Aminoplasmal B. Braun E (Solution) Instructions for Use

ATC Code

B05BA10 (Combined preparations for parenteral nutrition)

Clinical-Pharmacological Group

Agent for parenteral nutrition – amino acid and electrolyte solution

Pharmacotherapeutic Group

Parenteral nutrition agent, amino acid

Pharmacological Action

The main therapeutic effect of Aminoplasmal B. Braun E 5 is to supply the body with a substrate for protein synthesis during parenteral nutrition.

The administration of all amino acids necessary for protein synthesis (including conditionally essential and essential amino acids) contained in Aminoplasmal B. Braun E 5 ensures high nutritional efficiency and reduces the burden on the body during protein synthesis. To prevent the metabolism of the administered amino acids as an energy source, it is necessary to simultaneously administer Aminoplasmal B. Braun E 5 with energy donors, such as fat emulsions and carbohydrate solutions.

In addition to amino acids, Aminoplasmal B. Braun E 5 contains minerals necessary for maintaining water-electrolyte and acid-base balance.

Pharmacokinetics

Intravenously administered amino acids enter the intravascular and intracellular depots of endogenous free amino acids and, like them, function as a substrate for the synthesis of body proteins.

The bioavailability of all components of Aminoplasmal B. Braun E 5 upon intravenous administration is 100%.

In Aminoplasmal B. Braun E 5, the individual concentrations of amino acids are selected so that when this solution is administered intravenously, the relative increase in the concentration of each amino acid in the plasma does not exceed the normal range, which ensures the maintenance of amino acid homeostasis in the plasma.

Amino acids not involved in protein synthesis are metabolized as follows: as a result of transamination, amino groups are separated from the carbon skeleton; the carbon chains are then either oxidized to CO₂ or used as a substrate in the gluconeogenesis reaction in the liver. The amino groups are metabolized in the liver to urea.

Indications

Parenteral nutrition for the prevention and treatment of conditions of protein deficiency due to increased protein loss and/or increased protein requirements

• Moderate and severe injuries, polytrauma, burns, peritonitis, sepsis, multiple organ failure in accordance with metabolic needs;
• Conditions after extensive surgical interventions;
• Inflammatory bowel diseases (including Crohn’s disease, ulcerative colitis), intestinal fistulas;
• Nutritional disorders of various origins (cachexia).

ICD codes

Dosage Regimen

Solution

Aminoplasmal B. Braun E 5 is administered into peripheral and central veins.

For the administration of Aminoplasmal B. Braun E 5, only sterile systems for intravenous infusion should be used.

During the use of the drug, it is necessary to monitor the injection site (the site of puncture or catheterization) for signs of inflammation or infection.

The drug is supplied in bottles designed for single use. Any unused volumes of the drug must not be stored and should be discarded.

Do not use the drug if the solution is not clear, if the bottle shows obvious signs of damage, or if the seal is broken.

The dose of Aminoplasmal B. Braun E 5 depends on the nutritional status and individual needs of the patient for amino acids, electrolytes, and fluid.

Adults and children aged 14 years and older

Average daily dose

20-40 ml/kg body weight, which corresponds to 1-2 g of amino acids/kg body weight, 1400-2800 ml of the drug for a patient weighing 70 kg.

Maximum daily dose

40 ml/kg body weight, which corresponds to 2 g of amino acids/kg body weight, 140 g of amino acids or 2800 ml of the drug for a patient weighing 70 kg.

Maximum rate of administration

2 ml/kg body weight/h, which corresponds to 0.1 g of amino acids/kg body weight/h, 45 drops/min or 2.34 ml/min for a patient weighing 70 kg.

Children

The doses indicated below are averages. The dose should be selected according to the child’s age, stage, and severity of the disease.

For children aged 2 to 5 years

30 ml/kg body weight, which corresponds to 1.5 g of amino acids/kg body weight.

For children aged 5 to 14 years

20 ml/kg body weight, which corresponds to 1.0 g of amino acids/kg body weight.

