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 with 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 0.6-0.9 g amino acids/kg bw/day (0.10-0.15 g nitrogen/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 0.9-1.6 g amino acids/kg bw/day (0.15-0.25 g nitrogen/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/kg bw/day will provide 0.6-1.6 g amino acids/kg bw/day (corresponds to 0.10-0.25 g nitrogen/kg bw/day) and 14-35 kcal/kg bw/day of total energy (12-27 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:
In general, themaximum 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 infusion rate of this product 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 recommended infusion period is 14-24 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 35 ml/kg bw/day.

The recommended maximum daily dose of 35 ml/kg bw/day will provide 1.8 g amino acids/kg bw/day (corresponding to 0.28 g nitrogen/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g lipids/kg bw/day and a total energy content of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).

Paediatric population

Children (2-11 years)
Dosage:
The dose up to 35 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients.

Infusion rate:
Infusion rate should be determined according to the physician's decision, taking into account the maximum daily dose of the solution that can be administered to children (35 ml/kg bw/day).

The recommended maximum infusion rate is 2.4 ml/kg bw/h (corresponding to 0.12 g amino acids/kg/h, 0.30 g/glucose/kg/h and 0.09 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 14 hours 30 minutes (corresponding to the maximal daly dose of 35 ml/kg bw/day), except in exceptional cases and with careful monitoring.

The recommended infusion period is 12-24 hours.

The duration of treatment should not exceed 30 days.

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 35 ml/kg bw/day.

The recommended maximum daily dose of 35 ml/kg bw/day will provide 1.8 g amino acids/kg bw/day (corresponding to 0.28 g nitrogen/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g lipids/kg bw/day and a total energy content of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).

Adolescents (12-16/18 years)

In adolescents, SmofKabiven can be used as in adults.
Method of administration
Intravenous use, infusion into a central vein.
The four different package sizes of SmofKabiven are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven) should be added to SmofKabiven according to the patients need.

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