Normofundin G-5 (Solution) Instructions for Use

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

Manufactured By

B.Braun Melsungen AG (Germany)

Or

Gematek, LLC (Russia)

ATC Code

B05BB02 (Electrolytes in combination with carbohydrates)

Dosage Form

Normofundin G-5

Solution for infusion: bottle 100 ml 20 pcs, bottle 500 ml or 1 L 10 pcs.

Dosage Form, Packaging, and Composition

500 ml – plastic “Viaflex” containers (1) – plastic bags.
1 L – plastic “Viaflex” containers (1) – plastic bags.
500 ml – plastic containers (1) – plastic bags.
500 ml – plastic containers (1) – plastic bags (20) – cardboard boxes.
1 L – plastic “Viaflex” containers (1) – plastic bags (10) – cardboard boxes.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Electrolyte balance restoring agent

Pharmacological Action

The drug is an electrolyte solution with a total cation amount of 123 mmol/L. This composition was selected based on the need to compensate for disorders of the body’s electrolyte metabolism during metabolic stress. For this purpose, compared to electrolyte solutions with a composition close to blood plasma, the amount of sodium is reduced to prevent sodium and fluid retention, but remains sufficient to prevent the development of secondary hyperaldosteronism.

The relatively high concentration of potassium compared to electrolyte solutions with a composition close to blood plasma is due to the body’s increased need for potassium that arises in stressful situations under conditions of adequate fluid replacement, amounting to approximately 1 mmol of potassium/kg of body weight/day.

Acetates exert an alkalizing effect upon oxidation. The anionic composition is represented by a balanced combination of chlorides, which are not metabolized, and acetates, which are metabolized and prevent the development of metabolic acidosis.

Furthermore, the solution contains 5% glucose. From a physiological point of view, glucose is the primary source of energy with a caloric value of about 16 kJ/g or 3.75 kcal/g. Providing the body with glucose is necessary for the functioning of the nervous system tissues, erythrocytes, and renal medulla.

On one hand, glucose is converted into glycogen for carbohydrate reserves; on the other hand, it is metabolized in the glycolysis process into pyruvate or lactate to provide energy for the body’s cells. There is a close interrelationship between electrolytes and carbohydrate metabolism. Glucose absorption and the increased need for potassium are interconnected. If this is not taken into account, it can lead to a disturbance in potassium metabolism, which, in turn, can cause pronounced cardiac arrhythmias.

Some pathological conditions can lead to impaired glucose absorption processes (glucose intolerance), such as diabetes mellitus or conditions accompanied by “stress metabolism,” leading to reduced glucose tolerance (severe complications of the surgical or postoperative period, trauma). This can lead to hyperglycemia, which, in turn, depending on the severity, can lead to osmotic diuresis with subsequent development of hypertonic dehydration and hyperosmolar disorders up to hyperosmolar coma.

Excessive administration of glucose, especially in conditions accompanied by reduced glucose tolerance, can lead to serious impairment of glucose absorption and, due to the limitation of oxidative glucose absorption, to a greater conversion of glucose into fat. This, in turn, can be accompanied by a higher level of CO₂ in the body (problems associated with disconnection from mechanical ventilation), as well as increased fat infiltration into tissues, especially the liver. Patients with traumatic brain injury or cerebral edema are particularly at risk for glucose homeostasis disturbances. In these cases, even minor disturbances in blood glucose concentration and, consequently, an increase in plasma (serum) osmolarity can lead to noticeable exacerbations of cerebral disorders. A dose of 40 ml/kg body weight/day covers the necessary body requirements for carbohydrates, equal to 2 g of glucose/kg body weight/day (hypocaloric infusion therapy).

Pharmacokinetics

During infusions, glucose primarily enters the intravascular space with subsequent movement into the interstitial space. In the process of glycolysis, glucose is converted into pyruvate or lactate. Lactate then partially participates in the reactions of the Krebs cycle. Pyruvate is completely oxidized by oxygen to CO₂ and H₂O. The oxidation products of glucose are excreted by the lungs (CO₂) and kidneys (H₂O).

