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Important
Safety Information Important Safety Information
GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% GAMMAGARD LIQUID 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. Important Safety Information 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. 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. Aseptic meningitis syndrome (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). Full Prescribing Information
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 sucrose as a stabilizer accounted for a disproportionate share of the total number. GAMMAGARD S/D 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. Aseptic meningitis syndrome (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. Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex. IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis. 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. Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting, may occasionally occur.Full Prescribing Information GAMMAGARD S/D
IGIV 0.5g
GAMMAGARD S/D
[Immune Globulin Intravenous (Human)],
IgA less than 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 sucrose as a stabilizer accounted for a disproportionate share of the total number. GAMMAGARD S/D, IgA < 1 μg/mL, has a lower IgA concentration than GAMMAGARD S/D which has a concentration of 1 to 2.2 μg/mL. IGIV preparations depleted of IgA (0.4 to 2.9 μg/mL) were shown to be better tolerated by a limited number of patients who reacted to IGIV preparations with higher IgA concentrations. However, the concentration of IgA that will not provoke a reaction is not known, and therefore all IGIV preparations carry the risk of inducing an anaphylactic reaction to IgA. In such instances, a risk of anaphylaxis may exist despite the fact that GAMMAGARD S/D, IgA < 1 μg/mL, contains trace amounts of IgA. GAMMAGARD S/D 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. Aseptic meningitis syndrome (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. Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex. IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis. 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. Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting may occasionally occur. Full Prescribing Information GAMMAGARD S/D IGIV less than 1 µg/mL in a 5% solution 5 g, 10 g
IVEEGAM EN [Immune Globulin Intravenous (Human)] IVEEGAM EN IGIV, is indicated for replacement therapy in patients with primary immunodeficiency syndromes such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia (with or without hyper IgM) and Wiskott-Aldrich syndrome. IVEEGAM EN IGIV is also indicated in the treatment of Kawasaki syndrome when administered in conjunction with aspirin within ten days of onset of disease. Important Safety Information Various common minor reactions, such as headache, fever, fatigue, rigors, flushing, dizziness, rash including urticaria, wheezing or chest tightness, nausea, vomiting, back pain, chest pain, muscle cramps, infusion site reactions and changes in blood pressure may occasionally occur with infusions of Immune Globulin Intravenous (Human) [IGIV]. Aseptic meningitis syndrome has been reported to occur infrequently in association with IGIV, and discontinuation of treatment has resulted in remission within several days without sequelae. IVEEGAM EN IGIV is contraindicated in individuals who are known to have had an anaphylactic or severe systemic response to Immune Globulin (Human). Individuals with selective IgA deficiency should not receive IVEEGAM EN IGIV since these patients may experience severe reactions to the IgA that may be present. 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. IVEEGAM EN IGIV 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. Thrombotic events have been reported in association with IGIV. Patients at increased risk include those with a history of atherosclerosis, hypertension, advanced age, impaired cardiac output, hyperviscosity, hypercoagulable disorders and prolonged periods of immobilization. Aseptic meningitis syndrome has been reported to occur infrequently in association with IGIV, and discontinuation of treatment has resulted in remission within several days without sequelae. IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis. Certain components used in the packaging of IVEEGAM EN IGIV contain natural rubber latex. Please see IVEEGAM EN IGIV prescribing information for details.
POLYGAM S/D [Immune Globulin Intravenous (Human)] POLYGAM S/D IGIV is indicated for the treatment of primary immunodeficient states, such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Important Safety Information POLYGAM S/D IGIV is contraindicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern. Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of POLYGAM S/D IGIV. 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. POLYGAM S/D IGIV 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. Thrombotic events have been reported in association with IGIV. Patients at risk include those with a history of atherosclerosis, hypertension, advanced age, impaired cardiac output, hyperviscosity, hypercoagulable disorders and prolonged periods of immobilization. Aseptic meningitis syndrome has been reported to occur infrequently in association with IGIV, and discontinuation of treatment has resulted in remission within several days without sequelae. IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis. Certain components used in the packaging of POLYGAM S/D IGIV contain natural rubber latex. Various common minor reactions, such as headache, fever, fatigue, rigors, flushing, dizziness, rash including urticaria, wheezing or chest tightness, nausea, vomiting, back pain, chest pain, muscle cramps, infusion site reactions and changes in blood pressure may occasionally occur with infusions of Immune Globulin Intravenous (Human) [IGIV]. Please see the POLYGAM S/D [Immune Globulin Intravenous (Human)]
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