NUTRILIPID I.V. FAT EMULSION- soybean oil injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A)

Available from:

B. Braun Medical Inc.

INN (International Name):

SOYBEAN OIL

Composition:

SOYBEAN OIL 20 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.  Nutrilipid 20% injection is contraindicated in patients who have: - Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Nutrilipid 20% [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)]. There are no adequate or well controlled studies with Nutrilipid 20% in pregnant women. Additionally, animal reproduction studies have not been conducted with Nutrilipid 20%. It is not known whether Nutrilipid 20% can cause fetal harm when administered to a pregnant woman. Nutrilipid 20% should be given to a pregnant woman only if clearly needed. It is not known whether Nutrilipid 20% is present in hu

Product summary:

Nutrilipid 20% is supplied as a homogenous white and milky, sterile, nonpyrogenic, lipid injectable emulsion in the following strengths: NDC Number  Do not freeze. If accidentally frozen, discard the container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Use of the Pharmacy Bulk Package for admixing should be limited to up to four hours after opening. Admixtures should be used promptly with storage under refrigeration [2°C to 8°C (36°F to 46°F)] not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.

Authorization status:

New Drug Application

Summary of Product characteristics

NUTRILIPID I.V. FAT EMULSION- SOYBEAN OIL INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUTRILIPID 20% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NUTRILIPID 20%.
NUTRILIPID 20% (LIPID INJECTABLE EMULSION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1975
RECENT MAJOR CHANGES
Boxed Warning (Removed) 5/2023
Dosage and Administration (2.1) 5/2023
Warnings and Precautions (5.1, 5.2) 5/2023
INDICATIONS AND USAGE
Nutrilipid 20% is indicated as a source of calories and essential
fatty acids for parenteral nutrition and as a
source of essential fatty acids when a deficiency occurs when oral or
enteral nutrition is not possible,
insufficient, or contraindicated. (1)
DOSAGE AND ADMINISTRATION
Nutrilipid 20% Pharmacy Bulk Package is not intended for direct
intravenous administration. (2.1)
For intravenous infusion through a peripheral or central line (2.1)
Recommended dosage depends on age, energy expenditure, clinical
status, body weight, tolerance,
ability to metabolize and consideration of additional energy given to
the patient. (2.4)
For information on the age-appropriate infusion rate, see the full
prescribing information. (2.4, 5.1)
AGE
NUTRITIONAL REQUIREMENTS
Initial Recommended Dosage Maximum Dosage
Preterm and term infants (<1 year)
1 to 2 g/kg/day
3 g/kg/day
Pediatric patients 1 to 10 years
Pediatric patients 11 to <17 years
1 g/kg/day
2.5 g/kg/day
Adults
1 to 1.5 g/kg/day
2.5 g/kg/day
DOSAGE FORMS AND STRENGTHS
Injectable emulsion:
20% (50 g/250 mL)(0.2 g/mL) of lipid in 250 mL single-dose flexible
bag (3)
20% (100 g/500 mL)(0.2 g/mL) of lipid in 500 mL single-dose flexible
bag (3)
20% (200 g/1,000 mL)(0.2 g/mL) of lipid in 1,000 mL Pharmacy Bulk
Package (3)
CONTRAINDICATIONS
Known hypersensitivity to egg, soybean, peanut, or any of the active
or inactive ingredients. (4)
Severe disorders of lipid metabolism characterized by
hypertriglyceridemia (serum triglycerides >1,000
mg/dL). (4, 5