OliClinomel N4-550E/OliClinomel N7-1000E Special Precautions

Excessively rapid administration of total parenteral nutrition (TPN) solutions, including OliClinomel, can result in serious or fatal consequences.
The infusion must be stopped immediately if any sign or symptom of an allergic reaction (such as perspiration, fever, chills, headache, skin rashes, dyspnoea or bronchospasm) develops. This medicinal product contains egg and soya oil phosphatides. Egg and soya proteins can induce hypersensitivity reactions. Cross-allergy reactions between soya and peanut proteins have been observed.
Solutions containing dextrose, should be used with caution, in patients with known allergy to corn or corn products.
Ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including OLICLINOMEL, through the same infusion line (e.g., via Y-connector) because of the risk of precipitation of ceftriaxone-calcium salt.
If the same infusion line is used for sequential administration, the line must be thoroughly flushed with a compatible fluid between infusions. This only applies to products containing electrolytes.
Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary 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 the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation distal to the in-line filter and suspected precipitate formation in the blood stream have 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 pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.
Specific clinical monitoring is necessary when an intravenous infusion is being initiated.
Severe water/electrolyte imbalance disorders, severe fluid overload conditions and serious metabolism disorders must be corrected before beginning the infusion.
Do not add any other medicinal products or substances to any component of the bag or to the reconstituted emulsion without having previously checked their compatibility and the stability of the resulting preparation (in particular the stability of the lipid emulsion). The addition of an excess of calcium and phosphorus may cause calcium phosphate precipitates to be formed. The formation of precipitates or the destabilisation of the lipid emulsion could cause vascular occlusion (see "Incompatibilities" and "Special precautions for disposal and other handling" under Cautions for Usage).
Infection of the vascular access and septicaemia are complications that can arise in patients receiving parenteral nutrition, in particular in the event of poor catheter maintenance, or contaminated solutions, disease or the use of medicinal products with immunosuppressant effects. Careful attention to signs, symptoms and laboratory test results to detect a fever/chills, leukocytosis, technical complications related to the access device and HYPERglycaemia can help detect any infection early. Patients who need parenteral nutrition are often prone to complications involving infection because of HYPERglycemia, malnutrition and/or an underlying pathology. The risk of septic complications can be reduced by being careful to work in aseptic conditions when inserting and maintaining the catheter, and when preparing the nutritional formulation.
Monitor the water/electrolyte balance, serum osmolarity, serum triglycerides, the acid/base balance, blood glucose, liver and renal function, coagulation tests and blood counts, including platelet count, throughout the treatment.
Metabolic complications may occur if the supply of nutrients is not adapted to the requirements of the patient or if the metabolic capacity of a particular dietary component is not evaluated correctly. Undesirable metabolic effects may arise following the administration of excessive or insufficient nutrients, or inadequacy in a mixture, in relation to the requirements of a particular patient.
Serum triglyceride concentrations and the ability to eliminate lipids must be checked regularly.
Serum triglyceride concentrations must not exceed 3 mmol/l during the infusion. This concentration should be determined after at least 3 hours of continuous infusion.
If a lipid metabolism abnormality is suspected, it is recommended to perform this test daily, by measuring serum triglycerides 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 should only be administered when the plasma triglyceride concentration has returned to normal values.
Fat overload has been reported with similar products. The reduced or limited ability to metabolise the lipids in OliClinomel may result in a "fat overload syndrome", which may be caused by overdose, but the signs and symptoms of this syndrome can also occur when the product is administered according to the instructions (see also "Adverse Reactions").
In the event of HYPERglycaemia, the rate of infusion of OliClinomel must be adjusted and/or insulin must be administered.
Although OliClinomel N4-550E can be administered through a peripheral vein, thrombophlebitis can develop. The site of catheter implantation must be checked daily to detect any sign of thrombophlebitis (for OliClinomel N4-550E only).
If supplements are added, the final osmolarity of the mixture should be determined before administration. The final mixture will be administered intravenously through a central or peripheral vein according to the final osmolarity. If the final mixture being administered is HYPERtonic, it may cause vein irritation when administered into a peripheral vein.
Although the product naturally contains vitamins and trace elements, the quantities are not enough to meet the needs of the organism, trace elements and vitamins should be added in sufficient quantities to meet individual patient requirements and to prevent deficiencies from developing. Refer to the instructions concerning supplementing this product (see "Special precautions for disposal and other handling" under Cautions for Usage).
Caution should be exercised in administering OliClinomel to patients with increased osmolarity, adrenal insufficiency, heart failure or pulmonary dysfunction. Fluid status should be closely monitored.
Providing nourishment to patients in a state of advanced malnutrition can result in refeeding syndrome characterised by intracellular displacement of potassium, phosphorus and magnesium, with anabolism in the patient. Thiamine deficiency and fluid retention are also possible. These complications can be prevented through attentive monitoring and a gradual increase in the supply of nutrients, while being careful to avoid overfeeding. This syndrome has been reported with similar products.
Do not connect bags in series, in order to avoid the possibility of gas embolism due to air contained in the main bag.
Hepatic insufficiency: Exercise caution in patients with hepatic insufficiency, including cholestasis or elevated liver enzymes, because of the risk of neurological disorders developing or worsening, associated with HYPERammonaemia. Regular clinical examinations and lab tests are required/necessary, particularly liver function parameters, blood glucose, electrolytes and triglycerides.
Renal insufficiency: Exercise caution in patients with renal insufficiency, in particular if there is HYPERkalaemia, because of the risk of metabolic acidosis and HYPERazotaemia developing or worsening if extra-renal waste is not being removed. The fluid balance, triglycerides and electrolytes must be closely monitored in these patients.
Blood disorders: Exercise caution in patients with coagulation disorders and anaemia. The complete blood count and coagulation parameters must be closely monitored.
Endocrine and metabolic disorders: Exercise caution in patients with: Metabolic acidosis: administration of carbohydrates is not recommended in the presence of lactic acidosis. Regular clinical examinations and laboratory tests are necessary.
Diabetes: monitor glucose concentrations, glucosuria, ketonuria and, where applicable, adjust insulin dosages.
HYPERlipidaemia, because of the presence of the lipids in the emulsion for infusion. Regular clinical examinations and laboratory tests are necessary.
Amino acid metabolism disorders.
Extravasation: Extravasation has been reported with the administration of OliClinomel.
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.
When involving an extremity, the concerned limb should be elevated (for OliClinomel N4-550E only).
Depending on the extravasated product (including the product(s) being mixed with OLICLINOMEL, 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. If there is any deterioration of the affected area (continued pain, necrosis, ulceration, suspected compartment syndrome), surgery should be consulted immediately.
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 peripheral or central vein (for OliClinomel N4-550E) or the same central vein (for OliClinomel N7-1000E).
Effects on ability to drive and use machines: No studies of the effects on the ability to drive and use machines have been performed.
Use in Children: If administered to children over two years of age, it is essential to use a bag with a volume corresponding to the daily dose.
Vitamin and trace element supplementation is always required. Paediatric formulations should be used.