Aminoven solution for infusion 15% 500ml vials, 10pcs

Composition

Active ingredients:

L-isoleucine is 5.2 g,

L-leucine 8.9 g,

L-lysine acetate 15.66 g (corresponds to a content of L-lysine 11.1 g),

L-methionine 3.8 g,

L-phenylalanine 5.5 g,

L-threonine 8.6 g,

L-tryptophan 1.6 g,

L-valine 5.5 g,

L-arginine 20 g,

L-histidine 7.3 g,

L-alanine 25 g,

glycine 18.5 g,

L-Proline 17 g,

L-serine 9.6 g,

L-tyrosine 400 mg,

taurine 2 g;

Auxiliary substances:  

glacial acetic acid 4.45 g,

malic acid (to maintain the pH level) 4.9-6.1 g,

water d / i up to 1 l

Pharmacological action

Aminovene 15% is intended for parenteral nutrition of patients with various pathologies with low, normal or increased protein requirements, when enteral nutrition is ineffective or impossible.

The essential and non-essential L-amino acids contained in Aminovene are natural physiological compounds.

Like the amino acids that come from food and are obtained by breaking down proteins, parenterally administered amino acids enter the general pool of free amino acids in the blood plasma, and from it to cells for protein synthesis and to various metabolic pathways.

Indications

Complete or partial parenteral nutrition. Amino acid solutions are usually used in combination with a sufficient amount of energy sources (glucose, fat emulsions).

Prevention and therapy of protein loss when oral or enteral nutrition is impossible, insufficient, or contraindicated.

Use during pregnancy and lactation

No specific safety studies have been conducted on the use of Aminovene during pregnancy and lactation.

However, clinical experience with the use of similar parenteral solutions of amino acids indicates that there is no risk for pregnant and lactating women.

Before use of Aminovene to pregnant or lactating women, the risk-benefit ratio should be evaluated.

Contraindications

• Violation of amino acid metabolism.
• Metabolic acidosis.
• Renal failure in the absence of hemodialysis or hemofiltration.
• Severe liver failure.
• Fluid overload.
• Shock.
• Hypoxia.
• Decompensated heart failure.
• Newborns, children and children under 2 years of age: use adapted children’s amino acid preparations, the composition of which is specially designed to meet the metabolic needs of children (Aminovene Infant).
• It is not recommended to prescribe Aminovene 15% in children (under 18 years of age) due to the lack of sufficient experience of clinical use in this age group.

Interaction

Currently, the cases of interaction are unknown.

Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other medicinal products not intended for parenteral nutrition.

Aminovene can be mixed with Dipeptivene, strictly following the rules of asepsis.

Do not add other medications to the mixture.

How to take, course of use and dosage

Aminovene 15% should be administered only in the central veins. The infusion can be continued for as long as the patient’s clinical condition requires, based on the daily requirement for amino acids.

For adults

Average daily dose:  6.7-13.3 ml of Aminovene 15% per kg of body weight (equivalent to 1.0-2.0 g of amino acids per kg of body weight), which corresponds to 470-930 ml of Aminovene 5% for a patient with a body weight of 70 kg.

Maximum daily dose:  13.3 ml of Aminovene 15% per kg of body weight (equivalent to 2.0 g of amino acids per kg of body weight), which corresponds to 930 ml of Aminovene 15% for a patient with a body weight of 70 kg.

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

Children:  it is not recommended to use Aminovene 15% in children (under 18 years of age).

Newborns, children and children under 2 years of age: use adapted children’s amino acid preparations, the composition of which is specially designed to meet the metabolic needs of children (Aminovene Infant).

Overdose

Symptoms:  if an overdose of Aminovene or if the rate of its infusion is exceeded, the following symptoms may occur: chills, vomiting, nausea, increased excretion of amino acids through the kidneys.

Too fast infusion can cause the patient to become overloaded with fluid and disrupt the electrolyte balance.

Treatment:  in case of signs of overdose, the infusion should be stopped immediately. In the future, it may be resumed at a reduced dosage.

There is no specific antidote for overdose. Emergency measures should be of a general supportive nature, with special attention to the function of the respiratory and cardiovascular systems.

Monitoring of biochemical parameters and appropriate treatment of detected disorders is important.

Special instructions

It is recommended to use Aminovene 15% in children (under 18 years of age). Electrolyte levels, fluid balance, and kidney function should be monitored.

In the case of hypokalemia and/or hyponatremia, sufficient amounts of potassium and/or sodium should be administered simultaneously. The introduction of any solutions of amino acids can provoke acute folate deficiency, so patients should be administered folic acid daily. Caution should be exercised when infusing large volumes of fluid to patients with heart failure.

Any infusion into a peripheral vein can cause irritation of the vessel wall and thrombophlebitis. Therefore, it is recommended to inspect the catheter placement site daily. If the patient is also prescribed a fat emulsion, then it should be administered, if possible, simultaneously with Aminovene to reduce the risk of phlebitis.

The choice of placement of the catheter (central or peripheral vein) is determined by the final osmolarity of the mixture – for infusion into the peripheral vein, the osmolarity limit is 800-900 mosmol/l. In addition, the age, clinical condition of the patient and the condition of his peripheral veins should be taken into account. The rules of asepsis should be strictly observed, especially when inserting the catheter into the central vein. Use immediately after opening the bottle. Only for a single use. All unused solution residue in the vial and all mixture remaining after the infusion should be destroyed. Use only a clear, particle-free solution from an undamaged container.

Special storage conditions after mixing with other ingredients:  Aminovene can be mixed in sterile conditions with other parenteral nutrition products, such as fat emulsions, carbohydrates, and electrolytes.

Mixtures for parenteral nutrition should be used immediately. In exceptional cases, it is possible to store the mixture for no more than 24 hours. +2 – +8°C.

In case of hepatic and/or renal insufficiency, individual dosage is required.

Form of production

Solution for infusions

Storage conditions

At a temperature not exceeding 25 °C (do not freeze)

Shelf life

2 years

Active ingredient

Amino acids for parenteral nutrition

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Restoring water-salt balance