Neorondex - instructions for use, dose, side effects, contraindications

active substance: dextran (molecular weight 62500 ± 7500) (as a 6% solution in water for injection) 1 ml, (containing dextran (molecular weight 62500 ± 7500)) 60 mg;

auxiliary substance: sodium chloride 9 mg.

Description:Transparent, light yellow or yellow liquid.

Pharmacotherapeutic group:plasma-substituting agent

ATX: & nbsp

B.05.A.A Blood plasma preparations and plasma-substituting drugs

Pharmacodynamics:

Neorondex® is a blood substitute, a hyperosmotic solution with an osmolarity of 0.34-0.37 mmol / kg. Provides plazmozameschayuschee, antishock, replenishing the volume of circulating blood and antiaggregant effect.Due to the high osmotic pressure exceeding the oncotic pressure of plasma proteins by 2.5 times, it causes active involvement of tissue fluid (20-25 ml per 1 g of polymer) and retains it in the vascular bed for a sufficiently long period. Reduces the violation of systemic hemodynamics caused by hypovolemia, restores the volume of circulating blood, raises blood pressure, shock volume of blood and minute blood volume, eliminates spasm of peripheral vessels.

Increases the suspension resistance of blood, reduces its viscosity characteristics, has a pronounced antiadhesive and antiaggregant effect on platelets, helps to eliminate peripheral stasis and aggregation of erythrocytes, leads to improvement of rheological properties of blood, activation of microcirculation and tissue blood flow. Infusion reduces the risk of developing the syndrome of disseminated intravascular coagulation.

Pharmacokinetics:

Dextran is excreted from the body mainly by the kidneys, during the first 24 hours, about 50% is eliminated, and after 3 days only trace concentrations are determined in the blood.A small part accumulates in the reticuloendothelial system, where it is gradually cleaved with dextranases (acidic alpha-glucosidase) to dextrose (not a source of carbohydrate nutrition), which prevents deposits in the internal organs for a long time.

Indications:

- Prevention and treatment of shock conditions that developed as a result of acute blood loss (during labor, ectopic pregnancy, trauma), intoxication, sepsis, surgical intervention, burns;

- as a detoxifying agent, incl. as part of complex treatment purulent peritonitis;

- as an additive to perfusion fluid in devices of artificial blood circulation.

Contraindications:

Hypersensitivity, decompensated cardiovascular insufficiency, ongoing internal bleeding (liver, lungs, kidneys), craniocerebral trauma with increased intracranial pressure, kidney diseases accompanied by anuria, severe chronic renal failure, thrombocytopenia, and situations in which the introduction is not recommended massive volumes of fluid (high blood pressure, hypervolemia), hemorrhagic stroke.

Carefully:

Pronounced dehydration.

Pregnancy and lactation:

Adequate data on the safety of the use of the drug during pregnancy and lactation, obtained in the process of controlled clinical trials, are currently not available.

During pregnancy, the use of the drug is allowed only if the benefits for the mother exceeds the potential risk to the fetus.

During the lactation period, the drug should be used with caution.

Dosing and Administration:

Intravenous or intra-arterial, doses are determined by indications for use and the specific condition of the patient.

With the development of shock or acute blood loss, the drug is injected intravenously in doses of 400-2000 ml for an adult (5-25 ml / kg body weight of the patient). With an increase in systolic blood pressure to 80-90 mm Hg. Art. usually pass to a drop introduction at a rate of 3-3.5 ml / min (60-80 drops / min). Possible intra-arterial way of administration (in the same doses).

Infusion of the drug should be carried out under constant control of the main indicators of systemic hemodynamics. With a significant increase in central venous pressure reduce the dose and rate of administration, or completely stop.

With blood loss of more than 500-750 ml and severe anemia, the patient is combined with a blood transfusion, erythrocytic mass or red blood cell suspension necessary to eliminate tissue hypoxia, as well as fresh-frozen plasma containing hemostatic system factors.

In order to detoxify the body (including with purulent peritonitis), the drug is administered in a daily 5-10 ml / kg of body weight for 3-5 days.

With a burn shock: in the first 24 hours, 2-3 liters are injected, in the next 24 hours, 1.5 liters. Children in the first 24 hours - 40-50 ml / kg, the next day - 30 ml / kg.

With extensive and deep burns combined with the introduction of plasma, albumin, gamma globulin; with burns more than 30-40% of the body surface - with blood transfusion.

