Glycosteryl f10
Ukraine
Table of Contents
INSTRUCTIONS for medical use of the medicinal product GLYCOSTERIL F10 (Glycosteril F10)
Composition:
Active substances: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, fructose;
100 ml of solution contain: sodium chloride – 0.8 g; potassium chloride – 0.0298 g; calcium chloride dihydrate – 0.0242 g; magnesium chloride hexahydrate – 0.0254 g; fructose – 10 g;
Ionic composition per 1000 ml of solution: Na+ – 136.89 mmol; K+ – 4 mmol; Ca++ – 1.65 mmol;
Mg++ – 1.25 mmol; Cl– – 146.69 mmol;
Excipient: water for injections.
Pharmaceutical form. Infusion solution.
Main physicochemical characteristics: clear, colorless or slightly yellowish liquid; theoretical osmolarity – 845 mosmol/L; pH 3.0–6.0.
Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Solutions used for correction of electrolyte balance disorders. Electrolytes with carbohydrates. ATC code B05B B02.
Pharmacological properties.
Plasma-replenishing isotonic saline solution containing a balanced composition of ions necessary for the body and fructose. The medicinal product compensates for the loss of fluid, electrolytes, and partially energy, restores water-electrolyte balance. Fructose stimulates the formation of glucose and glycogen in the liver, improves glucose uptake into cells. Fructose metabolism occurs independently of insulin; therefore, blood glucose levels do not rise during its administration, which is important in the treatment of patients with diabetes mellitus. Fructose exerts a pronounced anti-ketogenic effect, has a slight diuretic action, and has a specific effect on protein metabolism manifested by sparing amino acids due to their reduced utilization in gluconeogenesis.
Clinical characteristics.
Indications. Use for partial parenteral nutrition in isotonic and hypotonic dehydration due to intractable vomiting, profuse diarrhea, intestinal obstruction, acute massive blood loss, burns, shock, collapse; to compensate carbohydrate requirements, including in diabetes mellitus and other disorders of glucose utilization, provided normal blood acid-base balance or with shifts toward alkalinity.
Contraindications. Edema, hypervolemia/hyperhydration, hypernatremia, hyperkalemia, decompensated cardiovascular insufficiency, acute renal failure, oliguria, anuria, intracranial hemorrhage, hypersensitivity to fructose and/or other components of the medicinal product, methanol intoxication, hyperlactatemia, hypertonic dehydration, metabolic acidosis.
Interaction with other medicinal products and other forms of interaction. The preparation must not be mixed with phosphate- or carbonate-containing solutions.
Sodium retention in the body may increase when used concomitantly with the following medicinal products: nonsteroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators, or ganglion blockers.
When potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, and potassium-containing preparations are used, the risk of hyperkalemia increases.
Concomitant use of the medicinal product "Glikosteril F10" and cardiac glycosides enhances the toxic effect of the latter due to the presence of Ca++ ions in the solution.
Special precautions for use.
During prolonged parenteral therapy, laboratory parameters should be monitored and clinical assessment of the patient's condition performed to monitor electrolyte concentrations and water-electrolyte balance every 6 hours (depending on the infusion rate).
Administration of intravenous solutions may lead to fluid and/or solution overload, hyperhydration, congestion, and pulmonary edema. The risk of dilutional effects is inversely proportional to the electrolyte concentration. The risk of solution overload causing congestion with peripheral edema and pulmonary edema is directly proportional to the electrolyte concentration.
If any signs of hypersensitivity reactions occur, administration of the solution must be stopped immediately and appropriate treatment initiated.
Due to the presence of sodium ions, the solution should be administered with caution to patients with arterial hypertension, cardiac and/or renal diseases, elderly patients, as well as patients with clinical conditions associated with sodium retention and edema, patients with hypoxia and hepatic insufficiency.
Solutions containing sodium should be used cautiously in patients receiving corticosteroids or corticotropin.
The potassium content requires caution when administering the solution to patients with cardiac diseases and clinical conditions associated with potassium retention.
In patients with impaired renal excretory function, administration of the solution may lead to sodium or potassium retention.
Calcium administration should be performed with consideration of electrocardiography (ECG) results, especially in patients receiving digitalis. Serum calcium levels do not always reflect tissue calcium levels.
The presence of calcium ions in the solution requires caution when co-administered with blood products due to the potential risk of coagulation.
Parenteral calcium administration requires particular attention in patients receiving cardiac glycosides.
Since each 100 mL of the preparation contains 10 g of fructose, it should be used with caution in patients with diabetes mellitus.
Prolonged use (more than 5 days) of "Glycosteryl F10" is not advisable, as it may lead to fructose-induced hyperglycemia and hypertriglyceridemia due to disturbances in lipid metabolism and reduced number of glucose transporters on the outer surfaces of cell membranes.
Use during pregnancy or breastfeeding. The medicinal product should be used during pregnancy or breastfeeding only if clearly needed and when the expected benefit to the mother outweighs the potential risk to the fetus/child.
Ability to affect reaction rate when driving or operating machinery. Data are lacking due to the exclusive use of the medicinal product under hospital conditions.
