Nutriflex 40/80 lipid - instructions for use, dose, side effects, contraindications

The composition of the preparation is indicated after mixing the contents of the container chambers in 1000 ml, as well as in packages of 1250 ml, 1875 ml and 2500 ml.

	in 1000 ml	in 1250 ml	in 1875 ml	in 2500 ml
Active substances:
Isoleucine	1.870 g	2.340 g	3,510 grams	4,680 g
Leucina	2,500 grams	3.130 g	4.700 g	6,260 g
Lysine hydrochloride	2.270 g	2.840 grams	4.260 g	5.680 grams
(corresponds to lysine)	1.810 grams	2.260 g	3,390 grams	4.520 grams
Methionine	1.570 g	1.960 g	2.940 g	3.920 grams
Phenylalanine	2,810 grams	3,510 grams	5.270 g	7.020 g
Threonine	1.460 g	1.820 grams	2.730 grams	3,640 g
Tryptophan	0.460 g	0.570 g	0.860 g	1.140 g
Valine	2.080 g	2,600 g	3.900 grams	5,200 grams
Arginine	2.160 g	2,700 grams	4,050 grams	5,400 grams
Histidine hydrochloride monohydrate	1,350 g	1.690 g	2.540 grams	3.380 grams
(corresponding to histidine)	1,000 grams	1.250 g	1.880 grams	2,500 grams
Glycine	1,320 g	1.650 g	2.480 grams	3,300 g
Alanina	3.880 grams	4.850 grams	7.280 grams	9,700 g
Pronina	2.720 g	3,400 grams	5,100 g	6,800 grams
Aspartic acid	1,200 grams	1,500 grams	2.250 g	3,000 grams
Glutamic acid	2,800 grams	3,500 g	5.250 g	7,000 g
Serina	2,400 g	3,000 grams	4,500 g	6,000 grams
Sodium hydroxide	0.640 g	0,800 g	1,200 grams	1,600 g
Sodium chloride	0.865 g	1.081 g	1.622 g	2.162 g
Sodium dihydrogen phosphate dihydrate	0.936 g	1.170 g	1.755 grams	2.340 g
Sodium acetate trihydrate	0.435 g	0.544 g	0.816 g	1.088 g
Potassium acetate	2.354 g	2.943 g	4,415 g	5.866 g
Magnesium acetate tetrahydrate	0.515 g	0.644 g	0.966 g	1.288 g
Calcium chloride dihydrate	0.353 g	0.441 g	0.662 g	0.882 g
Zinc acetate dihydrate	5,300 mg	6.625 mg	9.938 mg	13.250 mg
Glucose monohydrate	70,400 grams	88,000 g	132,000 g	176,000 g
(corresponding to anhydrous glucose)	64,000 g	80,000 grams	120,000 g	160,000 g
Medium chain triglycerides	20,000 g	25,000 g	37,500 grams	50,000 grams
Soybean oil beans	20,000 g	25,000 g	37,500 grams	50,000 grams
Auxiliary substances:
Acids of lemon monohydrate	0-0.336 g	0-0.420 g	0-0.630 g	0-0.840 g
Glycerol	5,000 grams	6,250 g	9.375 g	12,500 grams
Lecithin Egg	2,400 g	3,000 grams	4,500 g	6,000 grams
Sodium oleate	0.060 g	0.075 g	0.1125 g	0.150 g
Water for Injection	up to 1000 ml	up to 1250 ml	up to 1875 ml	up to 2500 ml

The emulsion after mixing the contents of the container chambers contains:		in 1000 ml	in 1250 ml	in 1875 ml	in 2500 ml
Amino acids [g]		32	40	60	80
Carbohydrates	[g]	64	80	120	160
Fats	[g]	40	50	75	100
Total nitrogen	[g]	4,6	5,7	8,6	11,4

