PolyChE - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspSolution for infusion.

Composition:

1 liter of solution contains:

Active ingredient: hydroxyethyl starch 200 / 0.5 - 60.0 g or 100.0 g;

auxiliary components: sodium chloride - 9.0 g; water for injection - up to 1 liter.

Theoretical osmolarity - 309 mosmol / l

Description:Transparent or slightly opalescent, colorless or with a greyish-yellow solution.

Pharmacotherapeutic group:plasma-substituting agent

Pharmacodynamics:

PolyHES is a hypertonic colloidal solution based on hydroxyethyl starch (hereinafter referred to as HES), a high-molecular compound consisting of polymerized dextrose residues. The source of HES production is native starch (amylopectin), which undergoes cleavage to produce molecules with a certain molecular weight, as well as hydroxyethylation, in which free hydroxyl groups of dextrose residues are replaced by hydroxyethyl groups over C2 / C6 bonds. HES is subjected to prolonged hydrolysis with serum amylase to form oncotically active oligo- and polysaccharides of different molecular weights.

PolyHES, a solution for infusions of 6% and 10% is a preparation of HES (pentahrachmal) with an average molecular weight of 200 kEa and a degree of substitution of about 0.5.

Due to the ability to bind and retain water, it has a volatile effect - the ability to increase the volume of circulating blood (hereinafter BCC) by 85-100% of the injected volume, which persists for 4-6 hours.

Providing plazmozameschayuschee action, restores the disturbed hemodynamics,

improves microcirculation, rheological properties of blood (by reducing

hematocrit), reduces the viscosity of plasma, reduces platelet aggregation and prevents the aggregation of red blood cells.

The similarity of the structure of HES with the structure of glycogen explains the high level of tolerability and the practical absence of adverse reactions.

Pharmacokinetics:

After intravenous administration is excreted by the kidneys (for 24 hours - about 70% of the administered dose of penta-starch) and with bile.

A small amount accumulates in the reticuloendothelial system (without toxic effect on the liver, lungs, spleen and lymph nodes), where it is cleaved by amylase and subsequently excreted by the kidneys and through the intestine.

Indications:

Prevention and treatment of hypovolemia (shock due to acute blood loss, incl.

intraoperative, trauma, burns, sepsis);

Prevention of arterial hypotension when injected into general anesthesia during spinal and epidural anesthesia.

Disturbance of microcirculation and therapeutic hemodilution, incl. isovolemic.

Contraindications:

Hypersensitivity (including starch), intracranial hypertension, intracranial hemorrhage, decompensated chronic heart failure, acute renal failure (oligo-, anuria), cardiogenic pulmonary edema, hyperhydration, hypervolemia, dehydration (if necessary correction of electrolyte metabolism), expressed disorders of the coagulation blood systems (including severe hemorrhagic diathesis, hypocoagulation), hyperchloremia, hypernatremia, hypokalemia, children under 18 years of age.

Carefully:

Lactation period, pregnancy, compensated chronic heart failure and chronic renal failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis, hypofibrinogenemia.

Dosing and Administration:

Enter intravenously drip or jet.

The dose and rate of administration are set individually, depending on the severity of hemodynamic disorders and the severity of the patient's condition.

The first 10-20 ml should be administered slowly (anaphylactoid reactions may develop).

For adults, the average daily dose is 33 ml / kg 6% solution or 20 ml / kg 10% solution.

With the development of shock in adults, the average daily dose is 0.5-1.5 liters, the maximum daily dose is 20 ml / kg 10% solution (1.5 liters per 75 kg) or 33 ml / kg 6% solution. When hemorrhagic shock is injected at a rate of up to 20 ml / kg / h. With septic and burn shock, the infusion rate is somewhat less. The maximum infusion rate should not exceed 20 ml / kg / h.

The daily dose and rate of administration are calculated depending on the magnitude of hemorrhage, hemoglobin and hematocrit. In patients without risk of cardiovascular and pulmonary complications, the duration of therapy is determined by the level of hematocrit (should be at least 30%). The maximum infusion rate depends on the initial parameters of hemodynamics and is 20 ml / kg / h.

For adults, the maximum daily dose is 33 ml / kg 6% solution or 20 ml / kg 10% solution.

With a view to hemodilution, the daily dose is 500 ml for several days to a total dose of 5 liters, which can be exceeded in exceptional cases and distributed for up to 4 weeks.

In the absence of an emergency situation, the recommended infusion rate is 30 minutes per 500 ml of solution.

Treatment and prevention of hypovolemia and shock: the maximum daily dose for 6% solution is 33 ml / kg, 10% solution - 20 ml / kg. The duration of application is determined by the duration and level of hypovolemia.

Hemodilution: administration is carried out isovolemically (with blood sampling) or hypervolemically (without sampling own blood) at small (250 ml), medium (500 ml) and high daily doses (2 times 500 ml). The criterion of effectiveness is the reduction of the hematocrit value determined for each patient. Infusion rate: 250 ml for 0.5-2 hours, 500 ml for 4-6 hours, 2 times 500 ml for 8-24 hours. The duration of the solution is 10 days.

Acute normovolemic hemodilution to reduce the introduction of donor blood during surgical operations: the solution is injected immediately before the operation in a ratio of 1: 1 with a hematocrit index according to Tsilya after acute normovolemic hemodilution of at least 30. Blood sampling - 2-3 times 500 ml of own blood, daily dose 2-3 times 500 ml of solution, the rate of blood sampling - 1 liter 15-30 minutes, the rate of drug administration - 1 liter for 15-30 minutes.Usually use a single injection of the drug immediately before the operation. Repeated use is possible if the initial hematocrit is within normal limits.

