Gammar-PIV Immune Globulin Indicated In U.S. For Adolescents And Children With Primary Immune Deficiency
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Gammar-PIV Immune Globulin Indicated In U.S. For Adolescents And Children With Primary Immune Deficiency

KING OF PRUSSIA, PA -- March 28, 2000 -- Aventis Behring L.L.C., formerly Centeon L.L.C., announced today that Gammar(R)-P I.V., Immune Globulin Intravenous (Human), is now indicated for the treatment of Primary Immune Deficiency (PID) in adolescents and children who are at an increased risk of infection. Gammar(R)-P I.V. is the first and only pasteurized immune globulin available intravenously in the U.S.

Primary immune deficiency affects approximately one in 10,000 people, or between 25,000 and 30,000 people, in the United States. With primary immune deficiency, a part of the immune system is missing or not functioning properly. The immune system is the body's defense mechanism that prevents infections from invading a person's body. Thus, the body is more vulnerable to becoming ill because the immune system is unable to fight off infections.

"Aventis Behring is proud to provide a new treatment option to adolescents and children who have been diagnosed with primary immune deficiency," said Alain Delongchamp, Vice President and General Manager of North America at Aventis Behring. "Many of these patients will require life-long therapy and Gammar-P I.V. will now be available at diagnosis, enabling them to enjoy a more normal childhood."

Gammar-P I.V. is pasteurized. Pasteurization is a viral inactivation process that has been used for more than one hundred years. It is designed to protect against microbial contamination in many products such as milk. Aventis Behring introduced pasteurization with Gammar-P I.V. in 1995. Unlike other viral inactivation processes, pasteurization is effective in inactivating lipid and certain non-lipid enveloped viruses.

Immune globulin intravenous (human) products, such as Gammar-P I.V. have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.

Gammar-P I.V. should not be given to people with isolated immunoglobulin A (IgA) deficiency. These individuals have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses, cannot be completely eliminated. Please see full prescribing information for more information about Gammar-P I.V.

Aventis Behring, formerly Centeon L.L.C., is a global leader in the plasma protein industry, providing a wide range of innovative, high quality therapies and unique support services to patients worldwide. Aventis Behring is dedicated to the research and development of proteins from human blood plasma and emerging technologies.

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