PLASMANATE Solution for infusion Ref.[11134] Active ingredients: Albumin

Plasmanate is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent 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 Grifols Therapeutics LLC [1-800-520-2807].

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

Solutions which are turbid or 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. Plasma Protein Fraction (Human) 5%, USP—Plasmanate contains no preservative.

Hypotension may occur, particularly following rapid infusion or intraarterial administration to patients on cardiopulmonary bypass. The blood pressure may normalize spontaneously after the slowing or discontinuation of the infusion. Vasopressors will also correct the hypotension.

Flushing, urticaria, back pain, nausea and headache have been occasionally reported by conscious patients.

Rapid infusion of Plasmanate (greater than 10mL/minute) has produced hypotension in patients undergoing surgery or in the preoperative or postoperative period. Blood pressure should be monitored during use and infusion slowed or ceased if sudden hypotension occurs.

Plasmanate does not provide coagulation factors and therefore does not correct coagulation disorders.

Plasmanate 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 or solutions containing alcohol.

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

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