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ASCENIV(immune globulin intravenous, human–slra)10% Liquid(十二)
where the final clinical visit date is defined as the specimen collection date of the final clinical visit for urinalysis,or the specimen collection date for the clinical laboratory tests at the final clinical visit and Day 0 date is the startdate of the first ASCENIV infusion. b Defined as bacterial pneumonia, bacterial meningitis, bacteremia/septicemia, osteomyelitis/septic arthritis, andvisceral abscess. c The calculation of antibiotic use includes subjects who received antibiotics for therapeutic use.
15 REFERENCES
1. Gupta N, Ahmed I, Nissel-Horowitz S, Patel D, Mehrotra B. Intravenous gammaglobulin-associated acute renal failure. Am JHematol 2001; 66:151-152.
2. Cayco, A.V., M.A. Perazella, and J.P. Hayslett. Renal insufficiency after intravenous immune globulin therapy: areport of two cases and an analysis of the literature. J Am Soc Nephrol 1997; 8:1788-1794.
3. Steinberger BA, Ford SM, Coleman TA. Intravenous immune globulin therapy results in post-infusional hyperproteinemia,increased serum viscosity, and pseudohyponatremia. Am J Hematol 2003; 73:97-100.
4. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events.Neurology 1994; 44:223-226.
5. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopeniawith intravenous immunoglobulin in elderly patients. Lancet 1986; 2:217-218.
6. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulinpreparations. Am J Hematol 2000; 65:30-34.
7. Casteels-Van Daele, M., et al. Intravenous immune globulin and acute aseptic meningitis [letter]. N Engl J Med 1990;323:614-615.
8. Kato, E., et al. Administration of immune globulin associated with aseptic meningitis [letter]. Jama 1988; 259:3269-3271.
9. Scribner, C.L., et al. Aseptic meningitis and intravenous immunoglobulin therapy [editorial, comment]. Ann Intern Med 1994;121:305-306.
10. Copelan EA, Stohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion1986; 26:410-412.
11. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J. Hemolysis after high-dose intravenous Ig.Blood 1993; 15:3789.
12. Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle & Nerve 1997;20:1142-1145.
13. Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin
(IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmune 1999; 13:129-135.
14. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion2001; 41:264-268.
15. Siber GA, Werner BG, Halsey NA, et al. Interference of immune globulin with measles and rubella immunization. J Pediatr1993; 122:204-211.
16. Salisbury D, Ramsay M, Noakes K, eds. Immunisation against infectious disease. The Stationery Office (TSO), London: UKDepartment of Health; 2009:426.
17. Hammarstrom L, Smith CIE. Placental transfer of intravenous immunoglobulin. Lancet 1986; 1:681.
18. Sidiropoulos D, Herrmann U, Morell A, von Muralt G, Barandun S. Transplacental passage of intravenousimmunoglobulin in the last trimester of pregnancy. J Pediatr 1986; 109:505-508.
16 HOW SUPPLIED/STORAGE AND HANDLING
ASCENIV is supplied in a single-use, tamper-evident vial. The components u |
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