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The maximum daily dose mentioned as follows 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 OLIMEL/PERIOLIMEL. 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 OLIMEL/PERIOLIMEL 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 OLIMEL/PERIOLIMEL, 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 per 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 OLIMEL, 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 OLIMEL per day, resulting in an intake of 140 g amino acids, 270 g glucose and 98 g lipids (i.e. 2,058 non-protein kcal and 2,622 total kcal).
For PERIOLIMEL, the maximal daily dose is defined by fluid intake, 40 ml/kg, corresponding to 1 g/kg amino acids, 3 g/kg glucose, 1.2 g/kg lipids, 0.8 mmol/kg sodium and 0.6 mmol/kg potassium. For a 70 kg patient, this would be equivalent to 2,800 ml PERIOLIMEL per day, resulting in an intake of 71 g amino acids, 210 g glucose and 84 g lipids (i.e. 1,680 non-protein kcal and 1,960 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 OLIMEL, the maximal infusion rate is 1.8 ml/kg/hour, corresponding to 0.10 g/kg/hour amino acids, 0.19 g/kg/hour for glucose and 0.07 g/kg/hour lipids.
For PERIOLIMEL, the maximal infusion rate is 3.2 ml/kg/hour, corresponding to 0.08 g/kg/hour amino acids, 0.24 g/kg/hour glucose and 0.10 g/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 OLIMEL/PERIOLIMEL, 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 OLIMEL, 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 as follows: See Table 7.
Click on icon to see table/diagram/imageFor PERIOLIMEL, the limiting factors for the previously mentioned paediatric age groups are phosphate concentration for daily dose (0.2 mmol/kg/day)a and lipid concentration for hourly rate, resulting in the following intakes: See Table 8.
Click on icon to see table/diagram/imageNormally, 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 daily dose and gradually increase it up to the maximal dosage (see previously mentioned).
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 Cautions for Usage.
Due to its high osmolarity, OLIMEL can only be administered through a central vein.
Due to its low osmolarity, PERIOLIMEL can be administered through a peripheral or 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.
