Posology : מינונים

4.2         Posology and method of administration
Posology
The appearance of the product after mixing the 3 chambers is a white emulsion.

The patient’s ability to eliminate lipids and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section 4.4.

The dose should be individualised to the patient’s clinical condition, body weight (bw), nutritional and energy requirements, adjusting dosage based upon additional oral/enteral intake.

The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress or anabolism).

Adults

The requirements are 0.10-0.15 g nitrogen/kg bw/day (0.6-0.9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.25 g nitrogen/kg bw/day (0.9-1.6 g amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.

Dosage:
The dosage range of 13-31 ml SmofKabiven Extra Nitrogen Electrolyte Free/kg bw/day corresponds to 0.14-0.32 g nitrogen/kg bw/day (0.85-2.0 g amino acids/kg bw/day) and 12-28 kcal/kg bw/day of total energy (8-19 kcal/kg bw/day of non-protein energy). This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight.

Infusion rate:
The usual maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h.

The infusion rate should not exceed 1.5 ml/kg bw/h (corresponding to 0.13 g glucose, 0.10 g amino acids, and 0.04 g lipids/kg bw/h). The recommended infusion period is 14-24 hours.

Intradialytic parenteral nutrition (IDPN)

The maximum infusion rate for intradialytic parenteral nutrition (IDPN) in stable adult patients on chronic renal replacement therapy is 3.0 ml/kg/h (corresponding to 0.20 g amino acids/kg/h, 0.25 g glucose/kg/h, and 0.09 g lipids/kg/h). Infusion volume in IDPN should be guided by the gap between oral food intake and recommended nutrient intakes, unavoidable nutrient losses caused by renal replacement therapy as well as by individual metabolic tolerance of the patient. The usual infusion time for use in IDPN is 3-5 hours, depending on the patient’s needs and the scheduled duration of the renal replacement therapy session. The maximum recommended daily dose remains unchanged.

Maximum daily dose:
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day.

The recommended maximum daily dose of 31 ml/kg bw/day will provide 2.0 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non- protein energy).

Paediatric population

Children (2-11 years)
Dosage:
The dose up to 31 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients.

Infusion rate:
The recommended maximum infusion rate is 1.8 ml/kg bw/h (corresponding to 0.12 g amino acids/kg/h, 0.15 g/glucose/kg/h and 0.05 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 17 hours, except in exceptional cases and with careful monitoring.
The recommended infusion period is 12-24 hours.

Maximum daily dose:
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day.

The recommended maximum daily dose of 31 ml/kg bw/day will provide 2 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy).

Adolescents (12-16/18 years)

In adolescents, SmofKabiven Extra Nitrogen Electrolyte Free can be used as in  adults.

Method of administration
Intravenous use, infusion into a central vein.
The three different package sizes of SmofKabiven Extra Nitrogen Electrolyte Free are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, electrolytes and vitamins should be added to SmofKabiven Extra Nitrogen Electrolyte Free according to the patients need.

For instructions on preparation of the medicinal product before administration, see section 6.6.