Amino acids for parenteral nutrition, Other preparations Minerals | Nutriflex 40/80 lipid emulsion for infusion 1875 ml containers built 5 pcs.

Release form

Emulsion for infusion

Packing

5 containers of 1875 ml.

Pharmacological action

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

The goal 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 indispensable 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, renal tubule epithelium, glucose is the only source of energy. In addition, glucose is a material for the construction of various cellular structures.

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

Medium chain triglycerides are more rapidly hydrolyzed, eliminated from the bloodstream, and completely oxidized compared to long chain triglycerides.

They are the main energy substrate, especially when the metabolism and utilization of long-chain triglycerides are 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 mainly for the prevention and treatment of the lack of essential fatty acids and only secondarily as an energy source.

Pharmacokinetics

Absorption

Bioavailability: Since Nutriflex 40/80 lipid is administered intravenously, the bioavailability of all its components is 100%. Consequently, all substances become available to metabolism immediately.

The maximum individual concentration of triglycerides depends on the dose, rate of administration, metabolic state and patient condition (degree of exhaustion). When prescribed according to the instructions for use in compliance with the dose, the concentration of triglycerides usually does not exceed 3 mmol / L.

Distribution of

Amino acids are part of the proteins of various body tissues. In addition, each amino acid is present in free form inside the cells and in the extracellular space.

Since glucose is soluble in water, it is delivered by blood to all organs and tissues. First, glucose enters the intravascular space, and then into the cell.

Subject to dosage recommendations, medium and long chain fatty acids bind almost completely to plasma salbumin.

When the dose is observed, medium and long chain fatty acids do not cross the blood-brain barrier and, therefore, do not enter the cerebrospinal fluid.

There are no data on penetration through the placental barrier and into breast milk.

Metabolism

Amino acids 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 liver gluconeogenesis. The amino group also turns into urea in the liver. Glucose is metabolized to CO2 and H2O. Some glucose is converted to fat.

After administration, triglycerides are hydrolyzed to glycerol and fatty acids. Both components are used in reactions of energy production, synthesis of biologically active molecules, gluconeogenesis and lipid resynthesis.

Excretion

A small amount of amino acids is excreted unchanged in the urine. Excess glucose is excreted in the urine only if the excretion threshold is reached. Both oil soybean triglycerides and medium chain triglycerides are completely metabolized to CO2 and H2O. Small amounts of lipids are lost when desquamating skin cells and other epithelium-coated membranes. Triglycerides are practically not excreted by the kidneys.

Contraindications

The drug cannot be prescribed in the following conditions:

Disorders of the amino acid metabolism

Disorders of the fat metabolism

Hyperkalemia, hypernatremia

Severe metabolic disturbances (ketoacidosis, coma of unclear etiology) uncorrectable by doses of insulin up to 6 units / hour

Acidosis

Intrahepatic cholestasis

Severe hepatic and renal failure

Severe heart failure

Hemorrhagic diathesis srdlkrom fatty fibromyloid sardolcoma to any of

excipients General contraindications for parenteral nutrition:

Severe circulatory disorders (collapse and shock)

Severe gi tissue poxia

Hyperhydration conditions

Disruption of water-electrolyte balance

Acute pulmonary edema, decompensated heart failure

Composition

Isoleucine,

leucine,

lysine hydrochloride,

methionine,

phenylalanine,

threonine,

tryptophan,

valine,

arginine monoglyutamat,

histidine hydrochloride monohydrate,

alanine,

aspartic acid,

glutamic acid,

glycine ,

proline,

serine,

soya bean oil,

medium chain triglycerides,

magnesium acetate tetrahydrate,

sodium acetate trihydrate,

sodium dihydrogen phosphate dihydrate, sodium

sodium hydroxide, sodium chloride sodium sulfide, sodium sulfide, sodium chloride, sodium chloride l chloride dihydrate,

zinc acetate,

electrolytes: sodium, potassium, calcium, magnesium, zinc, chloride, phosphate, acetate.

Dosage and administration

Intended for intravenous administration in peripheral and central veins.

The temperature of the emulsion to be introduced should be at room temperature.

The configuration of Nutriflex 40/80 lipid chambers allows you to add a fat emulsion last, to pre-evaluate compatibility with other added drugs.

