Stability of voriconazole injection in 0.9% sodium chloride and 5% dextrose injections.
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Biomedical subjects
Publications and source records attributed to Jean-Eudes Fontan.
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BACKGROUND: Duchenne muscular dystrophy (DMD) is often associated with obesity, which worsens the handicap early in the course of the disease. Nutritional assessment, however, can be difficult and often misleading in DMD. OBJECTIVE: Two methods of estimating body composition in DMD, skinfold-thickness (ST) measurement and bioelectrical impedance analysis (BIA), were compared with a reference method, labeled water dilution (WD). DESIGN: Body composition was estimated by using ST measurements and BIA (50 kHz, 800 mAmp), as well as the WD method (1 mL H2(18)O/kg) in 11 DMD patients with a mean (+/-SD) age of 10.0 +/- 2.5 y. RESULTS: When compared with the WD method, ST measurement significantly (P < 0.01) overestimated fat-free mass (FFM) (mean +/- SD ST: 24.5 +/- 5.9 kg; mean +/- SD WD: 18.2 +/- 2.5 kg), which led to an underestimation of the percentage of fat mass (%FM) (ST: 23.3 +/- 10.4%; WD: 40.1 +/- 17.1%; P < 0.05). In contrast, estimates obtained with BIA (FFM: 21.5 +/- 4.5 kg; %FM: 31.3 +/- 13.9%) did not differ from those obtained with WD. The difference from the reference method was less for BIA (mean: 3.3 kg; 95% CI: 0.8, 4.9 kg) than for ST (6.3 kg; 2.2, 8.6 kg). WD and BIA defined 73% and 55%, respectively, of the children as obese (%FM associated with body mass index cutoffs for obesity), whereas ST measurements defined 9% as obese (P < 0.01). CONCLUSIONS: Body-composition estimates by BIA are closer to those by WD than are those by ST measurement. Early detection of fat accumulation and longitudinal monitoring of nutritional care are 2 relevant applications of BIA to prevent obesity and hence lessen the burden of DMD.
BACKGROUND: Glutamine has been shown to acutely decrease whole-body protein degradation in Duchenne muscular dystrophy (DMD). OBJECTIVE: To improve nutritional support in DMD, we tested whether oral supplementation with glutamine for 10 d decreased whole-body protein degradation significantly more than did an isonitrogenous amino acid control mixture. DESIGN: Twenty-six boys with DMD were included in this randomized, double-blind parallel study; they received an oral supplement of either glutamine (0.5 g . kg(-1) . d(-1)) or an isonitrogenous, nonspecific amino acid mixture (0.8 g . kg(-1) . d(-1)) for 10 d. The subjects in each group were not clinically different at entry. Leucine and glutamine metabolisms were estimated in the postabsorptive state by using a primed continuous intravenous infusion of [1-(13)C]leucine and [2-(15)N]glutamine before and 10 d after supplementation. RESULTS: A significant effect of time was observed on estimates of whole-body protein degradation. A significant (P < 0.05) decrease in the rate of leucine appearance (an index of whole-body protein degradation) was observed after both glutamine and isonitrogenous amino acid supplementation [x +/-SEM: 136 +/- 9 to 124 +/- 6 micromol . kg fat-free mass (FFM)(-1) . h(-1) for glutamine and 136 +/- 6 to 131 +/- 8 micromol . kg FFM(-1) . h(-1) for amino acids]. A significant (P < 0.05) decrease in endogenous glutamine due to protein breakdown was also observed (91 +/- 6 to 83 +/- 4 micromol . kg FFM(-1) . h(-1) for glutamine and 91 +/- 4 to 88 +/- 5 micromol . kg FFM(-1) . h(-1) for amino acids). The decrease in the estimates of whole-body protein degradation did not differ significantly between the 2 supplemental groups. CONCLUSION: Oral glutamine or amino acid supplementation over 10 d equally inhibits whole-body protein degradation in DMD.
PURPOSE: To study the stability of levamisole oral solutions (25 mg/mL) prepared from powder and tablets stored at 4 +/- 3 degrees C and 23 +/- 2 degrees C in amber glass prescription bottles. METHODS: Levamisole 25 mg/mL solutions were prepared from commercially available 50-mg tablets or from pure powder in sterile water. Levamisole concentrations were determined in duplicate by a stability-indicating HPLC method at 0, 1, 2, 3, 4, 7, 14, 30, 60 and 90 days. The initial and final pHs of solutions were measured. RESULTS: The recovery of levamisole from tablets was 100 +/- 2.1%. No color or odour changes were observed during the study period. The oral solutions prepared from powder were stable at least 90 days stored at 4 and 23 degrees C. The oral solutions prepared from tablets were stable at least 90 days at 4 degrees C and 15 days when stored at 23 degrees C. The initial pH of solutions prepared from powder and tablets were 5.30 and 4.55, respectively. Initial and final pH values were significantly different (p<0.001) for the two solutions. CONCLUSIONS: Levamisole 25 mg/mL oral solutions can be prepared from tablets or powder with sterile water for irrigation and stored for 90 days under refrigeration, taking account of the lack of microbiological contamination.
