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Questions & Answers
Side Effects & Adverse Reactions
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 Inc. [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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss.
In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.
There is currently no drug history available for this drug.
This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.(1) The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate is clear and amber colored. Plasmanate must be administered intravenously.
This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.
The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. (5-8) The production steps from Pooled Plasma to Effluent IV-1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.