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Buminate 5% (Albumin) - Warnings and Precautions

 
 



WARNINGS

Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.

BUMINATE 5%, Albumin (Human), 5% 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 5%, Albumin (Human), 5% Solution, may be given rapidly to individuals with reduced plasma volume with the following exception: if a patient has a history of cardiac or circulatory disease, BUMINATE 5%, Albumin (Human), 5% Solution, should be administered slowly (5 to 10 mL per minute) to avoid too rapid a rise in the blood pressure.

Patients should always be carefully monitored in order to guard against the possibility of circulatory overload.

When BUMINATE 5%, Albumin (Human), 5% Solution, is used following injuries or surgery, the quick rise in blood pressure which follows administration makes it necessary to monitor the patient 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 5%, Albumin (Human), 5% Solution. It is not known whether BUMINATE 5%, Albumin (Human), 5% Solution, can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BUMINATE 5%, Albumin (Human), 5% Solution, should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE

The use of BUMINATE 5%, Albumin (Human), 5% Solution, in children has not been associated with any special or specific hazard, if the dose is appropriate for the child's body weight.

Page last updated: 2006-04-28

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