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Baxter and The Alzheimer's Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients With Alzheimer's Disease
Date:8/28/2007

yndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).

GAMMAGARD S/D

[Immune Globulin Intravenous (Human)]

GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

GAMMAGARD S/D must not be used in patients with selective IgA deficiency (IgA, 0.05 g/L) where the IgA deficiency is the only abnormality of concern.

Important Safety Information

Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D.

Immune Globulin Intravenous (Human) products have been reported to be

associated with renal dysfunction, acute renal failure, osmotic nephrosis,

and death. Patients predisposed to acute renal failure include patients

with any degree of pre-existing renal insufficiency, diabetes mellitus,

age greater than 65, volume depletion, sepsis, paraproteinemia, or

patients receiving known nephrotoxic drugs. Especially in such patients,

IGIV products should be administered at the minimum concentration

available and the minimum rate of infusion practicable. While these

reports of renal dysfunction and acute renal failure have been associated

with the use of many of the licensed IGIV products, those containing

sucros
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SOURCE Baxter International Inc.
Copyright©2007 PR Newswire.
All rights reserved

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