Nutriflex Lipid Peri 1250 mL Intravenous infusion

Supply of the daily requirement of energy, essential fatty acids, amino acids, electrolytes and fluids during parenteral nutrition for patients with mild to moderately severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated.

Posology
The dosage is adjusted according to the patientsu2019 individual requirements. The maximum daily dose is 40 mL/kg body weight, corresponding to:
- 1,28 g amino acids /kg body weight per day
- 2,56 g glucose /kg body weight per day
- 1,6 g fat /kg body weight per day
It is recommended that Nutriflexu00ae Lipid Peri be administered continuously. A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate avoids possible complications. The maximum rate of infusion is 2,5 mL/kg body weight per hour, corresponding to
- 0,08 g amino acids / kg body weight per hour
- 0,16 g glucose / kg body weight per hour
- 0,1 g fat / kg body weight per hour
For a patient weighing 70 kg this corresponds to an infusion rate of 175 mL per hour. The amount of amino acid administered is then 5,6 g/hour, of glucose 11,2 g/hour and of lipid 7,0 g/hour.
Method of administration
For intravenous infusion. Especially suitable for infusion into peripheral veins.
Duration of treatment
The duration of treatment for the indications stated should not exceed 7 days. Refer to section 6.6 for details of handling and preparation.

This product must not be administered in the following conditions:
u2022 Hypersensitivity to the active substances, to egg, peanut or soya protein or to any of the excipients listed in section 6.1
u2022 Disturbances of amino acid metabolism
u2022 Disturbances of lipid metabolism
u2022 Hypokalaemia; hyponatraemia
u2022 Unstable metabolism e.g. severe post aggression syndrome (an endocrine imbalance with glucose intolerance and peripheral resistance to insulin, which can result in persistent hyperglycaemic states with increased lipolysis and progressive proteolysis), unstabilised diabetes mellitus coma of unknown origin
u2022 Hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour
u2022 Acidosis
u2022 Intrahepatic cholestasis
u2022 Severe hepatic insufficiency
u2022 Severe renal insufficiency
u2022 Manifest cardiac insufficiency
u2022 Aggravating haemorrhagic diatheses
u2022 Acute myocardial infarction and stroke
u2022 Acute event of thromboembolism, lipid embolism.
On account of its composition Nutriflexu00ae Lipid Peri should not be used for neonates, infants and children under 2 years of age.
General contra-indications to parenteral nutrition are:
- Unstable circulatory status
- Inadequate cellular oxygen supply
- Fluid overload/overhydration
- Disturbances of the electrolyte and fluid balance
- Acute pulmonary oedema, decompensated cardiac insufficiency.

Caution should be exercised in cases of increased serum osmolarity. Disturbances of the fluid, electrolyte or acid-base balance, e.g. hyperhydration, hyperkalaemia, acidosis, should be corrected before the start of infusion. Too rapid infusion can lead to fluid overload with pathological serum electrolyte concentrations, hyperhydration and pulmonary oedema.
Any sign of symptoms of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion. The serum triglyceride concentration should be monitored when infusing Nutriflex u00ae Lipid Peri. Fasting lipaemia should be excluded in patients with suspected disturbances of lipid metabolism before starting infusion. The administration of lipids is contraindicated if there is fasting lipaemia. The presence of hypertriglyceridaemia 12 hours after lipid administration also indicates a disturbance of lipid metabolism.
Patients with impaired lipid metabolism Nutriflex u00ae Lipid Peri should be administered cautiously to patient with disturbances of lipid metabolism, e.g. renal insufficiency, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridaemia), and sepsis. If Nutriflex u00ae Lipid Peri is given to patients with these conditions, more frequent monitoring of serum triglycerides is mandatory. Depending on the patientu2019s metabolic condition, occasional hypertriglyceridaemia or increases of the blood glucose concentration may occur. If the plasma triglyceride concentration rises to more than 3 mmol/L during administration of lipid it is recommended that the infusion rate should be reduced. Should the plasma triglyceride concentration remain above 3 mmol/L the administration should be stopped until the level normalizes.
The administration of Nutriflex u00ae Lipid Peri 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. A dose reduction or interruption of administration is also indicated if the blood glucose concentration rises to more than 14 mmol/L (250 mg/dL) when administering the lipid.
Refeeding or repletion of malnourished or depleted patients may cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Adequate supplementation of electrolytes according to deviations from normal values is necessary. Controls of the serum electrolytes, the water balance, acid-base balance, and of blood cell counts, coagulation status, renal and hepatic function are necessary. Substitution of electrolytes, vitamins and trace elements may be necessary as required. As Nutriflex u00ae Lipid Peri contains zinc, magnesium, calcium and phosphate, care should be taken when it is co-administered with solutions containing these elements.
Nutriflex u00ae Lipid Peri should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination (see also section 4.5). Nutriflex u00ae Lipid Peri is a preparation of complex composition. It is, therefore, strongly advisable not to add other solutions (as long as compatibility is not proven u2013 see section 6.2). As with all intravenous solutions, especially for parenteral nutrition, strict aseptic precautions are necessary for the infusion of Nutriflex u00ae Lipid Peri. Additions can increase the overall osmolarity of the emulsion, consider with regard to peripheral administration and monitor the injection site. Infusion in peripheral veins may cause thrombophlebitis. Monitor infusion site daily for signs of thrombophlebitis. Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, especially copper and, in particular zinc. This should be considered in the dosing of trace elements, especially during long-term intravenous nutrition.
Patients with diabetes mellitus or renal function Like all large-volume infusion solutions, Nutriflex u00ae Lipid Peri should be administered with caution to patients with impaired renal function. There is only limited experience of its use in patients with diabetes mellitus or renal failure.
Nutriflex u00ae Lipid Peri contains sodium This medicinal product contains 1150 mg sodium per 1250 mL bag, equivalent to 58 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. The maximum daily dose of this product for a 70 kg adult is equivalent to 129 % of the WHO recommended maximum daily intake for sodium. Nutriflex u00ae Lipid Peri is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
Interference with laboratory tests: The fat content may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation) if blood is sampled before fat has been adequately cleared from the blood stream.

