Physicians have long wished for a preparation for intravenous administration which has the functions of native 7-globulin molecules but which has minimal untoward effects. S-sulfonated ?,-globulin (GGS) is a preparation which satisfies these requirements, and its intravenous administration results i
Clinical trial of sulfonated immunoglobulin preparation for intravenous administration
β Scribed by N. Kobayashi; N. Gohya; S. Matsumoto
- Publisher
- Springer
- Year
- 1981
- Tongue
- English
- Weight
- 554 KB
- Volume
- 136
- Category
- Article
- ISSN
- 0340-6997
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β¦ Synopsis
S-sulfonated gamma-globulin (GGS), derived from human gamma-globulin by selective sulfonation, retains the dimensional structure and antibody activity of 7S gamma-globulin. GGS does not bind with complement, and is therefore suitable for intravenous administration. Fc activity is recovered through in vivo conversion to intact globulin following IV administration. A total of 414 administrations of GGS was made to 48 patients with primary immunodeficiency syndrome. The frequency of episodes of fever, cough, and infections suffered by those patients who had been treated with other globulin preparations for about one year before the administration of GGS was compared with that following replacement GGS therapy for about one year. Symptomatic relief on administration of GGS was confirmed to be excellent. The administration of 100 mg/kg/BW of GGS resulted in the IgG level rising to 220 mg/dl, with a decrease to 100 mg/dl after one week. The IgG level at two weeks was 70 mg/dl. It is possible to maintain an IgG level of 200 mg/dl by administration of 100 mg/kg/BW of GGS once every 3-4 weeks.
π SIMILAR VOLUMES
A fast, reproducible, economical, and dependable automated counter method is recommended for the quality control of pharmaceutical preparations intended for intravenous administration. The USP gives no specifications on the limitations of particulate matter in intravenous products, while the BP spec