Aminoven Infant (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

B05BA01 (Amino acids)

Clinical-Pharmacological Group

Agent for parenteral nutrition – amino acid solution

Pharmacotherapeutic Group

Parenteral nutrition agent, amino acid

Pharmacological Action

Amino acid solutions for parenteral nutrition provide the body with substrates for protein synthesis.

The administration of all amino acids necessary for protein synthesis (including essential, conditionally essential, and non-essential amino acids) ensures high nutritional efficiency and reduces the metabolic burden on the body associated with protein synthesis.

In addition to amino acids, parenteral nutrition preparations may include minerals, dextrose, xylitol, and lipids.

Minerals are necessary to maintain water-electrolyte and acid-base balance.

As an energy source, amino acid solutions for parenteral nutrition may contain dextrose, xylitol, sorbitol, which are involved in the processes of glycolysis and gluconeogenesis.

Fat emulsion is a source of energy and essential fatty acids.

Indications

For parenteral nutrition in inpatient and outpatient settings to cover the daily requirement of patients for amino acids, electrolytes, and fluids during parenteral nutrition in patients with a catabolic state ranging from moderate to severe in cases where enteral nutrition is impossible, insufficient, or contraindicated, as well as in combination with it.

Parenteral nutrition agents should be used strictly in accordance with the indications in the medical instructions for use.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E46	Unspecified protein-energy malnutrition
E63.8	Other specified types of nutritional deficiency
R63.3	Feeding difficulties and mismanagement of food intake

ICD-11 code	Indication
5B50	Deficiency of weight in infants, children and adolescents
5B51	Exhaustion in infants, children and adolescents
5B52	Acute protein-energy malnutrition in infants, children and adolescents
5B53	Growth delay in infants, children and adolescents
5B54	Underweight in adults
5B71	Protein deficiency
5B7Z	Malnutrition, unspecified
8D40.0	Encephalopathy due to nutritional deficiency
MG43.3Z	Unspecified feeding difficulties

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer intravenously via a central or peripheral line.

Determine the dosage based on the patient’s body weight, clinical condition, and nutritional requirements.

For infants, initiate therapy with a low dose, typically 1.0 to 1.5 g of amino acids per kg of body weight per day.

Gradually increase the daily dose as tolerated, up to a maximum of 2.5 to 3.0 g of amino acids per kg.

Adjust the infusion rate to provide a continuous supply over 24 hours; do not administer as a bolus.

Control the infusion rate using a perfusion pump to ensure accuracy and safety.

Monitor the patient’s fluid and electrolyte balance closely during administration.

Regularly assess blood glucose, liver enzymes, and triglyceride levels.

Check acid-base status and renal function parameters frequently.

For total parenteral nutrition, combine with appropriate energy sources such as dextrose and lipid emulsions.

Ensure sterile technique during preparation and administration to prevent contamination.

Inspect the solution for particulate matter and discoloration before use; discard if present.

Do not use the same infusion line for blood products due to the risk of pseudoagglutination.

Adverse Reactions

Immune system disorders allergic reactions.

Cardiovascular system disorders phlebitis, thrombosis.

Respiratory system disorders bronchospasm.

Digestive system disorders nausea, vomiting.

Urinary system disorders renal aminoacidosis.

General disorders chills, redness.

Contraindications

General for parenteral nutrition: severe circulatory disorders (collapse and shock); pronounced tissue hypoxia; overhydration; disturbances of water-electrolyte balance; pulmonary edema; decompensated heart failure, severe renal failure; acute period of traumatic brain injury; coma or impaired brain functions that may cause a comatose state.

Before prescribing a parenteral nutrition preparation, contraindications for its use in a particular patient should be carefully studied.

With caution

Patients with increased plasma osmolarity, heart failure, hepatic and/or renal failure.

In children and adolescents under 18 years of age, only those parenteral nutrition preparations that are intended for the corresponding age category should be used.

Use in Pregnancy and Lactation

If it is necessary to prescribe a parenteral nutrition preparation during pregnancy, the presence of contraindications for use and precautions in the current clinical situation should be taken into account.

The use of parenteral nutrition solutions during lactation (breastfeeding) is not recommended.

Pediatric Use

In children and adolescents under 18 years of age, only those parenteral nutrition preparations that are intended for the corresponding age category should be used.

Special Precautions

Intravenous administration of amino acid solutions is accompanied by increased urinary excretion of trace elements, especially copper and zinc. This must be taken into account when selecting doses of trace elements, especially during long-term therapy.

When administering a parenteral nutrition preparation, regular monitoring of water-electrolyte balance and blood acid-base status, monitoring of blood sugar concentration, and serum ionogram should be performed. During long-term therapy, monitoring of blood parameters (coagulogram, liver function parameters) is necessary.

Due to the risk of pseudoagglutination, it is not recommended to use the same infusion systems for the administration of blood products and multicomponent amino acid solutions.

Use in pediatrics

During parenteral nutrition of young children, the following parameters must be taken into account: urine nitrogen, ammonia, glucose, electrolyte, triglyceride levels (with additional administration of fat emulsions), liver enzymes, serum osmolarity, acid-base balance, and water-salt metabolism. Too rapid infusion can lead to the loss of amino acids through the kidneys and, as a result, to an imbalance of amino acids.

In pediatrics, only those parenteral nutrition preparations that are intended for this category of patients should be used.

Drug Interactions

Parenteral nutrition preparations are multicomponent solutions. When adding other solutions or a lipid emulsion to the preparation used, the compatibility of all ingredients must be taken into account.

Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the insulin content in the blood.

Estrogens and oral contraceptives can increase the concentration of growth hormone caused by arginine and reduce the glucagon and insulin response to arginine.

With simultaneous use of arginine with spironolactone, the development of severe hyperkalemia is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Aminoven Infant [Fresenius Kabi Deutschland, GmbH (Germany)]
Infusion solution 6%: bottle 100 ml or 250 ml 10 pcs. with plastic holders or without them

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

Dosage Form

Aminoven Infant

Infusion solution 6%: bottle 100 ml or 250 ml 10 pcs. with plastic holders or without them

Dosage Form, Packaging, and Composition

Solution for infusion 6% transparent or slightly opalescent, from 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 content of L-lysine	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 content of L-tyrosine	2.52 g
N-acetyl-L-cysteine	420 mg,
Which corresponds to the content of L-cysteine	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 : water for injections – 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.

Aminoven Infant [Fresenius Kabi Deutschland, GmbH (Germany)]
Solution for infusion 10%: fl. 100 ml or 250 ml 10 pcs. with plastic holders or without them