Voluven - Instructions For Using The Solution, Price, Analogues, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Voluven

Voluven: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Voluven

ATX code: B05AA

Active ingredient: hydroxyethyl starch

Producer: Fresenius Cabi Deutschland GmbH (Germany)

Description and photo updated: 2019-27-08

Prices in pharmacies: from 4175 rubles.

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Voluven is a plasma replacement drug.

Release form and composition

Dosage form - solution for infusion 6%: colorless or slightly yellow liquid with a transparent or slightly opalescent structure (250 ml or 500 ml in polyolefin "flex" containers, in a cardboard box 15, 20 or 30 containers; 500 ml in plastic bottles with a loop-holder for a dropper, in a cardboard box 10 or 20 containers; each box also contains instructions for the use of Voluven).

Content of active substances in 1 liter of solution:

• Poly (O-2-hydroxyethyl) starch (degree of molar substitution 0.4; average molecular weight (Da) 130,000) - 60 g;
• Sodium chloride - 9 g;
• Electrolyte Na + - 154 mmol / l;
• Electrolyte Cl- - 154 mmol / l.

The theoretical osmolarity of the solution is 308 mOsm / l, the titratable acidity is less than 1 mmol NaOH / l, the pH is 4.0-5.5.

Auxiliary components: sodium hydroxide, hydrochloric acid, water for injection.

Pharmacological properties

Pharmacodynamics

Voluven is a plasma-substituting agent. It is a solution of hydroxyethylated starch (HES) obtained from amylopectin of waxy maize.

The average molecular weight of the drug is 130,000 Da, the degree of substitution is 0.4 (that is, there are 4 hydroxyethyl groups per 10 glucose residues of amylopectin).

Voluven (130 / 0.4) is an iso-oncotic plasma-replacing solution, so the volume of intravascular fluid increases in proportion to the injected volume of the drug.

HES is characterized by high tolerance and a low risk of anaphylactic reactions, due to its structural relationship with glycogen. The solution is highly stable and does not flocculate with temperature fluctuations.

The persistent volemic effect of Voluven reaches 100% within 4 hours from the moment the solution is introduced into the vascular bed. The therapeutic effect lasts up to 6 hours.

Pharmacokinetics

The pharmacokinetic parameters of HES are complex and depend on the molecular weight, the degree of molar substitution of hydroxyethyl starch and the nature of the molar substitution of C2 / C6 by hydroxyl groups.

After intravenous infusion, molecules weighing less than 60,000–70,000 Da (renal filtration threshold) are rapidly excreted by the kidneys in the urine. Larger molecules are cleaved by α-amylase in blood plasma and only then are excreted in the urine. The lower the degree of HES substitution, the faster it is hydrolyzed by α-amylase and excreted from the body, and the less its accumulation in blood plasma and tissues (in particular, in the cells of the immune system).

The volume effect of Voluven depends on the nature of the C2 / C6 substitution, which is 9: 1, that is, the arrangement of hydroxyl groups is more stable in the C2 position than in the C6 position (9 times). The volemic effect of HES is more stable if the C2 position contains ≥ 8 hydroxyl groups.

The average molecular weight of Voluven in vivo in the blood plasma in the first minutes after administration is 70,000–80,000 Da. This indicator remains above the renal filtration threshold during the entire period of therapy.

After infusion of the drug in a volume of 500 ml, its plasma clearance is 31.4 ml / min. After a single injection of 500 ml of Voluven, the half-life in the first phase is 1.4 hours, in the second phase - 12.1 hours.

After a single injection of 500 ml of the drug, the HES molecules are completely eliminated within 24 hours. After repeated infusions of the solution in the same volume for 10 consecutive days, no significant accumulation of the drug in the blood plasma was found.

With stable renal dysfunction (from mild to severe) and creatinine clearance (CC) 50 ml / min with the introduction of Voluven in the same dose (500 ml), however, this phenomenon has no clinical significance. Impairment of renal function does not affect the half-life of the drug in the final phase and the value of the maximum concentration in blood plasma. With CC> 30 ml / min, about 59% of the administered dose of Voluven is excreted in the urine, with CC 15-30 ml / min - 51%.

With the same plasma-substituting effect, Voluven (130 / 0.4) has better pharmacokinetics (with optimized metabolism and excretion) compared to HES 200 / 0.5. At the same time, Voluven is characterized by maximum safety in comparison with previous generations of HES: even with repeated use in high doses, it has a minimal effect on the hemostasis system, practically does not accumulate in tissues.

Indications for use

• Prevention and treatment of hypovolemia of any etiology and shock resulting from blood loss, trauma (including the spine with spinal cord injury), burns, multiple organ failure, sepsis, acute adrenal insufficiency, in the period after surgery, anaphylaxis and other conditions causing collapse;
• Therapeutic hemodilution;
• Acute normovolemic hemodilution;
• Filling the extracorporeal circulation apparatus.

Contraindications

• Hypervolemia;
• Hyperhydration;
• Congestive heart failure;
• Intracranial bleeding;
• Severe bleeding disorders;
• A state of dehydration, requiring correction of the water-electrolyte balance;
• Application in patients on hemodialysis;
• Severe renal failure with anuria or oliguria;
• Hypernatremia;
• Hyperchloremia;
• Hypersensitivity to Voluven's components.

With extreme caution, the drug should be used in severe liver failure.

Since there are no clinical data on the possibility of using Voluven during pregnancy and breastfeeding, during pregnancy, the drug can be prescribed only if the intended benefit to the mother outweighs the possible threat to the fetus.

