Woluwe

Active material: hydroxyethyl starch 130/0.4
When ATH: B05AA07
CCF: Plasma-drug
ICD-10 codes (testimony): E86, R57.1, R57.8, T79.4
When CSF: 21.05
Manufacturer: FRESENIUS KABI GERMANY GmbH (Germany)

Pharmaceutical form, composition and packaging

Solution for infusion 6% clear or slightly opalescent, a colorless or slightly yellow.

Excipients: sodium chloride 9 g / l (which is equivalent to the Na⁺ 154 mmol / l Cl^– 154 mmol / l), water d / and.

250 ml – konteynerы poliolefinovыe “frifleks” (30) – cardboard boxes.
500 ml – plastic bottles “Kabi Pack” (10) – cardboard boxes.

Pharmacological action

Plasma-drug.

Voluven a solution of hydroxyethyl starch (HES), which is produced from waxy maize amylopectin and characterized by molecular weight and degree of substitution. For Voluven average molecular weight of 130 000 Yes, and the degree of substitution 0.4, meaning, What's on 10 glucose residues in amylopectin accounts 4 hydroxyethyl group. HES structurally related glycogen, which explains its high tolerance and low risk of anaphylactic reactions. Voluven solution is very stable and does not allow the flocculation temperature fluctuations.

Voluven is izoonkoticheskim plasma-solution, so when administered fluid volume increases in proportion to the amount entered Voluven.

Long-lasting volume effect is Voluven 100% during 4 h after administration of the drug into the bloodstream. The therapeutic effect lasts up 6 no.

Pharmacokinetics

The pharmacokinetics of HES is complex and depends on the molecular weight HES, the molar degree of substitution and the nature of the substance molar substitution C2 / C6 hydroxyl groups.

After the on / in the HES molecule weight of less than 60 000-70 000 Yes (the threshold of renal filtration) rapidly excreted in the urine, while larger molecules are broken α-amylase plasma, then also excreted through the kidneys. The lower the degree of substitution of HES, the faster the drug is hydrolyzed α-amylase and excreted, the lower accumulation in the tissues (in particular, in cells of the immune system) and blood plasma. Character Substitution C2 / C6 affects the volume effect of the drug. This figure is at Voluven 9:1, ie. hydroxyl groups are located in a more stable position C2 9 times more, than C6. If the position C2 is ≥ 8 hydroxyl groups, the volume effect of HES stable, than the HES with the indicator less 8.

The average molecular weight of Voluven in vivo in the first minutes after the infusion of plasma 70 000-80 000 And it remains above the threshold of renal filtration throughout the entire treatment period.

After the introduction of 500 ml Voluven its clearance in plasma is 31.4 ml / min. After a single injection 500 ml of the preparation T_1/2 in the blood plasma in the first phase of deducing 1.4 no, and in the second phase – 12.1 no.

Single dose 500 ml Voluven HES molecules are completely removed from the body through 24 no. Repeated administration 500 ml HES 130/0.4 during 10 days substantial accumulation substances in plasma are not found.

Pharmacokinetics in special clinical situations

In patients with stable renal dysfunction (from mild to severe) and KK< 50 ml/min C_max HES in the blood was slightly higher, than patients with CC > 50 ml / min with the same dose of the drug administered (500 ml). Impaired renal function did not affect on T_1/2 in the final phase of deducing the magnitude and C_max HES in plasma. If CC > 30 ml / min in the urine excreted 59% administered dose, and when QC 15-30 ml / min – 51%.

Compared with HES 200/0.5 Voluven has improved pharmacokinetics (optimized metabolism and excretion), while maintaining its plasma-effect. This drug has a maximum safety when compared to previous generations of HES, tk. It has minimal effect on the hemostatic system even at repeated high doses, and virtually no its accumulation in the tissues.

Testimony

- Treatment and prevention of hypovolemia and shock of any origin (due to injury, incl. spinal injury with spinal cord injury, blood loss, burns, Sepsis, multiple organ failure, postoperatively, acute adrenal insufficiency, anaphylaxis and other conditions, accompanied by the development of collapse);

- Acute hemodilution normovolemycheskaya;

- Therapeutic hemodilution;

- Filling machine of extracorporeal circulation.

