Tetraspan (poly (O-2-hydroxyethyl)) solution for infusions 6% 500 ml. vials №10

Description

Tetraspan (poly (O-2-hydroxyethyl)) solution for infusions 6% 500 ml. vials №10

Composition

active substances: poly (O-2-hydroxyethyl) starch (HEC); sodium chloride; potassium chloride; calcium chloride dihydrate; magnesium chloride hexahydrate; sodium acetate trihydrate; L-malonic acid;

1000 ml of solution contain poly (O-2-hydroxyethyl) starch (HEC) (molar substitution: 0.42, average molecular weight: 130,000 Da) 60.0 g; sodium chloride 6.25 g; potassium chloride 0.3 g; calcium chloride dihydrate 0.37 g; magnesium chloride hexahydrate 0.2 g, sodium acetate trihydrate 3.27 g; L-malonic acid 0.67 g;

electrolyte concentration:

• sodium 140 mmol / l;
• potassium 4.0 mmol / l;
• calcium 2.5 mmol / l;
• magnesium 1.0 mmol / l;
• chlorides 118 mmol / l;
• acetates 24 mmol / l;
• have 5.0 mmol / l;
• pH 5.6–6.4;
• theoretical osmolarity 296 mOsmol / l;
• acid titer <2.0 mmol / L.

Excipients: sodium hydroxide, water for injections.

Dosage form

Solution for infusions.

Basic physical and chemical properties: light opalescent solution practically without particles.

Pharmacotherapeutic group

Blood substitutes and perfusion solutions. Preparations of hydroxyethylated starch.
ATX code B05A A07.

Pharmacological properties

This pharmaceutical agent 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 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 Tetraspan 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.
Also, the preparation contains electrolytes – sodium, potassium, magnesium, chloride, L-malonic acid. Chloride has the property of inhibiting the development of metabolic acidosis.

Indications

Tetraspan 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 one of the auxiliary components.
Contraindicated in:

• hyperhydration, including pulmonary edema;
• renal failure, oliguria, anuria;
• intracranial bleeding;
• 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

This drug Tetraspan 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.
When determining the pediatric dosage, as observations have shown, reducing the dosage to 10-20 ml per 1 kg of the patient’s weight does not cause a decrease in undesirable effects compared to the adult dosage.
In case of impaired renal or liver function, blood coagulation disorders, special care should be taken and the electrolyte content should be monitored.

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).