Volulight (Solution) Instructions for Use

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

ATC Code

B05AA07 (Hydroxyethyl starch)

Dosage Form

Volulight

Solution for infusion: “freeflex” type packages 250 ml 20, 30, 35 or 40 pcs.; “freeflex” type packages 500 ml 15 or 20 pcs. equipped with 2 connecting ports

Dosage Form, Packaging, and Composition

Solution for infusion transparent or slightly opalescent, colorless or pale yellow in color.

* with a molar substitution degree of 0.4 and an average molecular weight of 130 kDa

Excipients: hydrochloric acid or sodium hydroxide – q.s. to pH 5.7-6.5, water for injection – up to 1 L.

250 ml – polymer packages of the “freeflex” type (20), equipped with two polypropylene connecting ports – cardboard boxes.
250 ml – polymer packages of the “freeflex” type (30), equipped with two polypropylene connecting ports – cardboard boxes.
250 ml – polymer packages of the “freeflex” type (35), equipped with two polypropylene connecting ports – cardboard boxes.
250 ml – polymer packages of the “freeflex” type (40), equipped with two polypropylene connecting ports – cardboard boxes.
500 ml – polymer packages of the “freeflex” type (15), equipped with two polypropylene connecting ports – cardboard boxes.
500 ml – polymer packages of the “freeflex” type (20), equipped with two polypropylene connecting ports – cardboard boxes.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Colloidal plasma substitute with hemodynamic action, contains 6% (10%) hydroxyethyl starch (HES) in a balanced electrolyte solution. The average molecular weight of HES is 130,000 daltons, the molar substitution degree is 0.4.

The 6% solution is iso-oncotic, its volume effect is 100%.

The 10% solution is hyper-oncotic, therefore it has a pronounced volume effect exceeding 100%.

The duration of the volume effect mainly depends on the molar substitution degree of HES and, to a lesser extent, on the average molecular weight of HES. With isovolemic administration, the volume replacement effect persists for at least 6 hours.

HES hydrolysis products are oncotically active molecules that are excreted by the kidneys.

May reduce hematocrit and plasma viscosity.

The cation composition in the solution is identical to the physiological concentration of electrolytes in plasma. The anions are represented by chlorides, acetates, and malates, the purpose of which is to minimize the risk of hyperchloremia and acidosis. The addition of acetates and malates instead of lactates reduces the risk of lactic acidosis.

Pharmacokinetics

HES is a substance consisting of molecules with different molecular weights and molar substitution degrees. Both of these values affect the elimination rate. Small molecules are eliminated during glomerular filtration, while large molecules undergo enzymatic hydrolysis by alpha-amylase and are subsequently excreted by the kidneys. The hydrolysis rate is lower the higher the substitution degree.

Approximately 50% of the administered HES dose is excreted in the urine within 24 hours. After a single administration of 1000 ml of the solution, the plasma clearance is 19 ml/min, AUC 58 mg×h/ml. T_1/2 from serum is 12 h.

Indications

Treatment of hypovolemia in acute blood loss, if the use of crystalloid solutions is insufficient.

ICD codes

Dosage Regimen

The dose and rate of administration are set individually, depending on the severity of hemodynamic disturbances and the patient’s condition.

The use of the drug containing this medicinal product should be limited to the initial phase of blood volume restoration with a maximum time interval of 24 hours.

The first 10-20 ml should be administered slowly and under strict monitoring of the patient’s condition, which will allow for the earliest possible detection of any anaphylactoid reaction.

Adverse Reactions

The most frequent adverse effects are directly related to the therapeutic effects of HES solutions and the dose, i.e., hemodilution, which is the result of an increase in the intravascular space without the concomitant administration of blood components. Dilution of coagulation factors, including fibrinogen, may also occur. The resulting changes in coagulation factors should be corrected in accordance with the recommendations for the organization of transfusion care in medical institutions. Hypersensitivity reactions occur very rarely and are not dose-dependent.

From the blood and lymphatic system decrease in hematocrit and decrease in plasma protein content as a result of hemodilution.
Relatively high doses of HES lead to dilution of coagulation factors and thus to impaired hemostasis. Bleeding time and aPTT index may increase, and von Willebrand factor activity may decrease after administration of this medicinal product in high doses.

Effect on biochemical parameters a short-term increase in serum amylase levels is possible, which should not be regarded as impaired pancreatic function.

Allergic reactions anaphylactic reactions of varying severity up to anaphylactic shock are possible. There are no signs that allow predicting the likelihood or severity of anaphylactic reactions. Therefore, all patients receiving HES solutions should be under constant supervision by medical personnel. In case of the onset of an anaphylactic reaction (swelling of the face, tongue, or throat, difficulty swallowing or breathing, urticaria), administration should be stopped immediately and appropriate non-specific emergency therapy prescribed. Repeated infusions of HES solutions over several days may lead to skin itching.

Contraindications

Sepsis; burns; renal failure or undergoing renal replacement therapy; ongoing intracranial or intracerebral hemorrhage; critically ill patients (usually in the intensive care unit); hyperhydration; pulmonary edema; dehydration; severe hypernatremia or severe hyperchloremia; severe hepatic failure; chronic heart failure; severe coagulopathy; patients who have undergone organ transplantation; hypersensitivity to the medicinal product.

With caution

Patients with mild to moderate hepatic insufficiency; von Willebrand disease, hemorrhagic diathesis, hypofibrinogenemia.

At the first signs of coagulopathy, the drug should be discontinued.

Use in Pregnancy and Lactation

Currently, there are no reliable clinical data on use during pregnancy, so its use in pregnant women is possible only in cases where the expected benefit of treatment with the drug outweighs the possible risk to the fetus, especially in the first trimester.

It is not known whether hydroxyethyl starch is excreted in breast milk; a decision should be made to discontinue breastfeeding.

Use in Renal Impairment

Contraindication: renal failure or undergoing renal replacement therapy.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Adequate long-term data on the use of HES preparations in patients undergoing surgery or trauma are lacking. The expected benefit of treatment should be carefully weighed against the uncertain long-term safety. The possibility of using other available therapeutic measures should be considered.
For the earliest possible detection of anaphylactic reactions, the first 10-20 ml should be administered slowly and under constant supervision by medical personnel.

Since the 10% solution is hyper-oncotic, it must be taken into account that the volume effect exceeds the volume of the administered solution (by mobilizing extravascular fluid); therefore, special attention should be paid to the risk of hypervolemia.

Volume overload, which may occur due to overdose, should always be avoided, as it is particularly dangerous for patients with concomitant cardiac pathology, renal failure, as well as for elderly patients.

Adequate hydration of patients should be ensured.

Serum electrolyte levels, fluid balance, and renal function should be monitored. If necessary, electrolytes and fluid should be replenished according to the individual needs of the patient.

Monitoring of renal function is recommended for 90 days after infusion of the medicinal product.

Monitoring of the coagulation system function is necessary in patients undergoing open-heart surgery with cardiopulmonary bypass, as there is evidence of increased bleeding in such patients when using other HES preparations.

Due to the risk of allergic (anaphylactoid/anaphylactic) reactions, the patient should be under constant observation, and a low initial infusion rate of the drug should be ensured.

Drug Interactions

HES increases the nephrotoxicity of aminoglycoside antibiotics.

Concomitant use with anticoagulants may increase bleeding time.

When mixed with other medicinal products in one container or system, pharmaceutical incompatibility phenomena may be observed.

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.