The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as fever, shivering, rash or dyspnea) develop.įinomel contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Hypersensitivity or anaphylactic reaction Must only be administered through a central vein. Intravenous use, infusion into a central vein.įor instructions on reconstitution of the medicinal product before administration, see section 6.6.įor information on mixing with other infusions/blood before or during administration, see section 4.5 and 6.6. The dosage should be individualized depending on the patient's clinical status (see section 4.4). The safety and efficacy of Finomel in children and adolescent less than 18 years of age has not been established. The recommended maximum daily dose is 35 ml/kg bw/day which will provide 1.8 g amino acids/kg bw/day (corresponding to 0.29 g nitrogen/kg bw/day), 4.5 g glucose/kg bw/day, 1.40 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). The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding to 0.10 g amino acids, 0.25 g glucose and 0.08 g lipids/kg bw/h). The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acids 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h. The dosage range of 13-31 ml/kg bw/day will provide 0.7-1.6 g amino acids/kg bw/day (corresponds to 0.11-0.26 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). The recommended infusion period is 14-24 hours. The administration flow rate must be adjusted taking into account the dose being administered, the daily volume intake and the duration of the infusion. The flow rate should be increased gradually during the first hour. The maximum daily dose varies with the clinical condition of the patient and may change from day to day. burns or marked anabolism) the nitrogen need may be even higher. In patients with special conditions (e.g. In patients with moderate to high metabolic stress with or without malnutrition: 0.9-1.6 g amino acids/kg bw/day (0.15-0.25 g nitrogen/kg bw/day). In patients with normal nutritional state or in conditions with mild catabolic stress: 0.6-0.9 g amino acids/kg bw/day (0.10-0.15 g nitrogen/kg bw/day). The average daily requirements for adults are: Therefore, the bag size should be chosen accordingly. 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. See section 6.6 for instructions on the administration, preparation and handling of the product. It is recommended that after opening the bag, the content should be used immediately, and not stored for subsequent infusion. Non-protein calories / nitrogen ratio (kcal/g)Ī As sum of oil and phospholipids content.ī As sum of glucose and glycerol content in g x 4 kcal/g.Ĭ As sum of oil and phospholipids content in g x 9 kcal/g.ĭ Without phosphorus from lipid emulsion / with phosphorus from lipid emulsion.įor the full list of excipients, see section 6.1. Nutritional intakes of reconstituted emulsion, for each bag size: ![]() ![]() Date of first authorisation/renewal of the authorisation
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