Proplex-T
PROPLEX T Factor IX Complex Heat Treated
WARNING
This is a potent drug with potential hazards. For maximal safety and efficacy, carefully read and follow directions below.
DRUG DESCRIPTION
PROPLEX T*, Factor IX Complex, Heat Treated is a sterile product prepared from pooled normal human plasma. It contains, in concentrated form, clotting Factors II (prothrombin), VII, IX, and X. Other proteins are also present in minimal amounts. The product also contains a small amount of heparin, 1.5 units or less per mL of reconstituted material, as a stabilizing agent. This amount does not affect the clinical usefulness of the complex in moderate dosage.
PROPLEX T, Factor IX Complex, Heat Treated must be administered intravenously. During the manufacturing process, this product was heat treated at 60 ± 1.0°C for 144-153 hours. This heating step was designed to reduce the risk of transmission of hepatitis and other viral infections. However, no procedure has been shown to be totally effective in removing viral infectivity from PROPLEX T, Factor IX Complex, Heat Treated.
*Manufactured under U.S. Patent No. 4,495,278. The "T" indicates that the product is heat treated. ©Copyright 1986, 2002 Baxter Healthcare Corporation. All rights reserved.
Generic Name: Factor IX Complex
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