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  • Triomel 9 g/l Nitrogen 1070 kcal/l with Electrolytes
    / Teva


    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Emulsion for Infusion

    1000 ml, 1500 ml, 2000 ml

    not in the basket chart

    Dosage

    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.
    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) 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) and amino acid concentration for hourly rate. For the resulting intakes please refer to prescribing information.
    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.
    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.


    Indications

    TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion is indicated for parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.


    Contra-Indications

    – In premature neonates, infants, and children less than 2 years of age,
    – Hypersensitivity to egg, soybean, or peanut proteins, or to any of the active substances or excipients.
    – Congenital abnormalities of amino acid metabolism,
    – Severe hyperlipidaemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia,
    – Severe hyperglycemia,
    – Pathologically-elevated plasma concentrations of sodium, potassium, magnesium, calcium, and/or phosphorus.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    See prescribing information for full details.


    Manufacturer
    Baxter Healthcare Ltd., UK
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