Voluven, instructions for use: method and dosage

Voluven solution is administered intravenously (IV) by prolonged infusion.

The doctor prescribes the daily dose and infusion rate based on clinical indications (degree of blood loss, restoration or maintenance of hemodynamics, level of hemodilution (blood dilution)).

Due to the risk of anaphylactoid reactions, slow administration of the first 10-20 ml of solution is recommended under close monitoring of the patient's condition.

In emergency situations, to quickly replenish the circulating blood volume and compensate for hypovolemia, use the solution in plastic containers of 500 ml under pressure (to avoid the development of air embolism, the air must be removed from the container before the solution is injected).

When replenishing the volume of circulating blood, the daily dose of Voluven solution should not exceed:

• Adults - at the rate of 50 ml per 1 kg of the patient's body weight;
• Patients from 10 to 18 years old - 33 ml per 1 kg of body weight;
• Children 2-10 years old - 25 ml per 1 kg of weight;
• Infants and children under 2 years old - 25 ml per 1 kg of weight.

If necessary, the solution can be administered several times over several days. The duration of therapy depends on the severity and duration of hypovolemia, hemodilution, hemodynamic efficacy of the agent.

Side effects

• Laboratory indicators: possibly - an increase in the concentration of serum amylase; when using high doses - a decrease in hematocrit, plasma proteins, coagulation factors, dilution of blood components; due to a decrease in the activity of blood coagulation factor VIII (von Willebrand), bleeding time and other indicators of blood clotting may increase, which, 6 hours after the termination of the infusion, are restored to the initial level;
• Dermatological reactions: against the background of long-term administration of high doses - itching;
• Others: allergic reactions.

Overdose

In case of an overdose of the drug, an overload of the circulatory system occurs, which can manifest itself, for example, with pulmonary edema. The introduction of Voluven is discontinued and, if necessary, a diuretic is prescribed.

special instructions

During the period of plasma replacement therapy, the patient must be limited in fluid intake. Patients with severe renal impairment or heart failure are especially at risk of overhydration.

In severe dehydration, the patient should be prescribed saline solutions.

It is necessary to regularly monitor renal function and the level of fluid in the body, adhere to a sufficient amount of its intake in patients with severe liver failure, blood coagulation disorders, including severe cases of von Willebrand disease.

Infusion should be accompanied by monitoring of serum electrolytes.

High doses of Voluven can affect the agglutination reaction and give false positive results when determining the blood group. This should be taken into account when treating patients without an established blood group.

An increase in the level of serum amylase is possible against the background of the introduction of hydroxyethyl starch (HES) due to a delay in its excretion through the kidneys.

The use of Voluven is indicated for patients with diabetes mellitus, since it does not affect the increase in serum glucose after hydrolysis with alpha-amylase.

When used in pediatrics, the dose must be selected individually, taking into account hemodynamic parameters, the severity of the underlying disease, water balance, in accordance with the need for colloids.

The tolerability of Voluven when used during surgical interventions (except for cardiological ones) in children under 2 years old is comparable to the use of 5% albumin.

Application during pregnancy and lactation

In experiments conducted on animals, there was no direct or indirect negative effect on the course of pregnancy, fetal development, childbirth and postnatal development. There were no signs of teratogenicity. However, the experience of the clinical use of Voluven during pregnancy and lactation is not enough. In this regard, the drug can be prescribed only if the expected benefit outweighs the potential risks.

Pediatric use

There are no age restrictions for the use of a plasma-substituting agent. In children under 2 years of age who have undergone surgical interventions (with the exception of cardiological ones), the tolerance when used during the operation of Voluven is comparable to that when using 5% albumin.

With impaired renal function

The use of the drug is contraindicated in the presence of severe renal failure with anuria or oliguria, as well as in patients on hemodialysis.

For violations of liver function

With severe hepatic impairment, special care is required when using Voluven.

Drug interactions

It is recommended to avoid mixing the solution with other drugs. Mixing is allowed in exceptional situations, but in this case, you must first make sure that the drugs are compatible (precipitation, turbidity), mix the solution well and follow the rules of asepsis.

Analogs

Voluven's analogs are: Sodium chloride, Sodium chloride Brown, Sodium chloride-Vial, Sodium chloride-Senderesis, Refortan, Infukol, Tetraspan, Stabizol.

Terms and conditions of storage

Keep out of the reach of children.

Store in a dark, dry place at temperatures up to 25 ° C, do not freeze.

Shelf life of the solution: in vials - 5 years, in containers - 3 years.

Terms of dispensing from pharmacies

Released only to medical institutions.

Reviews about Voluven

Reviews about Voluven are left mainly by doctors, since this drug is used for health reasons in a hospital setting. The opinions of doctors about this drug are only positive, since it provides a 100% volemic effect, is well tolerated, practically does not violate hemostasis, does not accumulate in tissues, and is characterized by the best safety profile among other HES. It can be used in a daily dose of up to 50 ml / kg, which is important for major surgical operations, since large volumes of plasma-substituting drugs are required.

The price of Voluven in pharmacies

Approximate prices of Voluven: 1 bottle of 250 ml - 316–325 rubles, 1 bottle of 500 ml - 451–473 rubles, 30 bottles of 250 ml - 7716–8957 rubles, 10 bottles of 500 ml - 4177–4339 rubles …

Voluven: prices in online pharmacies

Drug name Price Pharmacy

Voluven 6% solution for infusion 500 ml 10 pcs. RUB 4175 Buy

Voluven solution for inf. 6% 500ml 10 pcs. 4327 RUB Buy

Voluven 6% solution for infusion 250 ml 30 pcs. 8567 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!