Recombinant human albumin (Solution) Instructions for Use

Marketing Authorization Holder

Tonghua Anruite Biopharmaceutical, Co. Ltd. (China)

Manufactured By

Medsintez Plant, LLC (Russia)

ATC Code

B05AA01 (Albumin)

Active Substance

Human albumin (BP British Pharmacopoeia)

Dosage Forms

	Recombinant Human albumin	Solution for infusion 50 mg/ml
		Solution for infusion 100 mg/ml
		Solution for infusion 200 mg/ml

Dosage Form, Packaging, and Composition

Solution for infusion

– containers (100 pcs.) – cardboard boxes – for hospitals
– containers (50 pcs.) – cardboard boxes – for hospitals
10 ml – vials – cardboard packs – By prescription
100 ml – containers – cardboard packs – By prescription
100 ml – vials – cardboard packs – By prescription
5 ml – vials (5 pcs.) – cardboard packs – By prescription
50 ml – containers – cardboard packs – By prescription
50 ml – vials – cardboard packs – By prescription

Solution for infusion

– containers (100 pcs.) – cardboard boxes – for hospitals
– containers (50 pcs.) – cardboard boxes – for hospitals
10 ml – vials – cardboard packs – By prescription
100 ml – containers – cardboard packs – By prescription
100 ml – vials – cardboard packs – By prescription
5 ml – vials (5 pcs.) – cardboard packs – By prescription
50 ml – containers – cardboard packs – By prescription
50 ml – vials – cardboard packs – By prescription

Solution for infusion

– containers (100 pcs.) – cardboard boxes – for hospitals
– containers (50 pcs.) – cardboard boxes – for hospitals
10 ml – vials – cardboard packs – By prescription
100 ml – containers – cardboard packs – By prescription
100 ml – vials – cardboard packs – By prescription
5 ml – vials (5 pcs.) – cardboard packs – By prescription
50 ml – containers – cardboard packs – By prescription
50 ml – vials – cardboard packs – By prescription

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

An agent 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 blood concentration, hypoproteinemia and hypoalbuminemia developing in nutritional dystrophy, nephrotic syndromes, glomerulonephritis, liver cirrhosis, prolonged purulent processes, gastrointestinal tract lesions with impaired patient nutrition (including peptic ulcer, tumors).

ICD codes

Dosage Regimen

Determine the dosage and infusion rate individually based on the patient’s condition, severity of hypoproteinemia, and fluid balance status.

Administer the solution intravenously by infusion. Do not administer as a bolus injection.

Select the concentration (50 mg/ml, 100 mg/ml, or 200 mg/ml) and volume based on clinical requirements for plasma expansion and protein replacement.

For hypovolemic shock, adjust the dose to achieve and maintain adequate circulation and blood pressure. A typical initial dose may be 25 g. Repeat administration if necessary, guided by clinical response.

For burn patients, administer to maintain plasma albumin levels above 2.5 g/100 ml and total protein levels above 5.2 g/100 ml.

In hypoproteinemia, calculate the dose based on the desired increase in plasma albumin. The approximate dose in grams is equal to (desired plasma level g/L – observed plasma level g/L) x plasma volume in liters x 2.

For adults, a single dose typically ranges from 12.5 g to 50 g of albumin, equivalent to 250 ml to 1000 ml of a 5% solution or 100 ml to 500 ml of a 20-25% solution.

Infuse 5% solutions at an initial rate of 1-2 ml per minute, gradually increasing to a maximum of 4 ml per minute.

Infuse 20-25% solutions at a slower rate, not exceeding 1 ml per minute, to avoid rapid plasma volume expansion.

Adjust the infusion rate for pediatric, elderly, or patients with compromised cardiac function. Monitor for signs of circulatory overload.

Monitor vital signs, hematocrit, and serum electrolyte levels during and after infusion. Assess for adequate urine output.

Discontinue administration immediately if signs of anaphylaxis or other severe reactions appear.

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 the administration of human albumin.

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

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

Drug Interactions

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

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.