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Solvent/detergent treatment does not alter the tolerance or uptake of human normal immunoglobulin for intramuscular injection
Author(s) -
Mould G. P.,
Sutton J. A.,
Matejtschuk P.,
Gascoigne E. W.,
Dash C. H.
Publication year - 2001
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1046/j.1423-0410.2001.00026.x
Subject(s) - pharmacokinetics , tolerability , antibody , bioavailability , intramuscular injection , medicine , adverse effect , pharmacology , immunoglobulin g , chemistry , immunology
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.