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Glucose 5% 200 ml solution for inf.fl.

Instructions for medical use of the drug GLUCOSE Trade name Glucose International nonproprietary name No Dosage form Solution for infusion 5%, 10% 200 ml, 400 ml Composition 1 liter of solution contains the active substance: dextrose monohydrate (glucose, in terms of anhydrous dextrose) – 50 , 0 g or 100.0 g excipients: sodium chloride, 0.1 M hydrochloric acid, water for injection. Osmolality From 266 to 326 mOsm/kg (for a concentration of 5%) From 541 to 662 mOsm/kg (for a concentration of 10%) Description Colorless transparent liquid Pharmacotherapeutic group Plasma replacement and perfusion solutions. Solutions for parenteral nutrition. Carbohydrates. ATC code B05BA03 Pharmacological properties Pharmacokinetics Absorbed completely by the body, not excreted by the kidneys (appearance in urine is a pathological sign). Pharmacodynamics Glucose enhances redox processes in the body, improves the antitoxic function of the liver, and covers part of the body's energy costs. Infusion of glucose solutions quickly replenishes water deficiency. Entering the tissues, it is phosphorylated, turning into glucose-6-phosphate, which is actively involved in many parts of the body’s metabolism. An isotonic 5% glucose solution has a detoxifying, metabolic effect, restores the volume of circulating blood, and is a source of valuable, easily digestible nutrients. When glucose is metabolized in tissues, a significant amount of energy is released, which is necessary for the functioning of the body. A hypertonic 10% glucose solution increases the osmotic pressure of the blood, improves metabolism, and increases myocardial contractility; improves the antitoxic function of the liver, dilates blood vessels, increases diuresis. Indications for use - hypoglycemia, carbohydrate deficiency - toxic infections, intoxication in liver diseases (hepatitis, liver dystrophy and atrophy, including liver failure) - hemorrhagic diathesis - dehydration (vomiting, diarrhea, postoperative period) - collapse, shock - for the preparation of drug solutions for intravenous administration. Method of administration and dosage. Isotonic glucose solution (5%) is administered intravenously (drip) at a maximum speed of up to 150 drops/min, the maximum daily dose is 2000 ml. A hypertonic solution (10%) is administered intravenously at a dose of 60 drops/min; the maximum daily dose for adults is 1000 ml. Intravenous bolus - 10-50 ml of 5% and 10% solutions. In adults with normal metabolism, the daily dose of administered glucose should not exceed 4-6 g/kg/day, that is, about 250-450 g/day (with a decrease in metabolic rate, the daily dose is reduced to 200-300 g), while the volume administered fluid - 30-40 ml/kg/day. For parenteral nutrition, along with fats and amino acids, children are given 6 g of glucose/kg/day on the first day, and subsequently up to 15 g/kg/day. When calculating the dose of glucose when administering 5% and 10% solutions, it is necessary to take into account the permissible volume of injected fluid: for a body weighing 2-10 kg - 100-165 ml/kg/day, for children weighing 10-40 kg - 45-100 ml/kg/day Rate of administration: in a normal metabolic state, the maximum rate of administration for adults is 0.25-0.5 g/kg/h (with a decrease in metabolic rate, the rate of administration is reduced to 0.125-0.25 g/kg/h). In children, the rate of administration should not exceed 0.5 g/kg/day; which for a 5% solution is about 10 ml/min - 200 drops/min (20 drops = 1 ml). In cases of severe dehydration, it is possible to administer 3-5 liters of isotonic glucose solution. For diabetic patients, glucose is administered under the control of its content in the blood and urine. Side effects - hyperglycemia, ion imbalance - fever - hypervolemia, acute left ventricular failure - when the rate of administration is increased - osmotic diuresis with loss of water, electrolytes and the development of hyperosmolar coma - at the injection site - development of infection, thrombophlebitis - depletion of the insular apparatus of the pancreas Contraindications - hypersensitivity - hyperglycemia - hyperlacticacidemia - hyperhydration - postoperative disorders of glucose utilization - cerebral edema - pulmonary edema - acute left ventricular failure - hyperosmolar coma With caution - decompensated chronic heart failure - diabetes mellitus under control of blood sugar levels - chronic renal failure (oligo-, anuria ) - hyponatremia Drug