Energy value	in 1000 ml	in 1250 ml	in 1875 ml	in 2500 ml
Amino acids [kJ (kcal)]	536(128)	670(160)	1005(240)	1340 (320)
Carbohydrates [kJ (kcal)]	1072(256)	1340 (320)	2010(480)	2680(640)
Fats [kJ (kcal)]	1592 (380)	1990(475)	2985(715)	3980(950)
Non-protein energy value [kJ (kcal)]	2664(636)	3330 (795)	4995 (1195)	6660(1590)
Total energy value [kJ (kcal)]	3200 (764)	4000 (955)	6000 (1435)	8000(1910)

Concentration of electrolytes (mmol)	in 1000 ml	in 1250 ml	in 1875 ml	in 2500 ml
Sodium	40,0	50,0	75,0	100,0
Potassium	24,0	30,0	45,0	60,0
Calcium	2,4	3,0	4,5	6,0
Magnesium	2,4	3,0	4,5	6,0
Zinc	0,024	0,03	0,045	0,06
Chlorides	38,4	48,0	72,0	96,0
Acetates	32,0	40,0	60,0	80,0
Phosphates	6,0	7,5	11,25	5,0

Osmolality	950 mOsm / kg
pH	5,0-6,0

Description:

Solutions of amino acids with electrolytes and glucose with electrolytes: transparent, pale yellow or yellow solutions.

Fat emulsion: an emulsion of the oil-in-water type of milky white color.

Pharmacotherapeutic group:nutrition parenteral remedy

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

Therapeutic action

The task of parenteral nutrition is to supply the body with all the necessary nutrients for the growth and regeneration of tissues, as well as the energy necessary to maintain all the functions of the body.

In this case, the most important amino acids, as some of them are indispensable in the synthesis of protein. 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 CNS, bone marrow, erythrocytes, epithelium of the renal tubules, glucose is the only source of energy. In addition, glucose is the material for constructing various cellular structures.

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

Medium chain triglycerides are faster hydrolyzed, eliminated from the bloodstream and completely oxidized compared to long-chain triglycerides.They are the main energy substratum, 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 co-factors of lipoprotein lipase.

Unsaturated fatty acids, which are part of long chain triglycerides, are used in the body mainly for the prevention and treatment of a deficiency of essential fatty acids and only in the second place as an energy source.

Pharmacokinetics:

Suction

Bioavailability:

Since Nutriflex 40/80 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, rate of administration, the state of metabolism, and the state of the patient (degree of depletion). When administered according to the instructions for use with a dose, the concentration of triglycerides usually does not exceed 3 mmol / l.

Distribution

Amino acids are part of the proteins of different, body tissues. In addition, each amino acid is present in a free form within the cells and in the extracellularspace.

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.

When observing the recommendations for dosing, medium chain and long chain fatty acids almost completely bind to plasma albumin.

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

Data on penetration through the placental barrier and into breast milk are absent.

Metabolism

Amino acids, not used in protein synthesis, are metabolized as follows. The amino group is split off from the carbon chain by transamination. The carbon chain is either oxidized to CO₂, or is utilized as a substrate for gluconeogenesis in the liver. The amino group also turns into the liver into urea.

Glucose is metabolized to CO₂ and H₂A. Some of the glucose is converted to fat.

After administration, triglycerides are hydrolyzed to glycerol and fatty acids.Both components are used in the reactions of energy generation, 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 elimination threshold is reached.

Both triglycerides of soybean oil, and medium-chain triglycerides are completely metabolized to CO₂ and H₂A. Small amounts of lipids are lost when the skin cells and other epithelial membranes are clipped. Triglycerides are practically not excreted by the kidneys.

Indications:

- Replenishment of energy requirements, essential fatty acids, amino acids, electrolytes, water with parenteral nutrition in patients with standard and moderately elevated metabolic needs, when conventional intake, food and enteral nutrition are not possible, insufficient or contraindicated.

- Parenteral nutrition in patients with hyperglycemia or the threat of its development.

- Parenteral nutrition with the availability of infusion only in peripheral veins (in outpatient settings, surgery units, at home).

