Posology : מינונים

4.2    Posology and method of administration

Posology
TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion is not recommended for use in children less than 2 years of age due to inadequate composition and volume (see sections 4.4; 5.1 and 5.2).

The maximum daily dose mentioned below should not be exceeded. Due to the static composition of the multi-chamber bag, the ability to simultaneously meet all nutrient needs of the patient may not be possible. Clinical situations may exist where patients require amounts of nutrients varying from the composition of the static bag. In this situation any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion. For example, paediatric patients may require greater than 0.2 mmol/kg/day of phosphate. In those situations, health care professionals may consider adjusting the volume (dose) of TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion,in order to meet these increased requirements.

In adults
The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolise the constituents of TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion, as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.

The average daily requirements are:
- 0.16 to 0.35 g nitrogen /kg body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and degree of catabolic stress,
- 20 to 40 kcal/kg,
- 20 to 40 ml fluid /kg, or 1 to 1.5 ml per expended kcal.

For TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion the maximal daily dose is defined by amino acids intake, 35 ml/kg corresponding to 2.0 g/kg amino acids, 3.9 g/kg glucose, 1.4 g/kg lipids, 1.2 mmol/kg sodium, and 1.1 mmol/kg potassium. For a 70 kg patient, this would be equivalent to 2450 ml TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion, per day, resulting in an intake of 140 g amino acids, 270 g glucose, and 98 g lipids (i.e.,    2058 non-protein kcal and 2622 total kcal).

Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.

For TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion, the maximal infusion rate is 1.8 ml/kg/hour, corresponding to 0.10 g/kg/hour amino acids, 0.19 g/kg/hour glucose, and 0.07g/kg/hour lipids.

In children greater than 2 years of age

There have been no studies performed in the paediatric population.
The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolise constituents of 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion, as well as additional energy or proteins given orally/enterally; therefore, the bag size should be chosen accordingly.

In addition, daily fluid, nitrogen, and energy requirements continuously decrease with age. Two groups, ages 2 to 11 years and 12 to 18 years, are considered.

For TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion in the 2 to 11 year age group, the limiting factors are phosphate concentration for daily dose (0.2 mmol/kg/day)a and lipid concentration for hourly rate. In the 12 to 18 year age group, the limiting factors are phosphate concentration for daily dose (0.2 mmol/kg/day)a and amino acid concentration for hourly rate. The resulting intakes are displayed below:


2 to 11 years                           12 to 18 years
TRIOMEL 9 g/l                           TRIOMEL 9 g/l nitrogen 1070                           nitrogen 1070
Recommendeda        kcal/l with          Recommendeda       kcal/l with electrolytes Max                        electrolytes Max
Constituent                                         Vol                                     Vol Maximum Daily Dose
Fluids (ml/kg/d)                60 – 120               13                50 – 80               13 Amino acids (g/kg/d)         1 – 2 (up to 3)           0.8                1–2                  0.8 Glucose (g/kg/d)              12 – 14 (up to                           3 – 10 (up to 1.5                                       1.5
18)                                      14)
Lipids (g/kg/d)                                                        0.5 – 2 (up to 0.5 – 3                0.5                                       0.5 3)
Total energy (kcal/kg/d)      60 – 90           14                        30 – 75                 14 Maximum Hourly Rate
TRIOMEL 9 g/l nitrogen
1070 kcal/l with                                3.3                                               2.1 electrolytes (ml/kg/h)
Amino acids (g/kg/h)            0.20           0.19                         0.12                  0.12 Glucose (g/kg/h)                 1.2           0.36                          1.2                  0.23 Lipids (g/kg/h)                 0.13           0.13                         0.13                  0.08 a: Recommended values from 2005 ESPGHAN/ESPEN Guidelines

Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.

In general, it is recommended to start the infusion for small children with low dose (i.e., 12.5 to 25 ml/kg) and gradually increase it up to the maximal dosage (see above).

Method and duration of administration

For single use only.
It is recommended that, after opening the bag, the contents are used immediately and not stored for subsequent infusion.

After reconstitution, the mixture is homogenous with a milky appearance.

For instructions for preparation and handling of the emulsion for infusion, see section 6.6.
Due to its high osmolarity, TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion, can only be administered through a central vein.

The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours.

Treatment with parenteral nutrition may be continued for as long as required by the patient’s clinical conditions.