interactions Glucose solutions should not be mixed with alkaloids (they decompose) or with general anesthetics (decreased activity). Glucose weakens the effect of analgesics and adrenomimetic drugs. When combining with other drugs, it is necessary to visually monitor compatibility (invisible chemical or therapeutic incompatibility is possible). Glucose is incompatible in solutions with aminophylline, soluble barbiturates, hydrocortisone, kanamycin, soluble sulfonamides, cyanocobalamin. Due to the fact that glucose is a fairly strong oxidizing agent, it should not be administered in the same syringe with hexamethylenetetramine. Do not use in the same system simultaneously, before or after blood transfusion due to the possibility of pseudoagglutination. When used simultaneously with thiazide diuretics and furosemide, their ability to influence the level of glucose in the blood serum should be taken into account. Insulin promotes the entry of glucose into peripheral tissues. Glucose solution reduces the toxic effect of pyrazinamide on the liver. The administration of a large volume of glucose solution contributes to the development of hypokalemia, which increases the toxicity of simultaneously taken digitalis preparations. Glucose solution is incompatible with the following combinations: - bevacizumab - benfotiamine + pyridoxine - cladribine - causes increased degradation of cladribine - pyridoxine + thiamine + cyanocobalamin + [lidocaine] - thioctic acid A solution of iron (III)-dextran hydroxide can be mixed with a 5% dextrose solution. Linezolid solution for infusion is compatible with 5% dextrose solution. Special instructions For more complete and rapid absorption of glucose, you can administer 4-5 units of short-acting insulin per 4-5 g of glucose subcutaneously. When administering glucose solutions, monitoring of electrolyte balance and glucose levels in the blood and urine is necessary. With repeated administration of the solution, disturbances in the functional state of the liver and depletion of the insular apparatus of the pancreas are possible. For diabetic patients, glucose is administered with caution, under the control of sugar levels in the blood and urine. To increase osmolarity, a 5% glucose solution can be combined with a 0.9% sodium chloride solution. Pregnancy and lactation The use of the drug during pregnancy and lactation is possible only when the expected benefit to the mother outweighs the potential risk to the fetus (adequate and strictly controlled studies have not been conducted). Peculiarities of the drug's influence on the ability to drive a vehicle or operate potentially dangerous machinery. The drug does not affect the ability to drive a vehicle or operate potentially dangerous machinery. Overdose Symptoms: hyperglycemia, glycosuria, hyperglycemic hyperosmolar coma, hyperhydration, water-electrolyte imbalance, increased liponeogenesis with increased production of carbon dioxide, which leads to a sharp increase in minute tidal volume, and, as a consequence, respiratory rate; fatty infiltration of the liver. Treatment: stop administering glucose, administer short-acting insulin, symptomatic therapy. Release form and packaging Solution for infusion 5%, 10%. 200 ml and 400 ml of the drug in glass bottles for blood, transfusion and infusion drugs with a capacity of 250 ml and 450 ml, respectively, sealed with rubber stoppers and crimped with aluminum caps. A label made from label or writing paper or self-adhesive paper is placed on each bottle. 24, 28 bottles of 200 ml or 12, 15 bottles of 400 ml with an equal number of instructions for use in the state and Russian languages are placed in corrugated cardboard boxes with gaskets and grids (for hospitals). Storage conditions Store at temperatures from 5 °C to 30 °C. Keep out of the reach of children! Freezing the drug, provided the bottle remains sealed, is not a contraindication to its use. Non-wetting of the inner surface of the bottle is not a contraindication to the use of the drug. Shelf life 3 years. Do not use after the expiration date. Conditions for dispensing from pharmacies By prescription. , Russian Federation. 440033, Penza, st. Druzhby, 4, tel/fax e-mail Name and country of the owner of the registration certificate JSC Biosintez, Russian Federation. Address of the organization that accepts claims from consumers on the quality of products (products) on the territory of the Republic of Kazakhstan: JSC Biosintez, Russian Federation 440033, Penza, st. Druzhby, 4, tel/fax e-mail

