Special precautions for disposal and other handling: To open: Remove the protective overpouch.
Discard the oxygen absorber / oxygen indicator sachet.
Confirm the integrity of the bag and of the non-permanent seals. Use only if the bag is not damaged, if the non-permanent seals are intact (i.e. no mixture of the contents of the 3 compartments), if the amino acids solution and the glucose solution are clear, colourless or slightly yellow, and practically free of visible particles, and if the lipid emulsion is a homogeneous liquid with a milky appearance.
Mixing the solutions and the emulsion: Ensure that the product is at room temperature when breaking the non-permanent seals.
Manually roll the bag onto itself, starting at the top of the bag (hanger end). The non-permanent seals will disappear from the side near the inlets. Continue to roll the bag until the seals are open along approximately half of their length.
Mix by inverting the bag at least 3 times.
After reconstitution, the mixture is a homogeneous emulsion with a milky appearance.
Additions: The capacity of the bag is sufficient to enable additions such as vitamins, electrolytes and trace elements.
Any addition (including vitamins) may be made into the reconstituted mixture (after the non-permanent seals have been opened and after the contents of the 3 compartments have been mixed).
Vitamins may also be added into the glucose compartment before the mixture is reconstituted (before opening the non-permanent seals and before mixing the 3 compartments).
When making additions to formulations containing electrolytes, the amount of electrolytes already present in the bag should be taken into account.
Additions must be performed by qualified personnel under aseptic conditions.
OLIMEL may be supplemented with electrolytes according to Table 10 as follows: See Table 10.
Click on icon to see table/diagram/image
PERIOLIMEL may be supplemented with electrolytes according to Table 11 as follows: See Table 11.
Click on icon to see table/diagram/image
Trace elements and vitamins: Stability has been demonstrated with commercially-available preparations of vitamins and trace elements (containing up to 1 mg of iron).
Compatibility for other additives is available upon request.
When making additions, the final osmolarity of the mixture must be measured before administration via a peripheral vein.
To perform an addition: Aseptic conditions must be observed.
Prepare the injection site of the bag.
Puncture the injection site and inject the additives using an injection needle or a reconstitution device.
Mix content of the bag and the additives.
Preparation of the infusion: Aseptic conditions must be observed.
Suspend the bag.
Remove the plastic protector from the administration outlet.
Firmly insert the spike of the infusion set into the administration outlet.
Administration: For single use only.
Only administer the product after the non-permanent seals between the 3 compartments have been broken and the contents of the 3 compartments have been mixed.
Ensure that the final emulsion for infusion does not show any evidence of phase separation.
After opening the bag the content must be used immediately. The opened bag must never be stored for a subsequent infusion. Do not reconnect any partially used bag.
Do not connect bags in series in order to avoid the possibility of air embolism due to gas contained in the primary bag.
Any unused product or waste material and all necessary devices must be discarded.
Incompatibilities: Do not add other medicinal products or substances to any components of the bag or to the reconstituted emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular the stability of the lipid emulsion).
Incompatibilities may be produced for example by excessive acidity (low pH) or inappropriate content of divalent cations (Ca2+ and Mg2+), which may destabilize the lipid emulsion.
As with any parenteral nutrition admixture, calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates.
OLIMEL/PERIOLIMEL contains calcium ions which pose additional risk of coagulation precipitated in citrate anticoagulated/preserved blood or components.
Ceftriaxone must not be mixed or administered simultaneously with intravenous calcium-containing solutions, including OLIMEL/PERIOLIMEL, through the same infusion line (e.g., via Y-connector) because of the risk of precipitation of ceftriaxone-calcium salt (see Precautions and Interactions).
Check compatibility with solutions administered simultaneously through the same administration set, catheter or cannula.
Do not administer before, simultaneously with or after blood through the same equipment because of the risk of pseudoagglutination.