Albutein

Hypovolemia: For restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate.

HypoAlbuteinemia: Human Albutein is indicated for severe Albutein deficiency caused by illness or active bleeding. When Albutein deficiency results from excessive protein loss, the effect of Albutein administration will be temporary unless the underlying disorder is reversed.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites: Human Albutein is indicated for maintenance of cardiovascular function following the removal of large volumes of ascitic fluid due to cirrhosis.

Ovarian Hyperstimulation Syndrome (OHSS): Human Albutein is indicated as a plasma expander in the fluid management of severe forms of ovarian hyperstimulation syndrome (OHSS).

Adult Respiratory Distress Syndrome (ARDS): Human Albutein is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS.

Burns: Human Albutein is indicated after >24 hours post burn in patients experiencing severe Albutein depletion in order to favor edema reabsorption.

Hemodialysis: Human Albutein is indicated in patients undergoing long term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.

Cardiopulmonary Bypass: Human Albutein is indicated in cardiopulmonary bypass procedures as part of the priming fluids.

Human albumin is not a glycoprotein. It has the lowest molecular weight (66,241 Daltons) of all plasma proteins. Because of its three dimensional structure, solutions of albumin have a lower viscosity than solutions of other plasma proteins. This is important since work performed by the heart depends in part on the viscosity of blood. Human albumin accounts quantitatively for more than half of the total proteins in the circulation (by weight) and represents approximately 10% of the protein synthesized in the liver. Approximately 40% of albumin is contained in the circulation. The remainder is located in the extravascular space of tissues, principally muscle, skin, and intestine. Human albumin 25% has a hyperoncotic effect. A major function of albumin is its role in osmotic regulation. Albumin is responsible for 75% of normal oncotic pressure within the intravascular space. Other physiological functions include binding and transport of molecules (hormones, enzymes, drugs and toxins); free radical scavenging; hemostatic effects (platelet function inhibition and antithrombotic effects); and capillary membrane permeability.

Hypovolemia:  Adults Initial dose of 25 g is suggested. Pediatric dosage should be adjusted based upon on age, weight and clinical conditions.

Hypoalbuminemia: 50-75 g

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites: 6-8 g for every 1000 mL of ascitic fluid removed

OHSS Adults: Adults 50-100 g over 4 hours and repeated at 4-12 hour intervals as necessary. 10-50 g: single infusion

ARDS: Adults 25 g over 30 minutes and repeated at 8 hours for 3 days if necessary.

Burns: The amount of albumin required to achieve adequate plasma volume and protein content should be determined by direct observation of vital signs or measurement of either plasma oncotic pressure or protein content

Hemodialysis: 100 ml

Cardiopulmonary Bypass: Required dose can be estimated from the difference between the desired and actual total serum protein concentration multiplied by the estimated plasma volume (approximately 40 mL per kg) times 2 (to account for extravascular deficit, which absorbs about half of the administered dose).

Human Albutein should not be mixed with other medicinal products including blood and blood components, but can be administered concomitantly with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate when medically necessary. Human Albutein should not be mixed with protein hydrolysates or solutions containing alcohol since these combinations may cause protein precipitation.

Human albumin is contraindicated in patients with a history of hypersensitivity to albumin, excipients used in its formulation, or components of the container.  Human albumin is also contraindicated in severely anemic patients and in patients with heart failure.

The most common adverse reactions include flushing, urticaria, fever, chills, nausea, vomiting, tachycardia and hypotension. These reactions normally disappear when the infusion rate is slowed or stopped. If a severe reaction such as shock or anaphylaxis occurs, the infusion should be stopped and appropriate treatment initiated.

No human or animal data are available to indicate the presence or absence of drug-associated risk. It is not known whether Human albumin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. No human or animal data are available to indicate the presence of absence of drug-associated risk. It is not known whether Human albumin is excreted in milk.

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 individualised according to situation and response. Pregnancy, lactation.

Pediatric Use: The adult dose may be given in children 12-16 years of age. Use of Human Albutein in children less than 12 years of age has not been clinically evaluated. If administered to children the dosage will vary with the clinical state and body weight of the individual. Typically, a dose one-fourth to one-half the adult dose may be administered. The usual rate of administration in children should be one-fourth the adult rate. Physicians should weigh the risks and benefits of Human Albutein in the pediatric population.

Hypervolemia may occur if the dosage and rate of infusion are too high. At the first clinical sign of circulatory overload, e.g. headache, dyspnea, jugular venous congestion, increased blood pressure, raised central venous pressure, or pulmonary edema, the infusion should be stopped and hemodynamic parameters carefully monitored. Additionally, diuresis or cardiac output should be increased in accordance with the severity of the clinical situation.

Plasma expanders

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.