Nutriflex 48/150 lipid emulsion for infusion 1875ml containers, 5pcs

Composition

Isoleucine, Leucine, Lysine hydrochloride, Methionine, phenylalanine, threonine, Tryptophan, valine, Arginine monoglutamate, Histidine hydrochloride monohydrate, Alanine, Aspartic acid, Glutamic acid, Glycine, proline, Serine, soybean oil, Medium chain Triglycerides, Magnesium acetate tetrahydrate, Sodium acetate Trihydrate, Sodium Dihydrogen Phosphate dihydrate, potassium acetate, sodium hydroxide, glucose monohydrate, sodium chloride, calcium chloride dihydrate, zinc acetate, electrolytes:  sodium, potassium, calcium, magnesium, zinc, chloride, phosphate, and acetate.

Pharmacological action

Pharmacodynamics : Therapeutic ACTIONTHE task of parenteral nutrition is to provide the body with all the necessary nutrients for tissue growth and regeneration, as well as the energy needed to maintain all body functions. At the same time, amino acids are most important, since some of them are essential in protein synthesis. Co-use of energy sources (carbohydrates and lipids) is necessary to avoid 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 tubule epithelium, glucose is the only source of energy. In addition, glucose is a material for building various cellular structures. Lipids have a 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 more rapidly hydrolyzed, eliminated from the bloodstream, and completely oxidized than long-chain triglycerides. They are the main energy substrate, especially when the process of metabolism and utilization of long-chain triglycerides is disrupted, for example, when there is 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 mainly for the prevention and treatment of a lack of essential fatty acids, and only secondarily as a source of energy. Pharmacokinetics: Absorption and Bioavailability: Since Nutriflex 48/150 lipid is administered intravenously, the bioavailability of all its components is 100%. Consequently, all substances become available to the metabolism immediately. The maximum individual concentration of triglycerides depends on the dose, the rate of use, the state of metabolism and the patient’s condition (degree of exhaustion). When prescribed according to the instructions for use, the concentration of triglycerides usually does not exceed 3 mmol/l. Distribution Amino acids are part of the proteins of various body tissues. In addition, each amino acid is present in a free form inside cells and in the extracellular space. Since glucose is water-soluble, it is delivered by the blood to all organs and tissues. First, glucose enters the intravascular space, and then inside the cell. If the dosage recommendations are followed, medium-chain and long-chain fatty acids are almost completely bound to plasma albumin. When the dose is met, medium-chain and long-chain fatty acids do not cross the blood-brain barrier and, therefore, do not enter the cerebrospinal fluid. Data on penetration through the placental barrier and into breast milk are not available. Metabolisms Amino acids that are not used in protein synthesis are metabolized as follows. The amino group is cleaved from the carbon chain by transamination. The carbon chain is either oxidized to CO2 or utilized as a substrate for gluconeogenesis in the liver. The amino group is also converted to urea in the liver. Glucose is metabolized to CO 2 and H2O. Some glucose is converted to fat. After use, triglycerides are hydrolyzed to glycerol and fatty acids. Both components are used in the reactions of energy formation, synthesis of biologically active molecules, gluconeogenesis and lipid resynthesis. Excretionnotable amounts of amino acids are excreted unchanged in the urine. Excess glucose is excreted in the urine only if the elimination threshold is reached. Both soybean oil triglycerides and medium-chain triglycerides are completely metabolized to CO 2 and H 2 O. Small amounts of lipids are lost when skin cells and other epithelial membranes are exfoliated. Triglycerides are practically not excreted by the kidneys.

Indications

Filling the needs for energy, essential fatty acids, amino acids, electrolytes, and water during parenteral nutrition in patients with moderately elevated metabolic needs, when normal food intake and enteral nutrition are impossible, insufficient, or contraindicated.

Contraindications

The drug should not be prescribed for the following conditions: :

• Disorders of amino acid metabolism
• Disorders of fat metabolism
• Hyperkalemia, hypernatremia
• Severe metabolic disorders (ketoacidosis, coma of unknown etiology)
• Severe hyperglycemia, uncorrected by insulin doses up to 6 units / hour
• Acidosis
• Intrahepatic cholestasis
• Severe liver and kidney failure
• Severe heart failure
• Hemorrhagic diathesis
• Acute phase of myocardial infarction
• Acute cases of thromboembolism, fat embolism
• Identified hypersensitivity to egg or soy protein, nut oil, or any of the excipients

General contraindications for parenteral nutrition:

• Severe circulatory disorders (collapse and shock)
• Severe tissue hypoxia
• Hyperhydration states
• Violations of the water-electrolyte balance
• Acute pulmonary edema, decompensated heart failure