Glucose solution d/inf 5% 200ml

Compound

Per 1 ml: Active ingredient: Dextrose (glucose) monohydrate in terms of dextrose 0.05; 0.1; 0.2; 0.4 g Excipients: Sodium chloride 0.00026 g 0.1 M hydrochloric acid solution to pH 3.0-4.1 Water for injection up to 1 ml Theoretical osmolarity 277; 555; 1110; 2220 mOsm/l

Pharmacokinetics

Glucose is metabolized in two different ways: anaerobic and aerobic. Dextrose, breaking down into pyruvic or lactic acid (anaerobic glycolysis), is metabolized to carbon dioxide and water, releasing energy. When using a dextrose solution to dilute and dissolve parenterally administered drugs, the pharmacokinetic properties of the solution will depend on the substance added.

Indications for use

5% glucose solution: - as a source of carbohydrates (separately or as part of parenteral nutrition if necessary); - for rehydration in case of fluid loss, especially in patients with a high need for carbohydrates; — for dilution and dissolution of parenterally administered drugs. 10% glucose solution: - as a source of carbohydrates (separately or as part of parenteral nutrition if necessary); - for rehydration in case of fluid loss, especially in patients with a high need for carbohydrates; — for dilution and dissolution of parenterally administered drugs; - for the prevention and treatment of hypoglycemia. 20% and 40% glucose solutions: - as a source of carbohydrates (separately or as part of parenteral nutrition if necessary), especially in cases where it is necessary to limit fluid intake; - hypoglycemia.

Contraindications

Isotonic glucose solution 5%: decompensated diabetes mellitus; other known forms of glucose intolerance (eg metabolic stress); hyperosmolar coma; hyperglycemia and hyperlactatemia; administration of the solution during the first 24 hours after head injury; hypersensitivity to the components of the drug; use in patients with a known intolerance to corn or corn products (when receiving dextrose from corn); contraindications to any drugs added to a glucose solution. Hypertonic glucose solution 10%: decompensated diabetes mellitus and diabetes insipidus; other known forms of glucose intolerance (eg metabolic stress); hyperosmolar coma; hyperglycemia, hyperlactatemia; hemodilution and extracellular hyperhydration or hypervolemia; severe renal failure (with oliguria or anuria); decompensated heart failure; generalized edema (including pulmonary and cerebral edema) and cirrhosis of the liver with ascites; administration of the solution during the first 24 hours after head injury; hypersensitivity to the components of the drug; use in patients with a known intolerance to corn or corn products (when receiving dextrose from corn); contraindications to any drugs added to a glucose solution. Hypertonic glucose solutions 20% and 40% (additionally): intracranial hemorrhage and hemorrhage in the spinal cord, childhood (for solutions over 20%).

With caution: Diabetes mellitus, intracranial hypertension, hyponatremia, childhood.

