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Dosage form: & nbspsolution for infusions
Composition:
Active substance:
Hydroxyethyl starch 60 g or 100 g
(MM 200 thousand Da, degree of substitution 0.5).
Excipients:
Sodium chloride - 9 g
Water for injections up to 1 liter
Description:Transparent or slightly opalescent, colorless or pale yellow liquid.
Pharmacodynamics:Plasmastabil 200 is a colloidal plasma-substituting solution based on hydroxyethyl starch (HES), a high-molecular compound consisting of polymerized dextrose residues. The source of the preparation is native starch (amylopectin) mainly obtained from potato tubers, corn wax grains, rice, wheat, which (starch) is cleaved in order to obtain molecules with a certain molecular mass, as well as hydroxyethylation, in which free hydroxyl groups of dextrose residues are replaced by hydroxyethyl groups over the C2 / C6 bonds. The latter contributes to a decrease in the rate of hydrolysis of aminopectin with serum amylase and an increase in the duration of its stay in the blood. The degree of hydroxyethylation is determined by the exponent of the degree of substitution. For hydroxyethylated starch, the average molecular weight and degree of substitution are the mostimportant factors that determine the effectiveness and duration of their volumetric substitution effect. Depending on the molecular weight and the degree of substitution, the hydroxylated starch is divided into the penta-starch group and the het-starch group. Pentacrachmal is a preparation of hydroxylated starch with an average molecular weight of 200 thousand Da and a degree of substitution of about 0.5 (200 / 0.5). Due to the ability to bind and retain water, the drug has the ability to increase the volume of circulating blood by 85-100 and 130-140% of the injected volume for 6% and 10% solution, respectively (the plasma-substituting effect persists for 4-6 hours). It restores disturbed hemodynamics, improves microcirculation, rheological properties of blood (by reducing the hematocrit), reduces the viscosity of plasma, reduces platelet aggregation and prevents the aggregation of erythrocytes.
The similarity of the structure of hydroxyethyl starch with the structure of glycogen explains the high level of tolerance and the practical absence of adverse reactions.
Pharmacokinetics:
A small amount of hydroxyethyl starch accumulates in the reticuloendothelial system (RES) (without manifestation of toxic effects on the liver, lungs, spleen and lymph nodes), where it is cleaved with amylase.After intravenous administration is excreted by the kidneys (for 24 hours - about 70% of the administered dose) and with bile. For hydroxyethyl starch with a molecular mass of 200 kD and molecular substitution of 0.5, the maximum concentration in plasma is 11.1 ± 2.7 mg / m.
Clearance-7.33 ml / min. The half-life is 4.94 hours. During the first 12 hours after the beginning of the introduction in the urine, there are 20.55-28.41 g of hydroxyethyl starch (49% of the injected volume).
Indications:Treatment of hypovolemia in acute blood loss, if the use of crystalloid solutions is insufficient.
Contraindications:Hypersensitivity (including starch), intracranial hypertension, intracranial hemorrhage, decompensated chronic heart failure (CHF), acute renal failure (oligo, anuria), cardiogenic pulmonary edema, hyperhydration, hypervolemia, dehydration (if necessary, electrolyte exchange correction), severe disorders of the blood coagulation system (including severe hemorrhagic diathesis, hypocoagulation), hyperchloremia, hyperpathy, hypokalemia, hemodialysis, not to be used in seriously ill patients atsientov, including in sepsis or in intensive care units, patients with impaired renal function, with open heart surgery, children up to 18 years.
Carefully:Compensated chronic heart failure and chronic renal failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis, hypofibrinogenemia.
Pregnancy and lactation:
The drug is contraindicated in the first trimester of pregnancy, in the II and III trimester of pregnancy - only in the presence of absolute indications for use. During lactation it is recommended to stop breastfeeding (no clinical studies have been performed).
AT experimental studies found that the drug does not have embryotoxic and teratogenic effects.
Dosing and Administration:
Enter intravenously drip or jet. Dose and speed of administration are set individually, depending on the severity of hemodynamic disorders, the severity of the patient's condition. The first 10-20 ml should be administered slowly (the possibility of developing anaphylactoid reactions).
Treatment of hypovolemia: The maximum daily dose for a 10% solution is 20 ml / kg (1.5 l per 75 kg body weight or 2 g / kg hydroxyethyl starch, the maximum infusion rate is 20 ml / kg / h (1.5 l / 75 kg / h or 2 g / kg) / h).The maximum daily dose for a 6% solution is 33 ml / kg, which corresponds to 2.5 liters per 75 kg of body weight or 2 g / kg of hydroxyethyl starch; the maximum rate of administration is 20 ml / kg / h (1.5 l / 75 kg / h or 1.2 g / kg / h). The duration of application is determined by the duration and level of hypovolemia.
When hypovolemia in adults, the average daily dose is 250-1000 ml.
The daily dose and rate of administration are calculated depending on the magnitude of hemorrhage, hemoglobin (Hb) and hematocrit.
In young patients with no risk of cardiovascular disease, the lung limit is a hematocrit score of 30% or less.
Side effects:
Allergic and anaphylactoid reactions, including hives, bronchospasm with difficulty breathing, pulmonary edema, heart failure, increased serum amylase activity; against a background of large doses - coagulopathy (transitory lengthening of clotting time, prothrombin and partial thrombin time), with hemodilution - a decrease (within 24 hours) of serum values ​​of total protein, albumin, calcium and fibrinogen.
