to specialist care in terms of waiting time. Finally, the model favours ongoing care, thanks to a single clinical history for both levels.


Assuntos
Continuidade da Assistência ao Paciente , Acessibilidade aos Serviços de Saúde , Medicina , Especialização , Humanos , Espanha
11.
Crit Care Med ; 26(5): 844-51, 1998 May.
Artigo em Inglês | MEDLINE | ID: mdl-9590313

RESUMO

OBJECTIVES: To evaluate and compare the clinical efficacy, impact on hemodynamics, safety profiles, and cost of combined administration of propofol and midazolam (synergistic sedation) vs. midazolam and propofol administered as sole agents, for sedation of mechanically ventilated patients after coronary artery bypass grafting. DESIGN: Prospective, controlled, randomized, double-blind clinical trial. SETTING: Intensive care unit of SCIAS-Hospital de Barcelona. PATIENTS: Seventy-five mechanically ventilated patients who underwent coronary artery bypass graft surgery under low-dose opioid anesthesia. INTERVENTIONS: According to the double-blind method, patients were randomly assigned to receive propofol (n = 25), midazolam (n = 25), or propofol combined with midazolam (n = 25). Infusion rates were adjusted to stay between 8 and 11 points on Glasgow Coma Score modified by Cook and Palma. MEASUREMENTS AND MAIN RESULTS: Mean +/- SD duration of sedation was 14.4 +/- 1.5 hrs, 14.1 +/- 1.1 hrs, and 14.7 +/- 1.9 hrs for the propofol, midazolam, and synergistic groups, respectively. The induction dose was 0.55 +/- 0.05 mg/kg for propofol as sole agent, 0.05 +/- 0.01 mg/kg for midazolam as sole agent, and 0.22 +/- 0.03 mg/kg for propofol administered in combination with 0.02 +/- 0.00 mg/kg of midazolam (p = .001). The maintenance dose was 1.20 +/- 0.03 mg/kg/hr for propofol as sole agent, 0.08 +/- 0.01 mg/kg/hr for midazolam as sole agent, and 0.50 +/- 0.09 mg/kg/hr for propofol administered in combination with 0.03 +/- 0.01 mg/kg/hr of midazolam (p < .001). All sedative regimens achieved similar efficacy in percentage of hours of adequate sedation (93% for propofol, 88% for midazolam, and 90% for the synergistic group, respectively). After induction, both propofol and midazolam groups had significant decreases in systolic blood pressure, diastolic blood pressure, left atrial pressure, and heart rate. Patients in the synergistic group had significant bradycardia throughout the study, without impairment in other hemodynamic parameters. Patients sedated with propofol or synergistic regimen awoke sooner and could be extubated before those patients sedated with midazolam (0.9 +/- 0.3 hrs and 1.2 +/- 0.6 hrs vs. 2.3 +/- 0.8 hrs, respectively, p = .01). Synergistic sedation produced cost savings of 28% with respect to midazolam and 68% with respect to propofol. CONCLUSIONS: In the study conditions, the new synergistic treatment with propofol and midazolam administered together is an effective and safe alternative for sedation, with some advantages over the conventional regimen with propofol or midazolam administered as sole agents, such as absence of hemodynamic impairment, >68% reduction in maintenance dose, and lower pharmaceutical cost.


Assuntos
Ansiolíticos/administração & dosagem , Sedação Consciente , Ponte de Artéria Coronária , Hipnóticos e Sedativos/administração & dosagem , Midazolam/administração & dosagem , Propofol/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Cuidados Críticos , Método Duplo-Cego , Combinação de Medicamentos , Sinergismo Farmacológico , Quimioterapia Combinada , Farmacoeconomia , Feminino , Escala de Coma de Glasgow , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Respiração Artificial
12.
Arch Esp Urol ; 50(9): 947-51, 1997 Nov.
Artigo em Espanhol | MEDLINE | ID: mdl-9527824