Some medication, like insulin, may interfere with the bodyu2019s lipase system. This kind of interaction seems, however, to be of only limited clinical importance. Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation. This may result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance. Soya-bean oil has a natural content of vitamin K 1 . This may interfere with the therapeutic effect of coumarin derivatives, which should be closely monitored in patients treated with such agents. Potassium-containing solutions like Nutriflex u00ae Lipid Peri should be used with caution in patients receiving drugs that increase serum potassium concentration, such as potassium-sparing diuretics (triamterene, amiloride, spironolactone), ACE inhibitors (e.g. captopril, enalapril), angiotensin-II-receptor antagonists (e.g. losartan, valsartan), ciclosporin and tacrolimus.
Corticosteroids and ACTH are associated with sodium and fluid retention. Nutriflex u00ae Lipid Peri should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination (see also section 4.4). Solutions containing amino acids, carbohydrate and lipids should not be mixed with other solutions due to the risk for incompatibilities or microbial contamination. Concomitant infusion with other medicines should also be avoided due to the risk of incompatibilities (see section 6.2).

Pregnancy
Safety and efficacy have not yet been established.
Lactation
Breastfeeding is not recommended if women need parenteral nutrition.
Fertility
Nutriflex u00ae Lipid Peri is manufactured with soy-bean oil that contains phytosterols in concentrations that could lead to disturbances of fertility.

Nutriflex u00ae Lipid Peri has no or negligible influence on the ability to drive and use machines.

Under conditions of correct use, in terms of dosing monitoring, observation of safety restrictions and instructions, undesirable effects may still occur. The following listing includes a number of systemic reactions that may be associated with the use of Nutriflex u00ae Lipid Peri.
Blood and lymphatic system disorders:
Less frequent: Hypercoagulation.
Frequency unknown: Hypokalaemia, hypophosphataemia, hypomagnesaemia, hypermagnesaemia, leucopenia, thrombocytopenia.
Immune system disorders:
Less frequent: Allergic reactions (e.g. anaphylactic reactions, dermal eruptions, laryngeal, oral and facial oedema).
Metabolism and nutrition disorders:
Less frequent: Loss of appetite, hyperlipidaemia, hyperglycaemia, metabolic acidosis. The frequency of these undesirable effects is dose-dependent and may be higher under the condition of absolute or relative lipid overdose.
Nervous system disorders:
Less frequent: Headache, drowsiness.
Vascular disorders:
Less frequent: Hypertension or hypotension, flush.
Respiratory, thoracic and mediastinal disorders:
Less frequent: Dyspnoea, cyanosis. Frequency unknown: Respiratory distress.
Gastrointestinal disorders:
Less frequent: Nausea, vomiting.
Hepatobiliary disorders:
Frequency unknown: Cholestasis.
Skin and subcutaneous tissue disorders:
Less frequent: Erythema, sweating Frequency unknown: Bluish discoloration of the skin due to reduced oxygen content of the blood (cyanosis).
Musculoskeletal and connective tissue disorders:
Less frequent: Back ache, pain in the chest, bones and lumbar region.
Cardiac disorders:
Frequency unknown: Fall or increase in blood pressure.
General disorders and administration site conditions:
Frequent: After a few days, vein irritation, phlebitis or thrombophlebitis may occur. Less frequent: Elevated body temperature, feeling cold, chills, Fat overload syndrome (see below for details). Frequency unknown: Infection of the injection site which can lead to septicaemia; irritation at the injection site. If signs of vein wall irritation, phlebitis, or thrombophlebitis occur, change of the infusion site should be considered. If any of the above mentioned side-effects occur the infusion should be discontinued or, if appropriate, the infusion should be continued at a lower dose level. Should the triglyceride level rise to above 11,4 mmol/L (1000 mg/dL) during infusion, the infusion must be stopped. With levels above 4,6 mmol/L (400 mg/dL), the infusion may be continued at a reduced dosage (see section 4.4). If the infusion is restarted, the patient should be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.

Overdose of Nutriflex u00ae Lipid Peri is not to be expected on proper administration.
Symptoms of fluid and electrolyte overdose
Hypertonic hyperhydration, electrolyte imbalance and pulmonary oedema.
Symptoms of amino acid overdose:
Renal amino acid losses with consecutive amino acid imbalances, sickness, vomiting and shivering.
Symptoms of glucose overdose:
Hyperglycaemia, glycosuria, dehydration, hyperosmolality, hyperglycaemic and hyperosmolar coma.
Symptoms of lipid overdose:
Lipid overdose may lead to the overload syndrome, characterised (for example) by fever, headache, abdominal pain, fatigue, hyperlipaemia, hepatomegaly with or without jaundice, splenomegaly, pathological disturbances of liver function, anaemia, reduction if platelet count, reduction in white cell count, hemorrhagic diathesis and haemorrhage, alternation of depression of blood coagulation factors (bleeding time, coagulation time, prothrombin time, etc.). The plasma triglyceride concentration should not exceed 3 mmol/L during infusion. Refer to section 4.8.
Treatment
Immediate cessation of infusion is indicated in the case of overdose. Further therapeutic measures depend on the particular symptoms and their severity. When infusion is recommenced after the symptoms have declined it is recommended that the infusion rate be raised gradually with monitoring at frequent intervals.