Contraindications:

The drug can not be administered under the following conditions:

- Revealed hypersensitivity to egg white or soy protein, walnut oil or any of the components of the drug;

- Congenital disorders of amino acid metabolism;

- Disturbances 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 unclear etiology);

- Expressed hyperglycemia, uncorrected by insulin doses up to 6 units / h;

- Intrahepatic cholestasis;

- Severe hepatic impairment;

- Severe renal failure in the absence of renal replacement therapy;

- Progressing hemorrhagic diathesis;

- Acute phase of myocardial infarction and stroke;

- Acute cases of thromboembolism, fat embolism;

- Children under 2 years.

General contraindications for parenteral nutrition:

- Unstable, life-threatening circulatory disorder (collapse and shock);

- Pronounced tissue hypoxia;

- Hyperhydration states;

- Violations of the water-electrolyte balance;

- Acute pulmonary edema;

- Decompensated heart failure.

Carefully:

Care should be taken with increasing serum osmolality.

Considering the possible risk of bulk overload when using Nutriflex 40/80 lipid, caution should be exercised in patients with impaired heart or kidney function.

The drug should be administered with caution to patients with impaired fat metabolism (eg, kidney failure, diabetes, pancreatitis, impaired liver function, hypothyroidism with hypertriglyceridemia and sepsis).

With these conditions, monitoring of serum triglyceride concentrations is mandatory.

Pregnancy and lactation:

Pregnancy

No studies have been performed to evaluate the effect of Nutriflex 40/80 lipid on the embryo or fetus. The purpose of the drug during pregnancy is possible if the potential benefit to the mother exceeds the potential risk to the fetus.

Breastfeeding period

As a rule, breast-feeding during parenteral nutrition is not recommended.

Dosing and Administration:

Intended for intravenous injection into peripheral and central veins.The temperature of the emulsion to be introduced must correspond to room temperature.

The configuration of the chambers of the preparation Nutriflex 40/80 lipid allows adding the fat emulsion in the last turn, in order to evaluate preliminary compatibility with other added drugs.

The technique of mixing the contents of the container chambers

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

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

2. Having pressed two hands on the upper left chamber of the container (containing glucose solution with electrolytes), destroy the septum 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. Having pressed two hands on the upper right chamber of the container (containing the fat emulsion), destroy the septum that separates it from the lower chamber;

5. If necessary, add fat-soluble vitamins through an additional port with a red protective cap;

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

In the absence, the need to add other "drugs to the drug Nutriflex 40/80 lipid, use the following procedure:

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

2. Having pressed two hands on the two upper chambers of the container, destroy the partitions that separate them from the lower chamber;

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

For infusion after mixing the contents of the container chambers:

- 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 for a special ring in the center of the container;

- Remove the white protective cap from the infusion port, connect the system for intravenous infusions and start infusion at the rate specified in these instructions for use.

Doses:

Are selected according to individual needs.

Children from 14 years 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 glucose / kg body weight / day,

- 1.6 g fat / kg 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 patients, childhood.

For children, it may be necessary to begin a diet with half the calculated dose. The dose should be increased to the maximum in stages in accordance with the individual metabolic capabilities of the body.

For children from 2 to 5 years 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 fat / kg body weight / day.

For children from 5 to 14 years old 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 fat / kg body weight / day.

Due to the age-specific features 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.

The rate of administration

Nutriflex 40/80 lipid is recommended for a long time. The stepwise increase in the rate of infusion during the first 30 minutes reduces the incidence of possible complications.

Maximum infusion rate - 2.5 ml / kg body weight / h, which corresponds to

- 0.08 g of amino acids / kg of body weight / h,

- 0.16 g glucose / kg body weight / h,

- 0.1 g fat / kg body weight / h.

For a patient with a body weight of 70 kg the maximum infusion rate is 175 ml / h.

At the same time, the rate of introduction of amino acids is 5.6 g / h, glucose - 11.2 g / h,

fats - 7.0 g / h.