Method of Administration and Dosage
Administer intravenously to adults. The dosage regimen should be determined by a physician based on the patient's age, body weight, clinical condition, and laboratory parameters.
Infuse intravenously by drip at a rate of 2.5 mL/kg/hour, i.e., 180 mL/hour for a body weight of 70 kg. The maximum dose is 15 mL/kg/day (1.5 g of fructose/kg/day), but not more than 1000 mL/day. The maximum infusion rate is 5 mL/kg/hour, i.e., 350 mL/hour for a body weight of 70 kg.
To rapidly achieve the target catalytic concentration of fructose, a bolus infusion of 50–60 mL of "Glycosteryl F10" is required.
Maintenance of the target fructose concentration is achieved by continuous infusion of "Glycosteryl F10" at a rate of 65 to 75 mL/hour over 12–24 hours.
For preoperative preparation in emergency surgical cases, administer "Glycosteryl F10" at a dose of 800–1200 mL in combination with colloidal and crystalloid solutions.
On the day before scheduled major surgeries in various surgical fields (abdominal, thoracic, cardiac, orthopedic and trauma surgery, oncology, neurosurgery), to prevent insulin resistance and hyperglycemia, administer 400 mL of "Glycosteryl F10" intravenously by drip infusion.
Children. Do not use in pediatric practice due to lack of clinical trials.
Overdose. Administration of excessive amounts of the solution may lead to disturbances in fluid balance, electrolytes (hypervolemia, hypernatremia, hypercalcemia, hyperchloremia), and acid-base equilibrium.
Exceeding the recommended infusion rate may result in tachycardia, increased arterial pressure, dyspnea, headache, chest pain, and abdominal pain. These symptoms usually resolve spontaneously after discontinuation or significant reduction of the infusion rate.
Adverse Reactions.
Immune system disorders: allergic reactions, including cutaneous and systemic manifestations, hyperthermia.
Cardiovascular system disorders: fluctuations in arterial pressure, edema, tachycardia.
Fluid and electrolyte imbalance: during massive infusion therapy, disturbances in electrolyte metabolism (potassium, calcium, sodium, chloride), lactic acidosis, and hyperhydration may occur.
Shelf life. 2 years.
Storage conditions. Store at a temperature not exceeding 25 °C in a place inaccessible to children.
Incompatibility. The drug must not be mixed with phosphate- or carbonate-containing solutions.
Packaging. 250 ml, 500 ml in polymer bags placed into transparent plastic bags.
Prescription category. Prescription only.
Manufacturer. Private Joint-Stock Company "Infuziya".
Manufacturer's location and address of business activity.
Ukraine, 23219, Vinnytsia region, Vinnytsia district, village Vinnytski Khutory, Nemyrivske Highway, bld. 84A.
INSTRUCTION
for medical use of medicinal product
GLYCOSTERIL F10
(Glycosteril F10)
Composition:
Active substances: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, fructose;
100 ml of solution contains: sodium chloride – 0.8 g; potassium chloride – 0.0298 g; calcium chloride dihydrate – 0.0242 g; magnesium chloride hexahydrate – 0.0254 g; fructose – 10 g;
Ionic composition per 1000 ml of solution: Na+ – 136.89 mmol; K+ – 4 mmol; Ca2+ – 1.65 mmol; Mg2+ – 1.25 mmol; Cl− – 146.69 mmol;
Excipient: water for injections.
Pharmaceutical form. Infusion solution.
Main physicochemical properties: transparent, colorless or slightly yellowish liquid; theoretical osmolarity – 845 mosmol/L; pH 3.0–6.0.
Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Solutions used to correct electrolyte imbalances. Electrolytes with carbohydrates. ATC code B05B B02.
Pharmacological properties.
An isotonic plasma-replacing saline solution containing a balanced composition of essential ions and fructose. The medicinal product compensates for fluid and electrolyte loss and partially for energy, restoring water-electrolyte balance. Fructose stimulates glucose and glycogen formation in the liver and improves glucose uptake into cells. Fructose metabolism occurs independently of insulin; its use does not increase blood glucose levels, which is important in the treatment of diabetic patients. Fructose exerts a pronounced anti-ketogenic effect, has a slight diuretic action, and has a specific effect on protein metabolism manifested by preservation of amino acids due to their reduced utilization in gluconeogenesis.
Clinical characteristics.
Indications. For use in partial parenteral nutrition in isotonic and hypotonic dehydration due to intractable vomiting, profuse diarrhea, intestinal obstruction, acute massive blood loss, burns, shock, and collapse; to compensate carbohydrate requirements, including in diabetes mellitus and other disorders of glucose utilization, provided normal acid-base balance or shifts toward alkalosis.
Contraindications. Edema, hypervolemia/hyperhydration, hypernatremia, hyperkalemia, decompensated cardiovascular insufficiency, acute renal failure, oliguria, anuria, intracerebral hemorrhage, hypersensitivity to fructose and/or other components of the medicinal product, methanol intoxication, hyperlactatemia, hypertonic dehydration, metabolic acidosis.
Interaction with other medicinal products and other types of interactions.
