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Dedicated to nourishing patients at every age and stage of life

Parenteral nutrition (PN). It’s a valuable source of nutrition for critically and chronically ill patients who are unable to receive the nutrients they need via the oral or enteral route. It’s also a complex process with room for errors. It certainly takes a “village”—an interdisciplinary approach—involving multiple healthcare professionals and several steps to ensure its safe delivery and administration.1 And it all starts with assessing your patient’s need for PN.

  • Soybean oil 30% (omega-6)
    Provides essential fatty acids

  • Medium-chain triglycerides 30%
    A source of rapidly available energy3

  • Olive oil 25% (omega-9)
    Supplies monounsaturated fatty acids and contains small amounts of linoleic acid and alpha-linolenic acid

  • Fish oil 15% (omega-3)
    A source of omega-3 fatty acids, including EPA and DHA

With the expansion of SMOFlipid’s indication to include patients of all ages, now healthcare providers and parents of infants and children on parenteral nutrition at home have another option to help nourish even the youngest patients. Discover the SMOF difference at: www.FreseniusKabiNutrition.com/deliver

INDICATIONS AND USAGE

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

IMPORTANT SAFETY INFORMATION

For intravenous infusion only into a central or peripheral vein. Use a non-vented non-DEHP 1.2 micron in-line filter set during administration. Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. The recommended dose for pediatrics is shown in Table 1, and do not exceed an infusion rate of 0.15 g/kg/hour. SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. Protect the admixed PN solution from light.

Table 1: Recommended Pediatric Dosage

Chart with pediatric dosage

SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides > 1,000 mg/dL).

Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who received parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests, if abnormalities occur consider discontinuation or dosage reduction.

Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of intravenous 100% soybean oil lipid emulsions have been reported in the literature.

Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.

Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: Monitor for signs and symptoms; monitor laboratory parameters.

Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates.

Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase and nosocomial infection.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at. 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information, for intravenous use here.

2675-OMEG-08-04/22

If you still can't find what you're looking for regarding our PN products or Fresenius Kabi Nutrition, let us know and we can help.

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References: 1. Vanek VW, Seidner DL, Allen P, et al. A.S.P.E.N. position paper: clinical role for alternative intravenous fat emulsions. Nutr Clin Pract. 2012;27:150-192. 2. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2022. 3. Deckelbaum RJ, Hamilton JA, Moser A, et al. Medium-chain versus long-chain triacylglycerol emulsion hydrolysis by lipoprotein lipase and hepatic lipase: implications for the mechanisms of lipase action. Biochemistry. 1990;29(5):1136-1142.