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Biomedical subjects

C H Dash

Publications and source records attributed to C H Dash.

At least 19 recordsLinked to original sources
PubMed2004

A retrospective survey on the safety of Replenine, a high-purity factor IX concentrate.

PURPOSE: To assess the safety of a plasma-derived highly purified factor IX concentrate (Replenine) in routine clinical use. METHODS: Following guidelines entitled Safety Assessment of Marketed Medicines (SAMM), safety data were collected in the UK by retrospective review of the hospital notes of 114 patients who received an estimated 14.8 million IU of Replenine. Included were 40 patients undergoing 44 surgical procedures or dental extractions [corrected]. RESULTS: The study detected a total of nine adverse events (AEs), four of which were possibly product-related, four that were unrelated to the product and one whose causality was unknown. None of these cases had been notified to the manufacturer through conventional spontaneous reporting procedures. One patient was switched from Replenine because of infusion site irritation, but no unexpected adverse reactions were noted. There were no reports of virus transmission or new factor IX inhibitor development. The mean factor IX recovery value was 1.44 IU/dl per IU/kg (95%CI: 1.31-1.57 IU/dl per IU/kg). CONCLUSIONS: The study was a practical application of the SAMM guidelines to the collection of pharmacovigilance data on patients with Haemophilia B. Replenine is well tolerated in routine clinical practice.

Adult↗
PubMed2004

A retrospective survey on the safety of Replenate, a high-purity factor VIII concentrate.

PURPOSE: To assess the safety of a highly purified, plasma-derived factor VIII concentrate (Replenate) in routine clinical use. METHODS: Following guidelines entitled safety assessment of marketed medicines (SAMM), safety data were collected in the UK on 194 patients who received an estimated 47.6 million IU of Replenate. This population included 47 patients undergoing 53 surgical operations or dental extractions. RESULTS: The study detected four cases of new factor VIII inhibitor development and twelve other adverse events, five that were unrelated to the product, five whose causality was unknown, one that was possibly product-related and one case due to possible lack of efficacy. Only one of these cases had been notified to the manufacturer through conventional spontaneous reporting procedures. Three patients were switched from Replenate as a result of an adverse event (one case of infusion site irritation and two cases of a rise in titre of an existing inhibitor), but no unexpected adverse reactions were noted and there were no reports of virus transmission. The median factor VIII recovery value was 2.17 IU/dl per IU/kg, but recovery was shown to be dependent on several variables, namely inhibitor status, treatment centre and the patient's body weight. The median factor VIII recovery in inhibitor-free patients was 2.28 IU/dl per IU/kg (range: 1.20-6.62). CONCLUSIONS: The study confirms that Replenate is well tolerated by the majority of patients in routine clinical practice.

Adolescent↗
PubMed2001

Solvent/detergent treatment does not alter the tolerance or uptake of human normal immunoglobulin for intramuscular injection.

BACKGROUND AND OBJECTIVES: The tolerability and pharmacokinetics of a solvent/detergent-treated intramuscular immunoglobulin were compared with those of the standard product. MATERIALS AND METHODS: Single, 750-mg intramuscular (i.m.) injections were administered to a total of 36 healthy individuals: 23 in a double-blind trial and 13 in an open trial. Changes in specific serum hepatitis A and hepatitis B antibodies were monitored for a period of up to 3 months postinjection. RESULTS: No serious adverse reactions were reported, and the bioavailability of the solvent/detergent-treated preparation was equivalent to that of the standard i.m. immunoglobulin. CONCLUSION: There is no evidence that solvent/detergent treatment alters the pharmacokinetics or tolerance of human normal immunoglobulin, but it offers additional assurance against potential virus transmission.

Adolescent↗
PubMed2000

The future of plasma derivatives. 17-18 April, 2000, Brussels, Belgium.

This two-day meeting was organised by Life Sciences Division of IBC Global Conferences Limited. It was attended by an international, multidisciplinary group of experts with differing expertise and perspectives on the provision of therapeutic products derived from human plasma. The delegates ranged from those involved with the collection of plasma donations, the scientists dedicated to improving the screening tests for virus markers, quality assurance personnel, clinicians, marketing and business managers, members of regulatory agencies in Europe and the Food and Drug Administration (FDA), providers of services to the industry and last, but not least, patient groups were represented. Fifteen to twenty countries were represented by the delegates and speakers. Although it might seem that the background and expertise of the audience was so wide that the lectures would have to be superficial, this was not the case. The whole process from plasma (or blood) collection to injection of a product into a patient was already well-known to senior members of the various organisations present and there is a tremendous amount of inter-dependence which enhances the necessary level of understanding. Nevertheless, the speakers were able to expand the knowledge of the delegates by their lucid and detailed presentations. The issues associated with development and implementation of new technologies, such as new NAT tests and different virus inactivation processes, were fully described. The spotlight also fell on the effects that changing patterns of demand for individual therapeutic proteins are having and will continue to have on the economics of the industry and on patient groups. Unlike other manufactured products, the raw material is the same for all plasma-derived products. Demand for all these products is limited by the availability of the donated plasma. Ideal demand for economic reasons is a balance of the extractable proteins in the donation. The implementation of European regulations was reviewed from the industry and from the regulators. Flexibility shown by the FDA in responding to the shortages of iv. immunoglobulins (Ig) was described, particularly with regard to clinical evaluation. Finally, the rationale for the need to revise the CPMP guidelines for clinical evaluation of certain plasma products was described as were the difficulties to be expected with implementation.

