Active substanceDextroseDextrose
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  • Dosage form: & nbspsolution for infusions
    Composition:

    Per 1 liter:

    aKept substances: dextrose (glucose) monohydrate in terms of dextrose 50 g / 100 g / 200 g;

    Excipients: sodium chloride 0.26 g, 0.1 M solution of hydrochloric acid to pH 3.0-4.5, water for injection up to 1.0 liter.

    Theoretical osmolarity, mOsmol / l - 277/555/1110.

    Description:

    Colorless (5% and 10%) or slightly yellowish transparent liquid (20%).

    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:
    Glucose strengthens redox processes in the body, improves the antitoxic function of the liver, increases the contractile activity of the myocardium, is the source of digestible carbohydrates.

    Pharmacodynamic properties of 5%, 10% and 20% of dextrose solutions are similar to those of glucose, the main source of energy of cellular metabolism.

    5% dextrose solution is an isotonic solution with an osmolarity of about 278 mOsm / l. Consumed caloric content of 5% dextrose solution is 200 kcal / l,

    10% dextrose solution is a hypertonic solution with osmolarity of about 555 mOsm / l. Consumed caloric content of 10% dextrose solution is 400 kcal / l.

    20% dextrose solution is a hypertonic solution with an osmolarity of about 1110 mOsm / l. Consumed caloric content of 20% dextrose solution is 680 kcal / l.

    Within the parenteral nutrition of 5%, 10% and 20%, dextrose solutions are administered as a source of carbohydrates (alone or as part of parenteral nutrition if necessary).

    5% and 10% dextrose solutions allow replenishment of fluid deficiency without simultaneous introduction of ions.

    A 20% dextrose solution provides the maximum amount of calories in a minimum volume of fluid.

    Dextrose, entering the tissues, is phosphorylated, turning into glucose-6-phosphate, which is actively included in many parts of the body's metabolism.

    With the use of dextrose solutions for dilution and dissolution of parenterally administered drugs, the pharmacodynamic properties of the solution will depend on the substance added.

    Pharmacokinetics:

    Glucose is metabolized in two different ways: anaerobic and aerobic.

    Dextrose, disintegrating into pyruvic or lactic acid (anaerobic glycolysis), is metabolized to carbon dioxide and water with the release of energy.

    When a solution of dextrose is used to dilute and dissolve the parenterally administered drugs, the pharmacokinetic properties of the solution will depend on the added substance.

    Indications:

    5% glucose solution:

    - as a source of carbohydrates (alone or as part of parenteral nutrition if necessary);

    - for rehydration in case of fluid loss, especially in patients with a high demand for carbohydrates;

    - for dilution and dissolution of parenterally administered drugs.

    10% glucose solution:

    - as a source of carbohydrates (alone or as part of parenteral nutrition if necessary);

    - for rehydration in case of fluid loss, especially in patients with a high demand for carbohydrates;

    - for dilution and dissolution of parenterally administered drugs;

    - for the prevention and treatment of hypoglycemia.

    20% glucose solution:

    - as a source of carbohydrates (alone or as part of parenteral nutrition, if necessary), especially when it is necessary to limit fluid intake;

    - hypoglycemia.

    Contraindications:

    Decompensated diabetes mellitus and diabetes insipidus; hyperosmolar coma; hemodilution andextracellular hyperhydration or hypervolemia; hyperglycemia and hyperlactatemia: severe renal failure (with oliguria or anuria); uncompensated heart failure; generalized edema (including edema of the lungs and brain) and cirrhosis of the liver with ascites; other known forms of glucose intolerance (eg, metabolic stress); hypersensitivity to the components of the drug; administration of the solution within the first 24 hours after trauma to the head; use of the same infusion system as for blood transfusion, because of the risk of hemolysis and thrombosis; patients with a known intolerance to corn or products from corn (in the preparation of dextrose from corn); contraindications to any drugs added to the glucose solution.

    Carefully:

    Diabetes mellitus, intracranial hypertension, hyponatremia, children's age.

    Pregnancy and lactation:

    A solution of dextrose 5% during pregnancy is usually used as a hydrating and vehicle when using other medications (in particular oxytocin).

    A solution of dextrose 5% and 10% can be safely applied during pregnancy and during breastfeeding, provided that the electrolyte balance and fluid balance are controlled and within the physiological norm. If the mother is given IV glucose, then the glucose concentration in her blood should not exceed 11 mmol / l.

    Feeding during infusion try not to interrupt.

