Intralipid 20%

Purified soybean oil, purified egg phospholipids.

Fat emulsion 200 mg/ml for infusion.
Each 1000 ml contains purified soybean oil 200 g, purified egg phospholipids 12 g, anhydrous glycerol 22 g. pH approx. 8.0.
Intralipid is a fat emulsion for intravenous use containing purified soybean oil emulsified with purified egg phospholipids. About 60% of the fatty acids in Intralipid are essential ones. Particle size and biological properties are similar to those of natural chylomicrons. The energy content of Intralipid 20% is 8.4 MJ (2,000 kcal) per litre. Intralipid as an energy source should be regarded as an integrated part of Fresenius Kabi's complete programme for intravenous nutrition. The administration of Intralipid also supplies the requirement of essential fatty acids.
Excipients/Inactive Ingredients: Water for injection to 1000 ml.

Intralipid is indicated as a source of energy and essential fatty acids for patients requiring intravenous nutrition.
Preoperative and postoperative nutritional disturbances in which a large supply of energy is necessary or desirable, e.g. in order to improve the nitrogen balance.
Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumors in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis) etc.
Burns. In extensive burns every additional supply of energy is of value as a means of reducing the frequently excessive nitrogen losses. A large supply of energy also improves the utilization of orally ingested protein as well as of infused Vamin. Intravenously administered fat is also indicated in patients in whom oral nutrition is inadequate.
Prolonged unconsciousness, e.g. following cranial traumata or poisoning in cases where tube feeding is inappropriate or impossible.
Impaired renal function, in which condition an adequate supply of energy is essential to reduce protein breakdown.
Cachexia.

The patient's ability to eliminate administered fat should govern the dosage (see IMPORTANT).
Adults: The quantity of intravenously administered fat should not normally exceed 3 g per kg bodyweight per day. When starting the infusion, the following points be observed. During the first 10 minutes the rate of infusion should be about 20 drops/minute. The infusion rate is then continually increased and after 30 minutes it can be stabilized at the desired rate: 40-60 drops/minute for Intralipid 10% and 25-40 drops/minute for Intralipid 20%, at which rates 500 ml can be infused in 3-5 and 5-7 hours respectively. The infusion times must not be shorter than 3 and 5 hours respectively.
Newborns and infants: The infant's ability to eliminate fat should govern the dosage. Recommended dosage per 24 hours is 0.5-4 g fat per kg bodyweight equivalent to 2.5-20 ml Intralipid 20% and 5-40 ml Intralipid 10% per kg bodyweight respectively. Recommended initial dose in very low-birth-weight infants and small for gestational age infants is 0.5 g fat per kg bodyweight per 24 hours. The dose should be increased in relation to the infant's ability to eliminate fat which should be checked daily- See Fat elimination test. The daily dose should preferably be administered at a constant rate over 24 hours by infusion pump.
Intralipid and Vamin solutions can be infused simultaneously, the two solutions being given, for instance, through a twin infusion set or separate sets connected to a single tap so that the mixture reaches the vein through the same cannula.
IMPORTANT: In cases where daily infusions of intravenous fat are indicated for more than one week the ability of the patient to eliminate administered fat should be tested. Before starting the infusion a fasting blood sample is taken as for ESR (citrate). The sample is centrifuges at 1,200-1,500 rpm. If the plasma is milky or markedly opalescent, the planned infusion should be postponed. In the conditions mentioned under PRECAUTIONS the patient's fat elimination ability should be checked daily.
Intralipid must not be mixed with other drugs, nutrient or electrolyte solutions, but can be infused simultaneously with Vamin by the method described above. The unused content of an opened bottle should be discarded and must not be kept for later use.

Intralipid is contraindicated only in conditions with severely disordered fat metabolism, such as in severe liver damage and acute shock.

Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes, certain forms of liver insufficiency, metabolic disorders and sepsis. If intravenous fat is considered to be indicated in patients with the above mentioned disorders, the elimination of fat should be checked daily (see IMPORTANT under Dosage & Administration). In cases of verified or suspected liver insufficiency, the condition as well as function of the liver must be closely followed.

In rare cases Intralipid causes a rise in temperature and chills. Rises in transaminases, alkaline phosphatases and bilirubin have been observed after 6-8 weeks infusion. All values quickly return to normal if the dosage is decreased (Intralipid is given every two or three days) or infusion of the fat emulsion is stopped for a while.

Parenteral Nutritional Products

B05BA02 - fat emulsions ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

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