Nutriflex 70/240 - instructions for use, dose, side effects, contraindications

	Up to sm	the			Up to sm	the
			After				After
Composition	Lower	Upper	mingled		Lower	Upper	blending
	camera	camera	and I		camera	camera -	HAnd I
	500 ml	500 ml	1000 ml		750 ml	750 ml	1500 ml
Active substances:
Isoleucine		4.11 g	4.11 g			6.17 g	6.17 g
Leucine		5.48 g	5.48 g			8.22 g	8.22 g
Lysine
hydrochloride		4.97 g	4.97 g			7.46 g	7.46 g
(corresponds
lysine)		3.98 g	3.98 g			5.97 g	5.97 g
Methionine		3.42 g	3.42 g			5.13 g	5.13 g
Phenylalanine		6.15 g	6.15 g			9.23 g	9.23 g
Threonine		3.18 g	3.18 g			4.77 g	4.77 g
Tryptophan		1.00 g	1.00 g			1.50 g	1.50 g
Valine		4.54 g	4.54 g			6.81 g	6.81 g
Arginine
glutamate		8.72 g	D 8.72 g			13.08 g	13.08 g
(corresponds
arginine,		4.73 g	4.73 g			7.10 g	7.10 g
glutamic
acid)		3.99 g	3.99 g			5.99 g	5.99 g
Histidine
hydrochloride
monohydrate		2.96 g	2.96 g			4.44 g	4.44 g
(corresponds
histidine)		2.19 g	2.19 g			3.29 g	3.29 g
Alanin		8.49 g	8.49 g			12.74 g	12.74 g
Aspartic		2.63 g	2.63 g			3.95 g	3.95 g
acid
Glutamic		2.15 g	2.15 g			3.23 g	3.23 g
acid
Glycine		2.89 g	2.89 g			4.34 g	4.34 g
Proline		5.95 g	5.95 g			. 8.93 g	8.93 g
Serin		5.25 g	5.25 g			7.88 g	7.88 g
Magnesium acetate		1.08 g	1.08 g			1.62 g	1.62 g
tetrahydrate
Sodium acetate		1.63 g	1.63 g			2.45 g	2.45 g
trihydrate
Potassium		2.00 grams	2.00 grams			3.00 grams	3.00 grams
dihydrogen phosphate
Potassium hydroxide		0.62 g	0.62 g			0.93 g	0.93 g
Sodium hydroxide		1.14 g	1.14 g			1.71 g	1.71 g
Dextrose
(glucose)
monohydrate	264.0 grams		264.0 grams		396.0 grams		396.0 grams
(corresponds
dextrose)	240.0 grams		240.0 grams		360.0 grams		360.0 grams
Calcium chloride	0.60 g		0.60 g		0.90 g		0.90 g
dihydrate
Excipients:
Lemon
acids
monohydrate	0.210 g	0.210 g	0.420 g	0.320 g		0.320 g	0.640 g
(corresponds
lemon
acid)	0.192 g	0.192 g	0.384 g	0.293 g		0.293 g	0.586 g
Water for	up to 500 ml	up to 500 ml	up to 1000 ml	up to 750 ml		up to 750 ml	up to 1500
injections							ml
Concentration of electrolytes:
Sodium	V	40,5	40.5 mmol			60,8	60,8
		mmol				mmol	mmol

Potassium		25,7 mmol	25.7 mmol		38,6 mmol	38,6 mmol
Calcium	4.1 mmol		4.1 mmol	6.2 mmol		6.2 mmol
Magnesium		5.0 mmol	5.0 mmol		7.5 mmol	7.5 mmol
Chlorides	8.2 mmol	41,3 mmol	49.5 mmol	12,3 mmol	62,0 mmol	74,3 mmol
Acetates		22,0 mmol	22.0 mmol		33,0 mmol	33,0 mmol
Dihydrogen phosphates		14,7 mmol	14.7 mmol		22,1 mmol	22,1 mmol
Content amino acids		70 grams	70 grams		105 grams	105 grams
Total nitrogen		10g	10g		15 grams	15 grams
Content carbohydrates	240 g		240 g	360 grams		360 grams
Non-protein caloric content (kJ (kcal))			4020(960)			6030 (1440)
General information caloricity (kJ (kcal))			5190 (1240)			7790 (1860)
Theoretical osmolality (mOsm / L)			2100			2100
pH			4,8-6,0			4,8-6,0

Description:

Solution of amino acids with electrolytes (the upper chamber of the container): a transparent pale yellow or yellow solution.

