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 any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of TRIOMEL. In adults The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolise the constituents of TRIOMEL as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.

5 mL per expended kcal. 2 mmol/kg potassium. , 2,408 non-protein kcal and 2,772 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.

08 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, 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 5 g/l nitrogen 990 kcal/l with electrolytes in both age groups, the magnesium concentration is the limiting factor for daily dose.

In the 2 to 11 year age group, the glucose and lipid concentrations are the limiting factor for hourly rate. In the 12 to 18 year age group, the glucose concentration is the limiting factor for hourly rate. 08 a: Recommended values from 2018 ESPGHAN/ESPEN/ESPR Guidelines 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 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.

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 randomized, 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 Frequencya Immune System Disorders Hypersensitivity reactions including hyperhidrosis, pyrexia, chills, headache, skin rash (erythematous, papular, pustular, macular, generalised rash), pruritus, hot flush, dyspnoea Not knownb Cardiac Disorders Tachycardia Commona Metabolism and Nutrition Disorders Decreased appetite Commona System Organ Class MedDRA Preferred Term Frequencya Hypertriglyceridemia Commona Abdominal pain Commona Diarrhoea Commona Nausea Commona Gastrointestinal Disorders Vomiting Not knownb Vascular Disorders Hypertension Commona General disorders and administration site conditions Extravasation which may result at infusion site level in: pain, irritation, swelling/oedema, erythema/warmth, skin necrosis, blisters/vesicles, inflammation, induration, skin tightness Not knownb a: Frequency 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).

b: ADRs 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.