Biological Products↗
PubMed1999

Clinical experience with a new solvent detergent-treated intravenous immunoglobulin free of hypotensive effects.

OBJECTIVE: To see if modifications to the processing of intravenous immunoglobulin to include a virus inactivation stage alter immunoglobulin G (IgG) resulting in hypotension in patients. METHODS: Clinical trials were done involving extensive patient monitoring during infusion: in vitro - testing for markers of hypotension, and in vivo - an animal model which closely simulates clinical use. RESULTS: No hypotensive response was seen in the animal model or clinical trial. CONCLUSIONS: The production process used does not damage IgG or create vaso-active kinins as the preparation was free of hypotensive effects.

Adolescent↗
PubMed1989

Antenatal administration of betamethasone to prevent respiratory distress syndrome in preterm infants: report of a UK multicentre trial.

In a prospective, randomized, double-blind, multicentre trial the effect of antenatal treatment with betamethasone phosphate was compared with placebo in the prevention of the respiratory distress syndrome (RDS) in preterm infants. The dose of betamethasone was 4 mg every 8 h for six doses, unless delivery occurred. The 251 women who were enrolled gave birth to 262 liveborn infants, 130 in the beta-methasone and 132 in the placebo group; the two groups were evenly matched in most respects. The diagnosis of RDS in the newborn was confirmed by two independent assessors. Seven of the 130 infants in the betamethasone group and 16 of the 132 in the placebo group developed RDS. In infants whose mothers had received at least three injections, RDS was also less frequent in the steroid group than in the placebo group (3/104 and 10/104 respectively; P less than 0.05). There was a significant reduction of RDS in those born between 24 h and 6 days after entry into the trial (0/30 and 8/45 respectively; P less than 0.05). The largest difference in frequency of RDS occurred in the subgroup of infants born before 34 weeks gestation, within 8 days of trial entry, and whose mothers had received at least three injections (0/27 steroid group and 7/32 placebo group; P = 0.03), and there were also significantly fewer neonatal deaths (2/27 and 13/32, respectively; P less than 0.01) in this subgroup. Betamethasone did not provoke earlier delivery. Premature rupture of the membranes and maternal hypertension did not seem to contraindicate the use of steroids: there was no increase in maternal or neonatal sepsis nor in stillbirth in hypertensive pregnancies in the steroid group. Neonatal jaundice was significantly less frequent in the steroid (55/129) than in the placebo group (81/127; P less than 0.01) but not in the subgroups born before 34 completed weeks gestation.

Betamethasone↗
PubMed1986

The volume of distribution of ceftazidime and albumin in normal, immature and infected bone.

The penetration of ceftazidime into bone was determined by measuring the volume of distribution of 14C-ceftazidime in infected and non-infected bone of adult mongrel dogs. The volume of distribution in non-infected cortical bone was 0.114 +/- 0.011 l/kg (mean +/- S.E.M.) and increased significantly in non-infected immature callus to 0.484 +/- 0.13 l/kg (P less than 0.05). In the presence of infection, the volume of distribution in non-infected cortical bone was 0.144 +/- 0.05 l/kg, and significantly higher in infected reactive cortical bone, 0.453 +/- 0.07 (P less than 0.05). We conclude that ceftazidime penetrates infected and non-infected bone and that this penetration is greater into immature bone.

Animals↗
PubMed1985

Cefuroxime in CMW bone cement. A clinical study.

This paper presents the results of adding the antibiotic cefuroxime to CMW bone cement in a group of patients undergoing total hip or knee replacement, in which the levels of cefuroxime were assayed in the blood, wound drainage fluid, urine and surplus bone cement. It was found that very small amounts of cefuroxime, less than 5%, were recovered in the urine, serum and drainage fluid in the first week following operation, and since it is known that cefuroxime is not metabolised or excreted elsewhere in the body, it must follow that approximately 95% remains in the bone cement as a potential source of prophylaxis against infection.

Adult↗
PubMed1985

Inhaled beclomethasone dipropionate in acute infections of the respiratory tract.