Maximum rate of administration

2 ml/kg body weight/hour, which corresponds to 0.1 g of amino acids/kg body weight/h.

If the requirement for amino acids exceeds 1 g/kg body weight per day, more concentrated amino acid solutions may be used to reduce the water load.

Duration of use

No restrictions on the duration of use of the drug have been identified.

Adverse Reactions

When following the recommendations regarding the specified precautions, rate of administration, and dosage, no side effects are observed; however, the development of allergic reactions is possible. Rarely occurring side effects (≥ 1:1000, < 1:100): nausea, vomiting, headache, chills, fever may be associated with the initiation of parenteral nutrition and are not specific to Aminoplasmal B. Braun E 5.

Contraindications

• Congenital disorders of amino acid metabolism;
• Severe circulatory disorders (shock);
• Severe hypoxia;
• Severe metabolic acidosis;
• Progressive hepatic failure;
• Acute renal failure, if hemofiltration or hemodialysis is not possible;
• Exceeding the maximum permissible concentration of electrolytes included in the drug in the blood plasma;
• Children under 2 years of age;
• General contraindications for infusion therapy (decompensated heart failure, acute pulmonary edema, hyperhydration);
• Hypersensitivity to the components of the drug.

With caution:Aminoplasmal B. Braun E 5 may be used only after a thorough assessment of the risk/benefit ratio in cases of

• Renal or hepatic insufficiency;
• Increased plasma osmolarity;
• Hypotonic dehydration;
• Disorders of amino acid metabolism due to causes that are not contraindications to the use of the drug.

Use in Pregnancy and Lactation

Currently, there are insufficient clinical data on the use of Aminoplasmal B. Braun E 5 during pregnancy and lactation; therefore, its use in pregnant and lactating women is possible only in cases where the expected benefit of treatment with the drug outweighs the possible risk of complications.

Use in Hepatic Impairment

Contraindicated in progressive hepatic failure.

With caution: Aminoplasmal B. Braun E 5 may be used only after a thorough assessment of the risk/benefit ratio in case of hepatic insufficiency.

For patients with hepatic insufficiency, an individual dosing regimen must be selected.

Use in Renal Impairment

Contraindicated in acute renal failure, if hemofiltration or hemodialysis is not possible.

With caution: Aminoplasmal B. Braun E 5 may be used only after a thorough assessment of the risk/benefit ratio in case of renal insufficiency.

For patients with renal insufficiency, an individual dosing regimen must be selected.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

To ensure complete absorption of amino acids, the administration of Aminoplasmal B. Braun E 5 should be carried out simultaneously with drugs that provide the body’s energy needs (fat emulsions and carbohydrate solutions), as well as vitamins and trace elements.

It should be taken into account that the possibility of administering the above components into peripheral veins will depend on the resulting osmolarity of these solutions.

During treatment, it is necessary to monitor water-electrolyte and acid-base balance, serum protein levels, serum osmolarity, blood glucose concentration, and liver function.

For patients with hepatic, renal, cardiac, or pulmonary insufficiency, an individual dosing regimen must be selected.

During prolonged administration (over several weeks), coagulation factors and blood cell composition should be monitored. In the presence of hypotonic dehydration, an adequate balance of water and electrolytes should first be restored, and then parenteral nutrition should be started.

Storage at temperatures below 15°C (59°F) may cause the formation of crystals, which dissolve when the solution is heated to 25°C (77°F) and gently shaken.

Overdose

Overdose or too rapid administration of the drug may lead to such phenomena as chills, nausea, vomiting, and increased excretion of amino acids by the kidneys. In such cases, the administration of the drug should be stopped and resumed later at a lower infusion rate.

Drug Interactions

Drug interactions are not known.

Mixing Aminoplasmal B. Braun E 5 with other components of parenteral nutrition (carbohydrates, fat emulsions, vitamins, trace elements) must be carried out under aseptic conditions. Their compatibility must be checked before use.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F) in a place protected from light. Do not freeze! Keep out of the reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

For use in hospitals.

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.