hloride (PVC) components that have DEHP (diethyl hexyl phthalate) as a plasticizer. Fat-containing fluids such as Intralipid® extract DEHP from these PVC components. Therefore it may be advisable to use a non-DEHP administration set for infusing admixtures which contain Intralipid®.
Do not use any bag in which there appears to be an oiling out on the surface of the emulsion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. whenever solution and container permit.
MIXING GUIDELINES AND LIMITATIONS
Investigations have been conducted which demonstrate the compatibility of Intralipid® 20% when properly mixed with either Novamine® (8.5%, 11.4% or 15%) or 8.5% Travasol® or 10% Travasol® Amino Acid Injections without Electrolytes for use in TPN therapy. Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition mixture.
Perform all manipulations in a suitable work area, such as a laminar flow hood.
Failure to follow the Mixing Guidelines and Limitations below, including recommended storage temperature, storage time. order of mixing, etc., may result in an unstable 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 TPN (Total Parenteral Nutrition) Admixture Container
Transfer Amino Acid Injection
Transfer Intralipid® 20%
Note: Amino Acid Injection, (Novamine® 8.5, 11.4 or 15% or 8.5 Travasol® 8.5 or 15% without electrolytes), Dextrose Injection and Intralipid® 20% may be simultaneously transferred to the admixture container using an automatic mixer. Admixing should be accompanied by gentle agitation to avoid localized concentration effects.
These 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.
It is essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth medium for microorganisms.
Additives other than those named above may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives (e.g., vitamins and minerals). Additives must not be added directly to Intralipid® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package and in no case should Intralipid® 20% be added to the TPN container first. Bags should be shaken gently after each addition to minimize localized concentration.
Supplemental electrolytes, trace metals or multivitamins may be required in accordance with the prescription of the attending physician.
The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to addition of divalent cations (Ca++ and Mg++) which have been shown to cause emulsion instability. Amino acid solutions exert a buffering effect protecting the emulsion.
The admixture should be |