100 patients with acute tracheitis, tracheobronchitis or bronchitis were randomly allocated to receive inhaled beclomethasone dipropionate (BDP) 100 micrograms qds or placebo as an adjunct to oral antihistamine and a tetracycline antibiotic. 2 patients were withdrawn from analysis, leaving 49 patients in each group. There was no evidence that inhaled BDP conferred any benefit or detriment on the progress of the condition as assessed by daily symptom scores and weekly clinic visits for up to 2 weeks. The same conclusion maintains when the patients were subdivided into two grades of severity as assessed by the physician when the patient first presented. Inhaled BDP would seem to have no role in the inflammatory process associated with those acute infections of presumed viral origins.

Acute Disease↗
PubMed1985

A new, modified form of inhaler ('Rotahaler') for patients with chronic obstructive lung disease.

A randomized study was carried out in 396 patients requiring inhalation therapy for chronic obstructive lung disease to assess whether a modified, breath-activated device for drug delivery ('Rotahaler') was more effective than the current standard model in opening the hard gelatin cartridge containing the drug in powder form ('Rotacaps'). 'Rotacaps' packaged in two different ways, one specially designed to protect them against environmental changes, were also compared. Patients were asked to open 5 cartridges of each type with each of the two devices. The modified 'Rotahaler' failed to open only 0.7% of both types of 'Rotacaps' whereas the standard model failed to open 13.6% of the foil-packed type and 16.9% of those from a special polypropylene container. There was a statistically significant difference between the two 'Rotahaler' devices and between the two types of 'Rotacaps' in the standard device. More patients preferred the modified 'Rotahaler' (160) than the standard (75). The results did not depend upon age, sex, nationality of the patients or previous 'Rotahaler' experience. It is concluded that the modifications substantially improve the performance of the 'Rotahaler' and should make it easier for patients to use.

Adolescent↗
PubMed1984

Extraction of ceftazidime in bone.

The extraction of ceftazidime has been measured in bone by means of the outflow dilution technique following injection into the perfused nutrient artery of the canine tibia. The instantaneous extraction was found to be 0.71 +/- 0.18 and the net extraction was 0.55 +/- 0.25 (mean +/- S.D. n = 5). The extraction of this antibiotic is relatively high and this experiment demonstrates the fact that antibiotics leave capillaries in bone and pass into the fluid spaces where they can act on pathogenic organisms.

Animals↗
PubMed1982

Prophylactic cefuroxime in total joint replacement.

Cefuroxime was given during operation to 95 patients undergoing 106 total joint replacements (hip 69: knee 37). Two regimes were used. Either 1 g was given intravenously with induction of anaesthesia and then two intramuscular injections of 1 g 6 and 12 h later, or 1.5 g was given intravenously with induction and two injections of 750 mg each intramuscularly 6 and 12 h later. The concentrations of cefuroxime in bone, capsule and blood were measured in 77 patients. The assays were carried out independently in two laboratories. In most instances concentrations in the bone were above the MICs for likely pathogens, even after allowing for any contaminating blood. Concentrations in synovial capsule were generally higher than in bone. After a follow-up period of 2 years, two patients developed deep infections. The overall infection rates are comparable with the best results reported in the literature using other prophylactic antibiotics or with ultra-clean air systems.

Adult↗
PubMed1981

The excretion of cefuroxime in human bile.

Cefuroxime is a broad spectrum cephalosporin antibiotic. An intravenous injection of cefuroxime 1.5 g was administered to 25 patients after induction of anaesthesia for cholecystectomy. Concentrations of antibiotic were measured and the mean levels in microgram/ml found to be: serum 120.5, common bile duct bile 42.8, gallbladder bile 5.4, gallbladder wall 39.2. The drug levels exceeded the minimum inhibitory concentrations for most organisms commonly encountered in the biliary tract. There was no difference in cefuroxime levels in bile from functioning or non-functioning gallbladders. It is suggested that the diffusion of antibiotic into and out of the inflamed gallbladder is similar to that in abscesses and in experimental tissue cages. No side effects, toxicity or wound infections occurred.

Bile↗
PubMed1980

Sputum and blood concentrations of cefuroxime in lower respiratory tract infection.

A detailed pharmacokinetic study of cefuroxime has been carried out. Levels of cefuroxime were determined in the blood, sputum, saliva, and urine of 23 patients receiving parenteral cefuroxime eight hourly for chest infections. Profiles were obtained after the first dose and on the final (fifth) day of treatment. Antibiotic levels in the sputum reached 0.8 mg/l within one hour of the first injection, and were maintained close to this value for six hours. There was a build-up by the fifth day, mean cefuroxime concentrations at this time reaching 1.8 mg/l. This concentration was maintained for a prolonged period. Salivary concentrations were detectable but low (maximum mean value was 0.6 mg/l). Concentrations of antibiotic were significantly higher in the serum than those observed after the same doses in volunteers. In the patients there was no build-up in serum levels between the first and fifth days. The data obtained explain the clinical efficacy of cefuroxime in the treatment of lower respiratory infections, and suggest that a 12-hour schedule may be feasible.

Bronchitis↗