Description

SMOFlipid is a lipid injectable emulsion designed for intravenous infusion, providing essential fatty acids and calories as part of parenteral nutrition. Manufactured by Fresenius Kabi, it serves both adults and pediatric patients, including term and preterm neonates, when traditional nutritional methods are inadequate or not feasible.

Composition

This sterile emulsion comprises a unique blend of oils per 100 mL:

• Soybean Oil: 6 g
• Medium-Chain Triglycerides (MCT): 6 g
• Olive Oil: 5 g
• Fish Oil: 3 g

These components are complemented by egg phospholipids, glycerin, and sodium oleate, with added vitamin E and vitamin K1. The formulation is adjusted to a pH of 6–9 using sodium hydroxide and is free from preservatives, gluten, lactose, and common dyes.

Physical Properties

• Lipid Concentration: 0.20 g/mL
• Energy Content: 2,000 kcal/L
• Osmolality: ~380 mOsm/kg water
• Aluminum Content: ≤25 mcg/L

The emulsion is supplied in containers that avoid natural rubber latex, PVC, and DEHP, available in various sizes from 45 mL to 1000 mL.

Administration

SMOFlipid is administered via intravenous infusion, suitable for both central and peripheral veins. It requires a non-vented, non-DEHP 1.2 micron in-line filter set and is intended for single use, with any unused portions to be discarded. Proper storage below 25°C and protection from light are essential, particularly when used in conjunction with vitamins or trace elements.

Dosage

Dosage varies by age and clinical needs:

• Adults: 1–2 g/kg/day, with a maximum infusion rate of 0.5 mL/kg/hour.
• Pediatric Patients: Tailored dosages with specific maximum rates, emphasizing gradual infusion rate increases.

Contraindications and Precautions

Contraindications include hypersensitivity to any ingredients such as fish, egg, or soybean, and certain metabolic or health conditions. Precautions highlight potential risks like rapid infusion reactions, liver disease, hypersensitivity, and interactions with vitamin K antagonists.

Monitoring and Adverse Reactions

Regular monitoring of liver function, serum triglycerides, and other parameters is recommended. Common adverse reactions include nausea, hyperglycemia, and increased liver enzymes, with serious risks such as allergic reactions and fat overload syndrome.

Compatibility

SMOFlipid can be mixed with specific amino acid, glucose, and electrolyte solutions for total parenteral nutrition, requiring careful compatibility checks with other medications.

Special Handling

Light protection, especially for young children, and proper disposal of unused portions are crucial. The integrity of the emulsion should be visually inspected before use, ensuring no phase separation or oiling out occurs.