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

Composition	To the ridiculous Lower camera	the Upper camera	After mixing	To the ridiculous Lower camera	the Upper camera	After mixing
	600 ml	400 ml	1000 ml	1200 ml	800 ml	2000 ml
Isoleucine		2.82 g	2.82 g		5.64 g	5.64 g
Leucine		3.76 g	3.76 g		7.52 g	7.52 g
Lysine hydrochloride (corresponding to lysine)		3.41 g (2.73 g)	3.41 g (2.73 g)		6.82 g (5.46 g)	6.82 g (5.46 g)
Methionine		2.35 g	2.35 g		4.70 g	4.70 g
Phenylalanine		4.21 g	4.21 g		8.42 g	8.42 g
Threonine		2.18 g	2.18 g		4.36 g	4.36 g
Tryptophan		0.68 g	0.68 g		1.36 g	1.36 g
Valine		3.12 g	3.12 g		6.24 g	6.24 g
Arginine monoglutamate (corresponding to arginine, glutamic acid)		5.98 g (3.24 g) (2.74 g)	5.98 g (3.24 g) (2.74 g)		11.96 g (6.48 g) (5.48 g)	11.96 g (6.48 g) (5.48 g)
Histidine hydrochloride monohydrate (corresponding to histidine)		2.03 g (1.50 g)	2.03 g (1.50 g)		4.06 g (3.00 g)	4.06 g (3.00 g)
Alanin		5.82 g	5.82 g		11.64 g	11.64 g
Aspartic acid		1.80 g	1.80 g		3.60 g	3.60 g
Glutamic acid		1.47 g	1.47 g		2.94 g	2.94 g
Glycine		1.98 g	1.98 g		3.96 g	3.96 g
Proline		4.08 g	4.08 g		8.16 g	8.16 g
Serin		3.60 g	3.60 g		7.20 g	7.20 g
Magnesium acetate thehydrate		1.23 g	1.23 g		2.46 g	2.46 g
Sodium acetate trihydrate		1.56 g	1.56 g		3.12 g	3.12 g
Sodium dihydrogen phosphate dihydrate		3.12 g	3.12 g		6.24 g	6.24 g
Potassium hydroxide		1.40 g	1.40 g		2.80 g	2.80 g
Sodium hydroxide		0.23 g	0.23 g		0.46 g	0.46 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	165.0 grams		165.0 grams	330.0 grams		330.0 grams
(corresponding to anhydrous glucose)	(150.0 g)		(150.0 g)	(300.0 g)		(300.0 g)
Calcium chloride dihydrate	0.53 g		0.53 g	1.06 g		1.06 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 +		37.2 mmol	37.2 mmol		74.4 mmol	74.4 mmol
Potassium +		25.0 mmol	25.0 mmol		50.0 mmol	50.0 mmol
Calcium ++	3.6 mmol		3.6 mmol	7.2 mmol		7.2 mmol
Magnesium		5.7 mmol	5.7 mmol		11.4 mmol	11.4 mmol
Chloride-	7.2 mmol	28.3 mmol	35.5 mmol	14.4 mmol	56.6 mmol	71.0 mmol
Dihydrogen phosphate-		20.0 mmol	20.0 mmol		40.0 mmol	40.0 mmol
Acetate-		22.9 mmol	22.9 mmol		45.8 mmol	45.8 mmol
Number of amino acids		48 grams	48 grams		96 grams	96 grams
Nitrogen		6.8 g	6.8 g		13.6 g	13.6 g
Non-protein caloric content kcal (kJ)	600 (2510)		600 (2510)	1200 (5025)		1200(5025)
Full caloric content kcal (kJ)	600(2510)	190(795)	790(3310)	1200 (5025)	380 (1590)	1580 (6615)
Osmolarity (mOsm / l)			1400			1400

Description:

The upper chamber (a solution of amino acids with electrolytes): 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 48/150 contains amino acids in one bag chamber, which are a substrate for protein synthesis and mineral substances necessary to maintain the water-electrolyte equilibrium and the 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 48/150 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 amino acid homeostasis in plasma.

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

Indications:

Used for parenteral nutrition in inpatient and outpatient settings for covering the daily requirement of the patients in energy, amino acids, electrolytes and fluids during parenteral nutrition in patients with the degree of catabolic moderate to pronounced in cases where enteral nutrition is impossible, insufficient or contraindicated, as well as combination with it, for example:

- Preoperative preparation;

- Conditions after extensive surgical interventions;

- Injuries of moderate to severe severity;

- Burns;

- Destructive inflammatory bowel disease (Crohn t.ch.bolezn, intestinal fistulas);

- Syndrome of the small intestine;

- Disturbances in diet (cachexia);

- Oncological diseases;

- Sepsis, peritonitis;

- Acute pancreatitis;

- Parenteral nutrition of patients with artificial ventilation.

Contraindications:

- Amino acid metabolism disorders;

- Hyperkalemia;

- Hyponatremia;

- Metabolic disorders (eg, diabetes mellitus);

- Coma of unclear etiology;

- Hyperglycemia, insulin doses nekorregiruemaya to 6 units / hour;

- Acidosis;

- Severe hepatic and / or renal insufficiency;

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

- Children under 2 years.

Common for parenteral nutrition

- Severe circulatory disorders (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 and risks before prescribing the drug during pregnancy. It is not recommended to breast-feed while using the drug.

Dosing and Administration:

Nutriflex 48/150 is intended for administration only in the central veins.

Method of preparation Nutriflex 48/150 for use:

Nutriflex 48/150 is a two-chamber bag, the compartments 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 dextrose 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 48/150 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 mt / day, which corresponds to 1.92 g of amino acids / kg mt / day and 6 g of glucose / kg mt / day.

Rate of administration:

The maximum infusion rate is 2 ml / kg mt / h, which corresponds to 0.096 g of amino acids / kg mt / h and 0.3 g glucose / kg mt / h.

Duration of use:

Restrictions on the duration of use of the drug is not revealed. Precautions when using the drug:

In patients with increased osmolarity of blood plasma, with heart failure, with hepatic and / or renal insufficiency.

For patients with cardiac, hepatic and renal insufficiency, the dosage and mode of administration of the drug are set individually.

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 administration of 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, an overdose of the drug is not observed

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 48/150 should be used in combination with lipid emulsions.

Before the start of infusion of Nutriflex 48/150, it is necessary to correct the water electrolyte balance and the acid-base state of the blood. Too rapid administration of the drug may result in a volume overload, a violation of the water electrolyte balance.

It is necessary to control the concentration of sugar in the blood. When hyperglycaemia occurs, the rate of administration of Nutriflex 48/150 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 of blood should be carried out, control of blood sugar concentration, ionograms of blood serum. 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, clear compliance with asepsis rules is necessary.

Nutriflex 48/150 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 bag or its leak tightness.

Form release / dosage:Solution for infusion.

Packaging:

Plastic double containers with a volume of 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-000169

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

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

Information update date: & nbsp26.02.2010

Illustrated instructions

Instructions

Nutriflex 48/150 (Nutriflex 48/150)