Aosta^® (Solution) Instructions for Use

Marketing Authorization Holder

Dalita, S.A. (Switzerland)

Manufactured By

Reliance Life Sciences Pvt. Ltd. (India)

ATC Code

B05AA01 (Albumin)

Active Substance

Human albumin (BP British Pharmacopoeia)

Dosage Form

Aosta®

Solution for infusion 20%

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a transparent or slightly opalescent liquid, almost colorless, yellowish, amber, or greenish in color.

100 ml – bottles – cardboard packs – Prescription only
50 ml – bottles – cardboard packs – Prescription only

Clinical-Pharmacological Group

Plasma substitute. Human albumin preparation

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; blood products and related agents; blood substitutes and plasma protein fractions

Pharmacological Action

A preparation obtained by fractionation of blood, plasma, placenta, serum from healthy donors.

It maintains the colloid-osmotic (oncotic) pressure of the blood, increases the circulating blood volume, and raises blood pressure.

It promotes the penetration of tissue fluid into the bloodstream. It is a source of protein.

Indications

Traumatic and postoperative shock, burns accompanied by dehydration and hemoconcentration, hypoproteinemia and hypoalbuminemia developing in nutritional dystrophy, nephrotic syndromes, glomerulonephritis, liver cirrhosis, prolonged purulent processes, lesions of the gastrointestinal tract with impaired patient nutrition (including peptic ulcer, tumors).

ICD codes

Dosage Regimen

Determine the dosage and infusion rate individually based on the patient’s clinical condition, indication, and response.

Administer the 20% solution intravenously only. Do not use if the solution is turbid or contains precipitates.

For hypovolemic or traumatic shock, administer an initial dose of 100-200 ml. Adjust subsequent doses based on the patient’s response and stabilization of vital signs.

For burn patients, administer to maintain plasma albumin levels above 2.5 g/100 ml. Calculate the total dose based on the extent of burns and laboratory parameters.

For hypoproteinemia, calculate the required dose based on the desired plasma albumin increase. A dose of 1-2 ml of 20% albumin per kg of body weight can raise plasma albumin by approximately 1 g/100 dl.

In patients with nephrotic syndrome, administer to maintain plasma albumin levels and manage edema. The dose is typically 0.5-1 g of albumin per kg of body weight, administered 1-3 times per week.

Adjust the infusion rate carefully. For a 20% solution, the initial infusion rate should not exceed 1-2 ml per minute. Gradually increase the rate to a maximum of 4 ml per minute if tolerated.

Monitor the patient’s hemodynamic status continuously during infusion. Observe for signs of circulatory overload, particularly in patients with compromised cardiac or renal function.

Do not exceed a daily dose of 2 g of albumin per kg of body weight. The total administered volume must be considered in the patient’s daily fluid balance.

For pediatric use, calculate the dose based on body weight and clinical condition, typically 0.5-1 g of albumin per kg of body weight. Administer at a slower, controlled rate.

Adverse Reactions

From the digestive system: nausea, vomiting, hypersalivation are possible.

From the cardiovascular system: arterial hypotension, tachycardia.

Allergic reactions: urticaria is possible; rarely – anaphylactic shock.

Other: increased body temperature, pain in the lumbar region are possible.

Contraindications

Thrombosis, arterial hypertension, ongoing internal bleeding, severe anemia, severe forms of heart failure, hypersensitivity to human albumin.

Use in Pregnancy and Lactation

During pregnancy, the use of human albumin is possible only in cases of extreme necessity.

Data on the safety of human albumin use during lactation are not available.

Use in Hepatic Impairment

Use is possible depending on the clinical situation.

Use in Renal Impairment

Use is possible depending on the clinical situation.

Pediatric Use

Use is possible depending on the clinical situation.

Geriatric Use

Use with caution in elderly patients due to the risk of cardiovascular system overload.

Special Precautions

Patients with dehydration should be provided with adequate fluid intake before administration of human albumin.

Use with caution in patients with reduced cardiac reserve due to an increased risk of developing acute heart failure.

When using preparations from human blood and plasma, the possibility of infection with infectious diseases cannot be completely excluded.

Drug Interactions

With simultaneous use of human albumin with ACE inhibitors, the risk of arterial hypotension increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.