Renal damage requiring hemodialysis.
Disorders of hemodynamics (with rapid administration or use of high doses), persistent skin itch (reversible). Increased activity of serum amylase (not associated with clinical manifestations of pancreatitis).
When using medium and high doses, it is difficult to treat the itchy skin (may appear several weeks after the end of treatment, last several months). When using high doses - an increase in bleeding time, which does not lead to clinically significant bleeding.
Overdose:
Symptoms: with rapid administration in large volumes, it is possible to develop acute left-ventricular failure and pulmonary edema, a clotting disorder!
Treatment: when there are complaints about a feeling of tightness in the chest, difficulty breathing, low back pain, chills, cyanosis, circulatory disturbance and breathing, stop the injection and conduct symptomatic therapy!
Interaction:
Hydroxyethylated starch increases the nephrotoxicity of antibiotics. Anticoagulants increase the time of bleeding.
Pharmaceutically incompatible with solutions of other drugs.
Special instructions:
Adequate long-term data on the use of hydroxyethyl starch in patients who underwent surgery or trauma are not available. The expected benefit of treatment should be carefully correlated with uncertain long-term safety. Other available therapeutic measures should be considered.
In connection with the possibility of developing allergic reactions, introduce the first 10-20 ml of the solution should be done slowly (drip), carefully monitoring the patient's condition.
Treatment should be carried out under the control of ions, white blood cells, platelets. hemoglobin, indicators of blood clotting, kidney function.
When the first signs of kidney and coagulopathy manifestations are discontinued, the drug should not be discontinued.
For 90 days after the infusion of the drug it is necessary to monitor the 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 possibility and necessity of therapy and be sure to carry outfrequent monitoring of fluid balance, as well as urinary retention rates.
It should be borne in mind that hydroxyethylated starch may affect clinical and chemical indices (glucose, protein, sedimentation rate of erythrocytes, fatty acid, cholesterol, sorbitol dehydrogenase, specific gravity of urine). The introduction of high doses of the drug leads to a decrease in hematocrit, hemoglobin concentration and plasma protein. The values ​​of hemoglobin below 10% and hematocrit below 27% are considered critical.
Starting with a total protein of less than 5 g / dl, administration of albumin is indicated. When blood loss exceeds 20-25% of the circulating blood volume, addition of the erythrocyte mass is also shown.
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 the head lowered, the airway released; then intravenously administered epinephrine, previously diluted 1 ml of the solution (1: 1 thousand) to 10 ml - first slowly injected 1 ml of the resulting solution (0.1 mg).while controlling the pulse and blood pressure; the introduction of einephrine can be repeated. Then 5% solution of human albumin is prescribed intravenously (to replenish the volume of circulating blood), glucocorticosteroids (GCS) (250-1000 ml of 11 rendinolone), and anti-opiate drugs.
In the treatment of patients whose blood group is not established, it must be borne in mind that the introduction of large volumes of hydroxyethylironapic starch may make it difficult to interpret the results of the agglutination reaction.
After intravenous administration of the drug, the activity of amylase in the blood increases markedly, which returns to the norm after 3-5 days (it may interfere with the laboratory diagnosis of pancreatitis without affecting the clinical picture).
The drug does not affect the definition of the blood group.
Non-wetting of the inner surface of the bottle or container is not a contraindication to the use of the drug. The presence of moisture in the secondary bag with the container is allowed provided the container is hermetically sealed.
Effect on the ability to drive transp. cf. and fur:
Studies to assess the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous speciesactivities that require a high concentration of attention and speed of psychomotor reactions, was not carried out.
Form release / dosage:
Solution for infusions 6% and 10%.
Packaging:
200 ml or 400 ml in bottles of glass for blood, transfusion and infusion preparations, sealed with rubber stoppers and crimped with aluminum or combined caps.
1. Each bottle, along with instructions for the use of the drug, is placed in a pack of cardboard.
2. For hospitals. For 1-24 bottles but 200 ml or 1-12 bottles of 400 ml with an equal number of instructions for the use of the drug are placed in a group package - boxes of cardboard corrugated.
For 250 ml or 500 ml in a soft polymer container.
1. Each container with instructions for use is packed in a secondary bag of film.
The text of instructions for the use of the drug can be applied thermographically on a secondary bag (the instruction is not included in the secondary bag).
For 1-24 containers of 250 ml or but 1-12 containers of 500 ml, sealed in secondary bags of film, are placed in boxes of cardboard corrugated.
2. Each container is packed in a secondary bag of film.On the bag is glued a self-adhesive multi-page label with text on instructions for the use of the drug.
For 1-24 containers of 250 ml or 1-12 containers of 500 ml, sealed in secondary bags of film, are placed in boxes of corrugated cardboard.
3. For hospitals. Each container is packed in a secondary bag of film.
For 1-24 containers but 250 ml or 1-12 containers but 500 ml, sealed in secondary bags of film, with an equal number of instructions for the use of the drug are placed in boxes of corrugated cardboard.
Storage conditions:At a temperature of 10 to 25 ° C. Freezing of the drug is not allowed. Keep out of the reach of children.
Shelf life:2 years. Do not use after the expiration date.
Terms of leave from pharmacies:On prescription
Registration number:LP-000624
Date of registration:21.09.2011 / 08.10.2015
The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
Manufacturer: & nbsp
Information update date: & nbsp17.01.2016
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