Nutriflex 40/80 lipid 1.25 l No. 5 plastic container

Nutriflex 40/80 lipid 1.25 l No. 5 plastic container

pharmachologic effect

The purpose of parenteral nutrition is to supply the body with all the necessary nutrients for tissue growth and regeneration, as well as the energy necessary to maintain all body functions.

In this case, amino acids are the most important, since some of them are essential in protein synthesis. Co-administration of energy sources (carbohydrates and lipids) is necessary to avoid the undesirable use of amino acids as an energy substrate.

Glucose is utilized by all tissues in the body. For some tissues and organs, such as the central nervous system, bone marrow, red blood cells, and renal tubular epithelium, glucose is the only source of energy. In addition, glucose is a material for building various cellular structures.

Lipids have high energy value and are also a source of essential fatty acids for the synthesis of cellular structures and prostaglandins. For this purpose, the fat emulsion contains medium-chain and long-chain triglycerides (soybean oil).

Medium chain triglycerides are hydrolyzed faster, eliminated from the bloodstream and are completely oxidized compared to long chain triglycerides. They are the main energy substrate, especially when the process of metabolism and utilization of long-term kidney triglycerides is disrupted, for example, with a lack of lipoprotein lipase and/or lipoprotein lipase cofactors. Unsaturated fatty acids, which are part of long-chain triglycerides, are used in the body primarily for the prevention and treatment of essential fatty acid deficiency and only secondarily as a source of energy.

Indications

• replenishment of the needs for energy, essential fatty acids, amino acids, electrolytes, water during parenteral nutrition in patients with standard and moderately increased metabolic needs, when normal food intake and enteral nutrition are impossible, insufficient or contraindicated;
• parenteral nutrition in patients with hyperglycemia or the threat of its development;
• parenteral nutrition if infusion is available only into peripheral veins (in an outpatient setting, surgery departments, at home).

Contraindications

The drug should not be prescribed for the following conditions:

• congenital disorders of amino acid metabolism;
• disorders of fat metabolism;
• pathologically high concentration of plasma electrolytes;
• unstable metabolism (for example, severe post-aggressive syndrome, decompensated hyperglycemia in diabetes mellitus, metabolic acidosis, coma of unknown etiology);
• severe hyperglycemia, uncorrectable with insulin doses up to 6 units/hour;
• intrahepatic cholestasis;
• severe liver failure;
• severe renal failure in the absence of renal replacement therapy;
• progressive hemorrhagic diathesis;
• acute phase of myocardial infarction and stroke;
• acute cases of thromboembolism, fat embolism;
• children under 2 years of age;
• revealed hypersensitivity to egg white or soybean protein, nut oil or any of the components of the drug.

General contraindications for parenteral nutrition:

• unstable, life-threatening circulatory disorder (collapse and shock);
• severe tissue hypoxia;
• states of hyperhydration;
• water-electrolyte imbalance;
• acute pulmonary edema;
• decompensated heart failure.

Carefully

Caution should be exercised when increasing serum osmolarity. Given the possible risk of volume overload when using Nutriflex 40/80 lipid, caution should be exercised in patients with impaired cardiac or renal function.

The drug should be administered with caution to patients with impaired fat metabolism (for example, renal failure, diabetes mellitus, pancreatitis, liver dysfunction, hypothyroidism with hypertriglyceridemia and sepsis). In these conditions, monitoring of serum triglyceride concentrations is mandatory.

Dosage

Mode of application

Intended for intravenous administration into peripheral and central veins.

The temperature of the injected emulsion should be at room temperature.

The configuration of the chambers of the drug Nutriflex 40/80 lipid allows you to add the fat emulsion last in order to preliminarily assess compatibility with other added drugs.

Method of mixing the contents of container chambers

If it is necessary to add other medications to the drug Nutriflex 40/80 lipid, use the following method:

1. Remove the secondary plastic bag from the container, unfold it and place the container on a hard, flat surface (table);

2. By pressing with both hands on the upper left chamber of the container (containing a solution of glucose with electrolytes), destroy the partition separating it from the lower chamber (containing a solution of amino acids with electrolytes);

3. If necessary, add electrolytes, trace elements and other compatible medications (including water-soluble vitamins) through the additional port with a red protective cap;

4. Pressing with both hands on the upper right chamber of the container (containing the fat emulsion), destroy the partition separating it from the lower chamber;

5. If necessary, add fat-soluble vitamins through the additional port with the red protective cap;

6. Gently mix the contents of all container chambers.

If there is no need to add other medications to Nutriflex 40/80 lipid, use the following method:

1. Remove the secondary plastic bag from the container, unfold it and place the container on a hard, flat surface (table);

2. Pressing with both hands on the two upper chambers of the container, destroy the partitions separating them from the lower chamber;

3. Gently mix the contents of all chambers of the container.

To carry out the infusion after mixing the contents of the container chambers:

• After moving the emulsion into the lower chamber, fold the container along the middle line separating the empty upper chambers from the lower one;
• Hang the container on the infusion stand by the special ring in the center of the container;
• Remove the white protective cap from the infusion port, connect the IV infusion system and begin infusion at the rate specified in these instructions for use.

