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

Autor: G P, Mould, J A, Sutton, P, Matejtschuk, E W, Gascoigne, C H, Dash
Rok vydání: 2001
Předmět:
Zdroj: Vox sanguinis. 80(3)
ISSN: 0042-9007
Popis: The tolerability and pharmacokinetics of a solvent/detergent-treated intramuscular immunoglobulin were compared with those of the standard product.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.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.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.
Databáze: OpenAIRE