Directions for use and doses

Intravenously (drip). The drug is usually administered into a peripheral or central vein. The concentration and dose of the administered solution depend on the age, body weight and clinical condition of the patient. The use of the drug should be carried out under regular medical supervision. Clinical and biological parameters should be carefully monitored, in particular blood glucose concentrations, as well as water and electrolyte balance. In adults with normal metabolism, the daily dose of administered glucose should not exceed 4-6 g/kg, i.e. about 250-450 g (with a decrease in metabolic rate, the daily dose is reduced to 200-300 g), while the daily volume of administered fluid is 30-40 ml/kg. For parenteral nutrition, along with fats and amino acids, children are given 6 g of glucose/kg/day on the first day, and subsequently up to 15 g/kg/day. Rate of administration: in a normal metabolic state, the maximum rate of administration for adults is 0.25-0.5 g/kg/h (with a decrease in metabolic rate, the rate of administration is reduced to 0.125-0.25 g/kg/h). In children, the rate of glucose administration should not exceed 0.5 g/kg/h. To ensure complete absorption of dextrose administered in large doses, short-acting insulin is simultaneously prescribed at the rate of 1 unit of insulin per 4-5 g of dextrose. With total parenteral nutrition, the administration of glucose should always be accompanied by the introduction of a sufficient amount of amino acid solutions, an emulsion of lipids, electrolytes, vitamins and microelements. For patients with diabetes mellitus, glucose is administered under the control of its content in the blood and urine. 5% glucose solution: Recommended dose as a source of carbohydrate (alone or as part of parenteral nutrition if necessary): 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 + additional 50 ml for each kg of body weight over 10 kg per day; - with body weight over 20 kg - 1500 ml + additional 20 ml for each kg of body weight over 20 kg per day. The rate and volume of infusion depend on the age, body weight, clinical condition and metabolism of the patient, as well as concomitant therapy. In children, they should be determined by the attending physician who has experience in the use of intravenous drugs in this category of patients. The threshold for glucose utilization in the body must not be exceeded in order 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 when used for dilution and dissolution of parenterally administered drugs is usually 50-250 ml per dose of the administered drug, but the required volume should be determined based on the instructions for use of the added drugs. In this case, the dose and rate of administration of the solution are determined by the properties and dosage regimen of the diluted drug. 10% Glucose Solution: Adults and Elderly The recommended doses in Table 1 serve as a guideline for use in adults weighing approximately 70 kg.

Note: Maximum volumes within recommended doses should be administered within 24 hours to avoid hemodilution. The maximum infusion rate should not exceed the threshold for glucose utilization in the patient's body, as this may lead to hyperglycemia. Depending on the patient's clinical condition, the rate of administration may be reduced to reduce the risk of osmotic diuresis. When using the drug for diluting and dissolving medications for infusion, the required volume is determined based on the instructions for use of the added medications. 20% glucose solution: Administration of 20% glucose solution is carried out only through the central vein. The rate of solution administration is up to 30-40 drops/min (1.5-2 ml/min). The maximum daily dose for adults is 500 ml. 40% glucose solution: The use of the drug should be carried out under regular medical supervision. The dosage regimen depends on the age, weight and clinical condition of the patient. Clinical and biological parameters should be carefully monitored, in particular blood glucose concentrations, electrolytes and fluid balance. A 40% glucose solution is administered intravenously at a rate of up to 30 drops/min (1.5 ml/min). The maximum daily dose for adults is 250 ml. After achieving the required concentration of glucose in the blood, the patient is transferred to the administration of 5% or 10% glucose solutions.

Storage conditions

At temperatures from 5 to 30 °C. Keep out of the reach of children.

Best before date

3 years. Do not use after expiration date.

