Aminoven infant instructions for use. Special storage conditions

Instructions for use

Aminoven Infant instructions for use

Dosage form

Transparent or slightly opalescent, colorless to light yellow solution.

Compound

1 liter of solution contains:

Amino acids 100 g, incl.

L-valine 9 g

L-isoleucine 8 g

L-leucine 13 g

L-lysine monoacetate 12 g, resp. L-lysine content 8.51 g

L-methionine 3.12 g

L-threonine 4.4 g

L-phenylalanine 3.75 g

L-alanine 9.3 g

L-arginine 7.5 g

Glycine 4.15 g

L-histidine 4.76 g

L-proline 9.71 g

L-serine 7.67 g

N-acetyl-L-tyrosine 5.176 g,

Which resp. L-tyrosine content 4.2 g

N-acetyl-L-cysteine 700 mg,

Which resp. L-cysteine content 520 mg

Taurine 400 mg

L-malic acid 2.62 g

Total nitrogen 14.9 g/l

Titratable acidity 27-40 mmol NaOH/l

Theoretical osmolarity 885 mOsm/l

Pharmacodynamics

The 10% amino acids included in the drug Aminoven Infant are physiological components. After parenteral administration, they are included in the pool of free amino acids in the body and participate in all metabolic processes, in particular, they are used for protein synthesis.

Pharmacokinetics

The bioavailability of the drug Aminoven infant is 6%, 10% when administered intravenously and is 100%. Amino acids are included in the general pool of free amino acids of the body and are distributed in the interstitial fluid and intercellular space of organs and tissues. The concentration of free amino acids in the blood plasma and cytoplasm of cells is regulated within narrow limits depending on the age, nutritional status and general condition of the patient. When administered correctly (slowly and at a constant speed), Aminoven infant 6%, 10% does not upset the balance of amino acids. In severe liver and kidney dysfunction, the regulation of amino acid balance is disrupted. In these cases, special formulations of amino acid solutions for parenteral nutrition should be used. Only a small portion of amino acids is eliminated by the kidneys. The plasma half-life of amino acids is highly dependent on age.

Side effects

Not detected when used correctly. When infusing the drug Aminoven infant 6%, 10% into peripheral veins, signs of a local reaction may be observed: redness, phlebitis, thrombosis. Daily monitoring of the puncture area is recommended.

Selling Features

prescription

Special storage conditions

Do not freeze. An open bottle of Aminoven Infant 10% should be stored in the refrigerator for no more than 24 hours.

Special conditions

When parenteral nutrition of young children, it is necessary to take into account the following indicators: urine nitrogen, ammonia, glucose, electrolytes, triglycerides (with additional administration of fat emulsions), liver enzymes, serum osmolarity, acid-base balance and water-salt metabolism.

Too rapid infusion may result in loss of amino acids through the kidneys, resulting in amino acid imbalance.

Indications

Aminoven infant 10% is intended for partial parenteral nutrition of newborns, young children and premature infants. Together with carbohydrate solutions, fat emulsions, as well as preparations of vitamins, electrolytes and microelements, it provides complete parenteral nutrition.

Contraindications

Like other amino acid solutions, Aminoven Infant 10% should not be administered in cases of amino acid metabolism disorders, metabolic acidosis, overhydration, or hypokalemia. For liver and kidney failure, individual dosing is required.

Drug interactions

Amino acid solutions should not be mixed with other medications due to the increased risk of microbial contamination.

The addition of other drugs to the drug Aminoven infant 6%, 10% should be avoided, as this may cause toxic reactions. In any case, it is necessary to ensure the compatibility of the drugs, maintaining sterility and thorough mixing. Solutions with the addition of other medications cannot be stored.

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Mode of application

Dosage

Aminoven infant 10% is intended for long-term intravenous drip administration, mainly into the central veins.

Maximum rate of administration: up to 0.1 g of amino acids per 1 kg of body weight per hour, which is equal to 1 ml per kg of body weight per hour.

Maximum daily dose:

Children under 1 year - 1.5-2.5 g of amino acids per 1 kg of body weight per day, or 15 - 25 ml of Aminoven infanta solution 10% per 1 kg of body weight per day.

Children aged 2-5 years - 1.5 g of amino acids per 1 kg of body weight per day, or 15 ml per 1 kg of body weight per day.

Children aged 6-14 years - 1.0 g of amino acids per 1 kg of body weight per day, which is equal to 10 ml per 1 kg of body weight per day.

Aminoven infant 10% is used as long as the need for parenteral nutrition continues.

