Food - Plant Source, Soybean Glycine soja .1 g/mL
Soybean Glycine soja · INJECTION, SOLUTION · Jubilant HollisterStier LLC
Food - Plant Source, Soybean Glycine soja is a prescription injection, solution containing soybean glycine soja at .1 g/mL, taken percutaneous. Manufactured by Jubilant HollisterStier LLC.
Key Facts
- Brand Name
- Food - Plant Source, Soybean Glycine soja
- Generic Name
- Soybean Glycine soja
- NDC Code (Product)
65044-3596- Manufacturer
- Jubilant HollisterStier LLC
- Strength
- .1 g/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS, SUBCUTANEOUS
- Marketing Status
- NON-STANDARDIZED ALLERGENIC
- Application #
- BLA103888
- Drug Class
- Allergens [CS]; Cell-mediated Immunity [PE]
- Marketing Start
- 04/19/1941
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 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. 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 & Administration
2 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 2.1 Administration Instructions Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Nutrilipid 20% is for intravenous infusion through a peripheral or central line. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Do not exceed the recommended maximum infusion rate in Table 1 [see Dosage and Adminis…
Contraindications
4 CONTRAINDICATIONS 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) ]. 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, 5.7 )
Drug Interactions
7 DRUG INTERACTIONS Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters (7.1) 7.1 Coumarin and Coumarin Derivatives The soybean oil in Nutrilipid 20% contains vitamin K1. Vitamin K can reverse the anticoagulant activity of coumarin and coumarin derivatives, including warfarin, which work by blocking recycling of vitamin K. Monitor laboratory parameters for anticoagulant activity in patients who are on both Nutrilipid 20% and coumarin or coumarin derivatives.
Adverse Reactions
6 ADVERSE REACTIONS Adverse Reactions described elsewhere in labeling: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions (5.1) ] Risk of Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Fat Overload Syndrome [see Warnings and Precautions (5.5) ] Refeeding Syndrome [see Warnings and Precautions (5.6)] Hypertriglyceridemia [see Warnings and Precautions (5.7) ] Aluminum Toxicity [see Warnings and Precautions (5.8) ] Adverse reactions include administration site reactions (e.g., erythema, extravasation, pain, phlebitis, pruritus, swelling), hyperlipidemia, hypercoagulability, thrombophlebitis, thrombocytopenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the cli…
Frequently Asked Questions
What is Food - Plant Source, Soybean Glycine soja used for?
Food - Plant Source, Soybean Glycine soja contains Soybean Glycine soja. It is a injection, solution taken percutaneous. Consult your doctor for specific uses.
Is Food - Plant Source, Soybean Glycine soja a controlled substance?
Food - Plant Source, Soybean Glycine soja is not classified as a controlled substance by the DEA.
What is the generic name for Food - Plant Source, Soybean Glycine soja?
The generic name for Food - Plant Source, Soybean Glycine soja is Soybean Glycine soja. There are no other listed brand versions of Soybean Glycine soja.
What is the NDC code for Food - Plant Source, Soybean Glycine soja .1 g/mL?
The NDC (National Drug Code) for Food - Plant Source, Soybean Glycine soja .1 g/mL is 65044-3596, listed by Jubilant HollisterStier LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)