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

Composition	Up to sm Lower camera	the Upper camera	After mixing	Up to sm Lower camera	the Upper camera	After mixing
	600 ml	400 ml	1000 ml	1200 ml	800 ml	2000 ml
Isoleucine		2.34 g	2.34 g		4.68 g	4.68 g
Leucine		3.13 g	3.13 g		6.26 g	6.26 g
Lysine hydrochloride (corresponding to lysine)		2.84 g (2.27 g)	2.84 g (2.27 g)		5.68 g (4.54 g)	5.68 g (4.54 g)
Methionine		1.96 g	1.96 g		3.92 g	3.92 g
Phenylalanine		3.51 g	3.51 g		7.02 g	7.02 g
Threonine		1.82 g	1.82 g		3.64 g	3.64 g
Tryptophan		0.57 g	0.57 g		1.14 g	1.14 g
Valine		2.60 g	2.60 g		5.20 g	5.20 g
Arginine monoglutamate (corresponding to arginine, glutamic acid)		4.98 g (2.70 g) (2.28 g)	4.98 g (2.70 g) (2.28 g)		9.96 g (5.40 g) (4.56 g)	9.96 g (5.40 g) (4.56 g)
Histidine hydrochloride monohydrate (corresponding to histidine)		1.69 g (1.25 g)	1.69 g (1.25 g)		3.38 g (2.50 g)	3.38 g (2.50 g)
Alanin		4.85 g	4.85 g		9.70 g	9.70 g
Aspartic acid		1.50 g	1.50 g		3.00 grams	3.00 grams
Glutamic acid		1.22 g	1.22 g		2.44 g	2.44 g
Glycine		1.65 g	1.65 g		3.30 g	3.30 g
Proline		3.40 g	3.40 g		6.80 g	6.80 g
Serin		3.00 grams	3.00 grams		6.00 g	6.00 g
Magnesium acetate tetrahydrate		0.86 g	0.86 g		1.72 g	1.72 g
Sodium acetate trihydrate		1.56 g	1.56 g		3.12 g	3.12 g
Potassium dihydrogen phosphate		0.78 g	0.78 g		1.56 g	1.56 g
Potassium hydroxide		0.52 g	0.52 g		1.04 g	1.04 g
Sodium hydroxide		0.50 g	0.50 g		1.00 g	1.00 g
Citric acid	0.25 g	0.17 g	0.42 g	0.50 g	0.34 g	0.84 g
monohydrate (corresponds to the acid of lemon)	0.229 g	0.155 g	0.384 g	0.457 g	0.310 g	0.776 g
Glucose monohydrate (corresponding to glucose anhydrous)	88.0 g (80.0 g)		88.0 g (80.0 g)	176.0 g (160.0 g)		176.0 g (160.0 g)
Sodium chloride	0.17 g		0.17 g	0.34 g		0.34 g
Calcium chloride dihydrate	0.37 g		0.37 g	0.74 g		0.74 g
Water for injections	up to 600 ml	up to 400 ml	up to 1000 ml	up to 1200 ml	up to 800 ml	up to 2000 ml
Electrolytes:
Sodium +	3.0 mmol	24.0 mmol	27.0 mmol	6.0 mmol	48.0 mmol	54.0 mmol
Potassium +		15.0 mmol	15.0 mmol		30.0 mmol	30.0 mmol
Calcium ++	2.5 mmol		2.5 mmol	5.0 mmol		5.0 mmol
Magnesium ++		4.0 mmol	4.0 mmol		8.0 mmol	8.0 mmol
Chloride-	8.0 mmol	23.6 mmol	31.6 mmol	16.0 mmol	47.2 mmol	63.2 mmol
D and hydrophosphate		5.7 mmol	5.7 mmol		11.4 mmol	11.4 mmol
Acetate-		19.5 mmol	19.5 mmol		39.0 mmol	39.0 mmol
Number of amino acids		40 grams	40 grams		80g	80g
Nitrogen		5.7 g	5.7 g		11.4 g	11.4 g
Non-protein caloric content kcal (kJ)	320(1340)		320(1340)	640 (2680)		640 (2680)
Full caloric content kcal (kJ)	320(1340)	160 (670)	480 (2010)	640 (2680)	320 (1340)	960 (4020)
Osmolarity (mOsm / l)			900			900

Description:

The upper chamber (a solution of amino acids with electrolytes): a transparent pale yellow or yellow solution. Lower chamber (glucose solution): a clear, colorless or pale yellow solution.