Glucose solution with electrolytes (lower chamber of the container): transparent a pale yellow or yellow solution.

Pharmacotherapeutic group:nutrition parenteral remedy

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

Pharmacological properties

Nutriflex 70/240 contains in one chamber of the container amino acids that are the substrate for protein synthesis, and electrolytes necessary to maintain the water-electrolyte balance, and in the second chamber - a solution of glucose with electrolytes.

Pharmacodynamics

The task of parenteral nutrition is to supply the body with all the necessary nutrients for tissue growth and regeneration. Amino acids are the main plastic material for protein synthesis. The introduction of all amino acids, including irreplaceable, conditionally replaceable and replaceable, provides high nutritional efficacy and reduces the burden on the body during protein synthesis. To avoid undesirable use of introduced amino acids as an energy substrate, simultaneous introduction of energy sources is necessary. One of the energy sources most adapted for the body is the dextrose, which alone or together with an additional injected fat emulsion covers the patient's need for non-protein calories.Electrolytes, which are part of the drug, serve to maintain the metabolic and physiological functions of the body.

Pharmacokinetics:

After intravenous administration of the drug Nutriflex 70/240, its components are immediately available for metabolism. Electrolytes contained in the preparation in the required quantities are involved in numerous specific biological processes.

Most amino acids are used for protein synthesis. Amino acids that are not included in protein synthesis are metabolized as follows: amino groups are cleaved from the carbon skeleton by transamination, the carbon skeleton either oxidizes to CO2 in a cycle of citric acid or is utilized as a substrate for gluconeogenesis in the liver. Amino groups after cleavage of proteins in muscle tissue are transported to the liver where they are used for the synthesis of urea or interchangeable amino acids.

Dextrose is metabolized to CO2 and H2O. Some dextrose is used to synthesize fats.

Indications:

Parenteral nutrition in inpatient and outpatient settings to meet the need for amino acids, energy,electrolytes and fluid in patients with moderate to severe catabolism in cases where a normal meal or enteral diet is impossible, insufficient or contraindicated.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- Congenital disorders of amino acid metabolism;

- Severe metabolic disorders, such as decompensated diabetes mellitus;

- Expressed hyperglycemia, requiring the introduction of short-acting insulin in an amount of more than 6 units / hour;

- Significant increase in the concentration in the blood plasma of any of the electrolytes that make up the drug;

- Continuing intracranial or intraspinal bleeding (due to trauma, vascular pathology or neurosurgical intervention on the spinal cord);

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

- Pronounced acidosis, tissue hypoxia;

- Coma of unknown etiology;

- Severe hepatic impairment;

- Severe renal failure (oligo or anuria) in the absence of renal replacement therapy;

- Hyperhydration;

- Pulmonary edema;

- Decompensated heart failure;

- Children up to 2 years.

Carefully:

In patients with increased plasma osmolarity.

Because Nutriflex 70/240 contains sodium salts, it must be administered with caution to patients with sodium retention.

Since Nutriflex 70/240 is usually administered in significant amounts, care must be taken when prescribing it to patients with cardiac or renal insufficiency.

Pregnancy and lactation:

At present, there is no sufficient clinical data on the use of the drug Nutriflex 70/240 during pregnancy and lactation, so it is possible use in pregnant and lactating women only in cases where the expected benefit of drug treatment exceeds the possible risk of complications.

When applying the drug, breast-feeding is not recommended.

Dosing and Administration:

Nutriflex 70/240 is intended for administration only in the central veins.

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

The preparation of the preparation Nutriflex 70/240 for use

Nutriflex 70/240 is a two-chamber container, the chambers of which are separated by a partition. One chamber is filled with a solution of amino acids with electrolytes, and the other - a solution of glucose with electrolytes.

