ClinOleic Warnings

Special clinical monitoring is required at the beginning of any intravenous infusion: The infusion must be stopped immediately if any signs or symptoms of an allergic reaction develop.
Patients who require parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or their underlying disease state.
Infection and sepsis may occur as a result of the use of intravenous catheters to administer parenteral formulations, or poor maintenance of catheters and contaminated solutions. Immunosuppression and other factors such as hyperglycemia, malnutrition and/or their underlying disease state may predispose patients to infectious complications.
The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation of the nutritional formula.
Careful monitoring of signs, symptoms, and laboratory test results (including fever, chills, leukocytosis, and hyperglycemia), and frequent checks of the access device for technical complications can help recognize early infections.
"Fat overload syndrome" has been reported with similar products. This may be caused by inappropriate administration (e.g., overdose and/or infusion rate higher than recommended, see OVERDOSAGE); however, the signs and symptoms of this syndrome may also occur when the product is administered according to instructions. The reduced or limited ability to metabolize the lipids contained in CLINOLEIC 20% accompanied by prolonged plasma clearance may result in a fat overload syndrome. This syndrome is associated with a sudden deterioration in the patient's clinical condition and is characterized by findings such as fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g., coma). The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.
CLINOLEIC is administered as part of a parenteral nutrition regimen. Refeeding severely undernourished patients with parenteral nutrition may result in the refeeding syndrome. The syndrome is characterized by the intracellular shift of potassium, phosphorus, and magnesium 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.
Do not make additions directly to the CLINOLEIC 20% bag.
If CLINOLEIC 20% is mixed with dextrose and/or amino acid solutions, the compatibility should be checked before administration (see INCOMPATIBILITIES and INSTRUCTIONS FOR USE/HANDLING AND DISPOSAL under Cautions for Usage). Formation of precipitates could result in vascular occlusion.
Plasma triglyceride levels and clearance should be monitored daily. The triglyceride concentration in serum under infusion should not exceed 3 mmol/l. Infusion should only be started when serum triglyceride levels have returned to baseline level.
During short-term or long-term intravenous nutrition, alkaline phosphatases and total bilirubin should be checked at regular intervals, depending on the health status of the patient.
Electrolyte or metabolism disorders should be corrected before CLINOLEIC 20% administration.
Fat emulsions should be administered simultaneously with carbohydrates and amino acids to avoid occurrence of metabolic acidosis.
The blood sugar, the acid-base balance, electrolytes, and the blood count must be checked at regular intervals.
As for any parenteral infusion, particular attention should be given on water balance, especially in patients with acute oliguria or anuria.
As other lipid emulsions, CLINOLEIC 20% should be used in extremely premature and/or very low birth-weight infant under the close supervision of a neonatologist. There is clinical experience for CLINOLEIC 20% infusion time, up to 7 days in neonates and up to 2 months in children.
CLINOLEIC 20% should be administered with caution in case of neonatal hyperbilirubinemia (total serum bilirubin > 200 umol/l). Total bilirubin levels should be monitored closely.