Dosage regimen

The drug is administered by continuous in / Infusion.

First 10-20 ml solution should be administered slowly, with careful monitoring of the patient, due to the risk of anaphylactoid reactions.

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

In situations, requiring fast compensation of hypovolemia and emergency volume replacement, can be used 500 mL of solution in plastic containers under pressure. At the same time before the introduction of Voluven necessary to remove air from the container to prevent the occurrence of air embolism.

The maximum daily dose is 50 ml / kg body weight / day, corresponding 3750 ml / day at body weight 75 kg.

In children under the age of 2 years, undergoing surgery (excluding cardiology), Voluven tolerability when used in operations was comparable to the tolerability 5% Albumin.

To volume replacement in Adult The maximum dose is 50 ml / kg / day; in Children and adolescents 10-18 years – 33 ml / kg / day; in children 2-10 years – 25 ml / kg / day; in infants and children up to 2 years – 25 ml / kg / day.

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

Side effect

Dermatological reactions: prolonged administration in high doses – itching.

From the laboratory parameters: may increase the concentration of serum amylase. In applying the drug in high doses as a result of the dilution effect of possible dilution of blood components, decrease in hematocrit, and clotting factors and plasma proteins. In this regard, during infusion may be decreased in activity of coagulation factor VIII (Villeʙranda). The bleeding time and other factors can increase blood clotting. However, these changes are significantly reduced compared with those of previous generations HES, and restored to the original level through 6 hours after cessation of infusion.

Other: allergic reactions of varying severity.

Contraindications

- Gipergidratatsiya;

- Gipervolemia;

- Congestive heart failure;

- Severe coagulation disorders;

- Intracranial bleeding;

- The state of dehydration, requiring correction of water and electrolyte balance;

- Severe renal failure with oliguria or anuria;

- The application of patients, hemodialysis;

- Hyperchloremia;

- Gipernatriemiya;

- Hypersensitivity to the drug.

Pregnancy and lactation

Clinical data on the use of the drug Voluven during pregnancy and lactation are absent.

Use of the drug during pregnancy is possible only in case of, if the potential benefit to the mother outweighs the potential risk to the fetus.

IN experimental studies animals revealed no direct or indirect adverse effects on pregnancy, development of the embryo / fetus, rodы and development postnatalynoe. No evidence of teratogenicity was observed.

Cautions

As with other solutions, during the plasma-treatment is necessary to avoid fluid overload. The risk increases hydration especially for patients with heart failure or severe renal impairment. In this case, the testimony of the infusion should be clarified.

In cases of severe dehydration should be preferred salt solutions. Particular caution is required in severe liver failure or blood clotting disorders, incl. in severe cases of von Willebrand disease. It is important to observe the maintenance of a sufficient amount of liquid, Regular monitoring of renal function and fluid balance.

It should monitor serum electrolytes.

When treating patients, blood which is not defined, it should be understood, Voluven that the introduction of high doses may affect the agglutination reaction and give false-positive results in the determination of blood group.

Introduction HES may increase serum amylase levels. This effect should not be seen as a violation of the functions of the pancreas, but as a result of formation of a complex of HES with amylase, followed by a delay of its elimination through the kidneys. Currently cases of this interaction is unknown. The drug does not affect the increase in serum glucose after hydrolysis of α-amylase and may be used in patients with diabetes mellitus.

Use in Pediatrics

The dose for children should be individualized according to need in colloids and taking into account the severity of the underlying disease, hemodynamic, water balance.

Overdose

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

Treatment: cessation of drug administration, if necessary, a diuretic should be appointed.

Drug Interactions

It should not be mixed with other drugs Voluven. If required in exceptional cases, it is necessary to check the compatibility of drugs (pomutnenye, precipitaciâ), abide by mixing aseptic techniques and ensure good mixing.

Conditions of supply of pharmacies

The drug is released only to medical institutions.

Conditions and terms

The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C; Do not freeze. Shelf-life of the drug in containers “frifleks” – 3 year, in vial – 5 years.

Use only clear solutions in undamaged containers. After opening the bottle or container solution should be used immediately. Unused solution should be discarded.