HUMAN ALBUMIN

IDENTIFICATION AND USE: used for treating a variety of conditions, including shock due to blood loss in the body, burns, low protein levels due to surgery or liver failure, and as an additional medicine in bypass surgery. It may be used for certain conditions as determined by your doctor. Human Albumin is a concentrate of plasma proteins from human blood. It works by increasing plasma volume or serum albumin levels.

Human Albumin is prepared from human pool plasma by alcoholic precipitation [12]. For pathogen inactivation albumin is pasteurized for at least 10 h at 60 °C (see also European Pharmacopoeia).

QUALITY CRITERIA: human albumin solutions for transfusion are obtained from human plasma proteins as sterile preparations which, according to the monograph ‘Human Albumin Solutions’ of the European Pharmacopoeia, must contain a minimum of 95% albumin. Aside from human albumin, preparations currently available have a sodium concentration between 87 and 160 mmol/l and a potassium concentration below 2 mmol/l. Because of variable electrolyte concentrations contained in albumin preparations, it is required to monitor the balance of water and electrolyte, especially when administering large amounts. Up to 3.2 g/l sodium octanoat and up to 4.29 g/l acetyltryptophan are added as stabilizers. All albumin preparations currently available contain less than 200 μg/l of aluminum.

Albumin solutions do not contain isoagglutinins or blood group substances and can thus be administered independent of the recipient’s blood group. They do not contain oxygen carriers, coagulation factors, or antibodies. Based on the manufacturing process and the pathogen inactivation involved, albumin preparations are considered to carry no risk of transmitting infections.

IMPROVING TRANSPORT CAPACITY FOR DRUGS: human albumin serves as a transport protein for many substances (e.g. bilirubin, drugs). It is doubtful whether in the case of hypoalbuminemia there may also be an increase in the ‘free’ unbound (biologically active) fraction of drugs (e.g. coumarin derivatives). Since an increase in the free fraction of a substance is most often followed by a more rapid metabolism or an increased elimination of this substance, no critical increase in the concentration of the free substance in plasma is to be anticipated in case of low levels of albumin. There is no risk of acute toxic effects resulting from hypoalbuminemia because of rapid migration of the unbound fraction of drugs from the intravascular to the extravascular space, so that a (low-level) balance is reached. In addition, apparently binding sites for drugs are lost in the production process of human albumin solutions. Administration of human albumin to improve the transport capacity for drugs is not recommended.

FREE RADICAL SCAVENGER AND FOR BINDING TOXIC SUBSTANCES: physiologically, albumin is assumed to serve as free radical scavenger and is able to bind toxic substances (e.g. free fatty acids). Therefore, albumin seems to be indicated in particular in patients with sepsis because toxic oxygen radicals play a role in pathogenesis and maintenance of sepsis. Allegedly albumin can also bind toxins in large-scale burns. Therefore, albumin solutions could have a beneficial effect in these patients. However, to date there are no confirmed factual data on the benefit of human albumin therapy regarding morbidity or mortality in humans. It is uncertain whether human albumin preparations currently commercially available have the same (radical scavenger) properties as natural albumin or whether they are altered by the manufacturing process.

ADVERSE REACTIONS: anaphylactoid reactions, fever, chills, rash, nausea, vomiting, tachycardia, hypotension.

DERMATOLOGIC SIDE EFFECTS: urticaria, skin rash, pruritus, edema, and erythema. Nervous system side effects have included headache, chills, and febrile reactions.

CARDIOVASCULAR SIDE EFFECTS: hypotension.

GASTROINTESTINAL SIDE EFFECTS: nausea, vomiting and increased salivation.

RESPIRATORY SIDE EFFECTS: bronchospasm.

FOUND IN THE FOLLOWING VACCINES: MMRV (PROQUAD), MMR (MMR-II)