Aminosol-Neo E - instructions for use, dose, side effects, contraindications

Active substances:	amount
L-isoleucine	5.00 g
L-leucine	7.40 g
L-valina	6.20 g
Llily (in the shape of Llysine monoacetate 9.31 g)	6.60 g
L-methionine	4.30 g
L-treonine	4.40 g
L-phenylalanine	5.10 g
L-alanine	15.00 g
L-arginine	12.00 g
Glycine	14.00 g
L-histidine	3.00 grams
L-prolin	15.00 g
L-tryptophan	2.00 grams
L-black acid	9.280 grams
Sodium glycerophosphate	9.4530 g
Calcium chloride	0.735 g
Magnesium chloride hexahydrate (anhydrous 0.286 g)	1.017 g
Potassium hydroxide	1.683 g
Excipients:
NaOH	q.s.
Water for Injection	up to 1000 ml
Ionic composition:
Na⁺	60 mmol
TO⁺	30 mmol
Ca⁺⁺	5 mmol
Mg⁺⁺	5 mmol
Cl^-	20 mmol
Acetates^-	45 mmol
Malatov^-	69.2 mmol
Glycerophosphates^-	30 mmol
Energy value:	1900 kJ / l or 440 kcal / l
Theoretical osmolality:	1137 mOsm / l

Description:Transparent solution from colorless to light yellow color.

Pharmacotherapeutic group:Parenteral nutrition - amino acids

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

AMINOSOL-NEO E is a combined preparation for parenteral nutrition that contains essential and non-essential amino acids in a balanced ratio (amino acids total 100.00 g / 1000 ml, nitrogen only 16.40 g / 1000 ml).All amino acids are in L-form, which ensures the possibility of their direct participation in the biosynthesis of proteins.

Contains eight essential amino acids (not synthesized in the human body): L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-treonine, L-tryptophan and L-valine. The conditionally interchangeable ones are considered L-arginine and L-histidine. Conditionally interchangeable amino acids are synthesized in the body, however, in some pathological conditions (for example, in renal and hepatic insufficiency) or because of age-related physiological characteristics (for example, in young children), their concentration does not reach the target value.

L-arginine participates in the cycle of conversion of ammonia into urea, binding toxic ammonium ions, which are formed during the catabolism of proteins in the liver.

L-isoleucine, L-leucine and L-valine - essential amino acids with branched side chains - satisfy the energy needs of the body, which is especially important in the early postoperative period.

Amino acids containing aromatic rings are necessary for the synthesis of high-grade proteins and are presented Lphenylalanine and L-tryptophan.

L-Abloc acid serves as an energy source for the synthesis of urea.

Cations and anions provide hyperosmolarity of the solution (1137 mOsmol / l), being elements for maintaining homeostasis.

Pharmacokinetics:

Parenterally introduced amino acids are used in the body in protein synthesis. The amino acids not used in this process are deaminated to form urea, which is then excreted in the urine. The half-life of amino acids in healthy people is 5-15 minutes.

Some amino acids can not undergo biotransformation and are excreted unchanged, the desired effect of the use of these compounds in this case is not achieved. This pharmacokinetic feature can be eliminated by injecting the drug slowly enough so that the concentration of amino acids in the blood does not increase sharply. Such a method of administration will avoid the excretion of amino acids through the kidneys in an unchanged form.

Indications:Parenteral nutrition is partial or complete (with the addition of fat emulsions), as well as prophylaxis and therapy of loss of proteins and fluids, when enteral nutrition is not possible.Severe cases of gastrointestinal diseases (obstruction, malabsorption, inflammatory bowel diseases, pancreatitis, intestinal fistulas), hypermetabolic conditions (trauma, burns, sepsis) and other cases requiring parenteral nutrition (for malignant diseases, in preparation for surgery and after surgery).

Contraindications:Metabolic acidosis, severe renal and hepatic insufficiency, shock, decompensated heart failure, hyperhydration, hyperkalemia, pregnancy and lactation, children under 18 years of age (efficacy and safety not established).

Carefully:Sepsis, essential hypertension, hepatic insufficiency of moderate and moderate severity, diabetes mellitus.

Pregnancy and lactation:

The effectiveness and safety of the drug during pregnancy and lactation are not established.

Dosing and Administration:

AMINOSOL-NEO E is used as an intravenous infusion through one of the central veins.

The dose is selected individually, according to the severity of the metabolic disorder and the body's need for amino acids and electrolytes.

