Medicinal Products

AMINOMIX 800E

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), Potassium Hydroxide (E525), Hydrochloric Acid (E507), Glucose Solution: Glucose, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Zinc Chloride
laboratory: Fresenius Kabi France

Injection solution for IV infusion
Box of 4 bicompartiment pockets of 2000 ml
All forms

Indication

AMINOMIX 800 E is indicated to meet the daily requirements of nitrogen (amino acids), glucose, electrolytes and fluid requirements of adults and children over 2 years, requiring parenteral nutrition (ie when oral nutrition or enteral is impossible, insufficient or contraindicated).

Dosage AMINOMIX 800E IV Injection for IV Infusion Pack 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 (including elderly subjects) and adolescents over 14 years old

Comply with the medical prescription.

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

· 1 g of amino acids and 4 g of glucose per kg of body weight per day,

· 1400 ml per day for a 70 kg patient.

Maximum infusion rate

1.25 ml per kg of body weight per hour, which corresponds to 0.06 g of amino acids and 0.25 g of glucose per kg of body weight per hour.

Maximum daily dosage

30 ml per kg of body weight, which corresponds to:

· 1.5 g of amino acids and 6 g of glucose per kg of body weight,

· 2100 ml for a 70 kg patient,

· 105 g of amino acids and 420 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, organ failure), the daily carbohydrate dose will be reduced to 200-300 g (equivalent to 3 g per kg of body 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 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 strongly recommended. To avoid overdose, especially when hyperconcentrated solutions are used, pump infusion is recommended.

Children and adolescents under 14 years

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 body weight, which corresponds to 1.25 g of amino acids and 5 g of glucose per kg of body weight per day.

Daily dose in children aged 5 to 14:

20 ml per kg of body weight, which corresponds to 1 g of amino acids and 4 g of glucose per kg of body weight per day.

Maximum infusion rate

1.25 ml per kg of body weight per hour, which corresponds to 0.06 g of amino acids and 0.25 g of glucose per kg of body weight per hour.

No clinical studies confirming the safety, tolerability and efficacy of the Aminomix 800 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 800 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 supplement of 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 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 800 E is contraindicated in the following cases:

· Congenital abnormalities of amino acid metabolism,

· Severe liver failure,

· Severe renal insufficiency, in the absence of hemodialysis, haemofiltration or haemodiafiltration,

· Hyperkalemia, hypernatremia,

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

· Severe hyperglycaemia due to insulin resistance, with low glucose tolerance despite the administration of large amounts of insulin,

· Known hypersensitivity to one of the constituents.

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 800 E is contraindicated in neonates and children under 2 years of age.

Side effects Aminomix 800th

No adverse effects of Aminomix 800 E are known, if properly administered.

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

Frequent

Rare

Rare

(> 1/100, <1/10)

(> 1/1000, <1/100)

(> 1/10 000, <1/1000)

Gastrointestinal disorders

Nausea, vomiting.

General disorders and administration site conditions

headache, chills, fever.

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