AMINOPLASMAL

Posology The dosage has to be adjusted according to the individual need of amino acids and fluid, depending on the clinical condition of the patient (nutritional status and/or degree of nitrogen catabolism due to underlying disease).

78 ml/min for a 70 kg patient Paediatric population Newborn infants, infants and toddlers less than two years of age. 3). Children and adolescents 2 to 18 years The dosages for the age groups stated below are average values for guidance.

The exact dosage should be adjusted individually according to age, developmental stage and prevailing disease. 0 g amino acids/kg body weight per day). 0 g/kg body weight/day or more, particular attention should be paid to the limitations of fluid input.

To avoid fluid overload, amino acid solutions with higher amino acid content may have to be used in such situations. 4). When given during dialysis amino acid losses into the dialysate have to be considered. 3). Duration of use This solution can be administered as long as parenteral nutrition is indicated.

Method of administration Intravenous use. For central venous infusion only.

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.

Undesirable effects are listed according to their frequencies as follows:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Immune system disorders Not known: Allergic reactions Gastrointestinal disorders Uncommon: Nausea, vomiting Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

3. Care should be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency. Caution should be exercised in patients with increased serum osmolarity. g. hypotonic dehydration, hyponatraemia, hypokalaemia) should be corrected prior to the administration of parenteral nutrition.

Serum electrolytes, blood glucose, fluid balance, acid-base balance and renal function should be monitored regularly. Monitoring should also include serum protein and liver function tests. ). Amino acid losses due to the dialysis procedure had to be taken into consideration when adjusting the dose.

Hepatic impairment In patients with hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy (grades I and II), the dose must be carefully adjusted according to individual needs and severity of organ insufficiency.

Amino acid solutions are only one component of parenteral nutrition. For complete parenteral nutrition, substrates for non-protein energy supply, essential fatty acids, electrolytes, vitamins, fluids and trace elements must be administered together with amino acids.

1% of the WHO adult recommended maximum daily sodium intake of 2 g. This should be kept in mind when administering the product to patients requiring dietary restriction of sodium.

g. shock) ● Hypoxia ● Metabolic acidosis ● Severe hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy (grades III and IV) ● Severe renal insufficiency in absence of renal replacement therapy ● Decompensated cardiac insufficiency ● Acute pulmonary oedema ● Disturbances of the electrolyte and fluid balance The medicinal product must not be administered to newborn infants, infants and toddlers less than two years of age, because the amino acid composition does not properly meet the special requirements of this paediatric age group.