5. WARNINGS
AlbuRx® 25, Albumin (Human) 25% solution is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been extremely reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses through alcohol fractionation and through heat treatment of the product in the final container for 10 hours at 60°C. Despite these measures, such products can still potentially transmit disease. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for Albumin (Human). There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-800-504-5434. The physician should discuss the risks and benefits of this product with the patient.
Turbid solutions must not be used. Do not begin administration more than 4 hours after introduction of the administration set. Partially used bottles must be discarded. There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of sterile water for injection as a diluent for AlbuRx® 25, Albumin (Human) 25% solution. Acceptable diluents include 0.9% sodium chloride or 5% dextrose in water.
6. PRECAUTIONS
Adequate precautions should be taken against circulatory overload and may include pulmonary auscultation or X-ray as well as monitoring the central venous or pulmonary artery wedge pressure. Special caution is indicated in patients with stabilized chronic anemia, congestive heart failure and renal insufficiency.
Pregnancy Category C
Animal reproduction studies have not been conducted with AlbuRx® 25, Albumin (Human) 25% solution. It is also not known whether AlbuRx® 25 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AlbuRx® 25 should be given to a pregnant woman only if clearly needed. There is, however, no evidence for any contraindication to the use of AlbuRx® 25 specifically associated with reproduction, pregnancy or the fetus.
Use an intravenous infusion set suitable for the infusion of blood and blood products.
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