Description
Release form
Emulsion for infusion
Pharmacological action of
Pharmacodynamics:
Therapeutic action of
The objective 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. The joint introduction 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 hydrolyze faster 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 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 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 48/150 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’s 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 albumin.
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 energy generation reactions, 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.
Indications
Supplementation of energy requirements, essential fatty acids, amino acids, electrolytes, water for parenteral nutrition in patients with moderately increased metabolic needs, when normal eating and enteral nutrition are impossible, insufficient or contraindicated.
Special instructions
If anaphylactic reactions such as fever, cramps, rash, or shortness of breath occur, the infusion should be stopped immediately.
Violations of the water-electrolyte balance or acid-base state, for example, hyperhydration, hyperkalemia, acidosis should be adjusted before the start of the infusion.
Too fast administration can lead to fluid overload with impaired electrolyte balance of blood plasma, hyperhydration and pulmonary edema.
With the introduction of Nutriflex 48/150 lipid, it is necessary to control the concentration of plasma triglycerides.
In patients with suspected impaired fat metabolism, there should not be hyperlipidemia when prescribing the drug. The introduction of fats with hyperlipidemia is contraindicated. Hypertriglyceridemia 12 hours after the administration of the drug indicates a violation of fat metabolism.
Depending on the patient’s metabolic state, transient hypertriglyceridemia may develop or plasma glucose concentration may increase. If the concentration of triglycerides in the plasma during the administration of lipids exceeds 3 mmol / l, recommended to reduce the rate of infusion. If the concentration of triglycerides in the plasma remains above 3 mmol / l, administration should be suspended until the concentration of lipids is normalized.
When increasing the concentration of glucose in the blood over 14 mmol / l (250 mg / dl), a dose reduction or stopping the infusion is necessary.
Like other carbohydrate-containing drugs, the administration of Nutriflex 48/150 lipid can lead to hyperglycemia. It is necessary to control the concentration of glucose in the blood. In the case of hyperglycemia, the rate of infusion should be reduced or insulin should be prescribed.
Intravenous administration of amino acids is accompanied by increased 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.
Resuming or administering parenteral nutrition in malnourished patients or in patients who have not received adequate nutrition can cause hypokalemia, hypophosphatemia, and hypomagnesemia. An adequate introduction of electrolytes is necessary in accordance with deviations from normal values.
It is necessary to control the concentration of blood plasma electrolytes, fluid balance, acid-base state, blood urea nitrogen and, with prolonged administration, the cellular composition, blood coagulation system and liver functions. The type and frequency of laboratory tests depends on the general condition of the patient.
The drug should not be administered through the same transfusion systems simultaneously, before or after the introduction of blood due to the risk of pseudoagglutination.
May require replenishment of electrolytes, vitamins, and trace elements.
The fat content in a preparation may decrease 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.
The infusion of Nutriflex 48/150 lipid, as with all intravenous drugs, must be carried out under aseptic conditions.
Nutriflex 48/150 lipid is a complex preparation. 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 infusion time) at a temperature of 25 ° C.
If filters are used during drug administration, they must be greaseproof.
After accidental freezing, the drug should not be used.
Use only intact packaging in which the solutions of amino acids and glucose are clear. Do not use packages in which there is an obvious phase separation (fat droplets) in a chamber with a fat emulsion.
Stir before use.
Single use container. Discard the remaining unused volumes of the drug.
Impact on the ability to drive transp. Wed and fur .:
The drug does not affect the ability to drive vehicles, mechanisms, as well as engage in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
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 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 lipid chambers allows fat emulsion to be added last, in order to preliminarily evaluate the compatibility with other added drugs.
Method of mixing the contents of the chambers of the
container If you need to add other drugs to the Nutriflex lipid preparation, use the following method:
Remove the secondary plastic bag from the container, unfold and lay the container on a firm, level surface (on the table)
Pressing the upper left chamber of the container with both hands (containing a solution of glucose with electrolytes), destroy the septum separating it from the lower chamber (containing a solution of amino acids with electrolytes)
If necessary, add electrolytes, trace elements and other compatible medications (including water-soluble vitamins) through an additional port with a red protective cap
With two hands pressing on the upper right chamber of the container (containing fat emulsion), destroy the septum separating it from the lower chamber
Add fat-soluble vitamins if necessary optional port with red
protective cap Gently mix the contents of all container chambers.
If there is no need to add other drugs to Nutriflex lipid, use the following procedure:
Remove the secondary plastic bag from the container, unfold and place the container on a firm, level surface (on the table)
Pressing the two upper chambers of the container with two hands, destroy the partitions, separating them from the bottom
camera Gently mix the contents of all the cameras in the container.
To carry out the infusion after mixing the contents of the container chambers:
After moving 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 / ki,
2.56 g of glucose / kg body weight / ki,
1.6 g fat / kg body weight / ki.
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 / ki,
2.88 g glucose / kg body weight / ki,
1.8 g fat / kg body weight / ki.
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 / ki,
1.92 g glucose / kg body weight / ki,
1.20 g fat / kg body weight / ki.
Due to the age-related characteristics of children, Nutriflex 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 ² ¹ ² ¹of administration
Long-term administration of Nutriflex 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 of
Administration of the drug Nutriflex lipid is not recommended for more than seven days.
Side effects
Adverse adverse reactions are listed below in organ systems and frequency of development. Most of the adverse side reactions associated with the use of this drug rarely develop (? 1/10000 – <1/1000). The following classification is usedadverse reactions by developmental frequency: Very frequent (? 1/10) Frequent (? 1/100, <1/10) Infrequent (? 1/1000, <1/100) Rare (? 1/10000, <1/1000) Very rare (<1/10000) Disorders of 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: increase or decrease in 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: irritation of veins, phlebitis or thrombophlebitis may develop after a few days of using the drug. Rare: headache, fever, sweating, feeling cold, chills, pain in the back, bones, chest, and lumbar region. 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. When reintroduced, 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 effects Nausea, vomiting, lack of appetite and hyperglycemia are symptoms that are the basis for the administration of parenteral nutrition or are often found in patients who are shown parenteral nutrition. Fat overload syndrome Impaired triglyceride utilization that 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 past diseases can affect fat metabolism. This syndrome can also develop against the background 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 kidney 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 48/150 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, may 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 48/150 lipid contains zinc and magnesium, which must be taken into account when prescribing other drugs containing these trace elements. Nutriflex 48/150 lipid is a complex preparation. Therefore, it is not recommended to add other solutions to it without first checking for compatibility, since otherwise emulsion stability cannot be guaranteed. Overdose With the correct prescription of the drug, an overdose is not observed. Symptoms of volume overload or overdose of electrolytes Hypertensive hyperhydration, electrolyte imbalance, pulmonary edema. Symptoms of an overdose of amino acids Loss of amino acids by the kidneys with the development of amino acid imbalance, 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 symptoms of overdose, the drug should be discontinued. Further therapy is selected individually depending on the severity of the symptoms. Infusion may be resumed later at a slower rate with constant monitoring. The concentration of triglycerides in blood plasma during infusion should not exceed 3 mmol / L. Storage conditions Store at a temperature not exceeding 25 ° C, in a dark place. Do not freeze. Keep out of the reach of children. Expiration 2 years. Terms of delivery from pharmacies Prescription
