23/06/2023
DESCRIPTION
ALBUCEL® is albumin (Human) 20%, prepared from the pools of adult human venous plasma obtained from healthy donors. Albucel is a
sterile, liquid preparation of albumin in aqueous solution. Each 100 mL of Albucel® contains 20 g of human albumin which is osmotically
equivalent to 400 mL of normal human plasma.
All plasma used in the manufacture of this product was tested by Nucleic Acid Tests (NAT) for HCV, HBV and HIV-1 and found to be non
reactive (negative).
INDICATIONS AND USAGE
Hypovolemic Shock
Albucel is hyperoncotic solution. Albucel is indicated in the emergency treatment of hypovolemia with or without shock associated with blood
loss, trauma and surgical procedure. On intravenous infusion, it will expand the plasma volume by an additional amount, three to four times
the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or
there is interstitial edema. If the patient is dehydrated, additional crystalloids must be given. The patient’s hemodynamic response should
always be monitored with usual precautions against circulatory overload. If there has been considerable loss of red blood cells, transfusion
with packed red blood cells is indicated. The total dose should not exceed the level of albumin found in the normal individual; i.e., about 2 g
per kg body weight in the absence of active bleeding. Albucel, with appropriate crystalloids, may offer therapeutic advantages in oncotic
deficits or in long-standing shock where treatment has been delayed.
Burn Therapy
An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been
established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted
extracellular fluid volume. Beyond 24 hours, Albucel is used in conjunction with adequate infusions of crystalloid to counteract
hemoconcentration and the hypoproteinemia, electrolytes and water that usually follow severe burns.
Hypoproteinemia (With or Without Edema)
Albumin is indicated in the treatment of hypoproteinemia caused by a loss of plasma protein. Loss of plasma protein may occur through
decreased absorption in gastrointestinal disorder, inadequate synthesis in chronic liver diseases or excessive urinary catabolism in chronic
liver diseases. Albumin serves to restore colloidal osmotic pressure and in, conjugation with a diuretic, promotes diuresis. During major
surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit. A similar situation can occur
in sepsis or intensive care patients. Treatment with Albucel may be of value in such cases.
Ascites
Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In
such circumstances, albumin infusion is used to support the blood volume.
Renal Dialysis
Although not part of the regular regimen of renal dialysis, Albucel can be used as an adjunct in patients who are undergoing long term
hemodialysis and are susceptible to shock or hypotension, or in dialysis patient who are hypovolemic and may not tolerate large volumes of
crystalloids infusion as treatment for shock and hypovolemia. The usual volume administered is about 100 mL, taking particular care to avoid
fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution. Albucel solution is suitable
for use in dialysis patients, as aluminum content is less than 200 μg.
Acute Liver Failure
In the uncommon situation of rapid loss of liver function with or without coma, administration of Albucel may serve the double purpose of
supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.
Neonatal Hemolytic Disease
The administration of Albucel may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of
kernicterus. Albucel solution is suitable for use in premature
babies, as aluminum content is less than 200 μg.
Acute Liver Failure
In the uncommon situation of rapid loss of liver function with or without coma, administration of Albucel may serve the double purpose of
supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.
Neonatal Hemolytic Disease
The administration of Albucel may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of
kernicterus. Albucel solution is suitable for use in premature babies, as aluminum content is less than 200 μg.
