Intratect IVIg Brochure

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Intratect® and Intratect® 100 g/l – Safety through Quality Immunoglobulin G antibodies are essential for maintaining the immune system, inflammation control and tissue regeneration. Antibody concentrates help rebalance the immune system when the body's own IgG antibody production or immune cell communication is dysfunctional. Highest demands are placed on the production of IgG concentrates from human plasma to ensure that human pathogenic viruses are not transmitted and plasma components that trigger undesired coagulation activation or compromise tolerance are removed during the production process. Biotest's Intratect® production process satisfies these rigorous criteria and is at the cutting edge of technology for intravenous immunoglobulin G concentrate production (IVIG). 4
Intratect® I Safety through Quality High purity and naturalness O The two-step process of the cation exchange chromatography guarantees 100 % immunoglobulin purity. O The IgG content of Intratect® and Intratect® 100 g/l is more than 98 %. The proportion of monomers and dimers is more than 99 %, with a maximum of only 0.3 % polymers. The final product contains no residual protein fragments. O IgG subclass distribution that closely matches that of normal serum. O The Intratect® process does not modify the IgG molecules. There is 99 % retention of the Fc part function. O Intratect® and Intratect® 100 g/l are sugar-free and isotonically stabilised with glycine. Excellent safety profile and good tolerability O Repeated donor plasma tests and a four-stage procedure to eliminate or inactivate viruses, including nanofiltration (20 nm), ensure the highest degree of protection against the transmission of human-pathogenic viruses. O Biotest compounds have been certified under the QSEAL program since 2001. O As Intratect® and Intratect® 100 g/l contain particularly low anti-A and anti-B isoagglutinin titers, with proper administration there is minimum risk of haemolysis. O All coagulation factors in the crude material are fully removed during the production process. Intratect® and Intratect® 100 g/l are free of thrombogenic activity. User-friendly O Intratect® and Intratect® 100 g/l are ready to use solutions and can be kept for a period of two years at 25 °C (room temperature). O Each patient is different and the required IVIG amount must be individually calculated. This is facilitated by different IVIG concentrations (5 % and 10 %) and five different package sizes. Intratect® – more than just the sum of its quality characteristics 5
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Page 15 and 16: NAPTT, TGT and determination of the
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Page 31 and 32: To be determined: Inpatient or stat
Page 33 and 34: To be determined: What is the ideal
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Intratect IVIg Brochure

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