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

    Active substance:


    Dextrose (glucose) monohydrate

    in terms of anhydrous substance)

    50 mg / 100 mg

    Excipients:


    Sodium chloride

    0.26 mg

    A 0.1 M solution of hydrochloric acid

    to pH 3.0-4.0

    Water for injections

    up to 1 ml

    Description:Colorless, clear 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:

    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.

    The pharmacodynamic properties of 5% and 10% 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 286.4 mOsm / l. Consumed caloric content of 5% dextrose solution is 200 kcal / l.

    10% dextrose solution is a hypertonic solution with osmolarity of 563.9 mOsm / l. Consumed caloric content of 10% dextrose solution is 400 kcal / l.

    Within the parenteral nutrition of 5% and 10%, 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.

    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 added substance.

    Pharmacokinetics:

    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.

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

    Indications:

    For 5% and 10% solutions of dextrose:

    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 10% dextrose solution additionally:

    For the prevention and treatment of hypoglycemia.

    Contraindications:

    For 5% and 10% solutions of dextrose:

    Decompensated diabetes mellitus; hyperosmolar coma; hemodilution and extracellular hyperhydration, hypervolemia; hyperglycemia and hyperlactatemia; severe renal failure (with oliguria or anuria); Decompensated heart failure; generalized edema (including edema of the lungs and brain) and cirrhosis of the liver with ascites; other known forms of intolerance to dextrose (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 solution of dextrose.

    For 10% dextrose solution additionally:

    Non-diabetes mellitus.

    Carefully:

    Diabetes mellitus without exacerbation, hyponatremia, intracranial hypertension.

    Pregnancy and lactation:

    A 5% dextrose solution is used during pregnancy as a hydrating and vehicle when using other medicines.

    Undesirable effects on the offspring when using a 5% solution of dextrose during pregnancy, childbirth and breastfeeding are absent.

    A 10% dextrose solution can be used during pregnancy and breastfeeding, provided that the electrolyte balance and fluid balance are monitored and are within physiological limits.

    When adding other medicines, the effect of the added substance on pregnancy and breastfeeding is treated separately.

    Dosing and Administration:

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

    The concentration and dose of the dextrose solution administered 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 should be closely monitored, in particular the concentration of dextrose in the blood, as well as the water-salt balance.

    5% dextrose solution

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

    For adults (body weight about 70 kg): from 500 to 3000 ml and day.

    For children, including newborns:

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

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

    - with a body weight of more than 20 kg - 1500 ml + an additional 20 ml for each kg of body weight over 20 kg per day.

    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. 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 dextrose utilization 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 application for dilution and dissolution of parenterally administered drugs -from 50 to 250 ml per dose of the drug administered, however, the required volume should be determined based on the instructions for the use of added medications. In this case, the dose and the speed of the injected solution are determined by the properties and dosage regimen of the diluted drug.

    10% dextrose solution

    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 of dextrose solutions in adults (70 kg) *

    Indication for use

    Initial daily dose

    Infusion rate

    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)

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

    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 dilution 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.

    Side effects:

    Undesirable 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)

    Infrequently (≥ 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 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.

    Undesirable reactions can also 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 assessed and adequate measures taken.

    Overdose:

    Symptoms: long-term use or high speed of large-volume infusion of 5% dextrose can lead to hyperosmolarity, dehydration, hyperglycemia, glucosuria, osmotic diuresis (due to hyperglycemia). Prolonged use or high infusion rate can lead to the accumulation of fluid with edema or water intoxication (together with hyponatremia).

    Prolonged infusion of 10% dextrose can lead to hyperglycemia, glucosuria, hyperosmolarity, osmotic diuresis and dehydration.Rapid infusion can create fluid accumulation in the body with hemodilution and hypervolemia, and if the body's ability to oxidize glucose is exceeded, rapid administration can cause hyperglycemia. There may also be a decrease in the concentration of potassium and inorganic phosphate in the blood plasma.

    When using dextrose solutions for infusions for dilution and dissolution of 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 must visually control them for incompatibility.

    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 and 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 condition, their clinical and biological parameters, in particular the concentration 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.

    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 into the body of pyrogens.

    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 osmolar.

    The compatibility of additionally administered drugs should be assessed before they are added to the solution (similar to the use of other parenteral solutionsditch). It is necessary to follow the recommendations for the dilution of the added medicines in accordance with the instructions for their use.It is necessary to check the resulting solution for discoloration and / or the appearance of a precipitate, insoluble complexes or crystals. Assessment of the compatibility of additional drugs with the drug is within the competence of the doctor.

    FROM microbiological point of view, a 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

    Have newborns, especially in premature or low birth weight, are at increased risk for hypo- or hyperglycemia, 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. 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 corn-dextrose, the use of the drug is contraindicated in patients with known intolerance to maize or maize products, since the following hypersensitivity reactions are possible: anaphylactic reactions, hypersensitivity, 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% and 10%.

    Packaging:

    For 200 or 400 ml in glass bottles, corked with rubber stoppers and crimped with aluminum or combined caps.

    1. A bottle with instructions for use is placed in a pack of cardboard.

    2. For hospitals. For 20, 24 bottles of 200 ml or 12 bottles of 400 ml with an equal number of instructions for use are placed in a group box - boxes of cardboard corrugated.

    250 ml or 500 ml in a soft polymer container made of a multilayered polymer film to make soft containers for infusion solutions or a film for the production of soft containers for three-layer co -extrasive infusion solutions based on polyolefin.

    1. Each container with instructions for use is packaged in a secondary bag of film.

    It is allowed to apply the text of the instruction for medical use thermographically to a secondary bag (the instruction is not included in the secondary bag).

    For 24 containers of 250 ml or 12 containers of 500 ml, sealed in secondary bags, placed in a group box - boxes of cardboard corrugated.

    2. Each container is packaged in a secondary bag of film.

    A self-adhesive multi-page label is glued onto the bag.

    For 24 containers of 250 ml or 12 containers of 500 ml, sealed in secondary bags, placed in a group box - boxes of cardboard corrugated.

    3. For hospitals. Each container is packaged in a secondary bag of film.

    For 24 containers of 250 ml or 12 containers of 500 ml sealed in secondary bags, with an equal number of instructions for use are placed in a group box - boxes of cardboard corrugated.

    Storage conditions:

    Store at a temperature of 5 to 30 ° C.

    Note.

    Keep out of the reach of children.

    Freezing the drug, provided that the tightness of the bottle (container) is not a contraindication to its use.

    In case of turbidity, do not use the solution.

    After transporting in conditions of negative temperatures, the bottles (containers) in the shipping container must be kept at a temperature of 15 to 25 ° C for at least 24 hours.

    The presence of moisture in the secondary bag with the container is allowed provided the container is hermetically sealed.

    Non-wetting of the inner surface of the bottle (container) is not a contraindication to the use of the drug.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001631 / 02
    Date of registration:29.01.2009 / 21.07.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
    Information update date: & nbsp21.04.2017
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