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| |  Gamimune to Fight Bacteria and Infection WEST HAVEN, Conn., Feb. 21, 1997 -- Gamimune(R) N was introduced today as the first intravenous immune globulin (IVIG) with four validated viral removal/inactivation steps. Originally introduced in 1986, Gamimune N has continuously maintained a safety record of no documented cases of viral transmission in more than 1.9 million calculated doses. The utilization of solvent/detergent treatment provides an additional safety step in Gamimune N's plasma viral removal/inactivation process. The announcement was made by Bayer Corporation in San Francisco at the joint meeting of the American Academy of Allergy, Asthma and Immunology, the American Association of Immunologists, and the Clinical Immunology Society. Gamimune N assists immunocompromised patients who lack the antibodies needed to fight bacteria and infection. "Gamimune N has been one of the safest plasma products on the market," said Jan Turek, senior vice president and general manager of Bayer's Worldwide Biological products. "The addition of the solvent/detergent process provides an additional measure of safety and exemplifies Bayer's commitment to provide patients with the safest plasma products possible." Ensuring Safety from Donor to Patient Gamimune N is derived from plasma, a pale yellow fluid extracted from circulating human blood that contains many therapeutic proteins. It is collected from healthy donors, purified and separated into different biological components after its safety and quality are tested and assured. Intensive donor screening prior to acceptance of the plasma donation is performed. If the plasma is found to be unacceptable it is destroyed and the donor may be deferred from donating again. Four Steps of Viral Removal/Inactivation Gamimune N is the first IVIG product to secure a high standard of safety through four viral removal/inactivation steps. -- The first step, using the Cohn-Oncley Cold Ethanol fractionation method, removes viruses bound to antibodies at the Fraction II & IIIW Suspension to Effluent III. -- The second step is a filtration process, proven to remove enveloped viruses which are models for hepatitis B and C, and non-enveloped viruses which are models for porcine parvovirus and hepatitis A. -- The third step utilizes solvent/detergent treatment with tri-n-butyl phosphate (TNBP) and sodium cholate. This step inactivates relevant and model enveloped viruses. The detergent breaks open the outer membrane, killing the virus. -- The final step involves a low pH incubation period which has been validated to reduce infectivity and inactivate relevant and model enveloped viruses. Gamimune N Gamimune N is indicated for (1) primary humoral immunodeficiency states in which there is a severe impairment in forming antibodies, (2) idiopathic thrombocytopenic purpura (ITP) patients that require an increase in platelets to undergo surgery or to control bleeding, (3) the reduction of septicemia and infection during bone marrow transplantation, and (4) bacterial infection associated with pediatric HIV infection.(a) Patients with a recognized need for Gamimune N will now benefit from the addition of solvent/detergent to its viral inactivation process, as well as a preparation that allows for greater convenience. Administered intravenously, the 10% concentrated liquid preparation is simple to prepare for administration. "The higher concentration in this formula of Gamimune N 10% allows for higher doses to be administered in a shorter period of time -- this is a great advantage for patients who previously spent hours and hours getting their infusion," said Dr. Erwin Gelfand, MD, chairman of the department for pediatrics at National Jewish Medical and Research Center, Denver, Co. "The reduced volume makes Gamimune N 10% a better choice for patients who are fluid restricted, and the addition of solvent/detergent process now adds an extra measure of safety." Gamimune N is available in 10, 50, 100 and 2OOmL vial sizes.
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