The maximum admissible rate of administration is 1 ml / kg / h, and the maximum daily dose is 20 ml / kg.

For a person weighing 70 kg, the maximum daily dose of the drug is 1400 ml, the recommended rate of administration is 20-35 drops / min.

Dosing for liver failure: patients with hepatic insufficiency do not tolerate an increased amount of amino acids, and therefore their protein requirements are 0.8-1.1 g / kg / day, which is 8-11 ml / kg / day in terms of Aminosol-Neo E solution.

Side effects:

Increased activity of liver enzymes, nausea, vomiting, abdominal pain, fatigue, urticaria, increased blood pressure, increased sweating, respiratory depression, tachycardia, fever, cyanosis, changes in blood composition, increased ammonia in the blood, irritation of the skin at the site of administration drug, thrombophlebitis.

Accelerated administration (see the recommended rate of administration in the "Application and dose" section) of the drug AMINOSOL-NEO E can cause hyperhydration and violation of electrolyte plasma composition (hyperkalemia).

Overdose:

Symptoms: nausea, vomiting, trembling, "hot flashes", increased sweating, fever, tachycardia.With a high rate of administration, hypervolemia and a violation of the electrolyte composition of the plasma are possible. High-risk patients may develop pulmonary edema and left ventricular failure, hyperammonemia, and hepatic encephalopathy (especially in patients with hepatic and renal insufficiency).

Treatment: infusion should immediately stop, ensure the monitoring of biochemical indicators, functions of the respiratory and cardiovascular systems.

There is no specific antidote.

Treatment is symptomatic.

With hyperkalemia - infusion 200-500 ml of 10% glucose solution with insulin in a dose of 1-3 ED for every 3-5 g of glucose. In case of an unsatisfactory result, the purpose of ion exchange resins and hemodialysis is indicated.

After the symptoms of an overdose have completely disappeared, the infusion can be resumed by reducing the infusion rate or dose.

Interaction:

It is not recommended to uncontrolled addition of other drugs to the solution of Aminosol-Neo E.

Pharmaceutically compatible with antibiotics - amikacin, ampicillin, cefotaxime, ceftriaxone, doxycycline, erythromycin, gentamicin, chloramphenicol, clindamycin, netilmicin, penicillin, piperacillin, tetracycline, tobramycin and vancomycin; other drugs - aminophylline, cyclophosphamide, cimetidine, cytarabine, digoxin, dopamine, famotidine, phytomenadione, fluorouracil, folic acid, furosemide, heparin, chlorpromazine, insulin, calcium gluconate, lidocaine, methyldopa, methylprednisolone, metoclopramide, methotrexate, morphine, nisatidine, norepinephrine, propranolol, ranitidine and riboflavin.

Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the insulin content in the blood.

Estrogens and oral contraceptives can cause an increase in the content of growth hormone caused by arginine, and lower the glucagon and insulin response to arginine.

The interaction of arginine with spironolactone causes severe hyperkalemia.

Arginine is incompatible with thiopental sodium.

Special instructions:

Arginine, which is part of the drug, can lead to a decrease in the concentration of phosphates and an increase in the concentration of potassium in the plasma. These changes are particularly pronounced in patients with diabetes mellitus.

It is necessary to constantly monitor the acid-base and electrolyte status, the balance of fluid in the body and the state of kidney function.

In the presence of hyponatremia in the appointment of this solution, it is necessary to monitor the concentration of sodium in the plasma.

AMINOSOL-NEO E can cause hyperkalemia, especially in diabetic patients and in patients under stress. With established hyperkalemia, the pharmacological correction described in the section "Overdose" is carried out. When adding standard power, pay attention to compatibility.

Apply only a clear solution from an intact vial!

Form release / dosage:

Solution for infusions 10%.

Packaging:

500 ml of solution in a glass bottle of glass II hydrolytic, sealed with a lid of rubber, metal and plastic, with the control of the first opening.

1 bottle together with a plastic holder and instructions for the use of cardboard.

For 10 bottles together with plastic holders and an equal number of instructions for use in a cardboard box (for hospitals).

Storage conditions:

Store in a dark place at a temperature of 15 to 25 ° C.

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:On prescription

Registration number:LS-000963

Date of registration:14.11.2011 / 02.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

Hemomont d.o.o. Montenegro

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp09.08.2017

Illustrated instructions

Instructions

Aminosol-Neo E (Aminosol Neo E)