Amine

Active material: combination of active ingredients. Solution for infusion 10%
When ATH: B05BA01
CCF: The preparation for parenteral nutrition – amino acid solution
ICD-10 codes (testimony): E46
When CSF: 21.08.01.01
Manufacturer: FRESENIUS KABI GERMANY GmbH (Germany)

Pharmaceutical form, composition and packaging

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

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

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

Pharmacological action

Amine 5 %, 10 %, 15 % for parenteral nutrition of patients with different pathologies 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 connections. As amino acids, from food and obtained by digestion of proteins, parenterally administered amino acids enter into a common pool of free amino acids of blood plasma, and out of the cells for protein synthesis in various metabolic pathways.

Pharmacokinetics

Pharmacokinetic characteristics of amino acids, administered intravenously, the same, like when they arrive with food. However, the amino acid food proteins first enter the portal vein of the liver, and only then into the systemic circulation, while as amino acids, introduced into the vein, directly into the systemic circulation.

Because amino acids are redistributed intravascular space into the extracellular fluid and carried into the cells of various tissues.

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

Balanced solutions of amino acids, including AMINE slow when administered do not substantially alter the physiological pool of amino acids.

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

Testimony

• full or partial parenteral nutrition.

Amino acid solution is usually used in combination with a sufficient amount of energy (glucose, fat emulsions).

• prevention and treatment of loss of protein, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosage regimen

Intravenously. Selection of the central or peripheral veins for administering AMINE 5 % and 10 % It depends on the final osmolarity when co-administered with other solutions. Amine 15 % It should be administered only in the central veins. The infusion can continue for as long, as required by the clinical condition of the patient, on the basis of the daily requirement of amino acids.

Amine 5%

Adult:

Average daily dose:

16-20 ml of the amine 5 % kg body weight (equivalently 0,8-1,0 amino acid g per kg of body weight), corresponding 1120-1400 ml of the amine 5 % for a patient weighing 70 kg.

The maximum daily dose:

20 ml of the amine 5 % kg body weight (equivalently 1,0 amino acid g per kg of body weight), corresponding 1400 ml of the amine 5 % for a patient weighing 70 kg.

Maximum infusion rate:

2,0 ml of the amine 5% per kg body weight per hour (equivalently 0,1 amino acid g per kg of body weight per hour).

Children:

The maximum daily dose for children 2 years – 16-20 ml of the amine 5 % kg body weight (equivalently 0,8-1,0 amino acid g per kg of body weight).

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

Amine 10 %

Adult:

Average daily dose: 10-20 ml of the amine 10 % kg body weight (equivalently 1,0-2,0 amino acid g per kg of body weight), corresponding 700 -1400 ml of the amine 10 % for a patient weighing 70 kg.

The maximum daily dose: 20 ml of the amine 10 % kg body weight (equivalently 2,0 amino acid g per kg of body weight), corresponding 1400 ml of the amine 5% for a patient weighing 70 kg.

Maximum infusion rate: 1,0 ml of the amine 10 % per kg body weight per hour (equivalently 0,1 amino acid g per kg of body weight per hour).

Children:

The maximum daily dose for children 2 years – 10-20 ml of the amine 10 % kg body weight (equivalently 1,0-2,0 amino acid g per kg of body weight).

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

Amine 15 %

Adult:

Average daily dose: 6,7-13.3 ml of the amine 15 % kg body weight (equivalently 1,0-2,0 amino acid g per kg of body weight), corresponding 470-930 ml of the amine 5% for a patient weighing 70 kg.

The maximum daily dose: 13,3 ml of the amine 15 % kg body weight (equivalently 2,0 amino acid g per kg of body weight), corresponding 930 ml of the amine 15 % for a patient weighing 70 kg.

Maximum infusion rate: 0,67 ml of the amine 15 % per kg body weight per hour (equivalently 0,1 amino acid g per kg of body weight per hour).

Children:

Do not use the amine 15 % children (to 18 years).

Side effect

When used properly, are unknown.

Side effects, developing in overdose, usually reversible and disappear when you stop the drug administration.

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

Contraindications

• violation of the metabolism of amino acids,
• metabolic acidosis,
• renal failure in the absence of hemodialysis or hemofiltration,
• severe liver failure,
• fluid overload,
• shock,
• gipoksiya,
• decompensated heart failure.

Clinical trials of the amine in newborns, infants and children up to 2 years has not been, therefore, the amine should not be administered to patients in these age groups.

For parenteral nutrition in neonates, infants and children up to 2 years old should use drugs adapted for children amino acids, the composition of which is specifically designed to meet the metabolic needs of children (Amines Infant).

Do not appoint amine 15 % children (to 18 years) due to lack of adequate clinical experience in this age group.

Pregnancy and lactation

Special Security Studies of the amine during pregnancy and lactation has not been. However, clinical experience with similar parenteral amino acid solutions shows a lack of risk to pregnant and lactating women. Before the introduction of the amine to pregnant or lactating women should weigh the "risk-benefit".

Cautions

It should monitor the level of electrolytes, fluid balance and renal function.

In the case of hypokalemia and / or hyponatremia be administered simultaneously sufficient quantities of potassium and / or sodium.

The introduction of any amino acid solutions can provoke an acute shortage of folate, therefore patients should be administered daily folic acid.

Caution should be exercised when large volumes of fluid infusion to patients with heart failure.

Any infusion into a peripheral vein may cause irritation of the vessel wall and thrombophlebitis. Therefore, it is recommended daily to inspect the catheter insertion site. If the patient is also scheduled introduction of fat emulsion, it should be possible to introduce simultaneously with Aminovenom to reduce the risk of phlebitis.

Selection of catheter insertion site (central or peripheral Vienna) determined the final osmolarity of the mixture – infusion into a peripheral vein is the limit of the osmolarity 800-900 mosmoli /. Besides, should take into account the age of, the clinical condition of the patient and the state of its peripheral veins.

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

Overdose

In overdose amine or in excess of the speed of its infusion can be observed: chills, vomiting, nausea, increasing the excretion of amino acids through the kidneys.

If signs of overdose infusion should be stopped immediately. In the future it is possible resumption at a reduced dosage.

Too rapid infusion may overload the patient with fluid and electrolyte imbalance.

The specific antidote does not exist in overdose. Emergency measures must be of a general nature of the support with particular attention to the function of the respiratory and cardiovascular systems. Importance has control of biochemical parameters and appropriate treatment of violations.

Drug Interactions

Ssluchai interaction unknown.

Because of the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other drugs, not intended for parenteral nutrition.

Amine can be mixed with Dipeptivenom, strictly aseptically. Do not add to the mixture the other drugs.

Conditions and terms

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

Shelf life – 2 year.