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Glycosteril

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GLICOSTERIL F5 solution for infusion

Instruction manual

For medical use of the drug

Glycosteril f5

(glucosteril f5)

Structure:

Active ingredients: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, fructose;

100 ml of the 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 - 5 g;

ionic composition per 1000 ml of solution: Na+136.89 mmol; TO+- 4 mmol; Sa++- 1.65 mmol;

Mg++- 1.25 mmol; Cl- 146.69 mmol;

excipient: water for injection.

Dosage form.

Solution for infusion.

Basic physical and chemical properties: transparent, colorless or slightly yellowish liquid; theoretical osmolarity - 568 mosmol / l; pH 3.0-6.0.

Pharmacotherapeutic group.

Blood substitutes and perfusion solutions. solutions used to correct electrolyte imbalance. electrolytes with carbohydrates. code atx v05v v02.

Pharmacological properties.

Plasma substituting isotonic saline solution containing a balanced composition of ions and fructose necessary for the body. the drug compensates for the loss of fluid, electrolytes and partly - energy, restores the water-salt balance. fructose stimulates the formation of glucose and glycogen in the liver, improves the flow of glucose into the cells. fructose metabolism is carried out independently of insulin, with its use the level of glucose in the blood does not increase, which is important in the treatment of patients with diabetes mellitus. fructose has a pronounced antiketogenic effect, has a slight diuretic effect, has a specific effect on protein metabolism, which manifests itself in the conservation of amino acids due to their lesser use in gluconeogenesis.

Clinical characteristics.

Indications.

For primary plasma replacement in case of blood loss and burns; iso- and hypotonic dehydration due to irrepressible vomiting, profuse diarrhea, intestinal obstruction, peritonitis; to partially compensate for the need for carbohydrates, including as part of complex therapy for patients with diabetes mellitus and other disorders of glucose utilization, under the condition of normal acid-base balance of the blood or when it shifts to the alkaline side.

Contraindications

Edema, hypervolemia / hyperhydration, hypernatremia, hyperkalemia, decompensated cardiovascular failure, acute renal failure, oliguria, anuria, cerebral hemorrhage, hypersensitivity to fructose and / or other components of the drug, methanol intoxication, hyperlacticemia, hyperlactemia, hyperlactemia, and hyperlactemia, hypertactemia, and hyperlactemia, hypertactemia, and hyperlactemia, hypertactemia, and hyperlactemia.

Interaction with other drugs and other types of interactions.

The drug should not be mixed with phosphate and carbonate solutions.

It is possible to increase sodium retention in the body while using such drugs: non-steroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators or ganglion blockers.

When using potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors and potassium preparations, the risk of developing hyperkalemia is increased.

With the simultaneous use of the drug "Glycosteryl F5" and cardiac glycosides, the toxic effect of the latter is enhanced due to the presence of Ca ions in the solution++.

Features of the application.

During long-term parenteral therapy, it is necessary to determine laboratory parameters and give a clinical assessment of the patients condition to monitor the concentration of electrolytes and water-electrolyte balance every 6 hours (depending on the rate of infusion).

The use of intravenous solutions can cause overloading with a liquid and / or solution, hyperhydration, congestion and pulmonary edema. The risk of dilution develops inversely with the concentration of electrolytes. The risk of developing an overload with a solution that causes congestion with peripheral edema and pulmonary edema is directly proportional to the concentration of electrolytes.

In case of any manifestations of a hypersensitivity reaction, immediately stop the solution and conduct the necessary treatment.

Due to the content of sodium ions, the solution should be used with caution in patients with arterial hypertension, with heart and / or kidney diseases, elderly patients, as well as patients with clinical conditions accompanied by sodium retention and edema, patients with hypoxia and liver failure.

Solutions containing sodium should be used with caution in patients who receive corticosteroids or corticotropin.

Potassium content requires caution when applying the solution to patients with heart diseases and clinical conditions, accompanied by a delay in potassium in the body.

In patients with reduced renal excretory function, the use of a solution can lead to a delay in sodium or potassium.

The appointment of calcium should be carried out taking into account the results of electrocardiography (ECG), especially for patients who use digitalis. Serum calcium levels do not always reflect tissue levels of calcium.

The presence of calcium ions in the solution requires caution when administered simultaneously with blood products because of the likelihood of developing coagulation.

Parenteral administration of calcium is necessary with particular attention to patients who receive cardiac glycosides.

Since every 100 ml of the drug contains 5 g of fructose, use with caution in patients with diabetes.

Long-term use (more than 5 days) of Glycosteril F5 is not practical, since this can be the cause of fructose-induced hyperglycemia and hypertriglyceridemia due to lipid metabolism disorders and a decrease in the number of glucose transporters on the outer surfaces of cell membranes.

Use during pregnancy or lactation.

The drug should be used during pregnancy or lactation only for health reasons in cases where the expected benefit of treatment for the mother prevails over the possible risk to the fetus / child.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Data are not available due to the use of the drug exclusively in a hospital setting.

