Infesol^® 100 (Solution) Instructions for Use

Marketing Authorization Holder

Berlin-Chemie/Menarini Pharma, GmbH (Germany)

Manufactured By

Berlin-Chemie, AG (Germany)

ATC Code

B05BA10 (Combined preparations for parenteral nutrition)

Dosage Form

Infesol® 100

Solution for infusion: bottles 250 ml or 500 ml 10 pcs. in a set with a holder

Dosage Form, Packaging, and Composition

Solution for infusion transparent, almost colorless or with a yellowish tint, with a specific odor.

Excipients : water for injections – 921.735 mg.

250 ml – glass bottles (10) in a set with a plastic holder – cardboard boxes.
500 ml – glass bottles (10) in a set with a plastic holder – cardboard boxes.

Clinical-Pharmacological Group

Agent for parenteral nutrition – amino acid and electrolyte solution

Pharmacotherapeutic Group

Parenteral nutrition agent, amino acid

Pharmacological Action

Amino acids are components necessary for protein synthesis. Solutions containing amino acids are administered as part of parenteral nutrition along with other components (fats, carbohydrates), electrolytes, and fluid. The concentration of free amino acids in plasma is subject to significant fluctuations, this applies both to individual amino acids and their total concentration. Infesol^® 100 is administered intravenously, and therefore its bioavailability is 100%.

Amino acids are completely used for protein synthesis. Amino acids that are not required for protein synthesis are not stored as a reserve like fatty acids and glucose. The breakdown of amino acids occurs through deamination of the α-amino group, which is metabolized to urea, which is excreted by the kidneys. The remaining carbon skeleton enters the citric acid cycle, where it is converted to acetyl-CoA, acetoacetyl-CoA, and pyruvate. A portion of amino acids (up to 5%) is excreted unchanged.

Indications

• Parenteral nutrition;
• Replenishment of fluid loss;
• Prevention and therapy of protein deficiency of various origins (in burns, surgeries, blood loss, etc.).

ICD codes

Dosage Regimen

The drug is administered intravenously by drip, slowly, with careful monitoring of the patient’s condition. The dosage is calculated depending on the clinical condition of the patient and their needs for amino acids, electrolytes, and fluid. It is necessary to start the infusion at a slower rate of administration and within the first hour bring the infusion rate to the required value.

Adults

Daily dose : 10-20 ml/kg body weight, which corresponds to 1.0-2.0 g of amino acids/kg.

Maximum daily dose : 20 ml/kg, which corresponds to 2.0 g of amino acids/kg.

Maximum infusion rate : 1 ml/kg/h, which corresponds to 0.1 g of amino acids/kg/h.

During parenteral nutrition as part of appropriate therapy in adults, the total amount of fluid administered should not exceed 40 ml/kg/day.

Children

Dosage data for children are average figures and should be determined individually according to age, level of physical development, and severity of the disease.

Daily dose for children aged 2 to 6 years

10 ml/kg, which corresponds to 1.0 g of amino acids/kg.

Daily dose for children aged 6 to 14 years

15 ml/kg, which corresponds to 1.5 g of amino acids/kg.

Maximum infusion rate : 1 ml/kg/h, which corresponds to 0.1 g of amino acids/kg.

Maximum daily dose is calculated based on the daily protein requirement.

The drug is used until the complete transition to the enteral method of nutrition.

Adverse Reactions

As a rule, Infesol^® 100 is well tolerated. When using the drug according to the indications in the recommended doses, the occurrence of side effects is unlikely. The occurrence of allergic reactions (urticaria, anaphylactic reactions) is possible. Very rarely, increased sweating, nausea, vomiting, chills, tachycardia may occur, as a rule, with too high an infusion rate.

Contraindications

Absolute contraindications

• Acute hemodynamic disturbance (including shock);
• Acute left ventricular failure;
• Total tissue hypoxia;
• Children under 2 years of age;
• Traumatic brain injury;
• Methanol intoxication;
• Severe hepatic failure.

With caution after assessing the ratio of expected benefit and possible risk in the following conditions

• Amino acid metabolism disorders;
• Hyperhydration;
• Hyperkalemia;
• Hyponatremia;
• Acidosis;
• Kidney diseases;
• Chronic heart failure grade I-IIA.

In hepatic and renal failure, individual dosing is required (selected by a doctor under the control of blood biochemical parameters).

Use in Pregnancy and Lactation

The drug is used during pregnancy and during lactation (breastfeeding) according to indications.

Use in Hepatic Impairment

In hepatic failure, individual dose selection is required. The drug is contraindicated in severe hepatic failure.

Use in Renal Impairment

Prescribe with caution in kidney diseases. In renal failure, individual dose selection is required.

Pediatric Use

The drug is contraindicated for use in children under 2 years of age.

Geriatric Use

Data on the use of Infesol 100 in the elderly are not provided.

Special Precautions

Monitoring of water-electrolyte balance, blood glucose concentration, and acid-base balance is necessary.

Exercise caution with increased serum osmolarity!

For complete parenteral nutrition, simultaneous administration of other infusion solutions containing fats, carbohydrates, electrolytes, vitamins, and trace elements is necessary.

Effect on ability to drive vehicles and operate machinery

Not established.

Overdose

If the intravenous administration rate is too fast, intolerance reactions (nausea, vomiting, chills), as well as loss of amino acids through the kidneys, may occur. Overdose can lead to amino acid intoxication, hyperhydration, and electrolyte imbalance.

When administering potassium-containing solutions in excessive amounts or at too high a rate, hyperkalemia may develop (increase in serum potassium > 6.5 mmol/L).

Symptoms of hyperkalemia may include: muscle weakness, sensory disturbance, cardiac rhythm and conduction disturbances.

Therapy for dosage

• Reduction of the infusion rate and, if necessary, interruption of administration;
• Appropriate restoration of electrolyte balance;
• Osmotic diuresis;
• In life-threatening cases – dialysis.

Drug Interactions

To date, there are no data on clinically significant interaction of the drug Infesol^® 100 with other medicines.

Due to the increased risk of microbial contamination and incompatibility, solutions containing amino acids should not be mixed with other medicines.

Storage Conditions

Storage conditions

Store at a temperature not exceeding 25°C (77°F) in a place protected from light, out of the reach of children.

Shelf Life

Shelf life

2 years.

Do not use after the expiration date. Use only transparent solutions in intact bottles.

After opening the bottle, the drug must be used immediately.

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.