Active substanceDextroseDextrose
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  • Dosage form: & nbspsolution for intravenous administration
    Composition:

    1 ml of the preparation contains:

    Active substance:

    Dextrose monohydrate (in terms of dextrose)

    400 mg

    Excipients:


    Sodium chloride

    0.26 mg

    0.1 M solution of hydrochloric acid or 0.1 M sodium hydroxide solution

    to pH 3.2-6.5

    Water for injections

    up to 1 ml

    Description:

    Transparent, colorless or slightly colored liquid.

    Pharmacotherapeutic group:Nutrition carbohydrate remedy
    ATX: & nbsp

    B.05.C   Irrigation solutions

    V.06.D   Other medications for nutrition

    V.04.C   Other diagnostic preparations

    Pharmacodynamics:

    Participates in various metabolic processes in the body. The infusion of glucose solutions partially replenishes the water deficiency. Dextrose, entering the tissue, phosphorylated, turning into glucose-6-phosphate, which is actively included in many parts of the body's metabolism.

    Dextrose solution 400 mg / ml is hypertonic, increases osmotic blood pressure, dilates blood vessels, increases diuresis.

    Pharmacokinetics:

    Bioavailability of glucose after intravenous injection is 100%. Glucose is metabolized in two different ways: anaerobic and aerobic. Dextrose, decomposing into pyruvic or lactic acid (anaerobic glycolysis), is metabolized to carbon dioxide and water with the release of energy.Usually, glucose is absorbed completely and not excreted by the kidneys.

    Indications:

    Hypoglycemia.

    As a source of carbohydrates (alone or as part of parenteral nutrition if necessary).

    Contraindications:

    Hypersensitivity to the drug components, hyperglycemia, hyperlactatemia, hyperhydration, postoperative disorders of glucose utilization; circulatory disorders that threaten edema of the brain and lungs; cerebral edema, pulmonary edema, acute left ventricular failure, hyperosmolar coma, children's age (without dilution), decompensated diabetes mellitus, intolerance to dextrose, including metabolic stress.

    Carefully:

    Decompensated chronic heart failure, chronic renal failure (oligo, anuria), hyponatremia, diabetes mellitus.

    Pregnancy and lactation:

    During pregnancy and during breastfeeding, the safety and efficacy of the drug is not established.

    The use of the drug during pregnancy and during breastfeeding is possible only if prescribed by the doctor, if the intended benefit to the mother exceeds the potential risk to the fetus or the baby.

    40% glucose solution during pregnancy and during breastfeeding can be used only under the condition of control by the doctor.

    Dosing and Administration:

    Intravenously (drip).

    The concentration and dose of the administered solution depend on the age, body weight and clinical state of the patient.

    The drug should be administered under regular medical supervision.

    Clinical and biological parameters, in particular the concentration of glucose in the blood, as well as the water-salt balance should be carefully monitored.

    Adults and adolescents aged 15 years and over: the maximum daily dose is 15 ml per kg of body weight per day, which corresponds to 6 g of glucose per kg of body weight per day. The maximum infusion rate is 0.62 ml per kg of body weight per hour, which corresponds to 0.25 g of glucose per kg of body weight per hour. For a patient with a body weight of 70 kg, the maximum infusion rate is 43 ml per hour (glucose 17.5 g per hour).

    Children: the maximum daily dose: premature infants - 18 g of dextrose per kg of body weight, or 45 ml per kg of body weight; full-term children - 15 g of dextrose per kg of body weight, or 37.5 ml per kg of body weight; 1-2 years - 15 g per kg of body weight / 37.5 ml per kg of body weight; 3-5 years - 12 g per kg of body weight / 30 ml per kg of body weight; 6-10 years - 10 g per kg of body weight / up to 25 ml per kg of body weight; 11-14 years - 8 g per kg of body weight / 20 ml per kg of body weight.When used in newborns, it is necessary to take into account the high osmolarity of the solution.

    Elderly patients: In general, doses recommended for adults are used, but caution should be exercised in patients with cardiac or renal failure when determining the volume of fluid administered and the dose of dextrose.

    Patients with reduced glucose metabolism (for example, in the early postoperative or post-traumatic period, with hypoxia, or organ failure): the concentration of glucose in the blood should be carefully monitored. To avoid hyperglycemia, the level of possible glucose oxidation should not be exceeded.

    For more complete assimilation of dextrose, administered in large doses, concomitantly with it prescribe insulin of short action at the rate of 1 unit of insulin per 4-5 g of dextrose.

    Patients with diabetes mellitus Dextrose is administered under the control of its concentration in the blood and urine. Maximum volumes within the recommended dosage should be administered within 24 hours to avoid haemodilution.

    The maximum infusion rate should not exceed the glucose disposal threshold in the patient's body, as this can lead to hyperglycemia.

    Depending on the clinical state of the patient, the rate of administration may be reduced to reduce the risk of osmotic diuresis.

    The drug may be injected intravenously in the course of treatment of hypoglycemic coma.

    The procedure for working with a polymer ampoule:

    1. Take an ampoule and shake it, holding it by the neck.

    2. Press the ampoule with your hand, while the drug should not be isolated, and rotate and separate the valve with rotating movements.

    3. Through the formed hole, immediately connect the syringe with the ampoule.

    4. Turn the ampoule over and slowly put the contents into the syringe.

    5. Put the needle on the syringe.

    If it is necessary to administer high doses of 40% dextrose, dextrose solutions should be used that are released in a volume sufficient to achieve the required dosage. Because 1 ampoule 10 ml contains 4 g of dextrose, and in cases where it is required to administer large doses of dextrose, it is necessary to use a significant amount of ampoules (more than 100), which can lead to inaccurate dosing.

