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. 4 g/kg lipids. , 2,058 non-protein kcal and 2,622 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.

07 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. 14 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, 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 in both age groups, the amino acid concentration is the limiting factor for daily dose.

In the 2 to 11 year age group, the glucose concentration is the limiting factor for hourly rate. In the 12 to 18 year age group, the amino acid 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.

After reconstitution, the mixture is homogenous with a milky appearance. 6. Due to its high osmolarity, TRIOMEL 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.

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 Decreased appetite Commona Metabolism and Nutrition Disorders 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.

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

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 hyperglycemia can help recognize 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.

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, 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 hyperazotemia 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 emulsion for infusion. Regular clinical and laboratory tests […]

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