Active substanceHydroxyethyl starchHydroxyethyl starch
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  • Dosage form: & nbspsolution for infusions
    Composition:
    Per 1 liter:
    Active substances:
    Hydroxyethyl starch with an average molecular weight of 175,000-225,000 and a degree of substitution of 0.45-0.55-60.0 g
    Excipients:
    Sodium chloride - 9.0 g,
    Water for injection up to 1 liter
    Theoretical osmolarity is 309 mOsmol / l.
    Description:Transparent or slightly opalescent, colorless or pale yellow liquid.
    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:
    Voleks, 6% infusion solution is a colloidal plasma-substituting hemodynamic agent based on hydroxyethyl starch (HES), a high-molecular compound consisting of polymerized dextrose residues. The source of HES production is native starch - (amylopectin), which undergoes cleavage 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 C2 / C6 bonds.HES is subjected to prolonged hydrolysis with serum amylase to form oncotically active oligo- and polysaccharides of different molecular weights.
    Voles due to the ability to bind and retain water has a volitional effect - the ability to increase the volume of circulating blood (BCC) by 85-100% of the injected volume, which persists for 4-6 hours.
    Provides plazmozameschayuschee action, restores disturbed hemodynamics, improves microcirculation, rheological properties of blood due to lower 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 tolerance and the practical absence of side effects.
    Pharmacokinetics:
    Volekam is excreted from the body by the kidneys (for the first day with urine, 40-50% of the administered dose is allocated) and with bile. The half-life is 3-6 hours.
    A small amount of the drug is delayed by the reticuloendothelial system (without toxic effect on the liver, lungs, spleen and lymph nodes), where it is gradually broken down by amylase and subsequently excreted by the kidneys and through the intestine. The drug is not metabolized to glucose or C02; the concentration of sugar in the blood after the introduction of Volekam does not change.
    Indications:
    Treatment of hypovolemia in acute blood loss, if the use of crystalloid solutions is insufficient.
    Contraindications:
    Hypersensitivity (including to starch), arterial hypertension, intracranial hemorrhage or acute impairment of cerebral circulation by hemorrhagic type, chronic heart failure in the stage of decompensation, renal failure, pulmonary edema (including cardiogenic), hyperhydration (including edema lungs), hypervolemia, dehydration (if necessary, correction of electrolyte metabolism), severe disorders of the blood coagulation system (including severe hemorrhagic diathesis, expressed hypocoagulation, pronounced hypos obrinogenemia), hyperchloremia, hypernatremia, hypokalemia, hemodialysis, severe hepatic insufficiency, burns, condition after organ transplantation.
    The first trimester of pregnancy, the period of breastfeeding, children under 18 years.
    Do not use in seriously ill patients, including sepsis or in patients residing in the intensive care unit, intensive care units.
    Do not use with open heart operations.
    Carefully:
    Hemorrhagic diathesis, compensated chronic heart failure, hepatic insufficiency of mild and moderate degree, intracranial hypertension, second and third trimester of pregnancy.
    Pregnancy and lactation:Volekam is contraindicated for use in pregnancy and lactation (if necessary, the drug should stop breastfeeding for the duration of Volekam treatment).
    Dosing and Administration:
    The drug Volekam appointed in the form of intravenous infusion. In the absence of other prescriptions, the drug is administered intravenously drip according to the need to replace the volume of the circulating plasma.
    The daily dose and the rate of intravenous administration are calculated depending on blood loss, hemoglobin concentration and hematocrit. If possible, the lowest effective dose should be given. The use of the drug Volekam should be limited to the initial stage of the recovery of bcc. The duration of administration should not exceed 24 hours.
    Given possible anaphylactic reactions, the first 10-20 ml should be administered slowly and with careful monitoring of the patient's condition.It should also take into account the risk of overloading the circulatory system in the rapid introduction of an ingot or too high a dose of the drug. Therapy should be carried out against a background of constant control of hemodynamics - in order to interrupt the infusion after reaching the appropriate target level of hemodynamic parameters.
    The maximum rate of infusion depends on baseline hemodynamics and is about 20 ml / kg body weight per hour. The maximum daily dose of 30 ml / kg, corresponding to 1.8 g of HES / kg body weight (e.g., for a patient weighing 75 kg - 2250 ml Volek drug).
    Side effects:Allergic and anaphylactoid reactions: nausea, vomiting, hypotension, tachycardia, hyperthermia, chills, pruritus, increased submandibular and parotid salivary gland, flu-like symptoms (headache, myalgia, peripheral edema), angioedema; rarely - shock, stop breathing and heart.
    When administered in high doses - increased bleeding, blood circulation overload. Hypocoagulation of the breeding. Pain in the lumbar region, lower hematocrit, hypoproteinemia (due to dilution).
    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.
    Overdose:If, upon introduction of Volekam, the initial signs of an adverse reaction or toxic effect develop, discontinue the drug administration and conduct symptomatic treatment.
    Interaction:
    The use of Volekam does not exclude the need for other anti-shock measures (anesthesia, the use of cardiac, vasotonic and other symptomatic means). The drug can also be used with crystalline drugs. With simultaneous use with aminoglycoside antibiotics can potentiate their nephrotoxicity.
