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

    5% solution

    100 ml of the preparation contain:

    active substance - dextrose anhydrous 5.0 g;

    adjuvant - water for injection up to 100 ml.

    Theoretical osmolarity is 286 mOsm / l.

    10% solution

    100 ml of the preparation contain:

    active substance - dextrose anhydrous 10.0 g;

    adjuvant - water for injection up to 100 ml.

    The theoretical osmolarity is 564 mOsm / l.

    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.

    Pharmacodynamic properties 5%, 10% dextrose solutions similar to the properties 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.

    Within the parenteral nutrition of 5%, 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 tissue, 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, decomposing 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.

    Contraindications:

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

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

    Dextrose Solution 5% and 10% 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. If the mother is given intravenous glucose, 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.

    If possible, during pregnancy and during breastfeeding, it is necessary to prescribe dextrose preparations for oral administration.

    Dosing and Administration:

    If possible, prescribe dextrose drugs for oral administration, especially in children.

    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-electrolyte balance, should be closely monitored.

    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.

    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 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.

    Table 1. Recommendations for dosing of dextrose solutions 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 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

    Children and teens

    The speed, volume of infusion and duration of administration of solutions 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.

    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 use

    Initial daily dose

    Initial ctoogrowth of infusion

    Newborns and premature babies

    Infants and young children

    (1-23 months)

    Children

    (2-11 years)

    Teens

    (from 12 to 16-18 years)

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

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

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

    - with a mass of more than 20 kg - 1500 ml + an additional 20 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 / h

    (9-18 mg / kg / min)

    4-8 ml / kg / h

    (7-14 mg / kg / min)

    From 4 ml / kg / h

    (7-8.5 mg / kg / min)

    Prevention and treatment of hypoglycemia

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

    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.

    5% glucose solution can be administered intravenously struyno 10-50 ml (it is advisable to use 5% glucose solution in ampoules).

    10% glucose solution can be administered intravenously struyno 10-50 ml (it is advisable to use 10% glucose solution in ampoules).

    Side effects:

    Adverse 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); often (> 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.

    Common disorders and disorders in the administration together

    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 undesired reactions occur, the solution should be discontinued.
    Overdose:

    Symptoms

    Long-term 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 if the body's ability to oxidize glucose is exceeded, 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, you should suspend the administration of the solution, assess the patient's condition, introduce short-acting insulin, and, if necessary, maintain symptomatic therapy.

    Interaction:

    For solutions of 5% and 10%. 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 a dextrose solution of the appropriate concentration 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:

    For glucose solutions, 5% and 10%. 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 rate of administration of the drug should be adjusted and / or a short-acting insulin should be 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, solutions of carbohydrates 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.

    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 assessed 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. When using a newborn syringe pump for intravenous administration, the container with the solution must not be left attached to the syringe. When using the 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 in the system that prevents the free flow of liquid.Devices for intravenous infusion and other equipment for the administration of drugs should be monitored regularly.

    If the preparation contains dextrose, obtained from corn, the use of the drug is contraindicated in patients with a known intolerance to corn, tk. a hypersensitivity reaction may appear: anaphylactic reactions, chills, fever.

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

    Clinical studies to assess the effect of the drug on the ability to manage vehicles and mechanisms have not been conducted.

    Form release / dosage:

    Solution for infusions, 5% and 10%.

    Packaging:

    For 100, 200, 250, 400 or 500 ml of the preparation in polypropylene bottles with holder loop, sealed with polypropylene lids with rubber lining and equipped with caps with tear-off rings for opening, welded onto the vial.

    One bottle, along with instructions for medical use, is placed in a consumer container (a pack of cardboard).

    For hospitals

    For 100, 200, 250, 400 or 500 ml of the preparation in polypropylene bottles with holder loop, sealed with polypropylene lids with rubber lining and equipped with caps with tear-off rings for opening, welded onto the vial.

    Vials with a volume of 100 ml in the amount of 120 vials, together with an equal number of instructions for medical use, are placed in a group container (cardboard box).

    Vials of 200 ml and 250 ml in quantities of 40 vials, together with an equal number of instructions for medical use, are placed in a group container (cardboard box).

    Vials with a volume of 400 and 500 ml in the amount of 30 vials, together with an equal number of instructions for medical use, are placed in a group container (cardboard box).

    Storage conditions:

    In the dark place at a temperature of no higher than 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-003457
    Date of registration:16.02.2016
    Expiration Date:16.02.2021
    The owner of the registration certificate:Kelun-Kazfarm, TOOKelun-Kazfarm, TOO The Republic of Kazakhstan
    Manufacturer: & nbsp
    Kelun-Kazpharm, TOO The Republic of Kazakhstan
    Representation: & nbspKelun-Kazfarm, TOOKelun-Kazfarm, TOOThe Republic of Kazakhstan
    Information update date: & nbsp22.04.2017
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