Dosage and administration.

Assign to adults intravenously. The dosage regimen is prescribed by the doctor depending on the age, body weight, clinical condition of the patient and laboratory parameters. administered intravenously at a rate of 3 ml / kg / h, i.e. 210 ml / h with a body weight of 70 kg. the maximum dose is 30 ml / kg / day (1.5 g fructose / kg / day), but not more than 2000 ml / day. the maximum infusion rate is 5 ml / kg / h, i.e. 350 ml / h with a body weight of 70 kg.

To quickly obtain the target catalytic concentration of fructose, it is necessary to carry out a jet infusion of 100–120 ml of Glycosteril F5.

Maintaining the target concentration of fructose is achieved by infusion of "Glycosteril F5" from 120 to 150 ml / h for 12-24 hours.

To prepare patients before surgery for urgent indications, “Glycosteril F5” should be used in a dose of 800–1200 ml in combination with colloidal and crystalloid solutions.

Children.

Do not use in pediatrics due to lack of clinical studies.

Overdose.

The introduction of too much solution can lead to imbalance in the fluid, electrolytes (hypervolemia, hypernatremia, hypercalcemia, hyperchloremia) and acid-base balance.

If the recommended rate of administration is exceeded, tachycardia, increased blood pressure, shortness of breath, headache, chest pain, and abdominal pain are possible. These symptoms quickly disappear on their own after the cessation or a significant decrease in the rate of administration of the solution.

Adverse Reactions

From the immune system: allergic reactions, including skin and systemic manifestations, hyperthermia.

From the cardiovascular system: fluctuations in blood pressure, edema, tachycardia.

Violations of the water-electrolyte balance: during massive infusion therapy, there may be a violation of the exchange of electrolytes (potassium, calcium, sodium, chlorine), lactic acidosis, hyperhydration.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 ° C out of the reach of children.

Incompatibility.

The drug should not be mixed with phosphate and carbonate solutions.

Packaging.

200 ml, 250 ml, 400 ml, 500 ml in bottles or 250 ml, 500 ml in polymer bags, which are placed in a transparent plastic bag.

Vacation category.

On prescription.

Manufacturer.

Private joint-stock company "infusion".

The location of the manufacturer and the address of the place of business.

Ukraine, 23219, Vinnitsa region, Vinnitsa district, s. Vinnytsia farms, st. Nemirovskoe highway, 84a.

GLICOSTERIL F10 solution for infusion

Instruction manual

For medical use of the drug

Glycosteril f10

(glucosterilf10)

Structure:

Active ingredients: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, fructose;

100 ml of the 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; TO+- 4 mmol; Sa++- 1.65 mmol;

Mg++- 1.25 mmol; Cl- 146.69 mmol;

excipient: water for injection.

Dosage form.

Solution for infusion.

Basic physical and chemical properties: transparent, colorless or slightly yellowish liquid; theoretical osmolarity - 845 mosmol / l; pH 3.0-6.0.

Pharmacotherapeutic group.

Blood substitutes and perfusion solutions. solutions used to correct electrolyte imbalance. electrolytes with carbohydrates. code atx v05v v02.

Pharmacological properties.

Plasma substituting isotonic saline solution containing a balanced composition of ions and fructose necessary for the body. the drug compensates for the loss of fluid, electrolytes and partly - energy, restores the water-salt balance. fructose stimulates the formation of glucose and glycogen in the liver, improves the flow of glucose into the cells. fructose metabolism is carried out independently of insulin, with its use the level of glucose in the blood does not increase, which is important in the treatment of patients with diabetes mellitus. fructose has a pronounced antiketogenic effect, has a slight diuretic effect, has a specific effect on protein metabolism, which manifests itself in the conservation of amino acids due to their lesser use in gluconeogenesis.

Clinical characteristics.

Indications.

Use for partial parenteral nutrition in case of iso- and hypotonic dehydration due to irrepressible vomiting, profuse diarrhea, intestinal obstruction, acute massive blood loss, burns, shock, collapse; to compensate for the need for carbohydrates, including diabetes mellitus and other disorders of glucose utilization, subject to normal acid-base balance of the blood or when it shifts to the alkaline side.

Contraindications

Edema, hypervolemia / hyperhydration, hypernatremia, hyperkalemia, decompensated cardiovascular failure, acute renal failure, oliguria, anuria, cerebral hemorrhage, hypersensitivity to fructose and / or other components of the drug, methanol intoxication, hyperlacticemia, hyperlactemia, hyperlactemia, and hyperlactemia, hypertactemia, and hyperlactemia, hypertactemia, and hyperlactemia, hypertactemia, and hyperlactemia.

Interaction with other drugs and other types of interactions.

The drug should not be mixed with phosphate and carbonate solutions.

It is possible to increase sodium retention in the body while using such drugs: non-steroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators or ganglion blockers.

When using potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors and potassium preparations, the risk of developing hyperkalemia is increased.