    When mixed with other drugs in one container and in one system, there may be phenomena of pharmaceutical incompatibility.
    Special instructions:
    Treatment should be controlled to ensure adequate rehydration of patients (at least 2-3 liters of fluid per day), bcc, electrolytes, leukocytes, platelets, hemoglobin, blood coagulation, kidney function.
    It should be borne in mind that HES can affect laboratory indicators (glucose, protein, erythrocyte sedimentation rate (ESR), fatty acids, cholesterol, sorbitol dehydrogenase, specific gravity of urine).
    After intravenous administration of the drug, the activity of amylase in the blood increases, which returns to the norm in 3-5 days (it may interfere with the laboratory diagnosis of pancreatin without affecting the clinical picture).
    Volekam does not affect the definition of the blood group.
    The introduction of high doses of the drug leads to a decrease in hematocrit, hemoglobin concentration and plasma protein. The hemoglobin value below 10 g% and the hematocrit below 30% are considered critical. Starting with a total protein of less than 5 g / dL, the administration of albumin is indicated. With blood loss above 20-25% BCC, additional administration of erythrocyte mass is indicated.
    If there is a lack of fibrinogen, the drug can be used only in case of emergency care, when the life of the patient is at risk in the absence of components of the donor blood.
    In connection with the possibility of developing allergic reactions after the introduction of the first 5-10 and the subsequent 30 drops, a break for 3 minutes is necessary,To determine the tolerability of the drug to the patient. Symptoms of anaphylaxis may appear within a few minutes. Symptoms that cause anxiety are severe itching and redness of the skin (a sudden rush of blood to the face, neck). Sometimes the patient suffers suffocation, there is a feeling of "coma in the throat". Characteristic for the next stage are nausea and cramps in the abdomen, as well as tachycardia and arterial hypotension, which can lead to loss of consciousness, up to the stopping of breathing and the cessation of cardiac activity.
    In case of intolerance reactions, the drug should be stopped immediately and the necessary emergency measures taken.
    Emergency measures of help in case of reaction of intolerance:
    Stop the infusion, leave the cannula in the vein.
    1. Skin reactions: Antihistamines.
    2. Tachycardia, a drop in blood pressure, nausea, vomiting: Antihistamines and glucocorticosteroids (100 mg of prednisolone intravenously).
    3. Shock, bronchospasm: Epinephrine (epinephrine) 0.05-0.1 mg slowly intravenously.
    4. Heart and / or respiratory arrest: Carrying out resuscitation measures taken in such cases.
    Patients should be under continuous medical supervision, additional therapeutic measures should be applied depending on the condition of the patients.
    The literature describes the relationship between the dose and frequency of itching in otoneurological diseases, such as sudden hearing loss, the appearance of tinnitus. With these diseases to reduce the incidence of itching is recommended to reduce the dose Volekam to 250 ml / day.
    At the beginning of therapy, it is required to monitor the serum levels of creatinine. With limiting values ​​of creatinine (1.2-2 mg / dL, or 106-177 μmol / L - compensated renal failure), it is necessary to correlate the possibility and necessity of the therapy and carefully monitor the water-electrolyte balance.
    When the first signs of impairment on the part of the kidneys appear, the drug should be discontinued. It is recommended to monitor the condition of the kidneys for at least 90 days after using the drug Volekam.
    In the treatment of patients with hypovolemia, severe hemodilution should be avoided.In case of repeated use, the parameters of blood coagulability should be carefully monitored. At the first signs of coagulopathy, the drug should be discontinued.
    Adequate long-term data on the use of the drug Volekam in patients who have undergone surgical intervention or were injured are absent. The expected benefit of treatment should be carefully correlated with uncertain long-term safety. Other available therapeutic measures should be considered.
    Due to the limited data on the use of Volekam in children, its use in this category of patients is not recommended.
    Effect on the ability to drive transp. cf. and fur:When using the drug should be careful when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.
    Form release / dosage:
    Solution for infusions 6%.
    Packaging:By 100, 250, 500 or 1000 ml into polymeric containers for single-use infusion solutions with two sterile ports.Each container is placed in a bag of polyethylene or polyethylene-polyamide film (a double sterile vacuum package).
    Containers in bags are placed in a box of corrugated cardboard: 50, 75, 96 pieces (100 ml), 24, 36, 48 pieces (250 ml), 12, 18, 24 pieces (500 ml), 6, 9 , 12 pieces (1000 ml). In the container box, instructions are put on the medical use of the drug and guidelines for the use of polymeric containers at the rate of 1 piece per 6 containers (for hospitals).
    Storage conditions:
    In a dry place at a temperature of 10 to 25 ° C. Freezing of the drug is not allowed. Keep out of the reach of children.
    After the expiry date of the drug, unused containers should be carefully opened, the contents drained into the drain.
    Shelf life:2 years. Do not use after expiry date.
    Terms of leave from pharmacies:For hospitals
    Registration number:LP-002724
    Date of registration:21.11.2014
    Expiration Date:21.11.2019
    The owner of the registration certificate:MEDSINTEZ FACTORY, LTD. MEDSINTEZ FACTORY, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.03.2017
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