2010/09/20

Aminoven

Composition, structure and packing

Solution for infusion of 5% transparent or slightly opalescent, colorless or slightly yellow.

1 l

L-isoleucine 2.5, the

L-leucine 3.7, the

L-lysine acetate, 4,655 g,

which corresponds to the content of L-lysine 3.3, the

L-methionine 2.15 PM

L-phenylalanine 2.25 PM

L-threonine 2.2, the

L-tryptophan 1 yr

L-valine 3.1, the

L-arginine 6 g.

L-histidine 1.5, the

L-alanine, 7 g glycine, 5.5 PM

L-Proline 5.6 g L-serine 3.25 PM

L-Tyrosine 200 mg.

Taurine 500 mg.

total content aminoksilot - 50 g / liter.

total nitrogen - 8.1 g / liter.

Energy value - 200 kcal / l (840 kJ / l)

titratable acidity - 12 mmolNaOH / liter.

Theoretical osmolarity - 495 mOsmol / l

pH 5.5-6.5

Excipients: glacial acetic acid, malic acid (to maintain the pH), water d / and.

Solution for infusion 10% transparent or slightly opalescent, colorless or slightly yellow.

1 liter.

L-isoleucine 2.5, the

L-leucine 3.7, the

L-lysine acetate, 4,655 g,

which corresponds to the content of L-lysine 3.3, the

L-methionine 2.15 PM

L-phenylalanine 2.25 PM

L-threonine 2.2, the

L-tryptophan 1 yr

L-valine 3.1, the

L-arginine 6 g.

L-histidine 1.5, the

L-alanine 7 g.

glycine 5.5 PM

L-proline, 5.6 PM

L-serine 3.25 PM

L-Tyrosine 200 mg.

Taurine 500 mg.

total content aminoksilot - 50 g / liter.

total nitrogen - 8.1 g / liter.

Energy value - 200 kcal / l (840 kJ / l)

titratable acidity - 12 mmol NaOH / l

Theoretical osmolarity - 495 mOsmol / l

pH 5.5-6.5

Excipients: glacial acetic acid, malic acid (to maintain the pH), water d / and.

Solution for infusion 15% transparent or slightly opalescent, colorless or slightly yellow.

1 liter.

L-isoleucine 5.2, the

L-leucine 8.9, the

L-lysine acetate, 15.66 g,

which corresponds to the content of L-lysine 11.1, the

L-methionine 3.8 g

L-phenylalanine 5.5, the

L-threonine 8.6, the

L-tryptophan 1.6, the

L-valine 5.5, the

L-Arginine 1920

L-histidine 7.3, the

L-alanine 1925

glycine 18.5 PM

L-proline 1917

L-serine 9.6, the

L-Tyrosine 400 mg.

Taurine 2

total content aminoksilot - 150 g / liter.

total nitrogen - 25.7 g / liter.

Energy value - 600 kcal / liter. (2520 kJ / l)

titratable acidity - 44 mmol NaOH / l

Theoretical osmolarity - 1505 mOsmol / l

pH 5.5-6.5

Excipients: glacial acetic acid, malic acid (to maintain the pH), water d / and.

Clinico-pharmacological group: The preparation for parenteral nutrition - a solution of amino acids

Pharmacological action

Aminov 5%, 10%, 15% intended for parenteral nutrition in patients with different pathologies with low, normal or increased protein requirements, when enteral feeding is ineffective or impossible. Contained in Aminovene essential and nonessential L-amino acids are natural physiological compounds. Like amino acids coming from food and produced by the splitting of proteins, parenteral amino acids act in a common pool of free amino acids in blood plasma, and from the cells for protein synthesis and various metabolic pathways.

Pharmacokinetics

Pharmacokinetic characteristics of amino acids, injectable, such as when entering the food. However, the amino acid food proteins first enter the portal vein of the liver, and only then into the systemic circulation, whereas the amino acids introduced into the vein, directly into the systemic circulation.

From the intravascular space amino acids are redistributed in the intercellular fluid and transported into the cells of various tissues.

Concentrations of free amino acids in plasma and tissues are regulated by endogenous mechanisms in a narrow range, which depends on age, nutritional status and clinical condition of the patient.

Balanced solution of amino acids, including Aminova with their slow introduction did not significantly alter the physiological pool of amino acids.

Only a small part imposed by the infusion of amino acids derived through the kidneys

Statement
total or partial parenteral nutrition.

Solutions of amino acids is usually used in combination with plenty of energy sources (glucose, fat emulsion).
prevention and treatment of loss of protein, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosage regimen

Intravenously. The choice of central or peripheral vein for the introduction of Aminova 5% and 10% depending on the final osmolarity with combined administration with other solutions. Aminov 15% should be imposed only in the central vein. Infusion can continue as long as required by the clinical condition of the patient, based on the daily needs of amino acids.

Aminov 5%

Adults:

Average daily dose:

16-20 ml Aminova 5% per kg body weight (equivalent to 0,8-1,0 g amino acids per kg body weight), which corresponds to 1120-1400 ml Aminova 5% for patients with body weight 70 kg.

