Albumin Human 5%

Indications

Albumin Human 5% is used for: Burns, Hypovolemia, Hypoalbuminemia, Adult Respiratory Distress Syndrome, Nephrosis, Cardiopulmonary Bypass Surgery, Hemolytic Disease of the Newborn, Ovarian Hyperstimulation Syndrome

Adult Dose

Intravenous Adult: Initially, 25 g of albumin, was adjusted according to the patient's response. Usual rates of infusion: Up to 5 ml/minute (5% solution). Intravenous Hypoproteinaemia Adult: Up to 2 g/kg daily. Usual rates of infusion: Up to 5 ml/minute (5% solution). In the treatment of shock initial dose of 500 mL of the 5% albumin solution is given as rapidly as tolerated. If response within 30 minutes is inadequate, an additional 500 mL of 5% albumin solution may be given. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 1000 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable. In severe burns immediate therapy should include large volumes of crystalloid with lesser amounts of 5% albumin solution to maintain an adequate plasma volume. After the first 24 hours, the ratio of albumin to crystalloid may be increased to establish and maintain a plasma albumin level of about 2.5 g/100 mL or a total serum protein level of about 5.2 g/100 mL. However, an optimal regimen for the use of colloids, electrolytes and water after severe burns has not been established. The infusion of Albumin (Human) as a nutrient in the treatment of chronic hypoproteinemia is not recommended. In acute hypoproteinemia, 5% albumin may be used in replacing the protein lost in hypoproteinemic conditions. Special Populations: Volume admin and rate of infusion must always be individualized according to the situation and response. Usual rates of infusion are up to 5 ml/min (5% soln).

Child Dose

Child: Up to 1 g/kg, adjusted according to patient's response. Usual rates of infusion: Up to 5 ml/minute (5% solution). Intravenous Neonatal hyperbilirubinemia Child: 1 g/kg of albumin before exchange transfusion. Usual rates of infusion: Up to 5 ml/minute (5% solution). Hypovolemia 5% albumin: 0.5-1 g/kg/dose IV infused over 1 hr; may infuse more rapidly for hypovolemic shock In severe burns The 50 mL dosage form would be appropriate for pediatric use, with a dose of 10-20 mL per kg of body weight infused intravenously at a rate up to 5-10 mL per minute. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 1000 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable. Special Populations: Volume admin and rate of infusion must always be individualized according to situation and response. Usual rates of infusion are up to 5 ml/min (5% soln).

Renal Dose

Administration

IV Preparation Reconstitution: If 5% human albumin is unavailable, dilute 25% human albumin with NS or D5W Do NOT use sterile water as diluent - risk of potentially fatal hemolysis and acute renal failure IV Administration For IV administration only 5% solution: Use for hypovolemia or patients who are intravascularly depleted Use within 4 hr after opening vial; discard unused portion Do not dilute 5% solution May give in combination or through same administration set as saline or carbohydrates Do not use with ethanol or protein hydrolysates; precipitation may form

Contra Indications

Hypersensitivity to albumin preparations or to any of the excipients. Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient. Examples of such conditions are: Decompensated cardiac insufficiency Hypertension Esophageal varices Pulmonary edema Hemorrhagic diathesis Severe anemia Renal and post-renal anuria

Precautions

Hypertension or low cardiac reserve; additional fluids for dehydrated patients. Monitor for signs of cardiac overload in injured or postoperative patients. May carry risk of viral transmission. Volume admin and rate of infusion must always be individualized according to the situation and response. Pregnancy, lactation. Monitoring Parameters Plasma and plasma substitutes are often used in very ill patients whose condition is unstable. Therefore, close monitoring is required and fluid and electrolyte therapy should be adjusted according to the patient’s condition at all times. Monitor electrolyte status. Monitor for signs of cardiac overload in injured or postoperative patients. Monitor hemodynamic performance: this may include: Arterial blood pressure and pulse rate Central venous pressure Pulmonary artery occlusion pressure Urine output Electrolytes Hematocrit/hemoglobin.

Pregnancy-Lactation

Pregnancy No human or animal data are available to indicate the presence or absence of drug-associated risk Lactation Unknown if excreted in human milk

Interactions

Do not mix with blood, blood components, protein hydrolysates, alcoholic solutions or other medicinal products except 0.9% saline or 5% dextrose. However, it can be administered, via a separate IV line, concomitantly with other parenterals. Risk of atypical reactions to ACE inhibitors in patients undergoing therapeutic plasma exchange with albumin human replacement.

Adverse Effects

Side effects of Albumin Human 5% : Frequency Not Defined Flushing Urticaria Fever Chills Nausea Vomiting Tachycardia Hypotension Potentially Fatal: Anaphylactic shock.

Mechanism of Action

Human albumin increases intravascular oncotic pressure and causes movement of fluids from interstitial into intravascular space. Human albumin solutions are available in various concentrations. Solutions containing 5% human albumin are usually used in hypovolemic patients, whereas more concentrated 25% solutions are recommended in patients in whom fluid and sodium intake must be minimised e.g. patients with hypoproteinaemia or cerebral oedema or in paediatric patients.