Aminoplasmal B. Braun 10% E

/ Lapidot

The dosage is adjusted according to the individual need of amino acids, electrolytes, and fluid depending on the clinical condition of the patient (nutritional status and/or degree of nitrogen catabolism due to underlying disease).
Adults and adolescents from 15 to 17 years:
Average daily dose: 10-20 ml /kg body weight (BW)
– 1.0–2.0 g amino acids/kg BW
– 700–1400 ml for a 70 kg patient
Maximum daily dose: 20 ml/kg BW
– 2.0 g amino acids/kg BW
– 140 g amino acids for a 70 kg patient
– 1400 ml for a 70 kg patient
Maximum infusion and drop rates, respectively:
1 ml/kg BW/h
– 0.1 g amino acids/kg BW/h
– 25 drops/min for a 70 kg patient
– 1.17 ml/min for a 70 kg patient
Children and adolescents up to 14 years:
The dosages for this age group as stated below are average values for guidance. The exact dosage should be adjusted individually according to age, developmental stage and prevailing disease.
Daily dose for 3rd to 5th year of life:
15 ml/kg BW
– 1.5 g amino acids/kg BW
Daily dose for 6th to 14th year of life:
10 ml/kg BW
– 1.0 g amino acids/kg BW
Maximum Infusion rate:
1 ml/kg BW/h
– 0.1 g amino acids/kg BW/h
Method of administration and duration of use
Intravenous use (central venous infusion).
It can be administered as long as there is an indication for parenteral
nutrition.
Aminoplasmal B. Braun 10 % E is only one component of parenteral nutrition.
In parenteral nutrition, amino acid supply must be combined with supply of calorie sources, essential fatty acids, electrolytes, vitamins, and trace elements.

Supply of amino acids as a substrate for protein synthesis in parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contra-indicated.
In parenteral nutrition, amino acid infusions should always be combined
with adequate calorie supply, e.g. in the form of carbohydrate infusions.

– Hypersensitivity to an amino acid present in the solution
– Congenital abnormalities of amino acid metabolism
– Severe circulation disorders with vital risk (e.g. shock)
– Hypoxia
– Metabolic acidosis
– Advanced liver disease
– Severe renal insufficiency without access to haemofiltration or haemodialysis
– High and pathological plasma concentration of one of the electrolytes included in the product
– Children under 2 years of age
– General contraindications of infusion therapy:
– uncompensated cardiac insufficiency
– acute pulmonary oedema
– hyperhydration

Aminoplasmal B. Braun 10 % E should only be administered after careful
benefit-risk assessment in the presence of disorders of amino acid metabolism
of other origin than stated under section 4.3 (See prescribing information for full details).
In patients with liver or renal insufficiency, the dose must be adjusted
according to individual requirements.
Caution should be exercised in patients with increased serum osmolarity.
Hypotonic dehydration should be corrected by adequate supply of fluid and electrolytes prior to parenteral nutrition.
Serum electrolytes, blood glucose, fluid balance, acid-base balance and renal function (BUN, creatinine) should be monitored regularly.
Monitoring should also include serum protein and liver function tests.
Care should be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency.
Aminoplasmal B. Braun 10 % E is applicable as part of a total parenteral nutrition regimen in combination with adequate amounts of energy supplements (carbohydrate solutions, fat emulsions), vitamins and trace
elements.
The site of infusion should be checked daily for signs of inflammation or infection.

Undesirable effects that, however, are not specifically related to the product but to parenteral nutrition in general may occur, especially at the beginning of parenteral nutrition.
Uncommon (< 1:100, ≥ 1:1000 of treated patients):
Gastrointestinal disorders: nausea, vomiting
General disorders: headache, shivering, fever

None known.

Studies in pregnant or breast-feeding women have not been conducted
with this medicinal product. There are no pre-clinical data regarding the
administration of Aminoplasmal B. Braun 10 % E during pregnancy.
Aminoplasmal B. Braun 10 % E should therefore be administered with
caution during pregnancy and lactation and only if deemed clearly indicated
after assessment of its benefits and possible risks.

Symptoms: Overdose or too high infusion rates may lead to intolerance reactions manifesting in the form of shivering, nausea, vomiting, and renal amino acid losses.
Treatment: If intolerance reactions occur, the amino acid infusion should be interrupted temporarily and resumed later on at a lower infusion rate.