Aminoveins of 15%

General characteristics. Structure:

Active ingredients: 5,2 g of L-izoleytsina, 8,9 g of a L-leucine, 16, 66 g of a L-lysine acetate that corresponds to the maintenance of 11,1 g of a L-lysine, 3,8 g of L-methionine, 5,5 g of L-phenylalanine, 8,6 g of L-threonine, 1,6 g of L-tryptophane, 5,5 g of L-valine, 20 g of L-arginine, 7,3 g of a L-histidine, 25 g of L-alanine, 18,5 g of glycine, 17 g of L-proline, 9,6 g of L-serine, 400 mg of L-tyrosine, 2 g of taurine.

The general content of amino acids is 150 g/l, the general nitrogen of 25.7 g/l, energy value of 600 kcal/l (2520 kJ/l), titrable acidity of 44 mmol of NaOH/l, theoretical osmolarity of 1505 ¼Äß¼/l, рН 5.5-6.5.

Excipients: glacial acetic acid, malic acid (for maintenance of level рН), water for injections.

Pharmacological properties:

Pharmacodynamics. Aminoveins of 15% it is intended for parenteral food of patients with various pathology with the low, normal or increased need for protein when the enteroalimentation is inefficient or it is impossible. The replaceable and irreplaceable L-amino acids which are contained in Aminovena are natural physiological compounds. As well as the amino acids arriving with food and received by the proteolysis, parenterally entered amino acids come to a common pool of free amino acids of a blood plasma, and from it to cells for protein synthesis and to various metabolic ways.

Pharmacokinetics. Pharmacokinetic characteristics of the amino acids entered intravenously, same as at their receipt with food. However amino acids of proteins of food at first get into a portal vein of a liver, and only then in a system blood stream while the amino acids entered into a vein get directly to a system blood stream.

From intravascular space of amino acid are redistributed in intercellular liquid and are transferred in cells of different fabrics.

Concentration of free amino acids in a blood plasma and fabrics are regulated by endogenous mechanisms in the narrow range which depends on age, a condition of food and a clinical condition of the patient.

The balanced solutions of amino acids, including Aminoven at their slow introduction significantly do not change a physiological pool of amino acids.

Only small part of the amino acids entered by infusion is removed through kidneys.

Indications to use:

— full or partial parenteral food. Solutions of amino acids usually apply in a combination with enough energy sources (glucose, fatty emulsions);

— prevention and therapy of losses of proteins when peroral or the enteroalimentation is impossible, are not enough or contraindicated.

Route of administration and doses:

Intravenously. The choice of the central or peripheral vein for Aminoven's introduction of 5% and 10% depends on final osmolarity at joint introduction with other solutions. Aminoveins of 15% it is necessary to enter only into the central veins. Infusion it is possible to continue so much time how many it demands a clinical condition of the patient, proceeding from the daily need for amino acids.

Aminoveins of 15%. Adults. Average daily dose: 6.7-13.3 Aminoven's ml of 15% for body weight kg (1.0-2.0 g of amino acids on body weight kg are equivalent) that corresponds to 470-930 ml of Aminoven of 5% for the patient with the body weight of 70 kg.

Maximum daily dose: 13.3 Aminoven's ml of 15% for body weight kg (2.0 g of amino acids on body weight kg are equivalent) that corresponds to 930 ml of Aminoven of 15% for the patient with the body weight of 70 kg.

Maximum speed of infusion: 0.67 Aminoven's ml of 15% for body weight kg an hour (0.1 g of amino acids on kg of mass of body/h are equivalent).

Children. Aminoven is not recommended to use 15% at children (up to 18 years).

Features of use:

Use at pregnancy and feeding by a breast. Special researches of safety of use of Aminoven during pregnancy and a lactation were not conducted. However clinical experience of use of similar parenteral solutions of amino acids testifies to lack of risk for pregnant women and the feeding women.

Before Aminoven's introduction pregnant women or the feeding women should estimate a ratio "risk advantage".

Use at abnormal liver functions. Contraindicated: heavy liver failure.

Use at renal failures. Contraindicated: a renal failure in the absence of a hemodialysis or haemo filtering.