Pharmacotherapeutic group:Parenteral nutrition.

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

Nutriflex 40/80 contains in one cell a bag of amino acids, which are a substrate for protein synthesis, and minerals,necessary to maintain the water-electrolyte and acid-base state of the blood, and in the second chamber - a solution of dextrose with solutions of electrolytes.

Pharmacodynamics

Intravenous amino acids enter the intravascular and intracellular depots of endogenous free amino acids.

The introduction of all the amino acids necessary for the synthesis of proteins (including essential, conditionally replaceable and interchangeable amino acids) contained in the preparation, provides high nutritional efficacy and reduces the burden on the body during protein synthesis.

Thus, the main therapeutic effect of Nutriflex 40/80 is to supply the body with a substrate for protein synthesis and energy due to glucose in parenteral nutrition.

Individual concentrations of amino acids in the preparation are chosen so that when the solution is injected intravenously, the increase in the concentration of each amino acid in the plasma does not go beyond the norm, which ensures the maintenance of the homeostasis of amino acids in the plasma.

Glucose is the energy carrier most adapted to the body and at the indicated dose itself or together with an additional lipid emulsioncovers the patient's needs in non-protein calories, protecting amino acids from misuse.

The combination of ingredients used in the preparation Nutriflex 40/80 in these concentrations, low osmolarity allows it to enter through peripheral veins, which significantly expands the indications for its use in various categories of therapeutic and surgical patients, both in intensive care units and in outpatient and home conditions.

Indications:

Used for parenteral nutrition in inpatient, outpatient and home settings to cover the daily requirement of patients for energy, amino acids, electrolytes and fluid during parenteral nutrition in patients with moderate catabolism, when enteral nutrition is impossible, insufficient or contraindicated, and also in combination with it , eg:

- Preoperative preparation;

- Conditions after extensive surgical interventions;

- Injuries of moderate to severe severity;

- Burns;

- Inflammatory-destructive diseases of the intestine (including Crohn's disease, intestinal fistula);

- Syndrome of the small intestine;

- Disturbances in diet (cachexia);

- Oncological diseases;

- Sepsis, peritonitis;

- Acute pancreatitis.

Contraindications:

- Amino acid metabolism disorders;

- Hyperkalemia;

- Hyponatremia;

- Metabolic disorders (eg, diabetes mellitus);

- Coma of unclear etiology;

- Hyperglycemia, uncorrected by insulin doses up to 6 units / hour;

- Acidosis;

- Severe hepatic and / or renal failure without hemodialysis;

- Individual intolerance to one of the components of the mixture;

- Children under 2 years.

Common for parenteral nutrition

- Severe circulatory disorders with a threat to life (collapse and shock);

- Pronounced tissue hypoxia;

- Hyperhydration;

- Violations of the water-electrolyte balance;

- Pulmonary edema;

- Decompensated heart failure.

Pregnancy and lactation:

Clinical studies have not been conducted. You should weigh the benefits / risks before prescribing the drug during pregnancy. It is not recommended to breast-feed while using the drug.

Dosing and Administration:

Method of preparation Nutriflex 40/80 for use Nutriflex 40/80 is a two-chamber bag, the branches of which are separated by a special seam.One chamber is filled with a solution of amino acids and electrolytes, and the other - a solution of glucose and electrolytes.

Immediately before the onset of parenteral administration, solutions of amino acids, glucose and electrolytes should be mixed. To do this you need:

- remove the two-chamber bag from the protective packaging,

- Expand and expand it on a flat surface (on a table),

- To break the separation joint by pressing both hands onto one of the bag chambers,

- take in hand and mix the contents of both chambers, moving the right and left side of the bag up and down.

After that, the solution is ready for use.

At the end of the infusion, the bag is discarded.

If necessary, Nutriflex 40/80 can be supplemented with lipid emulsions by introducing them into the finished solution through a special port located on the bag from above. If you want to add other ingredients to the finished solution, you need to use an additional port located at the bottom. All ingredients should be added in accordance with the rules of asepsis and their compatibility with each other.

