Uman Albumin (Solution) Instructions for Use

ATC Code

B05AA01 (Albumin)

Active Substance

Human albumin (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Plasma substitute. Human albumin preparation

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

A plasma-substituting preparation obtained by fractionation of blood and plasma from healthy donors. Albumin is a protein with a molecular weight of 69,000 daltons, which is a component of the protein fraction of human blood.

It replenishes the deficiency of plasma albumin, maintains the colloid-osmotic (oncotic) pressure of the blood, rapidly increases blood pressure and the total circulating blood volume, promotes the transition of fluid from tissues into the bloodstream, and has detoxification properties.

Pharmacokinetics

Pharmacokinetic data for Uman Albumin are not provided.

Indications

• Replacement therapy for albumin deficiency and blood loss (Uman Albumin 5%);
• Replacement therapy for severe albumin deficiency (Uman Albumin 20% and 25%).

ICD codes

Dosage Regimen

Solution

The dosage regimen and infusion rate are calculated based on the patient’s individual parameters.

The minimum value of colloid-osmotic pressure is 20 mm Hg (2.7 kPa).

When prescribing human albumin, the required dose in grams can be calculated using the following formula: [required total protein (g/l) – available total protein (g/l)] × plasma volume (l) × 2.

The physiological plasma volume can be calculated as corresponding to 40 ml/kg of body weight.

Since this formula is approximate in some cases, laboratory monitoring of protein concentration is recommended. In the case of extensive replacement therapy and when the hematocrit falls below 30%, transfusion of packed red blood cells is necessary to maintain oxygen transport by the blood.

The drug is administered only intravenously by drip.

The infusion rate is determined according to individual characteristics and indications; typically for a 5% solution – 5 ml/min, for 20% and 25% solutions – 1-2 ml/min. The maximum administration time is 3 hours. During plasmapheresis, the infusion rate should not exceed 30 ml/min.

When administering large volumes, the drug should be warmed to room temperature or body temperature before use.

Adverse Reactions

Rarely, moderate reactions are observed: flushing, urticaria, febrile state, nausea. These reactions usually stop after slowing down or stopping the administration of the drug.

In very rare cases, the administration of the drug may cause shock. In this case, the administration of the drug should be stopped and the necessary treatment carried out.

Contraindications

All conditions in which hypervolemia or its consequences (increased stroke volume, high blood pressure) or hemodilution may pose a risk to the patient.

• Decompensated heart failure;
• arterial hypertension;
• esophageal varices;
• pulmonary edema;
• hemorrhagic diathesis;
• Severe anemia;
• Renal and postrenal anuria;
• dehydration (if fluid replacement is not performed simultaneously).

Increased individual sensitivity to the components of the drug.

With caution, the drug should be prescribed for renal failure, thrombosis, ongoing internal bleeding, chronic heart failure.

Use in Pregnancy and Lactation

Uman Albumin should be used during pregnancy and breastfeeding only if the potential benefit to the mother outweighs the possible risk to the fetus or child.

Use in Renal Impairment

Should be prescribed with caution in renal failure.

Pediatric Use

It is necessary to take into account the fact that in children the physiological plasma volume depends on age.

Special Precautions

The colloid-osmotic pressure of a 20% albumin solution is 4 times higher than that of blood plasma. Consequently, when concentrated albumin is administered, special attention must be paid to adequate patient hydration. Patients should be carefully monitored for circulatory disorders and hyperhydration.

If the volume of the administered 20% or 25% albumin solution exceeds 200 ml, electrolyte solutions must be administered to maintain normal fluid balance. Alternatively, therapy can be continued with a 5% solution of human albumin.

When administering significant volumes, control of blood clotting time and hematocrit is necessary.

Special attention should be paid to ensuring that such blood components as clotting factors, electrolytes, platelets, and red blood cells are within normal limits.

In case of shock development, the infusion should be stopped and anti-shock therapy prescribed.

When administering drugs derived from human blood or plasma, infectious diseases caused by the transmission of infectious agents cannot be completely excluded. To reduce the risk of transmission of infectious agents, donors and the obtained preparations are carefully checked. Each unit of plasma used to obtain human albumin is tested for the absence of HBsAg, HIV 1, HIV 2. In addition, testing for the presence of hepatitis C virus RNA is performed using gene amplification. Only antigen-negative donor plasma samples are used in production. The manufacturing scheme of the drug includes a step for virus removal and inactivation. During ultrafiltration and diafiltration, metal ions are removed; thus, the risk of aluminum accumulation and the resulting toxicity is significantly reduced.

The drug can be used within the expiration dates indicated on the packaging. Before use, a visual inspection of the drug and packaging must be carried out: the solution must be transparent, free of any inclusions, the glass packaging must be sealed, without cracks. The label data (drug name, manufacturer, batch number, manufacturing date) must be recorded in the medical history.

Use in pediatrics

It is necessary to take into account the fact that in children the physiological plasma volume depends on age.

Overdose

With frequent administration of the drug in high doses, the development of hypervolemia may be observed.

At the first clinical signs of heart failure (headache, suffocation), increased blood pressure, increased central venous pressure, pulmonary edema, the infusion should be stopped immediately, and the patient’s blood parameters (hemoglobin, hematocrit) should be clearly monitored.

It is assumed that diuresis and cardiac output may increase depending on the severity of the clinical picture.

Drug Interactions

To date, no interactions of human albumin with other drugs have been registered.

The drug should not be mixed with other medicines, blood, or packed red blood cells, as this may lead to protein precipitation.

Storage Conditions

The drug should be stored in a place protected from light, out of the reach of children, at a temperature not exceeding 30°C (86°F). Do not freeze.

Shelf Life

Shelf life – 3 years (provided the packaging integrity is maintained and storage conditions are fully complied with).

The prepared solution should be used immediately.

Dispensing Status

The drug is dispensed by prescription.

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.