Doses:

Selected according to individual needs.

Children from 14 years old and adults

The maximum daily dose is 40 ml/kg body weight, which corresponds to

— 1.28 g amino acids/kg body weight/day,

— 2.56 g glucose/kg body weight/day,

— 1.6 g fat/kg body weight/day.

Children from 2 to 14 years old

These recommendations are based on average needs. The dose should be individually adapted depending on age, stage of development and severity of the disease. To calculate the dose, it is necessary to take into account the degree of hydration of pediatric patients.

For children, it may be necessary to start nutritional therapy at half the calculated dose. The dose should be increased to the maximum in stages in accordance with the individual metabolic capabilities of the body.

For children from 2 to 5 years old

the daily dose is 45 ml/kg body weight, which corresponds to

— 1.44 g amino acids/kg body weight/day,

— 2.88 g glucose/kg body weight/day,

— 1.8 g fat/kg body weight/day.

For children from 5 to 14 years old

The daily dose is 30 ml/kg body weight, which corresponds to

— 0.96 g amino acids/kg body weight/day,

— 1.92 g glucose/kg body weight/day,

— 1.20 g fat/kg body weight/day.

Due to the age characteristics of children, Nutriflex 40/80 lipid may not fully meet the energy requirement. In these cases, glucose solution or fat emulsion can be added to the parenteral nutrition program as needed.

Injection rate

Long-term administration of the drug Nutriflex 40/80 lipid is recommended. A stepwise increase in the infusion rate during the first 30 minutes reduces the incidence of possible complications.

The maximum infusion rate is 2.5 ml/kg body weight/h, which corresponds to

— 0.08 g amino acids/kg body weight/hour,

— 0.16 g glucose/kg body weight/hour,

— 0.1 g fat/kg body weight/hour.

For a patient weighing 70 kg, the maximum infusion rate will be 175 ml/hour. In this case, the rate of introduction of amino acids will be 5.6 g/h, glucose - 11.2 g/h, fats - 7. g/h.

Elderly patients

Doses do not differ from those recommended for other adult patients. However, metabolism can vary significantly in old age, so careful monitoring of this group of patients is necessary.

Patients with renal and/or liver failure

Doses are selected individually.

Duration of use

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

Side effects

• Blood and lymphatic system disorders: rare - hypercoagulation.
• Immune system disorders: rare - allergic reactions (for example, anaphylactic reactions, skin rash, swelling of the larynx, mouth and face).
• Metabolic and nutritional disorders: very rare - hyperlipidemia, hyperglycemia, metabolic acidosis.
• The incidence of these adverse reactions is dose dependent and may be higher with lipid overdose.
• Nervous system disorders: rare - drowsiness.
• Vascular disorders: rare - increased or decreased blood pressure, hot flashes.
• Disorders of the respiratory system, chest and mediastinal organs: rare - shortness of breath, cyanosis of the skin.
• Gastrointestinal disorders: uncommon - nausea, vomiting, loss of appetite.
• General disorders and disorders at the injection site: frequent - after a few days of using the drug, irritation of the veins, phlebitis or thrombophlebitis may develop; rare - headache, fever, sweating, feeling cold, chills, pain in the back, bones, chest and lumbar region; very rare - fat overload syndrome.

Overdose

When the drug is prescribed correctly, an overdose is not observed.

• Symptoms of volume overload or electrolyte overdose: hypertensive overhydration, electrolyte imbalance, pulmonary edema.
• Symptoms of amino acid overdose: loss of amino acids by the kidneys with the development of amino acid imbalance, nausea, vomiting, tremor.
• Symptoms of glucose overdose: hyperglycemia, glycosuria, dehydration, serum hyperosmolarity, hyperglycemic or hyperosmolar coma.
• Symptoms of lipid overdose: lipid overdose can lead to the development of fat overload syndrome.

Therapy

In cases of overdose symptoms, administration of the drug should be discontinued. Further therapy is selected individually depending on the severity of symptoms. The infusion may be resumed later at a slower rate with continuous monitoring. The concentration of triglycerides in blood plasma during infusion should not exceed 3 mmol/l.

Drug interactions

Potassium-containing solutions should be administered with caution to patients receiving medications that increase serum potassium concentrations, such as potassium-sparing diuretics, ACE inhibitors, cyclosporine, and tacrolimus. Soybean oil contains vitamin K1, which can interfere with the therapeutic effect of indirect anticoagulants - coumarin derivatives. Therefore, the therapeutic effect of indirect anticoagulants - coumarin derivatives must be carefully monitored.

Corticosteroids and corticotropin cause sodium and fluid retention in the body. Some drugs, such as insulin, can interact with the body's lipolytic enzymes. However, these interactions are of little clinical significance.

Administration of heparin in therapeutic doses leads to an increase in plasma lipolysis, which in turn can lead to a decrease in triglyceride clearance.

