Venofundin solution for infusion 6% 500ml container, 10pcs

Composition

>of 1000 ml of the solution contains: Active ingredients: Hydroxyethylated starch (HEC)(Average molecular weight 130,000 daltons Molar substitution degree 0.42) 60.0 Sodium chloride 9.0 GH Auxiliary Substances: Water for injection up to 1000 mlconcentration of electrolytes: Sodium 154 mmol / l Chloride 154 mmol/Lphysical and chemical characteristics: Theoretical osmolarity 309 mOsm / lrN 4.0-6.5

Pharmacological action

Pharmacotherapeutic group: plasma substituting mediacode ATX B 05 AA 07 PHARMACOLOGICAL properties Hydroxyethyl starch (HEC) is obtained from amylopectin and characterized by molecular weight and degree of substitution. For Venofundin, the average molecular weight of HES is 130,000 Da, and the degree of substitution is about 0.42. HES is structurally related to glycogen, which explains its high tolerance and low risk of anaphylactic reactions. Venofundin is an isoncotic solution, i. e. the intravascular volume of plasma increases with its infusion equivalent to the administered volume. Pharmacodynamics the duration of the volemic effect depends to a greater extent on the degree of molar substitution and to a lesser extent on the molecular weight. HES undergoes prolonged hydrolysis, which leads to the formation of oncotically active oligo-and polysaccharides of various molecular weights, which are excreted by the kidneys. Venofundin may reduce hematocrit and plasma viscosity. The volemic effect as a result of isovolemic use of Venofundin lasts at least 6 hours. Pharmacokinetics HEC is a mixture of molecules with different degrees of molar substitution and different molecular weights, both of which affect the rate of elimination. Small molecules are eliminated by glomerular filtration, while large molecules undergo enzymatic hydrolysis by alpha-amylase and are subsequently eliminated by the kidneys. The higher the degree of substitution, the lower the rate of hydrolysis. About 50% of the administered dose is excreted in the urine within 24 hours. After a single use of 1000 ml of Venofundin, the plasma clearance is 19 ml / min, the AUC is 58 mg * h / ml, and the area under the concentration-time curve is 58 mg * h/ml. The serum half-life corresponds to 12 hours.

Indications

• Prevention and treatment of hypovolemia and shock, for example, due to bleeding or trauma, intraoperative blood loss, burns, sepsis;
• Acute normovolemic hemodilution, therapeutic hemodilution;
• Filling of the extracorporeal circulatory system.

Contraindications

Hyperhydration, including pulmonary edema; Chronic heart failure; Renal failure with oliguric or anuric syndrome; Revealed sensitization to HES;Intracranial bleeding;Severe hypernatremia and hyperchloremia;Severe liver failure. With caution:  Venofundin should be used with extreme caution : In patients with hepatic insufficiency;With blood clotting disorders, especially with hemophilia and identified or suspected von Willebrand’s disease;The safety and efficacy of Venofundin use to children is not sufficiently studied, so its use in children is possible if the expected therapeutic effect of its use exceeds the potential.

Side effects

The most frequently occurring side effects are directly related to the main effects of HES solutions and the dose of the drug. It is possible to reduce coagulation factors due to hemodilution as a result of the introduction of HES solutions without parallel use of blood components. Allergic reactions occur quite rarely and do not depend on the dose of the drug administered. The effect on the circulatory and lymphatic system is often due to hemodilution, there is a decrease in hematocrit and protein concentration in blood plasma. Depending on the dose administered, HEC solutions can cause a decrease in the concentration of coagulation factors and, thus, affect blood clotting. The bleeding time and APTT index (Activated Partial Thromboplastin Time) may increase, and the activity of FVIII/vWF (von Willebrand factor VIII) may decrease. The introduction of HEC leads to an increase in the concentration of alpha-amylase in plasma, which is associated with the formation of a complex of alpha-amylase with starch, which, in turn, is slowly excreted by the renal and extrarenal pathways, which can be mistakenly regarded as a biochemical sign of pancreatitis. Anaphylactic reactionsin the introduction of HEC solutions, anaphylactic reactions of varying severity occur. Therefore, all patients receiving HEC solutions should be under constant supervision of medical personnel. If any anaphylactic reaction begins to develop, the infusion should be stopped immediately and emergency therapy should be initiated. The effectiveness of preventive use of corticosteroids has not been proven. Repeated infusions of HEC solutions over several days can lead to itching of the skin.

Interaction

To avoid incompatibilities, Venofundin should not be mixed with other medications.

How to take, course of use and dosage

For intravenous use. The daily dose and rate of use depend on the amount of blood loss and hemodynamic parameters. To detect the threat of anaphylactic reactions as early as possible, the first 10-20 ml of Venofundin should be administered slowly under the constant supervision of medical personnel. Maximum daily dose The daily dose and rate of use depend on the volume of bleeding and are determined by maintaining and restoring hemodynamic parameters. The maximum daily dose of Venofundin should not exceed 50 ml / kg of body weight, which corresponds to 3 g of HEC/kg / day (about 3500 ml / day with a body weight of 70 kg). Maximum injection rate The maximum rate of use depends on the clinical situation. In the acute stage of shock, a rate of use of up to 20 ml/kg of body weight per hour is recommended, which corresponds to 0.33 ml/kg of body weight per minute (1.2 g of HEC per kg of body weight per hour). In a critical situation, a rapid injection of 500 ml of the solution (under pressure) is possible. When the drug is administered under pressure, if Venofundin is used in plastic containers, all air from the containers and the injection system must first be removed to avoid the risk of embolism. The duration of therapy depends on the duration and severity of hypovolemia and the hemodynamic effect of the therapy and the level of hemodilution.

Overdose

The main risk of acute overdose is associated with the possibility of hypervolemic overload. In this case, Venofundin should be discontinued immediately and diuretics should be prescribed if necessary.

Special instructions

It is necessary to avoid volume overload, which can occur with an overdose of Venofundin, which is especially dangerous for patients with concomitant cardiac pathology, renal failure, and elderly patients. Serum electrolytes, water balance, and kidney function should be monitored. Adequate water use should be ensured. In the case of severe dehydration, the water-electrolyte balance should initially be normalized. To correctly determine the patient’s blood group, a blood sample must be taken before Venofundin is administered. To detect the threat of anaphylactic reactions as early as possible, the first 10-20 ml of Venofundin should be administered slowly under the constant supervision of medical personnel. Do not use if the solution is not clear or contains visible suspended particles, if the container or bag is damaged or pre-opened.

Storage conditions

Store at a temperature not exceeding 25°C, out of the reach of children. Do not freeze it.

Active ingredient

Hydroxyethyl Starch

Conditions of release from pharmacies

Prescription