OMEFLEX SPECIAL WITHOUT ELECTROLYTES

Posology The dosage should be adapted to the patients’ individual requirements. It is recommended that Omeflex special without electrolytes 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 – 18 years of age. No clinical studies were performed in the paediatric population.

Omeflex special 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 Omeflex special without electrolytes and therefore, should be individually adapted according to age, body weight, clinical condition and underlying disease.

Since Omeflex special without electrolytes does not contain electrolytes these nutrients have to be administered separately as appropriate. Due to the individual needs of paediatric patients, Omeflex special without electrolytes 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 Omeflex 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.

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 Omeflex 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.

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. 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.

Omeflex special without electrolytes is almost electrolyte free and therefore, used especially in patients with limited and/or specific electrolyte requirements. Sodium, potassium, calcium, magnesium and phosphate should be replaced according to clinical status related specific requirements.

Close monitoring of electrolyte levels are required. 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.

The serum triglyceride concentration should be monitored when infusing Omeflex special without electrolytes. 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.

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 Omeflex 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). Patients with intradialytic parenteral nutrition (IDPN) Intradialytic parenteral nutrition is intended for non-acutely ill malnourished dialysis patients where nutritional counselling or treatment with oral nutritional supplements was ineffective.

The selection of the appropriate Omeflex special without electrolytes volume to be used for IDPN should be guided by the gap between spontaneous intakes and the recommended intakes. Additionally, metabolic tolerance needs to be taken into consideration.

092 g/kg/hour lipids administered for 4 hours. 092 g/kg/hour lipids in a 4-hour dialysis session. For a 70 kg patient this corresponds to 27 g of amino acids, 67 g of glucose, 26 g of lipids and 644 ml of fluid. Duration of treatment The duration of treatment for the indications stated is not limited.