Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use
WARNINGS

The infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction (such as sweating, fever, shivering, headache, skin rashes or dyspnoea) develop. This medicinal product contains soybean oil and egg phospholipids. Soybean and egg proteins may cause hypersensitivity reactions. Cross- allergic reactions between soybean and peanut proteins have been observed.
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.
Infection and sepsis complications
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 hyperglycemia 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.

Hepatic Insufficiency

Use with caution in patients with hepatic insufficiency. Regular clinical and laboratory tests are required, particularly blood glucose, electrolytes and triglycerides (not exceeding 3 mmol/l during infusion).

Haematologic and thrombophlebitis

Use with caution in patients with coagulation disorders and anaemia. Blood count and coagulation parameters should be closely monitored

Thrombophlebitis may develop, particularly if peripheral veins are used. The catheter insertion site must be monitored daily for local signs of thrombophlebitis.

“Fat overload syndrome” may be caused by overdose and/or infusion rate higher than recommended.
However, the signs and symptoms of this syndrome may also occur when the product is administered according to instructions, e.g. in patients with reduced or limited ability to metabolize the lipids contained in ClinOleic 20%. 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.

Serious adverse reactions including acute respiratory distress and metabolic acidosis have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions.

ClinOleic 20% 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.
Patients at risk of refeeding syndrome include those with anorexia nervosa, chronic malnutrition (due to age or carcinoma), chronic alcoholism, prolonged fasting, or postoperative patients.

Baxter has not performed any compatibility studies of additions made directly to the ClinOleic 20% emulsion container. Destabilization of the lipid emulsion may result from such additions. If admixture into the ClinOleic 20% emulsion container is deemed necessary, insure that additives are compatible with the emulsion. Any additions to the container should be performed under strict aseptic conditions.

If ClinOleic 20% is mixed with glucose and/or amino acid solutions, the compatibility should be checked before administration (see Sections 6.2 and 6.6). Formation of precipitates could result in microvascular pulmonary emboli.

PRECAUTIONS

As for any parenteral infusion, particular attention should be given on monitoring fluid status, especially in patients with acute oliguria or anuria and in patients with pulmonary oedema or heart failure.

Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders must be corrected before starting the infusion.

Fat emulsions should be administered simultaneously with carbohydrates and amino acids to avoid occurrence of metabolic acidosis.

The blood sugar, serum triglycerides, the acid-base balance, electrolytes, serum osmolarity, kidney function, coagulation parameters and the blood count must be checked at regular intervals.

Parenteral nutrition should be used with caution in patients with pre-existing liver disease or liver insufficiency.
Liver function parameters should be closely monitored in these patients (see below).

Parenteral Nutrition Associated Liver Diseases (PNALD) including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in some patients on parenteral nutrition. The etiology of these disorders is thought to be multifactorial and may differ between patients. Patients developing abnormal laboratory parameters or other signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.

Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. When used in neonates and children below 2 years, ClinOleic 20% should be protected from light until administration is completed (see sections 6.3 and 6.6).

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