Use for children. Aminoven is not recommended to use 15% at children (up to 18 years). The maximum daily dose for children of 2 years - 10-20 ml of Aminoven of 10% for body weight kg (1.0-2.0 g of amino acids on body weight kg are equivalent).

The maximum rate of administering for children of 2 years does not differ from the maximum speed for adults.

The maximum daily dose for children from 2 years-16-20 ml of Aminoven of 5% for body weight kg (0.8-10 g of amino acids on body weight kg are equivalent).

The maximum rate of administering for children of 2 years does not differ from the maximum speed for adults.

Special instructions. It is necessary to control the level of electrolytes, balance of liquid and function of kidneys.

In case of a hypopotassemia and/or a hyponatremia it is necessary to enter enough potassium and/or sodium at the same time.

Administration of any solutions of amino acids can provoke acute shortage of folates therefore patients should enter folic acid daily.

It is necessary to show care at infusion of large volumes of liquid by the patient with heart failure.

Any infusion in a peripheral vein can cause irritation of a vascular wall and thrombophlebitis. Therefore it is recommended to examine a catheter installation site daily. If to the patient introduction of a fatty emulsion is also appointed, then it should be entered whenever possible along with Aminoven for decrease in risk of development of phlebitis.

The choice of an installation site of a catheter (the central or peripheral vein) is defined by final osmolarity of mix - for infusion in a peripheral vein the limit of osmolarity makes 800-900 ¼«ß¼«½ý/l. Besides, it is necessary to consider age, a clinical condition of the patient and a condition of his peripheral veins.

It is necessary to follow strictly rules of an asepsis, especially at installation of a catheter in the central vein.

Application instruction. To use right after opening of a bottle. Only for single use. Do not use drug expired. Use only the transparent, not containing particles solution from the unimpaired container. All unused rest of solution in a bottle and all mix which remained after infusion should be destroyed.

Use in pediatrics. Clinical trials of use of Aminoven for newborns, babies and children up to 2 years it was not carried out therefore patients of these age groups should not appoint Aminoven. For parenteral food of newborns, babies and children up to 2 years it is necessary to use the adapted children's drugs of amino acids which composition is specially developed for satisfaction of metabolic needs of children (Aminoven Infant).

Aminoven is not recommended to appoint 15% at children (up to 18 years) due to the lack of sufficient experience of a clinical use at this age group.

Side effects:

At the correct use are unknown.

The side effects developing at overdose are usually reversible and disappear at the termination of administration of drug.

Any infusion in a peripheral vein can cause irritation of a vascular wall and thrombophlebitis.

Interaction with other medicines:

Now cases of interaction are unknown.

Because of the increased risk of microbiological pollution and incompatibility, solutions of amino acids should not be mixed with other medicines which are not intended for parenteral food.

Aminoveins it is possible to mix with Dipeptiven, strictly following rules of an asepsis. It is not necessary to add to mix others medicinal means.

Contraindications:

— disturbance of metabolism of amino acids;

— metabolic acidosis,

— a renal failure in the absence of a hemodialysis or haemo filtering;

— heavy liver failure;

— overload liquid;

— shock;

— hypoxia;

— dekompensirovanny heart failure;

— newborn babies and children up to 2 years.

Overdose:

At Aminoven's overdose or when speeding its infusion can be observed: a fever, vomiting, nausea, increase in removal of amino acids through kidneys.

In case of signs of overdose infusion should be stopped immediately. Further its resuming at a reduced dosage is possible.

Too bystry infusion can cause an overload of the patient with liquid and disturbance of balance of electrolytes.

The specific antidote at overdose does not exist. The emergency actions have to have the general supporting character with special attention to function of respiratory and cardiovascular systems. Control of biochemical indicators and the corresponding treatment of the revealed disturbances is important.

Storage conditions:

To store at a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children. A period of validity - 2 years. Drug should not be used after the period of validity specified on packaging.

Special storage conditions after mixing with other components. Aminoveins it is possible to mix in sterile conditions with other drugs for parenteral food, such as fatty emulsions, carbohydrates and electrolytes. Mixes for parenteral food should be used immediately. Mix storage no more than 24 h is in exceptional cases possible at 2-8 °C.

Issue conditions:

According to the recipe

Packaging:

500 ml - bottles (10) - boxes cardboard. 1 l - bottles (6) - boxes cardboard.