Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A)
B. Braun Medical Inc.
SOYBEAN OIL
SOYBEAN OIL 20 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
New Drug Application
NUTRILIPID I.V. FAT EMULSION- SOYBEAN OIL INJECTION, SOLUTION B. BRAUN MEDICAL INC. ---------- 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 Perskaitykite visą dokumentą