LIPOFLEX SPECIAL WITHOUT ELECTROLYTES

Posology The dosage should be adapted to the patients’ individual requirements. It is recommended that this medicinal product be administered continuously. A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate avoids possible complications.

4 g lipid /kg body weight per day. 07 g lipid /kg body weight per hour. For a patient weighing 70 kg this corresponds to a maximum infusion rate of 119 ml per hour. 8 g of lipids per hour. 3). Children from 2-18years of age No clinical studies were performed in the paediatric population.

This medicinal product without electrolytes can provide only a basic nutrient and energy supply to the paediatric patients. Depending on the individual need Carnitine supplementation may be considered in paediatric patients expected to receive PN for more than 4 weeks.

The exact dosage depends on the patient's energy expenditure and the ability to metabolize the active ingredients of this medicinal product and therefore, should be individually adapted according to age, body weight, clinical condition and underlying disease.

Since Lipoflex special without electrolytes does not contain electrolytes, these nutrients have to be administered separately as appropriate. Due to the individual needs of paediatric patients, this medicinal product may not cover sufficiently the total energy, nutrient, electrolyte and fluid requirements.

In such cases additional amino acids, carbohydrates and/or lipids, minerals and/or fluids must be provided in addition, as appropriate. For calculation of dosage account must be taken of the hydration status of the paediatric patient.

The bag size should be chosen accordingly. In addition, the daily fluid, glucose and energy requirements decrease with age. Thus, two age groups, from 2 to 12 years and 12 to 18 years, are considered. Maximum daily dose According to the paediatric guidelines the dose depends not only on the age but also on the medical condition (acute, stable and recovery phase) of the paediatric patient.

For Lipoflex special without electrolytes in the paediatric age group 2 to 12 years the glucose concentration is the limiting nutrient in the acute phase, and the amino acid concentration in the stable and recovery phase. For the age group 12 to 18 years the maximum daily dose is limited by the glucose concentration in all medical conditions.

The resulting maximum daily doses are given in the table below. 3 - -

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 Lipoflex special without electrolytes.

g. anaphylactic reactions,dermal eruptions, laryngeal, oral and facial oedema) Metabolism and nutrition disorders Uncommon: Loss of appetite Very rare: 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 Rare:

Headache, drowsiness Vascular disorders Rare: Hypertension or hypotension, flush Respiratory, thoracic and mediastinal disorders Rare: Dyspnoea, cyanosis Gastrointestinal disorders Uncommon: Nausea, vomiting Hepatobiliary disorders Not known: Cholestasis Skin and subcutaneous tissue disorders Rare: Erythema, sweating Musculoskeletal and connective tissue disorders Rare: Pain in the back, bones, chest and lumbar region General disorders and administration site conditions Rare: Elevated body temperature, feeling cold, chills Very rare: Fat overload syndrome (details see below) Should adverse reactions occur, the infusion must be stopped.

4 mmol/l (1000 mg/dl) during infusion, the infusion must be stopped. 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.

Information on particular undesirable effects Nausea, vomiting and lack of appetite are symptoms often related to conditions for which parenteral nutrition is indicated, and may be associated with parenteral nutrition at the same time.

Fat overload syndrome Impaired capacity to eliminate triglycerides can lead to ‘fat overload syndrome’, which may be caused by overdose. Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the fat metabolism may be affected by ongoing or previous illnesses.

This syndrome may also appear during severe hypertriglyceridaemia, even at the recommended infusion rate, and in association with a sudden change in the patient’s clinical condition such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leucopenia, thrombocytopenia, coagulation disorder, haemolysis and reticulocytosis, abnormal liver function tests and coma.

The symptoms are usually reversible if the infusion of the fat emulsion is discontinued. Should signs of a fat overload syndrome occur, the infusion of this medicinal product should be discontinued immediately. 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.

Caution should be exercised in cases of increased serum osmolarity. Disturbances of the fluid, electrolyte or acid-base balance must 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 or symptom 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 this medicinal product.