    If the dextrose solution is added to the drug, the properties of the drug and its use during pregnancy and during breastfeeding are treated separately.

    Dosing and Administration:

    Intravenously (drip). The drug is usually injected into the peripheral or central vein.

    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 closely monitored.

    Dosage regimen of glucose solution for infusion of 5%

    The recommended dose as a source of carbohydrates (alone or as part of parenteral nutrition if necessary):

    For adults:

    - 500-3000 ml per day.

    For children, including newborns:

    - with a body weight of 0-10 kg - 100 ml / kg per day;

    - with a weight of 10-20 kg - 1000 ml + additional 50 ml for each kg of body weight over 10 kg per day;

    - with a mass exceeding 20 kg - 1500 ml + additional 20 ml for each kg of body weight over 20 kg per day.

    Infusion rate and volume depend on the age, body weight, clinical condition and metabolism of the patient, as well as on concomitant therapy. In children, they should be determined by the attending physician who has experience of using intravenous drugs in this category of patients.

    Do not exceed the glucose disposal threshold in the body to avoid hyperglycemia, so the maximum dose of dextrose varies from 5 mg / kg / min for adults and 10-18 mg / kg / min for newborns and children, depending on age and total body weight.

    The recommended dose for dilution and dissolution of parenterally administrable drugs is usually 50-250 ml per dose of the drug administered, however, the required volume should be determined based on the instructions for the use of the added medications. In this case, the dose and rate of administration of the solution are determined by the properties and dosage regimen of the diluted drug.

    Dosing regimen of glucose solution for infusion of 10%

    Adults and Seniors

    The recommended doses in Table 1 serve as a guideline for use in adults with a body weight of about 70 kg.

    Table 1. Recommendations for dosing in adults (70 kg) *

    Indication for use

    Initial daily dose

    Speed infusion

    Recommended duration of application

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

    500-3000 ml per day

    (7-40 ml / kg per day)

    5 mg / kg / min

    (3 ml / kg / h)

    The duration of treatment depends on the clinical condition of the patient

    Prevention and treatment of hypoglycemia

    Rehydration in case of fluid loss and dehydration in patients with high carbohydrate requirement

    For breeding and dissolution of parenterally administered drugs

    50-250 ml per dose of the drug administered

    Depending on the diluted drug

    Depending on the diluted drug

    * Maximum volumes within the recommended dosage should be administered within 24 hours to avoid hemodilution.

    Children and teens

    The speed and volume of infusion depends on the age, body weight, clinical condition and metabolism of the patient, as well as from concomitant therapy. They should be determined by the attending physician who has experience of using intravenous drugs in children. The recommended doses in Table 2 serve as a guideline for use in children and adolescents and depend on body weight and age.

    Table 2. Recommendations for dosing in children and adolescents

    Indication for application

    Initial daily dose

    Initial infusion rate

    Newborns and premature babies

    Babies and children early childhood

    (1-23 months)

    Children

    (2-11 years)

    Teens

    (from 12 to 16-18 years)

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

    - with a weight from 0 to 10 kg - 100 ml / kg / day;

    - with a weight of 10 to 20 kg - 1000 ml + additional 50 ml for each kg of body weight over 10 kg / day;

    - with a mass exceeding 20 kg -1500 ml + supplement20 ml for each kg of body weight over 20 kg / day

    6-11 ml / kg / h

    (10-18 mg / kg / min)

    5-11 ml / kg / hr

    (9-18 mg / kg / min)

    4-8 ml / kg / hr

    (7-14 mg / kg / min)

    From 4 ml / kg / h

    (7-8.5 mg / kg / min)

    Prevention and treatment of hypoglycemia





    Rehydration at case of fluid loss and dehydration in patients with high demand for carbohydrates





    For dilution and dissolution of parenterally administered drugs

    Initial dose: from 50 to 100 ml per dose of the drug administered. Regardless of age.

    Infusion rate: depending on the diluted drug. Regardless of age.

    * The speed, volume of infusion and duration of treatment depend on the age, body weight, clinical condition and metabolism of the patient, and also on concomitant therapy. They should be determined by the attending physician who has experience of using intravenous drugs in children.

    Note: Maximum volumes within the recommended dosage should be administered within 24 hours to avoid hemodilution.

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

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

    When using the drug for dilution and dissolution of medications for infusion introduction, the required volume is determined based on the instructions for the use of added medications.