Administration of the drug is carried out in the usual way with observance of the rules for carrying out transfusion: Before transfusion, a biological sample is carried out (after administration 5-10 drops are made for 3 minutes break, then another 10-15 drops are poured and after a similar break in the absence of symptoms of the reaction (rapidity of the pulse, lowering of arterial pressure, hyperemia of the skin, difficulty in breathing) continue the transfusion).

To prevent possibledehydration of tissues it is recommended to combine the infusion of the drug with the introduction of crystalloid solutions in a ratio of 1: 2.

Side effects:

Allergic reactions: (skin rash, anaphylactoid reactions: lowering of arterial pressure, collapse, oliguria, fever, chills, fever, nausea).

Can provoke bleeding, the development of acute renal failure.

With the rapid introduction of dextrans in large volumes, it is possible to develop acute left ventricular failure and pulmonary edema.

Overdose:

Symptoms: a feeling of restraint in the chest, difficulty breathing, low back pain, as well as chills, cyanosis, impaired blood circulation and breathing.

Treatment: Transfusion should be stopped, 10 ml of 10% calcium chloride solution, 20 ml 40% solution of dextrose, blockers H₁-gistamine receptors, glucocorticosteroids and conduct appropriate symptomatic therapy.

Interaction:

Aminocaproic acid, hydralazine, warfarin, ethanol 95%, dexamethasone incompatible with dextran.

Dextran prolongs the anticoagulant effects of heparin and heparin-like agents, as well as anticoagulants of indirect action.

Special instructions:

The frequency of administration of the drug is determined by the general condition of the patient and the possibility development of phenomena of "secondary" shock.

The drug can withstand freezing and can be transported at temperatures up to -10 ° C. Freezing of the drug is not a contraindication to its use when ,the condition of the tightness of the package.

Patients with severe dehydration are required to restore fluid deficiency prior to administration of dextrans, the rate of their administration should not exceed 500 ml / h. The introduction of recommended doses practically does not affect the hemostasis system. Exceeding the recommended dose may prolong bleeding time. Against the background of dextrans induced hemodilution, a decrease in protein and hemoglobin concentration in the plasma is possible. The amount of dextrans to be administered should be calculated in such a way that it does not reduce the hemoglobin below 90 g / l (hematocrit 27%) for a longer or shorter time.

Intravenous infusion of solutions of dextran can cause acute renal failure. The presumed mechanism of its origin is associated with the acquisition by blood, located in the glomeruli, of hyperosmolar properties,which leads to a decrease in the effective filtration pressure, which determines the rate of glomerular filtration.

The introduction of dextrans does not prevent the determination of the blood group and the conduct of the cross-sample by standard methods (it is recommended to wash the erythrocytes 0.9% solution of sodium chloride before the study).

The presence of dextran in the blood can influence the results of enzymatic methods based on papain.

When studying the concentration of glucose in the blood using solutions of sulfuric and acetic acids, you can get a glucose concentration greater than there is actually (the latter can hydrolyse dextran).

Dextran reduces the transparency of blood, its presence in the blood can change the results of measuring the concentration of bilirubin and protein.

It is recommended to take blood samples to establish the concentration of bilirubin and protein before the injection of dextran.

With the rapid introduction of dextrans in large volumes, it is possible to develop acute left ventricular failure and pulmonary edema.

In the case of anaphylactoid reactions, the drug should be discontinued immediately and, if necessary, without removing the needles from the vein, proceed with the measures to eliminate the transfusion reaction (blockers H₁-histamine receptors and cardiovascular agents, glucocorticosteroids, respiratory analeptics).

With a significant increase in central venous pressure, reduce the dose and speed of administration of the drug or completely stop its administration.

Effect on the ability to drive transp. cf. and fur:

The introduction of solutions of dextran does not affect the speed of psychomotor reactions and concentration of attention. At the same time, after the administration of dextran solutions, it is recommended to refrain from controlling vehicles and other potentially dangerous mechanisms.

Form release / dosage:

Solution for infusion, 60 mg / ml.

Packaging:

400 ml in bottles of glass.

Each bottle, together with instructions for use, is placed in a pack of cardboard box.

For hospitals: 24 bottles along with an equal number of instructions for use are placed in boxes of corrugated cardboard.

Storage conditions:At a temperature of no higher than 25 ° C.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001399

Date of registration:28.12.2011 / 02.06.2015

Date of cancellation:2016-12-28

The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

Representation: & nbsp"Belmedpreparaty" RUP "Belmedpreparaty" RUP

Information update date: & nbsp09.01.2016

Illustrated instructions

Instructions

Neorondex® (Neorondex®)