Method of mixing the contents of the chambers of the

container If you need to add other drugs to Nutriflex 40/80 lipid, use the following method:

1. Remove the secondary plastic bag from the container, expand and lay the container on a firm, even surface (on the table)

2. With two hands pushing on the upper left chamber of the container (containing glucose solution with electrolytes), destroy the septum separating it from the lower chamber (containing solution of amino acids with electrolytes)

3. When the need to add electrolytes, trace elements and other compatible medications (including water-soluble vitamins) through an additional port with a red protective cap

4. With two hands pushing on the upper right chamber of the container nera (containing fat emulsion), destroy the partition separating it from the bottom

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

6 cap. Mix the contents of all container chambers gently.

If you do not need to add other drugs to Nutriflex 40/80 lipid, use the following procedure:

1. Remove the secondary plastic bag from the container, unfold and lay the container on a firm, level surface (on the table)

2. Push the two upper hands with two hands container chambers, destroy the partitions separating them from the bottom

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

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

Having moved the emulsion to the lower chamber, fold the container along the midline separating the empty upper chambers from the lower

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 system for intravenous infusion and start the infusion at the speed specified in these instructions for use.

Doses:

are selected according to individual needs.

Children over 14 years old and adults

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

- 1.28 g of amino acids / kg body weight / day,

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

- 1.6 g of fat / kg body weight / day.

Children 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, the degree of hydration of pediatric patients must be taken into account.

For children, it may be necessary to start nutritional therapy with half the estimated dose. The dose should be increased to the maximum stepwise 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 of amino acids / kg body weight / day,

1.92 g of glucose / kg body weight / day,

1.20 g of fat / kg body weight /day.

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

Speed ​​of administration

Long-term administration of 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 / h,

0.16 g glucose / kg body weight / h,

0.1 g fat / kg body weight / h.

For a patient weighing 70 kg, the maximum infusion rate will be 175 ml / h. In this case, the rate of introduction of amino acids will be 5.6 g / h, glucose - 11.2 g / h, fat - 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 Nutriflex 40/80 lipid is not recommended for more than seven days.

Side effects

Disorders from the blood and lymphatic system: rare - hypercoagulation.

Immune system disorders: rare - allergic reactions (eg, anaphylactic reactions, skin rash, swelling of the larynx, mouth and face).

Metabolic and nutritional disorders: very rare - hyperlipidemia, hyperglycemia, metabolic acidosis.

The frequency of these adverse adverse reactions is dose dependent and may be higher in case of lipid overdose.

Disorders of the nervous system: 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.

Disorders of the gastrointestinal tract: infrequent - nausea, vomiting, loss of appetite.

General disorders and disorders at the injection site: frequent - vein irritation, phlebitis or thrombophlebitis may develop after a few days of using the drug - headache, fever, sweating, feeling cold, chills, back pain, bones, chest, lumbar areas are very rare - fat overload syndrome.

In the event of adverse adverse reactions, the infusion should be stopped or, if necessary, continued at a lower dose.

With repeated administration, especially at the beginning of the infusion, careful monitoring of the patient's condition is required. Blood plasma triglycerides should be monitored at increased intervals.

Additional information about some adverse side reactions

Nausea, vomiting, lack of appetite and hyperglycemia are symptoms that are the basis for prescribing parenteral nutrition or are often found in patients who are shown parenteral nutrition.

Fat overload syndrome

Impaired triglyceride utilization, which may be caused by an overdose, can lead to fat overload syndrome. Monitoring should be done to detect symptoms of metabolic overload early. Fat overload syndrome may be of genetic etiology (individual differences in metabolism), in addition, existing or transferred diseases can affect fat metabolism.

This syndrome can also develop in the presence of severe hypertriglyceridemia, even if the recommended rate of infusion is observed, and also against the background of the development of severe complications, such as renal failure or infection. Fat overload syndrome is characterized by hyperlipidemia, fever, fatty infiltration, hepatomegaly (with or without jaundice), splenomegaly, abdominal pain, anemia, leukocytopenia, thrombocytopenia, impaired blood coagulation, hemolysis and reticulocytosis, corresponding to liver functionosis, and liver functionosis.

Symptoms are reversible and usually disappear after stopping the infusion. In case of signs of fat overload syndrome, the administration of Nutriflex 40/80 lipid should be stopped immediately.

Drug Interactions

Potassium-containing solutions should be administered with caution to patients who are taking drugs that increase serum potassium, 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 - coumarins derivatives. Therefore, the therapeutic effect of indirect anticoagulants - coumarin derivatives should be carefully monitored.

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

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

Nutriflex 40/80 lipid contains zinc and magnesium, which must 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.

Storage conditions

In the dark place at a temperature of no higher than 25 РC.

Expiration

2 years

Deystvuyuschee substances

amino acids for parenteral POWER, Prochye Preparations Myneral

Dosage form

emulsion for infusion

B.Broun Melstungen AG, Germany