Nutriflex 70/180 lipid emulsion for infusion 1875ml containers, 5pcs

Composition

Auxiliary substances:

citric acid monohydrate 0-0.336 g,

glycerol 5 g,

egg lecithin 2.4 g,

sodium oleate 0.06 g,

d/i water-up to 1000 ml.

Osmolality: 2090 mOsm / kg. pH: 5.0-6.0.

Pharmacological action

Therapeutic action

Parenteral nutrition aims to provide the body with all the necessary nutrients for tissue growth and regeneration, as well as the energy needed to support 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.

Indications

•  Filling the needs for energy, essential fatty acids, amino acids, electrolytes, and water during parenteral nutrition in patients with moderately elevated and high metabolic needs, when normal food intake and enteral nutrition are impossible, insufficient, or contraindicated.
• If it is necessary to limit the volume of administered fluid (heart and kidney failure, a large volume of other administered solutions).

Contraindications

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

•   Identified hypersensitivity to egg white or soy bean protein, nut oil or any of the components of the drug;
• 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, uncorrected by insulin doses up to 6 units/h;
•   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.

General contraindications for parenteral nutrition:

• Unstable, life-threatening circulatory disorders (collapse and shock);
•   Severe tissue hypoxia;
• Hyperhydration conditions;
• Water-electrolyte balance disorders;
•   Acute pulmonary edema;
• Decompensated heart failure.

With caution

Caution should be exercised when increasing the osmolarity of the serum. Given the potential risk of volume overload when using Nutriflex 70/180 lipid, caution should be exercised in patients with impaired heart or kidney function.

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

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, <1/10)

Infrequent (≥1/1000,

Rare (≥1/10000,

Very rare (≤1/10000)

Disorders of the blood and lymphatic system

Rare: hypercoagulability.

Immune system disorders

Rare: allergic reactions (for example, anaphylactic reactions, skin rash, laryngeal, oral, and facial edema).

Metabolic and nutritional disorders

Very rare: hyperlipidemia, hyperglycemia, 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.

Vascular disorders

Rare: high or low blood pressure, hot flashes.

Respiratory, thoracic and mediastinal disorders

Rare: shortness of breath, cyanosis of the skin.

Disorders of the gastrointestinal tract

Infrequent: 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 about some adverse side effects

Nausea, vomiting, lack of appetite, and hyperglycemia are symptoms that are considered grounds for prescribing parenteral nutrition or are often present in patients who are indicated for parenteral nutrition.

Fat overload syndrome

A violation 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 70/180 lipid should be stopped immediately.

How to take, course of use and dosage

Method of application

It is intended for intravenous use only in the central veins.

The temperature of the introduced emulsion should correspond to room temperature.

The configuration of the chambers of the drug Nutriflex 70/180 lipid allows you to add the fat emulsion last, in order to pre-evaluate compatibility with other added drugs.

Method for mixing the contents of container chambers

If it is necessary to add other medicines to Nutriflex 70/180 lipid, use the following procedure:

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

2. Pushing two hands on the upper left chamber of the container (containing glucose with electrolytes), destroy wall, separating it from the lower chamber (containing the amino acid solution with electrolytes);

3. If you want to add electrolytes, trace elements and other compatible drugs (including water-soluble vitamins) via the auxiliary port with a red protective cap;

4. Pushing two hands on the upper right chamber of the container (containing fat emulsion), to destroy the partition separating her from the bottom of the camera;

5. If you want to add fat-soluble vitamins using additional port with a red protective cap;

6. Gently stir the contents of all the chambers of the container.

If there is no need to add other medications to Nutriflex 70/180 lipid, use the following procedure:

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

2. Press 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 the chambers of the container.

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

• After moving the emulsion to the lower chamber, fold the container along the middle one. a line that separates empty upper cells 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 speed specified 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 35 ml / kg of body weight, which corresponds

• to 2.0 g of amino acids/kg of body weight/day,
• 5.04 g of glucose/kg of body weight/day,1.4 g of fat/kg of 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 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 25 ml / kg of body weight, which corresponds

• to 1.43 g of amino acids/kg of body weight/day,
• 3.60 g of glucose/kg of body weight/day, -1.0 g of fat/kg of body weight/day.

For children from 5 to 14 years of age, the daily dose is 17.5 ml / kg of body weight, which corresponds

• to 1.0 g of amino acids/kg of body weight/day,
• 2.52 g of glucose/kg of body weight/day,
• 0.7 g of fat/kg of body weight/day.

Due to the age characteristics of children, Nutriflex 70/180 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.

Introduction rate

Long-term use of Nutriflex 70/180 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 -1.7 ml/kg of body weight/h, which corresponds

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

For a patient weighing 70 kg, the maximum infusion rate will be 119 ml/h. At the same time, the rate of introduction of amino acids will be 6.8 g/h, glucose – 17.1 g/h, fat – 4.8 g/h.

The maximum energy intake should not exceed 40 kcal / kg of body weight / day. In special cases (for example, for patients with burns), it is possible to increase this indicator.

Elderly patients

The doses 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 insufficiency

Doses are selected individually.

Duration of application

The duration of application of Nutriflex 70/180 lipid is not limited. With prolonged use, it is necessary to add appropriate amounts of trace elements and vitamins.

Overdose

If the drug is prescribed correctly, overdose is not observed.

Symptoms of volume overload or electrolyte overdose

Hypertonic 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 overdose,

An overdose of lipids can lead to the development of fat overload syndrome.

Therapy

In cases of overdose symptoms, the drug 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.

Interaction with other medicinal products

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 may 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 70/180 lipid contains zinc and magnesium, which should be taken into account when prescribing other drugs containing these trace elements.

Nutriflex 70/180 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.

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 70/180 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 plasma or blood 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 70/180 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 70/180 lipid, as with all drugs for intravenous use, should be carried out under aseptic conditions.

Nutriflex 70/180 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 retain obvious phase separation (fat droplets) in the fat emulsion chamber after shaking.

Mix thoroughly before use.

Container for one-time use. The remaining unused volumes of the drug are subject to destruction.

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.

Storage conditions

Store at a temperature not exceeding 25 °C in a place protected from light.

Do not freeze it.

Shelf life

2 years

Active ingredient

Amino acids for parenteral nutrition, Other preparations Minerals

Conditions of release from pharmacies

By prescription

Dosage form

emulsion for infusions