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warnings
Warnings Solutions of Albumin (Human), HUMAN ALBUMIN GRIFOLS ® 20% should not be used if they appear turbid or if there is sediment in the bottle. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. HUMAN ALBUMIN GRIFOLS ® 20% 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 certain viruses by pasteurization. Despite these measures, such products can still potentially transmit disease. 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. There is also the possibility that unknown infectious agents may be present in such products. 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 Biologicals, at 888-GRIFOLS [888-474-3657]. The physician should discuss the risks and benefits of this product with the patient. 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 Albumin (Human) 20%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
Adverse Reactions Allergic or pyrogenic reactions are characterized primarily by fever and chills; urticaria, rash, nausea, vomiting, tachycardia, headache and hypotension have also been reported. Should an adverse reaction occur, slow or stop the infusion for a short period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional HUMAN ALBUMIN GRIFOLS ® 20%, material from a different lot should be used. HUMAN ALBUMIN GRIFOLS ® 20% particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.