Refined Soyabean Oil + Purified Egg Lecithin + Glycerol (10% fat emulsion)

Indications

Refined Soyabean Oil + Purified Egg Lecithin + Glycerol (10% fat emulsion) is used for: Parenteral nutrition Preoperative and postoperative nutritional disturbances where an improved nitrogen balance is required; Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumours in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis); Burns, to reduce the frequently excessive nitrogen losses; Prolonged unconsciousness, eg. following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible; Impaired renal function where a concentrated source of energy may be indicated to reduce protein breakdown; Cachexia and Patients with essential fatty acid deficiency who cannot maintain or restore a normal essential fatty acid pattern by oral intake.

Adult Dose

Total Parenteral nutrition: As a part of TPN, administer IV via a peripheral vein or by central venous catheter. Fat emulsion should comprise no more than 60% of the patient\'s total caloric intake, with carbohydrates and amino acids comprising the remaining 40% or more of caloric intake. Adult: Initial infusion rate is 1ml/min for the first 15 to 30 mins. If no adverse reactions occur, the infusion rate can be increased to 2 ml/min. Infuse only 500 ml the first day and increase dose the following day. Do not exceed a daily dosage of 2.5 g/kg.

Child Dose

Total Parenteral nutrition: As a part of TPN, administer IV via a peripheral vein or by central venous catheter. Fat emulsion should comprise no more than 60% of the patient\'s total caloric intake, with carbohydrates and amino acids comprising the remaining 40% or more of caloric intake. Children: Initial infusion rate is 0.1ml/min for the first 10 to 15 mins. If no adverse reactions occur, the infusion rate can be increased to 1g/kg in 4 hours. Do not exceed a daily dosage of 3 g/kg. Infants: Starts at 0.5g/kg/24 hours and may be increased in relation to the infant's ability to eliminate fat. The maximum recommended dosage is 3g/kg/24 hours. Fatty acid deficiency: To correct EFAD, supply 8% to 10% of the caloric intake by IV fat emulsion to provide an adequate amount of linoleic acid.

Renal Dose

Administration

Contra Indications

It is contraindicated in conditions with severely disordered fat metabolism, such as in severe liver damage and acute shock. Hypersensitivity to egg-, soya- or peanut protein or to any of active substances or excipients.

Precautions

This contains soya oil and egg lecithin which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut. Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes, pancreatitis, certain forms of liver insufficiency, metabolic disorders and sepsis. Fatisol should be administered with caution as a strong correlation exists between C-reactive protein and the agglutination of Fatisol in seriously ill patients. It should be given with caution to neonates and premature infants with hyperbilirubinaemia and in cases with suspected pulmonary hypertension. In low birthweight infants, the risk of lipid infusions may outweigh potential benefits due to further diminution of defences against infection. In infants, metabolism of lipids in peripheral tissues may be diminished by infection and heparin administration. In neonates receiving long term parenteral nutrition, particularly premature neonates, platelet count, liver function tests and serum triglyceride concentration should be monitored. Use in Pregnancy & Lactation: Absolute safety of the foetus and the nursing infant has not been established. Therefore,it should be administered with caution during pregnancy and lactation.

Pregnancy-Lactation

Interactions

Adverse Effects

Side effects of Refined Soyabean Oil + Purified Egg Lecithin + Glycerol (10% fat emulsion) : This may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence <1%). Reports of other adverse events in conjunction with 10% fat emulsion infusion are extremely rare, less than one report of certain events per one million infusions. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (tachypnoea) and circulatory effects (hypertension, hypotension) have been described. Thrombosis, haemolysis, reticulocytosis, abdominal pain, tiredness, priapism and neurological adverse reactions including headaches, flushing, dyspnoea, slight pressure over the eyes and dizziness have been reported.

Mechanism of Action

This are isotonic and may be given by central or peripheral venous route. FatisolTM is formulated as a concentrated source of energy to be used together with carbohydrates and amino acids in parenteral nutrition, it is isotonic, and provides a source of basal phosphate requirements and a source of vitamin E.