Voluven, container 6%, 250ml, 30pcs

Composition

of 1000 ml:

active ingredients:

– poly(O-2-hydroxyethyl)starch 60 g (molar substitution degree-0.4; average molecular weight-130,000 Da)

– sodium chloride 9 g

excipients:

– sodium hydroxide (for pH correction) – q. s. ;

– hydrochloric acid (for pH correction) — q. s. ;

– water for injection-up to 1000 ml

-electrolytes: Na+ – 154 mmol / l; Cl – – 154 mmol/l

indicators:

theoretical osmolarity-308 mosmol / l;

titratable acidity-less than 1 mmol NaOH/l; pH-4-5.5

Pharmacological action

Voluven is a solution of hydroxyethylated starch (HEC) obtained from amylopectin of waxy ripe corn and characterized by its molecular weight and degree of substitution. For Voluven, the average molecular weight is 130,000 Da, and the degree of substitution is 0.4, which means that there are 4 hydroxyethyl groups for 10 glucose residues of amylopectin. HEC is structurally related to glycogen, which explains its high tolerance and low risk of anaphylactic reactions. Voluven is characterized by high stability of the solution and does not allow flocculation during temperature fluctuations.

Voluven is an isoncotic plasma-substituting solution. When it is administered, the volume of intravascular fluid increases in proportion to the volume of Voluven administered.

The persistent volemic effect of Voluven is 100% within 4 hours after the drug is introduced into the vascular bed. Duration of the therapeutic effect – up to 6 hours.

Indications

• treatment and prophylaxis of hypovolemia to any type of shock (due to injuries, including injuries of the spine with spinal cord injury, blood loss, burns, sepsis, multiorgan failure, postoperative, acute adrenal insufficiency, anaphylaxis and other conditions associated with the development of collapse);
• acute normovolemic hemodilution;
• therapeutic hemodilution;
• filling machine of extracorporeal circulation.

Use during pregnancy and lactation

 Use in children

 In children under 2 years of age who underwent surgery (excluding cardiology), the tolerability of Voluven during surgery was comparable to that of 5% albumin.

Contraindications

• hyperhydration;
• hypervolemia;
• congestive heart failure;
• severe blood clotting disorders;
• intracranial bleeding;
• a state of dehydration when water-electrolyte balance correction is required;
• severe renal failure with oliguria or anuria;
• use in patients undergoing hemodialysis;
• hyperchloremia;
• hypernatremia;
• hypersensitivity to the drug.

Side effects

Dermatological reactions:  with prolonged use in high doses – itching of the skin.

From the side of laboratory parameters:  it is possible to increase the concentration of serum amylase. When using the drug in high doses due to the dilution effect, dilution of blood components, reduction of hematocrit, as well as coagulation factors and plasma proteins is possible. In this regard, the activity of blood coagulation factor VIII (von Willebrand) may be reduced during the infusion. Bleeding time and other blood clotting parameters may increase. However, these changes are significantly reduced in comparison with those with HES infusion of previous generations, and are restored to the initial level 6 hours after stopping the infusion of the drug.

Other services:  allergic reactions of varying severity.

Interaction

Avoid mixing Voluven with other medications.

If this is required in exceptional cases, it is necessary to check the compatibility of medicinal products (turbidity, precipitation), observe the rules of asepsis when mixing and ensure good mixing.

How to take, course of use and dosage

The drug is administered by prolonged intravenous infusion.

The first 10-20 ml of the solution should be administered slowly, with careful monitoring of the patient’s condition, due to the risk of anaphylactoid reactions.

The daily dose and rate of infusion depend on the degree of blood loss, maintenance or restoration of hemodynamics, and the degree of hemodilution (blood dilution).

In situations that require rapid compensation of hypovolemia and emergency BCC replenishment,500 ml of the solution can be used in plastic containers under pressure. At the same time, before introducing Voluven, it is necessary to remove air from the container in order to prevent the occurrence of an air embolism.

The maximum daily dose is 50 ml / kg of body weight/day, which corresponds to 3750 ml/day with a patient’s body weight of 75 kg.

In children under 2 years of age who underwent surgery (excluding cardiology), the tolerability of Voluven during surgery was comparable to that of 5% albumin.

To replenish BCC in adults, the maximum dose is 50 ml / kg / day; in children and adolescents aged 10-18 years-33 ml/kg/day; in children aged 2-10 years-25 ml/kg/day; in newborns and children under 2 years-25 ml/kg/day.

Voluven can be administered repeatedly over several days, depending on the clinical situation. The duration of treatment depends on the duration and severity of hypovolemia, on the hemodynamic efficacy of the drug, and on hemodilution.

Overdose

Symptoms:  overload of the circulatory system (for example, pulmonary edema).

Treatment:  discontinuation of the drug, if necessary, a diuretic should be prescribed.

Special instructions

As with other solutions, fluid overload should be avoided during plasma replacement therapy. The risk of hyperhydration is particularly high in patients with heart failure or severe renal impairment. In this case, the indications for infusion should be clarified.

In cases of severe dehydration, salt solutions should be preferred. Special care should be taken in cases of severe hepatic insufficiency or blood clotting disorders, including severe cases of Von Willebrand’s disease. It is important to ensure adequate fluid supply, regular monitoring of kidney function and fluid balance.

Serum electrolytes should be monitored.

When treating patients whose blood type is not determined, it should be borne in mind that the introduction of Voluven in high doses can affect the agglutination reaction and give false positive results when determining the blood type.

The introduction of HES can lead to an increase in serum amylase levels. This effect should not be considered as a violation of the pancreatic function, but as a result of the formation of a complex of HES with amylase, followed by a delay in its excretion through the kidneys. Currently, cases of such interaction are unknown. The drug does not affect the increase in serum glucose levels after hydrolysis with alpha-amylase and can be used in patients with diabetes mellitus.

Use in pediatrics

The dose for children should be selected individually in accordance with the need for colloids and taking into account the severity of the underlying disease, hemodynamic parameters, and water balance.

Form of production

Solution for infusions

Storage conditions

In a dark place, at a temperature not exceeding 25 °C (do not freeze)

Shelf life

3 years

Active ingredient

Hydroxyethyl Starch

Conditions of release from pharmacies

By prescription

Description

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor, For Children as prescribed by a doctor

Indications

Diarrhea, Restoring water-salt balance