Nutrilipid I.v. Fat Emulsion

Nutrilipid I.v. Fat Emulsion Manufacturers

• B. Braun Medical Inc.
  

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  Nutrilipid I.v. Fat Emulsion | B. Braun Medical Inc.

  

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  2.1 Administration Instructions Nutrilipid® 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Nutrilipid® 20% is for intravenous infusion only 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. 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. 2.2 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). 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).

   

  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.

  Use of Admixtures in Nutrilipid® Infusion Bags for Direct Infusion

  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. Compatible supplemental medication (e.g., fat-soluble vitamins) may be added with a 19 to 22 gauge needle through the medication port. Additions to the bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to B. Braun Medical Inc., Medical Affairs. 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. 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 addition of additives and the emulsion has not separated during the addition of additives.

  Discard the admixture if precipitates or discoloration are observed.

  Step 1:  Prepare the medication port by removal of aluminum foil (Figure 5a).

  Step 2:  Puncture the resealable medication port by using a 19 to 22 gauge needle and inject additive(s) (Figure 5b).

   

  Step 3:  Mix thoroughly when additives have been introduced (Figure 6).

   

  Step 4:  The medication port may be swabbed with disinfection agent (e.g., iso-propanol or chlorhexidine) before re-puncturing.

  Step 5:  Inspect emulsion bag visually for particulates or separation of the emulsion. Discard the bag if any particulates or discoloration are observed.

  Do not store solutions containing additives.

  2.3 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: Transfer Dextrose Injection to the Total Parental Nutrition Pooling Bag Transfer Amino Acid Injection Transfer Nutrilipid® 20%

  Use gentle agitation during admixing to minimize localized concentration effects; shake bags gently after each addition.

  Alternatively, simultaneous transfer to the pooling bag of Amino Acid Injection, Dextrose Injection and Nutrilipid® 20% is also permitted. 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.

  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 (2-8°C) 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. 2.4 Dosing Considerations

  The dosing of Nutrilipid® 20% depends on the patient’s individual energy requirements, influenced by body weight, tolerance, clinical status, age-related growth rate in pediatric patients, and the ability to eliminate and metabolize fat.

  For partial parenteral nutrition, energy supplied by oral or enteral nutrition has to be taken into account. For complete parenteral nutrition, concomitant supplementation with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is necessary.

  Prior to administration of Nutrilipid® 20%, correct severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders. Before starting the infusion, obtain serum triglyceride levels to establish the baseline value.

  Recommended Adult and Pediatric Dosing

  The recommended nutritional requirements of fat and recommended dosages of Nutrilipid® 20% to be administered to meet those requirements for adults and pediatric patients are provided in Table 1, along with recommendations for the initial and maximum infusion rates.  The recommended duration of infusion for Nutrilipid® 20% is between 12 and 24 hours, depending on the clinical situation. Adjust the administration flow rate by taking into account the dose being administered, the daily volume/intake, and the duration of the infusion [see Overdosage (10)].

  Treatment with parenteral nutrition may be continued for as long as is required by the patient’s condition.

  In patients with elevated triglyceride levels, initiate Nutrilipid® 20% at a lower dosage, and advance in smaller increments, monitoring the triglyceride levels with each adjustment [see Warnings and Precautions (5.6) and (5.10)].

  When Nutrilipid® 20% is administered to correct essential fatty acid deficiency, 8% to 10% of the caloric input should be supplied by Nutrilipid® 20% in order to provide adequate amounts of linoleic and linolenic acids.

  Table 1:  Adult and Pediatric Nutritional Requirements1,2 as Provided by Nutrilipid® 20% and Infusion Rate for Direct Infusion Only

  *

  Nutrilipid® 20% Pharmacy Bulk Package is not intended for direct intravenous administration.

  †

  Daily dose should also not exceed a maximum of 60% of total energy requirements [see Overdosage (10)].

   Age  Nutritional Requirements  Direct Infusion Rate*   Recommended Initial Dosage and Maximum Dosage  Initial Maximum 

  Preterm and term infants (less than 1 year of age)

  [see Warnings and Precautions (5.1)]

  Initial 1 to 2 g/kg/day

  not to exceed 3 g/kg/day† 

   0.05 mL/min for the first 10 to 15 minutes; gradually increase to the required rate after 15 minutes  0.75 mL/kg/hour Pediatric patients 1 to 10 years of age

  Initial 1 to 2 g/kg/day

  not to exceed 3 g/kg/day† 

   0.75 mL/kg/hour Pediatric patients 11 to <17 years of age

  Initial 1 g/kg/day

  not to exceed 2.5 g/kg/day† 

   0.5 mL/kg/hour Adults

  1 to 1.5 g/kg/day

  not to exceed 2.5 g/kg/day† 

   0.5 mL/min for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes  0.5 mL/kg/hour

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