    Side effects:

    Disorders from the metabolism and nutrition: hypokalemia, hypomagnesemia, hypophosphatemia, dehydration, hypervolemia, hyperglycemia.

    Immune system disorders: hypersensitivity, anaphylactic reactions (possible manifestations in patients with allergies to maize).

    Vascular disorders: thrombosis of veins, phlebitis.

    Disorders from the kidneys and urinary tract: polyuria.

    General disorders and disorders at the site of administration: chills, fever, development of infection at the injection site, mild tenderness and thrombophlebitis at the site of intravenous administration.

    Overdose:

    Symptoms: hyperglycemia, glucosuria, hyperglycemia, hyperosmolar coma, hyperhydration, disturbance of water-electrolyte balance, fatty liver infiltration, acute left ventricular failure, ion balance disturbance.

    Treatment: stop the introduction of glucose, introduce short-acting insulin, symptomatic therapy.

    Interaction:
    The combined use of catecholamines and steroids decreases the absorption of glucose.

    When mixing with other medicinal products should be visually monitored for incompatibility. In the absence of compatibility studies, the drug should not be mixed with other drugs. Before adding any medication it is necessary to make sure that it is soluble and stable in water in the pH range of the preparation.After the addition of a compatible drug in the preparation, the resulting solution should be administered immediately. Medicines with known incompatibility can not be used.

    Do not administer dextrose solutions through the same infusion system as for blood transfusion, there is a risk of hemolysis and thrombosis.

    Special instructions:

    Glucose solution can not be administered quickly and for a long time. If a chill occurs during the administration of the solution, the administration should be stopped immediately.

    To prevent thrombophlebitis should be administered slowly through large veins.

    With the introduction of dextrose solutions, control of electrolyte balance, glucose in the blood and urine is necessary.

    It can be used as a component of various blood substitute and anti-shock liquids and for the preparation of solutions of drugs for intravenous administration.

    Since the tolerance of glucose (dextrose) may be impaired in patients with diabetes mellitus, renal insufficiency or in an acute critical condition, their clinical and laboratory parameters, in particular the content of electrolytes in blood plasma, including magnesium or phosphorus, should be closely monitored, concentration of glucose in the blood.In the presence of hyperglycemia, the speed of administration of the drug should be adjusted or short-acting insulin administered. In episodes of intracranial hypertension, a careful control of the concentration of glucose in the blood is necessary.

    The use of dextrose solutions can lead to hyperglycemia. Therefore, they are not recommended for administration after acute ischemic stroke, since hyperglycemia is associated with increased ischemic damage to the brain and prevents recovery. Particularly careful clinical monitoring is required at the beginning of intravenous administration of the drug.

    Carbohydrate solutions without sufficient electrolyte content can not be used for rehydration therapy, as this can lead to a significant decrease in serum electrolyte concentrations, in particular to severe hyponatremia and hypokalemia, with potentially harmful effects on the patient, such as brain damage or heart disease. In particular, children, elderly and weakened patients are at risk. In the case of deficiency of electrolytes, such as hyponatremia or hypokalemia, the solution should not be used without proper substitution of electrolytes.

    It is necessary to monitor the concentration of glucose and the content of electrolytes in the blood, the water balance, as well as the acid-base balance of the body.

    The appointment of hyperosmolar glucose solutions may lead to an increase in intracranial / intraspinal pressure in patients with a compromised integrity of the blood-brain barrier.

    Various conditions accompanied by metabolic disorders (eg, after surgery or after trauma, with hypoxia or organ failure) can slow the oxidative metabolism of glucose and lead to metabolic acidosis.

    Hyperglycemia should be properly monitored and, if necessary, controlled by the introduction of short-acting insulin. The introduction of insulin leads to an additional movement of potassium into the cells and, consequently, can cause hypokalemia or aggravate it.

    In newborns, especially preterm or low birth weight, the risk of developing hypoglycemic or hyperglycemia is increased, so careful monitoring of blood glucose levels is necessary during intravenous dextrose solutions to avoid long-term adverse effects.Hypoglycemia in newborns can lead to prolonged seizures, coma and brain damage.

    Hyperglycemia is associated with intraventricular hemorrhage, delayed bacterial and fungal infectious diseases, retinopathy of prematurity, necrotic enterocolitis, bronchopulmonary dysplasia, prolonged hospitalization and death.

    To avoid potentially fatal overdose of intravenous drugs in newborns, special attention should be paid to the method of administration.

    Devices for intravenous infusion and other equipment for the administration of drugs should be monitored regularly.

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

    The use of the drug does not affect the management of motor vehicles and occupations potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intravenous administration, 400 mg / ml.

    Packaging:

    By 5 or 10 ml into ampoules of low-density polyethylene or polypropylene, or into ampoules of colorless or colored glass.

    For 5 or 10 ampoules of low-density polyethylene or polypropylene together with instructions for use in a pack of cardboard.

    5 ampoules of glass in a contoured cell packaging from a polyvinylchloride film with a polymer film or a foil of aluminum lacquered or without a polymer film and a foil of aluminum lacquered, or in the form of a cardboard with cells for laying ampoules.

    For 1 or 2 contour squares or cardboard form together with instructions for use and a scarifier ampoule or without a scarifier ampullum in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    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-002858
    Date of registration:13.02.2015 / 13.03.2017
    Expiration Date:13.02.2020
    Date of cancellation:2020-02-13
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp02.05.2017
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