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The first 300 words of the full text of this section appear below.

Section 1. Active and Passive Immunization

Passive Immunization

Immune Globulin Intravenous

IGIV is made by individual manufacturers from pooled plasma of adults using methods designed to prepare a product suitable for IV use. The FDA recommends that the number of donors contributing to a pool used for IGIV be greater than 15 000 but no more than 60 000 donors. IGIV consists of more than 95% IgG and trace amounts of IgA and IgM. IGIV is available in lyophilized powder or as a premixed liquid solution, with final concentrations of IgG of 3% to 12% depending on the products. IGIV does not contain thimerosal. IGIV products vary in their sodium content, type and concentration of sugar, osmolarity and osmolality, pH, IgA content, volume load, and infusion rate. Each of these factors may contribute to tolerability. The FDA specifies that all IGIV preparations must have a minimum concentration of antibodies to measles virus, Corynebacterium diphtheriae, poliovirus, and hepatitis B virus. Antibody concentrations against other pathogens, such as Streptococcus pneumoniae, vary widely among products and even among lots from the same manufacturer.

Indications for the Use of IGIV
Adverse Reactions to IGIV
Precautions for the Use of IGIV

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INDICATIONS FOR THE USE OF IGIV

Initially, IGIV was developed as an infusion product that allowed patients with primary immunodeficiencies to receive enough IG at monthly intervals to protect them from infection until their next infusion. IGIV currently is approved by the FDA in the United States for 6 conditions (Table 1.9, p 59). IGIV products also may be useful for other conditions, although demonstrated efficacy from controlled trials is not available in all cases.


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  		Table 1.9. Uses of Immune Globulin Intravenous (IGIV) for Which There is Approval by . . . [Go to Full Text]


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