NUTRIFLEX PLUS

Posology Nutriflex plus is suitable for patients with normal tolerance for both glucose and fluid. Adults The dosage and infusion rate have to be adjusted individually according to the clinical status of the patients and their requirements of amino acids, glucose, energy, electrolytes and fluid.

If necessary, additional fluid, amino acid, glucose or lipid infusions may be given. g. parenteral nutrition during haemodialysis to compensate for dialysis related nutrients losses, higher infusion rates may have to be used. It is recommended that Nutriflex plus be administered continuously.

A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate prevents possible complications. 24 g glucose per kg body weight per hour. 8 g glucose per hour. 3). The dosage ranges stated below are values for guidance.

The exact dosage and infusion rate should be adjusted individually according to clinical status, age, developmental stage and underlying disease. In critically ill and metabolically unstable children, it is advisable to start with lower daily dosages or infusion rates and to increase them according to the patient’s condition.

If necessary, additional fluid, amino acid, glucose or lipid infusions may be given. g. in the early post-operative or posttraumatic period or in the presence of hypoxia or organ failure), the dosage should be adjusted to keep the blood glucose level close to normal values.

Close monitoring of blood glucose levels is recommended in order to prevent hyperglycaemia. 4). 3). Duration of treatment The duration of treatment for the indications stated is not limited. During administration appropriate supply of additional energy (preferably in the form of lipids), essential fatty acids, trace elements and vitamins is necessary.

Method of administration Intravenous use. For infusion into central veins only. Precautions to be taken before handling or administering the medicinal product The solution should always be brought to room temperature prior to infusion.

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Summary of the safety profile Undesirable systemic effects with the components of Nutriflex plus are rare (≥ 1/10,000 to < 1/1,000) and usually related to inadequate dosage and/or infusion rate. Those that do occur are usually reversible and regress when therapy is discontinued.

Listing of undesirable effects 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 (frequency cannot be estimated from the available data) Gastrointestinal disorders Rare: Nausea, vomiting, decreased appetite Information on particular undesirable effects If nausea, vomiting or decreased appetite occur, the infusion should be discontinued or, if appropriate, the infusion should be continued at a lower dose level.

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.

Caution should be exercised in cases of increased serum osmolarity. Like all solutions containing carbohydrates the administration of Nutriflex plus can lead to hyperglycaemia. The blood glucose level should be monitored. If there is hyperglycaemia, the rate of infusion should be reduced or insulin should be administered.

If the patient is receiving other intravenous glucose solutions concurrently, the amount of additionally administered glucose has to be taken into account. Abrupt discontinuation of high glucose infusion rates during parenteral nutrition may lead to hypoglycaemia, especially in children less than 3 years of age and in patients with disturbed glucose metabolism.

In these patient groups, tapering off of glucose administration is recommended. As a precaution it is recommended that patients should be monitored for hypoglycaemia for at least 30 minutes on the first day of abrupt discontinuation of parenteral nutrition.

Refeeding or repletion of malnourished or depleted patients may cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Close monitoring of serum electrolytes is mandatory. Adequate supplementation of electrolytes according to deviations from normal values is necessary.

Due to the risk of developing a severe lactic acidosis and/or a Wernicke encephalopathy a preexisting thiamin (Vitamin B1) deficiency must be corrected before infusion of glucose containing solutions. Substitution of additional energy in form of lipids may be necessary, as well an adequate supply of essential fatty acids, electrolytes, vitamins and trace elements.

As Nutriflex plus contains magnesium, calcium, and phosphate, care should be taken when it is co-administered with solutions containing these substances. Patients with organ impairments Like all large-volume infusion solutions, Nutriflex plus should be administered with caution to patients with impaired cardiac or renal function.

1 ● Inborn errors of amino acid metabolism ● Hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour ● Intracranial or intraspinal haemorrhage ● Acidosis ● Severe hepatic insufficiency ● Severe renal insufficiency in absence of renal replacement therapy On account of its composition, Nutriflex plus must not be used in newborn infants, infants and toddlers < 2 years of age.

g. g. coma of unknown origin, hypoxia, decompensated diabetes mellitus etc)