Nutriflex 40/80 lipid contains zinc and magnesium, which must be taken into account when prescribing other drugs containing these microelements.

Nutriflex 40/80 lipid is a drug with a complex composition. Therefore, it is not recommended to add other solutions to it without first checking for compatibility, since otherwise the stability of the emulsion cannot be guaranteed.

Pregnancy and lactation

Pregnancy

No studies have been conducted to evaluate the effect of Nutriflex 40/80 lipid on the embryo or fetus. Prescribing the drug during pregnancy is possible if the potential benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

In general, breastfeeding during parenteral nutrition is not recommended.

Use in childhood

Contraindicated in children under 2 years of age.

For impaired renal function

Given the possible risk of volume overload when using Nutriflex 40/80 lipid, caution should be exercised in patients with impaired renal function.

For liver dysfunction

The drug should be administered with caution to patients with impaired liver function

Use in old age

Doses do not differ from those recommended for other adult patients. However, metabolism may vary significantly in old age, so careful monitoring of this group of patients is necessary.

Conditions for dispensing from pharmacies

For hospitals.

Storage conditions and periods

Store at a temperature not exceeding 25°C in a place protected from light. Do not freeze. Keep out of the reach of children. Shelf life: 2 years.

Pharmacological properties of the drug Nutriflex special

Nutriflex special contains in one chamber amino acids, which are a substrate for protein synthesis, and minerals necessary to maintain the water-electrolyte and acid-base state of the blood, and in the second chamber - a solution of dextrose with a solution of electrolytes. Amino acids administered intravenously enter the intravascular and intracellular depots of endogenous free acids. The introduction of all amino acids necessary for protein synthesis (including essential, conditionally essential and non-essential) included in the preparation provides high nutritional efficiency and reduces the burden on the body during protein synthesis. Thus, the main therapeutic effect of the drug is to provide the body with substrates for protein synthesis and energy from glucose during parenteral nutrition. Individual concentrations of amino acids in the drug are selected in such a way that when this solution is administered intravenously, the increase in the concentration of each amino acid in the blood plasma does not go beyond normal limits, ensuring support for the homeostasis of amino acids in the blood plasma. Glucose is the most adapted energy carrier for the body; it provides the body’s need for non-protein calories, protecting amino acids from inappropriate use.

Indications for use of the drug Nutriflex special

Used for parenteral nutrition in patients with a moderate degree of catabolism, when enteral nutrition is impossible, insufficient or contraindicated:

• preoperative preparation;
• condition after surgical interventions;
• moderate to severe injuries;
• burns;
• inflammatory-destructive bowel diseases;
• short bowel syndrome;
• oncological diseases;
• sepsis, peritonitis;
• acute pancreatitis.

Contraindications to the use of the drug Nutriflex special

Disorders of amino acid metabolism, hyperkalemia, hyponatremia, metabolic disorders (for example, in diabetes mellitus), coma of unknown etiology, hyperglycemia uncorrected by insulin doses up to 6 U/h; acidosis, severe liver and/or kidney failure without hemodialysis therapy, individual sensitivity to any of the components of the mixture, breastfeeding in women, children under 2 years of age. General contraindications for parenteral nutrition: severe hematopoietic disorders, collapse, shock, severe tissue hypoxia, overhydration, water-electrolyte imbalance, pulmonary edema, decompensated heart failure.

Special instructions for the use of the drug Nutriflex special

Nutriflex is specially designed for administration into central veins. Before starting the infusion, it is necessary to correct the water-electrolyte balance and blood COR. Rapid administration of the drug can lead to volume overload and disruption of water and electrolyte balance. It is necessary to monitor blood sugar levels. If hyperglycemia occurs, the rate of administration of Nutriflex must be reduced or insulin administered in an appropriate dose. IV administration of amino acid solutions is accompanied by increased excretion of microelements in the urine, especially copper and zinc. This must be taken into account when selecting doses of microelements, especially during long-term therapy. Due to the risk of pseudoagglutination, it is not recommended to use the same infusion systems for administering blood products and multicomponent amino acid solutions. When administering the drug, it is necessary to regularly monitor the water-electrolyte balance and COR, blood sugar levels, and blood serum ionogram. During long-term treatment, blood parameters (coagulograms, liver function tests) should be monitored. If necessary, it is possible to add lipid emulsions, essential fatty acids, electrolytes, vitamins, and microelements. The drug Nutriflex is a multicomponent solution. When adding other solutions or lipid emulsions to it, the compatibility of all ingredients should be taken into account. The drug should be used immediately after mixing solutions of glucose and amino acids. It is possible to store the drug after mixing solutions of glucose and amino acids for up to 7 days at room temperature and up to 14 days when storing it in the refrigerator (taking into account the time of administration of the drug). Unused drug should not be stored. The drug is used with extreme caution during the treatment of patients with heart failure, severe liver and/or kidney failure. With total parenteral nutrition, Nutriflex is prescribed in combination with lipid emulsions. Do not use the drug if the solution is opaque, the container shows signs of damage or its seal is broken.