Stabisol^® HES 6% (Solution) Instructions for Use

Marketing Authorization Holder

Berlin-Pharma CJS (Russia)

Manufactured By

Berlin-Chemie, AG (Germany)

ATC Code

B05AA07 (Hydroxyethyl starch)

Active Substance

Hetastarch

Hetastarch (USAN)

Dosage Form

Stabisol® HES 6%

Infusion solution 6% (HES 450/0.7): bottle 250 ml or 500 ml 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 6% transparent or slightly opalescent, from colorless to light yellow.

Excipients : sodium chloride – 9 g, water for injections – 956.29 g.

250 ml – glass bottles (10) – cardboard boxes.
500 ml – glass bottles (10) – cardboard boxes.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Plasma substitute, hydroxyethyl starch (HES). HES is a high molecular weight compound consisting of polymerized glucose residues, obtained by hydroxyethylation of amylopectin, a natural polysaccharide contained in potato starch and waxy corn. Amylopectin is rapidly hydrolyzed in blood plasma, its presence in the bloodstream is about 20 min. To increase stability and duration of action, amylopectin is subjected to hydroxyethylation. The depth of this process is characterized by the degree of substitution.

The intensity and duration of the volume-replacing effect of HES preparations are determined by the molecular weight and degree of substitution of the HES substance. The higher the degree of substitution, the longer HES remains in the circulating blood. With a C₂/C₆ ratio greater than 8, HES is metabolized in the body significantly slower than with a ratio of less than 8.

Hetastarch has a molecular weight of 450,000-480,000 daltons and a degree of substitution of 0.6-0.8. It is characterized by slow elimination and high values of the residence time of the active substance in the body, which is due to the ability of the hydroxyethyl group located in the C₂ position to most effectively inhibit the biotransformation of hydroxyethyl starch by serum amylase.

When added to whole blood, hetastarch increases ESR.

Indications

As a plasma substitute for hypovolemia caused by bleeding, acute trauma, burns, sepsis, disorders of water and electrolyte balance in acute gastrointestinal diseases, and surgical interventions. For cardiopulmonary bypass.

ICD codes

Dosage Regimen

Administer intravenously only. Determine the dosage and infusion rate individually based on the patient’s blood loss, clinical condition, and hemodynamic response.

For adult patients, the usual initial dose is 500 ml to 1000 ml. The total daily dose should not exceed 20 ml per kg of body weight (approximately 1500 ml for a 75 kg patient).

Adjust the infusion rate according to clinical need. For severe hypovolemia, administer the initial portion as a rapid infusion. Continuously monitor circulatory parameters (e.g., blood pressure, heart rate, central venous pressure) during and after infusion.

The duration of therapy depends on the severity of hypovolemia. Treatment is typically limited to the first 24 to 48 hours of volume resuscitation. Do not exceed the maximum recommended cumulative dose.

For use in cardiopulmonary bypass, follow the specific priming protocol for the heart-lung machine. The dosage is integrated into the pump prime volume.

Discontinue infusion once adequate volume replacement is achieved or if signs of fluid overload or adverse reactions appear.

Adverse Reactions

Rare periorbital edema, urticaria, stridor, arterial hypotension.

Contraindications

Hypersensitivity to HES; chronic heart failure, kidney disease with oliguria or anuria not associated with hypovolemia, severe blood clotting disorders, intracranial bleeding, hyperhydration.

Use in Pregnancy and Lactation

The use of hetastarch is not recommended in the first trimester of pregnancy. In the second and third trimesters, use is possible in cases of extreme necessity, when the expected benefit of treatment for the mother outweighs the potential risk to the fetus.

Use in Hepatic Impairment

Use with caution in severe chronic liver diseases.

Use in Renal Impairment

Contraindicated in kidney disease with oliguria or anuria not associated with hypovolemia.

Pediatric Use

The efficacy and safety of hetastarch use in children have not been established.

Special Precautions

Use with caution in patients with thrombocytopenia and hypofibrinogenemia, and with pulmonary edema.

Before starting therapy and during the period of HES use, regular and thorough monitoring of serum creatinine content should be carried out.

When used in large volumes, HES can cause disturbances in blood clotting processes.

It should be borne in mind that when using HES, an increase in serum amylase activity is possible, which complicates the diagnosis of pancreatitis.

Can be used for leukapheresis.

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.