"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Factor IX Complex Heat Treated
This is a potent drug with potential hazards. For maximal safety and efficacy, carefully read and follow directions below.
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.
What are the possible side effects of factor IX complex (Bebulin VH, Profilnine SD, Proplex T)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using factor IX and call your doctor at once if you have a serious side effect such as:
- chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- weak or shallow breathing;
- feeling short of breath;
- headache, feeling like you might pass out;
- flushing (warmth,...
What are the precautions when taking factor ix complex (Proplex-T)?
Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other clotting disorders (e.g., disseminated intravascular coagulation-DIC), heart disease (e.g., coronary artery disease), immune system problems, recent surgery/procedure, liver disease.
Before having surgery, tell your doctor or dentist that you are using this medication.
Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral...
Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Proplex-T Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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