SMOFLIPID- smoflipid injection, emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A), MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U), OLIVE OIL (UNII: 6UYK2W1W1E) (OLIVE OIL - UNII:6UYK2W1W1E), FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

SOYBEAN OIL

Composition:

SOYBEAN OIL 6 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Use of SMOFlipid is contraindicated in patients with: - Known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients in SMOFlipid [see Warnings and Precautions (5.3)] - Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions (5.7)] Risk Summary Administration of the recommended dose of SMOFlipid is not expected to cause major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with SMOFlipid. There are risks to the fetus associated with severe malnutrition during pregnancy (see Clinical Considerations) . The estimated background risk of major birth defects and miscarriag

Product summary:

SMOFlipid is a sterile lipid injectable emulsion with a lipid content of 0.2 gram/mL available in Flexible Containers in the following sizes: Store below 25°C (77°F). Avoid excessive heat. Do not freeze. If accidentally frozen, discard container. Store in overpouch until ready for use. SMOFlipid 100 mL, 250 mL and 500 mL single-dose Flexible Containers. After removing the overpouch, infuse immediately. If not used immediately, the product should be stored at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. After removal from storage, infuse within 12 hours when using a Y-connector or within 24 hours if used as part of an admixture [see Dosage and Administration (2.2)] . SMOFlipid 1000 mL Pharmacy Bulk Package Use the Pharmacy Bulk Package immediately for admixing after removal from overpouch. If not used immediately, the product should be stored for no longer than 24 hours at 2°C to 8°C (36°F to 46°F). After removal from storage, and once the closure is penetrated, use Pharmacy Bulk Package contents within 4 hours [see Dosage and Administration (2.2)] . Admixtures Infuse admixtures containing SMOFlipid immediately. If not used immediately, admixtures should be stored at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. After removal from storage, infuse within 24 hours [see Dosage and Administration (2.2)] . Protect the admixed PN solution from light [see Dosage and Administration (2.2)].

Authorization status:

New Drug Application

Summary of Product characteristics

SMOFLIPID - SMOFLIPID INJECTION, EMULSION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SMOFLIPID SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SMOFLIPID.
SMOFLIPID (LIPID INJECTABLE EMULSION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.3)
5/2023
Warnings and Precautions (5.1)
5/2023
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 when oral
or enteral nutrition is not possible,
insufficient, or contraindicated. (1)
DOSAGE AND ADMINISTRATION
For intravenous infusion into a central or peripheral vein. (2.1)
SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy
admixture programs for the
preparation of three-in-one or total nutrition admixtures. (2.2)
Protect the admixed PN solution from light. (2.2)
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.
(2.3)
For information on the age-appropriate infusion rate, see the full
prescribing information (2.3, 5.1)
AGE
NUTRITIONAL REQUIREMENTS
Initial Recommended Dosage
Maximum Dosage
Birth to 2 years of age (including preterm and
term neonates)
0.5 to 1 g/kg/day
3 g/kg/day
Pediatric patients 2 to <12 years of age
1 to 2 g/kg/day
3 g/kg/day
Pediatric patients 12 to 17 years of age
1 g/kg/day
2.5 g/kg/day
Adults
1 to 2 g/kg/day
2.5 g/kg/day
DOSAGE FORMS AND STRENGTHS
SMOFlipid is a sterile, homogenous lipid injectable emulsion supplied
as 20 g of lipid/100 mL in 100 mL
single-dose Flexible Container, 50 g of lipid/250 mL in 250 mL
single-dose Flexible Container, 100 g of
lipid/500 mL in 500 mL single-dose Flexible Container, and 200 g of
lipid/1000 mL in 1000 mL Pharmacy
Bulk Package. (3)
CONTRAINDICATIONS
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