Overdose

If the dosage or rate of administration of the drug Aminoven infant 6%, 10% is exceeded, as with an overdose of other amino acid solutions, chills, nausea, vomiting, and renal aminoacidosis occur. Acute circulatory disorders may also occur. In this case, administration of the drug should be stopped immediately. When hyperkalemia occurs, administer 200 to 500 ml of a 5% glucose solution with the addition of 1-3 IU insulin for every 3-5 g of glucose.

Release form

solution for infusion

Owner/Registrar

FRESENIUS KABI DEUTSCHLAND, GmbH

International Classification of Diseases (ICD-10)

E46 Protein-energy deficiency, unspecified P78.9 Digestive system disorder in the perinatal period, unspecified P92.3 Underfeeding of a newborn P92.5 Difficulties in breastfeeding a newborn R63.3 Difficulties in feeding and introducing food

Pharmacological group

Parenteral nutrition preparation - amino acid solution

pharmachologic effect

The amino acids included in the drug Aminoven Infant 6%, 10% are physiological components. After parenteral administration, they are included in the pool of free amino acids in the body and participate in all metabolic processes, in particular, they are used for protein synthesis.

Pharmacokinetics

The bioavailability of the drug Aminoven infant is 6%, 10% when administered intravenously and is 100%. Amino acids are included in the general pool of free amino acids of the body and are distributed in the interstitial fluid and intercellular space of organs and tissues. The concentration of free amino acids in the blood plasma and cytoplasm of cells is regulated within narrow limits depending on the age, nutritional status and general condition of the patient. When administered correctly (slowly and at a constant speed), Aminoven infant 6%, 10% does not upset the balance of amino acids. In severe liver and kidney dysfunction, the regulation of amino acid balance is disrupted. In these cases, special formulations of amino acid solutions for parenteral nutrition should be used. Only a small portion of amino acids is eliminated by the kidneys. T 1/2 amino acids from plasma largely depends on age.

Aminoven infant 6%, 10% is intended for partial parenteral nutrition of newborns, young children and premature infants. Together with carbohydrate solutions, fat emulsions, as well as preparations of vitamins, electrolytes and microelements, it provides complete parenteral nutrition.

Like other amino acid solutions, Aminoven Infant 6%, 10% should not be administered in case of disorders of amino acid metabolism, metabolic acidosis, overhydration, hypokalemia. For liver and kidney failure, individual dosing is required.

Overdose

special instructions

For renal failure

In case of renal failure, individual dosing is required.

In case of liver dysfunction

In case of liver failure, individual dosing is required.

Drug interactions

Amino acid solutions should not be mixed with other medications due to the increased risk of microbial contamination.

Aminoven infant 6% intended for long-term intravenous drip administration into peripheral or central veins.

up to 0.1 g of amino acids per 1 kg of body weight, per hour = 1.67 ml/kg.

Maximum daily dose:

Children under 1 year - 1.5-2.5 g of amino acids per 1 kg of body weight, or from 25 ml to 40 ml of Aminoven infanta solution 6% per 1 kg of body weight per day.

Children 2-5 years old - 1.5 g of amino acids per 1 kg of body weight, or 25 ml per 1 kg of body weight per day.

Aminoven infant 10% intended for long-term intravenous drip administration, mainly into the central veins.

Maximum injection rate: up to 0.1 g of amino acids per 1 kg of body weight per hour, which is equal to 1 ml per kg of body weight per hour.
Maximum daily dose:

Children under 1 year - 1.5-2.5 g of amino acids per 1 kg of body weight per day, or 15-25 ml of Aminoven infanta solution 10% per 1 kg of body weight per day.

Children aged 2-5 years - 1.5 g of amino acids per 1 kg of body weight per day, or 15 ml per 1 kg of body weight per day.

Children aged 6-14 years - 1.0 g of amino acids per 1 kg of body weight per day, which is equal to 10 ml per 1 kg of body weight per day.

Aminoven infant 6%, 10% is used as long as the need for parenteral nutrition remains.

Storage conditions and shelf life

In a place protected from light at a temperature not exceeding 25 ° C. Do not freeze. An open bottle of Aminoven infant 6%, 10% should be stored in the refrigerator for no more than 24 hours. Keep out of the reach of children. Shelf life is 24 months. Use immediately after opening the bottle. Do not use Aminoven Infant after the expiration date. Use if the solution is clear and the packaging is not damaged.

Fresenius Kabi AB Fresenius Kabi Austria GmbH Fresenius Kabi Deutschland GmbH

Country of origin

Austria Germany

Product group

Infusion solutions

Parenteral nutrition preparation - amino acid solution

Description of the dosage form

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

pharmachologic effect

After parenteral administration, amino acids are included in the body's pool of free amino acids and participate in all metabolic processes, in particular, they are used for protein synthesis. Taurine is not part of proteins, but is necessary for the normal development of the brain and retina, and for the normal metabolism of bile acids.

Pharmacokinetics

When administered intravenously, bioavailability is 100%. Amino acids are distributed in the interstitial fluid and intercellular space of organs and tissues. When administered correctly (slowly and at a constant speed), Aminoven infant does not upset the balance of amino acids. A small portion of amino acids is eliminated by the kidneys.

Special conditions

An open bottle of the drug should be stored in the refrigerator at a temperature not exceeding 10 °C for no more than 24 hours.

Compound

1 liter of amino acid 100 g, incl. L-valine 9 g L-isoleucine 8 g L-leucine 13 g L-lysine monoacetate 12 g, which is resp. L-lysine content 8.51 g L-methionine 3.12 g L-threonine 4.4 g L-tryptophan 2.01 g L-phenylalanine 3.75 g L-alanine 9.3 g L-arginine 7.5 g glycine 4.15 g L-histidine 4.76 g L-proline 9.71 g L -serine 7.67 g N-acetyl-L-tyrosine 5.176 g, which is resp. L-tyrosine content 4.2 g N-acetyl-L-cysteine 700 mg, which is resp. L-cysteine content 520 mg taurine 400 mg L-malic acid 2.62 g total nitrogen 14.9 g/l titratable acidity 27-40 mmol NaOH/l theoretical osmolarity 885 mOsm/l pH 5.5-6.0

Aminoven Infant indications for use

Aminoven infant 6%, 10% is intended for partial parenteral nutrition of newborns, young children and premature infants. Together with carbohydrate solutions, fat emulsions, as well as preparations of vitamins, electrolytes and microelements, it provides complete parenteral nutrition.

Aminoven Infant is a parenteral nutrition solution intended for administration to the youngest patients, whose age does not exceed 2 years. As is known, the nutrition of children, especially infants, should differ significantly in composition from the diet of an adult. It is to meet such needs that such drugs are created. But you won’t give medicine without finding out its contraindications and side effects. Surely you won't?! Therefore, I propose to find out what the instructions for using the product say about Aminoven Infant. It details the dosages and what to do if you overfed your child with the drug.

Composition and release form

The parenteral nutrition solution contains the following compounds: L-valine, L-isoleucine, L-lysine monoacetate, L-methionine, L-threonine, L-tryptophan, L-phenylalanine, L-alanine, L-arginine, glycine, L -histidine, L-proline, L-serine, N-acetyl-L-tyrosine, N-acetyl-L-cysteine. The amino acid content can be either 6 or 10 percent of the total weight of the drug.

Among the excipients, the following compounds should be noted: L-malic acid, as well as water for injection. Available in the form of a transparent, slightly opalescent solution, devoid of any impurities.

The drug cannot be purchased in retail pharmacy chains, since it is supplied exclusively to medical hospitals.

pharmachologic effect

To begin with, it should be noted that there are many conditions in which conventional enteral nutrition becomes impossible or ineffective. For example, premature babies born much earlier than their due date usually require this type of feeding.

This solution is a balanced and completely physiological product intended for parenteral nutrition of children under 2 years of age. After administration, amino acids are completely integrated into the pool of nitrogenous compounds, and from there they can be directed to any needs of the growing organism, but above all, to the processes of biosynthesis of protein structures.

It should be noted that the bioavailability coefficient is 100 percent. Removal of the end products of protein metabolism is carried out primarily through the liver or excretory system. Therefore, the health status of these organs may impose some restrictions on the use of this solution.

Indications for use

The use of the drug is indicated exclusively in situations where normal enteral nutrition is not possible. It should be noted that Aminoven Infant is rarely used as a monotherapy. Most often, it is used in combination with glucose solutions and fat emulsions.

Contraindications for use

The drug Aminoven Infant is strictly inadmissible in the presence of the following conditions:

Severe pathology of nitrogen metabolism;
Conditions characterized by disturbances in potassium metabolism;
Metabolic acidosis of any etiology;
Overhydration;
Shock states of any etiology;
Malformations of the organs of the cardiovascular system, occurring against the background of severe insufficiency;
Diseases of the excretory system occurring against the background of severe renal failure and the simultaneous impossibility of hemodialysis.

