INOVAN-18 [18 Amino Acids] Solution for IV infusion

INOVAN-18

instructions for medical use of the medicinal product

Tradename

Inovan-18, Inovan -18

International non-proprietary name

Amino acids for parenteral nutrition, Aminoacids for parental nutrition

Composition

Each 100 ml solution contains:

active substances: L - glycine 760 mg, L - phenylalanine 533 mg, L - arginine hydrochloride 500 mg, L - leucine 490 mg, L - lysine hydrochloride 430 mg, L - valine 360 mg, L - isoleucine 352 mg, L - aspartic acid 250 mg, L - histidine hydrochloride 250 mg, L - threonine 250 mg, L - methionine 225 mg, L - alanine 200 mg, L - proline 100 mg, L - serine 100 mg, L - tryptophan 90 mg, L - glutamine acid 75 mg, L - tyrosine 25 mg, L -cystine 10 mg

excipients: with orbitol, sodium bisulfite, water for injection

Dosage form

Solution for infusion.

Pharmacotherapeutic group

Means of parenteral nutrition - amino acids .

Pharmacological properties

Pharmacodynamics

It is intended for parenteral nutrition of patients with various pathologies with a low, normal or increased need for protein, when enteral nutrition is ineffective or impossible. The interchangeable and irreplaceable L -amino acids contained in this product are natural physiological compounds. Like dietary amino acids obtained from protein breakdown, parenterally administered amino acids enter the total pool of free amino acids in the blood plasma, and from there into cells for protein synthesis and into various metabolic pathways .

Pharmacokinetics

Pharmacokinetic characteristics of amino acids administered intravenously are the same as when taken with food. However, food protein amino acids first enter the portal vein of the liver, and only then into the systemic circulation, while amino acids injected into the vein enter directly into the systemic circulation.

From the intravascular space, amino acids are redistributed into the intercellular fluid and transferred into the cells of different tissues.

Plasma and tissue concentrations of free amino acids are regulated by endogenous mechanisms over a narrow range, which depends on the age, nutritional status, and clinical condition of the patient.

Balanced solutions of amino acids do not significantly change the physiological pool of amino acids when they are slowly introduced.

Only a small part of the amino acids introduced by infusion is excreted through the kidneys.

For most amino acids T _1/2 in plasma is 10-30 minutes.

Indications for use

To meet the body's need for essential and non-essential amino acids in patients requiring parenteral nutrition, when enteral nutrition is ineffective or impossible.

Contraindications

·        hypersensitivity to active substances or any of the components of the drug;

·        metabolic acidosis;

·        violation of amino acid metabolism;

·        severe renal and hepatic insufficiency;

·        liquid overload;

·        shock;

·        hypoxia;

·        decompensated heart failure;

·        pregnancy and lactation;

·        children and adolescents under 18 years of age (efficacy and safety have not been established).

Dosage and administration

The drug is administered intravenously by drip, slowly, with careful monitoring of the patient's condition. The dosage is calculated depending on the clinical condition of the patient and his needs for amino acids, electrolytes and fluids. It is necessary to start the infusion at a slower rate of administration and, within the first hour, bring the rate of administration to the required value.

Average daily dose : 10-20 ml/kg of body weight, which corresponds to 1.0-2.0 g of amino acids/kg.

Maximum daily dose : 20 ml/kg, corresponding to 2.0 g of amino acids/kg.

With parenteral nutrition as part of appropriate therapy in adults, the total amount of fluid administered should not exceed 40 ml / kg / day.

Special instructions and precautions

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 an acute folate deficiency, so patients should be given daily folic acid.

Caution should be exercised when infusing large volumes of fluid in 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 site of the catheter daily.

It is not recommended to use the solution of this agent in children and adolescents under the age of 18 due to the lack of sufficient clinical experience in this age group.

Use only transparent solution o r e n o d r e n o g o f a c o n o n a !

All unused amounts of solution must be destroyed!

Use during pregnancy and during breastfeeding

Efficacy and safety of use during pregnancy and breastfeeding   not installed .

Interaction with other drugs

No interactions are currently known.

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

Side effect

When using the drug according to indications in recommended doses, the occurrence of side effects is unlikely. Allergic reactions (urticaria, anaphylactic reactions) may occur. Very rarely, there may be increased sweating, nausea, vomiting, chills, tachycardia, usually at too high a rate of administration.

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

If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms:   nausea, vomiting, skin redness, increased sweating, fever, tachycardia.

Treatment:   symptomatic. It is necessary to reduce the rate of administration or stop the administration of the drug.

Storage conditions

Store in a place protected from light, at a temperature not exceeding 25 ⁰ С. Do not freeze.

Keep out of the reach of children.

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

In vials of 250 ml. 1 bottle with instructions for use in a cardboard box.