BACKGROUND: The proteasome inhibitor bortezomib (BTZ), used in antineoplastic chemotherapy, must be diluted in NaCl 0.9% for injection and stored for no more than 3 hours in a syringe or 8 hours in a vial. Better information on its stability could improve storage. OBJECTIVE: To assess the stability of BTZ solution (1 mg/mL) in syringes and vials. METHODS: BTZ 1-mg/mL solutions were prepared by adding sterile NaCl 0.9% to Velcade vials containing 3.5 mg of lyophilized BTZ. Syringes were filled with 1 mL of solution and stored in the dark at 5 degrees C or 60 degrees C; others were not protected from light and stored at 22 degrees C. Velcade vials containing 1 mL of solution were stored at 5 degrees C in the dark. Samples were taken at various times over 23 days and assayed in duplicate. An HPLC method for assaying the stability of BTZ was validated. Appearance and pH were recorded. RESULTS: There was no color change or precipitation in the samples, and the pH was stable. Oxidation, light, and storage temperature all affected the chemical stability of BTZ. The mean concentrations of BTZ in syringes stored for 2, 3, and 5 days at 60, 22, and 5 degrees C were >95% of the initial concentration. The mean concentration of BTZ in vials stored for 5 days at 5 degrees C was >95% of the initial concentration. CONCLUSIONS: BTZ stored refrigerated in vials or syringes and protected from light is chemically stable for 5 days after reconstitution.
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Two investigations, one carried out throughout France (PediAD) and the other exclusively in Robert Debré pediatric hospital (PediEM), focus on the difficulties encountered by nursing staff when administering drugs to children, and the risk of medication errors. Medication errors can arise from dysfunctions at all stages of the drugs circuit, and may involve doctors, pharmacists or nursing staff. In pediatric hospitals they are mainly related to the lack of commercial products specifically designed Jor children. In Robert Debré Hospital, only one-third of commercial products in stock are authorized for pediatric use with no age limit. Thus, even in a hospital where drug distribution is entirely computerized (PCS Patient Care System software), where dispensing is based on the DIP system (daily, individual, and personal) but is not con trolled, and where almost all requirements for sterile and non sterile preparations are met but where validation is only partial, the system is far from being error-free. Two major improvements are planned. First, dispensing will be automated in 2006. With the current shortage of pharmacy technicians, this will securitize drug dispensing and provide for therapeutic and economic traceability. Second, integration of a pharmacist within each medical team is being compared with validation of prescriptions by a pharmacist in the hospital pharmacy.
AIM: The aim of this study was to evaluate the rates and types of drug prescription and administration errors in one pediatric nephrology ward, comparing two dispensing schemes: the first one defined as handwritten prescription plus ward stock distribution system (WSDS), and the second one as computerized prescription plus unit dose drug dispensing system (UDDDS). METHOD: Data were collected over an 8-week period, from 1 February to 31 March 1999. Two fifth-year pharmacy students photocopied prescription and administration documents on the ward each day, under the supervision of a senior pharmacist. The medical record analysis was used to compare the prescription with the administration report. Prescribing and administration medication errors were classified according to the American Society of Health-System Pharmacists. RESULTS: Prescribing errors: overall, for both dispensing schemes, a total of 511 prescriptions, resulting in 4532 prescribed drugs (an average of 9 drugs per prescription) were prescribed. The total prescription error rate was 20.7% (937 of 4532), resulting in 1.9 errors per patient per day. The computerized prescription error rate was 10.6% (419 of 3943), the handwritten prescription error rate was 87.9% (518 of 589). This difference was very significant (P < 0.0001). ADMINISTRATION ERRORS: The total opportunity of administration errors was 4589 (sum of administered and omitted drugs). The total administration error rate was 23.5% (1077 of 4589) including wrong administration time, and 11.7% (538 of 4589) excluding administration time. The administration error rate, including administration associated with time errors, was only 22.5% (888 of 3943) for computerized prescription + UDDDS, compared with 29.3% (189 of 646) for handwritten prescriptions plus WSDS (P < 0.001). Excluding administration associated with time errors, the administration error rates were 9.7% and 24.3%, respectively (P < 0.0001). CONCLUSION: The drug prescription and administration error rates were significantly decreased using computerized prescription plus UDDDS as compared with handwritten prescription plus WSDS in a pediatric unit (even with potential biases taken into account).