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

- remove from the container an external plastic bag,

- unfold and put it on a firm flat surface (on the table),

- press two hands on one of the chambers of the container until the septum separates the two chambers,

- gently mix the contents of the container.

After mixing, the preparation is ready for use.

The device of a two-chamber container allows aseptic mixing of amino acid solutions, dextrose and, if necessary, fat emulsion, which can be added through a special port located on the container from above.

To introduce a fat emulsion into a container, a Nutriflex transfer set can be used.

If you need to add other components to the preparation, for example, electrolytes, 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 and the speed of administration are selected according to individual needs.

Adults and children from 14 years of age

The maximum daily dose 25 l / kg body weight, which corresponds to 1.75, g amino acids / kg body weight and 6.0 g of dextrose / kg of body weight.

In the case of disturbed glucose oxidation due to hypoxia or multiple organ failure in the post-operative or post-traumatic period, the dose of dextrose administered should be selected so that the normal level of glucose in the blood is maintained. In order to prevent the development of hyperglycemia, continuous monitoring of the glucose concentration in the blood is recommended.

Maximum injection rate

1.0 ml / kg body weight / hour, which corresponds to 0.07 g amino acids / kg body weight / hour and 0.24 g dextrose / kg body weight / hour.

For a patient with a body weight of 70 kg, this corresponds to a maximum infusion rate of 70 ml / h, an amino acid injection rate of 5 g / h, a rate of dextrose 17 g / h.

Children

The following doses are averaged. The dose should be selected in accordance with the child's age, stage and severity of the disease. If necessary, additional administration of a solution of dextrose and fat emulsion is possible.

For children from 2 to 5 years:

21 ml / kg body weight / day, corresponding to 1.47 g of amino acids / kg of body weight / day and 5.04 g of dextrose / kg of body weight / day.

For children from 5 to 14 years:

14 ml / kg of body weight / day, corresponding to 0.98 g of amino acids / kg of body weight / day and 3.36 g of dextrose / kg of body weight / day.

Maximum injection rate

1 ml / kg of body weight / hour, which corresponds to 0.07 g of amino acids / kg of body weight / hour and 0.24 g of dextrose / kg of body weight / hour.

If higher doses are required, it is necessary to take into account the existing limitations on the maximum daily volume of the fluid administered depending on the age:

- for children from 2 to 5 years 80-100 ml / kg of body weight,

- for children from 5 to 10 years 60 - 80 ml / kg body weight,

- for children from 10 to 14 years 50 - 70 ml / kg of body weight.

Duration of application

Duration of application of the preparation Nutriflex 70/240 in accordance with the indications is not limited. In the case of prolonged use, it is necessary to ensure the introduction of essential fatty acids, electrolytes, trace elements and vitamins in appropriate quantities.

Side effects:

Adverse reactions with the use of Nutriflex 70/240 are rare (from 1/10000 to 1/1000) and are usually associated with exceeding the dose and / or rate of administration of the drug.Upon discontinuation of administration of the drug, these adverse side effects disappear.

From the side of metabolism and nutrition

Parenteral nutrition of depleted patients or patients with malnutrition initiated in the volume of complete need and with a high rate of administration, without adequate compensation for potassium, magnesium and phosphates, may lead to the development of a refeeding syndrome (renewed food syndrome) characterized by hypokalemia, hypophosphatemia and hypomagnesemia. Clinical manifestations develop within a few days after the onset of parenteral nutrition and manifest as hemolytic anemia as a consequence of hypophosphatemia, as well as somnolence.

From the gastrointestinal tract

Nausea and vomiting.

From the side of the kidneys

In the case of polyuria due to excess infusion speed and the development of hyperosmolarity of the plasma, it is necessary to reduce the infusion rate or to suspend the administration of Nutriflex 70/240.

Adverse adverse reactions associated with abrupt discontinuation of drug use

A sharp cessation of the administration of high doses of dextrose can cause a state of hypoglycemia,especially in children under 3 years old and in patients with impaired glucose tolerance. It is recommended to gradually stop the injection of dextrose.

Overdose:

If properly administered, an overdose of the drug does not occur.