Side effects

Adverse side effects are listed below by organ system and frequency of development. Most of the adverse side effects associated with the use of this drug are rare (≥1/10000 – The following classification of adverse side effects by frequency of development is used: Very frequent (≥1/10)Frequent (≥1/100, Infrequent (≥1/1000, Rare (≥1/10000, Very rare (Blood and lymphatic system disorders Rare: hypercoagulation. Immune system disorders Rare: allergic reactions (e. g., anaphylactic reactions, skin rash, laryngeal, oral, and facial edema). Metabolic and nutritional disorders are very rare: hyperlipidemia, hyperglycemia, and metabolic acidosis. The frequency of these adverse reactions depends on the dose and may be higher with an overdose of lipids. Nervous system disorders Rare: drowsiness. Vasoconstriction disorders: increased or decreased blood pressure, hot flashes. Respiratory, thoracic, and mediastinal disorders Rare: shortness of breath, skin cyanosis. Disorders of the gastrointestinal tract: frequent: nausea, vomiting, loss of appetite. General disorders and disorders at the injection site are frequent: after a few days of using the drug, venous irritation, 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. In case of adverse side effects, the infusion should be stopped or, if necessary, continued at a lower dose. With repeated use, especially at the beginning of the infusion, careful monitoring of the patient’s condition is required. Plasma triglycerides should be monitored with increased frequency. Additional information on some adverse side effects Nausea, vomiting, lack of appetite, and hyperglycemia are symptoms that warrant parenteral nutrition or are often present in patients who are indicated for parenteral nutrition. Fat overload syndromethe breakdown of the ability to utilize triglycerides, which can be caused by an overdose, can lead to “fat overload”syndrome. Monitoring should be carried out for early detection of symptoms of metabolic overload. The fat overload syndrome may be of genetic etiology (individual differences in metabolism), in addition, existing or previous diseases may affect fat metabolism. This syndrome can also develop with severe hypertriglyceridemia, even if the recommended infusion rate is met, or with severe complications such as kidney failure or infection. Fat overload syndrome is characterized by hyperlipidemia, fever, fat infiltration, hepatomegaly (with or without jaundice), splenomegaly, abdominal pain, anemia, leukocytopenia, thrombocytopenia, blood clotting disorders, hemolysis and reticulocytosis, abnormal liver function tests and coma. Symptoms are reversible and usually disappear after the infusion is stopped. If signs of fat overload syndrome appear, the use of Nutriflex 48/150 lipid should be stopped immediately.

Interaction

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. Soy bean oil contains vitamin K1, which can interfere with the therapeutic effect of indirect anticoagulants-coumarin derivatives. Therefore, the therapeutic effect of indirect coumarin-derived anticoagulants should be carefully monitored.Corticosteroids and corticotropin cause sodium and fluid retention in the body. Some medications, such as insulin, can interact with the body’s lipolytic enzymes. However, these interactions have little clinical significance. use of therapeutic doses of heparin leads to an increase in plasma lipolysis, which in turn can lead to a decrease in triglyceride clearance. Nutriflex 48/150 lipid contains zinc and magnesium, which should be taken into account when prescribing other drugs containing these trace elements. Nutriflex 48/150 lipid is a complex drug. 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.

How to take, course of use and dosage

It is intended for intravenous use into peripheral and central veins. The temperature of the introduced emulsion should correspond to room temperature. The configuration of the Nutriflex lipid product chambers allows you to add the fat emulsion last, in order to pre-evaluate compatibility with other added drugs. Method of mixing the contents of the container chambers If you need to add other drugs to the Nutriflex lipid preparation, use the following method:

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

To perform an infusion after mixing the contents of the container chambers:

• After moving the emulsion to 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 rack by a special ring in the center of the container.
• Remove the white protective cap from the infusion port, connect the intravenous infusion system and start the infusion at the rate indicated in these instructions for use.

Doses:They are selected according to individual needs. Children from 14 years of age and adults The maximum daily dose is 40 ml / kg of body weight, which corresponds

• to 1.28 g of amino acids/kg of body weight/ci,
• 2.56 g of glucose/kg of body weight/ci,
• 1.6 g of fat/kg of body weight/ci.

Children from 2 to 14 years of age These recommendations are based on average needs. The dose should be individually adapted depending on the 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 paediatric patients. For children, it may be necessary to start therapeutic nutrition with half the calculated dose. The dose should be increased to the maximum in stages according to the individual metabolic capabilities of the body. For children from 2 to 5 years of age, the daily dose is 45 ml / kg of body weight, which corresponds

• to 1.44 g of amino acids/kg of body weight/ci,
• 2.88 g of glucose/kg of body weight/ci,
• 1.8 g of fat/kg of body weight/ci.

For children from 5 to 14 years of age, the daily dose is 30 ml / kg of body weight, which corresponds

• to 0.96 g of amino acids/kg of body weight/ci,
• 1.92 g of glucose/kg of body weight/ci,
• 1.20 g of fat/kg of body weight/ci.

Due to the age characteristics of children, Nutriflex lipid may not fully meet the energy requirement. In these cases, a glucose solution or fat emulsion can be added to the parenteral nutrition program as needed. Speed of use Long-term use of Nutriflex lipid is recommended. A gradual 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 of body weight / h, which corresponds

• to 0.08 g of amino acids/kg of body weight/h,
• 0.16 g of glucose/kg of body weight/h,
• 0.1 g of fat/kg of body weight/h.

