nspect Omegaven for particulate matter and discoloration. Discard the bottle if any particulates or discoloration are observed.
Gently invert the bottle before use. Use Omegaven only if the emulsion is homogeneous and the container is undamaged.
Strict aseptic techniques must be followed.
Hang the bottle using the attached hanger and start infusion.
After connecting the infusion set, start infusion of Omegaven immediately. Complete the infusion within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture.
For single use only. Discard unused portion.
2.2 Admixing Instructions
If Omegaven is administered as part of a PN admixture, follow the instructions below.
Prepare the admixture in PN containers using strict aseptic techniques to avoid microbial contamination.
Do not add Omegaven directly to the empty PN container; destabilization of the lipid emulsion may occur.
When Omegaven is administered with other infusion solutions (e.g., amino acids, dextrose), the compatibility of the solutions used must be ensured. Questions related to compatibility may be directed to Fresenius Kabi USA, LLC, at 1-800-551-7176.
The following proper mixing sequence must be followed to minimize pH-related problems by ensuring that typically acidic dextrose solutions are not mixed with lipid emulsions alone:
Transfer dextrose solution to the PN container.
Transfer amino acid solution to the PN container.
Transfer Omegaven to the PN container.
Simultaneous transfer of amino acid solution, dextrose solution, and Omegaven using an automated compounding device is also permitted; follow automated compounding device instructions as indicated.
Use gentle agitation during admixing to minimize localized concentration effects; shake container gently after each addition.
The prime destabilizers of emulsions are excessive acidity (such as a pH less than 5) and inappropriate electrolyte content. Care should be taken if adding divalent cations (e.g., Ca++ and Mg++), which have been shown to cause emulsion instability. Amino acid solutions exert buffering effects that can protect the emulsion from destabilization.
Inspect the admixture to ensure that precipitates have not formed during preparation of the admixture 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 admixture. Discard the admixture if any of these are observed.
The remaining contents of a partly used PN container must be discarded.
Start infusion of admixtures containing Omegaven immediately. If not used immediately, admixtures may be stored for up to 6 hours at room temperature or up to 24 hours under refrigeration. Complete the infusion within 24 hours after removal from storage.
Follow the instructions of each product included in the admixture.
2.3 Dosing Information
Dosing Considerations
Prior to administration of Omegaven, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level.
Initiate Omegaven dosing as soon as direct or conjugated bilirubin (DBil) levels are 2 mg/dL or greater in pediatric patients who are expected to be PN-dependent for at least 2 weeks.
The dosing of Omegaven depends on each patient's energy requirements, which may be influenced by age, body weight, tolerance, clinical status, and ability to metabolize and eliminate lipids.
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