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

    Active substance: dekstrmonohydrate (dextrose) 50.00 g in terms of anhydrous;

    Excipients: sodium chloride 0.26 g, 0.1 M solution of hydrochloric acid to a pH of 3.0 to 5.0, water for injection to 1 liter.

    Theoretical osmolarity is 286 mOsm / l.

    Description:A clear, colorless 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 dextrose solutions partially replenishes the water deficiency. Dextrose, entering the tissues, is phosphorylated, turning into glucose-6-phosphate, which actively is included in many parts of the body's metabolism.

    5% dextrose solution is isotonic with blood plasma.

    The preparation is an isotonic solution with osmolarity of about 286 mOsm / l. The pharmacodynamic properties of this solution are similar to those of glucose, the main source of energy of cellular metabolism. In the framework of parenteral nutrition is administered as a source of carbohydrates. Consumed caloric content of 5% dextrose solution is 200 kcal / l. The solution of the drug allows you to fill the lack of fluid without the simultaneous introduction of ions.

    When using a solution of dextrose for dilution and dissolution of parenterally administered Pharmacodynamic properties of the solution will depend on the substance added.

    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:

    - 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.

    Contraindications:

    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 swelling 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 corn products;

    - contraindications to any drugs added to the glucose solution.

    Carefully:

    Chronic heart failure in the stage of compensation, chronic renal failure in the stage of compensation, hyponatremia, diabetes mellitus in the stage of compensation.

    Pregnancy and lactation:

    Glucose 5% infusion solution can be used in pregnancy as a hydrating and vehicle when using other medicines (especially oxytocin). There is no evidence of undesirable effects on the fetus or the baby when using 5% glucose solution during pregnancy, childbirth and during breastfeeding.

    When adding other drugs, their effect on pregnancy and lactation is treated separately.

    A dextrose solution of 5% (glucose) can be safely used during pregnancy and during breastfeeding, provided that the electrolyte balance and fluid balance are controlled and are within the physiological norm.

    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.

    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 body weight of 10-20 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 svyshe 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.

    Side effects:

    Adverse reactions (HP) are grouped according to the systems and organs in accordance with the MedDRA dictionary and HP WHO developmental frequency classification:

    very often (≥ 1/10);

    often (≥1 / 100 to <1/10);

    infrequently (≥ 1/1000 to <1/100);

    rarely (≥1 / 10000 to <1/1000);

    very rarely (<1/1000);

    frequency unknown - (frequency can not be determined based on 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 may also be associated with a drug that has been added to pactweapon. The likelihood of other unwanted reactions depends on the properties of the particular added drug.

    If undesired reactions occur, the solution should be discontinued.

    Overdose:

    Long-term use or high-speed infusion of large volumes can lead to hyperosmolarity, dehydration, hyperglycemia, glucosuria, osmotic diuresis (due to hyperglycemia) and dehydration, and also cause edema or water intoxication (together with hyponatremia).

    Rapid infusion can lead to the accumulation of excess fluid in the body with hemodilution and hypervolemia, and if the body's ability to oxidize glucose is higher, it can cause hyperglycemia. There may also be a decrease in potassium and inorganic phosphate in the serum.

    Signs and symptoms of overdose associated with the use of a solution of dextrose as a solvent for other drugs are determined by the properties of these drugs. In this case, an overdose should be suspended administration of the solution, assess the patient's condition, if necessary, maintain symptomatic therapy.

    Interaction:

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

    To increase osmolarity 5% dextrose solution can be combined with 0.9% sodium chloride solution.

    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 5% 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 and 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 in patients with diabetes mellitus, renal insufficiency or in an acute critical condition, the tolerance of glucose (dextrose) may be impaired,it is necessary to closely monitor their clinical and biological parameters, in particular, the concentration of glucose in the blood and the concentration of electrolytes in the blood plasma, including magnesium or phosphorus. In the presence of hypoglycemia, the speed of administration of the drug should be adjusted or short-acting insulin administered (subcutaneously 4-5 units at the rate of 1 unit of short-acting insulin for 4-5 g of dextrose).

    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.

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

    PThe solution 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 administered prior to infusion or during infusion through the site input (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 osmolarity.

    The compatibility of additionally administered drugs should be assessed before they are added to the solution (similar to the use of other parenteral solutions). 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.

    Children and teens

    In newborns, especially in prematurity or those born with low body weight, the risk of developing hypo- or hyperglycemia is increased,therefore, during the intravenous administration of dextrose solutions, careful monitoring of blood glucose concentration is necessary in order to avoid long-term undesirable consequences. 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 premature infants, 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.

    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 connect partially used containers.

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

    Does not affect the ability to drive vehicles.

    Form release / dosage:Solution for infusion, 5%.
    Packaging:

    By 250 and 500 ml into containers of a multilayer film polymer.

    32 containers with a capacity of 250 ml or 20 containers with a capacity of 500 ml place in transport containers (for hospitals). The number of instructions for use is equal to the number of primary packagings in the shipping container.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Freezing the drug, provided that the integrity of the packaging is not a contraindication to its use. After transport under adverse temperatures, the containers in the shipping container must be conditioned at a temperature of 15 to 25 ° C until completely thawed.

    If clouding, do not use the contents of the container.

    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-001636
    Date of registration:09.04.2012
    Expiration Date:09.04.2017
    The owner of the registration certificate:POLISAN NTPF, LLC POLISAN NTPF, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspPOLYSAN NTFF TOV POLYSAN NTFF TOV Russia
    Information update date: & nbsp03.05.2017
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