special instructions

Since glucose (dextrose) tolerance may be impaired in patients with diabetes mellitus, renal failure, or those in acute critical condition, their clinical and biological parameters should be especially carefully monitored, in particular the concentration of electrolytes in the blood plasma, including magnesium or phosphorus, blood glucose concentration. If hyperglycemia is present, the rate of drug administration should be adjusted or short-acting insulin should be prescribed. Typically, glucose is completely absorbed by the body (normally it is 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 concentration of potassium in the blood plasma and, if necessary, administer additional potassium to avoid hypokalemia. During episodes of intracranial hypertension, careful monitoring of blood glucose concentrations 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 brain damage and impedes recovery. Particularly careful clinical monitoring is required when starting 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, water balance, as well as the acid-base state of the body. The solution should be inspected before use. Use only a clear solution without visible inclusions and if the packaging is not damaged. Administer immediately after connecting to the infusion system. The solution should be administered using sterile equipment in compliance with the rules of asepsis and antisepsis. To avoid air embolism, remove air from the infusion system using a solution. Do not connect containers in series to avoid air embolism, which may occur due to air being drawn in from the first container before the solution is administered from the second container. Delivering intravenous solutions contained in soft plastic containers under increased pressure to increase the flow rate may result in air embolism if residual air in the container is not completely removed before administration. The use of an IV system with a gas outlet may result in an air embolism if the gas outlet is open. Soft plastic containers should not be used with these systems. Added substances can be administered before infusion or during infusion through the injection site (if there is a special port for drug administration). Adding other drugs to the solution or violating the administration technique may cause fever due to the possible entry of pyrogens into the body. If adverse reactions develop, the infusion should be stopped immediately. When adding other drugs before parenteral administration, it is necessary to check the isotonicity of the resulting solution. Complete and thorough mixing under aseptic conditions is mandatory. Solutions containing additional substances should be used immediately; their storage is prohibited. If additional nutrients are administered, the osmolarity of the resulting mixture should be determined before infusion. The resulting mixture must be administered through a central or peripheral venous catheter depending on the final osmolarity. The compatibility of additionally administered drugs must be assessed before adding them to the solution (similar to the use of other parenteral solutions). Assessing the compatibility of additionally administered drugs with the drug is the responsibility of the physician. It is necessary to check the resulting solution for changes in color and/or the appearance of sediment, insoluble complexes or crystals. You should study the instructions for use of the added medications. From a microbiological point of view, the diluted drug should be used immediately. The exception is dilutions prepared under controlled and aseptic conditions. After preparing the solution, the timing and conditions of its storage before administration are the responsibility of the user and should be no more than 24 hours at a temperature of 2 to 8 ° C. Children Newborns, especially those born prematurely or with low birth weight, have an increased risk of developing hypo- or hyperglycemia Therefore, during the period of intravenous administration of dextrose solutions, careful monitoring of blood glucose concentration is necessary to avoid long-term undesirable consequences. Hypoglycemia in newborns can lead to prolonged seizures, coma, and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, delayed bacterial and fungal infections, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged hospitalization, and mortality. To avoid potentially fatal overdose of intravenous drugs in neonates, special attention must be paid to the route of administration. When using a syringe pump for intravenous administration of drugs to newborns, the container with the solution should not be left attached to the syringe. When using an infusion pump, all clamps on the system must be closed before removing the system from the pump or turning it off, regardless of whether there is a device in the system that prevents the free flow of fluid. IV infusion devices and other drug administration equipment should be monitored regularly. If the drug contains dextrose derived from corn, the drug is contraindicated in patients with a known intolerance to corn or corn products, because The following manifestations of hypersensitivity are possible: anaphylactic reactions, chills and fever. For containerized products: Containers should be discarded after a single use. Any unused dose should be discarded. Do not reconnect partially used containers.

Description

5% and 10% solutions: clear, colorless liquid. 20% and 40% solutions: transparent, colorless to light yellow liquid.

Conditions for dispensing from pharmacies

On prescription

Dosage form

Solution for infusion

Use in children

Children and Adolescents: The rate and volume of infusion depend on the age, body weight, clinical condition and metabolism of the patient, as well as concomitant therapy. They should be determined by a physician experienced in the use of intravenous drugs in children.

Manufacturer and organization accepting consumer complaints

Limited Liability Company "Grotex" (LLC "Grotex")

Pharmacodynamics

Glucose enhances redox processes in the body, improves the antitoxic function of the liver, enhances the contractile activity of the myocardium, and is a source of easily digestible carbohydrates. The pharmacodynamic properties of 5%, 10%, 20% and 40% dextrose solutions are similar to the properties of glucose, the main source of energy in cellular metabolism. 5% dextrose solution is an isotopic solution with an osmolarity of approximately 277 mOsm/L. The caloric intake of a 5% dextrose solution is 200 kcal/l. 10% dextrose solution is a hypertonic solution with an osmolarity of approximately 555 mOsm/L. The caloric intake of a 10% dextrose solution is 400 kcal/l. 20% dextrose solution is a hypertonic solution with an osmolarity of approximately 1110 mOsm/L. The caloric intake of a 20% dextrose solution is 680 kcal/l. 40% dextrose solution is a hypertonic solution with an osmolarity of approximately 2220 mOsm/L. The caloric intake of a 40% dextrose solution is 1360 kcal/l. As part of parenteral nutrition, 5%, 10%, 20%, and 40% dextrose solutions are administered as a source of carbohydrate (alone or as part of parenteral nutrition as needed). 5% and 10% dextrose solutions allow you to replenish fluid deficiency without the simultaneous administration of ions. A 20% dextrose solution provides the maximum amount of calories in a minimum volume of liquid. A 40% dextrose solution allows you to restore the concentration of glucose in the blood during hypoglycemia with the introduction of a minimal amount of liquid, increases the osmotic pressure of the blood, and increases diuresis. Dextrose, entering tissues, is phosphorylated, turning into glucose-6-phosphate, which is actively involved in many parts of the body's metabolism. When using dextrose solutions to dilute and dissolve parenterally administered drugs, the pharmacodynamic properties of the solution will depend on the substance added.