    Dosing regimen of glucose solution for infusions of 20%

    Introduction of 20% glucose solution is carried out only through the central vein.

    The rate of administration of the solution is up to 30-40 cap / min (1.5-2 ml / min). The maximum daily intake for adults is 500 ml.

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

    With complete parenteral nutrition, the introduction of glucose should always be accompanied by the introduction of a sufficient number of amino acid solutions, emulsions of lipids, electrolytes, vitamins and trace elements.

    Side effects:

    Unwanted reactions (HP) are grouped according to systems and bodies in accordance with the vocabulary MedDRA and classification of the frequency of development HP WHO:

    Very often (≥ 1/10)

    Frequently (≥ 1/100 to <1/10)

    Not often (≥ 1/1000 to <1/100)

    Rarely (≥ 1/10000 to <1/1000)

    Very rarely (<1/10000)

    The frequency is unknown - (the frequency can not be determined from the available data).

    From the immune system

    The frequency is unknown: anaphylactic reactions, hypersensitivity.

    From the side of metabolism and nutrition

    The frequency is unknown: violations of the water-electrolyte balance (hypokalemia, hypomagnesemia and hypophosphatemia), hyperglycemia, hemodilution, dehydration, hypervolemia.

    From the heart

    Frequency unknown: acute left ventricular failure.

    From the side of the vessels

    The frequency is unknown: venous thrombosis, phlebitis.

    From the skin and subcutaneous tissues

    The frequency is unknown: increased sweating.

    From the side of the kidneys and urinary tract

    Frequency unknown: polyuria.

    General disorders and disorders at the site of administration

    The frequency is unknown: chills, fever, infection at the injection site, irritation at the injection site, extravasation, tenderness at the injection site.

    Laboratory and instrumental data

    The frequency is unknown: glucosuria,

    Unwanted reactions may be associated with a drug that has been added to the solution. The likelihood of other unwanted reactions depends on the properties of the particular added drug.

    If undesirable reactions occur, the solution should be discontinued, the patient should be evaluated, and adequate measures taken.

    Overdose:

    Symptoms: prolonged infusion administration of the drug may lead to hyperglycemia, glucosuria, hyperosmolarity, osmotic diuresis and dehydration. Rapid infusion can create fluid accumulation in the body with hemodilution and hypervolemia,and with an increase in the body's ability to oxidize glucose, rapid administration can cause hyperglycemia. There may also be a decrease in potassium and inorganic phosphate in the blood plasma.

    When using a solution of dextrose for infusion to dilute and dissolve other medications for intravenous administration, the clinical signs and symptoms of an overdose may be related to the properties of the medications used.

    Treatment: when symptoms of an overdose appear, suspend the administration of the solution, assess the patient's condition, introduce short-acting insulin, and, if necessary, maintain symptomatic therapy.

    Interaction:

    The combined use of catecholamines and steroids decreases the absorption of dextrose (glucose).

    When mixed with other drugs, you need to visually control them for compatibility.

    For the dilution or dissolution of other drugs, the drug should be used only if there are indications of dilution with dextrose solution in the instructions for use for this medication.

    In the absence of information on compatibility, 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.

    When introducing dextrose solutions through the same infusion system as for blood transfusion, there is a risk of hemolysis and thrombosis.

    Special instructions:

    Since the tolerance of glucose (dextrose) may be impaired in patients with diabetes mellitus, renal insufficiency or in an acute critical state, their clinical and biological parameters, in particular the concentration of electrolytes in blood plasma, including magnesium or phosphorus, concentration glucose in the blood. In the presence of hyperglycemia, the speed of administration of the drug should be adjusted or short-acting insulin administered.Usually, glucose is fully absorbed by the body (normally not excreted by the kidneys), so the appearance of glucose in the urine can be a pathological sign.

    AT In case of prolonged administration or the use of dextrose in high doses, it is necessary to monitor the potassium concentration in the blood plasma and, if necessary, to administer potassium additionally to avoid hypokalemia.

    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.

    For rehydration therapy, carbohydrate solutions should be used in combination with electrolyte solutions to avoid electrolyte imbalance (hyponatremia, hypokalemia).

    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 state of the body.

    Before use, the solution should be inspected. Use only a clear solution without visible inclusions and in the absence of damage to the packaging. Enter directly after connecting to the infusion system.

    The solution should be administered with the use of sterile equipment in compliance with the rules of aseptic and antiseptic.

    To avoid air embolism, remove air from the infusion system with a solution.