For a patient weighing 70 kg, the maximum infusion rate is 175 ml/h. The rate of introduction of amino acids will be 5.6 g/h, glucose – 11.2 g/h, fat – 7. g/h. Elderly patientsdoses do not differ from those recommended for other adult patients. However, metabolism can vary significantly in the elderly, so careful monitoring of this group of patients is necessary. Patients with renal and/or hepatic insufficiencydoses are selected individually. Duration of application The use of Nutriflex lipid is not recommended for more than seven days.

Overdose

If the drug is prescribed correctly, overdose is not observed. Symptoms of volume overload or electrolyte overdosehypertonic hyperhydration, electrolyte imbalance, pulmonary edema. Symptoms of an amino acid overdose Loss of amino acids by the kidneys with the development of a violation of the amino acid balance, metabolic acidosis, nausea, vomiting, tremor. Symptoms of glucose overdose: hyperglycemia, glucosuria, dehydration, serum hyperosmolarity; hyperglycemic or hyperosmolar coma. Symptoms of lipid overdosingoverdose of lipids can lead to the development of fat overload syndrome. Therapy In cases of symptoms of overdose, the drug use should be discontinued. Further therapy is selected individually, depending on the severity of symptoms. The infusion can be resumed later at a slower rate with constant monitoring. The concentration of triglycerides in the blood plasma during the infusion should not exceed 3 mmol/l.

Special instructions

If anaphylactic reactions occur, such as fever, convulsions, rash, or shortness of breath, the infusion should be stopped immediately. Violations of the water-electrolyte balance or acid-base state, for example, hyperhydration, hyperkalemia, acidosis should be corrected before starting the infusion. Too rapid use can lead to fluid overload with impaired plasma electrolyte balance, hyperhydration, and pulmonary edema. When the drug Nutriflex 48/150 lipid is administered, it is necessary to monitor the concentration of plasma triglycerides. Patients with suspected impaired fat metabolism should not have hyperlipidemia when prescribing the drug. The introduction of fats in hyperlipidemia is contraindicated. Hypertriglyceridemia 12 hours after use of the drug indicates a violation of fat metabolism. Depending on the state of the patient’s metabolism, transient hypertriglyceridemia may develop or the concentration of glucose in the blood plasma may increase. If the concentration of triglycerides in plasma during the use of lipids exceeds 3 mmol/l, it is recommended to reduce the infusion rate. If the concentration of triglycerides in plasma remains above 3 mmol/l, the use should be suspended until the lipid concentration normalizes. If the blood glucose concentration increases above 14 mmol / l (250 mg / dl), it is necessary to reduce the dose or stop the infusion. Similar to other carbohydrate-containing medications, use of Nutriflex 48/150 lipid can lead to hyperglycemia. It is necessary to monitor the concentration of glucose in the blood. If hyperglycemia develops, the infusion rate should be reduced or insulin should be prescribed. Intravenous use of amino acids is accompanied by an increase in the excretion of trace elements in the urine, especially copper and zinc. This should be taken into account when prescribing trace elements, especially with prolonged parenteral nutrition. Resumption or use of parenteral nutrition in malnourished patients or patients who have not received adequate nutrition may cause hypokalemia, hypophosphatemia, and hypomagnesemia. Adequate use of electrolytes is necessary in accordance with deviations from normal values. It is necessary to monitor the concentration of blood plasma electrolytes, fluid balance, acid-base state, blood urea nitrogen and, with prolonged use, cellular composition, blood clotting system and liver functions. The type and frequency of laboratory tests depend on the general condition of the patient. The drug should not be administered through the same transfusion systems simultaneously, before or after blood use due to the risk of pseudoagglutination. You may need to replenish electrolytes, vitamins, and trace elements. The fat content of the drug may reduce the accuracy of laboratory tests (for example, bilirubin, lactate dehydrogenase, oxygen saturation) if blood samples are taken during or immediately after the end of the drug infusion. Infusion of the drug Nutriflex 48/150 lipid, like all drugs for intravenous use, should be carried out under aseptic conditions. Nutriflex 48/150 lipid is a complex drug. Therefore, it is not recommended to add other solutions to it without special indications.The emulsion should be used immediately after mixing, or it can be stored at a temperature of 2-8 °C for 4 days, and additionally for 48 hours (including the infusion time) at a temperature of 25 °C. If filters are used during the use of the drug, they must be fat-permeable. After accidental freezing, the drug should not be used. Use only undamaged packages that contain clear solutions of amino acids and glucose. Do not use packages that have obvious phase separation (fat droplets) in the fat emulsion chamber. Mix thoroughly before use. Container for one-time use. The remaining unused volumes of the drug should be discarded. Influence on the ability to drive vehicles and mechanisms:The drug does not affect the ability to drive vehicles, mechanisms, or engage in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Emulsion for infusions

Storage conditions

Store at a temperature not exceeding 25 °C, in a place protected from light. Do not freeze it. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Amino acids for parenteral nutrition, Other preparations Minerals

Conditions of release from pharmacies

Prescription