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(lipid injectable emulsion) for Intravenous Use



Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.

Autopsy findings included intravascular fat accumulation in the lungs.

Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

[See WARNINGS AND PRECAUTIONS and Use in Specific Populations]


CLINOLIPID Lipid Injectable Emulsion, USP is a sterile, non-pyrogenic lipid emulsion for intravenous infusion. CLINOLIPID injection is a lipid emulsion containing a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The lipid content is 0.20 g/mL. In CLINOLIPID injection, the mean composition of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 - 44.0 mg/mL) and a-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 - 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter.

The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L.

Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6 .0 -9.0.

The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:

Structure of olive and soybean oils - Illustration

The major component fatty acids are linoleic (13.8-22.0%), oleic (44.3-79.5%), palmitic (7.6-19.3%), linolenic (0.5-4.2) and stearic (0.7-5.0%). These fatty acids have the following chemical and structural formulas:

Major component fatty acids - Structural Formula Illustration

CLINOLIPID 20% has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion)

Drug product contains no more than 25 mcg/L of aluminum.

Last reviewed on RxList: 10/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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