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. In those situations, health care professionals may consider adjusting the volume (dose) of TRIOMEL 12 g/l nitrogen 950 kcal/l 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, 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).

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 taking into account the dose being administered, the daily volume intake, and the duration of the infusion.

05 g/kg/hour lipids.

Patients on intradialytic parenteral nutrition (IDPN):

Intradialytic parenteral nutrition is intended for non-acutely ill malnourished patients. g. by dietary interview and the recommended intakes. Additionally, metabolic tolerance needs to be taken into consideration. 09 g/kg/hour lipids, administered over 4 hours.

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, 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, in the 2 to 11 year age group, amino acid concentration is the limiting factor for both daily dose and for hourly rate.

In the 12 to 18 year age group, amino acid concentration is the limiting factor for both daily dose and hourly rate. 06 aRecommended 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). 6 mL/kg/hour in children 2 to 11 […]

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, dyspnoea Not knownb Cardiac Disorders Tachycardia Common Decreased appetite CommonMetabolism and Nutrition Disorders Hypertriglyceridaemia Common Abdominal pain Common Diarrhoea Common Nausea Common Gastrointestinal Disorders Vomiting Not knownb 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.

4). Fat overload syndrome (very rare) Fat overload syndrome has been reported with similar products. g. 9); however, the signs and symptoms of this syndrome may also occur at the start of an infusion when the product is administered according to instructions.

The reduced or limited ability to metabolise the lipids contained in TRIOMEL 12 g/l nitrogen 950 kcal/l accompanied by prolonged plasma clearance may result in a “fat overload syndrome”. g. coma). The syndrome is usually reversible when infusion of the lipid emulsion is stopped.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

uk/yellowcard.

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). 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). Precipitates of various natures have been reported even in the absence of phosphate salt in the solution. 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).

6). Vascular-access infection and sepsis are complications that may occur in patients receiving parenteral nutrition, particularly in case of poor maintenance of catheters, immunosuppressive effects of illness or drugs. Careful monitoring of signs, symptoms, and laboratory test results for fever/chills, leukocytosis, technical complications with the access device, and hyperglycaemia can help recognise early infections.

Patients who require parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or their underlying disease state. The occurrence of septic complications can be decreased with heightened emphasis on aseptic techniques in catheter placement and maintenance, as well as aseptic techniques in the preparation of the nutritional formula.

Specific clinical monitoring is required when an intravenous infusion is started. Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders must be corrected before starting the infusion.

Monitor water and electrolyte balance, serum osmolarity, serum triglycerides, acid/base balance, blood glucose, liver and kidney function tests, coagulation tests, and blood count, including platelets, throughout treatment. Elevated liver enzymes and cholestasis have been reported with similar products.

Monitoring of serum ammonia should be considered if hepatic insufficiency is suspected. Metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements, or the metabolic capacity of any given dietary component is not accurately assessed.

Adverse metabolic effects may arise from administration of inadequate or excessive nutrients or from inappropriate composition of an admixture for a particular patient's needs. Administration of amino acid solutions may precipitate acute folate deficiency; folic acid is, therefore, recommended to be given daily.

Extravasation Catheter site should be monitored regularly to identify signs of extravasation. If extravasation occurs the administration should be stopped immediately, keeping the inserted catheter or cannula in place for immediate management of the patient.

If possible, aspiration should be performed through the inserted catheter/cannula in order to reduce the amount of fluid present in the tissues before removing the catheter/cannula. Depending on the extravasated product (including the product(s) being mixed with TRIOMEL 12 g/l nitrogen 950 kcal/l, if applicable) and the stage/extent of any injury, appropriate specific measures should be taken.

Options for management may include non-pharmacologic, pharmacologic and/or surgical intervention. In case of large extravasation, plastic surgeon advice should be sought within the first 72 hours. The extravasation site should be monitored at least every 4 hours during the first 24 hours, then once daily.

The infusion should not be restarted in the same central vein. Hepatic Insufficiency Use with caution in patients with hepatic insufficiency because of the risk of developing or worsening neurological disorders associated with hyperammonaemia.

Regular clinical and laboratory tests are required, particularly liver function parameters, blood glucose, electrolytes and triglycerides. Renal Insufficiency Use with caution in patients with renal insufficiency, particularly if hyperkalaemia is present, because of the risk of developing or worsening metabolic acidosis and hyperazotaemia if extra-renal waste removal is not being performed.

Fluid, triglycerides and electrolyte status should be closely monitored in these patients. Hematologic Use with caution in patients with coagulation disorders and anaemia. Blood count and coagulation parameters should be closely monitored.

Endocrine and Metabolism Use with caution in patients with: - Metabolic acidosis. Administration of carbohydrates is not recommended in the presence of lactic acidosis. Regular clinical and laboratory tests are required. - Diabetes mellitus.

Monitor glucose concentrations, glucosuria, ketonuria and, where applicable adjust insulin dosages. - Hyperlipidaemia due to the presence of lipids in the […]

1 - Congenital abnormalities of amino acid metabolism Severe hyperlipidaemia or severe disorders of lipid metabolism characterised by hypertriglyceridaemia - Severe hyperglycaemia