The maximum daily dose:

20 ml Aminova 5% per kg body weight (equivalent to 1.0 g amino acids per kg body weight), which corresponds to 1400 ml Aminova 5% for patients weighing 70 kg.

Maximum infusion rate:

2,0 ml Aminova 5% per kg of body weight per hour (equivalent to 0.1 g amino acids per kg of body weight per hour).

Children:

The maximum daily dose for children from 2 years - 16-20 ml Aminova 5% per kg body weight (equivalent to 0,8-1,0 g amino acids per kg body weight).

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

Aminov 10%

Adults:

Average daily dose: 10-20 ml Aminova 10% per kg body weight (equivalent to 1,0-2,0 g amino acids per kg body weight), which corresponds to 700 ml -1400 Aminova 10% for patients weighing 70 kg.

The maximum daily dose: 20 ml Aminova 10% per kg body weight (equivalent to 2.0 g amino acids per kg body weight), which corresponds to 1400 ml Aminova 5% for patients weighing 70 kg.

Maximum infusion rate: 1.0 ml Aminova 10% per kg body weight per hour (equivalent to 0.1 g amino acids per kg body weight per hour).

Children:

The maximum daily dose for children from 2 years - 10-20 ml Aminova 10% per kg body weight (equivalent to 1,0-2,0 g amino acids per kg body weight).

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

Aminov 15%

Adults:

Average daily dose: 6,7-13.3 Aminova ml of 15% per kg body weight (equivalent to 1,0-2,0 g amino acids per kg body weight), which corresponds to 470-930 ml Aminova 5% for patients weighing 70 kg .

The maximum daily dose: 13.3 ml Aminova 15% per kg body weight (equivalent to 2.0 g amino acids per kg body weight), which corresponds to 930 ml Aminova 15% for patients weighing 70 kg.

Maximum infusion rate: 0.67 ml Aminova 15% per kg of body weight per hour (equivalent to 0.1 g amino acids per kg body weight per hour).

Children:

Do not use Aminova 15% of children (under 18).

Side effect

When properly implemented, is unknown.

Side effects, developing an overdose, usually reversible and disappear when the cessation of the drug.

Any infusion of a peripheral vein may cause irritation of the vessel wall and thrombophlebitis

Contraindications
violation of the metabolism of amino acids,
metabolic acidosis
renal insufficiency in the absence of hemodialysis or hemofiltration,
severe hepatic insufficiency,
overload fluid
shock
hypoxia
decompensated heart failure.

Clinical trials of Aminova newborns, infants and children under 2 years has not been so Aminova should not assign patients to these age groups.

For parenteral nutrition in neonates, infants and children up to 2 years should be adapted to use children's medicines amino acid composition of which is specifically designed to meet the metabolic needs of children (Aminova Infante).

Do not assign Aminova 15% in children (under 18) due to lack of sufficient clinical experience in this age group.

Pregnancy and lactation

Special security research application Aminova during pregnancy and lactation was conducted. However, clinical experience with similar parenteral solutions of amino acids indicates the absence of risk to pregnant and lactating women. Before the introduction of Aminova pregnant or lactating women should assess the ratio of the risk-benefit.

Cautions

Should monitor the level of electrolytes, fluid balance and kidney function.

In the case of hypokalemia and / or hyponatremia should simultaneously introduce sufficient quantities of potassium and / or sodium.

Introduction of any solutions of amino acids could trigger an acute shortage of folate, so patients should introduce folic acid daily.

Care should be taken when infusion of large volumes of fluid to patients with heart failure.

Any infusion of a peripheral vein may cause irritation of the vessel wall, and thrombophlebitis. Therefore, we recommend a daily basis to inspect the place catheter. If the patient is also assigned to the introduction of fat emulsion, it should be entered as possible while Aminovenom to reduce the risk of phlebitis.

Selecting the catheter (central or peripheral Vienna) is determined by the final osmolarity of the mixture - for infusion into the peripheral vein limit the osmolarity of 800-900 mosmol / liter. Furthermore, it should take into account age, clinical condition of the patient and his state of peripheral veins.

It should strictly observe the rules of asepsis, especially when installing a catheter into the central vein.

Overdose

In case of overdose Aminova or in excess of the rate of its infusion can occur: chills, vomiting, nausea, increased excretion of amino acids through the kidneys.

If signs of an overdose infusion should be stopped immediately. In the future, may resume it at a reduced dosage.

Too rapid infusion may cause overloading of the patient fluid and electrolyte imbalance.

Specific antidote for an overdose does not exist. Urgent measures should be general support nature with particular attention to the function of the respiratory and cardiovascular systems. It is important to control the biochemical factors and appropriate treatment of violations.

Drug Interactions

Ssluchai interaction is unknown.

Because of the risk of microbiological contamination and incompatibility, solutions of amino acids should not be confused with other drugs, not intended for parenteral nutrition.

Aminov can be mixed with Dipeptivenom, strictly observing the rules of asepsis. Do not add to the mixture of other medicines.

Terms and Conditions of storage

Store at temperatures not above 25 ° C. Do not freeze.

Shelf life - 2 years.