Fatisol 0.1

INDICATIONS

Intravenous Fat Emulsion is a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for >5 days). It is a source of essential fatty acids when a deficiency occurs. Part of the intravenous diet in all parenteral nutrition indications ... Read moreIntravenous Fat Emulsion is a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for >5 days). It is a source of essential fatty acids when a deficiency occurs. Part of the intravenous diet in all parenteral nutrition indications including:

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.

PHARMACOLOGY

Intravenous Fat Emulsion is a preparation of 10% refined soyabean oil intended to be used as an intravenous nutrient. Intravenous fat emulsion prevents Essential Fatty Acid Deficiency (EFAD) and corrects the clinical manifestations of EFAD. However, for patients requiring complete parenteral nutrition, complementary vitamin supplements are required.Intravenous Fat Emulsion are prepared from either soyabean or safflower oil and provide a mixture of neutral triglycerides, predominantly unsaturated fatty acids. The major components of fatty acids are linoleic, oleic, palmitic acids. In addition, Fatisol contains 1.2% egg yolk phospholipids as an emulsifier and glycerol to adjust tonicity. IV Fat emulsions are isotonic and may be given by central or peripheral venous route. Fatisol 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.

DOSAGE

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.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 0.5 g/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. The left over contents of opened bottles should be discarded & not saved for later use.Do not use any bottles in which there appears to be separation of the emulsion.

INTERACTION

Some drugs, like insulin, may interfere with the body's lipase system. This kind of interaction seems, however, to be of only limited clinical importance. Heparin in clinical doses causes a transient increase in lipolysis in plasma, resulting in a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase.

SIDE EFFECTS

Intravenous fat emulsion 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 are not (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.

PREGNANCY & LACTATION

Absolute safety of the foetus and the nursing infant has not been established. Therefore, Intravenous fat emulsion should be administered with caution during pregnancy and lactation.

PRECAUTIONS & WARNINGS

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. Fatisol 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.

THERAPEUTIC CLASS

Parenteral nutritional preparations

STORAGE CONDITIONS

Store at 15°C to 30°C in a dry place protected from light. Keep out of reach of children. Do not use if there is evidence of excessive creaming or aggregation, if excessive free oil droplets are visible, if the bag is leaking or if the bottle is damaged, solution is frozen, discolored or contains particles. The left over contents of opened bag or bottles should be discarded & not saved for later use. This contains no preservatives.