Normally, glucose is not eliminated by the kidneys. In pathological conditions (such as diabetes mellitus, reduced glucose tolerance) with hyperglycemia (blood glucose concentration 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

• Hypertonic dehydration;
• Isotonic dehydration;
• Providing the body with fluid and electrolytes with partial coverage of energy needs during infusion therapy in the postoperative and post-traumatic period;
• As a carrier for compatible concentrated electrolyte solutions and other medicinal products during infusion therapy.

ICD codes

Dosage Regimen

Normofundin G-5 is administered into peripheral and central veins.

Recommended doses

The drug dose is selected individually and depends on the blood glucose level, the patient’s need for fluid and electrolytes.

Adults

Maximum daily dose – 40 ml/kg body weight, which corresponds to 2.0 g glucose/kg body weight, 4 mmol sodium/kg body weight and 0.7 mmol potassium/kg body weight.

Maximum rate of administration – 5 ml/kg body weight/h, which corresponds to 0.25 g glucose/kg body weight/h and 0.09 mmol potassium/kg body weight/h.

Children under 18 years

Daily doses for children should be selected individually, according to need, blood glucose level and water-electrolyte balance status.

When selecting doses for children under 18 years, the following limitations of the maximum daily volume of fluid and glucose administered, as well as the maximum rate of glucose administration, must be taken into account.

Maximum daily volume of fluid administered

• Children on day 1 of life 60-120 ml/kg body weight;
• Children on day 2 of life 80-120 ml/kg body weight;
• Children on day 3 of life 100-130 ml/kg body weight;
• Children on day 4 of life 120-150 ml/kg body weight;
• Children on day 5 of life 140-160 ml/kg body weight;
• Children on day 6 of life 140-180 ml/kg body weight;
• Children from day 7 to the first month of life inclusive 140-160 ml/kg body weight;
• Children from the second month of life 120-150 ml/kg body weight;
• Children from 1 year to 2 years inclusive 80-120 ml/kg body weight;
• Children from 3 years to 5 years inclusive 80-100 ml/kg body weight;
• Children from 6 years to 12 years inclusive 60-80 ml/kg body weight;
• Children from 13 years to 18 years 50-70 ml/kg body weight.

Maximum daily dose of glucose

• Children from 1 year to 2 years inclusive 12-15 g glucose/kg body weight;
• Children from 3 years to 5 years inclusive 12 g glucose/kg body weight;
• Children from 6 years to 10 years inclusive 10 g glucose/kg body weight;
• Children from 11 years to 14 years inclusive 8 g glucose/kg body weight.

Maximum rate of glucose administration

• Children from 1 year to 2 years inclusive 8-10 mg glucose/kg body weight/min;
• Children from 3 years to 5 years inclusive 8-10 mg glucose/kg body weight/min;
• Children from 6 years to 10 years inclusive 8-10 mg glucose/kg body weight/min;
• Children from 11 years to 14 years inclusive 5-6 mg glucose/kg body weight/min.

Duration of use

The solution can be used for several days. The duration of use is determined by the clinical condition of the patient and laboratory parameters.

General recommendations for the use of carbohydrates

With normal metabolism, the total amount of carbohydrates administered should not exceed 350-400 g/day. When such doses are administered, glucose is completely absorbed. Prescribing higher doses may cause the development of adverse side reactions and lead to fatty infiltration of the liver. In conditions of impaired metabolism, for example, after extensive operations or trauma, hypoxic stress or organ failure, the daily dose should be reduced to 200-300 g, which corresponds to 3 g/kg body weight/day. The selection of individual doses includes mandatory laboratory monitoring.

The following dose limitations for adults must be strictly observed: 0.25 g glucose/kg body weight/h and up to 6 g/kg body weight/day. The administration of solutions containing carbohydrates, regardless of concentration, should always be accompanied by monitoring of blood glucose levels, both during surgical intervention and during conservative patient management. To prevent carbohydrate overdose, the use of infusion pumps is recommended, especially when using solutions with a high concentration of carbohydrates.

