Albumina Humana Kedrion

Uses

Burns, Hypovolemia, Hypoalbuminemia, Hypoproteinaemia, Adult Respiratory Distress Syndrome, Nephrosis, Cardiopulmonary Bypass Surgery, Hemolytic Disease of the Newborn, Ovarian Hyperstimulation Syndrome, Acute hypovolaemic shock, Neonatal hyperbilirubinaemia

Albumina Humana Kedrion is also used to associated treatment for these conditions: Acute Pyelonephritis, Allergies, Hypoalbuminemia, Hypoproteinemia, Hypovolaemia, Shock, Hypovolemic, Acute fulminant liver failure, Central volume depletion, Hyperbilirubinemia in neonates, Post-operative albumin loss

How Albumina Humana Kedrion works

The main function of albumin results from its contribution to plasma colloid oncotic pressure and transport function .

Albumin stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins. Other physiological functions include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity .

Exogenously administered albumin increases the oncotic pressure of the intravascular system, moving fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. The increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume while maintaining cardiac output in shock. In dehydrated patients, negligible effects exist on circulating blood volume. In addition to the above albumin replaces protein in patients with hypoproteinemia until the cause of the deficiency can be determined .

This drug has thousands of endogenous and exogenous targets. Human albumin also binds and carries a plethora of hydrophobic molecules, such as endogenous (i.e., cholesterol, fatty acids, bilirubin, thyroxine) or exogenous substances (for example, drugs and toxins), transition metal ions, as well as gas (nitric oxide NO), with resulting implications for their solubilisation, transport, metabolism, and detoxification .

Dosage

Albumina Humana Kedrion dosage

25% solution:

• Adult: Initially, 25 g of albumin, adjusted according to patient's response. Usual rates of infusion: 1 -2 ml/minute.
• Child: Up to 1 g/kg, adjusted according to patient's response. Usual rates of infusion: 1 -2 ml/minute. Not to exceed 250 g/48 hr or 6 g/kg/day

20% solution:

• Adult: Initially, 25 g of albumin, adjusted according to patient's response. Usual rates of infusion: Up to 1 -2 ml/minute
• Child: Up to 1 g/kg, adjusted according to patient's response. Usual rates of infusion: Up to 1 -2 ml/minute
• Intravenous Hypoproteinaemia for adult: Up to 2 g/kg daily. Usual rates of infusion: Up to 1 -2 ml/minute
• Intravenous Neonatal hyperbilirubinaemia for child: 1 g/kg of albumin before exchange transfusion. Usual rates of infusion: Up to 1 -2 ml/minute
• Special Populations: Volume admin and rate of infusion must always be individualised according to situation and response. Usual rates of infusion are up to 1 -2 ml/min

5% solution:

• Adult: Initially, 25 g of albumin, adjusted according to patient's response. Usual rates of infusion: Up to 5 ml/minute.
• Child: Up to 1 g/kg, adjusted according to patient's response. Usual rates of infusion: Up to 5 ml/minute.
• Intravenous Hypoproteinaemia for adult: Up to 2 g/kg daily. Usual rates of infusion: Up to 5 ml/minute.
• Intravenous Neonatal hyperbilirubinaemia for child: 1 g/kg of albumin before exchange transfusion. Usual rates of infusion: Up to 5 ml/minute.
• Special Populations: Volume admin and rate of infusion must always be individualised according to situation and response. Usual rates of infusion are up to 5 ml/min.

Side Effects

Allergic reactions, nausea, vomiting, increased salivation, fever and chills; vascular overload, haemodilution and pulmonary oedema.

Toxicity

In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated .

The most common adverse reactions are rigors, hypotension, tachycardia with increased heart rate, fever, chills, nausea, vomiting, dyspnea and/or bronchospasm, skin rash/pruritus. Stop the infusion immediately if anaphylaxis, with or without shock is observed .

Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the volume status of the patient. When clinical signs of cardiovascular overload occur (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately .

Precaution

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.

Food Interaction

Volume of Distribution

Albumin is distributed throughout the extracellular space and more than 60% of the body albumin pool is located in the extravascular fluid space .

In healthy adults, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion of albumin. There is considerable individual variation in the effect of albumin on plasma volume, however , .

In some patients, the plasma volume can remain elevated for several hours. In critically ill patients, however, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate that is difficult to predict .

Pregnancy & Breastfeeding use

Pregnancy Category C. Animal reproduction studies have not been performed with Albumin (Human). It is also not known whether Albumin (Human) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albumin (Human) should be given to a pregnant woman only if necessary.

Labor and Delivery: It is also not known whether Albumin (Human) can cause fetal harm when administered to a woman during labor or delivery of if it will affect reproductive capacity. Albumin (Human) should be given during labor or delivery only if necessary.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Albumin (Human) should be given to nursing mothers only if necessary. Because many drugs are excreted in human milk, caution should be exercised when Albumin (Human) is administered to a lactating woman.

Contraindication

Cardiac failure, severe anaemia, history of hypersensitivity, parenteral nutrition.

Special Warning

Pediatric Use: Data on the use of Albumin (Human) 20% in children including premature babies are very limited. The product should be administered to pediatric patients only if needed.

Geriatric Use: Clinical studies did not include a sufficient number of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Storage Condition

• Albumin (Human) may be stored for 36 months at 2 to 25° C from the date of manufacture.
• Store protected from light.
• Do not freeze.
• Do not use after expiration date.
• Do not use if turbid.

Innovators Monograph

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