Olimel N12E Dosage/Direction for Use

Posology: OLIMEL N12E is not recommended for use in children less than 2 years of age due to inadequate composition and volume (see Precautions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
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, 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 OLIMEL N12E. In those situations, health care professionals may consider adjusting the volume (dose) of OLIMEL N12E 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 N12E, 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. Special populations may require up to 0.4 g nitrogen/kg body weight (2.5 g of amino acids/kg); 20 to 40 kcal/kg; 20 to 40 mL fluid /kg, or 1 to 1.5 mL per expended kcal.
For OLIMEL N12E, the maximal daily dose is defined by amino acids intake, 26 mL/kg corresponding to 2.0 g/kg amino acids, 1.9 g/kg glucose, 0.9 g/kg lipids. For a 70 kg patient, this would be equivalent to 1,820 mL OLIMEL N12E per day, resulting in an intake of 138 g amino acids, 133 g glucose, and 64 g lipids (i.e., 1,171 non-protein kcal and 1,723 total kcal).
In Continuous Renal Replacement Therapy (CRRT): For OLIMEL N12E, the maximal daily dose is defined by amino acids intake, 33 mL/kg corresponding to 2.5 g/kg amino acids, 2.4 g/kg glucose, 1.2 g/kg lipids. For a 70 kg patient, this would be equivalent to 2,310 mL OLIMEL N12E per day, resulting in an intake of 175 g amino acids, 169 g glucose, and 81 g lipids (i.e., 1,486 non-protein kcal and 2,187 total kcal).
In patients with morbid obesity: The dosage should be calculated on basis of the ideal body weight (IBW). For OLIMEL N12E, the maximal daily dose is defined by amino acids intake, 33 mL/kg IBW corresponding to 2.5 g/kg amino acids, 2.4 g/kg glucose, 1.2 g/kg lipids. For a 70 kg patient, this would be equivalent to 2,310 mL OLIMEL N12E per day, resulting in an intake of 175 g amino acids, 169 g glucose, and 81 g lipids (i.e., 1,486 non-protein kcal and 2,187 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 N12E, the maximal infusion rate is 1.3 mL/kg/hour, corresponding to 0.10 g/kg/hour amino acids, 0.10 g/kg/hour glucose, and 0.05 g/kg/hour lipids.
In children, greater than 2 years of age and adolescents: 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 N12E, 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 N12E in the 2 to 11 year age group, amino acid and magnesium concentrations are the limiting factor for daily dose. In this age group, the amino acid concentration is the limiting factor for hourly rate. In the 12 to 18 year age group, amino acid and magnesium concentrations are the limiting factor for daily dose. In this age group, the amino acid concentration is the limiting factor for hourly rate. The resulting intakes are displayed as follows: See Table 4.

Click on icon to see table/diagram/image

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 daily dose and gradually increase it up to the maximal dosage (see previous text).
Maximal infusion rate is 2.6 mL/kg/hour in children 2 to 11 years of age and 1.6 mL/kg/hour in children 12 to 18 years of age.
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 Special precautions for disposal and other handling under Cautions for Usage.
Due to its high osmolarity, OLIMEL N12E must 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.