Refortan 130 (hydroxyethyl starch, sodium chloride) solution for infusions 250 ml. №1 vial

Description

Refortan 130 (hydroxyethyl starch, sodium chloride) solution for infusions 250 ml. №1 vial

Composition

active substances: hydroxyethyl starch, sodium chloride;

1000 ml of infusion solution contains 60 g of hydroxyethyl starch (HEC) with an average molecular weight of 130,000 and a degree of molar substitution of 0.42 and sodium chloride 9 g (Na+ – 154 mmol/l, Cl- – 154 mmol/l);

excipient: water for injections.

Medicinal form

Solution for infusions.

Basic physical and chemical properties: transparent, colorless or slightly yellowish liquid. Concentration of electrolytes: Na+ – 154 mmol/l, Cl- – 154 mmol/l; pH 4.0–7.0; theoretical osmolarity 309 mosmol/l; titrated acidity < 1.0 mmol/l.

Pharmacotherapeutic group

Blood substitutes and perfusion solutions. Hydroxyethylated starch preparations.
ATX code B05A A07.

Pharmacological properties

This pharmaceutical agent Refortan 130 solution belongs to the group of drugs – blood substitutes and perfusion substances.
It is used as a colloidal substitute for blood plasma volumes. The main component is hydroxyethyl starch.
After the application of this isooncotic solution, an increase in the intravascular volume of plasma content in the blood occurs, and the increase is proportional to the volume of the drug administered.

The duration of the effect of increasing plasma volume depends on various factors, including the amount of molecular weight and, to a greater extent, molar substitution.

This drug is capable of causing a decrease in hematocrit and increases the level of viscosity of the plasma component of the blood. Causes a decrease in platelet aggregation and prevents erythrocyte aggregation. Activates the transfer of water into blood from body tissues.

After the drug is administered, its effect continues for at least six hours in a row, circulating for a long time in the bloodstream.

Indications

Refortan 130 solution is used to eliminate hypovolemia (decrease in the volume of circulating blood) caused by acute blood loss.
Usually used in cases where the use of crystalloids alone is insufficient.

Contraindications

The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.

Contraindicated in:

• hyperhydration, including pulmonary edema;
• renal failure, oliguria, anuria;
• intracranial bleeding, sepsis, burns;
• severe hypernatremia or severe hyperchloremia, hypervolemia;
• severe liver dysfunctions;
• congestive heart failure.

Application during pregnancy and lactation

It is permissible to use this drug in the treatment of pregnant women in cases of urgent need.
If it is necessary to administer the drug during breastfeeding, then during treatment, lactation should be suspended.

Method of administration and dosage

This drug Refortan 130 solution is administered intravenously, in doses as low as possible with the greatest effectiveness, for the shortest possible period of time. The dose depends on the amount of blood loss.

During treatment, hemodynamics are continuously monitored in order to stop the administration as soon as its level returns to normal.

The first 10-20 ml of the drug is injected slowly in order to timely detect and prevent the development of a possible anaphylactic reaction.

Usually, in case of shock blood loss, 20 ml of the drug is injected per 1 kg of body weight, per hour. For life-threatening blood loss, up to 500 ml is administered manually (no more than 50 ml per 1 kg of body weight per day).
When infusing, it is necessary to remove the air from the container as much as possible.

In case of impaired renal or liver function, blood coagulation disorders, special care should be taken and the electrolyte content should be controlled.

Overdose

Overdose can cause hypervolemia. With this development of events, it is necessary to immediately stop the infusion of the drug, if necessary, use diuretics.

Side effects

In some cases, there may be some side effects in the form of:

• decreased hematocrit and decreased plasma protein concentration as a result of hemodilution;
• possible lengthening of the period of blood coagulation;
• anaphylactic shock, angioedema, allergic urticaria, hypotension, dyspnea, bronchospasm, tachycardia, arterial hypertension;
• increased serum alpha-amylase concentrations.

Repeated infusions over several days may cause a rash (may appear several weeks after the end of therapy).