Nutriflex 48/150 lipid - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspemulsion for infusions

Composition:

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 1000ml	in 1250 ml	in 1875 ml	in 2500 ml
Active substances:
Isoleucine	2.260 g	2,820 grams	4.230 g	5,640 g
Leucina	3.010 grams	3,760 g	5,640 g	7,520 g
Lysine hydrochloride	2.730 grams	3,410 grams	5.120 g	6.820 grams
(corresponds to lysine)	2.180 grams	2.730 grams	4,100 g	5.460 g
Methionine	1.880 grams	2.350 g	3.530 grams	4.700 g
Phenylalanine	3,370 grams	4,210 g	6,320 g	8,420 g
Threonine	1.740 g	2.180 grams	3.270 g	4,360 g
Tryptophan	0.540 g	0.680 grams	1.020 g	1.360 g
Valine	2,500 grams	3.120 g	4,680 g	6,240 g
Arginine	2.590 g	3.240 g	4.860 g	6.480 grams
Histidine hydrochloride monohydrate	1.620 g	2.030 g	3,050 g	4,060 g
(corresponding to histidine)	1,200 grams	1,500 grams	2.250 g	3,000 grams
Glycine	1.580 grams	1.980 grams	2.970 g	3.960 grams
Alanina	4,660 g	5.820 grams	8.730 g	11.640 g
Proline	3,260 g	4,080 grams	6.120 g	8.160 g
Aspartic acid	1.440 g	1,800 grams	2,700 grams	3,600 grams
Glutamic acid	3,370 grams	4,210 g	6,320 g	8,420 g
Serina	2,880 grams	3,600 grams	5,400 grams	7,200 g
Sodium hydroxide	0.781 g	0.976 g	1.464 g	1.952 grams
Sodium chloride	0.402 g	0.503 g	0.755 g	1.006 g
Sodium dihydrogen phosphate dihydrate	1.872 grams	2.340 g	3,510 grams	4,680 g
Sodium acetate trihydrate	0.222 g	0.277 g	0.416 g	0.554 g
Potassium acetate	2.747 g	3.434 g	5.151 g	6.868 g
Magnesium acetate tetrahydrate	0.686 g	0.885 g	1.287 g	1.716 g
Calcium chloride dihydrate	0.470 g	0.588 g	0.882 g	1.176 g
Zinc acetate dihydrate	5.264 mg	6,580 mg	9.870 mg	13.160 mg
Glucose monohydrate	132,000 g	165,000 g	247.500 grams	330,000 g
(corresponding to anhydrous glucose)	120,000 g	150,000 grams	225,000 g	300,000 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

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]	38,4	48	72	96
Carbohydrates [g]	120	150	225	300
Fats [g]	40	50	75	100
Total nitrogen [g]	5,44	6,8	10,2	13,6

Energy value

in 1000 ml

in 1250 ml

in 1875 ml

in 2500 ml

Amino acids

[kJ (kcal)]

640

(152)

800

(190)

1200

(285)

1600

(380)

Carbohydrates

[kJ (kcal)]

2008

(480)

2510

(600)

3765

(900)

5020

(1200)

Fats

[kJ (kcal)]

1592

(380)

1990

(475)

2985

(715)

3980

(950)

Non-protein energy value

[kJ (kcal)]

3600

(860)

4500

(1075)

6750

(1615)

9000

(2155)

Total energy value

[kJ (kcal)]

4240

(1012)

5300

(1265)

7950

(1900)

10600

(2530)

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	28,0	35,0	52,5	70,0
Calcium	3,2	4,0	6,0	8,0
Magnesium	3,2	4,0	6,0	8,0
Zinc	0,024	0,03	0,045	0,06
Chlorides	36,0	45,0	67,5	90,0
Acetates	36,0	45,0	67,5	90,0
Phosphates	12,0	15,0	22,5	30,0

Osmolality	1540 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

Fatty emulsions

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 48/150 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, the rate of administration, the metabolic state and the patient's state (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 various tissues of the body. In addition, each amino acid is present in a free form inside 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.

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 moderately increased metabolic needs, when normal food intake and enteral nutrition are not possible, insufficient or contraindicated.

Contraindications:

The drug can not be administered under the following conditions:

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

- atborn disorders of amino acid metabolism;

- Mr.ablation of fat metabolism;

- Pan atomically high concentration of plasma electrolytes;

- Mr.An unstable metabolism (for example, severe post-aggressive syndrome, decompensated hyperglycemia in diabetes mellitus, metabolic acidosis,coma of unclear etiology);

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

- atnutriphechenochny cholestasis;

- tsevere hepatic impairment;

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

- Pregressing hemorrhagic diathesis;

- aboutstria phase of myocardial infarction and stroke;

- aboutsevere cases of thromboembolism, fat embolism;

- dUp to 2 years old.