Elderly patients

Doses do not differ from those recommended for other adult patients. Nevertheless, the 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 application

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

Side effects:

Adverse side reactions are listed below for organ systems and frequency of development. Most adverse adverse reactions associated with the use of this drug are rare (> 1/10000 - <1/1000).

The following classification of adverse reactions by frequency of development is used:

Very frequent (≥1 / 10)

Frequent (≥1 / 100, <1/10)

Infrequent (≥1 / 1000, <1/100)

Rare (≥1 / 10000, <1/1000)

Very rare (<1/10000)

Violations of the blood and lymphatic system

Rare: hypercoagulation.

Immune system disorders

Rare: allergic reactions (for example, anaphylactic reactions, skin rash, swelling of the larynx, mouth and face).

Disorders from the metabolism and nutrition

Very rare: hyperlipidemia, hyperglycemia, metabolic acidosis.

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

Disturbances from the nervous system

Rare: drowsiness.

Vascular disorders

Rare: increase or decrease in blood pressure, "hot flashes".

Disturbances from the respiratory system, chest and mediastinal organs

Rare: dyspnea, cyanosis of the skin.

Disorders from the gastrointestinal tract

Infrequent: nausea, vomiting, loss of appetite.

General disorders and disorders at the site of administration

Frequent: after a few days of using the drug, vein irritation, phlebitis or thrombophlebitis may develop.

Rare: headache, fever, sweating, a feeling of cold, chills, pain in the back, bones, chest and lumbar region.

Very rare: fat overload syndrome.

In case of adverse adverse reactions, the infusion should be stopped or, if necessary, continued in a smaller dose.

When re-introduction, especially at the beginning of the infusion, careful monitoring of the patient's condition is required. Triglycerides of blood plasma should be monitored with increased frequency.

Additional information on certain adverse reactions

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

The syndrome of fat overload

Violation of the ability to dispose of triglycerides, which can be caused by an overdose, can lead to a syndrome of "fat overload."It is necessary to monitor for the early detection of symptoms of metabolic overload. The syndrome of fat overload can be a genetic etiology (individual differences in metabolism), in addition, the fat metabolism can be influenced by existing or transferred diseases. This syndrome can also develop against a background of severe hypertriglyceridemia, even with the recommended infusion rate, as well as against the development of severe complications such as kidney failure or infection.

The fat-congestion syndrome is characterized by hyperlipidemia, fever, fatty infiltration, hepatomegaly (with or without jaundice), splenomegaly, abdominal pain, anemia, leukocytopenia, thrombocytopenia, blood clotting disorder, hemolysis and reticulocytosis, non-normative functional tests of the liver and coma. Symptoms are reversible and usually disappear after discontinuation of the infusion. In case of signs of fat overload syndrome, the administration of Nutriflex 40/80 lipid should be stopped immediately.

Overdose:

With proper administration of the drug, an overdose is not observed.

Symptoms of bulk overload or overdose of electrolytes

Hypertensive hyperhydration, electrolyte balance disorders, pulmonary edema.

Symptoms of an overdose of amino acids

Loss of amino acids by the kidneys with the development of a violation of the amino acid balance, nausea, vomiting, tremor.

Symptoms of an overdose of glucose

Hyperglycemia, glucosuria, dehydration, hyperosmolarity of the serum, hyperglycemic or hyperosmolar coma.

Symptoms of lipid overdose

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 can 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.

Interaction:

Solutions containing potassium should be administered with caution to patients who receive medications that increase potassium concentration in the serum, for example potassium-sparing diuretics, ACE inhibitors, ciclosporin and tacrolimus.

Soybean oil contains vitamin K₁, which can disrupt the therapeutic effect of indirect anticoagulants - coumarin derivatives. Therefore, the therapeutic effect of indirect anticoagulants - coumarin derivatives should be carefully monitored.

Corticosteroids and corticotropin cause a delay in sodium and fluid in the body.

Some drugs, such as insulin, can interact with lipolytic enzymes of the body. However, these interactions have little clinical significance.