Symptoms of bulk overload or an overdose of electrolytes:

Hypertonic hyperhydration, electrolyte imbalance, pulmonary edema.

Symptoms of an overdose of amino acids:

Loss of amino acids by the kidneys with the development of violations of amino acid balance, metabolic acidosis, nausea, vomiting, tremor.

Symptoms of an overdose of dextrose:

Hyperglycemia, glucosuria, dehydration, plasma hyperosmolality, hyperglycemic 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 after the symptoms of an overdose disappear with less speed and under constant control.

Interaction:

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

Solutions containing potassium should be used with caution in patients who are prescribed drugs that increase the potassium concentration in the plasma, such as potassium-sparing diuretics (triamterene, amiloride), angiotensin converting enzyme (ACE) inhibitors, cyclosporins and tacrolimus.

Nutriflex 70/240 is a multicomponent solution. When adding other solutions or emulsions, it is necessary to consider the compatibility of all ingredients.

Special instructions:

Before the infusion of the drug Nutriflex 70/240, it is necessary to correct such violations of the water-electrolyte balance and the acid-base state of the blood as hypotonic dehydration, hyponatremia and hypokalemia.

In patients with impaired renal function, the dose of the drug should be carefully selected in accordance with the individual needs of the patient, the severity of renal dysfunction and the type of renal replacement therapy (hemodialysis, hemofiltration, etc.).

In patients with insufficient functions of the liver, adrenal glands, cardiac and pulmonary insufficiency, an individual choice of dose and speed of drug administration is necessary depending on the needs of the patient and the severity of violations of the functions of the organs.

Too fast administration of the drug can lead to fluid overload with an increase in the concentration of electrolytes in the plasma, hyperhydration and pulmonary edema. It is necessary to monitor the concentration of glucose in the blood. When hyperglycemia occurs, the rate of administration of Nutriflex 70/240 should be reduced or introduce an appropriate dose of insulin.

To avoid the development of a refeeding syndrome (renewable food syndrome), it is necessary to start parenterally feeding depleted patients step by step with care, paying attention to the introduction of potassium, magnesium and phosphates in appropriate amounts.

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.

The frequency and type of control of water-electrolyte balance, acid-base state, blood glucose concentration, blood urea nitrogen, liver functions depend on the general condition of the patient.

With prolonged use of the drug, the cellular composition and the blood coagulation system must be controlled.

When carrying out full parenteral nutrition, it is necessary to provide the patient with the necessary amount of electrolytes, microelements, vitamins and fat emulsion, a source of essential fatty acids.

Because of the risk of pseudoagglutination, the use of the same infusion system for the administration of blood products and Nutriflex 70/240 is not recommended.

If possible, continuous administration of Nutriflex 70/240 is recommended.

As with all solutions administered intravenously, strict adherence to aseptic rules is necessary.

It is necessary to start the injection immediately after the connection with the infusion system.

It is possible to store the drug after mixing the dextrose 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 infusion).

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.

Do not use the drug if the solution is not clear, the package has obvious signs of damage or the integrity of the container has been compromised.

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:

Solution for infusion.

Packaging:1000 ml or 1500 ml in plastic double containers (a chamber with a solution of amino acids with electrolytes of 500 ml or 750 ml respectively, a chamber with a solution of glucose with electrolytes of 500 ml or 750 ml respectively) from an elastic two-layer film (inner layer - polypropylene, outer - polyamide 11), which meets the requirements of the European Pharmacopoeia. The chambers are separated by a partition made of polypropylene. The container is placed in a secondary transparent plastic bag.

Between the container and the secondary plastic bag or between the containers of the container is an oxygen absorber placed in a special bag.

For 5 containers together with instructions for use in an appropriate quantity in a cardboard box (for hospitals).

Storage conditions:

Store at a temperature of 2 ° C to 25 ° C in a dark place. Do not freeze!

Keep out of the reach of children.

Shelf life:

18 months.

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

Terms of leave from pharmacies:On prescription

Registration number:LS-000329

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: & nbsp31.07.2012

Illustrated instructions

Instructions

Nutriflex 70/240 (Nutriflex 70/240)