General contraindications for parenteral nutrition:

- Mr.life-threatening circulatory disorder (collapse and shock);

- atsevere tissue hypoxia;

- fromstates of hyperhydration;

- Mr.the collapse of the water-electrolyte balance;

- aboutpulmonary edema of the lungs;

- dCompensated heart failure.

Carefully:

Care should be taken with increasing serum osmolality.

Considering the possible risk of volumetric overload when using Nutriflex 48/150 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

There have been no studies to evaluate the effect of the drug Nutriflex 48/150 lipid on an 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:

Mode of application

Intended for intravenous administration only in the central veins.

The temperature of the emulsion to be introduced must correspond to room temperature.

The configuration of the chambers of the preparation Nutriflex 48/150 lipid allows to add the fat emulsion in the last turn, in order to preliminary assess the compatibility with other added drugs.

The technique of mixing the contents of the container chambers

If you need to add other drugs to the drug Nutriflex 48/150 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, microelements and other compatible medicinal preparations (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.

If there is no need to add other drugs to the drug Nutriflex 48/150 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:

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

- 4.8 g of glucose / kg of 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 of 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 40 ml / kg of body weight, which corresponds to:

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

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

-1.6 g fat / kg body weight / day.

For children from 5 to 14 years old The daily dose is 25 ml / kg of body weight, which corresponds to:

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

- 3.0 g glucose / kg body weight / day,

- 1.0 g fat / kg body weight / day.

Due to the age-specific features of children, Nutriflex 48/150 lipid may not fully meet the energy need. In these cases, a glucose solution or fat emulsion can be added to the parenteral nutrition program as needed.

The rate of administration

It is recommended a long-term introduction of the drug Nutriflex 48/150 lipid. The stepwise increase in the rate of infusion during the first 30 minutes reduces the incidence of possible complications.

Maximum infusion rate - 2.0 ml / kg body weight / h, which corresponds to:

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

- 0.24 g glucose / kg body weight / h,

- 0.08 g fat / kg body weight / h.

For a patient with a body weight of 70 kg, the maximum infusion rate is 140 ml / h. At the same time, the rate of introduction of amino acids is 5.4 g / h, glucose 16.8 g / h, fats 5.6 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), this indicator can be increased.

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

Duration of application of the drug Nutriflex 48/150 lipid is not limited. With prolonged use, it is necessary to add appropriate amounts of trace elements and vitamins.

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 (eg, 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: shortness of breath, 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 about some adverse side effects 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 if the recommended rate of infusion, as well as against the development of serious complications, such as kidney failure or infection. fat overload syndrome is characterized by hyperlipidaemia, fever, fatty infiltration, hepatomegaly (with or without icterus), splenomegaly, abdominal pain, anemia, leukopenia, thrombocytopenia, disturbance of blood clotting, hemolysis and reticulocytosis not corresponding normal liver functional tests and coma. Symptoms are reversible and usually disappear after discontinuation of the infusion. In case of signs of fat overload syndrome, the administration of the drug Nutriflex 48/150 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 acid kidneys with the development of violations of the amino acid balance, metabolic acidosis, nausea, vomiting, tremor.

Symptoms of an overdose of glucose

Hyperglycemia, glucosuria, dehydration, hyperosmolarity of 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 48/150 lipid contains zinc and magnesium, which must be considered when prescribing other drugs containing these trace elements.

Nutriflex 48/150 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 the drug Nutriflex 48/150 lipid is administered, 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,administration of the drug Nutriflex 48/150 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.

Renewal or parenteral nutrition in depleted patients or patients not receiving 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 plasma electrolytes, the balance of the liquid, the acid-base state, blood urea nitrogen and, with prolonged administration, the cellular composition, the blood coagulation 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 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 48/150 lipid, as well as all preparations for intravenous administration, should be performed under aseptic conditions.

Nutriflex 48/150 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 the infusion time) at a temperature of 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 packages in which there is an obvious separation of phases (fatty drops) in the fat-emulsion chamber.

Stir well before use.

Container for single use. The remaining unused quantities of the drug should be discarded.

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. Between the chambers of the container or between the container and the secondary plastic bag is an oxygen absorber.

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

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-002299

Date of registration:14.12.2011

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: & nbsp14.03.2016

Illustrated instructions

Instructions

Nutriflex 48/150 lipid (Nutriflex 48/150 lipid)