Refordez-Novofarm (hydroxyethyl starch) solution for infusions 6% 400 ml. vial

Description

Refordez-Novofarm (hydroxyethyl starch) solution for infusions 6% 400 ml. vial

Composition

active substance: hydroxyethyl starch;

1 ml of solution contains 60 mg of hydroxyethyl starch;

excipients: sodium chloride, water for injections.

Medicinal form

Solution for infusions.

Main physicochemical properties: transparent colorless or slightly opalescent liquid; theoretical osmolarity is about 308 mosmol/l.

Pharmacotherapeutic group

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

Pharmacological properties

Refordez-Novofarm solution is a colloidal plasma substitute containing 6% hydroxyethyl starch (HEC) in an isotonic (0.9%) sodium chloride solution. The average molecular weight (MW) of the colloid is 200,000 daltons, and the degree of molar substitution (MZ) is 0.5. Refordez-Novofarm is an iso-oncotic solution, that is, the increase in blood plasma volume is almost equivalent to the injected volume of the drug.

The duration of the effect of increasing the blood plasma volume depends primarily on the MH indicator and to a lesser extent on the MM. As a result of intravenous hydrolysis of HEK polymers, smaller molecules are constantly formed, which, in turn, exhibit oncotic activity before being excreted by the kidneys.

During the infusion of the medicinal product, the hematocrit index and blood plasma viscosity decrease. Infusion of the drug in patients with hypovolemia normalizes the volume of circulating blood, and also improves hemodynamics and heart function. Blood volume is maintained for at least 6 hours.

Indications 

Refordez-Novofarm solution is used to eliminate hypovolemia (reducing 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 Refordez-Novofarm solution 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 lactation should be suspended for the duration of treatment.

Method of administration and dosage

Dosage recommendations for the prevention and treatment of hypovolemia and hypovolemic shock.

HEK should be used in the lowest effective dose for the shortest period of time. Treatment should be accompanied by monitoring of hemodynamics and should be stopped immediately after reaching the appropriate indicators of hemodynamics.

Unless otherwise suggested, the drug is administered as a drip infusion in accordance with the volume of blood required for replacement. Because of possible anaphylactic reactions, the first 10-20 ml of Refordez-Novofarm should be administered slowly, carefully monitoring the patient’s condition. The risk of overloading the circulatory system with too fast administration and too large a dose should be taken into account. The daily dose and rate of infusion depend on the amount of blood loss and the hematocrit index. For young patients who are not at risk of cardiovascular or pulmonary complications, a hematocrit of 30% is considered to be the cut-off point for use of a colloidal plasma substitute.

Maximum daily dose

The therapeutic limit should be set according to the dilution effect.

Reference figure: a maximum of approximately 2 g hydroxyethyl starch/kg body weight (corresponding to approximately 33 ml/kg body weight). Usually infuse from 500 to 1000 ml per day.

Maximum infusion rate

Depending on the state of hemodynamics, up to 20 ml/kg of body weight per hour.

Dosage recommendations for blood dilution for therapeutic purposes (hemodilution). Hemodilution can be carried out in conditions of isovolemia (with bloodletting) or hypervolemia (without bloodletting).

Daily dose and rate of infusion:

• Low dose: 1 × 250 ml/day for 0.5-2 hours.
• Average dose: 1 × 500 ml/day for 4-6 hours.
• High dose: 2 x 500 ml/day for 8-24 hours.

Method and duration of use.

Method of administration – intravenous infusion. The duration of treatment depends on the patient’s condition and the degree of hypovolemia.

During treatment with Refordez-Novofarm, it is necessary to ensure that the patient’s body receives a sufficient amount of liquid.

Note: the relationship between the dose and the frequency of pruritus in otoneurological diseases, such as sudden hearing loss, tinnitus, has been described. In these diseases, to reduce the frequency of itching, it is recommended to limit the dose to 500 ml/day.

Children

Do not use the medicine for children.

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).