VAMINOLACT

5 g amino acids/kg/d) on the second day onwards. 0 g AA/kg/d Gradual dose increase to the target dose should be used during the first days of infusion. 0 g AA/kg/d AA = amino acids; bw = body weight The duration of infusion should be at least 8 hours, preferably 12 hours as cyclic infusion or 24 hours as continuous infusion.

In neonates and infants, the recommended duration of continuous infusion is 24 hours/d. Method of administration For intravenous use only. 6). g. glucose and lipid emulsion (Intralipid®) should be provided together with electrolytes, trace elements (Peditrace® or Additrace®) and vitamins (Solivito® N, Vitlipid® N Infant or Vitlipid® N Adult).

As with all infusions, care should be taken to avoid complications of catherisation including air embolism and central venous thrombosis. Strict asepsis should be maintained especially in the immunosuppressed patient. Hypertonic preparations such as amino acid solutions and concentrated glucose solutions are commonly infused into a central vein.

Vaminolact may also be infused into a peripheral vein when given simultaneously with a fat emulsion (Intralipid) through the same cannula, since the reduced osmolality of the overall mixture may reduce the risk of thrombophlebitis.

For safe administration of intravenous fluids from non-collapsible containers, a giving set with integral airway is recommended.

Nausea may occur rarely. Thrombophlebitis may occur when peripheral veins are used, but the incidence is reduced by the simultaneous infusion of a fat emulsion. Abnormal liver function tests have been observed during intravenous infusion, but these return to normal when artificial feeding is stopped.

Cholestasis has been reported in some patients receiving intravenous nutrition. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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In extremely sick, premature and small babies requiring neonatal intensive care, liver function is likely to be immature and/or disturbed. Amino acids which, to a large extent, are metabolised by the liver may therefore accumulate in plasma.

In this clinical condition, monitoring of amino acid concentration during therapy is advisable. Care must be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency. Amino acid infusions must also be administered with caution to patients with disturbances in protein metabolism.

Hyperkalaemia, hypernatraemia and acidosis should be corrected prior to commencement of intravenous nutrition; serum electrolytes, blood glucose levels, acid base balance and fluid levels should be regularly monitored. 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.

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Vaminolact is contraindicated in patients with irreversible liver damage and in severe uraemia where dialysis facilities are not available. 1.