In case of pathology of the liver and kidneys, in the vast majority of cases, a dose adjustment of the drug is required.

Application and dosage

Aminoven Infant 6% is administered exclusively intravenously, into peripheral or central veins, at a rate of up to 0.1 g per 1 kg of patient body weight.

Aminoven Infant should be used immediately after the bottle is depressurized. You should pay attention to a very important circumstance - there should be no sediment in the container with the drug. Slight opalescence of the solution is allowed.

The maximum daily dose should not exceed the following values. Children under 1 year - 20 - 40 milliliters of the drug per 1 kg of body weight. Patient older than 1 year - 25 ml per kilogram.

10% Aminoven Infant is injected mainly into the central veins, at a rate not exceeding 0.1 g per kilogram. For children under 1 year of age, the dosage should be as follows: 15-25 ml per kg of body weight.

For patients aged from one to one and a half years - 15 ml per 1 kg of body weight per day. Children older than this age are administered 10 ml per 1 kg of body weight.

special instructions

When using Aminoven Infant, blood counts should be especially carefully monitored, with regard to electrolytes. If a deviation from the norm is detected, replacement therapy must be immediately carried out.

The rate of administration of the drug should be especially carefully controlled, since rapid administration increases the rate of loss of amino acids with the kidneys, and as a consequence, an imbalance of these compounds.

Overdose

If the recommended amounts of the drug are not observed, an overdose of the drug may occur, manifested in the form of nausea, vomiting, short-term increase in body temperature, and the appearance of symptoms of renal acidosis. In this case, you must immediately stop further use of the solution and carry out the necessary symptomatic therapy.

Side effects

As a rule, Aminoven Infant is well tolerated by patients. In rare cases, undesirable manifestations in the form of phlebitis or thrombosis at the injection site are possible.

Analogs

Aminoven Infant can be replaced by the following drugs: Aminoven, Aminoplasmal Hepa, Aminosol-Neo, Aminosteril, Neframin, Hepasol-Neo, Dipeptiven, Hymix.

Conclusion

I remind you that all products intended for parenteral nutrition must be prescribed in strict accordance with the indications. Unauthorized use is strictly unacceptable, as it may lead to negative consequences.

Instructions for use

Clinical and pharmacological group

Parenteral nutrition preparation - amino acid solution

Release form, composition and packaging

Solution for infusion 10%

	1 l
L-isoleucine	8 g
L-leucine	13 g
L-lysine monoacetate	12 g,
	8.51 g
L-methionine	3.12 g
L-phenylalanine	3.75 g
L-threonine	4.4 g
L-tryptophan	2.01 g
L-valine	9 g
L-arginine	7.5 g
L-histidine	4.76 g
glycine	4.15 g
L-alanine	9.3 g
L-proline	9.71 g
L-serine	7.67 g
N-acetyl-L-tyrosine	5.176 g,
	4.2 g
N-acetyl-L-cysteine	700 mg,
	520 mg
taurine	400 mg
L-malic acid	2.62 g
total amino acid content 100 g total nitrogen content 14.9 g pH 5.5-6.0 theoretical osmolarity 885 mOsm/l

Excipients: d/i water - up to 1 l.

Solution for infusion 6% transparent or slightly opalescent, colorless to light yellow.

	1 l
L-isoleucine	4.8 g
L-leucine	7.8 g
L-lysine monoacetate	7.2 g,
which corresponds to the L-lysine content	5.11 g
L-methionine	1.872 g
L-phenylalanine	2.25 g
L-threonine	2.64 g
L-tryptophan	1.206 g
L-valine	5.4 g
L-arginine	4.5 g
L-histidine	2.856 g
glycine	2.49 g
L-alanine	5.58 g
L-proline	5.826 g
L-serine	4.602 g
N-acetyl-L-tyrosine	3.106 g,
which corresponds to the L-tyrosine content	2.52 g
N-acetyl-L-cysteine	420 mg,
which corresponds to the L-cysteine content	312 mg
taurine	240 mg
L-malic acid	1.572 g
total amino acid content 60 g total nitrogen content 9 g titratable acidity 27-40 mmol NaOH/l pH 5.5-6.0 theoretical osmolarity 531 mOsm/l

Excipients: d/i water - up to 1 l.

100 ml - glass bottles (10) - cardboard boxes.
100 ml - glass bottles with plastic holders (10) - cardboard boxes.
250 ml - glass bottles (10) - cardboard boxes.
250 ml - glass bottles with plastic holders (10) - cardboard boxes.