Depending on the patient’s metabolic condition, occasional hypertriglyceridaemia may occur. 6 mmol/l (400 mg/dl) during administration of lipids it is recommended to reduce the infusion rate. 4 mmol/l (1000 mg/dl), as these levels have been associated with acute pancreatitis.

g. renal insufficiency, diabetes mellitus, pancreatitis, impaired hepatic function, hypothyroidism (with hypertriglyceridaemia), sepsis, and metabolic syndrome. 4 mmol/l (1000 mg/dl). In combined hyperlipidaemias and in metabolic syndrome, triglyceride levels react to glucose, lipids and overnutrition.

Adjust dose accordingly. Assess and monitor other lipid and glucose sources, and drugs interfering with their metabolism. The presence of hypertriglyceridaemia 12 hours after lipid administration also indicates a disturbance of lipid metabolism.

Like all solutions containing carbohydrates the administration of this medicinal product 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. An interruption of administration of the emulsion may be indicated if the blood glucose concentration rises to above 14 mmol/l (250 mg/dl) during administration.

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, the acid-base balance and of blood cell counts, coagulation status, hepatic and renal function are necessary.

This product does not contain electrolytes. Therefore sufficient amounts of electrolytes must be administered together with Lipoflex special without electrolytes according to the patient’s requirements. A sufficient potassium substitution has to be ensured.

It may be necessary to supply also trace elements and vitamins. Close monitoring of serum electrolytes is mandatory. This applies especially for re- feeding or repletion of malnourished or depleted patients who are at special risk to develop hypokalaemia, hypophosphataemia and hypomagnesaemia.

5). This medicinal product is a preparation of complex composition. 2). As with all intravenous solutions, especially for parenteral nutrition, strict aseptic precautions are necessary for the infusion of this medicinal product. Elderly patients Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

Patients with diabetes mellitus, impaired cardiac or renal function Like all large-volume infusion solutions, this medicinal product should be administered with caution to patients with impaired cardiac or renal function. There is only limited experience of its use in patients with diabetes mellitus or renal failure.

e. it is essentially ‘sodium-free’. g. bilirubin, lactate dehydrogenase, oxygen saturation) if blood is sampled before fat has been adequately cleared from the blood stream.

4 Acute phase = resuscitation phase when the patient requires vital organ support (sedation, mechanical ventilation, vasopressors, fluid resuscitation); Stable phase = patient is stable on, or can be weaned, from this vital support; Recovery phase = patient who is mobilizing.

1 g/kg/day can be given, which also provides an adequate intake of linolenic acid (ALA) with all 20% lipid emulsions currently registered for pediatric use (Lapillonne et al. 2018). For children, it might be necessary to start the nutritional therapy with half of the target dosage.

The dosage should be increased stepwise according to the individual metabolic capacity up the maximum dosage. Maximum infusion rate According to the paediatric guidelines the maximum hourly infusion rate depends not only on age but also on the medical condition (acute, stable and recovery phase) of the paediatric patient.

For Lipoflex special without electrolytes the glucose infusion rate is the limiting factor for both paediatric age groups in all medical conditions. The resulting maximum hourly infusions rates are given in the table below. 4). Duration of treatment The duration of treatment for the indications stated is not limited.

During the administration of Lipoflex special without electrolytes it is necessary to provide an appropriate amount of electrolytes, trace elements and vitamins. Duration of infusion of one single bag The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h.

Method of administration Intravenous use. For central venous infusion only. 4 mmol/l) ● severe coagulopathy ● hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour ● acidosis ● intrahepatic cholestasis ● severe hepatic insufficiency ● severe renal insufficiency in absence of renal replacement therapy ● aggravating haemorrhagic diatheses ● acute thrombo-embolic events, lipid embolism.

On account of its composition, this medicinal product must not be used in newborn infants, infants and toddlers under 2 years of age. g. severe postaggression syndrome, coma of unknown origin) ● inadequate cellular oxygen supply ● disturbances of the electrolyte and fluid balance ● acute pulmonary oedema ● decompensated cardiac insufficiency