Injection-site considerations

Unfortunately transplants require 6-7 foetal brains to obtain enough transplantable material for one patient, which itself raises ethical considerations, and as the tissue cannot diffuse its influence is restricted, even with multiple injection sites, and only a fraction (approx. 20%) of the neurons survive. Also without knowledge of the cause of PD the transplant could meet the same fate as the original neurons. The concept, however, demands perseverance and a number of variants are being tried. 

The protective efficacy of Engerix B has been demonstrated in a number of trials, in the context of infants, children and adults. Seroprotection rates (measured as serum anti-hepatitis B antibody titres above a value of 10 mlU ml-1) of over 95 per cent were usually recorded. The product was found to be generally well tolerated. The most frequently reported adverse effects were local reactions at the injection sites, fever, headache and dizziness. Special consideration to risk benefit ratio should be given to MS patients, as exacerbations of this condition have been (rarely) reported following administration of hepatitis B and other vaccines. Engerix B is manufactured and marketed by GlaxoSmithKline. 

The xanthines are readily absorbed by the oral and rectal routes. Although these agents can be administered by injection (aminophylline is a soluble salt of theophylline), intravascular administration is indicated only in status asthmaticus and apnea in premature infants. Intramuscular injection generally produces considerable pain at the injection site. 

Some preservatives can cause injection site reactions, which is another factor that needs consideration when choosing a preservative. In clinical trials that focused on the evaluation of preservatives and buffers in Norditropin , pain perception was observed to be lower in formulations containing phenol and benzyl alcohol as compared to a formulation containing m-cresol (69). Interestingly, among the commonly used preservatives, benzyl alcohol possesses anesthetic properties (70). 

Formulation evaluation studies [56] showed that there was considerable scope for manipulating the pharmacokinetic profile of doramectin via the formulation vehicle. An oil-based vehicle of sesame oikethyl oleate (90 10) was found to provide high therapeutic and persistent efficacy against a wide range of endo-and ectoparasites [57-59], with excellent injection-site toleration, and so doramectin was selected for development. 

Discussion. The injection site was selected because of geological and hydrological considerations (Fig. 16.6) ... 

LYMErix safety data reported to the Vaccine Adverse Event Reporting System (VAERS) from 21 December 1998 to 31 October 2000 mentioned reports of adverse events associated with Lyme vaccine in prelicensure trials, including injection site reactions, transient arthralgia and myalgia within 30 days of vaccination, fever, and a flu-like illness (7). Allergic reactions were reported to the VAERS and some could have plausibly been linked to the vaccine because of the short latency between vaccination and reaction onset. No clear patterns in age, sex, time to onset, or vaccine dose were identified, although the unexpected predominance of reports of arthrosis in men might warrant further consideration. 

In the present authors opinion, acceptable advances might be made in addressing injection site residue issues through consideration, development, and possible adoption of the proposals of Sanquer et They questioned... 

EMEA/CVMP/520190/2007—consultation. Reflection Paper on Injection Site Residues Considerations for Risk Assessment and Residue Surveillance, European Medicines Authority, Committee for Medicinal Products for Veterinary Use, 2008 (available at http //www.ema.europa.eu/ docs/en GB/document library/Scientific guide line/2009/10/WC500004430.pdf) accessed 12/06/10). 

Design and (Operation Important design and operation considerations for deep-well injection are related to (1) well-site selection, (2) pretreatment, (3) installation of an injec tion well, and (4) monitoring. Important factors related to these design and operation considerations are reported in Table 25-76. As noted in the table, wastes are usually treated prior to injec tion to prevent clogging of the formation and damage to equipment. Particles greater than about 1 to 5 Im must be removed. Typically, treated wastes must be filtered prior to... 

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