ver cirrhosis or other chronic liver disease in adults and children. 9, 10, 11, 12 albuminex 5% infusion plus administration of vasoactive drugs is indicated in the treatment of type i hepatorenal syndrome. 6 for patients with spontaneous bacterial peritonitis, albuminex 5% is indicated as adjuvant treatment to antibiotic therapy. 9, 10, 13 1.3 hypoalbuminemia including from burns albuminex 5% is indicated in patients with severe burn injury (> 20% total body surface area), but not until at least 12 to 24 hours after the burn, in order to correct protein loss, decrease overall fluid requirements, decrease systemic edema and stabilize cardiovascular hemodynamics without fluid overload (initial resuscitation should be with crystalloids). 8, 14 albuminex 5% is also indicated in patients with pre- or post-operative hypoproteinemia and for third space protein loss due to infection or burns. 1.4 acute nephrosis albuminex 5% is indicated in patients with acute nephrosis in combination with loop diuretics to reinforce the diuretic therapeutic effect, which is reduced by hypoalbuminemia, and for the correction of reduced oncotic pressure. 15, 16 1.5 acute respiratory distress syndrome (ards) albuminex 5% is indicated in conjunction with diuretics to correct fluid volume overload associated with ards. 17, 18, 19 1.6 cardiopulmonary bypass albuminex 5% is indicated in cardiopulmonary bypass procedures as part of the priming fluids to passivate the synthetic surfaces of the extracorporeal circuit and maintain the patient's colloid oncotic pressure. 20, 21, 22, 23, 24, 25

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 when large volumes of albumin are being infused, control of coagulation parameters and hematocrit value is essential. also, ensure adequate substitution of other blood constituents such as coagulation factors, electrolytes, platelets and erythrocytes, as appropriate. 5.4 clinical hemodynamics parameters the colloid osmotic pressure of albuminex 5% is about the same as plasma. the following parameters should be assessed during administration of albuminex 5%: arterial blood pressure and pulse rate central venous pressure pulmonary artery occlusion pressure urine output electrolytes hematocrit/hemoglobin 5.5 pre-infusion preparation albuminex 5% 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 5%.

rds) adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. ( 2.1 ) cardiopulmonary bypass procedures adults: initial dose of 25 g. ( 2.1 ) 2.1 dosage the concentration of albuminex 5% used, its dosage, and infusion rate should be adjusted to the patient's individual requirements and clinical indication. indication dose hypovolemia hypovolemia adults: initial dose of 25 g. if hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. for acute liver failure: initial dose of 12 to 25 g. an infusion rate of 1-2 ml per minute is usually indicated. for renal dialysis; the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload. prevention of central volume depletion after paracentesis due to cirrhotic ascites adults: 8 g for every 1000 ml of ascitic fluid removed. hypoalbuminemia including from burns adults: 50 to 75 g for pre- and post-operative hypoproteinemia: 50 to 75 g. in burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. after 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 ml or a serum protein concentration of 5.2 g per 100 ml. third space protein loss due to infection or burns: initial dose of 50 to 100 g. an infusion rate of 1-2 ml per minute is usually indicated in the absence of shock. treatment should always be guided by hemodynamic response. acute nephrosis adults: 25 g together with diuretic once a day for 7-10 days adult respiratory distress syndrome (ards) adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. cardiopulmonary bypass procedures adults: initial dose of 25 g. additional amounts may be administered as clinically indicated. 2.3 administration visually inspect the solution for particulate matter and discoloration prior to administration, whenever solution and container permit. do not use if there are any particulates seen or if the solution is discolored. if a large volume is infused, ensure that the vial is at room temperature before infusion. do not dilute with sterile water for injection as hemolysis may occur. albuminex 5% may be diluted with 0.9% saline or 5% dextrose. begin the infusion within 4 hours of piercing the vial stopper (the product does not contain any preservative). adjust the rate of infusion according to the individual patient's hemodynamic and other physiological responses, using appropriate clinical monitoring.

sion. 6.2 clinical trials experience no clinical studies were done using albuminex 5%.

ternal condition. 8.4 pediatric use no human or animal data. use only if clearly needed. 8.5 geriatric use no human or animal data. use only if clearly needed.

in healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. there is considerable individual variation in the effect of albumin on plasma volume. in some patients, the plasma volume can remain elevated for several hours. in critically ill patients, however, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.