Doses:

Are selected according to individual needs.

The maximum daily dose is 40 ml / kg bw. / day, which corresponds to 1.6 g amino acids / kg mt / day and 3.2 g glucose / kg mt / day.

The rate of administration

The maximum infusion rate - 2 ml / kg mt / h, which corresponds to 0.08 g amino acids / kg mt / h and 0.16 g glucose / kg m. t / hour.

Duration of application

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

Precautions when using the drug:

With caution - in patients with heart failure, severe hepatic and / or renal insufficiency.

Nutriflex 40/80 is a special solution intended for insertion into peripheral veins. When carrying out therapy, it is necessary to take into account the state of the veins and periodically change the place of administration of the solution.

Side effects:

Side effects occur very rarely. When discontinuing therapy, they are quickly reversible. The introduction of the drug may lead to allergic reactions, chills, nausea, vomiting. Due to the high osmolarity of the solution, in some cases there may be signs of increased diuresis. In such cases The drug should be discontinued and resumed later with a lower infusion rate.

In case of side effects, not described in the manual, patients should inform their physician about them.

Overdose:

With proper administration of the drug, there is no overdose of the drug. Symptoms of bulk overload or an overdose of electrolytes:

Hypertonic hyperhydration, disturbances of water-electrolyte balance, pulmonary edema.

Symptoms of an overdose of amino acids:

Loss of amino acids in the urine with the development of violations of amino acid balance, vomiting, tremor.

Symptoms of an overdose of glucose:

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

Therapy:

In cases of symptoms of drug overdose, the administration of the solution 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 frequent monitoring.

Interaction:Not described.

Special instructions:

With complete parenteral nutrition Nutriflex 40/80 should be used in combination with lipid emulsions.

Before starting the infusion of Nutriflex 40/80, the water-electrolyte balance and the acid-base state of the blood should be corrected. Too rapid introduction of the drug can lead to volumetric overload, disruption of the water-electrolyte balance.

It is necessary to control the concentration of sugar in the blood. If hyperglycaemia is present, the rate of administration of Nutriflex 40/80 should be reduced or the appropriate dose of insulin administered.

Intravenous introduction of amino acid solutions is accompanied by increased release of urine microelements, especially copper and zinc. This should be taken into account when selecting doses of trace elements, especially during long-term therapy.

Because of the risk of pseudoagglutination, the use of the same infusion systems for the administration of blood products and multicomponent amino acid solutions is not recommended.

When the drug is administered, regular monitoring of water electrolyte balance and acid-base state, blood sugar concentration, ionograms of blood serum should be carried out. When performing long-term therapy, it is necessary to monitor blood levels (coagulogram, liver function).

If necessary, it is possible to add lipid emulsions, essential fatty acids, electrolytes, vitamins and microelements.

As with all solutions administered intravenously, it is necessary to strictly observe aseptic rules.

Nutriflex 40/80 is a multicomponent solution. When adding other solutions or a lipid emulsion, it is necessary to take into account the compatibility of all the ingredients.

The drug is supplied in plastic double containers, designed for single use. Any unused volumes of the drug are not subject to storage and must be discarded.

The drug should be used immediately after mixing glucose solutions and amino acids. It is possible to store the drug after mixing glucose and amino acid solutions for up to 7 days at room temperature and up to 14 days while storing it in the refrigerator (including the time of drug administration).

Do not use the drug if the solution is not clear, there are obvious signs of damage on the container or its leak tightness.

Form release / dosage:

Solution for infusion.

Packaging:Plastic double containers 1000 ml and 2000 ml. The container is put in a secondary transparent plastic bag.For 5 containers with instructions for use in a cardboard box.

Storage conditions:

Inaccessible to children, protected from light at a temperature of no higher than 25 ° C.

Shelf life:

2 years.

The drug should not be used after the date indicated on the label.

Terms of leave from pharmacies:For hospitals

Registration number:LS-000219

Date of registration:26.02.2010

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

Manufacturer: & nbsp

B. BRAUN MEDICAL, AG Germany

Information update date: & nbsp26.02.2010

Illustrated instructions

Instructions

Nutriflex 40/80 (Nutriflex 40/80)