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

Nutriflex 40/80 lipid contains zinc and magnesium, which must be considered when prescribing other drugs containing these trace elements.

Nutriflex 40/80 lipid is a preparation of a complex composition. Therefore, it is not recommended to add other solutions to it without first checking for compatibility, otherwise the stability of the emulsion can not be guaranteed.

Special instructions:

When anaphylactic reactions such as fever, seizures, rash or dyspnea occur, 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 the start of infusion.

Too fast administration can lead to fluid overload with a violation of the electrolyte balance of blood plasma, hyperhydration and pulmonary edema.

When administering the drug Nutriflex 40/80 lipid, it is necessary to control the concentration of triglycerides of the blood plasma.

Patients with suspected abnormalities in fat metabolism should not have hyperlipidemia when prescribing the drug. Introduction of fats in hyperlipidemia is contraindicated. Hypertriglyceridemia 12 hours after the administration of the drug indicates a violation of the metabolism of fats. Depending on the state of the patient's metabolism, transient hypertriglyceridemia may develop or the concentration of glucose in blood plasma may increase. If the concentration of triglycerides in the plasma during lipid administration exceeds 3 mmol / l, it is recommended to reduce the infusion rate. If the concentration of triglycerides in the plasma is maintained above 3 mmol / L, administration should be suspended until the lipid concentration is normalized.

With an increase in blood glucose concentrations above 14 mmol / l (250 mg / dl), a dose reduction or discontinuation of infusion is necessary.

Like other drugs containing carbohydrates, the administration of the drug Nutriflex 40/80 lipid can lead to hyperglycemia. It is necessary to monitor the concentration of glucose in the blood. In the case of hyperglycemia, the rate of infusion should be reduced or insulin administered.

Intravenous introduction 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 assigning microelements, especially with prolonged parenteral nutrition. Resumption or holding parenteral nutrition in depleted patients or patients who did not receive 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 electrolytes of blood plasma, fluid balance, acid-base state, blood urea nitrogen and, with long-term administration, cellular composition, blood coagulation system and liver functions. View and the frequency of laboratory tests depends on the general condition of the patient.

The drug should not be administered through the same systems for transfusion simultaneously, before or after the introduction of blood due to the risk of pseudoagglutination.

It may be necessary to replenish electrolytes, vitamins and trace elements.

The content of fats in the preparation may reduce the accuracy of laboratory tests (for example, bilirubin, lactate dehydrogenase, oxygen saturation) if blood samples are taken during or immediately after the infusion of the drug.

Infusion of the drug Nutriflex 40/80 lipid, as well as all preparations for intravenous administration, should be performed under aseptic conditions.

Nutriflex 40/80 lipid is a preparation of a complex composition. 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 2-8 ° C for 4 days, and additionally for 48 hours (including infusion time) at 25 ° C.

If filters are used when injecting the drug, they must be fat-permeable.

After accidental freezing, the drug is not to be used.

Use only intact packages in which solutions of amino acids and glucose are transparent. Do not use packaging in which, after shaking, the apparent phase separation (fat drops) is retained in the fat emulsion chamber.

Stir well before use.

Container for single use. Remaining unused quantities of the drug are subject to destruction.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles, mechanisms, as well as engage in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Emulsion for infusion.

Packaging:

For 1250 ml, 1875 ml and 2500 ml in plastic containers.

The container is put in a secondary transparent plastic bag and placed in a protective cardboard cell. Between the container and the secondary plastic bag or between the containers of the container is an oxygen absorber.

For 5 containers with instructions for use in a cardboard box (for hospitals).

Storage conditions:

Store at a temperature of no higher than 25 ° C, in a place protected from light. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:LS-002278

Date of registration:13.12.2011 / 29.01.2016

Expiration Date:Unlimited

The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany

Manufacturer: & nbsp

B. BRAUN MELSUNGEN, AG Germany

Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company

Information update date: & nbsp07.12.2016

Illustrated instructions

Instructions

Nutriflex 40/80 lipid (Nutriflex 40/80 lipid)