Presentation and Status in Health Basket
Emulsion for Infusion
100 , 250 , 350 , 500, 1,000 ml
Posology: The posology depends on energy expenditure, the patient’s clinical status, body weight, and ability to metabolize ClinOleic 20%, as well as additional energy given orally/enterally. Therefore, the dosage should be individualized and the bag size chosen accordingly.
Adults: The posology is 1 to a maximum of 2 g lipids/kg/day. The initial infusion rate must be slow and not exceed 0.1 g lipids or 0.5 ml (10 drops) per minute for 10 minutes then gradually increased until reaching the required rate after half an hour. Never exceed 0.15 g lipids/kg/hour (0.75 ml/kg/hour).
Children: ClinOleic 20% should be administered as a continuous 24h/day infusion. It is recommended not to exceed a daily dose of 3g-lipids/kg b.w. and an infusion rate of 0.15 g lipids/kg b.w./h.
Daily dose should be increased gradually during the first week of administration.
Premature newborns and low birth weight infants: The use of ClinOleic 20% is restricted to premature infants of 28 weeks of gestational age or more. ClinOleic 20% should be administered as a continuous 24h/day infusion. The initial daily dose should be 0.5-1.0g lipids/kg b.w. The dose may be increased by 0.5-1.0g lipids/kg b.w. every 24 hours up to a daily dose of 2.0 g lipids/kg b.w.
See prescribing information for full details.
Source of lipids during parenteral nutrition in situations where oral or enteral feeding is impossible, insufficient or contraindicated.
Hypersensitivity to egg protein, soya protein or peanut protein or to any of the active substances or excipients.
Severe dyslipidemia and non corrected metabolism disorders including lactic acidosis and uncompensated diabetes.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormalities occur, the infusion must be stopped. 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 medicdbinal product contains soya-bean oil and egg phospholipids, which may rarely cause hypersensitivity reactions. Cross-allergic reactions between soya proteins 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. Reduced ability to remove lipids may result in a ?at overload syndrome?which may be caused by overdose but may also occur at the start of an infusion according to instruction, the effects of which are usually reversible after the lipid infusion is stopped. Elevated liver enzymes and cholestasis have been reported with lipid products. 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. Hydroelectrolytic 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 μmol/ l). Total bilirubin levels should be monitored closely.
The most frequent ADRs noted for ClinOleic 20% in clinical trials were nausea/vomiting, which occurred in more that 2% of the patients.
See prescribing information for full details.
Complete information about incompatibilities is not available.
No interaction studies have been performed with ClinOleic 20%.
ClinOleic 20% contains vitamin K, naturally present in lipid emulsions. The amount of Vitamin K in recommended doses of ClinOleic 20%, are not expected to influence effects of coumarin derivatives.
The lipids contained in this emulsion may interfere with the results of certain laboratory tests if the blood sample is taken before the lipids are eliminated from the serum (these are generally eliminated after a period of 5 to 6 hours without receiving lipids). Refer to the laboratory testing system product information regarding potential assay interference associated with lipemic samples.
Pregnancy and Lactation
The safety of administration of ClinOleic 20% during pregnancy and lactation has not been established.
Therefore, ClinOleic 20% should not be used during pregnancy and lactation except after special consideration.
A reduced ability to remove the lipids may result in a “fat overload syndrome” which may be caused by overdose, the effects of which are usually reversible after the lipid infusion is stopped.