OliClinomel N4-550E/OliClinomel N7-1000E Dosage/Direction for Use

Posology: Dosage depends on energy expenditure, the clinical condition, the patient's body weight and ability to metabolise the constituents of OliClinomel, as well as on energy intake or additional proteins taken orally or provided by enteral feeding. The size of bag must therefore be selected in consequence.
The prescription may be continued for as long as the patient's clinical condition makes it necessary.
In the adult: Requirements: Average nitrogen requirements are 0.16 to 0.35 g/kg/day (approximately 1 to 2 g of amino acids/kg/day). Energy requirements vary depending on the patient's nutritional condition and level of catabolism. On average, these are 20 to 40 kcal/kg/day. Average daily fluid requirements are usually within the range of 1 to 1.5 mL per expended kcal and require adjustment based on the patient's fluid and metabolic status.
Maximum daily dose: OliClinomel N4-550E: The maximum daily dose is 40 ml/kg body weight (equivalent to 0.88 g of amino acids, 3.2 g of glucose and 0.8 g of lipids, 0.84 mmol of sodium and 0.64 mmol of potassium per kg), i.e. 2800 ml of the emulsion for infusion for a patient weighing 70 kg.
OliClinomel N7-1000E: The maximum daily dose is 33 ml/kg body weight (equivalent to 1.32 g of amino acids, 5.28 g of glucose and 1.32 g of lipids, 1.06 mmol of sodium and 0.79 mmol of potassium per kg), i.e. 2310 ml of the emulsion for infusion for a patient weighing 70 kg.
In children above two years of age: No study has been undertaken in the paediatric population.
Energy requirements vary depending on patient's age, nutritional condition/state and level of catabolism.
Posology: The prescription is based on fluid intake and daily nitrogen requirements.
These intakes should be adjusted based on the child's hydration status.
The guidelines for maximal recommended hourly rate of infusion and volume per day for pediatric patients are: Maximum Daily Dose: OliClinomel N4-550E: See Table 6.

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OliClinomel N7-1000E: See Table 7.

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Maximum Hourly Rate: OliClinomel N4-550E: See Table 8.

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OliClinomel N7-1000E: See Table 9.

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Method of administration: For single use only.
After opening the bag, it is recommended to use the contents immediately and not to store them for later infusion.
Appearance following reconstitution: homogenous liquid with a milky appearance.
For instructions for preparation and handling of the emulsion for infusion, see "Special precautions for disposal and other handling" under Cautions for Usage.
BY INTRAVENOUS ADMINISTRATION THROUGH A CENTRAL OR PERIPHERAL VEIN (because of the low osmolarity of OliClinomel N4-550E) (for OliClinomel N4-550 E only).
BY INTRAVENOUS ADMINISTRATION THROUGH A CENTRAL VEIN ONLY (because of the high osmolarity of OliClinomel N7-1000E) (for OliClinomel N7-1000E only).
The recommended duration of the parenteral nutrition infusion is between 12 and 24 hours.
The administration flow rate must be adjusted based on the dose being administered, the characteristics of the final mixture to be administered, the daily volume intake and the duration of the infusion (see "Precautions").
It is customary to increase the administration rate gradually during the first hour.
Maximum infusion rate: As a general rule, do not exceed 3 ml (for OliClinomel N4-550E) or 1.5 ml (for OliClinomel N7-1000E) of the emulsion for infusion/kg/hour, i.e. 0.06 g of amino acids, 0.24 g of glucose and 0.06 g of lipids per kg body weight per hour.
The maximum daily dose should not be exceeded in adult and pediatric patients. 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 the impact of any volume (dose) adjustments must be taken into consideration and the resultant effect this will have on the dosing of all other nutrient components of OliClinomel N4-550E/OliClinomel N7-1000E.