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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

ation

GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.

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

sucrose as a stabilizer accounted for a disproportionate share of the

total number.

Glycine, an amino acid, is used as a stabilizer. GAMMAGARD

LIQUID does not contain sucrose.

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Components used in the packaging of this product are latex-free.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

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

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