Albumax

ALBUMAX is a 20% solution of purified human serum albumin prepared by Cohn ethanol fractionation method from normal pooled plasma obtained from healthy blood donors. After purification, the product is stabilized with sodium caprylate and acetyl tryptophan and passed through sterilizing filter.
ALBUMAX contains no preservatives. It is prepared from units of human plasma that have been tested and found negative for HBsAg, anti-HIV1/HIV2 and anti-HCV, and is heated at 60°C for 10 hrs. This heat treatment completely destroys the causative agents of viral hepatitis and AIDS. There are no known cases of viral hepatitis which have resulted from the administration of albumin.
Characteristics: Osmotically equivalent to four times an equal volume of plasma.
Requires no typing or cross-matching.
Room temperature storage for up to thirty six (36) months.
Can be used in conjunction with other fluids, such as 5% glucose.
Formulation: See Table 1.

Click on icon to see table/diagram/image

Physiology of Albumin: The total body albumin mass is about 300 g, Forty percent, or 120 g, is found in the plasma. Daily albumin synthesis in a normal adult is about 16 g. The half-life of albumin is approximately 20 days. For each 500 ml blood lost, a person loses only 12 g, or 4%, of the total body albumin. Thus, albumin in a four-unit hemorrhage (2000 ml) is entirely replaced by normal synthesis in 3 days.

Pharmacology: The primary function of albumin is to provide colloidal osmotic pressure within the circulation. The intravenous administration of albumin results in drawing extravascular fluid into the vascular system. Albumin contributes to the buffer capacity of the plasma, has transport functions and provides a large reserve of amino acids.

ALBUMAX is indicated for: The prevention or treatment of hypovolemic syndrome and the aversion of cardiovascular collapse.
Emergency treatment of shock: Hemorrhagic, traumatic or due to loss of plasma; Shock in acute hemorrhagic, pancreatitis.
Burns: In the initial treatment and stages of burn therapy.
Hypoproteinemia with or without edema: Liver cirrhosis or hepatitis B; Nephrotic syndromes; Cerebral edema.
Neonatal hyperbilirubinemia.

The total dosage of ALBUMAX will vary with the individual. In adults, the usual dose is 25 to 75 g (125 to 375 ml) as human serum albumin per day be given. An initial infusion of 100 ml is suggested, and additional amounts may be administered as clinically indicated. The dosage in children will vary with the clinical state and body weight. A dose one quarter to one half the adult dose may be administered, or dosage may be calculated on the basis of 2.2 ml per kilogram of body weight (0.44 g/kg).
The recommended dosages for specific disease states are as follows: See Table 2.

Click on icon to see table/diagram/image

ALBUMAX is administered intravenously. In the treatment of the patient in shock with greatly reduced blood volume, it may be administered as rapidly as necessary in order to improve the clinical condition and restore normal blood volume.
This may be repeated in 15-30 minutes if the initial dose fails to prove adequate. In the patient with a slightly low or normal blood volume, the rate of administration is not more than 1 ml per minute (20 drops/min). The usual rate or administration in children should be calculated on one quarter to one half the adult rate.

ALBUMAX is contraindicated in patients with hypertension, severe anemia or cardiac failure in the presence of normal or increased intravascular volume.

Should not be used if turbid, or more than 4 hours after the contents have been exposed.
Any remaining contents should be discarded.
Should be administered carefully to patients with low cardiac reserve.
Should not be infused rapidly, because it causes vascular overload with resultant pulmonary edema.
Patients should be closely monitored for signs of increased venous pressure.
Should be administered with additional fluids to patients with marked dehydration.
Should not be used after frozen.
ALBUMAX may be administered with the usual dextrose of saline intravenous solutions. However, certain solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with ALBUMAX since these combinations may cause the proteins to precipitate.

Allergic reactions or adverse reactions due to high plasma protein levels from excess albumin administration may occur.
Such conditions may produce fever and chills primarily.
Rash, nausea, vomiting and tachycardia have also been reported.
Albumin, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

Store at temperatures not exceeding 25°C. Do not freeze. Maximum validity is 36 months from the date of manufacture.

Intravenous & Other Sterile Solutions

B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.

Rx