Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

Do not administer through a peripheral vein.
An excessively fast administration of total parenteral nutrition (TPN) solutions, including Oliclinomel, 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, dyspnea or bronchospasm) develop.. This medicinal product contains soybean oil and egg phosphatide. Soybean and egg proteins may cause hypersensitivity reactions.
Cross-allergic reactions between soybean and peanut proteins have been observed.

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.

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). Excess addition of calcium and phosphorus may result in the formation of calcium phosphate precipitates. Formation of precipitates or destabilization of the lipid emulsion could result in vascular occlusion (see section 6.2 and 6.6) 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 tests 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.
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.

Serum triglyceride concentrations and the ability of the body to remove lipids must be checked regularly.

Oliclinomel N7- 1000 E,                  9. 6. 2015, RH                                  Page 4 of 14 Serum triglyceride concentrations must not exceed 3 mmol/l during the infusion. These concentrations should not be determined before a minimum of a 3-hour period of continuous infusion.

If a lipid metabolism abnormality is suspected, it is recommended that tests be performed 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 serum triglyceride concentrations have returned to normal values.

Fat overload syndrome has been reported with similar products. The reduced or limited ability to metabolize the lipids contained in Oliclinomel 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 section 4.8).

In the event of hyperglycaemia, the infusion rate of Oliclinomel must be adjusted and/or insulin administered.

When making additions, the final osmolarity of the mixture must be measured before administration. The mixture obtained should 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. (See section 6.6)

Caution should be exercised in administering Oliclinomel to patients with increased osmolarity, adrenal insufficiency, heart failure or pulmonary dysfunction.

Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. This syndrome has been reported with similar products.

Do not connect bags in series in order to avoid the possibility of air embolism due to residual air contained in the primary bag.

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.



Oliclinomel N7- 1000 E,                   9. 6. 2015, RH                                   Page 5 of 14 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 are required.
• Amino acid metabolism disorders

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 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 central vein.


Special precautions in paediatrics
When administered to children greater than 2 years old, it is essential to use a bag which has a volume corresponding to the daily dosage.
Vitamin and trace element supplementation is always required. Paediatric formulations should be used.

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