AMINOPLASMAL PAEDIATRIC

Posology Paediatric population The dosages for the age group stated below are average values for guidance. The exact dosage should be adjusted individually according to age, developmental stage and prevailing disease. Dosing should be commenced below target infusion rate value and be increased to target value within the first hour.

0 g /kg body weight 15 - 30 ml/kg body weight. 0 g amino acids/kg body weight per day). 4). 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.

6). During preparation of mixtures a light protecting overwrap might not be suitable. Nevertheless, attention should be paid to reduce light exposure as much as possible during preparation of mixtures.

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. Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products.

6). During preparation of mixtures a light protecting overwrap might not be suitable. Nevertheless, attention should be paid to reduce light exposure as much as possible during preparation of mixtures. 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. ). In patients with hepatic insufficiency, 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. Paediatric formulations should be used in the case of micronutrients.

During long-term use (several weeks), the blood count and coagulation factors should be monitored more carefully.

g. shock) ● Hypoxia ● Metabolic acidosis ● Severe hepatic insufficiency ● Severe renal insufficiency in absence of renal replacement therapy ● Decompensated cardiac insufficiency ● Acute pulmonary oedema ● Disturbances of the electrolyte and fluid balance