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

Active substanceDextran [cf.m.m.mass 50,000-70000]Dextran [cf.m.m.mass 50,000-70000]

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Polyglukin

solution d / infusion

MOSFARM, OJSC Russia

Polyglukin

solution d / infusion

Promomed Rus, Open Company Russia

Polyglukin

solution d / infusion

KRASFARMA, JSC Russia

Polyglukin

solution d / infusion

MAKSFARM, OJSC Russia

Dosage form: & nbspsolution for infusions

Composition:

Dextran with molecular weight from 54000 to 66000 - 60 g, sodium chloride - 9 grams, water for injection - up to 1 liter.

Description:Transparent, colorless or with a yellow hue of liquid.

Pharmacotherapeutic group:plasma-substituting agent

ATX: & nbsp

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

Pharmacodynamics:

Blood substitute, hyperosmotic solution with osmolarity 308 mOsm / l. Provides plazmozameschayuschee, anti-shock, replenishing the volume of circulating blood (bcc) and antiaggregant effect. Due to the high osmotic pressure, which exceeds 2.5 times the oncotic pressure of plasma proteins, it causes active involvement of tissue fluid (20-25 ml per 1 g of polymer) and keeps it in the vascular bed for a sufficiently long period. Eliminates violations of systemic hemodynamics, restores bcc, raises blood pressure (BP), shock volume of blood (KOK) and minute volume of blood (IOC), eliminates spasm of peripheral vessels.The introduction has a positive effect on the normalization of the basic indicators of the acid-base state (CBS) and gas composition of the blood. 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 improved rheological properties of blood, activation of microcirculation and increased tissue blood flow. Infusions reduce the risk of developing DIC syndrome. Non-toxic, apyrogenous.

Pharmacokinetics:It is excreted 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 (RES), where it is gradually cleaved with dextranases (acidic alpha-glucosidase) to dextrose (not a source of carbohydrate nutrition), which prevents deposition in internal organs for a long period.

Indications:

To improve hemorheology and microcirculation and reduce the propensity to thrombosis in surgical interventions and conservative treatment of conditions,accompanied by a syndrome of increased viscosity and thickening of the blood; disturbance of macro- and microhemodynamics, improvement of rheological properties of blood, normalization of arterial and venous blood flow, thrombosis, prevention of DIC syndrome.

Prevention and treatment: shock conditions (developed as a result of acute blood loss, including during childbirth, ectopic pregnancy, trauma, combined lesions, intoxications and sepsis), surgical and burn shock; ischemic stroke; addition to the perfusion fluid with the use of apparatus of artificial circulation.

Contraindications:

Hypersensitivity, cardiovascular insufficiency, ongoing internal bleeding, craniocerebral trauma (CMT), intracranial hypertension, hemorrhagic stroke, anuria, thrombocytopenia, clinical situations in which the introduction of large volumes of liquids is undesirable (including arterial hypertension, hyperkalemia in background of hematocrit less than 0.3), severe chronic renal failure (CRF).

Carefully:Pronounced dehydration.

Dosing and Administration:

In / in the drip, with acute blood loss - in /a (in a hospital setting).The volume and rate of administration is determined by the patient's condition, blood pressure (BP), heart rate (heart rate), and hematocrit.

Transfusion is performed in the usual way in compliance with the rules of production of transfusion: before transfusion biological test (after the administration of 5-10 drops, a 3-minute break is made, then another 10-15 drops are added and after another break, in the absence of symptoms of the reaction (rapidity of the pulse, decrease in blood pressure, skin hyperemia, difficulty breathing) continue to transfuse).

With developed shock or acute blood loss - in / in jet, 0.4-2 L (5-25 ml / kg). After raising blood pressure to 80-90 mm Hg. usually go to the drip introduction at a rate of 3-3.5 ml / min (60-80 cap / min). Possible in / a mode of administration (in the same dosages). 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.

When blood loss is more than 500-750 ml and severe anemization of the patient combine the administration of the drug with blood transfusion, erythrocyte mass or red blood cell suspension,necessary for the elimination of tissue hypoxia, as well as fresh frozen plasma containing factors of the hemostasis system.

To prevent operational blood loss, as well as to achieve artificial hemodilution, prevent thrombosis and reduce the tendency to develop or progress the ICE syndrome the drug is administered in doses of 5-10 ml / kg (for children - 10-15 ml / kg) for 30-60 minutes before surgery (in the case of a significant decrease in blood pressure go to the jet injection, with a decrease in blood pressure below 60 mm Hg - at/a). The volume of infusion during surgery is determined by the magnitude of operational blood loss (hematocrit should not fall below 0.3). In the postoperative period, drip-drop administration is an effective method of preventing shock.

With burn shock: in the first 24 hours, 2-3 liters are introduced, 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. To prevent possible dehydration of the tissues, it is recommended to combine the infusion of the preparation with the introduction of crystalloid solutions in a ratio of 1: 2.

Side effects:

Allergic reactions (hyperemia and itching of the skin, angioedema).

Special instructions:

The drug can withstand freezing and can be transported at temperatures down to -10 ° C. Freezing of the drug is not a contraindication to its use provided that the packaging remains hermetically sealed.

Patients with severe dehydration are required to restore fluid deficiency prior to the administration of dextrins, 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 dextrins caused by hemodilution, a decrease in the protein and Hb concentration in the plasma is possible. The amount of dextrins to be administered should be calculated in such a way as not to reduce Hb below 90 g / l (hematocrit 27%) for a more or less prolonged time.

The introduction of dextrins 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 with 0.9% solution NaCl before the study).

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

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

Dextrin reduces the transparency of the blood, and 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 administration of dextrins.

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

In case of complaints of chest tightness, shortness of breath, back pain, as well as upon the occurrence of chills, cyanosis, poor circulation and respiration transfusion should be stopped, in / to enter 10 ml of a 10% solution SaS1₂, 20 ml of 40% dextrose solution, antihistamines, glucocorticosteroids and appropriate symptomatic therapy.

Form release / dosage:Solution for infusion, 6%.

Packaging:

For 100, 200 or 400 ml in glass bottles for blood, transfusion and infusion preparations, with a capacity of 100, 250 and 450 ml respectively.

On 1 bottle together with the instruction on application place in a pack from cards on the box.

For 28 bottles of 100 ml and 200 ml or 15 bottles of 400 ml of the preparation together with instructions for use in an amount corresponding to the number of bottles are placed in boxes of corrugated cardboard with pads and nest boxes made of corrugated cardboard (for hospitals) .

For 8 or 12 bottles of 100 ml or 200 ml or 6 bottles of 400 ml of the product are packed in a wrapper from a shrink film. 3, 2 or 2 packs of 100 ml, 200 ml or 400 ml, respectively, along with instructions for use in an amount corresponding to the number of bottles, are placed in boxes of corrugated cardboard (for hospitals).

Storage conditions:

In a dry place at a temperature of not more than +25 FROM.

Keep out of the reach of children.

Shelf life:2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000604/08

Date of registration:12.02.2008

The owner of the registration certificate:MAKSFARM, OJSC MAKSFARM, OJSC Russia

Manufacturer: & nbsp

MAKSFARM, OJSC Russia

Information update date: & nbsp11.01.2016

Illustrated instructions

Instructions

Polyglukin (Polyglucinum)