Sterofundin G-1 (Solution) Instructions for Use

Marketing Authorization Holder

Gematek, LLC (Russia)

ATC Code

B05BB02 (Electrolytes in combination with carbohydrates)

Dosage Form

Sterofundin G-1

Solution for infusion

Dosage Form, Packaging, and Composition

Solution for infusion

Theoretical osmolarity 364 mOsm/l
Energy value: 167.5 kJ/l (40 kcal/l)
Carbohydrate content: 10 g/l

100 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
500 ml – bottles (10 pcs.) – cardboard boxes – for hospitals

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; solutions for intravenous administration; solutions affecting water-electrolyte balance

Pharmacological Action

An isotonic solution, the electrolyte composition of which is similar to the composition of extracellular fluid. The solution is used to correct the content of electrolytes in the blood serum and acid-base balance disorders.

Electrolytes are necessary to ensure or maintain normal osmotic conditions in the extra- and intracellular space.

The anionic composition is represented by a balanced combination of non-metabolizable chlorides with acetates and malates, which are metabolized to bicarbonate. Malates are oxidized and have a moderate alkalizing effect. The molar concentration of acetates and malates is close in molar concentration to the bicarbonate buffer of blood plasma, which contributes to adequate correction of metabolic acidosis.

Dextrose is a primary source of energy with a caloric value of about 16.75 kJ/g, or 4 kcal/g. Providing the body with dextrose is necessary for the functioning of the nervous system tissues, erythrocytes, and renal medulla. This low concentration of glucose, on the one hand, satisfies the minimum needs of the body and prevents the development of hypoglycemia, and on the other hand, reduces the risk of hyperglycemia compared to more concentrated dextrose solutions.

Pharmacokinetics

The bioavailability of all its components is 100%. Sodium and Chlorides are mainly distributed in the extracellular space, while Potassium, Magnesium, and Calcium are localized inside cells. Dextrose during infusion primarily moves from the intravascular to the intracellular space. Electrolytes are not directly metabolized. Acetates are metabolized in the liver, heart, and other tissues under the influence of acetyl-CoA synthetase. The resulting acetyl-CoA is further metabolized in the Cori cycle reactions and converted into carbon dioxide and water.

Malates are oxidized in the Krebs cycle under the influence of malate dehydrogenase to carbon dioxide and water.

The concentration of dextrose (glucose) in the blood plasma is regulated within narrow limits and varies in the range of 3.9-5.6 mmol/l (70-100 mg/dl). Dextrose is universally metabolized as a natural substrate of the body’s cells. In the process of glycolysis, glucose is metabolized to pyruvates or lactates. Then lactates partially participate in the reactions of the Krebs cycle. Under aerobic conditions, pyruvates are completely oxidized to carbon dioxide and water.

Sodium, Potassium, Magnesium, and Chlorides are excreted mainly by the kidneys. Calcium is excreted in approximately equal amounts by the kidneys and through the intestines. The excretion of acetates and malates by the kidneys during infusion increases, but their metabolism in the body’s tissues proceeds so quickly that only a small amount of them enters the urine. The products of complete oxidation of glucose are excreted through the lungs (carbon dioxide) and kidneys (water). Normally, glucose is practically not excreted by the kidneys. In pathological conditions (for example, in diabetes mellitus, in the postoperative or post-traumatic period) with hyperglycemia (with a blood glucose concentration of more than 120 mg/100 ml or 6.7 mmol/l), glucose is excreted by the kidneys (glucosuria) when the maximum glomerular filtration rate is exceeded (180 mg/100 ml or 10 mmol/l).

Indications

For adults and children aged 0 to 18 years:

For correction of isotonic dehydration; correction of hypotonic dehydration; replacement of extracellular fluid with an isotonic solution with partial coverage of energy needs in children; dilution of compatible concentrated solutions of electrolytes and other medicinal products.

ICD codes

Dosage Regimen

Administered intravenously into peripheral and central veins. In case of use for acute hypovolemia, the solution must be administered quickly, by pressure infusion, having previously removed all air from the packaging and infusion system before starting the infusion to exclude the risk of air embolism during the infusion.

In adults and children, the dose should be selected in accordance with individual needs for carbohydrates, fluid, and electrolytes. When calculating the dose, one should be guided by the degree of dehydration and the clinical condition of the patient.

For maintenance infusion therapy, administer in a daily dose corresponding to no more than 400 mg of dextrose/kg of body weight, 5.8 mmol of sodium/kg of body weight and 0.16 mmol of potassium/kg of body weight.

In case of additional fluid loss (for example, caused by fever, diarrhea, vomiting), it must be compensated in accordance with its volume and composition.

In case of dehydration, higher doses may be required. When calculating the dose, one should be guided by the degree of dehydration and the clinical condition of the patient.

Adverse Reactions

Local reactions frequency unknown – including pain at the injection site, vein irritation, thrombophlebitis and extravasation.

Contraindications

Hypersensitivity to the active substances or to any of the excipients included in the used drug; overhydration; acute and chronic heart failure; severe renal failure with oliguria or anuria in the absence of renal replacement therapy (hemodialysis or hemofiltration); hyperglycemia requiring the administration of short-acting insulin in an amount of IU/h and more; hyperkalemia; hypertonic dehydration; hyperchloremia; diseases in which sodium intake should be limited (pulmonary edema, arterial hypertension, eclampsia).

