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BRIEF SUMMARY OF PRESCRIBING INFORMATION:
These highlights do not include all the information needed to use Smoflipid safely and effectively. See full prescribing information, including Boxed Warning, for Smoflipid available at www.smoflipid.com
SMOFLIPID (lipid injectable emulsion), for intravenous use
INDICATIONS AND USAGE
Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use: The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
DOSAGE AND ADMINISTRATION
For intravenous infusion only into a peripheral or central vein.
Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy given to the patient.
The usual daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day.
DOSAGE FORMS AND STRENGTHS
Smoflipid is a lipid injectable emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 mL.
WARNING: DEATH IN PRETERM INFANTS
See full prescribing information for complete boxed warning.
Deaths in preterm infants have been reported in literature.
Autopsy findings included intravascular fat accumulation in the lungs.
Preterm and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients.
Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1,000 mg/dL.
WARNINGS AND PRECAUTIONS (also see BOXED WARNING)
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.
Infection, Fat Overload Syndrome, Refeeding Complications, and Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters including serum triglycerides.
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants.
Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction.
ADVERSE REACTIONS (also see Warnings and Precautions)
Most common adverse drug reactions (>1%) from clinical trials were nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, increased blood triglycerides, hypertension, sepsis, dyspepsia, urinary tract infection, anemia and device related infection.
To report suspected adverse reactions, contact Fresenius Kabi USA, LLC, at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Coumarin and Coumarin Derivatives, Including Warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters.