Nutrifat

Purified soybean oil, purified egg yolk phospholipids.

100 mg/12 mg/mL emulsion for IV infusion: Each mL contains: Purified Soybean Oil 100 mg, Purified Egg Yolk Phospholipids 12 mg, Glycerin 22 mg, Water for Injection q.s.
200 mg/12 mg/mL emulsion for IV infusion: Each mL contains: Purified Soybean Oil 200 mg, Purified Egg Yolk Phospholipids 12 mg, Glycerin 22 mg, Water for Injection q.s.
The product is creamy white liquid. The product is sterile fat emulsion for intravenous infusion. It contains purified soybean oil for injection and purified egg yolk phospholipids for injection. The particle size and biological properties of the product are similar to those of natural chylomicrons.

Pharmacology: Toxicology: Some unsaturated fatty acids, which cannot be synthesized by the body itself but need to be absorbed from vegetable oil, are the indispensable nutrients of the body. Essential fatty acids are the precursors of physiological activators such as prostaglandin, thromboxane, leukotriene, etc. Fatty acids are the main energy substance of the human body and fatty acid is an important source of energy in the body. In the condition of sufficient oxygen supply, fatty acid can be broken down into carbon dioxide and water in the body and release a large amount of energy, which can be used by the body in the form of adenosine triphosphate (ATP). Except for brain tissue, most of the tissues can oxidize fatty acid, of which liver and muscle are the most active.
Phospholipids are the basic skeleton for the composition of cell biomembrane (cell membrane, nuclear membrane and mitochondrial membrane) lipid bilayer and the main ingredient for the composition of all kinds of lipoprotein. It takes part in the transport of fat and cholesterol. If the content of phospholipid in plasma is too low, the rate of cholesterol/lecithin will increase and cholesterol deposition will be observed easily which will cause atherosclerosis. Thus, phospholipid has an effect on anti-hypercholesterolemia. In addition, phospholipid, cholate and cholesterol form the colloidal particles in the gall, which benefit the dissolution and excretion of cholesterol. Phospholipid is distributed widely in the nature. In plants, the content of phospholipid is more abundant in seeds such as soybean, etc. In animals, the content of phospholipid is the highest in nerve tissues.

Indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of essential fatty acids deficiency (EFAD).

Nutrifat should be administered as a part of intravenous nutrition via peripheral vein or by central venous infusion.
Adult patients: The initial rate of infusion in adults should be 1 ml/minute for the first 15 to 30 minutes of infusion. If no untoward reactions occur (see Adverse Reactions), the infusion rate can be increased to 2 ml/minute. Not more than 500 ml of Nutrifat should be infused into adults on the first day of therapy. If the patient has no untoward reactions, the dose can be increased on the following day. The daily dosage should not exceed 2.5 g of fat/kg of body weight (25 ml of Nutrifat per kg). Nutrifat should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.
Pediatric patients: The dosage for premature infants starts at 0.5 g fat/kg body weight/24 hours (5 ml Nutrifat) and may be increased in relation to the infant's ability to eliminate fat. The maximum dosage recommended by the American Academy of Pediatrics is 3 g fat/kg/24 hours. The initial rate of infusion in older pediatric patients should be no more than 0.1 ml/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 1 ml of Nutrifat/kg/hour. The daily dosage should not exceed 3 g of fat/kg of body weight. Nutrifat should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.

In the event of fat overload during therapy, stop the infusion of Nutrifat until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-evaluate the patient and institute appropriate corrective measures. See Precautions.

The administration of Nutrifat is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.

Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g fat/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant's ability to eliminate the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.

The product should be used with great caution in patients with fat metabolism hypofunction, such as hepatic insufficiency, renal insufficiency, diabetic ketoacidosis, pancreatitis, hypothyroidism (accompanied by hyperlipidemia) and septicemia. When the product is infused in these patients, the concentration of serum triglyceride should be observed closely. If the product is used successively in patient for more than I week, the fat clearance capacity of patient should be examined.
The product should be used with great caution in patients who are allergic to soy protein. Allergic test should be carried out before the use of the product. In blood collection, if the product has not been cleared completely from the bloodstream yet, it will interfere with other laboratory test items (such as bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin, etc.). For most of the patients, the product can be cleared completely 5-6 hours after the infusion of the product. If the product is used for more than 1 week, fat clearance test must be carried out. The specific operation is as follows: Collect the blood sample and centrifuge before infusion. If the plasma exhibits creamy, the original infusion plan should be delayed (the method is not applicable to patients with hyperlipidemia). If the fat clearance capacity of patients is reduced, serum triglyceride had better be examined again. The remaining drug solution, which is not used in I time after being opened, should be discarded and cannot be used once more. Examine in detail before use and the product cannot be used if any of the following cases is observed: (1) Drug solution turbidity; (2) Slight crack is observed in the body and opening of the bottle; (3) Cottony mycelium group is observed; (4) Foreign matter is observed; (5) Discoloration of drug solution; (6) Sealing is loosened.
Use in Pregnancy and Lactation: Pregnancy Category C: Animal reproduction studies have not been conducted with Nutrifat. It is also not known whether Nutrifat can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nutrifat should be given to a pregnant woman only if clearly needed. Caution should be exercised when Nutrifat is administered to a nursing woman.
Use in Children: For infants and children, the most reliable method of monitoring fat clearance capacity is determining the level of serum triglyceride regularly. The product should be used with great caution in newborn babies and premature infants accompanied by hyperbilirubinemia or patients with suspicious pulmonary hypertension. See Dosage & Administration.

Use in Pregnancy and Lactation: Pregnancy Category C: Animal reproduction studies have not been conducted with Nutrifat. It is also not known whether Nutrifat can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nutrifat should be given to a pregnant woman only if clearly needed. Caution should be exercised when Nutrifat is administered to a nursing woman.

It will cause increase in body temperature. Cold fits, nausea and vomiting can be observed occasionally. Other side reactions are observed rarely, including: Instant and early side reaction: High allergic reaction (allergic reaction, rash and urticaria), respiratory influence (such as tachypnea), circulating influence (such as hypertension or hypotension), hemolysis, mesh polycythemia, abdominal pain, headache, tiredness, priapism, etc.
Tardive side reaction: If the product is infused for a long term, thrombocytopenia may be observed in infants. In addition, long-term parenteral nutrition will also cause transient abnormality in the hepatic function index even without using the product. Phlebitis, angialgia and hemorrhagic tendency can be observed occasionally.
If fat clearance capacity of patient is diminished, fat overload syndrome may still be caused even if the infusion rate is normal. Fat overload syndrome can also be observed occasionally in patients with renal dysfunction and infections. The manifestation of fat overload syndrome: hyperlipidemia, fever, fatty infiltration, organ dysfunction, etc. However, the above-mentioned symptoms will disappear as long as the infusion is stopped in general.

Store at temperatures not exceeding 25°C.

Parenteral Nutritional Products

B05BA - Solutions for parenteral nutrition ; Used in I.V. solutions.

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