Nutriflex 40/80 lipid emulsion for infusion 1875ml containers, 5pcs

Composition

Isoleucine,

leucine,

lysine hydrochloride,

methionine,

phenylalanine,

threonine,

tryptophan,

valine,

arginine, and monoglutamate,

histidine hydrochloride monohydrate,

alanine,

aspartic acid,

glutamic acid,

glycine,

Proline,

serine,

soybean oil,

medium chain triglycerides,

magnesium acetate Tetra hydrate,

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

NUTRIFLEX 40/80 LIPID is a three-chamber system for parenteral nutrition.

The task of parenteral nutrition is to provide the body with all the necessary nutrients for tissue growth and regeneration, as well as the energy necessary 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.

Indications

Filling the daily requirement for energy, essential fatty acids, amino acids, electrolytes and water with parenteral nutrition

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

Disorders of the blood and lymphatic system:  rare – hypercoagulation.

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 – increased or decreased 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:  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 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 40/80 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 40/80 lipid contains zinc and magnesium, which should be taken into account when prescribing other drugs containing these trace elements.

Nutriflex 40/80 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 chambers of the drug Nutriflex 40/80 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 medications to the preparation Nutriflex 40/80 lipid, use the following method:

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

2. By pressing with both hands on the upper left chamber of the container (containing a glucose solution 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 an additional port with a red protective cap.

4. By 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 an additional port with a red protective cap;

6. Carefully mix the contents of all the container chambers.

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

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

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

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

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/day,

– 2.56 g of glucose/kg of body weight/day,

– 1.6 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 45 ml / kg of body weight, which corresponds

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

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/day,
• 1.92 g of glucose/kg of body weight/day,
• 1.20 g of fat/kg of body weight/day.

Due to the age characteristics of children, Nutriflex 40/80 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 40/80 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 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

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

Storage conditions

In a dark place, at a temperature not exceeding 25 °C.

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