Olimel N12E Caution For Usage

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 destabilise 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 N12E 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 N12E, through the same infusion line (e.g., via Y-connector) because of the risk of precipitation of ceftriaxone-calcium salt (see Precautions and Interactions).
Due to the risk of precipitation, OLIMEL N12E should not be administered through the same infusion line or admixed together with ampicillin or fosphenytoin.
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.
Special precautions for disposal and other handling: To open: Remove the protective overpouch.
Discard the oxygen absorber sachet.
Confirm the integrity of the bag and of the nonpermanent seals. Use only if the bag is not damaged; if the nonpermanent seals are intact (i.e., no mixture of the contents of the 3 compartments); if the amino acid 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 nonpermanent seals.
Manually roll the bag onto itself, starting at the top of the bag (hanger end). The nonpermanent 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 additions (including vitamins) may be made into the reconstituted mixture (after the nonpermanent 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 nonpermanent seals and before mixing the 3 compartments).
Additions must be performed by qualified personnel under aseptic conditions.
OLIMEL N12E formulation may be supplemented with electrolytes, inorganic/organic phosphate and with commercially available preparations of multi-vitamin products (such as Cernevit) and multi-trace element products (such as Nutryelt). The maximal total levels for additions listed in the table as follows were demonstrated by stability data and should not be considered dosage recommendations. The supplementation should be dictated by the patient's clinical needs and should not exceed nutritional guidelines. The electrolytes already present in the bag should be taken into account when reaching the maximal total level.
Compatibility may vary between products from different sources and health care professionals are advised to carry out appropriate checks when mixing OLIMEL N12E with other parenteral solutions. (See Tables 6 and 7.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

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.
Preparation steps for the administration of OLIMEL: 1. Tear from the top to open the overpouch.
2. Peel the front of the overpouch to reveal the OLIMEL bag. Discard the overpouch and oxygen absorber sachet.
3. Place the bag flat on a horizontal and clean surface with the handle facing in front of the patient.
4. Lift the hanger area to remove solution from the upper bag. Roll the upper part of the bag firmly until peal seals are fully open (approximately half way).
5. Mix by turning the bag upside-down at least 3 times.
6. Hang the bag. Twist off the protector from the administration outlet. Firmly plug the spike connector.
Administration: For single use only.
Only administer the product after the nonpermanent 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 contents 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.