Side effects

Adverse reactions (HP) are grouped by systems and organs in accordance with the MedDRA dictionary and the WHO classification of the incidence of HP development: very often (? 1/10), often (? 1/100 to <1/10), infrequently (? 1/1000 to <1/100), rare (? 1/10000 to <1/1000), very rare (<1/10000), frequency unknown - (frequency cannot be determined based on available data). From the immune system Frequency unknown: anaphylactic reactions, hypersensitivity. Metabolic and nutritional disorders Frequency unknown: water and electrolyte imbalance (hypokalemia, hypomagnesemia and hypophosphatemia), hyperglycemia, hemodilution, dehydration, hypervolemia. Vascular disorders Frequency unknown: venous thrombosis, phlebitis. From the skin and subcutaneous tissues Frequency unknown: increased sweating. From the kidneys and urinary tract Frequency unknown: polyuria. General and injection site disorders Not known: chills, fever, injection site infection, injection site irritation, extravasation, injection site tenderness. Laboratory and instrumental data Frequency unknown: glycosuria. Adverse reactions may also be related to the drug that was added to the solution. The likelihood of other adverse reactions depends on the properties of the specific drug added. If undesirable reactions occur, administration of the solution should be stopped.

Use during pregnancy and breastfeeding

Dextrose solution 5% is commonly used during pregnancy as a hydration agent and as a vehicle for other medications (particularly oxytocin). Dextrose solution 5% and 10% can be used safely during pregnancy and breastfeeding, provided that electrolyte and fluid balance are monitored and within physiological limits. If a woman in labor is given intravenous glucose, the concentration of glucose in her blood should not exceed 11 mmol/l. Try not to interrupt feeding during the infusion. Prescription of 20% and 40% dextrose solutions during pregnancy and breastfeeding is possible only as prescribed and under the supervision of a physician if the expected benefit to the mother outweighs the potential risk to the fetus or infant. If dextrose solution is added to a medicinal product, the properties of the medicinal product and its use during pregnancy and breastfeeding are considered separately.

Interaction

The combined use of catecholamines and steroids reduces the absorption of dextrose (glucose). When mixed with other drugs, they must be visually monitored for incompatibility. For dilution or dissolution of other drugs, the drug should be used only if there are instructions for dilution with dextrose solution in the instructions for use for this drug. In the absence of information on compatibility, the drug should not be mixed with other drugs. Before adding any drug, it must be ensured that it is soluble and stable in water within the pH range of the drug. After adding a compatible drug to the preparation, the resulting solution should be administered immediately. Medicines with known incompatibility should not be used. When administering dextrose solutions through the same infusion system as for blood transfusion, there is a possible risk of hemolysis and thrombosis.

Overdose

Symptoms.

Long-term infusion of the drug can lead to hyperglycemia, glycosuria, 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 infusion can cause hyperglycemia. There may also be a decrease in potassium and inorganic phosphate in the blood plasma. When dextrose infusion solution is used to dilute and dissolve other intravenous drugs, clinical signs and symptoms of overdose may be related to the properties of the drugs used.

Treatment.

If symptoms of overdose appear, the administration of the solution should be suspended, the patient's condition assessed, short-acting insulin administered, and, if necessary, supportive symptomatic therapy.

Impact on the ability to drive vehicles and operate machinery

Not applicable (due to the use of the drug exclusively in a hospital setting).