Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use
The serum triglyceride concentration should be regularly monitored during the infusion of Lipofundin MCT/LCT 10%.
Depending on the patient’s metabolic condition, occasional hypertriglyceridaemia may occur.
If the plasma triglyceride concentration exceeds 4.6 mmol/l during administration of the lipid emulsion, it is recommended to reduce the infusion rate. The infusion must be interrupted if the plasma triglyceride concentration exceeds 11.4 mmol/l.

Disorders of the fluid, electrolyte or acid-base balance must be corrected before the start of infusion.

Controls of serum electrolytes, fluid balance, acid-base balance, cardiovascular function and – during long-term administration – of blood cell counts, coagulation status and hepatic function are necessary.

Hypersensitivity reactions to an ingredient of Lipofundin MCT/LCT 10% (e.g. due to traces of protein in soya-bean oil or egg phospholipids for injection) are extremely rare, but cannot be totally excluded for sensitised patients. Infusion of Lipofundin MCT/LCT should immediately be discontinued in case of appearance of any sign of allergic reaction, e.g. fever, shivering, rash, dyspnoea.

Energy supply with lipid emulsions alone could cause metabolic acidosis. It is therefore recommended to infuse an adequate quantity of intravenous carbohydrates and amino acids along with the fat emulsion.

For patients requiring complete parenteral nutrition, complementary carbohydrate, amino acid, electrolyte, vitamin, and trace element supplements are required. Also, an adequate total fluid intake has to be ensured.

Mixing with incompatible substances might lead to breaking of the emulsion or to precipitation of particles (see sections 6.2 and 6.6), both resulting in a high risk of embolism.

In solutions with higher lipid concentration (e.g. Lipofundin MCT/LCT 20%), the ratio of emulsifier (phospholipid) to oil is lower than in lower concentrated lipid emulsions. This ensures a favourable lower plasma concentration of triglycerides, phospholipids, free fatty acids as well as the pathological lipoprotein-X in the patient`s blood. Therefore higher concentrated lipid emulsions like Lipofundin MCT/LCT 20% should be preferred over lower concentrated lipid emulsions.

Elderly patients

Caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

Patients with impaired lipid metabolism

Lipofundin MCT/LCT 10% should be administered cautiously to patients with disturbances of lipid metabolism, e.g. renal insufficiency, diabetes mellitus, pancreatitis, impaired hepatic function, hypothyroidism (with hypertriglyceridaemia), and sepsis. If Lipofundin MCT/LCT 10% is administered to patients with these conditions, close monitoring of serum triglycerides is necessary. The dose should be adjusted to the metabolic tolerance. The presence of hypertriglyceridaemia 12 hours after lipid administration also indicates a disturbance of lipid metabolism.

Paediatric population

Free fatty acids (FFA) compete with bilirubin for albumin binding sites. Especially very premature infants may be at increased risk of hyperbilirubinaemia due to high levels of FFA released from triglycerides resulting in a high FFA/albumin ratio. In parenterally fed infants at risk of hyperbilirubinaemia, serum triglyceride and bilirubin levels should be monitored and lipid infusion rate be adjusted if deemed necessary. During infusion Lipofundin MCT/LCT 10% should be protected from phototherapy light to decrease the formation of potentially harmful triglyceride hydroperoxides.
The serum triglyceride concentration should be regularly monitored during the infusion of Lipofundin MCT/LCT 10%, especially if there is an increased risk of hyperlipidaemia. A stepwise increase of the daily dose may be advisable.
Depending on the patient’s metabolic condition, occasional hypertriglyceridaemia may occur.
In infants dose reduction should be considered if the plasma triglyceride concentration during infusion exceeds 2.8 mmol/l. In older children dose reduction should be considered if the plasma triglyceride concentration during infusion exceeds 4.5 mmol/l.

Light exposure of mixtures 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 infants aged to 2 years old, Lipofundin MCT/LCT 10% should be protected from light exposure after preparation for infusion until administration is completed (see sections 4.2, 6.3 and 6.6).

Interference with laboratory tests

Lipids may interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) when the blood sample is taken before the lipids have been eliminated from the bloodstream; this may take 4 to 6 hours.

Effects on Driving