AMINOMIX 500 E is indicated for the daily needs of nitrogen (acids, amines), glucose, electrolytes and fluid requirements, adults and children over 2 years of age, requiring parenteral nutrition (ie When oral or enteral nutrition is impossible, insufficient or contraindicated).
INTRAVENOUS INFUSION BY CENTRAL PATH.

The dosage is a function of the amino acid needs, carbohydrates, electrolytes and fluid requirements and depends on the clinical condition of the patient (nutritional and severity of the catabolism created by the disorder, metabolic). >

In case of additional energy requirements, it is recommended to administer emulsions, lipids.

Start the infusion at a flow rate below the desired flow then increase to recommended flow over a 2-3 day period.

Adults (including elderly subjects) and adolescents over 14 years

Comply with the medical prescription.

The recommended dosage is 20 ml per kg body weight per day, corresponding to

· 1 g of amino acids and 2.4 g of glucose per kg of body weight per day

· 1400 ml per day for a 70 kg patient

Flow rate, maximum perfusion.

2 ml per kg of body weight per hour, corresponding to 0.1 g of amino acids and 0.24 g of glucose per kg of body weight per hour.

Daily Maximum Dose

40 ml per kg body weight, which corresponds to

· 2 g of amino acids and 4.8 g of glucose per kg of body weight

· 2800 ml for a 70 kg patient

· 140 g of amino acids and 336 g of glucose in a 70 kg patient.
General principles of use and dosage for carbohydrates and general recommendations for fluid needs should be taken into account.

Under normal metabolic conditions, the total daily intake of carbohydrates should be limited to 300-400 g. This limit corresponds to the maximum oxidation capacity. If this dosage is exceeded, undesirable liver effects may occur.

In metabolic, deteriorated conditions (post-trauma, hypoxia, organic insufficiency), the daily dose of carbohydrates will be reduced to 200-300 g (equivalent to 3 g per kg body weight), adaptation; Individual dosing regimen requires adequate monitoring of the patient.

The following restrictions for glucose should be strictly adhered to in adults: 0.25 g per kg of body weight per hour and up to 6 g per kg of body weight per day

When administering carbohydrate solutions, regardless of the concentration, monitoring of blood glucose levels is highly recommended. In order to avoid overdose, especially if hyperconcentrated solutions are used, pump infusion is recommended.

Children and adolescents under 14 years

The dosage recommended in the child is only an orientation based on mean values. The dosage should be adapted individually according to the age of the child, its development and the existence of a disorder underlying
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Daily dose in children 2 to 5 years

25 ml per kg of body weight, corresponding to 1.25 g of amino acids and 3 g of glucose per kg of body weight per day. >
Daily dose in children from 5 to 14 years

20 ml per kg of body weight, which corresponds to 1 g of amino acids and 2.4 g of glucose per kg of body weight per day. >
Maximum infusion rate

1.25 ml per kg of body weight per hour, corresponding to 0.06 g of amino acids and 0.15 g of glucose per kg of body weight per hour.
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No clinical studies confirming the safety, safety and efficacy of the Aminomix 500 E solution have been performed in children or adolescents.

Processing time

Only for parenteral nutrition in the short and medium term if Aminomix 500 E is the only solution for parenteral nutrition administered at the recommended dosage depending on the general condition of the patient and the extent of catabolism. However, a supplementary intake of lipids, vitamins and trace elements must be considered from the beginning of treatment.

The solution may also be administered in the same therapeutic indications when oral or enteral nutrition is insufficient or impossible for a longer duration if adequate intake of lipids, vitamins and trace elements is ensured.

Clear and colorless to slightly yellowish solution.

Class: Pharmacotherapeutic: Solutions for parenteral nutrition, ATC code: B05BA10.
Since amino acids derived from the ingestion and assimilation of dietary proteins, those administered parenterally enter the free amino acid stock and in all consecutive metabolic pathways.

AMINOMIX 500 E contains all essential amino acids and various non-essential amino acids in similar proportion to that present in the other standard amino acid solutions. They are used for endogenous proteosynthesis. In addition, certain amino acids exert special physiological functions.

Glucose is metabolized as an energy carrier by virtually all tissues. It enters the cycle of glycolysis after phosphorylation. The metabolism of glucose as an energy substrate or precursor of endogenous synthesis is well documented.

Electrolytes are essential nutrients for the maintenance and correction of hydroelectrolytic homeostasis.

Zinc is an oligo-element which assures different physiological functions and plays a special role in wound healing and immune defenses in the majority of patients, malnourished
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Not applicable.

