In the case of oral or enteral nutrition, inadequate or contraindicated in children over 2 years of age, the adolescent and the adult

In parenteral nutrition, amino acid infusions must always be associated with adequate caloric intake, eg in the form of carbohydrate solutions.


Dosage

The dosage should be adjusted according to the individual amino acid requirements and individual water requirements which depend on the patient's clinical condition (nutritional status and / or degree of nitrogen catabolism induced by the underlying pathology) .

Adults and adolescents from 14 to 17 years

Dose, daily average

20 - 40 ml / kg body weight

≃ 1.0 - 2.0 g amino acid / kg body weight

≃ 1400 - 2800 ml for a 70 kg patient

Daily maximum dose

40 ml / kg body weight

≃ 2.0 g / amino acid / kg body weight

≃ 140 g of amino acids for a 70 kg patient

≃ 2800 ml for a 70 kg patient

Maximum infusion rate, respectively

2 ml / kg body weight / hour

≃ 0,1 g amino acid / kg body weight / hour

≃ 45 drops / minute, for a 70 kg patient

≃ 2.34, ml / minute for a 70 kg patient
Children and adolescents from 2 to 13 years

Dosages for this age group, as presented below, are recommended mean values. The exact dosage should be adjusted individually according to age, developmental condition and pathology.


30 ml / kg body weight

≃ 1.5 g of amino acids / kg body weight

Daily dose in children aged 5 to 13 years

20 ml / kg body weight

≃ 1.0 g / amino acid / kg body weight

Maximum infusion rate

2 ml / kg body weight / hour

≃ 0,1 g amino acid / kg body weight / hour

In the case of amino acid requirements of 1 g / kg body weight / day or more, particular attention should be paid to the limits of water intakes. In such cases, and in order to avoid any water overload, it will be necessary to use solutions with higher concentrations of amino acids.

Duration of use

Can be administered as long as parenteral nutrition is indicated.
Mode of administration

Intravenous use.

AMINOPLASMAL 8, an infusion solution, is only one component of parenteral nutrition. In parenteral nutrition, the amino acid intake should be combined with a supply of sources of calories, essential fatty acids, electrolytes, vitamins and trace elements.

Clear solution, colorless to slightly yellow straw.

Class, pharmacotherapeutic solutions for parenteral nutrition

Code: ATC: B05BA01.

The purpose of parenteral nutrition is to provide all the nutrients necessary for the growth, maintenance and regeneration of body tissues, etc.

Amino acids are of particular importance since they are in part essential to the synthesis of proteins. The amino acids administered intravenously are incorporated into the amino acid reserves, intracellular and intravascular respectively. The endogenous and exogenous amino acids serve as substrates for the synthesis of structural or functional proteins.

In order to avoid the metabolism of amino acids for the production of energy but also to supply the other energy-consuming processes in the body an energy supply is required (in the form of carbohydrates Or lipids).

Without object.

Hypersensitivity to the active substances or to any of the excipients mentioned under Composition.
· Congenital abnormalities of amino acid metabolism

· Severe traffic disorders with a risk, vital (example: shock).

· Hypoxia.

· Metabolic acidosis.

· Advanced liver disease.

· Severe renal impairment with no possibility of haemofiltration or hemodialysis

· Children under 2 years because the nutritional intake does not adequately cover the specific needs of this pediatric population

· General contraindications for infusion treatments

O Uncompensated cardiac insufficiency

O Acute pulmonary edema.

O Hyperhydration.

AMINOPLASMAL 8: solution for infusion should only be administered after careful evaluation of the benefit / risk ratio for disorders of the amino acid metabolism of origin other than those mentioned in the Contraindications section.

Hypotonic dehydration should be corrected by a suitable hydro-electrolyte intake before parenteral nutrition

In the event of hypokalaemia and / or hyponatremia, appropriate quantities of potassium and / or sodium shall be provided.

In patients with hepatic or renal insufficiency, the dose should be adjusted according to individual needs.

Exercise special attention in patients with increased serum osmolality

The serum electrolyte concentration, blood glucose, water balance, acid-base equilibrium and renal function (blood urea nitrogen (BUN), creatinine) should be monitored regularly. Br>

Monitoring should also include serum protein concentration and liver function tests.

Precautions should be taken when infusing large volumes in patients with heart failure.
AMINOPLASMAL 8, an infusion solution, is useful as a component of total parenteral nutrition in combination with suitable amounts of energy substrates (carbohydrate solutions, lipid emulsions), vitamins, trace elements, Electrolytes.

In the event that AMINOPLASMAL 8 is administered in combination with other nutrient solutions, the possibility of peripheral venous perfusion depends on the resulting osmolarity of the mixture. >

The injection site should be examined daily for signs of inflammation or infection

None known.

This medicinal product must not be mixed with other medicinal products, except those mentioned in the section 'Instructions for use, handling and disposal'
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If, as part of the implementation of total parenteral nutrition, it is necessary to add other nutrients such as carbohydrates, lipids, vitamins and trace elements to this medication, the addition should be Under strict aseptic conditions. Mix well after adding any additives. Pay special attention to compatibility issues

Check the integrity of the cap and the clarity of the solution before use.

In the case where Aminoplasmal 8 is administered in combination with other nutrient solutions, the possibility of peripheral perfusion depends on the osmolarity resulting from the mixture. >

Symptoms

Overdose or high infusion rates can lead to intolerance reactions that manifest as nausea, chills, vomiting, and kidney damage.
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Processing

In case of intolerance reactions, the perfusion of amino acids should be interrupted temporarily and subsequently re-initiated at a lower infusion rate
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No studies have been conducted in pregnant or nursing women. There are no preclinical data on the administration of AMINOPLASMAL 8, solution for infusion during pregnancy.
AMINOPLASMAL 8, solution for infusion, should therefore be administered with caution, during pregnancy and lactation and only after having clearly evaluated the benefits expected in relation to the possible risks.

However, adverse reactions that are not specifically related to the product but to parenteral nutrition in general may occur especially at the beginning of parenteral nutrition.

List of adverse reactions

Adverse reactions are listed according to their frequency, as follows

Very common (≥ 1/10)

Common (≥ 1/100;