Medicinal Products

AMINOMIX 500E Solution for infusion Box of 4 bicompartiment pockets of 2000 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active Ingredients: Amino Acid Solution: Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, Histidine, Glycine, Serine, Tyrosine, Taurine, Alanine, Proline, Sodium Glycerophosphate, Acetic Acid (E260) Hydroxide
laboratory: Fresenius Kabi France

Injection solution for IV infusion
All forms

Indication

- AMINOMIX 500 E is indicated to meet the daily requirements of nitrogen (amino acids), glucose, electrolytes and fluid needs of adults and children over 2 years, requiring parenteral nutrition (ie when nutrition oral or enteral is impossible, insufficient or contraindicated).
- AMINOMIX 500 E is particularly suitable for patients with limited glucose tolerance.

Dosage AMINOMIX 500E Solution for infusion Box of 4 bicompartiment pockets of 2000 ml

INTRAVENOUS INFUSION BY CENTRAL PATH.
- The dosage depends on the need for amino acids, carbohydrates, electrolytes and fluid needs and depends on the clinical condition of the patient (nutritional, and severity of the catabolism created by the metabolic disorder).
- In case of additional energy needs, it is recommended to administer lipid emulsions.
- Start the infusion at a rate below the desired rate and then increase to the recommended rate over a 2-3 day period.
ADULTS (OF WHICH ARE SUBJECTED AGES) AND ADOLESCENTS OVER 14 YEARS OLD:
- The recommended dosage is 20 ml per kg of weight per day, corresponding to:
. 1 g of amino acids and 4 g of glucose per kg of weight per day,
. 1400 ml per day for a patient weighing 70 kg.
- Maximum infusion rate:
2 ml per kg of weight per hour, which corresponds to:
0.1 g of amino acids and 0.24 g of glucose per kg of weight per hour.
- Maximum daily dosage:
40 ml per kg of weight, which corresponds to:
. 2 g of amino acids and 4.8 g of glucose per kg of weight,
. 2800 ml for a patient weighing 70 kg,
. 140 g of amino acids and 336 g of glucose in a 70 kg patient.
- The general principles of use and dosage for carbohydrates as well as general recommendations for fluid needs should be taken into account.
- Under normal metabolic conditions, the total daily carbohydrate intake should be limited to 300-400 g. This limit corresponds to the maximum oxidation capacity. If this dosage is exceeded, hepatic side effects may occur.
- Under deteriorated metabolic conditions (post-trauma, hypoxia, organic insufficiency), the daily dose of carbohydrates will be reduced to 200-300 g (equivalent to 3 g per kg of weight); individual dosage adjustment requires adequate monitoring of the patient.
- The following restrictions for glucose should be strictly observed in adults:
0.25 g per kg of weight per hour and up to 6 g per kg of weight per day.
- When administering carbohydrate solutions, whatever the concentration, monitoring of blood levels is strongly recommended. To avoid overdose, especially when hyperconcentrated solutions are used, pump infusion is recommended.
CHILDREN AND ADOLESCENTS UNDER 14:
- The recommended dosage in children is only an orientation based on average values. The dosage should be individually adjusted according to the age of the child, its development and the existence of an underlying disorder.
- Daily dose in children aged 2 to 5:
25 ml per kg of weight, which corresponds to:
1.25 g of amino acids and 3 g of glucose per kg of weight per day.
- Daily dose in children aged 5 to 14:
20 ml per kg of weight, which corresponds to:
1 g of amino acids and 2.4 g of glucose per kg of weight per day.
- Maximum infusion rate:
1.25 ml per kg of weight per hour, which corresponds to:
0.06 g of amino acids and 0.15 g of glucose per kg of weight per hour.
- No clinical studies confirming the safety, tolerability and efficacy of the AMINOMIX 500 E solution have been conducted in children or adolescents.
DURATION OF THE TREATMENT :
- Only for parenteral nutrition in the short and medium term, if AMINOMIX 500 E is the only solution for parenteral nutrition administered, depending on the general condition of the patient and the extent of catabolism if the recommended dosage is maintained.
- However, a complementary contribution in lipids, vitamins and trace elements must be considered from the beginning of the treatment.
- The solution can also be administered in the same therapeutic indications when the oral or enteral nutrition is insufficient or impossible for a longer duration, if a sufficient intake of lipids, vitamins and trace elements is ensured.

Against indications

- AMINOMIX 500 E is contraindicated in the following cases:
. known hypersensitivity to one of the constituents,
. congenital abnormalities of amino acid metabolism,
. severe hepatic insufficiency,
. severe renal insufficiency, in the absence of hemodialysis, haemofiltration or haemodiafiltration,
. hyperkalemia, hypernatremia,
. unstable metabolism (eg, severe catabolism, unstable diabetes, undefined comatose state),
. Severe hyperglycemia due to insulin resistance, with low glucose tolerance despite administration of large amounts of insulin.
- General contraindications of parenteral nutrition:
. circulatory instability that is life-threatening (collapse and shock),
. cellular hypoxia or metabolic acidosis,
. hyperhydration / circulatory overload and / or acute pulmonary edema,
. decompensated heart failure / congestive heart failure.
- An existing hyponatremia must be compensated before the start of treatment.
- Due to its composition (amino acids), AMINOMIX 500 E is contraindicated in newborns and children under 2 years of age.

Aminomix 500e side effects

- No adverse effects of AMINOMIX 500 E are known, if correctly administered.
- However, undesirable effects, which are not specifically related to the product, but to parenteral nutrition in general, can occur, particularly at the beginning of treatment:
- Rare (= 1/1000 of treated patients):
. gastrointestinal disorders: nausea, vomiting,
. general disorders: headache, chills, fever.

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