AMINOPLASMAL 12

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Isoleucine, Leucine, Lysine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, Histidine, Alanine, Glycine, Aspartic acid, Glutamic acid (E620), Proline, Serine, Tyrosine
laboratory: B-Braun Melsungen

Injection solution for IV infusion
Box of 10 bottles of 500 ml
All forms

Indication

Contribution of amino acids as substrates of protein synthesis in the context of parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated.

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

Dosage AMINOPLASMAL 12 Solution for IV infusion Box of 10 vials of 500 ml

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

Adults and adolescents aged 15 to 17:

Average daily dose:
12.5 - 25 ml / kg body weight	≃ 1.0 - 2.0 g amino acids / kg body weight
	≃ 875 - 1750 ml for a 70 kg patient
Maximum daily dose:
25 ml / kg of body weight	≃ 2.0 g amino acids / kg body weight
	≃ 140 g of amino acids for a 70 kg patient
	≃ 1750 ml for a 70 kg patient
Maximum infusion rate, respectively:
1.2 ml / kg of body weight / hour	≃ 0.1 g amino acids / kg body weight / hour
	≃ 30 drops / minute for a 70 kg patient
	≃ 1.4 ml / minute for a 70 kg patient

Children and adolescents up to 14 years old:

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

Daily dose in children aged 2 to 4:
18 ml / kg of body weight	≃ 1.5 g amino acids / kg body weight
Daily dose in children aged 5 to 13:
12 ml / kg of body weight	≃ 1.0 g amino acids / kg body weight
Maximum infusion rate:
1.22 ml / kg of body weight / hour	≃ 0.1 g amino acids / kg body weight / hour

Administration mode

Intravenous way.

May be administered as long as parenteral nutrition is indicated.

AMINOPLASMAL 12, solution for infusion, is only one component of parenteral nutrition. In parenteral nutrition, the intake of amino acids must be combined with a supply of sources of calories, essential fatty acids, electrolytes, vitamins and trace elements.

Against indications

· Hypersensitivity to an amino acid present in the solution.

· Congenital abnormalities of amino acid metabolism.

· Severe circulation with life-threatening conditions (eg shock).

· Hypoxia.

· Metabolic acidosis.

· Advanced liver disease.

· Severe renal insufficiency without possibility of hemofiltration or hemodialysis.

· Child under 2 years old

· General contraindications for infusion therapy.

o Cardiac insufficiency not compensated.

o Acute pulmonary edema.

o Hyperhydration.

Adverse effects Aminoplasmal 12

Adverse effects that, however, are not specifically related to the product but to parenteral nutrition in general, may occur, particularly at the beginning of parenteral nutrition. Rare (<1/100, ≥ 1/1000 treated patients):

· Gastrointestinal disorders: nausea, vomiting.

· General disorders: headache, tremor, fever.