CONTRAINDICATIONS
Zemaira is contraindicated in individuals with a known hypersensitivity to any of its components. Zemaira is also contraindicated in individuals with a history of anaphylaxis or severe systemic response to A1-PI products.
Individuals with selective IgA deficiencies who have known antibodies against IgA (anti-IgA antibodies) should not receive Zemaira, since these patients may experience severe reactions, including anaphylaxis, to IgA that may be present in Zemaira.
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REFERENCES
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Stoller JK, Brantly M, et al. Formation and current results of a patient-organized registry for (alpha)1-antitrypsin deficiency. Chest 118(3):843-848, 2000.
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McElvaney NG, Stoller JK, et al. Baseline Characteristics of Enrollees in the National Heart, Lung, and Blood Institute Registry of (alpha)1-Antitrypsin Deficiency. Chest 111:394-403, 1997.
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Eriksson S. Pulmonary Emphysema and Alpha1-Antitrypsin Deficiency. ACTA Med Scand 175(2):197-205, 1964.
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Eriksson S. Studies in (alpha)1-antitrypsin deficiency. ACTA Med Scan Suppl. 432:1-85, 1965.
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Morse JO. Alpha1-Antitrypsin Deficiency. N Engl J Med 299:1045-1048; 1099-1105, 1978.
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Crystal RG. (alpha)1-Antitrypsin Deficiency, Emphysema, and Liver Disease; Genetic Basis and Strategies for Therapy. J Clin Invest 85:1343-1352, 1990.
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World Health Organization. Alpha-1-Antitrypsin Deficiency; Report of a WHO Meeting. Geneva. 18-20 March 1996.
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Gadek JE, Crystal RG. (alpha)1-Antitrypsin Deficiency. In: The Metabolic Basis of Inherited Disease 5th ed. Stanbury JB, Wyngaarden JB, Frederickson DS, et al., eds: New York, McGraw-Hill. 1983; pp. 1450-1467.
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American Thoracic Society. Guidelines for the Approach to the Patient with Severe Hereditary Alpha-1-Antitrypsin Deficiency. Am Rev Respir Dis 140:1494-1497, 1989.
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Gadek JE, Fells GA, Zimmerman RL, Rennard SI, Crystal RG. Antielastases of the Human Alveolar Structures; Implications for the Protease-Antiprotease Theory of Emphysema. J Clin Invest 68:889-898, 1981.
Prolastin® is a registered trademark of Bayer Corporation.
Manufactured by:
Aventis Behring L.L.C.
Kankakee, IL 60901 U.S.A.
U.S. License No. 1281
19131-02
Revised: December 2003
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