With the simultaneous use of the drug "Glycosteryl F10" and cardiac glycosides, the toxic effect of the latter is enhanced due to the presence of Ca ions in the solution++.

Features of the application.

During long-term parenteral therapy, it is necessary to determine laboratory parameters and give a clinical assessment of the patients condition to monitor the concentration of electrolytes and water-electrolyte balance every 6 hours (depending on the rate of infusion).

The use of intravenous solutions can cause overloading with a liquid and / or solution, hyperhydration, congestion and pulmonary edema. The risk of dilution develops inversely with the concentration of electrolytes. The risk of developing an overload with a solution that causes congestion with peripheral edema and pulmonary edema is directly proportional to the concentration of electrolytes.

In case of any manifestations of a hypersensitivity reaction, immediately stop the solution and conduct the necessary treatment.

Due to the content of sodium ions, the solution should be used with caution in patients with arterial hypertension, with heart and / or kidney diseases, elderly patients, as well as patients with clinical conditions accompanied by sodium retention and edema, patients with hypoxia and liver failure.

Solutions containing sodium should be used with caution in patients who receive corticosteroids or corticotropin.

Potassium content requires caution when applying the solution to patients with heart diseases and clinical conditions, accompanied by a delay in potassium in the body.

In patients with reduced renal excretory function, the use of a solution can lead to a delay in sodium or potassium.

The appointment of calcium should be carried out taking into account the results of electrocardiography (ECG), especially for patients who use digitalis. Serum calcium levels do not always reflect tissue levels of calcium.

The presence of calcium ions in the solution requires caution when administered simultaneously with blood products because of the likelihood of developing coagulation.

Parenteral administration of calcium is necessary with particular attention to patients who receive cardiac glycosides.

Since every 100 ml of the drug contains 10 g of fructose, use with caution in patients with diabetes.

Prolonged use (more than 5 days) of Glycosteril F10 is not practical, since this can be the cause of fructose-induced hyperglycemia and hypertriglyceridemia due to lipid metabolism disorders and a decrease in the number of glucose transporters on the outer surfaces of cell membranes.

Use during pregnancy or lactation.

The drug should be used during pregnancy or lactation only for health reasons in cases where the expected benefit of treatment for the mother prevails over the possible risk to the fetus / child.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Data are not available due to the use of the drug exclusively in a hospital setting.

Dosage and administration.

Assign to adults intravenously. The dosage regimen is prescribed by the doctor depending on the age, body weight, clinical condition of the patient and laboratory parameters. administered intravenously at a rate of 2.5 ml / kg / h, i.e. 180 ml / h with a body weight of 70 kg.the maximum dose is 15 ml / kg / day (1.5 g fructose / kg / day), but not more than 1000 ml / day. the maximum infusion rate is 5 ml / kg / h, i.e. 350 ml / h with a body weight of 70 kg.

To quickly obtain the target catalytic concentration of fructose, it is necessary to carry out a jet infusion of 50-60 ml of Glycosteril F10.

Maintaining the target concentration of fructose is achieved by infusion of "Glycosteril F10" from 65 to 75 ml / h for 12-24 hours.

To prepare patients before surgery for urgent indications, “Glycosteril F10” should be used in a dose of 800–1200 ml in combination with colloidal and crystalloid solutions.

On the eve of large planned operations in various fields of surgery (abdominal, thoracic, cardiac surgery, orthopedics and traumatology, oncology, neurosurgery) to prevent insulin resistance and hyperglycemia, 400 ml of “Glycosteril F10” should be intravenously dripped.

Children.

do not use in pediatrics due to lack of clinical studies.

Overdose.

The introduction of too much solution can lead to imbalance in the fluid, electrolytes (hypervolemia, hypernatremia, hypercalcemia, hyperchloremia) and acid-base balance.

If the recommended rate of administration is exceeded, tachycardia, increased blood pressure, shortness of breath, headache, chest pain, and abdominal pain are possible. These symptoms quickly disappear on their own after the cessation or a significant decrease in the rate of administration of the solution.

Adverse Reactions

From the immune system: allergic reactions, including skin and systemic manifestations, hyperthermia.

From the cardiovascular system: fluctuations in blood pressure, edema, tachycardia.

Violations of the water-electrolyte balance: during massive infusion therapy, there may be a violation of the exchange of electrolytes (potassium, calcium, sodium, chlorine), lactic acidosis, hyperhydration.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 ° C out of the reach of children.

Incompatibility.

The drug should not be mixed with phosphate and carbonate solutions.

Packaging.

250 ml, 500 ml in polymer bags, which are placed in a transparent plastic bag.

Vacation category.

On prescription.

Manufacturer.

Private joint-stock company "infusion".

The location of the manufacturer and the address of the place of business.

Ukraine, 23219, Vinnitsa region, Vinnitsa district, s. Vinnytsia farms, st. Nemirovskoe highway, 84a.

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2020-07-30
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