Posology : מינונים

4.2. Posology and method of administration

Posology

The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolize the constituents of Oliclinomel, as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.

The administration may be continued for as long as is required by the patient’s clinical conditions.

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Requirements
Average nitrogen requirements are 0.16 to 0.35 g/kg/day (approximately 1 to 2 g amino acids/kg/day).
Energy requirements vary depending on the patient’s nutritional condition and level of catabolism. On average these are 25 to 40 kcal/kg/day.

Maximum daily dose
The maximum daily dose is 40 ml/kg body weight (equivalent to 0.88 g amino acids, 3.2 g glucose, 0.8 g lipids, 0.84 mmol of sodium and 0.64 mmol potassium /kg), i.e. 2800 ml of the emulsion for infusion for a patient weighing 70 kg.


In children greater than two years of age

There have been no studies performed in the pediatric population.

Requirements
Average nitrogen requirements are 0.35 to 0.45 g/kg/day (approximately 2 to 3 g amino acids/kg/day).
Energy requirements vary depending on the patient’s age, nutritional condition and level of catabolism. On average these range between 60 and 110 kcal/kg/day.

Posology
The dosage is based on fluid intake and daily nitrogen requirements.
These intakes should be adjusted to take account of the child’s hydration status.

Maximum daily dose
The maximum daily dose is 100 ml/kg body weight (equivalent to 2.2 g amino acids, 8 g glucose, 2 g lipids, 2.1 mmol sodium and 1.6 mmol potassium per/ kg body weight)

As a general rule, do not exceed doses of 3 g/kg/day amino acids and/or 17 g/kg/day glucose and/or 3 g/kg/day lipids, except in particular cases.


Method and duration of administration
For single use only.

It is recommended that after opening the bag, the contents should be used immediately and not stored for subsequent infusion

Appearance after reconstitution: Homogeneous liquid with a milky appearance.

For instructions for preparation and handling of the emulsion for infusion, see section 6.6.
BY INTRAVENOUS ADMINISTRATION THROUGH A CENTRAL OR PERIPHERAL VEIN (Due to low osmolarity of OLICLINOMEL)]

The recommended duration of the parenteral nutrition infusion is between 12 and 24 hours.

The administration flow rate should be adjusted to take account of the dose being administered, the characteristics of the final mixture being infused, the daily volume intake and the duration of the infusion (see section 4.4.).


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Normally, the flow rate should be increased gradually during the first hour.

Maximum infusion rate
As a general rule, do not exceed 3 ml/kg/hour of the emulsion for infusion, i.e. 0.06 g amino acids, 0.24 g glucose and 0.06 g lipids/kg body weight/hour.