General recommendations for the use of fluid and electrolyte solutions

A dose of 30 ml of solution/kg body weight/day covers only the physiological needs of the body for fluid. In patients who have undergone surgery and in critically ill patients, fluid requirements increase due to reduced renal concentrating function and increased excretion of metabolic products, which leads to the need to increase fluid intake to approximately 40 ml/kg body weight/day. Additional losses (fever, diarrhea, fistulas, vomiting, etc.) must be compensated by an even higher administration of fluid, the level of which is established individually. The actual individual level of fluid requirement is determined by sequential monitoring of clinical and laboratory parameters (urine output, serum and urine osmolarity, determination of excreted substances).

The basic replacement of the most important cations, sodium and potassium, is 1.5-3.0 mmol/kg body weight/day and 0.8-1.0 mmol/kg body weight/day, respectively. Actual needs during infusion therapy are determined by the state of water-electrolyte balance.

Contraindications

• Hyperhydration;
• Hypotonic dehydration;
• Hyperkalemia.

With caution: hyponatremia; renal failure with a tendency to hyperkalemia; hyperglycemia not controlled by insulin in a dose of up to 6 units/h.

Use in Pregnancy and Lactation

Normofundin G-5 can be used in pregnant and lactating women in cases where the expected benefit from treatment with the drug outweighs the possible risk of complications.

Use in Renal Impairment

With caution renal failure with a tendency to hyperkalemia.

Pediatric Use

Daily doses for children should be selected individually, according to need, blood glucose level and water-electrolyte balance status.

When selecting doses for children under 18 years, the following limitations of the maximum daily volume of fluid and glucose administered, as well as the maximum rate of glucose administration, must be taken into account.

Geriatric Use

For elderly persons, the dose of the administered drug must be reduced due to the risk of volume overload.

Special Precautions

Clinical monitoring should include control of water-electrolyte balance.

In the presence of arterial hypertension, the prescription of sodium chloride and fluid volume should be individualized.

For elderly persons, the dose of the administered drug must be reduced due to the risk of volume overload.

The solution should not be administered through the same transfusion systems, simultaneously, before or after blood administration due to the risk of pseudoagglutination.

Only a solution containing 70 mmol/L sodium can be used for the therapy of hypertonic dehydration. Correction of dehydration should be carried out for at least 48 hours.

Administration of the solution in postoperative, post-traumatic or other conditions accompanied by impaired glucose tolerance must be carried out under constant monitoring of glucose concentration. If necessary, insulin administration is recommended.

Do not freeze!

Effect on ability to drive vehicles, operate machinery

The drug does not affect the ability to drive vehicles, operate machinery, or engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Overdose

Symptoms

Overdose of the drug may lead to such phenomena as hyperhydration with increased skin turgor, venous congestion and development of general edema with subsequent development of pulmonary edema. Disturbances in electrolyte metabolism (hyperkalemia), acid-base balance, as well as hyperglycemia may also be observed.

Treatment

Immediate cessation of infusion, prescription of diuretics, correction of electrolyte levels and acid-base status with constant monitoring of water-electrolyte balance.

Glucose overdose

Symptoms

Hyperglycemia, glucosuria, dehydration, serum hyperosmolarity, hyperglycemic or hyperosmolar coma.

Treatment

Immediate cessation of infusion; rehydration; insulin administration with constant monitoring of blood glucose levels; replacement of electrolyte losses, monitoring of acid-base balance.

Drug Interactions

To avoid precipitate formation, Normofundin G-5 should not be mixed with drugs containing oxalates, phosphates, carbonates or bicarbonates. Suxamethonium and potassium, when administered together, may have a negative effect on heart rhythm due to pronounced hyperkalemia.

Storage Conditions

Store the drug in places inaccessible to children at a temperature from 2 to 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

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.