Aminoplasmal B. Brown E 5, 500 ml (8 g nitrogen/L)

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

Active ingredient

Amino acids for parenteral nutrition, Other preparations Minerals

Composition

6.000 g

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How to take, the dosage

Aminoplasmal B. Brown E 5 is administered into peripheral and central veins.
Only sterile intravenous infusion systems should be used to administer Aminoplasmal B. Brown E 5. During administration of the drug it is necessary to monitor the injection site (puncture site, or catheterization) for signs of inflammation or infection.

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

The drug should not be used if the solution is not clear, the bottle shows obvious signs of damage or the seal is broken.
The dose of Aminoplasmal B. Brown E 5 depends on the nutritional status and individual patient needs for amino acids, electrolytes and fluid.

Adults and children from 14 years old
The average daily dose is 20-40 ml/kg of body weight, which corresponds to 1-2 g of amino acids/kg of body weight, 1400-2800 ml of the preparation for a patient with body weight of 70 kg.

The highest daily dose is 40 ml/kg of body weight, which corresponds to 2 g amino acids/kg of body weight, 140 g of amino acids or 2800 ml of the preparation for a patient with 70 kg body weight.

Maximum infusion rate is 2 ml/kg of body weight/hour, which corresponds to 0.1 g amino acids/kg of body weight/hour, 45 drops/min or 2.34 ml/min for a patient with 70 kg body weight.

Children

The doses given below are averaged. The dose should be adjusted according to the age of the child, the stage and severity of the disease.
For children from 2 to 5 years:
30 ml/kg body weight, which corresponds to 1.5 g of amino acids/kg body weight.
For children from 5 to 14 years:
20 ml/kg of body weight, which corresponds to 1.0 g amino acids/kg of body weight.
Maximum infusion rate
2 ml/kg of body weight/hr, which corresponds to
If the demand for amino acids exceeds 1 g/kg of body weight/hr, more concentrated amino acid solutions can be used to decrease the water load.
Duration of use
There are no restrictions on the duration of drug use.

Interaction

Medicinal interactions are not known.

Mixing Aminoplasmal B. Brown E 5 with other components of parenteral nutrition (carbohydrates, fat emulsions, vitamins, micronutrients) should be performed aseptically.

It is necessary to check their compatibility before use.

Special Instructions

To ensure complete absorption of amino acids, the administration of Aminoplasmal B. Brown E 5 should be carried out simultaneously with the preparations providing energy requirements of the body (fat emulsions and carbohydrate solutions), as well as vitamins and trace elements.

It should be noted that the ability to introduce the above components into the peripheral veins will depend on the resultant osmolarity of these solutions.

Water-electrolyte and acid-base balance, serum protein levels, serum osmolarity, blood glucose concentration and liver function should be monitored during treatment.

For patients with hepatic, renal, cardiac and pulmonary insufficiency the individual dosing regime should be selected.
During prolonged administration (over several weeks) coagulation factors and blood cellular composition should be controlled. In case of hypotonic dehydration it is necessary to restore the adequate water and electrolyte balance first of all and then to start parenteral nutrition.
Storing at the temperature below 15 °С may cause crystal formation which dissolve at heating of the solution to 25 °С and light shaking.

Contraindications

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

Caution
Aminoplasmal B. Brown E 5 may be used only after careful assessment of the risk/benefit ratio in cases:

• Hepatic or renal insufficiency,
• Elevated plasma osmolarity,
• Hypotonic dehydration, and in all cases of impaired amino acid metabolism due to causes that are not contraindications to the drug.

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Side effects

No adverse effects are observed if the recommendations regarding the specified precautions, speed of administration and dosage are followed, but allergic reactions are possible.

Rare side effects (>1:1000, <1:100): nausea, vomiting, headache, chills, fever may be associated with the beginning of parenteral nutrition and are not specific to Aminoplasmal B. Brown E5.

Overdose

Overdose or too rapid administration of the drug may result in phenomena such as chills, nausea, vomiting and increased renal excretion of amino acids.

In such cases, the drug should be stopped and resumed later with a slower infusion rate.

Pregnancy use

Currently, there is no sufficient clinical data on the use of Aminoplasma B. Brown E 5 during pregnancy and lactation, so it is possible to use it in pregnant and lactating women only when the expected benefits of treatment with the drug exceed the possible risk of complications.