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Plasmix – infusion solution

INSTRUCTIONS FOR MEDICAL USE

PLAZMIX

Trade name of the drug: Plazmix

Active substance (INN): Hydroxyethyl starch

Dosage form: solution for infusion.

Contents:

100 ml of the solution contains:

Active ingredient: hydroxyethyl starch (HEK 200/05) – 6.0 g.

Excipients: sodium chloride, water for injections.

Description: colorless or slightly yellowish transparent liquid.

Pharmacotherapeutic group: plasma substitutes.

ATX code: B05AA07

Pharmacological properties

Pharmacodynamics

Plasma substitute medicine. It is 6% isotonic solution of hydroxyethylated starch (HES) (hydroxyl derivative of acidic hydrolysis product of corn starch) with average molecular weight 200000 daltons and degree of substitution 0.5, which means that for 10 glucose residues of amylopectin there are 5 hydroxyethyl groups.

Due to the ability to bind and retain water GEC has the ability to increase the CIC by 85-100% of the injected volume (plasma substitution effect is stable for 4-6 hours). It restores impaired hemodynamics, improves microcirculation, blood rheological properties (by reducing hematocrit index), reduces blood viscosity, reduces platelet aggregation and prevents erythrocyte aggregation.

Similarity of the structure of hydroxyethyl starch with that of glycogen explains good tolerability of the drug, it has no local irritant and immunotoxic effects. It accumulates in cells of reticulo-endothelial system (RES) and has no toxic effect on liver, lungs, spleen and lymph nodes.

Pharmacokinetics

Absorption and distribution

Cmax is 11.1 ± 2.7 mg/ml. Small amount is accumulated in DES (without toxic effect on liver, lungs, spleen and lymph nodes), where it is degraded by amylase.

Excretion

Clearance is 7.33 ml/min. After intravenous administration it is excreted with the urine (24 hours – about 70% of the injected dose of ECP) and with the bile. T1/2 – 4.94 hours.

Sodium chloride is excreted mainly with urine, and a small amount is excreted with sweat through the skin.

Indications for use

Prophylaxis and therapy of insufficient blood plasma volume (hypovolemia) and shock due to operations, trauma, infections and burns. Blood Thinning (hemodilution) for therapeutic purposes.

Dosage and administration

If not prescribed otherwise, the drug is administered as a drop infusion in accordance with the required blood volume replacement. Due to possible anaphylactic reactions, the first 10-20 ml of the drug should be infused slowly and with careful monitoring of the patient’s condition. The risk of overloading the circulatory system if the drug is administered too quickly and at too high a dose must be taken into account. The daily dose and infusion rate depend on the amount of blood loss and hematocrit value.

In young patients who have no risk of cardiovascular or pulmonary complications, a hematocrit number of 30% is considered limiting with respect to the need for colloidal plasma exchange.

When prescribing the dose, it should be taken into account that the intravascular volume injected has the effect of a larger volume.

Maximum infusion rate

Depending on the relevant cardiocirculatory situation, up to 20 ml/kg body weight per hour.

Maximum daily dose

The therapeutic limit is set by the liquefaction effect.

Reference figure:

Maximum of about 2 g hydroxyethyl starch/kg body weight (corresponding to a maximum of about 33 mL/kg body weight)

Typically 500 to 1,000 ml/day is infused.

The duration of treatment depends on the area of application or the amount of blood volume reduction.

Dosage recommendations for therapeutic blood thinning (hemodilution)

It can be administered in conditions of isovolemia (accompanied by bloodletting) or hypervolemia (without bloodletting).

Daily dose and infusion rate:

Low dose: 1 x 250 mL/day for 0.5 to 2 hours

Medium dose: 1 x 500 ml/day for 4-6 hours

High dose: 2 x 500 ml/day for 8 to 24 hours

Note: The literature describes the relationship between dose and frequency of itching in otoneurological conditions such as severe hearing loss, tinnitus. In these diseases, in order to reduce the incidence of itching, dose limitation to a maximum of 500 ml/day (corresponding to 30 g hydroxyethyl starch/day) is recommended.

SIDE EFFECTS

All degrees of intolerance reactions are possible. In case of intolerance reactions it is necessary to interrupt the infusion and initiate conventional emergency measures. Too rapid infusion, as well as administration of significant amounts of the drug may lead to acute pressure on the circulatory system by the volume of fluid.

Prolonged, daily administration of the drug in the medium to higher dose range often causes itching that is almost untreatable. It may also appear several weeks after the end of therapy, last for months, and be quite debilitating. Rarely, renal pain has been reported. In these cases, it is necessary to stop the infusion, to ensure sufficient fluid intake into the body and to monitor serum creatinine values frequently.

Due to the liquefaction effect, hydroxyethyl starch infusion leads, depending on the dose, to a decrease in hematocrit and plasma protein concentration. Due to the liquefaction effect, a transient increase in clotting time and bleeding time is possible.

Contraindications

  • Hypersensitivity to the active substance (allergy to starch);
  • States of dehydration;
  • Hyperhydration states;
  • Hypervolemia;
  • Hypokalemia;
  • Hyperchloremia;
  • Hypernatremia;
  • Decompensated heart failure;
  • Renal failure accompanied by oliguria or anuria (creatinine > 2 mg/dL);
  • Pulmonary edema;
  • Intracranial hemorrhage;
  • Severe clotting disorders;
  • Newborns, infants, children under 2 years of age;
  • Patients undergoing hemodialysis treatment;
  • Pregnancy, I trimester. In other terms of pregnancy, the drug may be used only for vital indications.

In addition, caution is recommended when using in patients with hepatic insufficiency.

Drug interactions

When mixed with other medicinal products in the same container or in the same system, pharmaceutical incompatibility phenomena may be observed. ECP during concomitant use with aminoglycoside antibiotics may potentiate their nephrotoxicity.

Special Indications

Control of serum creatinine is necessary at the beginning of therapy. At creatinine limit values (1.2-2.0 mg/dl or 106-177 µmol/l, respectively, compensated renal failure), treatment should be carefully considered; careful monitoring of fluid balance and urine retention rates is also necessary. Adequate fluid intake should be monitored. Renal function should be monitored during therapy. Serum ionogram and water balance should be monitored. Dilution of plasma proteins (including clotting factors) should be considered; if necessary, replenishment should be carried out according to need. Due to the liquefaction effect there may be a transient increase in clotting time and bleeding time.

Caution should be exercised in the presence of hemorrhagic diathesis.

Hydroxyethyl starch infusions lead to increased serum alpha-amylase levels. This is not indicative of pancreatic disease.

After opening the vial the drug should be used immediately. Do not store the opened vial.

Do not use the drug again from a vial that has already been in use.

Use only clear solution in an undamaged vial! Failure to observe the storage and transportation conditions can lead to the formation of micro-cracks on the vial, thus increasing the risk of microbial contamination of the solution.

For single-use sampling only!

Do not freeze or heat!

Use during pregnancy and lactation

Though it is established that the drug does not have embryotoxic and teratogenic effects, administration of the drug during the first trimester of pregnancy is undesirable. The drug should be used in II and III trimesters of pregnancy only in case of vital indications.

It is unknown whether the drug is excreted with breast milk, therefore caution must be exercised when prescribing the drug to women during lactation.

Overdose

In case of overdose, there is a danger of:

  • acute pressure on the circulatory system by the volume of fluid
  • Blood clotting disorders.

Treatment: stop the infusion.

Form of production

Solutions for infusion: 6% in 100 ml or 200 ml in vials.

Storage conditions

Store in a dry, dark place at temperatures under 25°C. Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Available with a doctor’s prescription.

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