With caution

Use under careful control in the following conditions: hypernatremia; renal failure; disorders in which hyperkalemia may develop, such as Addison’s disease, sickle cell anemia, extensive tissue damage; simultaneous use of drugs that increase the concentration of potassium in the blood serum; disorders in which calcium intake is indicated to be limited, for example, sarcoidosis; congenital disorders of lactate metabolism in children; pregnancy.

Use in Pregnancy and Lactation

Data on the use of glucose, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and malic acid in pregnant women are absent or limited (less than 300 pregnancy outcomes).

Data on reproductive toxicity in animals are insufficient.

Since all components of this agent are present in the body in their natural form, its use according to indications is possible. Nevertheless, caution should be exercised when using this medicinal product during pregnancy.

Since all components of this agent are present in the body in their natural form, no negative effects are expected when used during breastfeeding. Therefore, use during breastfeeding according to indications is possible.

Use in Renal Impairment

Contraindicated in severe renal failure with oliguria or anuria in the absence of renal replacement therapy (hemodialysis or hemofiltration).

Use under careful control in mild to moderate renal failure.

Pediatric Use

Used according to indications in children aged 0 to 18 years.

Special caution is required when using this agent in newborns and infants, since the risk of lactic acidosis when using the acetate contained in this medicinal product in case of acetate metabolism disorders cannot be excluded.

Geriatric Use

Elderly patients generally require the usual adult doses, but caution is necessary in elderly patients with concomitant diseases, such as heart and renal failure.

Special Precautions

To prevent the development of osmotic demyelination syndrome, the increase in serum sodium concentration should not exceed 9 mmol/l/day. General recommendations in most cases imply a sufficient correction rate within 4-6 mmol/l/day, depending on the patient’s condition and concomitant risk factors.

In case glucose metabolism is impaired (for example, in the early postoperative, post-traumatic period or in the presence of hypoxia or organ failure), doses should be adjusted to maintain blood glucose levels close to normal values.

Clinical monitoring during the use of this agent should include control of blood glucose and electrolyte concentrations, as well as acid-base balance and fluid balance.

Elderly patients, due to the increased likelihood of developing heart and renal failure, require constant monitoring during treatment, and the dose must be carefully selected to avoid the development of disorders of the cardiovascular system and kidneys caused by hypervolemia.

Patients receiving cardiac glycosides should be administered solutions containing Potassium and Calcium with caution.

When using this agent as a solvent, it is necessary to take into account the safety data of its mixing with the added drug, provided by the manufacturer of the corresponding drug. Before mixing with additional components, their compatibility with this agent must be confirmed. Before using this agent in combination with other solutions via a Y-connector, it is recommended to check the compatibility of the solutions planned for use.

The solution is not recommended to be administered simultaneously with blood products using the same infusion system due to the risk of pseudoagglutination.

Due to the presence of calcium, the possibility of extravasal penetration of the solution during intravenous infusion must be excluded.

Use in pediatrics

Daily doses for children should be selected individually, in accordance with the need, blood glucose level and water-electrolyte balance status. When calculating the dose, one should be guided by the degree of dehydration and the clinical condition of the patient.

The risk of developing hypoglycemia or hyperglycemia in newborns and premature infants with low birth weight is increased. To avoid the development of persistent adverse reactions during the administration of solutions containing dextrose, careful monitoring of blood glucose levels is necessary.

Special caution is required when using this agent in newborns and infants, since the risk of lactic acidosis when using the acetate contained in this medicinal product in case of acetate metabolism disorders cannot be excluded. These very rare conditions of acetate metabolism disorders may first appear when this medicinal product is administered.

Drug Interactions

Simultaneous use with drugs that cause sodium retention (for example, corticosteroids, NSAIDs) may lead to the development of edema.

Preparations from licorice root have the ability to retain Sodium and water (with the occurrence of edema and arterial hypertension).

Potassium-sparing diuretics (amiloride, spironolactone, triamterene), ACE inhibitors, NSAIDs, cyclosporine, tacrolimus and suxamethonium can increase the concentration of potassium in the blood serum. Simultaneous use of these drugs with potassium-containing solutions can lead to severe hyperkalemia (especially in renal failure), which, in turn, can cause cardiac arrhythmia.

Administration of potassium may reduce the effect of cardiac glycosides.

ACTH, corticosteroids and “loop” diuretics may increase the excretion of potassium by the kidneys.

Administration of calcium may enhance the inotropic and toxic effect of cardiac glycosides. In patients receiving cardiac glycosides, Calcium may cause cardiac arrhythmia with a possible fatal outcome, especially with intravenous administration.

Thiazide diuretics and vitamin D can enhance the reabsorption of calcium in the kidneys and cause hypercalcemia.

Calcium forms complex compounds with tetracycline antibiotics, reducing their effectiveness.

Solutions containing Calcium should not be mixed with ceftriaxone.

Interaction with drugs that affect glucose metabolism, for example, with corticosteroids, should be taken into account.

Alkalinization of urine due to the use of bicarbonates or bicarbonate precursors leads to increased excretion of acidic products by the kidneys.

The T_1/2 of drugs whose metabolites are predominantly bases, especially sympathomimetics (for example, ephedrine, pseudoephedrine) and CNS stimulants, increases with simultaneous use with malate-containing solutions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.