In a critical situation, a quick injection of 500 ml of solution (under pressure) is possible. When the preparation is administered under pressure, all air from the vial must be previously removed (risk of developing embolism). Speed with intraoperative administration, as well as in patients with burn and septic shock should be reduced. In therapeutic hemodilution PolyCES 200 is used for multi-day or multi-week infusion schemes.

Multi-day infusion scheme: daily dose - 0.5-1 l; with sudden deafness and "intermittent" lameness - 500 - 750 ml / day; at an acute phase of an ischemic stroke - 750 - 1000 ml / sut. The rate of administration is 75-250 ml / h, the course duration is 5-10 days. In the acute phase of ischemic stroke, the so-called loading dose of 250-500 ml can be introduced at the beginning of therapy, and the rate of administration can be increased to 250-500 ml / h. j

With a multi-week infusion scheme, infusion is carried out 2-3 times a week for 250-500 ml at a rate of 125-250 ml / h, the duration of therapy is 3-6 weeks.In most cases, adaptation of the injected volume of the drug (and, if necessary, bleeding) to hemodynamic and / or hemo-rheological parameters (central venous pressure - 15 mm Hg, hematocrit - 38-42%, etc.) is recommended.

Side effects:Allergic reactions, rarely - anaphylactoid reactions, nausea, vomiting, hypotension, tachycardia, fever, headache (stopping the drug). Hemodynamic disorders, persistent reversible skin itching (with rapid administration or use of high doses). Increased activity of serum amylase (not associated with clinical manifestations of pancreatitis).

Overdose:Pharmaceutically incompatible with solutions of other drugs. If mixing with other medicinal products is necessary, a complete asepsis should be followed; it is necessary to ensure compatibility and good mixing of drugs.

Special instructions:

In connection with the possibility of developing allergic reactions, administer the first 10-20 ml of the solution slowly (drip), carefully monitoring the patient's condition. I

Treatment should be carried out under the control of bcc, the content of electrolytes, leukocytes, platelets, hemoglobin, blood coagulation indicators, kidney function. At the beginning of therapy, it is required to monitor the serum levels of creatinine. At the limit values of creatinine (1.2-2 mg / dl or 106-177 μmol / l - compensated renal failure), it is necessary to carefully weigh the need for therapy and carry out dynamic monitoring of fluid balance.

It should be borne in mind that the HES can affect clinical and chemical indices (glucose, protein, erythrocyte sedimentation rate, cholesterol, sorbitol dehydrogenase, specific the weight urine).

The introduction of high doses of the drug leads to a decrease in hematocrit, Hb concentration and plasma protein. Values of hemoglobin below 10 g% and hematocrit below 27% are considered critical. Starting with a total protein of less than 5 g / dL, the administration of albumin is indicated. When blood loss is more than 20-25% of BCC, additional administration of erythrocyte masses.

In the case of shock conditions caused by the predominant loss of water and electrolytes (vomiting, diarrhea, burns), after initial treatment with the drug, further treatment should be carried out using a balanced solution of electrolytes.

Do not mix the drug with other drugs in the same container and in the same system.

During treatment, it is necessary to ensure a sufficient supply of fluid in the body. When anaphylactoid reactions occur, the drug should be discontinued. The patient should be transferred to the "lying" position with raised lower limbs above the level of the head, to release the airways; intravenously epinephrine, previously diluted 1 ml of the solution (1: 1 thousand) to 10 ml - you must first slowly inject 1 ml of the resulting solution (0.1 mg), while monitoring the pulse and blood pressure. The introduction of epinephrine can be repeated. Then 5% solution of human albumin (for replenishment of BCC), glucocorticosteroid preparations (250-1000 mg of prednisolone), antihistamine drugs are intravenously administered.

Patients should be under continuous medical supervision, additional therapeutic measures should be taken depending on the condition of the patients.

In the treatment of patients whose blood group is not established, it should be borne in mind that the introduction of large volumes of HES can make it difficult to interpret the results of the agglutination reaction when determining the blood group I.

After the administration of the drug, the activity of amylase in the blood increases markedly, which returns to the norm in 3-5 days (it may complicate the laboratory diagnosis of pancreatitis without affecting the clinical picture).

Form release / dosage:

Solution for infusions 6% and 10%.

Packaging:

For 200 ml in bottles of glass with a capacity of 250 ml, sealed with stoppers made of rubber compound, crimped with aluminum or combined caps'; The bottle together with the instruction for use is placed in a pack of cardboard box.

For a hospital: 24 bottles of 200 ml without packs with 5-10 instructions for use are placed in a box of corrugated cardboard.

For 250 and 500 ml in polymeric containers for infusion solutions.

Each container is accompanied by instructions for use.

For a hospital, 20 polymer containers of 250 ml, or 10 containers of 500 ml with 5-10 instructions for use are placed in a box of corrugated cardboard.

Storage conditions:

In a dry place at a temperature of 10 ° to 25 ° C. In a place inaccessible to children. Freezing of the drug is not allowed.

Shelf life:

1 year. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001798/08

Date of registration:17.03.2008

The owner of the registration certificate:INTASOL, LLC INTASOL, LLC Russia

Manufacturer: & nbsp

INTASOL, LLC Russia

Information update date: & nbsp24.01.2016

Illustrated instructions

Instructions

PolyChE (PolyHes)