    Do not join the containers sequentially to avoid air embolism, which may occur due to sucking air from the first container until the solution is completed from the second container.

    The supply of intravenous solutions contained in soft plastic containers under increased pressure to increase the flow rate can lead to air embolism, if the residual air in the container is not completely removed before administration.

    The use of the system for intravenous administration with a gas outlet can lead to air embolism with an open gassing. Soft plastic containers with such systems should not be used.

    The added substances can be injected before infusion or during infusion through the injection site (if there is a special port for drug administration).

    Adding other medications to the solution or disturbing the technique of administration can cause fever due to the possible entry of pyrogens into the body.

    If unwanted reactions develop, the infusion should be stopped immediately.

    When adding other medications before parenteral administration, it is necessary to check the isotonicity of the resulting solution.

    Complete and thorough mixing in aseptic conditions is mandatory.

    Solutions containing additional substances should be applied immediately, their storage is prohibited.

    With the introduction of additional nutrients, the osmolarity of the resulting mixture should be determined before the infusion begins.

    The resulting mixture must be administered through a central or peripheral venous catheter, depending on the final osmolarity.

    The compatibility of additionally administered drugs should be evaluated before they are added to the solution (similar to the use of other parenteral solutions). Assessment of the compatibility of additional drugs with the drug is within the competence of the doctor.It is necessary to check the resulting solution for discoloration and / or the appearance of a precipitate, insoluble complexes or crystals. You should study the instructions for the use of added medications.

    From a microbiological point of view, the diluted drug should be applied immediately. Exceptions are dilutions prepared in controlled and aseptic conditions. Otherwise, after the preparation of the solution, the terms and conditions of its storage prior to the introduction are the responsibility of the user.

    Children

    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, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged hospitalization and mortality.

    To avoid potentially lethal overdose of intravenous medications in newborns, special attention should be paid to the method of administration. To treat "symptomatic" hypoglycemia, it is preferable to use a 10% solution of glucose. It is necessary to constantly monitor the level of glucose and blood and, if necessary, adjust it. It should be borne in mind that newborns with different pathologies have unequal needs for exogenous glucose. A sharp cessation of infusion can cause hypoglycemia, so the glucose dose is reduced gradually, the glucose solution is not titrated when the baby has normoglycemia with glucose at 4 mg / kg / min.

    When using a newborn syringe pump for intravenous administration, the container with the solution must not be left attached to the syringe.

    When using an infusion pump, before removing the system from the pump or switching it off, all the system clamps must be closed, regardless of the presence of a device that prevents free-flowing fluid.

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

    If the preparation contains dextrose from corn, the use of the drug is contraindicated in patients with a known intolerance to corn or corn products. the following manifestations of hypersensitivity are possible: anaphylactic reactions, chills and fever.

    For preparations in containers:

    Dispose of containers after a single use.

    Dispose of each unused dose.

    Do not reconnect partially used containers.

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

    Not applicable (due to the use of the drug only in the hospital).

    Form release / dosage:

    Solution for infusions, 5%, 10% and 20%.

    Packaging:

    50, 100, 200, 250, 400, 500, 1000, 1500, 2000, 2500, 3000. 3500, 4000, 4500 or 5000 ml (glucose, infusion solution 5%) or 50, 100, 200, 250, 400, 500 or 1000 ml (glucose, infusion solution 10%, 20%) in 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: 75 pieces (50 ml), 50, 75, 96 pieces (100 ml), 30 pieces (200 ml), 24, 36, 48 pieces (250 ml), on 15 pieces (400 ml), on 12, 18, 24 pieces (500 ml), on 6, 9, 12 pieces (1000 ml), on 4 pieces (1500, 2000 or 2500 ml (a glucose, a solution for infusions of 5% )), 3 pieces (3000 or 3500 ml (glucose, solution for infusions 5%)), 2 pieces (4000, 4500 or 5000 ml (glucose, solution for infusions 5%)).

    In the box with containers, they put instructions on the medical use of the drug and guidance on the use of infusion solutions in polymer containers at the rate of 1 piece per 6 containers (for hospitals).

    Storage conditions:

    In a dry place, at a temperature of 5 to 30 ° C.

    Keep out of the reach of children.

    It is allowed to freeze the drug provided the container is kept tight.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N003434 / 01
    Date of registration:17.03.2009 / 10.11.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:PLANT MEDSINTEZ, LLC PLANT MEDSINTEZ, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp02.05.2017
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