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Plasbumin-25 (Albumin) - Warnings and Precautions

 
 



WARNINGS

Plasbumin-25 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. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. 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 Bayer Corporation [1-800-288-8371].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

As with any hyperoncotic protein solution likely to be administered in large volumes, severe hemolysis and acute renal failure may result from the inappropriate use of Sterile Water for Injection as a diluent for Albumin (Human), 25%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. Please refer to the DOSAGE AND ADMINISTRATION section for recommended diluents.

Solutions which have been frozen should not be used. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Partially used vials must be discarded. Vials which are cracked or which have been previously entered or damaged should not be used, as this may have allowed the entry of microorganisms. Albumin (Human) 25%, USP (Plasbumin®-25) contains no preservative.

PRECAUTIONS

GENERAL

Patients should always be monitored carefully in order to guard against the possibility of circulatory overload. Plasbumin-25 is hyperoncotic, therefore, in the presence of dehydration, albumin must be given with or followed by addition of fluids. 4

In hemorrhage the administration of albumin should be supplemented by the transfusion of whole blood to treat the relative anemia associated with hemodilution.8 When circulating blood volume has been reduced, hemodilution following the administration of albumin persists for many hours. In patients with a normal blood volume, hemodilution lasts for a much shorter period.4,9,10

The rapid rise in blood pressure which may follow the administration of a colloid with positive oncotic activity necessitates careful observation to detect and treat severed blood vessels which may not have bled at the lower blood pressure.

DRUG INTERACTIONS

Plasbumin-25 is compatible with whole blood, packed red cells, as well as the standard carbohydrate and electrolyte solutions intended for intravenous use. It should, however, not be mixed with protein hydrolysates, amino acid solutions nor those containing alcohol.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Plasbumin-25. It is also not known whether Plasbumin-25 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasbumin-25 should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE

Safety and effectiveness in the pediatric population have not been established.

CAUTION

Rx only

U.S. federal law prohibits dispensing without prescription.

Page last updated: 2006-11-15

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