Dipeptiven (Concentrate) Instructions for Use

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

ATC Code

B05XB02 (Alanylglutamine)

Dosage Form

Dipeptiven

Concentrate for preparation of solution for infusion 20%: bottle 50 ml or 100 ml 10 pcs. with holders or without them

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for infusion in the form of a transparent liquid from colorless to pale yellow.

Excipients : water for injections – up to 1 l.

Theoretical osmolarity 921 mOsm/l.
PH 5.4-6.0.

50 ml – glass bottles with a capacity of 50 ml (10) with holders or without – cardboard boxes.
100 ml – glass bottles with a capacity of 100 ml (10) with holders or without – cardboard boxes.

Clinical-Pharmacological Group

Glutamine preparation for parenteral nutrition

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; additives to solutions for intravenous administration; amino acids

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 burden on the body that arises during protein synthesis.

In addition to amino acids, preparations for parenteral nutrition may include minerals, dextrose, xylitol, as well as 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 needs of patients for amino acids, electrolytes, and fluid 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.

Means for parenteral nutrition should be used strictly in accordance with the indications in the instructions for medical use.

ICD codes

Dosage Regimen

Administer Dipeptiven exclusively by intravenous infusion after dilution. Never administer the concentrate directly.

Add Dipeptiven to a commercially available amino acid solution before infusion. The maximum concentration of Dipeptiven in the final admixture must not exceed 3.5%.

The standard dosage for adult patients is 1.5-2.0 ml/kg body weight per day, equivalent to 0.3-0.4 g N(2)-L-alanyl-L-glutamine/kg/day.

Do not exceed a maximum daily dose of 2.0 ml Dipeptiven/kg.

The volume of amino acid solution to which Dipeptiven is added should not exceed 500 ml per 100 ml of Dipeptiven.

Mix the solutions thoroughly. The resulting infusion mixture must be inspected visually for particulate matter and discoloration prior to administration. Discard if any abnormalities are observed.

Adjust the total volume of amino acids and Dipeptiven according to the patient’s daily fluid requirements and tolerance.

The infusion rate of the final mixture is determined by the patient’s tolerance of the total amino acid load and volume. A typical infusion rate for a standard amino acid solution is approximately 1.0-1.5 ml/kg/hour.

Monitor the patient’s acid-base balance and plasma ammonia levels during therapy, especially in patients with hepatic impairment.

Adverse Reactions

From the immune system allergic reactions.

From the cardiovascular system phlebitis, thrombosis.

From the respiratory system bronchospasm.

From the digestive system nausea, vomiting.

From the urinary system renal aminoacidosis.

General disorders chills, redness.

Contraindications

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

Before prescribing a preparation for parenteral nutrition, the 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 the age of 18 years, only those preparations for parenteral nutrition that are intended for the corresponding age category should be used.

Use in Pregnancy and Lactation

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

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

Pediatric Use

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

Special Precautions

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

When administering a preparation for parenteral nutrition, regular monitoring of water-electrolyte balance and acid-base status of the blood, monitoring of blood sugar concentration, and serum ionogram should be carried out. During long-term therapy, monitoring of blood parameters (coagulogram, liver function indicators) 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 indicators must be taken into account: urine nitrogen, ammonia content, glucose, electrolytes, triglycerides (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 preparations for parenteral nutrition that are intended for this category of patients should be used.

Drug Interactions

Preparations for parenteral nutrition 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 cause an increase in the concentration of growth hormone caused by arginine and reduce the glucagon and insulin response to arginine.

With the 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.