TRIOMEL

2). 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, 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 TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes.

In those situations, health care professionals may consider adjusting the volume (dose) of TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes 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 12 g/l nitrogen 950 kcal/l with electrolytes, as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.

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. 5 g of amino acids/kg). 5 mL per expended kcal. 9 g/kg lipids. , 1,171 non-protein kcal and 1,723 total kcal).

2 g/kg lipids. , 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). 2 g/kg lipids. , 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.

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 TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes, 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 12 g/l nitrogen 950 kcal/l with electrolytes, in the 2 to 11 year age group, amino acid and magnesium concentrations are the limiting factor for daily dose.

9). At the beginning of the infusion, any of the following abnormal signs (sweating, fever, shivering, headache, skin rashes, dyspnoea) should be cause for immediate discontinuation of the infusion: The adverse drug reactions (ADRs) reported with TRIOMEL 9 g/l nitrogen 1070 kcal/l in a randomised, double-blind, active-controlled, efficacy and safety study, are listed in the table below.

, postsurgical fasting, severe malnutrition, enteral intake insufficient or forbidden) were included and treated; patients in the TRIOMEL group received drug product up to 40 mL/kg/d over 5 days. The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to TRIOMEL.

System Organ Class MedDRA Preferred Term Frequency0 Immune System Disorders Hypersensitivity reactions including hyperhidrosis, pyrexia, chills, headache, skin rash (erythematous, papular, pustular, macular, generalized rash), pruritus, hot flush, dyspnea Not known0 Cardiac Disorders Tachycardia Common Decreased appetite CommonMetabolism and Nutrition Disorders Hypertriglyceridaemia Common Abdominal pain Common Diarrhoea Common Nausea Common Gastrointestinal Disorders Vomiting Not known0 Vascular Disorders Hypertension Common Extravasation which may result at infusion site level in: pain, irritation, swelling/oedema, erythema/warmth, skin necrosis, blisters/vesicles, inflammation, induration, skin tightness Not known0 Pyrexia Not known0 General disorders and administration site conditions Chills Not known0 aFrequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from the available data) bADRs reported during post-marketing experience with TRIOMEL The following class-like-adverse drug reactions (ADRs) have been described in other sources in relation to similar parenteral nutrition products; the frequency of these events is not known.

An excessively fast administration of total parenteral nutrition (TPN) solutions may result in severe or fatal consequences. The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, skin rashes, or dyspnea) develop.

This medicinal product contains soya-bean oil, and egg phospholipids. Soya-bean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soya-bean and peanut proteins have been observed. 3). Ceftriaxone must not be mixed or administered simultaneously with any calcium- containing IV solutions even via different infusion lines or different infusion sites.

Ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation.

In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites.

2). Pulmonary vascular precipitates causing pulmonary vascular embolism and respiratory distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. 2). Suspected precipitate formation in the blood stream has also been reported.

In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates. If signs of respiratory distress occur, the infusion should be stopped and medical evaluation initiated. Do not add other medicinal products or substances to any components of the bag or to the reconstituted emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular, the stability of the lipid emulsion).

1 - Congenital abnormalities of amino acid metabolism - Severe hyperlipidaemia or severe disorders of lipid metabolism characterised by hypertriglyceridaemia - Severe hyperglycaemia - Pathologically-elevated plasma concentrations of sodium, potassium, magnesium, calcium, and/or phosphorus