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 dyspnoea) develop. This medicinal product contains soybean oil and egg phosphatides. Soybean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut proteins have been observed.
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. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion, considering the advice to flush infusion lines between solutions (see Interactions and Incompatibilities under Cautions for Usage).
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. Excessive addition of calcium and phosphate increases the risk of formation of calcium phosphate precipitates (see Incompatibilities under Cautions for Usage).
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).
Formation of precipitates or destabilization of the lipid emulsion could result in vascular occlusion (see Incompatibilities and Special precautions for disposal and other handling under Cautions for Usage).
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 cases of poor maintenance of catheters, immunosuppressive effects of illness or drugs. Careful monitoring of signs, symptoms and laboratory test results for fever/chills, leucocytosis, technical complications with the access device and hyperglycaemia 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 occurence 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. PERIOLIMEL: When involving extremity, the concerned limb should be elevated.
Depending on the extravasated product (including the product(s) being mixed with OLIMEL/PERIOLIMEL, 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 four hours during the first 24 hours, then once daily.
For OLIMEL, the infusion should not be restarted in the same central vein.
For PERIOLIMEL, the infusion should not be restarted in the same peripheral or 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 electrolytes status should be closely monitored in these patients.
Haematologic: 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: The 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 are required.
Amino acid metabolism disorders.
Serum triglycerides concentrations and the ability of the body to remove lipids must be checked regularly.
Serum triglycerides concentrations must not exceed 3 mmol/l during the infusion.
If a lipid metabolism abnormality is suspected, it is recommended to measure serum daily triglyceride levels after a period of 5 to 6 hours without administering lipids. In adults, the serum must be clear in less than 6 hours after stopping the infusion containing the lipid emulsion. The next infusion must only be administered when the serum triglyceride concentrations have returned to baseline values.
Fat overload syndrome has been reported with similar products. The reduced or limited ability to metabolise the lipids contained in OLIMEL/PERIOLIMEL may result in a "fat overload syndrome", which may be caused by overdose; however, the signs and symptoms of this syndrome may also occur when the product is administered according to instructions (see also Adverse Reactions).
In the event of hyperglycaemia, the infusion rate of OLIMEL/PERIOLIMEL must be adjusted and/or insulin administered.
Do not administer OLIMEL through a peripheral vein.
For PERIOLIMEL, thrombophlebitis may develop if peripheral veins are used. The catheter insertion site must be monitored daily for local signs of thrombophlebitis.
When making additions, the final osmolarity of the mixture must be measured before administration. The mixture obtained must be administered through a central or peripheral venous line depending on its final osmolarity. If the final mixture administered is hypertonic, it may cause irritation of the vein when administered into a peripheral vein.
Although there is a natural content of trace elements and vitamins in the product, the levels are insufficient to meet body requirements, and these should be added to prevent deficiencies from developing. See instructions for making additions to this product.
Caution should be exercised in administering OLIMEL/PERIOLIMEL to patients with increased osmolarity, adrenal insufficiency, heart failure or pulmonary dysfunction.
In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium or water-soluble vitamins. These changes can occur within 24 to 48 hours; therefore careful and slow initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, trace elements and vitamins.
Do not connect bags in series in order to avoid the possibility of air embolism due to residual gas contained in the primary bag.
Special precautions in paediatrics: When administered to children greater than 2 years of age, it is essential to use a bag that has a volume corresponding to the daily dosage.
OLIMEL/PERIOLIMEL is not suitable for use in children less than 2 years of age because: The glucose intake is too low, leading to a low glucose / lipid ratio; The absence of cysteine makes the amino acids profile inadequate; Calcium is too low; The bag volumes are not appropriate.
In children greater than 2 years of age, the amount of phosphate limits the daily intakes; therefore, all macronutrients and calcium should be supplemented.
Maximal infusion rate for OLIMEL is 3.3 ml/kg/hour in children of 2 to 11 years of age and 2.1 ml/kg/hour in children 12 to 18 years of age.
Maximal infusion rate for PERIOLIMEL is 4.3 ml/kg/hour in children 2 to 18 years of age.
Vitamin and trace elements supplementation is always required. Paediatric formulations must be used.
To avoid risks associated with excessively rapid infusion rates, it is recommended to use a continuous and controlled infusion.
OLIMEL/PERIOLIMEL must be administered with caution to patients with a tendency towards electrolyte retention.
Intravenous infusion of amino acids is accompanied by increased urinary excretion of trace elements, in particular copper and zinc. This should be taken into account in the dosing of trace elements, especially during long-term intravenous nutrition.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.