Soybean oil

Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction. ( 5.2, 8.4 ) Hypersensitivity reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur. Infections, Fat Overload Syndrome, and Refeeding Syndrome, Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters. ( 5.4 , 5.5 , 5.6, 5.7 ) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm neonates. ( 5.8, 8.4 ) 5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions.

Prolonged parenteral nutrition administration in patients with renal impairment may result in aluminum reaching toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions that contain aluminum. Patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration of total parenteral nutrition products. 5.9 Monitoring / Laboratory Tests Monitor fluid status closely in patients with pulmonary edema or heart failure. Throughout treatment, monitor serum triglycerides [see Warnings and Precautions ] , fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count (including platelets), and coagulation parameters.

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 Administration and Warnings and Precautions ]. Use a non-vented infusion set or close the air vent on a vented set. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Use a dedicated line without any connections.

Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Use a 1.2 micron in-line filter. Nutrilipid 20% can be infused concurrently into the same vein as carbohydrate-amino acid solutions by means of a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps.

Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Conventional administration sets contain polyvinyl chloride (PVC) components that have DEHP as a plasticizer.

Preparation Instructions for Nutrilipid 20% Bags for Direct Infusion Caution: Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Step 1: Inspect infusion bag overwrap and primary bag and do not use if damaged. Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink.

Use only if container and seals are intact. Step 2: To open, tear overwrap starting from the tear notches (Figure 1). Remove Nutrilipid 20% bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap. Step 3: Inspect Nutrilipid 20% bag visually (Figure 2). Nutrilipid 20% is a homogenous white and milky, sterile, nonpyrogenic lipid injectable emulsion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect Nutrilipid 20% to ensure that the emulsion has not separated. Discard the bag if any particulates or discoloration are observed. Step 4: Remove aluminum foil of outlet port at the bottom of the bag (Figure 3a) and attach administration set (Figure 3b).

Do not use/penetrate blocked port. Step 5: Hang bag on IV Pole (Figure 4). If infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump. Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates.

If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism. Overwrap Illustration Figure 1 Tear Overwrap Figure 2 Inspect Bag Blocked port illustration Figure 3a and 3b Peel Foil and Insert Spike Do not use blocked port illustration Figure 4 Hang Bag

Preparation Instructions for Admixing Using Total Parenteral Nutrition Pooling Bags Prepare the admixture into pooling bags using strict aseptic techniques to avoid microbial contamination. Do not add additives directly to Nutrilipid 20% Pharmacy Bulk Package. Some additives may be incompatible and should not be used. If it is deemed advisable to introduce additives, prepare the admixture using strict aseptic techniques to avoid microbial contamination.

Additions to the pooling bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to B. Braun Medical Inc., Medical Affairs. Do not add Nutrilipid 20% to the pooling bag first; destabilization of the lipid may occur from such an admixture. The following proper mixing sequence must be followed to minimize pH related problems by ensuring that typically acidic Dextrose Injections are not mixed with lipid emulsions alone: Manual Admixing Manually transfer Dextrose Injection to the Total Parental Nutrition Admixture Container Manually transfer Amino Acid Injection Manually transfer Nutrilipid 20% Use gentle agitation during admixing to minimize localized concentration effects; shake bags gently after each addition.

Automated Device Admixing When admixing parenteral nutrition using an automated device, the Nutrilipid 20% must be separated from the dextrose product by an amino acid product or other non-acidic products. The prime destabilizers of emulsions are excessive acidity (such as pH below 5) and inappropriate electrolyte content.

Give careful consideration to additions of divalent cations (Ca ++ and Mg ++ ), which have been shown to cause emulsion instability. Amino acid solutions exert buffering effects that protect the emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Inspect Nutrilipid 20% to ensure that: precipitates have not formed during the mixing or addition of additives and the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. Discard the admixture if any of the above are observed.

If using an Automated Device, follow the manufacturer instructions. 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.

Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism.

Protect the admixed parenteral nutrition solution from light.