warnings and cautions
5 WARNINGS AND PRECAUTIONS Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment. ( 5.1 ) Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status. Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. ( 5.2 ) When concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. ( 5.3 ) Assessment of electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is administered. ( 5.4 ) Do not dilute with sterile water for injection. ( 5.5 ) This product is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. ( 5.6 ) 5.1 Hypersensitivity Reactions Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the infusion and implementation of appropriate medical treatment. 5.2 Hypervolemia Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately. Use albumin with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. Examples of such conditions are: Decompensated heart failure Hypertension Esophageal varices Pulmonary edema Hemorrhagic diathesis Severe anemia Renal and post-renal anuria 5.3 Laboratory Parameters 20% - 25% human albumin solutions are relatively low in electrolytes compared to 4% - 5% human albumin solutions so if comparatively large volumes are to be replaced, care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes). 5.4 Clinical Hemodynamics Parameters Colloid-osmotic effect of human albumin 25% is approximately five times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration. Patients with marked dehydration require administration of additional fluids. The following parameters should be assessed during administration of ALBUMINEX 25%: Arterial blood pressure and pulse rate Central venous pressure Pulmonary artery occlusion pressure Urine output Electrolytes Hematocrit/hemoglobin 5.5 Pre-infusion Preparation ALBUMINEX 25% must not be diluted with sterile water for injection as this may cause hemolysis in recipients. The product can be diluted in an isotonic solution (e.g., 5% dextrose in water or 0.9% sodium chloride) [see Dosage and Administration (2.2) ]. 5.6 Infectious Diseases Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for ALBUMINEX 25%.