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).
[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
|SOURCE Baxter International Inc.|
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