RESUMO

OBJECTIVE: To evaluate the ability of computerized tomography (CT) to stage transitional cell carcinoma of the upper urinary tract. METHODS: 29 transitional cell carcinoma of the upper urinary tract submitted to nephroureterectomy were retrospectively evaluated. All 29 tumors had preoperative CT scans performed to stage the lesion. The pathological staging was compared to that of CT. RESULTS: 10 of the 29 tumors had CT evidence of tumor extension and 19 had localized noninvasive tumor on CT. Of the 10 patients with CT findings of tumor extension, 2 (20%) had superficial tumors and 8 (80%) had tumors that invaded into the adventitial fat, renal parenchyma or perirenal fat (pT3, pT4). Of the 19 patients with localized noninvasive tumor on CT, 13 (68%) had superficial tumors and 6 (32%) had pT3 or pT4 tumors. CT sensitivity for tumor invasion was 57% with a specificity of 87.5%. CONCLUSIONS: Our analysis shows that CT is of limited value in staging these tumors. When CT demonstrates direct tumor extension through the renal pelvic or ureteral wall, it is a sensitive indicator of high-stage tumor. However, the results obtained in low stage tumors must be viewed with caution.


Assuntos
Neoplasias Renais/diagnóstico por imagem , Neoplasias Renais/patologia , Tomografia Computadorizada por Raios X , Humanos , Invasividade Neoplásica , Estadiamento de Neoplasias , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Urotélio
15.
Arch Esp Urol ; 48(8): 836-8, 1995 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-8526541

RESUMO

OBJECTIVES: This study shows the contribution of the different imaging methods in the diagnosis of retroperitoneal ganglineuroma. METHODS: A retroperitoneal mass was incidentally detected in a young male patient. Patient evaluation included plain abdominal radiography, intravenous urography, ultrasound and computed tomography. RESULTS: Ultrasound and computed tomography provide information on tumor characteristics and extent, although it has no diagnostic specifity and does not permit distinguishing ganglioneuroma from other neural crest tumors.


Assuntos
Ganglioneuroma/diagnóstico , Neoplasias Retroperitoneais/diagnóstico , Adulto , Humanos , Masculino
16.
Eur J Epidemiol ; 6(3): 248-52, 1990 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-2253727

RESUMO

To estimate the prevalence of HIV-1, HIV-2 and HTLV-I among female prostitutes, and to identify possible risk factors for HIV transmission in this collective, sera and epidemiological information from 71 prostitutes were obtained. Using the local network of a well-defined area in southern Catalonia, all prostitution bars were identified and their working women interviewed using a previously validated questionnaire. Eight sera were found positive for HIV-1 antibodies. Of those, 7 sera were also positive in the HIV-2 assay, probably as a result of cross-reactivity between the two viruses. All sera were negative for HTLV-I antibodies. In our area, where intravenous drug users (IVDUs) account for the majority of AIDS cases, the use of drugs by the prostitutes or by their steady sexual partners seems to be the most important risk factor for HIV infection in that group.


Assuntos
Infecções por HIV/transmissão , Soroprevalência de HIV , Trabalho Sexual , Adolescente , Adulto , Western Blotting , Dispositivos Anticoncepcionais Masculinos/estatística & dados numéricos , Ensaio de Imunoadsorção Enzimática , Feminino , Infecções por HIV/epidemiologia , Humanos , Pessoa de Meia-Idade , Fatores de Risco , Comportamento Sexual , Espanha/epidemiologia , Abuso de Substâncias por Via Intravenosa/epidemiologia , Inquéritos e Questionários
20.
J Parenter Sci Technol ; 43(5): 246-9, 1989.
Artigo em Inglês | MEDLINE | ID: mdl-2809933

RESUMO

Three pyrogen assay methods [the rabbit method, Limulus Amebocyte Lysate (LAL) gelation and chromogenic substrate, and bioburden prior to sterilization] were evaluated in three standard batches of small-volume parenteral preparations; i.e., water for injection, sodium chloride 0.9% injection, and sodium bicarbonate 8.4% injection. The same preparations were also assayed after contamination with Escherichia coli followed by sterilization. All methods gave the same results with the water for injection and the sodium chloride 0.9%. With sodium bicarbonate 8.4%, only the rabbit method was valid. For sodium chloride 0.9%, the chromogenic substrate method was valid; the gelation method was not valid. Endotoxins from the manufacturing plant were less pyrogenic in rabbits than were standard endotoxins or those from hospital E. coli.


Assuntos
Embalagem de Medicamentos , Infusões Parenterais/normas , Serviço de Farmácia Hospitalar , Pirogênios/análise , Contaminação de Medicamentos , Métodos
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