WARNINGS
Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. 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 BUMINATE 25%, Albumin (Human), 25% Solution. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. BUMINATE 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 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 (See Description). Despite these measures, such products can still potentially transmit disease. Based on effective donor screening and product manufacturing processes, albumin carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. 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 Baxter Healthcare Corporation at 1-800-423-2862. The physician should discuss the risks and benefits of this product with the patient.
PRECAUTIONS
Certain components used in the packaging of this product contain natural rubber latex.
BUMINATE 25%, Albumin (Human), 25% Solution must be administered intravenously at a rate not to exceed 1mL/min to patients with normal blood volume. More rapid administration might cause circulatory overload and pulmonary edema.
A rise in blood pressure after 25% albumin infusion necessitates careful observation of the injured or post-operative patient in order to detect and treat severed blood vessels that may not have bled at a lower blood pressure.
PREGNANCY—CATEGORY C
Animal reproduction studies have not been conducted with BUMINATE 25%, Albumin (Human), 25% Solution. It is not known whether BUMINATE 25%, Albumin (Human), 25% Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BUMINATE 25%, Albumin (Human), 25% Solution should be given to a pregnant woman only if clearly needed.
PEDIATRIC USE
The use of BUMINATE 25%, Albumin (Human), 25% Solution in children has not been associated with any special or specific hazard, if the dose is appropriate for the child's body weight.
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