FDA label 7a5bc0ff-1dd9-4c8f-918f-97dd52bf2a86

5.1 Warnings Following reports that 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) 7 , if dilution is required, acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. 6 Albutein ® 20% is made from pooled human plasma. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases, including a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD). Although no cases of transmission of viral diseases or CJD have ever been identified for albumin, the risk of infectious agents cannot be totally eliminated. The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient. Solutions of Albutein ® 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.

5. WARNINGS AND PRECAUTIONS Risk of infectious agents ( 5.1 ) Patients with low cardiac reserve ( 5.2 ) 5.1 Warnings Following reports that 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) 7 , if dilution is required, acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. 6 Albutein ® 20% is made from pooled human plasma. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases, including a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD). Although no cases of transmission of viral diseases or CJD have ever been identified for albumin, the risk of infectious agents cannot be totally eliminated. The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient. Solutions of Albutein ® 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. 5.2 Precautions Albutein ® 20% should be administered with caution to patients with low cardiac reserve. Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure. A rapid rise in blood pressure following infusion necessitates careful observation of injured or postoperative patients to detect and treat severed blood vessels that may not have bled at a lower pressure. Patients with marked dehydration require administration of additional fluids. Albutein ® 20% may be administered with the usual dextrose and saline intravenous solutions. However, certain solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with Albutein ® 20% since these combinations may cause the proteins to precipitate. See also PATIENT COUNSELING INFORMATION ( 17 ).

6. ADVERSE REACTIONS The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension. 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 Albutein ® 20%, material from a different lot should be used. Albutein ® 20%, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .