Nutriflex 40/80 (Solution) Instructions for Use

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

Manufactured By

B. Braun Medical, AG (Switzerland)

ATC Code

B05BA10 (Combined preparations for parenteral nutrition)

Dosage Form

Nutriflex 40/80

Infusion solution 1 L or 2 L: plastic dual-chamber containers; chamber 1 – dextrose solution; chamber 2 – amino acid solution with electrolytes

Dosage Form, Packaging, and Composition

Solution for infusion (chamber 1 – dextrose solution).

Solution for infusion (chamber 2 – amino acid solution with electrolytes).

Excipients: water for injections.

1 L – plastic dual-chamber containers (1) chamber 1: dextrose solution 600 ml; chamber 2: amino acid solution with electrolytes 400 ml – plastic bags (5) – cardboard boxes.
2 L – plastic dual-chamber containers (1) chamber 1: dextrose solution 1200 ml; chamber 2: amino acid solution with electrolytes 800 ml – plastic bags (5) – cardboard boxes.

Clinical-Pharmacological Group

Drug for parenteral nutrition – solution of amino acids, carbohydrates, electrolytes

Pharmacotherapeutic Group

Parenteral nutrition agent

Pharmacological Action

Amino acids administered intravenously enter the intravascular and intracellular pools of endogenous free amino acids.

The administration of all amino acids necessary for protein synthesis (including essential, conditionally essential, and non-essential amino acids) contained in the preparation ensures high nutritional efficiency and reduces the burden on the body during protein synthesis.

Thus, the main therapeutic effect of Nutriflex 40/80 is to supply the body with a substrate for protein synthesis and energy from glucose during parenteral nutrition.

The individual concentrations of amino acids in the preparation are selected so that when this solution is administered intravenously, the increase in the concentration of each amino acid in the plasma does not exceed the normal range, which ensures the maintenance of amino acid homeostasis in the plasma.

Glucose is the most adapted energy carrier for the body and, in the indicated dose, alone or together with an additionally administered lipid emulsion, covers the patient’s needs for non-protein calories, protecting amino acids from non-targeted use.

The combination of ingredients used in Nutriflex 40/80 in these concentrations, and its low osmolarity, allows it to be administered through peripheral veins, which significantly expands the indications for its use in various categories of therapeutic and surgical patients, both in intensive care units and in outpatient and home settings.

Indications

Used for parenteral nutrition in inpatient and outpatient settings to cover the daily needs of patients for energy, amino acids, electrolytes, and fluid during parenteral nutrition in patients with a degree of catabolism from moderate to severe in cases where enteral nutrition is impossible, insufficient, or contraindicated, as well as in combination with it, for example:

• Preoperative preparation;
• Conditions after extensive surgical interventions;
• Moderate and severe trauma;
• Burns;
• Inflammatory-destructive bowel diseases (including Crohn’s disease, intestinal fistulas);
• Short bowel syndrome;
• Nutritional disorders (cachexia);
• Oncological diseases;
• Sepsis, peritonitis;
• Acute pancreatitis;
• Parenteral nutrition of patients with artificial lung ventilation.

ICD codes

Dosage Regimen

Methodology for preparing Nutriflex 40/80 for use

Nutriflex 40/80 is a dual-chamber bag, the compartments of which are separated by a special seam. One chamber is filled with an amino acid and electrolyte solution, and the other with a glucose and electrolyte solution.

Immediately before the start of parenteral administration, the amino acid, glucose, and electrolyte solutions should be mixed. For this it is necessary:

• Remove the dual-chamber bag from the protective packaging,
• Unfold and lay it on a flat surface (on a table),
• Break the separating seam by pressing with both hands on one of the chambers of the bag,
• Take in your hands and mix the contents of both chambers by moving the right and left parts of the bag up and down.

After this, the solution is ready for use. At the end of the infusion, the bag is discarded.

If necessary, lipid emulsions can be added to the Nutriflex 40/80 preparation by introducing them into the ready solution through a special port located on the top of the bag. If it is necessary to add other ingredients to the ready solution, an additional port located at the bottom must be used. All ingredients must be added in compliance with aseptic rules and taking into account their compatibility with each other.

Doses

Selected according to individual needs. The maximum daily dose is 40 ml/kg/day, which corresponds to 1.6 g of amino acids/kg/day and 3.2 g of glucose/kg/day.

Infusion rate

The maximum infusion rate is 2 ml/kg/h, which corresponds to 0.08 g of amino acids/kg/h and 0.16 g of glucose/kg/h.

Duration of use

Administration of Nutriflex 40/80 is not recommended for more than seven days.

Precautions for use of the drug

With caution – in patients with heart failure, severe hepatic and/or renal failure.

Nutriflex 40/80 is a special solution intended for administration into peripheral veins. During therapy, it is necessary to take into account the condition of the veins and periodically change the site of solution administration.

Adverse Reactions

Side effects occur very rarely. They are quickly reversible upon discontinuation of the therapy. Administration of the drug may lead to allergic reactions, chills, nausea, vomiting. Due to the high osmolarity of the solution, in some cases, signs of increased diuresis may appear. In such cases, the administration of the drug should be stopped and resumed later at a lower infusion rate.

In case of side effects not described in the instructions, patients should inform their attending physician.

Contraindications

• Disorders of amino acid metabolism;
• Hyperkalemia;
• Hyponatremia;
• Metabolic disorders (for example, in diabetes mellitus);
• Coma of unclear etiology;
• Hyperglycemia, not correctable with insulin doses up to 6 units/h;
• Acidosis;
• Severe hepatic and/or renal failure;
• Children under 2 years of age;
• Individual intolerance to one of the components of the mixture.

General for parenteral nutrition

• Severe circulatory disorders (collapse and shock);
• Severe tissue hypoxia;
• Hyperhydration;
• Disorders of water-electrolyte balance;
• Pulmonary edema;
• Decompensated heart failure.

Use in Pregnancy and Lactation

No clinical studies have been conducted. The benefits/risk should be weighed before prescribing the drug during pregnancy. Breastfeeding is not recommended while using the drug.

Use in Hepatic Impairment

Contraindicated in severe hepatic failure.

Use in Renal Impairment

Contraindicated in severe renal failure.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

For total parenteral nutrition, Nutriflex 40/80 should be used in combination with lipid emulsions.

Before starting the infusion of Nutriflex 40/80, the water-electrolyte balance and acid-base status of the blood should be corrected. Too rapid administration of the drug can lead to volume overload, disturbance of water-electrolyte balance.

Monitoring of blood sugar concentration is necessary. If hyperglycemia occurs, the rate of administration of Nutriflex 40/80 must be reduced or an appropriate dose of insulin administered.

Intravenous administration of amino acid solutions is accompanied by increased excretion of trace elements in the urine, especially copper and zinc. This must be taken into account when selecting doses of trace elements, especially during long-term therapy.

Due to the risk of pseudoagglutination, it is not recommended to use the same infusion systems for the administration of blood products and multicomponent amino acid solutions.

During the administration of the drug, regular monitoring of water-electrolyte balance and acid-base status, blood sugar concentration, and serum ionogram should be carried out. During long-term therapy, monitoring of blood parameters (coagulogram, liver function indicators) is necessary.

If necessary, it is possible to add lipid emulsions, essential fatty acids, electrolytes, vitamins and trace elements.

As with all solutions administered intravenously, strict adherence to aseptic rules is necessary.

The drug Nutriflex 40/80 is a multicomponent solution. When adding other solutions or a lipid emulsion to it, the compatibility of all ingredients must be taken into account.

The drug is supplied in plastic dual-chamber containers designed for single use. Any unused volumes of the drug are not subject to storage and must be discarded.

The drug must be used immediately after mixing the glucose and amino acid solutions. Storage of the drug after mixing the glucose and amino acid solutions is possible for up to 7 days at room temperature and up to 14 days when stored in a refrigerator (including the time of drug administration).

Do not use the drug if the solution is not clear, if there are obvious signs of damage on the container, or if its tightness is broken.

Overdose

With proper prescription of the drug, overdose is not observed.

Symptoms of volume overload or electrolyte overdose

Hypertonic hyperhydration, disturbances of water-electrolyte balance, pulmonary edema.

Symptoms of amino acid overdose

Loss of amino acids in the urine with the development of amino acid imbalance, vomiting, tremor.

Symptoms of glucose overdose

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

Therapy

In cases of symptoms of drug overdose, the administration of the solution should be stopped. Further therapy is selected individually depending on the severity of the symptoms. The infusion can be resumed later at a lower rate with frequent monitoring.

Drug Interactions

Not described.

Storage Conditions

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

Shelf Life

Shelf life – 2 years.

Dispensing Status

For use in hospitals 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.