FINOMEL

For single use only. It is recommended that after opening the bag, the content should be used immediately, and not stored for subsequent infusion. 6 for instructions on the administration, preparation and handling of the product. Posology The dosage should be individualized depending on energy expenditure, the patient’s clinical status, body weight, and ability to metabolize constituents of Finomel, as well as additional energy or proteins given orally/enterally.

Therefore, the bag size should be chosen accordingly. 15 g nitrogen/kg bw/day). 25 g nitrogen/kg bw/day). g. burns or marked anabolism) the nitrogen need may be even higher. The maximum daily dose varies with the clinical condition of the patient and may change from day to day.

The flow rate should be increased gradually during the first hour. The administration flow rate must be adjusted taking into account the dose being administered, the daily volume intake and the duration of the infusion. 9). The recommended infusion period is 14-24 hours.

26 g nitrogen/kg bw/day) and 14-33 kcal/kg bw/day of total energy (11-27 kcal/kg bw/day of non-protein energy). 15 g/kg bw/h. 08 g lipids/kg bw/h). 40 g lipids/kg bw/day and a total energy content of 38 kcal/kg bw/day (corresponding to 30 kcal/kg bw/day of non-protein energy).

Paediatric population The safety and efficacy of Finomel in children and adolescent less than 18 years of age has not been established. No data are available. 4). Method of administration Intravenous use, infusion into a central vein.

6. 6.

The following adverse reactions have been reported with other similar products. 4) Dyspnea Gastrointestinal disorders Nausea, Vomiting General disorders and administration site conditions Pyrexia, Extravasation Investigations Hepatic enzyme increased Injury, poisoning and procedural complications Fat overload syndrome, Parenteral nutrition associated liver disease Description of selected adverse reactions • Fat overload syndrome Fat overload syndrome has been reported with similar products.

g. 9); however, the signs and symptoms of this syndrome may also occur at the start of an infusion when the product is administered according to instructions. 4). • Refeeding syndrome Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic.

Thiamine deficiency and fluid retention may also develop. In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium and water soluble vitamins.

These changes can occur within 24 to 48 hours. 4. 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.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard

Must only be administered through a central vein. Hypersensitivity or anaphylactic reaction The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as fever, shivering, rash or dyspnea) develop.

Finomel contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soybean and peanut. 3). Pulmonary vascular precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition.

In some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution.

Suspected in vivo precipitate formation has also been reported. In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates. If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.

Infection and sepsis Since an increased risk of infection is associated with the use of any vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation. Fat overload syndrome “Fat overload syndrome” has been reported with similar products.

, overdose and/or infusion rate higher than recommended); however, the signs and symptoms of this syndrome may also occur when the product is administered according to instructions. The reduced or limited ability to metabolize the lipids contained in Finomel accompanied by prolonged plasma clearance may result in a fat overload syndrome.

, coma). The syndrome is usually reversible when the infusion of the lipid emulsion is stopped. Use in patients with impaired lipid metabolism. Monitor the patient’s capacity to eliminate lipids by checking the triglyceride levels. 6 mmol/l during infusion.

g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma)