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Landmark Rh Immune Globulin Celebrates 40 Years of Saving Babies' Lives
Date:2/9/2009

ization. They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (300 micro grams or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells. A single dose of MICRhoGAM contains sufficient anti-D (50 micro grams or 250 IU) to suppress the immune response to up to 2.5 mL of Rh-positive red blood cells.

The final product contains 5 +/- 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 micro grams per dose, are present. The pH range is 6.20-6.55 and IgG purity is greater than or equal to 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system.

CLINICAL PHARMACOLOGY

RhoGAM and MICRhoGAM act by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred.

NOTE: For complete prescribing information, see package insert.


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SOURCE Ortho-Clinical Diagnostics, Inc.
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