Sterofundin G5 (Solution) Instructions for Use

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

ATC Code

B05BB02 (Electrolytes in combination with carbohydrates)

Dosage Form

Sterofundin G5

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

Dosage Form, Packaging, and Composition

Excipients : water for injections up to 1000 ml.

100 ml – polyethylene bottles (20) – cardboard boxes.
500 ml – polyethylene bottles (10) – cardboard boxes.
1 L – polyethylene bottles (10) – cardboard boxes.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Electrolyte balance restoring agent

Pharmacological Action

Regarding the most important cations, the composition of the solution is similar to that of blood plasma.

Due to this, the solution is used to correct water-electrolyte disorders.

When electrolyte solutions are used, the osmotic balance is restored and/or maintained both inside and outside the cells.

Malate is oxidized and has a moderate alkaline effect.

The solution contains 5% glucose.

At a dose level of 40 ml/kg body weight/day, the amount of glucose administered is sufficient to cover the body’s requirement of 2 g/kg body weight/day (hypocaloric infusion therapy).

Indications

• Isotonic dehydration;
• Hypotonic dehydration;
• Replacement of extracellular volume with an isotonic solution with partial coverage of the body’s energy needs;
• For diluting concentrated electrolyte solutions and medicinal products.

ICD codes

Dosage Regimen

Doses

The dose is selected individually according to the patient’s fluid and electrolyte requirements.

Maximum daily dose

Up to 40 ml per kg body weight/day, corresponding to 2 g glucose/kg body weight/day.

Infusion rate

Up to 5 ml/kg body weight/hour (1.7 drops/kg min), corresponding to 0.25 g glucose/kg body weight/hour.

For patients with a body weight of 70 kg, the maximum infusion rate is 350 ml/hour or 120 drops/min. This corresponds to 17.5 g of glucose per hour.

Duration of use

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

Method of administration

For intravenous administration.

General recommendations for the use of carbohydrates

With normal metabolism, the total amount of carbohydrates administered should not exceed 350 to 400 g per day.

When such doses are administered, glucose is completely oxidized.

Prescription of higher doses may cause side effects, such as fatty liver infiltration.

In conditions of impaired metabolism, for example, after extensive surgery 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.

Selection of individual doses includes mandatory laboratory monitoring.

The following dose limitations for adults must be strictly observed: 0.25 g glucose per kg body weight per hour and up to 6 g per kg body weight/day.

When prescribing solutions containing carbohydrates (regardless of concentration), blood glucose concentration must always be monitored, both during surgery and during conservative patient management.

To prevent carbohydrate overdose, the use of infusion pumps is recommended, especially when using solutions with high carbohydrate concentrations.

General recommendations for the use of fluids and electrolyte solutions

A level of 30 ml of solution per kg body weight per day covers only the physiological fluid requirements of the body.

In patients who have undergone surgery and in resuscitated patients, fluid requirements are increased due to reduced renal concentrating function and increased excretion of metabolic products, which necessitates an increase in fluid intake to approximately 40 ml/kg body weight per day.

Additional losses (fever, diarrhea, fistulas, vomiting, etc.) must be compensated by an even higher fluid administration, the level of which is set individually.

The actual individual level of fluid requirement is determined by sequential monitoring of clinical and laboratory parameters (urine output, serum and urine osmolality, determination of excreted substances).

Basic replacement of the most important cations sodium and potassium reaches 1.5-3 mmol per kg/body weight/day and 0.8-1.0 mmol per kg body weight/day, respectively.

Actual requirements during infusion therapy are determined by electrolyte balance and monitoring of plasma electrolyte concentrations.

Adverse Reactions

When all precautions regarding the dose and infusion rate of the drug are observed, side effects do not occur.

Contraindications

• Hyperhydration;
• Hypertonic dehydration;
• Hypokalemia;
• Hypernatremia;
• Hyperchloremia;
• Diseases in which sodium intake should be limited, such as heart failure, edema, pulmonary edema, hypertension, eclampsia, severe renal failure;
• Persistent hyperglycemia not controlled by insulin at a dose of up to 6 units/hour.

Use in Pregnancy and Lactation

The drug can be used during pregnancy and lactation, but should be used with caution in eclampsia.

Use in Renal Impairment

Contraindicated in severe renal failure.

Special Precautions

Compared to healthy people, glucose tolerance is reduced in patients with metabolic changes characteristic of the postoperative or post-traumatic period.

The older the patient and the more severe their underlying disease, surgery, or trauma, the more frequently metabolic disorders associated with impaired glucose tolerance, similar to diabetes, can develop.

Clinical monitoring should include control of serum electrolytes, particularly potassium, and water balance.

In various conditions with impaired glucose tolerance (hyperglycemia), glucose concentration monitoring must be performed.

Overdose

Volume overload and electrolyte overdose.

Symptoms

Overdose of the drug can lead to such phenomena as hypertonic hyperhydration, electrolyte disturbances, pulmonary edema.

Therapy

The infusion should be stopped immediately, diuretics should be prescribed with constant monitoring of plasma electrolytes; correction of electrolyte balance.

Glucose overdose.

Symptoms

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

Therapy

The infusion should be stopped immediately; rehydration should be performed; insulin should be prescribed with constant blood glucose control; replacement of electrolyte losses, monitoring of acid-base balance.

Drug Interactions

To avoid incompatibility, the following drugs should not be mixed with Sterofundin

• Drugs that form a precipitate when mixed with the components of the solution;
• Drugs containing salts of weak organic acids of alkaline or rare earth metals, poorly soluble in water;
• Drugs that are unstable, decompose, or lose effectiveness in an acidic environment.

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

Storage Conditions

Store at a temperature not exceeding 25°C (77°F) in places inaccessible to children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

For use in hospitals.

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.