AMINOMIX 500 E is contraindicated in the following cases

· Congenital abnormal metabolism of amino acids

· Severe hepatic impairment

· Severe renal failure in the absence of hemodialysis, hemofiltration or hemodiafiltration

· Hyperkalaemia, hypernatremia

· Unstable metabolism (eg catabolism, severe, unstable diabetes, comatose state, undefined)

Severe hyperglycemia by insulin resistance with low glucose tolerance despite the administration of large amounts of insulin

· Known hypersensitivity to any of the constituents

General contraindications of parenteral nutrition

· Life-threatening circulatory instability (collapse and shock)

· Cellular hypoxia or metabolic acidosis

· Hyperhydration / circulatory overload and / or edema, acute pulmonary

· Decompensated heart failure / insufficiency · congestive heart failure

Existing hyponatraemia must be compensated before treatment begins

Due to its amino acid composition, AMINOMIX 500 E is contraindicated in newborns and children under the age of 2 years
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In the case of administration of the infusion, for a period of less than 24 hours, the perfusion rate should be increased gradually during the first hour and decreased progressively during the last hour to avoid sudden changes in blood glucose .

Individual dose adjustment is recommended in patients with hepatic, renal, adrenal, cardiac or pulmonary insufficiency
During the course of treatment, blood glucose, ionogram, equilibrium, acid-base, fluid balance and blood count should be monitored regularly.
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In the event of a significant increase in blood glucose, the infusion should be discontinued and the glycemic peaks should be treated if necessary.
In particular, regular clinical and biological monitoring is required in patients with
· Disorder of amino acid metabolism

Hepatic impairment (taking into account the risks of neurological disorders or aggravation of neurological disorders, pre-existing in relation to hyperammonemia)

Kidney failure, especially in cases of pre-existing hyperkalaemia, if there are risks of onset or aggravation of metabolic acidosis, and hyperazolemia resulting from renal clearance disorders < Code>
· Diabetes (blood glucose, glycosuria, ketonuria, insulin dosage)

· Lactic acidosis and hyperosmolarity.

In case of long-term use (several weeks), blood count and coagulation factors should be monitored.
Precautions, particular for pediatric use

The dosage should be adjusted according to age, nutritional status and the existence of an underlying disorder and, if necessary, oral or parenteral supplementation of proteins will be administered. >

For administration in children over 2 years of age, it is essential to use a package which provides the equivalent of the dosage required per day in a single container.

In addition, it is important that the treatment be supplemented with preparations, providing energy, vitamins and trace elements. Pediatric formulations should be used for this supplementation

No interaction is currently known,

Incompatibilities may arise as a result of the addition of polyvalent cations, eg, calcium, particularly when combined with heparin. Do not add inorganic phosphate due to the risk of precipitation of calcium phosphate and magnesium.

For safety, microbiological and risk of incompatibility, AMINOMIX 500; E should not be mixed with other medicines. AMINOMIX 500 E can be mixed aseptically with other nutrients, eg lipids, additional electrolytes, trace elements and vitamins. Care should be taken to ensure adequate and particular mixing, to avoid any incompatibilities

The product may be stored on the basis of the stability data supplied by the manufacturer but only if the mixture has been under controlled and validated aseptic conditions. >

No substance shall be added to the infusion system without prior verification of compatibility

In case of incorrect administration (dosage or flow), signs of hyperglycaemia, hyperhydration and hyperosmolarity as well as disturbances of acid-base balance and electrolyte balance can be observed

As with other solutions containing amino acids, too rapid infusion can also cause chills, nausea, vomiting and increased urine loss, in amino acids.
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In the event of the occurrence of such manifestations, the infusion should be immediately discontinued or continued at a lower rate according to the most appropriate attitude.
In the case of hyperkalaemia, infusion of 200 to 500 ml of 10% glucose solution with the addition of 1 to 3 U of unmodified insulin with 3-5 g glucose is recommended. In the event of failure of all attempts, administration of a potassium chelating cation exchanger may be indicated. Dialysis is inevitable in extreme cases.

No clinical data regarding the administration of AMINOMIX 500 E in pregnant women and breast-feeding are available. Studies in animals to evaluate the reproductive toxicity of AMINOMIX 500 E have not been performed. It is therefore preferable not to administer AMINOMIX 500 E during pregnancy or breastfeeding

However, if administration of AMINOMIX 500 E is absolutely necessary after evaluation of the benefit / risk ratio, AMINOMIX 500 E should be administered with caution during pregnancy and lactation. >

No adverse effects of Aminomix 500 E are known if administered correctly

However, undesirable effects, which are not specifically related to the product, but to parenteral nutrition in general, may occur, especially at the beginning of treatment

Common

Uncommon

Rare

(> 1/100, 1/1000, 1 / 10,000,