The drug must not be mixed with phosphate- or carbonate-containing solutions.
Concomitant use of nonsteroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators, or ganglion blockers may increase sodium retention in the body.
Concomitant use of potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, and potassium-containing preparations increases the risk of hyperkalemia.
Concomitant administration of Glycosteril F10 and cardiac glycosides enhances the toxicity of the latter due to the presence of Ca2+ ions in the solution.
Special precautions. During prolonged parenteral therapy, laboratory parameters and clinical status of the patient must be monitored to assess electrolyte concentrations and fluid-electrolyte balance every 6 hours (depending on the infusion rate).
Intravenous solutions may cause fluid and/or solution overload, hyperhydration, congestion, and pulmonary edema. The risk of dilution is inversely proportional to the electrolyte concentration. The risk of solution overload leading to congestion with peripheral edema and pulmonary edema is directly proportional to the electrolyte concentration.
If any signs of hypersensitivity reactions occur, infusion must be stopped immediately and appropriate treatment initiated.
Due to sodium ion content, the solution must be used with caution in patients with arterial hypertension, heart and/or kidney diseases, elderly patients, patients with clinical conditions associated with sodium retention and edema, patients with hypoxia, and those with hepatic insufficiency.
Solutions containing sodium must be used cautiously in patients receiving corticosteroids or corticotropin.
Potassium content requires caution when administering the solution to patients with heart diseases and clinical conditions associated with potassium retention in the body.
In patients with impaired renal excretory function, administration of the solution may lead to sodium or potassium retention.
Calcium administration must be performed considering electrocardiography (ECG) results, especially in patients receiving digitalis. Serum calcium levels do not always reflect tissue calcium levels.
The presence of calcium ions in the solution requires caution when co-administered with blood products due to the risk of coagulation.
Parenteral calcium administration requires special attention in patients receiving cardiac glycosides.
Since each 100 ml of the drug contains 10 g of fructose, it must be used cautiously in diabetic patients.
Prolonged use (more than 5 days) of Glycosteril F10 is not advisable, as it may cause fructose-induced hyperglycemia and hypertriglyceridemia due to lipid metabolism disorders and reduced number of glucose transporters on the outer surfaces of cell membranes.
Use during pregnancy or breastfeeding. The medicinal product should be used during pregnancy or breastfeeding only when strictly indicated and when the expected benefit to the mother outweighs the potential risk to the fetus/child.
Effect on the ability to drive or operate machinery. Data are unavailable due to the exclusive use of the medicinal product in a hospital setting.
Administration and dosage. Administer intravenously to adults. The dosing regimen is determined by the physician based on age, body weight, clinical condition, and laboratory parameters. Administer intravenously by drip infusion at a rate of 2.5 ml/kg/h, i.e., 180 ml/h for a body weight of 70 kg. Maximum dose – 15 ml/kg/day (1.5 g fructose/kg/day), but not exceeding 1000 ml/day. Maximum infusion rate – 5 ml/kg/h, i.e., 350 ml/h for a body weight of 70 kg.
To rapidly achieve target catalytic fructose concentration, perform a bolus infusion of 50–60 ml of Glycosteril F10.
Maintenance of target fructose concentration is achieved by infusing Glycosteril F10 at a rate of 65–75 ml/h over 12–24 hours.
For preoperative preparation in emergency cases, administer 800–1200 ml of Glycosteril F10 in combination with colloidal and crystalloid solutions.
On the eve of major elective surgeries in various surgical fields (abdominal, thoracic, cardiac, orthopedic and trauma surgery, oncology, neurosurgery), to prevent insulin resistance and hyperglycemia, administer 400 ml of Glycosteril F10 intravenously by drip infusion.
Children. Not recommended for use in pediatrics due to lack of clinical studies.
Overdose. Administration of excessive amounts of the solution may lead to disturbances in fluid, electrolyte (hypervolemia, hypernatremia, hypercalcemia, hyperchloremia), and acid-base balance.
Exceeding the recommended infusion rate may cause tachycardia, increased arterial pressure, dyspnea, headache, substernal pain, and abdominal pain. These symptoms resolve rapidly after cessation or significant reduction of the infusion rate.
Adverse reactions.
Immune system disorders: allergic reactions, including cutaneous and systemic manifestations, hyperthermia.
Cardiovascular system disorders: fluctuations in arterial pressure, edema, tachycardia.
Fluid and electrolyte imbalance: during massive infusion therapy, disturbances in electrolyte metabolism (potassium, calcium, sodium, chloride), lactic acidosis, and hyperhydration may occur.
Shelf life. 2 years.
Storage conditions. Store at a temperature not exceeding 25 °C in a place inaccessible to children.
Incompatibility. The drug must not be mixed with phosphate- or carbonate-containing solutions.
Packaging. 250 ml, 500 ml in polymer bags placed into transparent plastic bags.
Prescription category. Prescription only.
Manufacturer. Private Joint-Stock Company "Infuziya".
Manufacturer's location and address of business activity.
Ukraine, 23219, Vinnytsia region, Vinnytsia district, village Vinnytski Khutory, Nemyrivske Highway, bld. 84A.